Ya 20131219 03

ĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ć
(Guideline for Leaflet Development)

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ć
đøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ć
úÜüĆîìĊęǰ3 ÖøÖãćÙö 2556
ÿćøïĆâ
Āîšć
ïììĊę 1 ĒîüìćÜìĆęüĕðĔîÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ć
1. ïìîĞćǰ(Introduction) 1
2. ĀúĆÖÖãĀöć÷ (Legal basis) 1-2
3. ×Ăïđ×ê 2
4. îĉ÷ćöýĆóìŤ 2-3
5. ĀúĆÖÖćøÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ć 3-4
6. ×šĂÖĞćĀîéĔîÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ć 4-5
ïììĊę 2 ĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïïčÙúćÖøìćÜÖćøĒóì÷Ť 6-30
Ö. ×šĂÖĞćĀîéìĆęüĕðÿĞćĀøĆïÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïïčÙúćÖøìćÜÖćøĒóì÷Ť 6
1. õćþćĒúąýĆóìŤìĊęĔßš 6
2. úĆÖþèą×ĂÜđĂÖÿćøÖĞćÖĆï÷ć 6
2.1 đĂÖÿćøÖĞćÖĆï÷ćìĊęĒîïĕðÖĆïñúĉêõĆèæŤ 6
2.2 ×šĂöĎúđĂÖÿćøÖĞćÖĆï÷ćđóČęĂĔßšÿĞćĀøĆïÖćøìüîÿĂïēé÷ñĎšðøąđöĉî/đÝšćĀîšćìĊę 6-7
3. ÙčèúĆÖþèąìĆęüĕð×ĂÜđîČĚĂĀć 7
4. đĂÖÿćøĂšćÜĂĉÜĀúĆÖ 7-8
5. ×šĂÖĞćĀîéĔîÖćøĒÿéÜðøĉöćè÷ćĒúąĀîŠü÷×ĂÜÙüćöĒøÜ 8
6. ×šĂÖĞćĀîéĀĆü×šĂ×ĂÜđĂÖÿćøÖĞćÖĆï÷ćõćþćĕì÷ÿĞćĀøĆïïčÙúćÖøìćÜÖćøĒóì÷Ť 8-10
×. øć÷úąđĂĊ÷éĒúą×šĂÖĞćĀîéÿĞćĀøĆïĒêŠúąĀĆü×šĂ×ĂÜđĂÖÿćøÖĞćÖĆï÷ć 10
ÿĞćĀøĆïïčÙúćÖøìćÜÖćøĒóì÷Ť
1. đĂÖÿćøÖĞćÖĆï÷ćĒïïǰSummary of Product Characteristics (SPC) 10
ĀĆü×šĂìĊęǰ1 ßČęĂñúĉêõĆèæŤǰ(Name of the Medicinal Product) 10-11
ĀĆü×šĂìĊęǰ2 ÿŠüîðøąÖĂïĒúąðøĉöćèêĆü÷ćÿĞćÙĆâ (Qualitative and quantitative composition) 11-14
ĀĆü×šĂìĊęǰ3 úĆÖþèąĒúąøĎðĒïï÷ćìćÜđõÿĆßÖøøö (Pharmaceutical Form) 14
ĀĆü×šĂìĊęǰ4 ÙčèÿöïĆêĉìćÜÙúĉîĉÖ (Clinical Particulars) 15
4.1 ×šĂïŠÜĔßš (Therapeutic indication) 15-17
4.2 ×îćé÷ćĒúąüĉíĊÖćøïøĉĀćø÷ć (Posology and method of administration) 17-18
4.3 ×šĂĀšćöĔßš (Contraindication) 19
4.4 ÙĞćđêČĂîóĉđýþ Ēúą×šĂÙüøøąüĆÜĔîÖćøĔßš÷ć (Special warning 19-20
and precautions for use)
4.5 ĂĆîêøÖĉøĉ÷ćÖĆï÷ćĂČęîėĀøČĂĂĆîêøÖĉøĉ÷ćĂČęîė (Interactions with other 20
medicinal products and other forms of interactions)
ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

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4.6 ÖćøĔßšĔîÿêøĊöĊÙøøõŤĒúąÿêøĊøąĀüŠćÜĔĀšîöïčêø (Pregnancy and lactation) 20-23
4.7 ñúêŠĂÙüćöÿćöćøëĔîÖćø×Ćï×ĊęĒúąìĞćÜćîÖĆïđÙøČęĂÜÝĆÖø (Effects on ability 23
to drive and use machine)
4.8 ĂćÖćøĕöŠóċÜðøąÿÜÙŤ (Undesirable effects) 23-25
4.9 ÖćøĕéšøĆï÷ćđÖĉî×îćé (Overdose) 25
ĀĆü×šĂìĊęǰ5 ÙčèÿöïĆêĉìćÜđõÿĆßüĉì÷ć (Pharmacological Properties) 25
5.1 ÙčèÿöïĆêĉìćÜđõÿĆßóúýćÿêøŤ (Pharmacodynamic properties) 25
5.2 ÙčèÿöïĆêĉìćÜđõÿĆßÝúîýćÿêøŤ (Pharmacokinetic properties) 26
5.3 ×šĂöĎúÙüćöðúĂéõĆ÷ÝćÖÖćøýċÖþćóøĊÙúĉîĉÖ (Preclinical safety data) 27
ĀĆü×šĂìĊęǰ6 øć÷úąđĂĊ÷éìćÜđõÿĆßÖøøö (Pharmaceutical Particulars) 27
6.1 øć÷ÖćøêĆü÷ćĕöŠÿĞćÙĆâ (List of excipients) 27
6.2 ÙüćöĕöŠđ×šćÖĆî×ĂÜ÷ć (Incompatibilities) 27
6.3 Ăć÷č×ĂÜ÷ć (Shelf life) 27
6.4 ×šĂÙüøøąüĆÜóĉđýþĔîÖćøđÖĘï÷ć (Special precautions for storage) 27
6.5 úĆÖþèąĒúąÿŠüîðøąÖĂï×ĂÜõćßîąïøøÝč (Nature and contents of container) 28
ĀĆü×šĂìĊęǰ7 ßČęĂñĎšøĆïĂîčâćêñúĉêĀøČĂîĞćĀøČĂÿĆęÜ÷ćĒñîðŦÝÝčïĆîđ×šćöćĔîøćßĂćèćÝĆÖø 28
(Marketing Authorization Holder)
ĀĆü×šĂìĊęǰ8 đú×ìąđïĊ÷îêĞćøĆï÷ć (Marketing Authorization Numbers) 28
ĀĆü×šĂìĊęǰ9 üĆîìĊęĕéšøĆïĂîčöĆêĉìąđïĊ÷îêĞćøĆï÷ć (Date of authorization) 28
ĀĆü×šĂìĊęǰ10 üĆîìĊęöĊÖćøĒÖšĕ×ðøĆïðøčÜđĂÖÿćø (Date of revision of the text) 28
2. đĂÖÿćøÖĞćÖĆï÷ćĒïïǰPackage Insert 28
ĀĆü×šĂìĊęǰ1 ßČęĂñúĉêõĆèæŤǰ(Product Name) 28
ĀĆü×šĂìĊęǰ2 ßČęĂĒúąÙüćöĒøÜ×ĂÜêĆü÷ćÿĞćÙĆâ (Name and Strength of Active Ingredient (s)) 28
ĀĆü×šĂìĊęǰ3 úĆÖþèą×ĂÜñúĉêõĆèæŤ (Product Description) 28
ĀĆü×šĂìĊęǰ4 đõÿĆßóúýćÿêøŤĒúąđõÿĆßÝúîýćÿêøŤǰ(Pharmacodynamics/Pharmacokinetics) 29
4.1 đõÿĆßóúýćÿêøŤ (Pharmacodynamics) 29
4.2 đõÿĆßÝúîýćÿêøŤ (Pharmacokinetics) 29
ĀĆü×šĂìĊęǰ5 ×šĂïŠÜĔßš (Indication) 29
ĀĆü×šĂìĊęǰ6 ×îćé÷ćìĊęĒîąîĞćǰ(Recommended Dose) 29
ĀĆü×šĂìĊęǰ7 üĉíĊÖćøĔßš÷ć (Mode of Administration) 29
ĀĆü×šĂìĊęǰ8 ×šĂĀšćöĔßš (Contraindication) 29
ĀĆü×šĂìĊęǰ9 ÙĞćđêČĂîĒúą×šĂÙüøøąüĆÜ (Warning and Precautions) 29
ĀĆü×šĂìĊęǰ10 ĂĆîêøÖĉøĉ÷ćÖĆï÷ćĂČęîėǰ(Interactions with Other Medicaments) 29
ĀĆü×šĂìĊęǰ11 ÿêøĊöĊÙøøõŤĒúąÿêøĊøąĀüŠćÜĔĀšîöïčêø (Pregnancy and Lactation) 29
ĀĆü×šĂìĊęǰ12 ĂćÖćøĕöŠóċÜðøąÿÜÙŤ (Undesirable Effects) 30
ĀĆü×šĂìĊęǰ13 ÖćøĕéšøĆï÷ćđÖĉî×îćéĒúąüĉíĊÖćøøĆÖþć (Overdose and Treatment) 30
ĀĆü×šĂìĊęǰ14 ÿõćüąÖćøđÖĘïøĆÖþć (Storage Condition) 30
ĀĆü×šĂìĊęǰ15 øĎðĒïï÷ćĒúą×îćéïøøÝčìĊęöĊÝĞćĀîŠć÷ (Dosage Forms and Packaging Available) 30

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ĀĆü×šĂìĊęǰ16 ßČęĂĒúąìĊęĂ÷ĎŠ×ĂÜñĎšñúĉêĀøČĂîĞćĀøČĂÿĆęÜ÷ćĒñîðŦÝÝčïĆîđ×šćöćĔîøćßĂćèćÝĆÖø 30
(Name and Address of Manufacturer/Marketing Authorization Holder)
ĀĆü×šĂìĊęǰ17 üĆîìĊęöĊÖćøĒÖšĕ×ðøĆïðøčÜđĂÖÿćø (Date of Revision of Package Insert) 30
ïììĊę 3 ĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßî 31-45

Ö. ×šĂÖĞćĀîéìĆęüĕðĔîÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßî 31
1. õćþćĒúąýĆóìŤìĊęĔßš 31
2. úĆÖþèą×ĂÜđĂÖÿćø 31
2.1 đĂÖÿćøÖĞćÖĆï÷ćìĊęĒîïĕðÖĆïñúĉêõĆèæŤ 31-32
2.2 ×šĂöĎúđĂÖÿćøÖĞćÖĆï÷ćđóČęĂĔßšÿĞćĀøĆïÖćøìüîÿĂïēé÷ñĎšðøąđöĉî/đÝšćĀîšćìĊę 32
3. ÙčèúĆÖþèąìĆęüĕð×ĂÜđîČĚĂĀć 32-33
4. đĂÖÿćøĂšćÜĂĉÜĀúĆÖ 33-34
5. ×šĂÖĞćĀîéĀĆü×šĂ×ĂÜđĂÖÿćøÖĞćÖĆï÷ćõćþćĕì÷ÿĞćĀøĆïðøąßćßî 34-35
6. ÙüøđÖĘï÷ćîĊĚĂ÷ŠćÜĕø 35-36
×. øć÷úąđĂĊ÷éĔîÖćøÝĆéìĞćǰ“×šĂöĎúđĂÖÿćøÖĞćÖĆï÷ćđóČęĂĔßšÿĞćĀøĆïÖćøìüîÿĂï 36
ēé÷ñĎšðøąđöĉî/đÝšćĀîšćìĊę”
I.ÿŠüîêšî×ĂÜđĂÖÿćø: ßČęĂ÷ćǰÙüćöĒøÜǰøĎðĒïï÷ćǰĒúąßČęĂÖćøÙšć 36-38
1. ÷ćîĊĚÙČĂ÷ćĂąĕø 38
1.1 ÷ćîĊĚöĊßČęĂÿćöĆâüŠćĂąĕøǰǰǰǰǰ 38
1.2 ÷ćîĊĚĔßšđóČęĂĂąĕø 38
1.3 ĔĀšøąïč×šĂöĎúÿĞćÙĆâĂČęîėǰ(êćöÙüćöÝĞćđðŨî) 38-39
2. ×šĂÙüøøĎšÖŠĂîĔßš÷ć 39
2.1 ĀšćöĔßš÷ćîĊĚđöČęĂĕø 39
2.2 ×šĂÙüøøąüĆÜđöČęĂĔßš÷ćîĊĚ 39-40
3. üĉíĊĔßš÷ć 40
3.1 ×îćéĒúąüĉíĊĔßš 40-41
3.2 ĀćÖúČöÖĉî÷ćÙüøìĞćĂ÷ŠćÜĕø 42
3.3 ëšćÖĉî÷ćîĊĚđÖĉî×îćéìĊęĒîąîĞćǰÙüøìĞćĂ÷ŠćÜĕø 42
4. ×šĂÙüøðäĉïĆêĉøąĀüŠćÜĔßš÷ć 42-43
5. ĂĆîêøć÷ìĊęĂćÝđÖĉéÝćÖ÷ć 43
5.1 ĂćÖćøìĊęêšĂÜĀ÷čé÷ćĒúšüøĊïĕðóïĒóì÷ŤìĆîìĊ 43
5.2 ĂćÖćøìĊęĕöŠÝĞćđðŨîêšĂÜĀ÷čé÷ć ĒêŠëšćöĊĂćÖćøøčîĒøÜĔĀšĕðóïĒóì÷ŤìĆîìĊ 43-44
6. ÙüøđÖĘï÷ćîĊĚĂ÷ŠćÜĕø 44
II. ×šĂÙüćöøŠüöìšć÷đĂÖÿćøǰ(disclaimer) 44
III. ñĎšñúĉê/ñĎšîĞćđ×šć/ñĎšĒìîÝĞćĀîŠć÷ 45
IV.đĂÖÿćøîĊĚðøĆïðøčÜÙøĆĚÜÿčéìšć÷đöČęĂ 45

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õćÙñîüÖǰ1 Ùüćöøšć÷ĒøÜ×ĂÜĂćÖćøĕöŠóċÜðøąÿÜÙŤÝćÖćøĔßš÷ć 46
õćÙñîüÖǰ2 êĆüĂ÷ŠćÜđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßî 47-48
õćÙñîüÖǰ3 êĆüĂ÷ŠćÜēÙøÜøŠćÜđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßî 49-50
õćÙñîüÖǰ4 ĒîüìćÜÖćøìéÿĂïđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîǰ 51-56

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ïììĊęǰ1
ĒîüìćÜìĆęüĕðĔîÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ć
(General Guideline for Development of Leaflet)
1. ïìîĞćǰ(Introduction)
đĂÖÿćøÖĞćÖĆï÷ćđðŨîđĂÖÿćøĀúĆÖìĊęöĊÙüćöÿĞćÙĆâĔîÖøąïüîÖćøÙüïÙčö÷ćǰöĊüĆêëčðøąÿÜÙŤđóČęĂĔĀšñĎšÿĆęÜĔßš÷ćǰ
ñĎšðśü÷ĒúąðøąßćßîǰöĊ×šĂöĎúìĊęëĎÖêšĂÜǰđßČęĂëČĂĕéšǰđðŨîÖúćÜǰĂŠćîĂĂÖđ×šćĔÝĕéšǰĒúąöĊ×šĂöĎúÙøïëšüîđóČęĂĔĀšÖćøĔßš÷ć
đðŨîĕðĂ÷ŠćÜÿöđĀêčñú
đĂÖÿćøÖĞćÖĆï÷ćĔßšđðŨîÖøĂïĔîÖćøÿČęĂÿćø×šĂöĎú×ĂÜñúĉêõĆèæŤ÷ćøąĀüŠćÜñĎšðøąÖĂïÖćøĒúąïčÙúćÖø
ìćÜÖćøĒóì÷ŤǰÖćøÙüïÙčöÖćøēÛþèćĒúąÖćøÿŠÜđÿøĉöÖćø×ć÷÷ć×ĂÜñĎšðøąÖĂïÖćøǰĒúąĔßšđðŨîÖøĂïĔîÖćøĔßš
ñúĉêõĆèæŤ÷ćîĆĚîėǰ×ĂÜïčÙúćÖøìćÜÖćøĒóì÷ŤǰǰéĆÜîĆĚîǰÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćÝĆÖđñ÷ĒóøŠđĂÖÿćø
ÖĞćÖĆï÷ćìĊęĕéšøĆïĂîčöĆêĉÿĎŠÿćíćøèąǰđßŠîǰìćÜÿČęĂĂĉîđìĂøŤđîĘê đóČęĂĔĀšÿćöćøëđ×šćëċÜ×šĂöĎú×ĂÜñúĉêõĆèæŤ÷ćĔîüÜÖüšćÜ
ĕéšĂ÷ŠćÜìĆęüëċÜǰÿąéüÖǰĒúąøüéđøĘü
éĆÜîĆĚîǰÝċÜÝĞćđðŨîêšĂÜöĊÖćøÖĞćĀîéĒîüìćÜìĆęüĕðĔîÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰđóČęĂĔĀšöĊ×šĂöĎú÷ćìĊęëĎÖêšĂÜǰ
đßČęĂëČĂĕéšǰĒúąđðŨîÖúćÜǰàċęÜÝĞćđðŨîĔîÖćøĔßš÷ćĂ÷ŠćÜÿöđĀêčñúǰúéÙüćöđÿĊę÷ÜĀøČĂđóĉęöðøąē÷ßîŤÝćÖÖćøĔßš÷ćǰđóČęĂĔĀš
ðøąē÷ßîŤìĊęĕéšøĆïđĀîČĂÙüćöđÿĊę÷Ü×ĂÜ÷ćǰîĂÖÝćÖîĆĚîǰ÷ĆÜĔßšđðŨîĒîüìćÜĔîÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćöćêøåćîǰ
đóČęĂĔĀšñĎšðøąÖĂïÖćøÿćöćøëîĞćĕðĔßšĔîÖćø×ċĚîìąđïĊ÷îêĞćøĆï÷ćēé÷đÞóćą÷ćÿćöĆâĕéšĂ÷ŠćÜÿąéüÖǰøüéđøĘü
2. ĀúĆÖÖãĀöć÷ (Legal basis)

2.1 óøąøćßïĆââĆêĉ÷ćǰó.ý.2510 ĒúąÞïĆïĒÖšĕ×đóĉęöđêĉö
öćêøćǰ4 ïĆââĆêĉÙüćöĀöć÷×ĂÜǰ“đĂÖÿćøÖĞćÖĆï÷ć” éĆÜîĊĚ “ÖøąéćþĀøČĂüĆêëčĂČęîĔéìĊęìĞćĔĀšðøćÖä
ÙüćöĀöć÷éšü÷øĎð øĂ÷ðøąéĉþåŤ đÙøČęĂÜĀöć÷ĀøČĂ×šĂÙüćöĔé ė đÖĊę÷üÖĆï÷ćìĊęÿĂéĒìøÖĀøČĂøüöĕüšÖĆïõćßîąĀøČĂ
ĀĊïĀŠĂïøøÝč÷ć”
ĀîšćìĊę×ĂÜñĎšøĆïĂîčâćê÷ćĒñîðŦÝÝčïĆîđÖĊę÷üÖĆïÞúćÖĒúąđĂÖÿćøÖĞćÖĆï÷ćÖĞćĀîéĕüšĔîöćêøćǰ25 éĆÜîĊĚ
öćêøć 25 (4) ĔßšÞúćÖĒúąđĂÖÿćøÖĞćÖĆï÷ćêćöìĊęĕéš×ċĚîìąđïĊ÷îêĞćøĆï÷ćĕüš Ēúą×šĂÙüćöĔîÞúćÖĒúą
đĂÖÿćøÖĞćÖĆï÷ćêšĂÜĂŠćîĕéšßĆéđÝî đĂÖÿćøÖĞćÖĆï÷ćëšćđðŨîõćþćêŠćÜðøąđìýêšĂÜöĊÙĞćĒðúđðŨîõćþćĕì÷éšü÷
öćêøć 25 (5) ÝĆéĔĀšöĊÙĞćđêČĂîÖćøĔßš÷ćĕüšĔîÞúćÖĒúąìĊęđĂÖÿćøÖĞćÖĆï÷ć ÿĞćĀøĆï÷ćìĊęøĆåöîêøĊðøąÖćýêćö
öćêøć 76 (9) ĔîÖøèĊÞúćÖöĊđĂÖÿćøÖĞćÖĆï÷ćĂ÷ĎŠéšü÷ ÙĞćđêČĂîÖćøĔßš÷ćÝąĒÿéÜĕüšìĊęÿŠüîĔéÿŠüîĀîċęÜ×ĂÜÞúćÖĀøČĂ
đĂÖÿćøÖĞćÖĆï÷ćÖĘĕéš
2.2 ÖãÖøąìøüÜüŠćéšü÷Öćø×ċĚîìąđïĊ÷îêĞćøĆï÷ćǰó.ý. 2555 ĂĂÖêćöÙüćöĔîóøąøćßïĆââĆêĉ÷ćǰó.ý.
2510
ĕéš öĊ×šĂÖĞ ćĀîéđóĉę öđêĉ öđÖĊę ÷üÖĆ ïĒÿéÜ×š ĂÙüćöĀøČ ĂÿĆ âúĆ ÖþèŤ ï îÞúćÖĀøČ Ă đĂÖÿćøÖĞ ćÖĆ ï ÷ćǰÖćø÷Čę î
ĀúĆ ÖåćîĒÿéÜ×š ĂöĎ úÙč èõćóǰðøąÿĉ ìíĉ õćóǰĒúąÙüćöðúĂéõĆ ÷×ĂÜ÷ćĔîÖćø×Ă×ċĚ îìąđïĊ ÷îêĞ ćøĆ ï÷ćǰđóČę ĂĔĀš
ÿĂéÙúšĂÜÖĆï×šĂêÖúÜÙüćöøŠüööČĂéšćîÖćøÙšć×ĂÜðøąßćÙöđýøþåÖĉÝĂćđàĊ÷îđÖĊę÷üÖĆïÖćø×ċĚîìąđïĊ÷îêĞćøĆï÷ćǰ
ĒúąđöČęĂöĊÖćøĂĂÖÖãÖøąìøüÜĄǰÖĞćĀîéĔĀšêšĂÜöĊÖćøĒÿéÜĀúĆÖåćî×šĂöĎúÙčèõćóǰðøąÿĉìíĉõćóǰĒúą
ÙüćöðúĂéõĆ÷×ĂÜ÷ćêćöĀúĆÖđÖèæŤìĊęÖĞćĀîéĔĀöŠǰǰìąđïĊ÷îêĞćøĆï÷ćìĊę×ċĚîìąđïĊ÷îĕüšÖŠĂîÖĘÝąêšĂÜöĊÖćøĒÖšĕ×ĔĀš

1
ÿĂéÙúšĂÜÖĆïìąđïĊ÷îêĞćøĆï÷ćìĊęöĊÖćø×ċĚîìąđïĊ÷îĔĀöŠǰēé÷ÖćøĂĂÖÙĞćÿĆęÜĔĀšöĊÖćøĒÖšĕ×ìąđïĊ÷îêĞćøĆï÷ćêćööćêøćǰ
86 ìüĉ
öćêøÖćøĔîÖãÖøąìøüÜĄǰìĊęđÖĊę÷ü×šĂÜÿøčðìĊęÿĞćÙĆâĕéšéĆÜîĊĚ
“....×šĂǰ3 ñĎšøĆïĂîčâćêñúĉê÷ćĀøČĂñĎšøĆïĂîčâćêîĞćĀøČĂÿĆęÜ÷ćđ×šćöćĔîøćßĂćèćÝĆÖøñĎšĔéðøąÿÜÙŤÝą×ċĚî
ìąđïĊ÷îêĞćøĆï÷ć ĔĀš÷ČęîÙĞć×Ă×ċĚîìąđïĊ÷îêĞćøĆï÷ćêŠĂóîĆÖÜćîđÝšćĀîšćìĊęóøšĂöéšü÷đĂÖÿćøĀøČĂĀúĆÖåćîêćöìĊęøąïč
ĕüšĔîĒïïÙĞć×ĂĒúąêćöìĊęÖĞćĀîéĕüšǰéĆÜêŠĂĕðîĊĚǰ… (2) ĀúĆÖåćîĒÿéÜ×šĂöĎúÙčèõćóǰðøąÿĉìíĉõćóǰĒúąÙüćö
ðúĂéõĆ÷×ĂÜ÷ćǰ(3) ÞúćÖĒúąđĂÖÿćøÖĞćÖĆï÷ćǰ....”
“×šĂǰ6 óîĆÖÜćîđÝšćĀîšćìĊęĂćÝÖĞćĀîéĔĀšñĎšøĆïĔïÿĞćÙĆâÖćø×ċĚîìąđïĊ÷îêĞćøĆï÷ćêćö×šĂ 5 ÖøąìĞćÖćøǰÜé
đüšîÖćøÖøąìĞćǰĀøČĂêšĂÜöĊõćøąĀîšćìĊęĀøČĂ÷ĂöøĆïõćøąĀîšćìĊęĀøČĂÙüćöøĆïñĉéßĂïïćÜðøąÖćøđìŠćìĊęÝĞćđðŨîđóČęĂ
ÖćøÙčšöÙøĂÜñĎšïøĉēõÙǰéĆÜêŠĂĕðîĊĚ
(1) ÖĞćĀîéßŠĂÜìćÜÖćøÝĞćĀîŠć÷
(2) øć÷ÜćîĂćÖćøĂĆîĕöŠóċÜðøąÿÜÙŤ
(3) ĒÿéÜ×šĂÙüćöĀøČĂÿĆâúĆÖþèŤïîÞúćÖĀøČĂđĂÖÿćøÖĞćÖĆï÷ć
(4) ÖĞćĀîéøĎðĒïï×ĂÜ÷ćĀøČĂ×îćéïøøÝč×ĂÜ÷ć
(5) ĒÿéÜÿĆâúĆÖþèŤÖĞćÖĆïĕüšïîđöĘé÷ćĀøČĂĒÙðàĎú”
“×šĂǰ9 ïøøéćÙĞć×ĂĒúąĔïÿĞćÙĆâÖćø×ċĚîìąđïĊ÷îêĞćøĆï÷ćêćöÖãÖøąìøüÜîĊĚĔĀšđðŨîĕðêćöĒïïìĊęøĆåöîêøĊ
ÖĞćĀîéēé÷ðøąÖćýĔîøćßÖĉÝÝćîčđïÖþć”
3. ×Ăïđ×ê
ĒîüìćÜîĊĚđðŨîĒîüìćÜìĆęüĕðĔîÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćìĊęĔßšÖĆï÷ćĒñîðŦÝÝčïĆîÿĞćĀøĆïöîčþ÷ŤĒúą÷ćÝćÖ
ÿöčîĕóøĒñîðŦÝÝčïĆîÿĞćĀøĆïöîčþ÷Ť
4. îĉ÷ćöýĆóìŤ
4.1 ÷ćĔĀöŠ (New Drugs) Āöć÷ëċÜǰ
1) êĞćøĆï÷ćìĊęöĊêĆü÷ćÿĞćÙĆâđðŨîêĆü÷ćĔĀöŠ (New Chemical Entities) ĀøČĂĂîčóĆîíŤĔĀöŠ øüöëċÜ
ÿćøðøąÖĂïđßĉÜàšĂî đĂÿđìĂøŤ ĀøČĂđÖúČĂĔĀöŠ ìĊęĕöŠđÙ÷öĊÖćø×ċĚîìąđïĊ÷îĔîðøąđìýĕì÷öćÖŠĂî
2) ÷ćìĊęöĊ×šĂïŠÜĔßšĔĀöŠ (New Indication)
3) êĞćøĆï÷ćìĊęđðŨîÿĎêøñÿöĔĀöŠ (New Combination) àċęÜĀöć÷ëċÜ êĞćøĆï÷ćñÿöìĊęðøąÖĂïéšü÷
êĆü÷ćĔĀöŠĒúą/ĀøČ Ă êĆü÷ćÿĞćÙĆâìĊę ×ċĚîìąđïĊ ÷îĕüšĒúš üêĆĚÜĒêŠ 2 ßîĉ éñÿöÖĆî ĒêŠĕöŠàĚĞćÖĆïêĞ ćøĆï ÷ćñÿöìĊę
×ċĚîìąđïĊ÷îĒúšü
4) ÷ćìĊęöĊøĎðĒïïĔĀöŠ×ĂÜÖćøĔĀš÷ć (New Delivery System) ēé÷đðŨîÖćøóĆçîćøąïïîĞćÿŠÜ÷ćĒïïĔĀöŠ
àċęÜìĞćĔĀš Bioavailability ×ĂÜ÷ćĒêÖêŠćÜĕðÝćÖđéĉöĂ÷ŠćÜöĊîĆ÷ÿĞćÙĆâ
5) ÷ćìĊęöĊßŠĂÜìćÜÖćøĔĀš÷ćĒïïĔĀöŠ (New Route of Administration)
6) ÷ćìĊęöĊøĎðĒïïĔĀöŠ (New Dosage Form) ×ĂÜ÷ćĔĀöŠìĊęĕéšøĆïĂîčöĆêĉĔĀš×ċĚîìąđïĊ÷îêĞćøĆï÷ćĒúšü
7) ÷ćìĊęöĊÙüćöĒøÜĔĀöŠ (New Strength) ×ĂÜ÷ćĔĀöŠìĊęĕéšøĆïĂîčöĆêĉĔĀš×ċĚîìąđïĊ÷îêĞćøĆï÷ćĒúšü
4.2 ÷ćÿćöĆâǰ(Generic Drugs) Āöć÷ëċÜǰ
1) ÷ćìĊęöĊÿĎêøêĆü÷ćÿĞćÙĆâ (Active Ingredients) ĒúąøĎðĒïï÷ć (Dosage Form) đĀöČĂîÖĆï÷ćìĊęđÙ÷×ċĚî
ìąđïĊ÷îêĞćøĆï÷ćĕüšđðŨî÷ćÿćöĆâ
2) ÷ćÝĞćóüÖüĉêćöĉîĒúąđÖúČĂĒøŠ àċęÜĕöŠöĊêĆü÷ćÿĞćÙĆâĔĀöŠ
2
ìĆĚÜîĊĚ÷ćêćö×šĂ 1) Ēúą 2) ÝąêšĂÜĕöŠöĊ×šĂïŠÜĔßšĔĀöŠ (New Indication)
4.3 ÷ćÿćöĆâĔĀöŠǰ(New Generic Drugs) Āöć÷ëċÜǰ
1) êĞ ć øĆ ï ÷ćÿćöĆ â ĒñîðŦ Ý Ýč ïĆ î ÿĞ ć ĀøĆ ï öîč þ ÷Ť ìĊę öĊ ÿĎ ê øêĆ ü ÷ćÿĞ ć ÙĆ â ǰ×îćéÙüćöĒøÜǰĒúąøĎ ð Ēïï÷ć
đĀöČĂîÖĆïêĞćøĆï÷ćêšîĒïïìĊęđðŨî÷ćĔĀöŠǰ(New Drugs) àċęÜĕéšøĆïĂîčöĆêĉ×ċĚîìąđïĊ÷îêĆĚÜĒêŠðŘó.ý. 2534 ìčÖðøąÖćø
2) êĞćøĆï÷ćÿćöĆâĔĀöŠìĊęöĊøĎðĒïïĒêÖêŠćÜÝćÖêĞćøĆï÷ćêšîĒïïìĊęÙèąĂîčÖøøöÖćøóĉÝćøèć×ċĚîìąđïĊ÷î
êĞćøĆï÷ćĒñîðŦÝÝčïĆîÿĞćĀøĆïöîčþ÷ŤìĊęđðŨî÷ćÿćöĆâĔĀöŠóĉÝćøèćĂîčâćê
4.4 ÷ćßĊüüĆêëčǰ(Biological products) Āöć÷ëċÜ ÷ćĒñîðŦÝÝčïĆîàċęÜñúĉêÝćÖÿĉęÜöĊßĊüĉêēé÷ÖøąïüîÖćø
đóćąđúĊĚ÷ÜÝčúĉîìøĊ÷ŤĀøČĂđàúúŤßĆĚîÿĎÜǰ(Eukaryotic cells) ÖćøÿÖĆéÿćøÝćÖđîČĚĂđ÷ČęĂÿĉęÜöĊßĊüĉêìĆĚÜöîčþ÷ŤǰÿĆêüŤǰĒúąóČßǰ
(Extraction of substances from biological tissues including human, animal, and plant tissues
(Allergens)) đìÙîĉÙéĊđĂĘîđĂÿć÷ñÿöǰ(Recombinant DNA or rDNA techniques) đìÙîĉÙÖćøñÿöêŠćÜóĆîíčŤǰ
(Hybridoma techniques) Öćø×÷ć÷óĆîíčŤÝčúĉîìøĊ÷ŤĔîêĆüĂŠĂîĀøČĂĔîÿĆêüŤǰ(Propagation of microorganisms in
embryo or animals) ÖćøÿÖĆéĀøČĂĒ÷ÖÝćÖđúČĂéĒúąóúćÿöćǰ(Derived from blood and plasma) ĀøČĂ
ÖøąïüîÖćøĂČęîìĊęøĆåöîêøĊÖĞćĀîéđóĉęöđêĉöēé÷ðøąÖćýĔîøćßÖĉÝÝćîčđïÖþć
4.5 ÷ćßĊüüĆêëčÙúšć÷ÙúċÜ (Biosimilars) Āöć÷ëċÜǰ÷ćßĊüüĆêëčìĊęöĊúĆÖþèąÙúšć÷ÙúċÜÖĆîĔîĒÜŠÙčèõćóǰ
ÙüćöðúĂéõĆ÷ǰĒúąðøąÿĉìíĉõćóǰđöČęĂđðøĊ÷ïđìĊ÷ïÖĆï÷ćßĊüüĆêëčĂšćÜĂĉÜìĊęĕéšøĆïÖćø×ċĚîìąđïĊ÷îêĞćøĆï÷ćĒúšüĂ÷ŠćÜ
đêĘöøĎðĒïï
4.6 ÷ćßĊüüĆêëčĂšćÜĂĉÜǰ(Reference biological medicinal product: RBP) Āöć÷ëċÜǰ÷ćßĊüüĆêëčìĊę
îĞ ć öćĔßš Ăš ć ÜĂĉ Ü ĔîÖćøýċ Ö þćđðøĊ ÷ ïđìĊ ÷ ïÙüćöÙúš ć ÷Ùúċ Ü ÖĆ î ÖĆ ï ÷ćßĊ ü üĆ ê ëč Ù úš ć ÷Ùúċ Ü ēé÷êøÜǰĒúąđðŨ î
÷ćßĊüüĆêëčêšîĒïïìĊęöĊÖćø×ċĚîìąđïĊ÷îĔîðøąđìýĕì÷Ă÷ŠćÜđêĘöøĎðĒïïǰĀøČĂêćöìĊęÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćø
Ēúą÷ćðøąÖćýÖĞćĀîé
4.7 ÷ćêšîĒïï (Originator Product) Āöć÷ëċÜǰ÷ćđÙöĊĀøČĂ÷ćßĊüüĆêëčìĊęĕéšøĆïÖćø×ċĚîìąđïĊ÷îéšü÷
đĂÖÿćøĂ÷ŠćÜđêĘöøĎðĒïïǰìĆĚÜéšćîÙčèõćóǰǰðøąÿĉìíĉõćóĒúąÙüćöðúĂéõĆ÷
4.8 ÷ćÝćÖÿöčîĕóøĒñîðŦÝÝčïĆî Āöć÷ëċÜǰ÷ćÿĞćđøĘÝøĎðìĊęðøąÖĂïéšü÷êĆü÷ćÿĞćÙĆâìĊęĕéšÝćÖÿöčîĕóøìĊę
đðŨîĕðêćöĀúĆÖđÖèæŤÖćø×ċĚîìąđïĊ÷îêĞćøĆï÷ćÝćÖÿöčîĕóøĒñîðŦÝÝčïĆî
5. ĀúĆÖÖćøÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ć
đĂÖÿćøÖĞćÖĆï÷ćđðŨ îöćêøÖćøÿĞćÙĆâĔîÖøąïüîÖćø×ċĚîìąđïĊ÷îĒúąìïìüîìąđïĊ÷ îêĞćøĆï ÷ćìĊę đðŨ î
đÙøČęĂÜöČĂĔîÖćøÙüïÙčöÙüćöđÿĊę÷Ü×ĂÜ÷ćĒúąÖćøðøąđöĉîðøąē÷ßîŤÖĆïÙüćöđÿĊę÷Ü×ĂÜ÷ć đĂÖÿćøÖĞćÖĆï÷ćđðŨî
öćêøÖćøÝĆé ÖćøÙüćöđÿĊę÷ Ü×ĆĚ îóČĚ î åćîìĊę ÙüøöĊÖćøðøĆï ðøč ÜĔĀš ìĆî ÿöĆ÷ÿĂéÙúš ĂÜÖĆï ×š ĂöĎ úĔĀöŠìĊęđÖĉ é ×ċĚî êúĂé
ßŠüÜđüúć×ĂÜüÜÝøßĊüĉêñúĉêõĆèæŤ÷ćǰĒúąĔßšđðŨîđÙøČęĂÜöČĂđóČęĂđóĉęöðøąē÷ßîŤÝćÖÖćøĔßš÷ćēé÷ÿŠÜđÿøĉöÖćøĔßš÷ćĂ÷ŠćÜ
ÿöđĀêčñúǰĀøČĂúéÙüćöđÿĊę÷Üēé÷ÖćøÝĞćÖĆéÖćøĔßš÷ćǰēé÷ĂćÝĔßšøŠüöÖĆïöćêøÖćøĂČęîĔîĒñîÖćøÝĆéÖćøÙüćöđÿĊę÷Üǰ
(risk management plan) ĕéšöćêøÖćøìĊęđĀöćąÿöđóČęĂúéÙüćöđÿĊę÷ÜĔĀšîšĂ÷ìĊęÿčé×èąìĊęđóĉęöðøąē÷ßîŤÝćÖÖćøĔßš
÷ćĔĀšĕéšöćÖìĊęÿčéǰñŠćîÖćøÝĆéÖćøĔĀšöĊÖćøĔßš÷ćĂ÷ŠćÜđĀöćąÿöǰëĎÖÙîǰëĎÖēøÙ
ĀćÖ×šĂöĎúđðúĊę÷îĒðúÜĕðĒúą÷ćĕöŠöĊÙüćöÿöéčú×ĂÜðøąē÷ßîŤÖĆïÙüćöđÿĊę÷ÜǰǰĂćÝêšĂÜđóĉÖëĂîìąđïĊ÷î
êĞćøĆï÷ćǰđüšîĒêŠÝąöĊöćêøÖćøÝĆéÖćøÙüćöđÿĊę÷ÜìĊęÿćöćøëÙüïÙčöÙüćöđÿĊę÷ÜÝćÖÖćøĔßš÷ćĔĀšöĊðøąē÷ßîŤöćÖÖüŠć
ÙüćöđÿĊę÷Üĕéš êĆüĂ÷ŠćÜ×ĂÜöćêøÖćøéĆÜÖúŠćüđßŠîǰÖćøêĉéêćöĂćÖćøĕöŠóċÜðøąÿÜÙŤĒïïÿöĆÙøĔÝĔîÖøèĊìĊęđĀêčÖćøèŤ
ĕöŠøšć÷ĒøÜĒúąĕöŠĒîŠĔÝüŠćÝąđÖĉéÝćÖ÷ćǰÖćøøüïøüö×šĂöĎúđóĉęöđêĉöĀćÖĕöŠĒîŠĔÝüŠćđÖĉéÝćÖ÷ćǰÖúĕÖĕöŠßĆéđÝîǰ
ĀøČĂĕöŠìøćïðŦÝÝĆ÷đÿĊę÷ÜǰÖćøđóĉęöÙĞćđêČĂîïîÞúćÖĔîÖøèĊìĊęđðŨîĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęøšć÷ĒøÜǰēé÷đÞóćąĂćÖćøìĊę

3
ĕöŠÿćöćøëĀúĊÖđúĊę÷ÜĕéšǰêúĂéÝîǰÖćøĒÖšĕ×ÞúćÖĒúąđĂÖÿćøÖĞćÖĆï÷ćđóČęĂúéÙüćöđÿĊę÷Üéšü÷ÖćøÝĞćÖĆé×šĂïŠÜĔßšĀøČĂ
đóĉęö×šĂĀšćöĔßšĔîñĎšìĊęöĊÙüćöđÿĊę÷ÜÿĎÜǰóøšĂöìĆĚÜÖćøêĉéêćöñú×ĂÜöćêøÖćøÝĆéÖćøÙüćöđÿĊę÷Ü
đĂÖÿćøÖĞćÖĆï÷ćìĊęöĊêĆü÷ćÿĞćÙĆâĀøČĂÿĎêøêĆü÷ćñÿöìĊęđĀöČĂîÖĆîĔîøĎðĒïï÷ćđéĊ÷üÖĆîǰêšĂÜöĊĀĆü×šĂĒúą
đîČĚ ĂĀćÿĂéÙúš ĂÜÖĆ î đðŨ î ĕðĔîĒîüìćÜđéĊ ÷ üÖĆ î ǰĀćÖđĂÖÿćøÖĞ ćÖĆ ï ÷ćöĊ ÙüćöĒêÖêŠ ćÜÖĆ î ǰÝąêš ĂÜöĊ ÖćøĒÖš ĕ×
đðúĊę÷îĒðúÜĔĀšÿĂéÙúšĂÜĔÖúšđÙĊ÷ÜÖĆîĔĀšöćÖìĊęÿčéđÿöĂǰĒêŠÖćøĔßšëšĂ÷ÙĞćĕöŠÝĞćđðŨîêšĂÜđĀöČĂîÖĆîĕéšǰÖćøÝĆéìĞć
đĂÖÿćøÖĞćÖĆï÷ćÝċÜöĊĀúĆÖÖćøĔĀšđîČĚĂĀćöĊÙüćöÿĂéÙúšĂÜÖĆî1
6. ×šĂÖĞćĀîéĔîÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ć
đĂÖÿćøÖĞćÖĆï÷ćöĊ 2 ðøąđõì ĕéšĒÖŠ
1. đĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïïčÙúćÖøìćÜÖćøĒóì÷Ťǰ(ÿćöćøëÝĆéìĞćĒïïǰSummary of Product
Characteristics ĀøČĂǰPackage Insert) øć÷úąđĂĊ÷é×šĂÖĞćĀîéĔîïììĊęǰ2
2. đĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîǰĀøČĂǰPatient Information Leaflet ĀøČĂ PIL øć÷úąđĂĊ÷é
×šĂÖĞćĀîéĔîïììĊęǰ3
×šĂÖĞćĀîéìĆęüĕðĔîÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ć
6.1 ÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćĒêŠúąðøąđõì×šćÜêšîÙüøÿĂéÙúšĂÜÖĆïðøąđõì×ĂÜ÷ćêćöÖãĀöć÷ éĆÜ
êćøćÜìĊęǰ1
êćøćÜìĊęǰ1 ÖćøĒÿéÜđĂÖÿćøÖĞćÖĆï÷ćĒ÷Öêćöðøąđõì÷ć
ðøąđõì÷ć đĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆï đĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆï
ïčÙúćÖøìćÜÖćøĒóì÷Ť** ðøąßćßî
÷ćÿćöĆâðøąÝĞćïšćî* ÿöĆÙøĔÝ öĊ
÷ćïøøÝčđÿøĘÝìĊęĕöŠĔßŠ÷ćĂĆîêøć÷ĀøČĂ÷ćÙüïÙčöóĉđýþ* ÿöĆÙøĔÝ öĊ
÷ćĂĆîêøć÷Ēúą÷ćÙüïÙčöóĉđýþ öĊ ÿöĆÙøĔÝ
* ÷ćìĊęĂîčâćêĔĀšēÛþèćēé÷êøÜêŠĂñĎšïøĉēõÙ, đðŨîǰOver-the-Counter Products
**đĂÖÿćøÖĞćÖĆï÷ćĒïïǰSummary of Product Characteristics ĀøČĂǰPackage Insert
đĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîĔĀšĔßšĔîÖøèĊđðŨî÷ćÿćöĆâðøąÝĞćïšćîǰĀøČĂ÷ćïøøøÝčđÿøĘÝìĊęĕöŠĔßŠ÷ćĂĆîêøć÷
ĀøČĂ÷ćÙüïÙčöóĉđýþǰìĆĚÜîĊĚǰÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćÝąĕéšðøąÖćýÖĞćĀîé×ĆĚîêĂîĒúąøą÷ąđüúćĔî
ÖćøéĞćđîĉîÖćøĔĀšđðŨîĕðêćö×šĂÖĞćĀîé×šćÜêšîêŠĂĕð
ÖøèĊ÷ćìĊęöĊÖćøÖĞćĀîéĔĀšöĊÖćøĒÿéÜ×šĂÙüćöĔîđĂÖÿćøÖĞćÖĆï÷ćĔîðøąÖćýÖøąìøüÜÿćíćøèÿč×ĀøČĂÙĞćÿĆęÜ
ÞïĆïêŠćÜė ìĊę÷ĆÜöĊñúïĆÜÙĆïĔßšĂ÷ĎŠ đßŠî ÷ćìĊęĕéšøĆïÖćø÷ÖđüšîĕöŠđðŨî÷ćĂĆîêøć÷ êćöðøąÖćýÖøąìøüÜÿćíćøèÿč×
đøČęĂÜ÷ćĂĆîêøć÷ ÞïĆïìĊę 4 ÞïĆïìĊę 10 ĒúąÞïĆïìĊę 17 ĔĀšĔßšđĂÖÿćøÖĞćÖĆï÷ćêćöìĊęÖĞćĀîéĕüšÝîÖüŠćÝąĕéšöĊÖćø
÷ÖđúĉÖĀøČĂðøąÖćýĒÖšĕ×
6.2 êšĂÜöĊđĂÖÿćøÖĞćÖĆï÷ćõćþćĕì÷ ĀćÖöĊõćþćĂĆÜÖùþêšĂÜöĊđîČĚĂĀćĔÝÙüćöÿĂéÙúšĂÜÖĆîÖĆïÞïĆï
õćþćĕì÷Ēúą÷ČęîöćóĉÝćøèćéšü÷ǰÿĞćĀøĆïđĂÖÿćøÖĞćÖĆï÷ćõćþćĂČęîė ĔĀšøĆïøĂÜüŠćöĊ×šĂÙüćöêøÜêćöõćþćĕì÷
1
World Health Organization. “Review of Applications for Marketing Authorization of Multisource (Generic) Pharmaceutical Products”
in the Blue Book-Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products.
Spain; 2011:35.
4
đüšîĒêŠđĂÖÿćøÖĞćÖĆï÷ćđóČęĂÖćøÿŠÜĂĂÖĔĀšóĉÝćøèćđðŨîÖøèĊĕðǰÿĞćĀøĆïđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîĀćÖđðŨî
ÞïĆïìĊęöĊõćþćĂĆÜÖùþĀøČĂõćþćĂČęîĂćÝĔßšĀĆü×šĂĒêÖêŠćÜÖĆïÞïĆïõćþćĕì÷ĕéš
6.3 ĔĀšÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćĒ÷ÖÖĆîêćöøĎðĒïïĒúąÙüćöĒøÜ×ĂÜ÷ćǰđüšîĒêŠǰëšćøüöÖĆîđðŨîÞïĆïđéĊ÷ü
ĒúšüĕöŠöĊñúêŠĂ×šĂïŠÜĔßšĒúąÙüćöðúĂéõĆ÷ÝćÖÖćøĔßš÷ćǰÝċÜĂîčēúöĔĀšĔßšøŠüöÖĆîĕéšǰ
6.4 ×šĂïŠÜĔßšìĊęĒÿéÜĔîđĂÖÿćøÖĞćÖĆï÷ćìčÖðøąđõì êšĂÜøąïčëċÜÖćøĔßšĀøČĂüĆêëčðøąÿÜÙŤ×ĂÜñúĉêõĆèæŤ
àċęÜêšĂÜßĆéđÝîüŠćöčŠÜĀöć÷đóČęĂÖćøøĆÖþć ðŜĂÜÖĆîǰïĞćïĆéǰïøøđìćĀøČĂüĉîĉÝÞĆ÷ēøÙĀøČĂÿõćüą×ĂÜēøÙǰēé÷øąïčßČęĂēøÙ
ĀøČĂÿõćüą×ĂÜēøÙđðŜćĀöć÷ìĊęđÞóćąđÝćąÝÜĕüšĂ÷ŠćÜßĆéđÝîǰàċęÜêšĂÜöĊĀúĆÖåćîìćÜüĉßćÖćøìĊęîŠćđßČęĂëČĂÿîĆïÿîčî
Ă÷ŠćÜđóĊ÷ÜóĂǰ(supported by substantial evidence) ìĆĚÜîĊĚǰ×šĂïŠÜĔßšìĊęĂîčâćêÝĞćđðŨîêšĂÜöĊðøąē÷ßîŤöćÖÖüŠć
ÙüćöđÿĊę÷Ü×ĂÜ÷ćǰêćöđÖèæŤìĊęÖĞćĀîé ĒúąĕöŠĂîčâćêĔĀš÷ćĔéĒÿéÜ×šĂïŠÜĔßšìĊęĕöŠÝĞćđóćąđÝćąÝÜ ĀøČĂĕöŠöĊ×šĂöĎúìĊę
đóĊ÷ÜóĂĔîÖćøÖĞćĀîé×îćé÷ćǰÿĞćĀøĆïĀúĆÖåćîìĊęĔßš×ċĚîÖĆïðøąđõì×ĂÜ÷ćǰêćöĒîüìćÜìĊęÿĞćîĆÖÜćîÙèąÖøøöÖćø
ĂćĀćøĒúą÷ćÝąĕéšðøąÖćýÖĞć Āîé ÿĞ ćĀøĆï ÷ćÿĎê øñÿöĔĀšóĉÝćøèćêćöĒîüìćÜÖćøóĉÝ ćøèć÷ćÿĎê øñÿöìĊę
ÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćÝąĕéšðøąÖćýÖĞćĀîéðøąÖĂïéšü÷
6.5 ×šĂÙüćöĔéėǰĔîđĂÖÿćøÖĞćÖĆï÷ćìĊęđðøĊ÷ïđìĊ÷ïðøąÿĉìíĉñúǰ(effectiveness) ĀøČĂÙüćöðúĂéõĆ÷
×ĂÜÖćøĔßš÷ćîĊĚÖĆï÷ćĂČęîĔî×šĂïŠÜĔßšđéĊ÷üÖĆîǰÝąêšĂÜöĊĀúĆÖåćîÿîĆïÿîčîĂ÷ŠćÜđóĊ÷ÜóĂǰĀúĆÖåćîéĆÜÖúŠćüêšĂÜđðŨî
ÖćøýċÖþćìĊęöĊÖúčŠöÙüïÙčöàċęÜöĊÙčèõćóéĊ (adequate and well-controlled studies) ÿĞćĀøĆïñúĉêõĆèæŤ÷ć
ßĊüüĆêëč×šĂÙüćöéĆÜÖúŠćüÝąêšĂÜöĊĀúĆÖåćîÿîĆïÿîčîĂ÷ŠćÜđóĊ÷ÜóĂǰ(substantial evidence)

5
ïììĊęǰ2
ĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïïčÙúćÖøìćÜÖćøĒóì÷Ť
(Guideline for Development of leaflet for Healthcare Professionals)
đĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïïčÙúćÖøìćÜÖćøĒóì÷ŤöĊüĆêëčðøąÿÜÙŤđóČęĂĔĀšñĎšÿĆęÜĔßš÷ćöĊ×šĂöĎúìĊęëĎÖêšĂÜǰđßČęĂëČĂĕéšǰ
đðŨîÖúćÜǰĒúąöĊ×šĂöĎúÙøïëšüîđóČęĂĔßšðøąÖĂïÖćøêĆéÿĉîĔÝĔîÖćøÿĆęÜĔßš÷ćĕéšĂ÷ŠćÜÿöđĀêčñúǰÝċÜÝĞćđðŨîêšĂÜöĊÖćø
ÖĞćĀîéĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïïčÙúćÖøìćÜÖćøĒóì÷Ť đóČęĂĔĀšöĊ×šĂöĎú÷ćìĊęëĎÖêšĂÜǰđßČęĂëČĂĕéšǰ
ĒúąđðŨîÖúćÜ àċęÜÝĞćđðŨîĔîÖćøĔßš÷ćĂ÷ŠćÜÿöđĀêčñúǰúéÙüćöđÿĊę÷ÜĀøČĂđóĉęöðøąē÷ßîŤÝćÖÖćøĔßš÷ćǰÝîðøąē÷ßîŤìĊę
ĕéš øĆï đĀîČĂÙüćöđÿĊę ÷Ü×ĂÜ÷ćǰîĂÖÝćÖîĆĚî ǰ÷Ć ÜĔßšđ ðŨî ĒîüìćÜĔîÖćøÝĆ éìĞ ćđĂÖÿćøÖĞ ćÖĆ ï÷ćöćêøåćîǰđóČęĂĔĀš
ñĎšðøąÖĂïÖćøÿćöćøëîĞćĕðĔßšĔîÖćø×ċĚîìąđïĊ÷îêĞćøĆï÷ćēé÷đÞóćą÷ćÿćöĆâĕéšĂ÷ŠćÜÿąéüÖǰøüéđøĘü
ìĆĚÜîĊĚđĂÖÿćøÖĞćÖĆï÷ćéĆÜÖúŠćüêšĂÜđðŨîđĂÖÿćøìĊęÿćöćøëÙšîĀć×šĂöĎúĕéšÿąéüÖǰøüéđøĘüǰĒúąĂŠćîĕéšÜŠć÷
ēé÷ÖćøĔßšÖćøĒïŠÜÿéöõŤǰĒïïêĆüĂĆÖþøǰÿĊêĆüĂĆÖþøǰóČĚîĀúĆÜĒúą×îćéêĆüĂĆÖþøǰìĊęÿćöćøëĂŠćîĕéšßĆéđÝî
ĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïïčÙúćÖøìćÜÖćøĒóì÷ŤðøąÖĂïéšü÷ǰ2 ÿŠüîǰÙČĂǰ
Ö. ×šĂÖĞćĀîéìĆęüĕðÿĞćĀøĆïÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïïčÙúćÖøìćÜÖćøĒóì÷Ť
×. øć÷úąđĂĊ÷éĒúą×šĂÖĞćĀîéÿĞćĀøĆïĒêŠúąĀĆü×šĂ×ĂÜđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïïčÙúćÖøìćÜÖćøĒóì÷Ť
ĔîÖøèĊìĊęöĊĒîüìćÜđÞóćąĔîÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ć×ĂÜ÷ćïćÜÖúčŠöǰđßŠîǰ÷ćêšćîÝčúßĊóǰĔĀšéĎĒîüìćÜ
đÞóćąđóĉęöđêĉöðøąÖĂïéšü÷
Ö. ×šĂÖĞćĀîéìĆęüĕðÿĞćĀøĆïÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïïčÙúćÖøìćÜÖćøĒóì÷Ť
1. õćþćĒúąýĆóìŤìĊęĔßš
×šĂöĎúìĆĚÜĀöéĔîđĂÖÿćøÖĞćÖĆï÷ćõćþćĕì÷ÿĞćĀøĆïïčÙúćÖøìćÜÖćøĒóì÷ŤĔßšõćþćĕì÷đðŨîĀúĆÖǰýĆóìŤ
đÞóćąìćÜÖćøĒóì÷ŤĔĀšĒðúēé÷ÖćøđìĊ÷ïđÙĊ÷ÜÖĆïóÝîćîčÖøö×ĂÜøćßïĆèæĉê÷ÿëćîÞïĆïðŦÝÝčïĆîǰøŠüöÖĆïĂõĉíćî
ÙĞćýĆóìŤìĊęÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćÖĞćĀîéǰüÜđúĘïéšü÷ÙĞćõćþćĂĆÜÖùþđìŠćìĊęÝĞćđðŨîǰĀćÖêšĂÜÖćøìĆï
ýĆóìŤÝćÖÙĞćĂĆÜÖùþĔĀš÷ċéêćöĀúĆÖøćßïĆèæĉê÷ÿëćî
ÖćøĔßšõćþćĂĆÜÖùþēé÷ĕöŠêšĂÜĒðúĔĀšÖøąìĞćĔîÖøèĊêŠĂĕðîĊĚ
- ĕöŠöĊýĆóìŤïĆââĆêĉõćþćĕì÷
- öĊýĆóìŤïĆââĆêĉìĊęđðŨîõćþćĕì÷ĒêŠĂćÝìĞćĔĀšđ×šćĔÝÙúćéđÙúČęĂî đ÷ĉęîđ÷šĂ ĕöŠĕéšĔÝÙüćö đßŠîǰßČęĂ×ĂÜ
ÝčúßĊóǰßČęĂĀîŠü÷üĆéǰßČęĂēøÙĀøČĂĂćÖćøĕöŠóċÜðøąÿÜÙŤǰàċęÜ÷ĆÜĕöŠöĊýĆóìŤïĆââĆêĉđðŨîêšî
- ßČęĂ÷ćĀøČĂêĆ ü÷ćĕöŠÿĞćÙĆâĔĀšĔßšõćþćĂĆÜÖùþĒìîĕéšǰđüš îĒêŠǰßČęĂêĆ ü÷ćÿĞćÙĆâĔî “ĀĆü×šĂìĊę 2
ÿŠüîðøąÖĂïĒúąðøĉöćèêĆü÷ćÿĞćÙĆâ” ĔĀšĔßšõćþćĕì÷ĒúšüüÜđúĘïßČęĂõćþćĂĆÜÖùþǰ
2. úĆÖþèą×ĂÜđĂÖÿćøÖĞćÖĆï÷ć
2.1 đĂÖÿćøÖĞćÖĆï÷ćìĊęĒîïĕðÖĆïñúĉêõĆèæŤ
đĂÖÿćøÖĞćÖĆï÷ćìĊęĒîïĕðÖĆïñúĉêõĆèæŤǰÙüøđðŨîđĂÖÿćøìĊęÿćöćøëÙšîĀć×šĂöĎúĕéšÿąéüÖøüéđøĘüǰĒúąĂŠćî
ĕéšÜŠć÷ēé÷ĔßšÖćøĒïŠÜÿéöõŤǰĒïïêĆüĂĆÖþøǰÿĊêĆüĂĆÖþøǰóČĚîĀúĆÜĒúą×îćéêĆüĂĆÖþøìĊęÿćöćøëĂŠćîĕéšßĆéđÝî
2.2 ×šĂöĎúđĂÖÿćøÖĞćÖĆï÷ćđóČęĂĔßšÿĞćĀøĆïÖćøìüîÿĂïēé÷ñĎšðøąđöĉî/đÝšćĀîšćìĊę
đĂÖÿćøÖĞćÖĆï÷ćìĊęĔßšĔîÖćøðøąđöĉîìąđïĊ÷îêĞćøĆï÷ćǰÙüøÝĆéđêøĊ÷ö×šĂöĎúĒîüêĆĚÜǰ(portrait) ĒïïÙĂúĆöîŤ
đéĊ÷üǰìĆĚÜĔîøĎðđĂÖÿćø×îćéǰA4 ĒúąĒôŜö×šĂöĎúĂĉđúĘÖìøĂîĉÖÿŤǰéšü÷ßčéĒïïĂĆÖþø TH SarabunPSK ×îćéĕöŠ

6
îšĂ÷ÖüŠćǰ14 points ĀøČĂđìĊ÷ïđìŠć øą÷ąĀŠćÜøąĀüŠćÜĂĆÖþøĒïïðøÖêĉǰÖćøðøĆïđêĘöĒîüǰ(justification) Ēïïßĉé
×ĂïĀøČĂĒïïÖøąÝć÷ øą÷ą×ĂïïîĒúąúŠćÜǰ2.54 àö. àšć÷Ēúą×üćǰ2.54 àö. ĔîĒêŠúąðøąē÷Ù×ĂÜđĂÖÿćø
ÖĞćÖĆï÷ćĔĀšĒÿéÜøć÷úąđĂĊ÷éÖćøĂšćÜĂĉÜ×šĂöĎúĔîđĂÖÿćøÖĞćÖĆï÷ćǰóøšĂöĒîïđĂÖÿćøĂšćÜĂĉÜĒÿéÜøć÷úąđĂĊ÷é
×šĂöĎúĔĀšÙøïìčÖĀĆü×šĂĂ÷ŠćÜÿöïĎøèŤēé÷ĒîïÿĞćđîćđĂÖÿćøĂšćÜĂĉÜĔîÿŠüîìĊęđÖĊę÷ü×šĂÜ ĒúąĒôŜö×šĂöĎúĂĉđúĘÖìøĂîĉÖÿŤ
öćðøąÖĂïÖćøóĉÝćøèćéšü÷
đĂÖÿćøÖĞćÖĆï÷ćìĊęñŠćîÖćøðøąđöĉîĒúšüêšĂÜðøĆïðøčÜĒÖšĕ×ĔĀšđøĊ÷ïøšĂ÷ǰëĎÖêšĂÜ ĕöŠöĊøĂ÷×ĊéÛŠćĀøČĂúć÷öČĂ
ßČęĂ (final draft) ĒúšüĒîïĕüšÖĆïìąđïĊ÷îêĞćøĆï÷ćóøšĂöĒôŜö×šĂöĎúĂĉđúĘÖēìøîĉÖÿŤ (file .doc ĀøČĂǰ.pdf àċęÜĕöŠĔßŠ
øĎðõćó) ÖŠĂîÖćøĂîčöĆêĉìąđïĊ÷îêĞćøĆï÷ćĀøČĂĂîčâćêĒÖšĕ×ìąđïĊ÷îêĞćøĆï÷ć Ēúąđñ÷ĒóøŠđĂÖÿćøéĆÜÖúŠćüìćÜ
đüĘïĕàêŤêćöĀúĆÖÿćÖúêŠĂĕð
3. ÙčèúĆÖþèąìĆęüĕð×ĂÜđîČĚĂĀć
đîČĚĂĀć×ĂÜđĂÖÿćøÖĞćÖĆï÷ćÙüøđðŨîÖćøĔĀš×šĂöĎú×ĂÜñúĉêõĆèæŤ÷ćìĊęÿĂéÙúšĂÜÖĆï×šĂïŠÜĔßšĒúąñĎšðśü÷
ĀúĆÖìĊęĔßš÷ćǰÖøąßĆïǰßĆéđÝî ëĎÖêšĂÜǰđðŨîðŦÝÝčïĆîǰöĊøć÷úąđĂĊ÷éđóĊ÷ÜóĂ øüöëċÜǰöĊ×šĂöĎú×ĂÜñĎšðśü÷ÖúčŠöđÞóćąêćö
ÙüćöÝĞćđðŨîǰ
đîČĚĂĀćĕöŠđðŨîúĆÖþèąÖćøēÛþèćÿøøóÙčèđóČęĂÿŠÜđÿøĉöÖćøĔßš÷ćǰĀšćöĔÿŠ×šĂöĎúìĊęĕöŠêøÜÖĆï×šĂđìĘÝÝøĉÜǰĀøČĂ
ÝÜĔÝĔĀšđÖĉéÙüćöđ×šćĔÝñĉéǰ
đðŨî×šĂöĎúìĊęöĊĒĀúŠÜĂšćÜĂĉÜìĊęđßČęĂëČĂĕéšǰàċęÜêšĂÜĒîïđĂÖÿćøĂšćÜĂĉÜìĊęÿîĆïÿîčîđîČĚĂĀćĔîđĂÖÿćøöćéšü÷đÿöĂǰ
đîČęĂÜÝćÖđðŨî÷ćìĊęĔßšĔîöîčþ÷Ťǰ×šĂöĎúìĊęĔßšÿîĆïÿîčîðøąÿĉìíĉõćó×ĂÜ÷ćÝċÜÝĞćđðŨîêšĂÜđðŨî×šĂöĎúìĊęýċÖþćĔî
öîčþ÷Ťéšü÷üĉíĊÖćøĒúąÖøąïüîÖćøìĊęîŠćđßČęĂëČĂ đßŠî đðŨî randomized controlled trial ìĊęöĊÝĞćîüîñĎšðśü÷öćÖ
đóĊ÷ÜóĂǰÖøąïüîÖćøüĉÝĆ÷ëĎÖêšĂÜǰĒúąÖćøÿøčðñúêøÜêćöñúúĆóíŤ×ĂÜÜćîüĉÝĆ÷ǰĕöŠÖúŠćüĂšćÜđÖĉîÖüŠć×šĂöĎúìĊęöĊ
×šĂöĎúìĆĚÜĀöéđðŨîĕðđóČęĂßŠü÷ĔĀšđÖĉéÖćøÿĆęÜĔßš÷ćĕéšĂ÷ŠćÜÿöđĀêčñúǰĒúąßŠü÷ĔĀšđÖĉéÙüćöðúĂéõĆ÷ÿĎÜÿčéĔî
ÖćøĔßš÷ćéĆÜÖúŠćü
ÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćĔĀšÝĆéìĞć×šĂöĎú÷ćĒ÷ÖêćöøĎðĒïïǰĒúąÙüćöĒøÜ×ĂÜ÷ćǰđüšîĒêŠ ëšćøüöÖĆîĒúšü
ĕöŠöĊñúêŠĂ×šĂïŠÜĔßšĒúąÙüćöðúĂéõĆ÷ÝćÖÖćøĔßš÷ćǰÝċÜĂîčēúöĔĀšĔßšøŠüöÖĆîĕéšǰđßŠîǰĕöŠÙüøîĞćđĂÖÿćøÖĞćÖĆï÷ćìĊęđðŨî
÷ćêšćîÝčúßĊóøĎðĒïï÷ćÞĊéöćøüöĕüšÖĆï÷ćêšćîÝčúßĊóßîĉéđéĊ÷üÖĆîìĊęĔßšđðŨî÷ćõć÷îĂÖ
đĂÖÿćøÖĞ ć ÖĆ ï ÷ćđðŨ î ×š Ă öĎ ú đÞóćąđÝćąÝÜ×ĂÜĒêŠ ú ąñúĉ ê õĆ èæŤ ǰ Ýċ Ü ĕöŠ ÙüøĔĀš ×šĂöĎ ú ×ĂÜñúĉ ê õĆ è æŤ ĂČę îǰ
êĆüĂ÷ŠćÜđßŠîǰÖćøøąïč×îćéĒúąüĉíĊĔßš×ĂÜ÷ćßîĉéĂĂÖùìíĉĝîćîĔîđĂÖÿćøÖĞćÖĆï÷ć×ĂÜñúĉêõĆèæŤìĊęĂĂÖùìíĉĝìĆîìĊ
“đßŠîđéĊ÷üÖĆîÖĆï÷ćĂČęîĔîÖúčŠö.... ÷ćîĊĚìĞćĔĀš....” đüšîĒêŠđðŨîÙĞćđêČĂî×ĂÜ÷ćìĆĚÜÖúčŠöêćöÖãĀöć÷ ĀøČĂđðŨîðøąē÷ßîŤ
êŠĂÖćøÙčšöÙøĂÜñĎšïøĉēõÙĀøČĂĒîąîĞćēé÷ĀîŠü÷ÜćîìĊęìĞćĀîšćìĊęÙüïÙčö÷ć
4. đĂÖÿćøĂšćÜĂĉÜĀúĆÖ
ĔîÖøèĊìĊęđðŨîñúĉêõĆèæŤ÷ćìĊę÷Čęî×šĂöĎúĔîÙĞć×Ă×ċĚîìąđïĊ÷îêĞćøĆï÷ćÙøïëšüîìĆĚÜéšćîÙčèõćóǰóøĊÙúĉîĉÖĒúą
ÙúĉîĉÖǰ(full dossiers) ĔĀšóĉÝćøèćÝćÖđĂÖÿćøĔîÙĞć×Ă×ċĚîìąđïĊ÷îêĞćøĆï÷ćéĆÜÖúŠćüđðŨîđĂÖÿćøĀúĆÖǰĂ÷ŠćÜĕøÖĘ
êćöǰĒîąîĞćĔĀšĔßšđĂÖÿćøĂšćÜĂĉÜĀúĆÖðøąÖĂïÖćøóĉÝćøèćéšü÷
ÿĞćĀøĆïđĂÖÿćøĂšćÜĂĉÜĀúĆÖìĊęĔßšÖĆï÷ćēé÷ìĆęüĕðǰĔĀšĔßšđĂÖÿćøĂšćÜĂĉÜéĆÜîĊĚǰ(÷ÖđüšîĕöŠÿćöćøëÙšîĀć×šĂöĎú
éĆÜÖúŠćüĕéš)
1. đĂÖÿćøÖĞćÖĆï÷ćõćþćĕì÷ĒúąõćþćĂĆÜÖùþ×ĂÜ÷ćêšîĒïï ìĆĚÜĔîøĎðÿĉęÜóĉöóŤĒúą electronic format
ìĊę×ċĚîìąđïĊ÷îÖĆïÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ć

7
2. đĂÖÿćøÖĞćÖĆï÷ć×ĂÜ÷ćêšîĒïïǰĀøČĂìĊęĕéšøĆïĂîčöĆêĉÝćÖǰstringent regulatory authorities1 ìĊęđðŨîìĊę
÷ĂöøĆï ēé÷ìĆęüĕðĒîąîĞćĔĀšÿČïÙšîÝćÖđüĘïĕàêŤ×ĂÜĂÜÙŤÖøĂćĀćøĒúą÷ćĂ÷ŠćÜîšĂ÷ǰ5 ĒĀúŠÜÙČĂǰÿĀøĆåĂđöøĉÖćǰ
ÿĀõćó÷čēøðǰÿĀøćßĂćèćÝĆÖøǰĒÙîćéćǰĒúąĂĂÿđêøđúĊ÷ǰ
3. Gold Standard Clinical Pharmacology Monograph CD-ROM
4. USPDI ĀøČĂǰDrugDex Drug Evaluation Monograph Ĕîåćî×šĂöĎú Micromedex
5. American Hospital Formulary Service (AHFS) Monograph
6. Drug Information Handbook
7. ĂČęîėǰđßŠîǰBritish National Formulary (BNF) monograph, Drug facts and comparisons,
Handbook of injectable drugs đðŨîêšî
5. ×šĂÖĞćĀîéĔîÖćøĒÿéÜðøĉöćè÷ćĒúąĀîŠü÷×ĂÜÙüćöĒøÜǰ
đîČęĂÜÝćÖöĊøć÷ÜćîüŠćÖćøĒÿéÜðøĉ öćè÷ćĒúąĀîŠ ü÷×ĂÜÙüćöĒøÜ×ĂÜêĆü ÷ćÿĞćÙĆâēé÷êĆü ÷ŠĂĀøČĂÝč é
ìýîĉ÷öĂćÝìĞćĔĀšđÖĉéÙüćöđ×šćĔÝÙúćéđÙúČęĂîĔîÖćøïøĉĀćø÷ćǰ(medication error) ĕéšǰÝċÜÙüøðäĉïĆêĉéĆÜîĊĚ
(1) øąïčĀîŠü÷×ĂÜðøĉöćè÷ćđðŨîõćþćĕì÷éšü÷ÙĞćđêĘöêćöøąïïđöêøĉÖĒúąĕöŠĔßšĂĆÖþø÷ŠĂ ĔîìčÖĀĆü×šĂ×ĂÜ
đĂÖÿćøÖĞćÖĆï÷ćǰđüšîĒêŠĔîĀĆü×šĂìĊę 1 ßČęĂñúĉêõĆèæŤǰĂîčēúöĔĀšøąïčĀîŠü÷×ĂÜÙüćöĒøÜđðŨîÙĞć÷ŠĂìĊęđðŨîÿćÖúĕéš
ÿĞćĀøĆï÷ćßĊüüĆêëčĔĀšĔßšĀîŠü÷×ĂÜðøĉöćèêćöìĊęÿćÖú÷ĂöøĆï
(2) ĕöŠÙüøđ×Ċ÷îêĆüđú×ìĊęöĊÝčéìýîĉ÷öēé÷ĕöŠÝĞćđðŨîǰđßŠîǰ3 öĉúúĉÖøĆö ĕöŠĔßŠǰ3.0 öĉúúĉÖøĆöǰĒúąĕöŠĔßŠǰ0.003
ÖøĆöǰǰĀćÖđðŨî×îćé÷ćêĆĚÜĒêŠǰ1 ÖøĆö ÙüøøąïčĀîŠü÷đðŨîÖøĆöǰđßŠîǰ2 ÖøĆöǰĕöŠĔßŠǰ2000 öĉúúĉÖøĆöǰĔîÖøèĊìĊę×îćé÷ć
êęĞćÖüŠćǰ1 ÖøĆöǰÙüøøąïčĀîŠü÷đðŨîöĉúúĉÖøĆöǰđßŠîǰ500 öĉúúĉÖøĆöǰĕöŠĔßŠǰ0.5 ÖøĆöǰǰÿĞćĀøĆï×îćé÷ćêęĞćÖüŠćǰ1 öĉúúĉÖøĆöǰ
ÙüøøąïčĀîŠü÷đðŨîĕöēÙøÖøĆöǰđßŠîǰ300 ĕöēÙøÖøĆöǰĕöŠĔßŠǰ0.3 öĉúúĉÖøĆöǰǰëšćÝĞćđðŨîêšĂÜøąïčĀîŠü÷đðŨîìýîĉ÷öǰĒêŠ
ĕöŠöĊêĆüđú×ĀîšćÝčéìýîĉ÷öǰÙüøđ×Ċ÷îđú×ýĎî÷ŤĀîšćÝčéìýîĉ÷öéšü÷ǰđßŠîǰ0.5 öĉúúĉÖøĆöǰĕöŠĔßŠǰ.5 öĉúúĉÖøĆö
6. ×šĂÖĞćĀîéĀĆü×šĂ×ĂÜđĂÖÿćøÖĞćÖĆï÷ćõćþćĕì÷ÿĞćĀøĆïïčÙúćÖøìćÜÖćøĒóì÷Ťǰ
êšĂÜÝĆéìĞćĔĀšöĊĀĆü×šĂêćö×šĂêÖúÜĂćđàĊ÷îǰ(ÿćöćøëđúČĂÖĔßšĒïïǰSummaryof Product Characteristics
ĀøČĂǰPackage Insert) ēé÷ĀĆü×šĂĔîđĂÖÿćøÖĞćÖĆï÷ćÙüøđøĊ÷ÜúĞćéĆïĀĆü×šĂêćö×šĂêÖúÜĂćđàĊ÷î ACTD đóČęĂĔĀš
ÿĂéÙúšĂÜÖĆïĒîüìćÜÿćÖúǰđßŠîǰÿĀøĆåĂđöøĉÖćǰÿĀõćó÷čēøð éĆÜîĊĚ
6.1 ĀĆü×šĂĒïïǰSummary of Product Characteristics
1. ßČęĂñúĉêõĆèæŤǰ(Name of the Medicinal Product)
1.1 ßČęĂ÷ćǰ (Product name)
1.2 ÙüćöĒøÜ (Strength)
1.3 øĎðĒïï÷ć (Pharmaceutical dosage form)
2. ÿŠüîðøąÖĂïĒúąðøĉöćèêĆü÷ćÿĞćÙĆâ (Qualitative and Quantitative Composition)
2.1 ÿŠüîðøąÖĂïêĆü÷ćÿĞćÙĆâ (Qualitative declaration)
2.2 ðøĉöćèêĆü÷ćÿĞćÙĆâ (Quantitative declaration)
3. úĆÖþèąĒúąøĎðĒïï÷ćìćÜđõÿĆßÖøøö (Pharmaceutical Form)
4. ÙčèÿöïĆêĉìćÜÙúĉîĉÖ (Clinical Particulars)
1
WHO. Guide on Submission of Documentation for Prequalification of Innovator Finished Pharmaceutical
Products Approved by Stringent Regulatory Authorities. 2010.
8
4.1 ×šĂïŠÜĔßšǰ(Therapeutic indication)
4.2 ×îćé÷ćĒúąüĉíĊÖćøĔßš÷ć (Posology and method of administration)
4.3 ×šĂĀšćöĔßš (Contraindication)
4.4 ÙĞćđêČĂîóĉđýþ Ēúą×šĂÙüøøąüĆÜĔîÖćøĔßš÷ć (Special warning and precautions for use)
4.5 ĂĆîêøÖĉøĉ÷ćÖĆï÷ćĂČęîėĀøČĂĂĆîêøÖĉøĉ÷ćĂČęîė (Interactions with other medicinal products
and other forms of interactions)
4.6 ÖćøĔßšĔîÿêøĊöĊÙøøõŤĒúąÿêøĊøąĀüŠćÜĔĀšîöïčêø (Pregnancy and lactation)
4.7 ñúêŠĂÙüćöÿćöćøëĔîÖćø×Ćï×ĊęĒúąìĞćÜćîÖĆïđÙøČęĂÜÝĆÖøǰ(Effects on ability to drive and
use machine)
4.8 ĂćÖćøĕöŠóċÜðøąÿÜÙŤ (Undesirable effects)
4.9 ÖćøĕéšøĆï÷ćđÖĉî×îćé (Overdose)
5. ÙčèÿöïĆêĉìćÜđõÿĆßüĉì÷ć (Pharmacological Properties)
5.1 ÙčèÿöïĆêĉìćÜđõÿĆßóúýćÿêøŤ (Pharmacodynamic properties)
5.2 ÙčèÿöïĆêĉìćÜđõÿĆßÝúîýćÿêøŤ (Pharmacokinetic properties)
5.3 ×šĂöĎúÙüćöðúĂéõĆ÷ÝćÖÖćøýċÖþćóøĊÙúĉîĉÖ (Preclinical safety data)
6. øć÷úąđĂĊ÷éìćÜđõÿĆßÖøøö (Pharmaceutical Particulars)
6.1 øć÷ÖćøêĆü÷ćĕöŠÿĞćÙĆâ (List of excipients)
6.2 ÙüćöĕöŠđ×šćÖĆî×ĂÜ÷ć (Incompatibilities)
6.3 Ăć÷č×ĂÜ÷ć (Shelf life)
6.4 ×šĂÙüøøąüĆÜóĉđýþĔîÖćøđÖĘï÷ć (Special precautions for storage)
6.5 úĆÖþèąĒúąÿŠüîðøąÖĂï×ĂÜõćßîąïøøÝč (Nature and contents of container)
7. ßČęĂñĎšøĆïĂîčâćêñúĉêĀøČĂîĞćĀøČĂÿĆęÜ÷ćĒñîðŦÝÝčïĆîđ×šćöćĔîøćßĂćèćÝĆÖø (Marketing Authorization
Holder)
8. đú×ìąđïĊ÷îêĞćøĆï÷ć (Marketing Authorization Numbers)
9. üĆîìĊęĕéšøĆïĂîčöĆêĉìąđïĊ÷îêĞćøĆï÷ć (Date of First Authorization/Renewal of the Authorization)
10. üĆîìĊęöĊÖćøĒÖšĕ×ðøĆïðøčÜđĂÖÿćø (Date of Revision of the Text)
6.2 ĀĆü×šĂĒïïǰPackage Insert
1. ßČęĂñúĉêõĆèæŤǰ(Product Name)
2. ßČęĂĒúąÙüćöĒøÜ×ĂÜêĆü÷ćÿĞćÙĆâ (Name and Strength of Active Ingredient (s))
3. úĆÖþèą×ĂÜñúĉêõĆèæŤ (Product Description)
4. đõÿĆßóúýćÿêøŤĒúąđõÿĆßÝúîýćÿêøŤǰ(Pharmacodynamics/Pharmacokinetics)
5. ×šĂïŠÜĔßš (Indication)
6. ×îćé÷ćìĊęĒîąîĞćǰ(Recommended Dose)
7. üĉíĊÖćøĔßš÷ć (Mode of Administration)
8. ×šĂĀšćöĔßš (Contraindication)
9. ÙĞćđêČĂîĒúą×šĂÙüøøąüĆÜ (Warning and Precautions)
10. ĂĆîêøÖĉøĉ÷ćÖĆï÷ćĂČęîėǰ(Interactions with Other Medicaments)
11. ÿêøĊöĊÙøøõŤĒúąÿêøĊøąĀüŠćÜĔĀšîöïčêø (Pregnancy and Lactation)

9
12. ĂćÖćøĕöŠóċÜðøąÿÜÙŤ (Undesirable Effects)
13. ÖćøĕéšøĆï÷ćđÖĉî×îćéĒúąüĉíĊÖćøøĆÖþć (Overdose and Treatment)
14. ÿõćüąÖćøđÖĘïøĆÖþć (Storage Condition)
15. øĎðĒïï÷ćĒúą×îćéïøøÝčìĊęöĊÝĞćĀîŠć÷ (Dosage Forms and Packaging Available)
16. ßČęĂĒúąìĊęĂ÷ĎŠ×ĂÜñĎšñúĉêĀøČĂîĞćĀøČĂÿĆęÜ÷ćĒñîðŦÝÝčïĆîđ×šćöćĔîøćßĂćèćÝĆÖø (Name and Address
of Manufacturer/Marketing Authorization Holder)
17. üĆîìĊęöĊÖćøĒÖšĕ×ðøĆïðøčÜđĂÖÿćø (Date of Revision of Package Insert)
ĔîÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćìĆĚÜÿĂÜĒïïǰñĎšøĆïĂîčâćêÿćöćøëđúČĂÖĒÿéÜđĂÖÿćøÖĞćÖĆï÷ćìĊęöĊđîČĚĂĀćÿĆĚî
ĀøČĂ÷ćüĕéšêćöÙüćöđĀöćąÿöǰēé÷ßîĉéÿĆĚîĒêÖêŠćÜÖĆïßîĉé÷ćüĔîǰ2 ðøąđéĘîÿĞćÙĆâÙČĂǰ
x ÖćøĔĀš×šĂöĎúēé÷÷ŠĂ×ĂÜĀĆü×šĂÙčèÿöïĆêĉìćÜđõÿĆßüĉì÷ć (ĀĆü×šĂđõÿĆßóúýćÿêøŤĒúąđõÿĆßÝúîýćÿêøŤ)
x ÖćøĕöŠøąïčđîČĚĂĀćøć÷ÜćîÖćøüĉÝĆ÷ìćÜÙúĉîĉÖ
×. øć÷úąđĂĊ ÷ éĒúą×šĂ ÖĞ ć ĀîéÿĞ ćĀøĆ ï ĒêŠ ú ąĀĆü ×š Ă ×ĂÜđĂÖÿćøÖĞ ć ÖĆ ï÷ćÿĞ ćĀøĆ ï ïčÙ úćÖøìćÜ
ÖćøĒóì÷Ť
1. đĂÖÿćøÖĞćÖĆï÷ćĒïïǰSummary of Product Characteristics (SPC)
ĀĆü×šĂìĊę 1 ßČęĂñúĉêõĆèæŤǰ(Name of the Medicinal Product)
ĔĀšĒÿéÜ ßČęĂ÷ćǰ(Product name) ÙüćöĒøÜ (Strength) ĒúąøĎðĒïï÷ć (Pharmaceutical dosage
form) êćöøĎðĒïïéĆÜîĊĚ
<ßČęĂÖćøÙšć> <ÙüćöĒøÜ> <øĎðĒïï÷ć>
øć÷úąđĂĊ÷éÖćøĒÿéÜßČęĂ÷ćǰÙüćöĒøÜǰĒúąøĎðĒïï÷ć×šćÜêšîĔĀšđðŨîĕðêćö×šĂÖĞćĀîééĆÜîĊĚ
1.1 ßČęĂ÷ćǰ(Product name) đðŨîÖćøĒÿéÜßČęĂÖćøÙšć×ĂÜñúĉêõĆèæŤ
ĔîÖøèĊ÷ćìĊęöĊĒêŠßČęĂÖćøÙšćõćþćĂĆÜÖùþìĊę÷Čęî×ĂĒÖšĕ×đðúĊę÷îĒðúÜđĂÖÿćøÖĞćÖĆï÷ćõćþćĕì÷ĒúąđðŨî÷ćìĊę
ĕéšøĆïĔïÿĞćÙĆâÖćø×ċĚîìąđïĊ÷îêĞćøĆï÷ćÖŠĂîĒîüìćÜîĊĚĔĀšøąïčǰĔĀšüÜđúĘïõćþćĕì÷đðŨîÙĞćĂŠćîêćöøćßïĆèæĉê÷ÿëćî
ĕüšìšć÷ßČęĂÖćøÙšćõćþćĂĆÜÖùþǰǰđßŠîǰ Tra A (êøćđĂ) đðŨîêšî
ĔîÖøèĊìĊęßČęĂÖćøÙšćöĊÙüćöĒøÜĒúąøĎðĒïï÷ćĂ÷ĎŠĒúšüĕöŠÝĞćđðŨîêšĂÜøąïčÙüćöĒøÜĀøČĂøĎðĒïï÷ćàĚĞć ßČęĂ
ÖćøÙšćõćþćêŠćÜðøąđìýĂČęîėǰĔĀšÝĆé×šĂÙüćöĔîìĞćîĂÜđéĊ÷üÖĆî÷ÖđüšîÖøèĊ÷ćÿŠÜĂĂÖ
ÖøèĊìĊę×ĂĔßšđĂÖÿćøÖĞćÖĆï÷ćÞïĆïđéĊ÷üÖĆîǰĔĀšøąïčßČęĂ÷ćĒ÷ÖêćöÙüćöĒøÜĒúąøĎðĒïï÷ćǰïøøìĆéúą 1 ßČęĂǰ
đßŠî
êøćđĂǰ250 öĉúúĉÖøĆöêŠĂǰ5 öĉúúĉúĉêø ßîĉéîĚĞćđßČęĂöǰ
êøćđĂǰ250 öĉúúĉÖøĆöǰßîĉéđöĘé
êøćđĂǰôĂøŤêǰ500 öĉúúĉÖøĆöǰßîĉéđöĘé
Tra A 250 mg/5 ml syrup
Tra A 250 mg tablet
Tra A forte 500 mg tablet

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1.2 ÙüćöĒøÜ (Strength)
(1) øąïčÙüćöĒøÜêćö×š ĂÖĞć ĀîéĔîÖćøĒÿéÜðøĉö ćè÷ćĒúąĀîŠü ÷×ĂÜÙüćöĒøÜǰ(éĎø ć÷úąđĂĊ ÷éĔî
“×šĂÖĞćĀîéĔîÖćøĒÿéÜðøĉöćè÷ćĒúąĀîŠü÷ÙüćöĒøÜ” )
(2) ÖøèĊñúĉêõĆèæŤöĊĀúć÷ÙüćöĒøÜǰĔĀšøąïčÙüćöĒøÜĒúąĀîŠü÷ĕðĔîĒîüìćÜđéĊ÷üÖĆîǰđßŠîǰ250 öĉúúĉÖøĆö
500 öĉúúĉÖøĆö 750 öĉúúĉÖøĆöǰđðŨîêšîǰ(ĕöŠĔßŠđ×Ċ÷îđðŨîǰ250 öĉúúĉÖøĆöǰ0.5 ÖøĆö 750 öĉúúĉÖøĆö êćöúĞćéĆï)
(3) ÖøèĊìĊęđðŨî÷ćÝćÖÿöčîĕóøĒñîðŦÝÝčïĆî ĔĀšøąïčÙüćöĒøÜêćööćêøåćîìĊęøąïčĕüšĔîêĞćøć÷ćìĊęøĆåöîêøĊ
ðøąÖćýǰĀøČĂĒîüìćÜÖćøÙüïÙčöÙčèõćó×ĂÜ÷ćéĆÜÖúŠćüàċęÜđðŨîìĊę÷ĂöøĆïǰ
1.3 øĎðĒïï÷ć (Pharmaceutical dosage form)
ĒÿéÜøĎðĒïï÷ćìĊęđðŨîöćêøåćîêćöìĊęÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćÖĞćĀîé
ĀĆü×šĂìĊęǰ2 ÿŠüîðøąÖĂïĒúąðøĉöćèêĆü÷ćÿĞćÙĆâ (Qualitative and quantitative composition)

ĔĀšĒÿéÜ×šĂöĎúÿŠüîðøąÖĂïêĆü÷ćÿĞćÙĆâ (Qualitative Declaration) ĒúąðøĉöćèêĆü÷ćÿĞćÙĆâ
(Quantitative Declaration) êćöøĎðĒïïéĆÜîĊĚ
Ĕîǰ1 <ĀîŠü÷> ðøąÖĂïéšü÷ <ßČęĂõćþćĕì÷×ĂÜêĆü÷ćÿĞćÙĆâǰđÖúČĂ/đĂÿđìĂøŤ/ĕăđéøê > <(ßČęĂêĆü÷ćÿĞćÙĆâ
õćþćĂĆÜÖùþ)> <ÙüćöĒøÜ>
đßŠîǰĔîǰ1 đöĘéǰðøąÖĂïéšü÷ àĆúôćđöíĂÖàćēàúǰ(Sulfamethoxazole) 400 öĉúúĉÖøĆöǰĒúąǰĕêøđöēíóøĉö
(Trimethoprim) 80 öĉúúĉÖøĆö
ÖøèĊìĊęĔßšđĂÖÿćøÖĞćÖĆï÷ćøŠüöÖĆîĔĀšøąïčßČęĂÖćøÙšćÖĞćÖĆïĕüšÖŠĂîÖćøøąïčÿŠüîðøąÖĂïĒúąðøĉöćè×ĂÜ÷ć
ĒêŠúąøĎðĒïïĒúąÙüćöĒøÜđÿöĂ êćöøĎðĒïïéĆÜîĊĚ
<ßČęĂÖćøÙšć>
Ĕîǰ1 <ĀîŠü÷> ðøąÖĂïéšü÷ <ßČęĂõćþćĕì÷×ĂÜêĆü÷ćÿĞćÙĆâǰđÖúČĂ/đĂÿđìĂøŤ/ĕăđéøêǰ> <(ßČęĂêĆü÷ćÿĞćÙĆâ
õćþćĂĆÜÖùþ)> <ÙüćöĒøÜ>
ĒîüðäĉïĆêĉĔîÖćøĒÿéÜ×šĂöĎúêĆü÷ćÿĞćÙĆâöĊéĆÜîĊĚ
1) đĂÖÿćøÖĞćÖĆï÷ćõćþćĕì÷ĔĀšøąïčßČęĂÿćöĆâìćÜ÷ćđðŨîõćþćĕì÷ǰêćöéšü÷øĎðĒïïđÖúČĂ/đĂÿđìĂøŤ/ĕă
đéøê ĒúąÙüøüÜđúĘ ï õćþćĂĆ ÜÖùþĕüš éš ü ÷ǰÿŠ ü îđĂÖÿćøÖĞ ćÖĆ ï ÷ćõćþćĂĆ ÜÖùþĔĀš øąïč ßČęĂÿćöĆ âìćÜ÷ćđðŨ î
õćþćĂĆÜÖùþǰêćöéšü÷đÖúČĂ/đĂÿđìĂøŤ/ĕăđéøê
2) ßČęĂÿćöĆâìćÜ÷ćĔßšêćööćêøåćî International Nonproprietary Names (INNs) ĔîÖøèĊìĊęßČęĂǰINNs
ĕöŠđðŨîìĊęøĎšÝĆÖĔĀšüÜđúĘïßČęĂÿćöĆâĂČęîĕüšìšć÷ßČęĂǰINNs ĀćÖĕöŠöĊßČęĂǰINNs ĔĀšĔßšßČęĂÿćöĆâìćÜ÷ćêćöìĊęÿĞćîĆÖÜćî
ÙèąÖøøöÖćøĂćĀćøĒúą÷ćÖĞćĀîé ēé÷øąïčßČęĂĔĀšÙøïìĆĚÜøĎðĒïï×ĂÜđÖúČĂĀøČĂđĂÿđìĂøŤĀøČĂĕăđéøê×ĂÜ÷ćîĆĚîǰ
đßŠî ĂąöĂÖàĉàĉúúĉîĕìøĕăđéøêǰĀøČĂǰĒĂöóĉàĉúúĉîēàđéĊ÷ö
3) ßČęĂÿćöĆâìćÜ÷ćõćþćĕì÷ĔĀšđ×Ċ÷îêćöĀúĆÖđÖèæŤüĉíĊÖćøđ×Ċ÷î×ĂÜøćßïĆèæĉê÷ÿëćîǰ
4) ÖøèĊìĊęđðŨî÷ćÝćÖÿöčîĕóøĒñîðŦÝÝčïĆî ĔĀšøąïčßČęĂÿćöĆâìćÜ÷ćêćöêĞćøć÷ćìĊęøĆåöîêøĊðøąÖćýǰĀøČĂ
ĒîüìćÜÖćøÙüïÙčöÙčèõćó×ĂÜ÷ćéĆÜÖúŠćüàċęÜđðŨîìĊę÷ĂöøĆï
ĒîüðäĉïĆêĉĔîÖćøĒÿéÜÙüćöĒøÜ×ĂÜêĆü÷ćÿĞćÙĆâöĊéĆÜîĊĚǰ
1) ĔĀšøąïčÙüćöĒøÜêćöĒîüìćÜìĊęøąïčĔîĀĆü×šĂìĊęǰ1 ßČęĂñúĉêõĆèæŤ

11
2) ÖøèĊêĆü÷ćÿĞćÙĆâĂ÷ĎŠĔîøĎð×ĂÜđÖúČĂǰĀøČĂĕăđéøêǰ(hydrate form)
2.1.1) ĔĀšøąïčðøĉöćè×ĂÜêĆü÷ćÿĞćÙĆâêćöêĆü÷ćìĊęĂĂÖùìíĉĝǰđßŠîǰßČęĂÿćøĔîøĎðđïÿǰøĎðÖøéǰ(acid) ĀøČĂøĎð
ðøćýÝćÖîĚĞćǰ(anhydrous) (ĀøČĂ÷ćßĊüüĆêëčøąïčǰbiological activity êćöĀîŠü÷ÿćÖú)
đßŠîǰ“60 mg toremifene (as citrate)” ēìøĉöĉôŘî (ĔîøĎðđÖúČĂàĉđêøì) 60 öĉúúĉÖøĆöǰĀøČĂ
“toremifene citrate equivalent to 60 mg toremifene” ēìøĉöĉôŘîàĉđêøìÿööĎúÖĆïēìøĉöĉôŘî 60 öĉúúĉÖøĆö
“500 mg amoxicillin (as trihydrate)” ĂąöĂÖàĉàĉúúĉîǰ(ĔîøĎðĕìøĕăđéøê) 500 öĉúúĉÖøĆöǰĀøČĂǰ
“Amoxicillin trihydrate equivalent to 500 mg amoxicillin” ĂąöĂÖàĉàĉúúĉîĕìøĕăđéøêǰÿööĎúÖĆïĂąöĂÖàĉ
àĉúúĉîǰ500 öĉúúĉÖøĆö”
2.1.2) ĔîÖøèĊìĊęêĆü÷ćÿĞćÙĆâđðúĊę÷îĕðĂ÷ĎŠĔîøĎðđÖúČĂĀøČĂĕăđéøêĀúĆÜñÿö÷ćǰĔĀšøąïčðøĉöćèêĆü÷ćÿĞćÙĆâìĊę
ĂĂÖùìíĉĝǰēé÷ĂšćÜĂĉÜêĆü÷ćÿĞćÙĆâĔîøĎðđÖúČĂĀøČĂĕăđéøêǰìĊęđÖĉé×ċĚîĀúĆÜđêøĊ÷ö÷ćĕüšéšü÷
2.1.3) ĀćÖêĆü÷ćÿĞćÙĆâ×ĂÜñúĉê õĆèæŤ÷ćĔéöĊÖćøøąïčÙüćöĒøÜĔîøĎð×ĂÜđÖúČ ĂĀøČĂĕăđéøêöćĂ÷ŠćÜ
ÖüšćÜ×üćÜđðŨîđüúćîćîǰĂćÝĒÿéÜðøĉöćè×ĂÜêĆü÷ćÿĞćÙĆâéĆÜÖúŠćüĔîøĎð×ĂÜđÖúČĂĀøČĂĕăđéøêÖĘĕéšǰđßŠîǰĒÿéÜđðŨîǰ
“diltiazem hydrochloride 60 mg” ìĆĚÜßîĉéđöĘéĒúąÞĊé
3) ÖøèĊêĆü÷ćÿĞćÙĆâĂ÷ĎŠĔîøĎð×ĂÜđĂÿđìĂøŤĒúą÷ćēóøéøĆÖǰ(pro-drugs)
ĔĀšøąïčðøĉöćè×ĂÜêĆü÷ćÿĞćÙĆâĔîøĎðđĂÿđìĂøŤĀøČĂēóøéøĆÖǰ(pro-drugs) ĔîÖøèĊđðŨîêĆü÷ćÿĞćÙĆâìĊęđÙ÷
ĂîčöĆêĉìąđïĊ÷îêĞćøĆï÷ćĕüšĒúšüĂćÝĒÝšÜðøĉöćè×ĂÜêĆü÷ćÿĞćÙĆâêćöêĆü÷ćìĊęĂĂÖùìíĉĝÖĘĕéš
đßŠîǰ“75 mg of fosphenytoin is equivalent to 50 mg of phenytoin” ĀøČĂǰ“ôĂÿđôîĉìĂ÷îŤǰ75 öĉúúĉÖøĆöǰ
ÿööĎúÖĆïđôîĉìĂ÷îŤǰ50 öĉúúĉÖøĆö”
4) ÖøèĊ÷ćñÜñÿöîĚĞćÖŠĂîĔßšÿĞćĀøĆïøĆïðøąìćîǰǰßîĉé÷ćîĚĞćĒ×üîêąÖĂîĀøČĂ÷ćîĚĞćĔÿǰ(Oral powders
for solution or suspension)
4.1) ĔĀšøąïčðøĉöćè×ĂÜêĆü÷ćÿĞćÙĆâêŠĂĀîċęÜĀîŠü÷ðøĉöćêøĀúĆÜñÿöîĚĞćǰĔîïćÜÖøèĊÙüøøąïčÙüćöđ×šö×šî
ĔîĀîŠü÷ēöúćøŤǰ(molar concentration) êćöÙüćöđĀöćąÿöǰ
4.2) ÖøèĊ÷ćñÜĒïŠÜêćö×îćéĔßšǰ(single-dose preparation) ĔĀšøąïčðøĉöćè×ĂÜêĆü÷ćÿĞćÙĆâêŠĂĀîċęÜ
ĀîŠü÷×ĂÜ×îćéĀîċęÜöČĚĂ÷ćǰ(unit dose)
5) ÖøèĊ÷ćÞĊéǰ(Parenterals)
5.1) ÖøèĊ÷ćÞĊéǰ(Parenterals) ÷ÖđüšîǰßîĉéñÜìĊęñÿöÖŠĂîĔßšǰ(powder for reconstitution)
5.1.1) ÖøèĊ÷ćÞĊéĒïŠÜêćö×îćéĔßšǰàċęÜïøøÝč÷ćĔîĀîċęÜ×îćéÖćøøĆÖþćĕüšĔîïøøÝčõĆèæŤđéĊ÷üÖĆî (single-
dose parenterals)
ēé÷ìĆę ü ĕðĔĀš øąïčð øĉ öćè×ĂÜêĆ ü ÷ćÿĞ ćÙĆ âêŠ ĂĀîċę ÜĀîŠ ü ÷ïøøÝč õĆ èæŤ ǰēé÷ĕöŠ øüöðøĉ öćèìĊę ï øøÝč đ Öĉ îĕüšǰ
(overages/overfills) đßŠîǰ20 öĉúúĉÖøĆöǰîĂÖÝćÖîĊĚǰÙüøøąïčðøĉöćèêĆü÷ćÿĞćÙĆâêŠĂĀîċęÜöĉúúĉúĉêøǰĒúąðøĉöćêø
×ĂÜ÷ćìĆĚÜĀöéǰ(total labeled volume) êćöìĊęĒÿéÜĔîÞúćÖĕüšéšü÷
đüšîĒêŠÖøèĊìĊęöĊÖćøÙĞćîüè×îćéÖćøøĆÖþćēé÷ĔßšîĚĞćĀîĆÖêĆüĀøČĂóČĚîìĊęñĉüĀøČĂêĆüĒðøĂČęîėǰ(partial use)
ĔĀšøąïčðøĉöćè×ĂÜêĆü÷ćÿĞćÙĆâêŠĂĀîċęÜĀîŠü÷öĉúúĉúĉêøǰîĂÖÝćÖîĊĚǰÙüøøąïčðøĉöćè×ĂÜêĆü÷ćÿĞćÙĆâêŠĂðøĉöćêø×ĂÜ
÷ćìĆĚÜĀöéìĊęĒÿéÜĕüšĔîÞúćÖĕüšéšü÷ǰìĆĚÜîĊĚĕöŠÙüøĒÿéÜðøĉöćèìĊęïøøÝčĕüšđÖĉîǰ(overages/overfills)
5.1.2) ÖøèĊ÷ ćÞĊéðøĉöćêøöćÖĔîøĎðĒïï÷ćĀúć÷ĀîŠü÷ǰ(multi-dose and large volume
parenterals) ĔĀšøąïčðøĉöćè×ĂÜêĆü÷ćÿĞćÙĆâêŠĂöĉúúĉúĉêøǰĀøČĂǰêŠĂǰ100 öĉúúĉúĉêøǰĀøČĂêŠĂǰ1,000 öĉúúĉúĉêøǰđðŨî
êšîǰêćöÙüćöđĀöćąÿöǰđüšîĒêŠÖøèĊ÷ćüĆÙàĊîĔîøĎðĒïï÷ćĀúć÷ĀîŠü÷ǰ(multidose vaccines) ìĊęöĊ×îćéĔßšđìŠćėǰ
ÖĆîǰĔĀšøąïčÙüćöĒøÜêŠĂĀîċęÜĀîŠü÷ðøĉöćêø×ĂÜ×îćéĔßšǰ(per dose volume) ìĆĚÜîĊĚĕöŠÙüøĒÿéÜðøĉöćèìĊęïøøÝčĕüš
đÖĉîǰ(overages/overfills)
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5.1.3) ĔîÖøèĊ×ĂÜ÷ćïćÜßîĉéǰđßŠîǰÿćøìċïøĆÜÿĊđĂÖàŤǰ(X-ray contrast media) Ēúą÷ćÞĊéìĊęöĊđÖúČĂǰĂîĉ
îìøĊ÷ŤđðŨîÿŠüîðøąÖĂïĔĀšøąïčðøĉöćè×ĂÜêĆü÷ćÿĞćÙĆâđðŨîöĉúúĉēöúǰ(millimoles) êćöÙüćöđĀöćąÿöǰÿĞćĀøĆï
ÿćøìċïøĆÜÿĊđĂÖàŤöĊĕĂēĂéĊîđðŨîêĆü÷ćÿĞćÙĆâĔĀšøąïčðøĉöćè×ĂÜĕĂēĂéĊîǰ(iodine) êŠĂöĉúúĉúĉêøǰđóĉęöđêĉöĕüšéšü÷
5.2) ÖøèĊ÷ćÞĊéßîĉéñÜìĊęñÿöÖŠĂîĔßšǰ
ĔĀš ø ąïč ð øĉ ö ćè×ĂÜêĆ ü ÷ćÿĞ ć ÙĆ â ìĆĚ Ü ĀöéĔîïøøÝč õĆ è æŤ ǰ ēé÷ĕöŠ Ù üøĒÿéÜðøĉ ö ćèìĊę ï øøÝč ĕ üš đ Öĉ îǰ
(overages/overfill) ĒúąøąïčðøĉöćèêĆü÷ćÿĞćÙĆâêŠĂöĉúúĉúĉêø×ĂÜ÷ćìĊęñÿöĒúšüǰđüšîĒêŠǰöĊüĉíĊÖćøñÿöĀúć÷üĉíĊĀøČĂ
öĊ×îćéÖćøĔßš÷ćĀúć÷×îćéàċęÜÿŠÜñúĔĀš÷ćìĊęñÿöĒúšüöĊÙüćöđ×šö×šîÿčéìšć÷ĒêÖêŠćÜÖĆîǰ
5.3) ĔĀšøąïč×šĂÙüćöüŠćǰ“ĀšćöîĞćðøĉöćèÿŠüîìĊęïøøÝčĕüšđÖĉîǰ(overages/overfills) öćĔßšĔîÖćøøĆÖþć”
êĆüĂ÷ŠćÜ ÷ćǰA ÖĞćĀîéïîđĂÖÿćøÖĞćÖĆï÷ćüŠćöĊêĆü÷ćǰ100 ĕöēÙøÖøĆöêŠĂǰ0.5 öĉúúĉúĉêøǰĒêŠĔĀšǰdiluents
öć 0.7 öĉúúĉúĉêøǰ ĀšćöđìĊ÷ïđÙĊ÷ÜüŠćđöČęĂñÿöĒúšüǰĀćÖéĎé÷ćöćĕéšǰ0.6 öĉúúĉúĉêøǰÝąöĊêĆü÷ćìĊęîĞćĕðĔßšĕéšǰ120
ĕöēÙøÖøĆöǰđðŨîêšî
6) ÖøèĊ÷ćßîĉéđ×šö×šîǰ(Concentrates)
ĔĀš ø ąïč ìĆĚ Ü ðøĉ ö ćè×ĂÜêĆ ü ÷ćÿĞ ć ÙĆ â êŠ Ă öĉ ú úĉ úĉ ê øĔî÷ćßîĉ é đ×š ö ×š î ǰĒúąðøĉ ö ćèêĆ ü ÷ćÿĞ ć ÙĆ â ìĆĚ Ü Āöéǰ
îĂÖÝćÖîĆĚîǰÙüøøąïčðøĉöćèêĆü÷ćÿĞćÙĆâêŠĂöĉúúĉúĉêø×ĂÜ÷ćìĊęđÝČĂÝćÜĒúšüéšü÷ǰđüšîĒêŠ÷ćìĊęñÿöĒúšüöĊÙüćöđ×šö×šî
ÿčéìšć÷ĒêÖêŠćÜÖĆî
7) ÖøèĊ÷ćĒñŠîĒðąßîĉéîĞćÿŠÜ÷ćñŠćîñĉüĀîĆÜ (Transdermal patches)
ĔĀšøąïčðøĉöćè×ĂÜêĆü÷ćÿĞćÙĆâéĆÜîĊĚǰðøĉöćèêĆü÷ćÿĞćÙĆâêŠĂĒñŠîĒðąǰ(per patch) ×îćé÷ćđÞúĊę÷ìĊęîĞćÿŠÜ
êŠĂĀîċęÜĀîŠü÷đüúćǰ(mean dose delivered per unit time) ĒúąóČĚîìĊęñĉüìĊęöĊÖćøÿŠÜñŠćî÷ćǰđßŠîǰĔîĒêŠúąĒñŠî
Ēðą×îćéǰ10 êćøćÜđàîêĉđöêøǰöĊ÷ćđĂÿìøćĕéĂĂúǰ750 ĕöēÙøÖøĆöǰàċęÜðúéðúŠĂ÷÷ćđĂÿìøćĕéĂĂúǰ25
ĕöēÙøÖøĆöìčÖǰ24 ßĆęüēöÜǰ
8) ÖøèĊ÷ćĒïïĀúć÷ĀîŠü÷ǰ(multidose) ĔîøĎðĒïï×ĂÜĒ×ĘÜǰ(solid) ĀøČĂÖċęÜĒ×ĘÜǰ(semi-solid)
ēé÷ìĆęüĕðĔĀšøąïčðøĉöćè×ĂÜêĆü÷ćÿĞćÙĆâêŠĂĀîċęÜĀîŠü÷×ĂÜ×îćéĀîċęÜöČĚĂ÷ćǰ(unit dose) ĔîÖøèĊðäĉïĆêĉ
ĕöŠĕéšĔĀšøąïčðøĉöćè×ĂÜêĆü÷ćÿĞćÙĆâêŠĂÖøĆöǰêŠĂǰ100 ÖøĆöǰĀøČĂøšĂ÷úąǰêćöÙüćöđĀöćąÿö
9) ÖøèĊ÷ćóŠî/÷ćÿĎéóŠî
øąïčêĆü÷ćÿĞćÙĆâêŠĂÖćøóŠîĀîċęÜÙøĆĚÜ
10) ÖøèĊ÷ćßĊüüĆêëčǰ(Biological medicinal products)
10.1) ÙüćöĒøÜ×ĂÜ÷ć
ĔĀšĒÝšÜðøĉöćèđðŨîĀîŠü÷öüúǰ(mass units) ĀîŠü÷×ĂÜùìíĉĝìćÜßĊüõćóǰ(biological activity) ĀøČĂĀîŠü÷
ÿćÖúǰ(International Units) êćöÙüćöđĀöćąÿöǰàċęÜĀîŠü÷×ĂÜ÷ćÙüøÿĂéÙúšĂÜÖĆïêĞćøć÷ćìĊęøĆåöîêøĊðøąÖćý
ĀøČĂêĞćøć÷ćìĊęđðŨîìĊę÷ĂöøĆïĔîøąéĆïÿćÖú
ĔîÖøèĊǰpegylated proteins ĔĀšĒÿéÜ×šĂöĎúéĆÜîĊĚǰ
Ö.øąïčðøĉöćèìĊęÿĂéÙúšĂÜÖĆïÙüćöĒøÜìĊęĕéšÝćÖÖćøêøüÝüĉđÙøćąĀŤǰ(assay) ĒúąđðŨîðøĉöćè×ĂÜēðøêĊî
đìŠćîĆĚîǰǰĀšćöÖĞćĀîéÙüćöĒøÜēé÷đðøĊ÷ ïđìĊ÷ïÖĆ ïñúĉêõĆèæŤēðøêĊî ĂČęîĔîÖúčŠöÖćøøĆ ÖþćđéĊ÷ üÖĆîĕöŠüŠ ćÝąđðŨ îǰ
pegylated ĀøČĂǰnon pegylated Ēúą
×.ĔĀšøć÷úąđĂĊ÷éēðøêĊîÿĆÜ÷čÙǰ(protein conjugate) éĆÜîĊĚǰ
“êĆü÷ćÿĞćÙĆâđðŨîǰēðøêĊîÿĆÜ÷čÙ (protein conjugate) àċęÜēÙüćđúîàŤÖĆîøąĀüŠćÜǰ<ßîĉé×ĂÜēðøêĊîǰøąïïÖćø
ñúĉê> Ēúąǰ<ßČęĂóĂúĉđöĂøŤĔîēðøêĊîÿĆÜ÷čÙ>
“The active substance is a covalent conjugate of <type of protein, production system> with
<name of polymer contained in conjugate>”
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10.2) ĒĀúŠÜÖĞćđîĉéìćÜßĊüüĉì÷ćǰ(biological origin) ×ĂÜêĆü÷ćÿĞćÙĆâǰ
øąïčĒĀúŠÜÖĞćđîĉé×ĂÜêĆü÷ćÿĞćÙĆâēé÷ÿøčðǰ
ĔîÖøèĊÖćøĔßšđìÙēîēú÷ĊéĊđĂĘîđĂúĎÖñÿöǰ(recombinant DNA technology) Ùüøøąïčßîĉé×ĂÜđàúúŤìĊęĔßš
ĔîÖćøñúĉêǰēé÷øĎðĒïï×šĂÙüćöìĊęĒÿéÜđðŨîéĆÜîĊĚ
“ñúĉêĔîđàúúŤ XXX <ēé÷ĔßšđìÙēîēú÷ĊéĊđĂĘîđĂúĎÖñÿö>”
“produced in XXX cells <by recombinant DNA technology>”
êĆüĂ÷ŠćÜĔîÖćøøąïčĒĀúŠÜÖĞćđîĉéìćÜßĊüüĉì÷ćǰđßŠîǰ
“produced in human diploid (MRC-5) cells”,
“produced in Escherichia coli cells by recombinant DNA technology”,
“produced in chick-embryo cells”,
“produced from the plasma of human donors”,
“produced from human urine”,
“produced from <animal>blood”,
“produced from porcine pancreatic tissue”,
“produced from porcine intestinal mucosa”.
10.3) ×šĂÖĞćĀîéđÞóćą×ĂÜ÷ćĂĉööĎēîēÖúïĎúĉîǰ(normal immunoglobulins)
ĔĀšøąïčøšĂ÷úą×ĂÜðøĉöćèĂĉööĎēîēÖúïĎúĉîßîĉéÝĊ (immunoglobulin G ĀøČĂǰIgG) ĒêŠúąßîĉé÷ŠĂ÷ǰ
(subclass) êŠĂðøĉöćèìĆĚÜĀöé×ĂÜĂĉööĎēîēÖúïĎúĉîßîĉéÝĊǰ(total IgG) Ēúšüêćöéšü÷×ĊéÝĞćÖĆéÿĎÜÿčéǰ(upper limit) ×ĂÜ
ðøĉöćèĂĉööĎēîēÖúïĎúĉîßîĉéđĂǰ(IgA)
10.4) ×šĂÖĞćĀîéđÞóćą×ĂÜüĆÙàĊîǰ(vaccines)
ĔĀšĒÿéÜðøĉöćèêĆü÷ćÿĞćÙĆâêŠĂ×îćéÖćøøĆÖþćǰ(dose unit) đßŠîǰêŠĂǰ0.5 öĉúúĉúĉêøǰĔîÖøèĊöĊÿćøðøčÜøĎð
÷ćǰ(adjuvant) ĔĀšøąïčßîĉéĒúąðøĉöćèĕüšéšü÷
ÿŠüîêÖÙšćÜǰ(residues) ìĊęöĊÙüćöÿĞćÙĆâĔĀšøąïčĕüšéšü÷ǰđßŠîǰĒĂúïĎöĉî×ĂÜĕ×Š×ćüǰ(ovalbumin) ìĊęĔßšĔî
ÖøąïüîÖćøñúĉêüĆÙàĊî
îĂÖÝćÖîĊĚÙüøýċÖþćđóĉęöđêĉöÝćÖĒîüìćÜÿćÖúêŠćÜėǰ×ĂÜ÷ćüĆÙàĊî ǰđßŠîǰCHMP guidelines on
biotechnological medicinal products đðŨîêšî
ĀĆü×šĂìĊę 3 úĆÖþèąĒúąøĎðĒïï÷ćìćÜđõÿĆßÖøøö (Pharmaceutical Form)

ĔĀšĒÿéÜ×šĂöĎúêćö×šĂÖĞćĀîééĆÜîĊĚ
3.1 ĒÿéÜ×šĂÙüćöêćöøĎðĒïïéĆÜîĊĚǰ
<øĎðĒïï÷ć> <úĆÖþèąõć÷îĂÖìĊęđĀĘîĕéšéšü÷êćđðúŠćǰ>
3.2 øąïčøĎðĒïï÷ćìĊęĒÿéÜĔĀšđĀĘîëċÜǰdrug delivery system đßŠîǰĂĂÖùìíĉĝîćîǰĂĂÖùìíĉĝìĆîìĊǰ÷ćđöĘé
đÙúČĂïĒêÖêĆüĔîúĞćĕÿšǰđðŨîêšîǰêćööćêøåćîøĎðĒïï÷ćìĊęÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćÖĞćĀîé
3.3 øąïč úĆ Ö þèąõć÷îĂÖìĊę đ ĀĘ î ĕéš éš ü ÷êćđðúŠ ć ǰđßŠ î ǰøĎ ð øŠ ć ÜǰÿĊ ǰ ÖćøđÙúČ Ă ïđöĘ é ÷ćǰ×îćéǰĂĆ Ö þøĒúą
đÙøČęĂÜĀöć÷ïîđöĘé÷ćǰđðŨîêšî
3.4 ĔîÖøèĊ÷ćđöĘéǰ(tablet) ìĊęöĊđÿšîĒïŠÜđöĘé÷ć ÙüøøąïčĔĀšßĆéđÝîëċÜüĆêëčðøąÿÜÙŤ×ĂÜÖćøöĊđÿšîĒïŠÜđöĘé÷ćîĆĚîǰ
đßŠîǰ“đÿšîĒïŠÜđöĘé÷ćöĊĕüšđóČęĂĒïŠÜ÷ćĔĀšÖúČîÜŠć÷ ĀšćöĔßšĒïŠÜ×îćé÷ć" “đÿšîĒïŠÜđöĘé÷ćöĊĕüšđóČęĂĒïŠÜ×îćé÷ć” đðŨîêšî
Āöć÷đĀêč ĔĀšñĎšðøąÖĂïÖćøĒÿéÜ×šĂöĎúĔĀšÿĂéÙúšĂÜÖĆïñúĉêõĆèæŤ×ĂÜĒêŠúąïøĉþĆì

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ĀĆü×šĂìĊęǰ4 ÙčèÿöïĆêĉìćÜÙúĉîĉÖ (Clinical Particulars)
ðøąÖĂïéšü÷ĀĆü×šĂ÷ŠĂ÷éĆÜîĊĚ
4.1 ×šĂïŠÜĔßš (Therapeutic indication)
4.2 ×îćé÷ćĒúąüĉíĊÖćøĔßš÷ć (Posology and method of administration)
4.4 ÙĞćđêČĂîóĉđýþ Ēúą×šĂÙüøøąüĆÜĔîÖćøĔßš÷ć (Special warning and precautions for use)
4.5 ĂĆîêøÖĉøĉ÷ćÖĆï÷ćĂČęîėĀøČĂĂĆîêøÖĉøĉ÷ćĂČęîė (Interaction with other medicinal products and
other forms of interactions)
4.7 ñúêŠĂÙüćöÿćöćøëĔîÖćø×Ćï×ĊęĒúąìĞćÜćîÖĆïđÙøČęĂÜÝĆÖø(Effects on ability to drive and use
machine)
4.1 ×šĂïŠÜĔßš (Therapeutic Indication)

×šĂïŠÜĔßšìĊęĒÿéÜĔîđĂÖÿćøÖĞćÖĆï÷ćìčÖðøąđõìǰêšĂÜøąïčëċÜÖćøĔßšĀøČĂüĆêëčðøąÿÜÙŤ×ĂÜñúĉêõĆèæŤàċęÜêšĂÜ
ßĆéđÝîüŠćöčŠÜĀöć÷đóČęĂÖćøøĆÖþćǰðŜĂÜÖĆîǰïĞćïĆéǰïøøđìćĀøČĂüĉîĉÝÞĆ÷ēøÙĀøČĂÿõćüą×ĂÜēøÙ ēé÷øąïčßČęĂēøÙĀøČĂ
ÿõćüą×ĂÜēøÙđðŜćĀöć÷ìĊęđÞóćąđÝćąÝÜĕüšĂ÷ŠćÜßĆéđÝîǰàċęÜêšĂÜöĊĀúĆÖåćîìćÜüĉßćÖćøìĊęîŠćđßČęĂëČĂÿîĆïÿîčîĂ÷ŠćÜ
đóĊ÷ÜóĂǰ(supported by substantial evidence) ìĆĚÜîĊĚǰ×šĂïŠÜĔßšìĊęĂîčâćêÝĞćđðŨîêšĂÜöĊðøąē÷ßîŤöćÖÖüŠćÙüćö
đÿĊę÷Ü×ĂÜ÷ćǰêćöđÖèæŤìĊęÖĞćĀîé ĒúąĕöŠĂîčâćêĔĀš÷ćĔéĒÿéÜ×šĂïŠÜĔßšìĊęĕöŠÝĞćđóćąđÝćąÝÜ ĀøČĂĕöŠöĊ×šĂöĎúìĊę
đóĊ÷ÜóĂĔîÖćøÖĞćĀîé×îćé÷ćǰÿĞćĀøĆïĀúĆÖåćîìĊęĔßš×ċĚîÖĆïðøąđõì×ĂÜ÷ćǰìĊęÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą
÷ćÝąĕéšðøąÖćýÖĞćĀîé ÿĞćĀøĆï÷ćÿĎêøñÿöĔĀšóĉÝćøèćêćöĒîüìćÜÖćøóĉÝćøèć÷ćÿĎêøñÿöìĊęÿĞćîĆÖÜćîĄǰÝąĕéš
ðøąÖćýÖĞćĀîéðøąÖĂïéšü÷
ĔîïćÜÖøèĊñúĉêõĆèæŤĂćÝöĊüĆêëčðøąÿÜÙŤĂČęîė ìĊęĕöŠđðŨîêćöÙüćöĀöć÷×šćÜêšî đßŠîǰĔßšđðŨîêĆüìĞćúąúć÷ǰ
Öćøøąïč×šĂïŠÜĔßšĔĀšóĉÝćøèćđðŨîÖøèĊĕðêćöÙüćöđĀöćąÿö
ĔîÖøèĊ×ĂÜ÷ćìĆęüĕðǰ“ĀúĆÖåćîéĆÜÖúŠćü” Āöć÷ëċÜǰÖćøýċÖþćìĊęöĊÖúčŠöÙüïÙčöàċęÜöĊÙčèõćóéĊ (adequate
and well-controlled studies) ĀøČĂĀúĆÖåćîìĊęĒÿéÜüŠćđðŨî÷ćǰwell established medicine êćöĀúĆÖđÖèæŤ/
ĒîüìćÜìĊęìĊęÿĞćîĆÖÜćîĄǰÝąĕéšðøąÖćýÖĞćĀîé ÿĞćĀøĆï÷ćÿĎêøñÿöĔĀšóĉÝćøèćêćöĀúĆÖđÖèæŤÖćøóĉÝćøèć÷ćÿĎêø
ñÿöìĊęÿĞćîĆÖÜćîĄǰÝąĕéšðøąÖćýÖĞćĀîéðøąÖĂïéšü÷ǰÿĞćĀøĆï÷ćßĊüüĆêëčǰ×šĂïŠÜĔßšìĆĚÜĀöéìĊęøąïčĕüšÝąêšĂÜöĊĀúĆÖåćî
ìćÜüĉßćÖćøìĊęîŠćđßČęĂëČĂÿîĆïÿîčîĂ÷ŠćÜđóĊ÷ÜóĂ
ĔîđĂÖÿćøÖĞćÖĆï÷ćÝąêšĂÜĕöŠöĊ×šĂÙüćöđÖĊę÷üÖĆï×šĂïŠÜĔßšĀøČĂÿøøóÙčèìĊęîĂÖđĀîČĂĕðÝćÖ×šĂïŠÜĔßšìĊęøąïčĕüš
ĔîĀĆü×šĂîĊĚǰ
ĀćÖ×šĂïŠÜĔßšĔé×ĂÜ÷ćđðŨîìĊęđßČęĂÖĆîēé÷ìĆęüĕðüŠćĂćÝöĊðøąÿĉìíĉñúǰĀøČĂöĊÖćøĔßš÷ćĔî×šĂïŠÜĔßšîĆĚîĂ÷ŠćÜ
ÖüšćÜ×üćÜǰĒêŠêŠĂöćöĊĀúĆÖåćîđßĉÜðøąÝĆÖþŤìĊęĒÿéÜüŠć×šĂïŠÜĔßšîĆĚîĕöŠöĊðøąÿĉìíĉñúÝøĉÜǰĀøČĂĕéšøĆïðøąē÷ßîŤĕöŠÙčšöÖĆï
ÙüćöđÿĊę÷ÜÝćÖÖćøĔßš÷ćĔî×šĂïŠÜĔßšéĆÜÖúŠćüǰÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćĂćÝĔĀšñšĎøĆïĂîčâćêêšĂÜøąïč
×šĂÙüćöîĊĚǰǰǰ“ĕöŠÙüøĔßš÷ćîĊĚĔîÖøèĊ.............đóøćą............”êĆüĂ÷ŠćÜđßŠîǰ“ĕöŠÙüøĔßšǰnifedipine Ēïïǰimmediate
release ĔîÖćøøĆÖþćēøÙÙüćöéĆîēúĀĉêÿĎÜǰĒúąÙüïÙčöÙüćöéĆîēúĀĉêĔîøą÷ą÷ćüǰđóøćąđÿĊę÷ÜêŠĂñúĕöŠóċÜðøąÿÜÙŤ
êŠĂĀĆüĔÝĒúąĀúĂéđúČĂéìĊęøčîĒøÜ”

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×šĂïŠÜĔßšǰ(Indication) öĊđîČĚĂĀćđðŨîĕðêćö×šĂÖĞćĀîéđøČęĂÜǰ“×šĂÖĞćĀîéìĆęüĕðÿĞćĀøĆïÖćøÝĆéìĞćđĂÖÿćø
ÖĞćÖĆï÷ćÿĞćĀøĆïïčÙúćÖøìćÜÖćøĒóì÷Ť ×šĂ 3. ÙčèúĆÖþèąìĆęüĕð×ĂÜđîČĚĂĀć” ĒúąöĊ×šĂÖĞćĀîéđóĉęöđêĉöéĆÜêŠĂĕðîĊĚ
1) ĔĀšøąïč×šĂïŠÜĔßšĔĀšÖøąßĆïĒúąßĆéđÝîüŠćĔßšǰ“øĆÖþć” ĀøČĂǰ“ðŜĂÜÖĆî” ĀøČĂǰ“ïøøđìćĂćÖćø” ĀøČĂǰ
“üĉîĉÝÞĆ÷” ēøÙĀøČĂÿõćüą×ĂÜēøÙìĊęđðŨîđðŜćĀöć÷×ĂÜÖćøĔßš÷ćǰêĆüĂ÷ŠćÜđßŠîǰøĆÖþćēøÙđïćĀüćîßîĉéìĊę1 ēé÷
ÙüïÙčöøąéĆïîĚĞćêćúĔîđúČĂéǰïøøđìćĂćÖćøðüéýĊøþąĒïï tension headache đðŨîêšîǰĀćÖêšĂÜÖćøĔßšÙĞćüŠćǰ
“øĆÖþć” ÙüøöĊÙüćöĀöć÷ëċÜǰÖćøøĆÖþćēøÙĀøČĂ×ÝĆéēøÙĔĀšĀć÷×ćéǰĀøČĂ ÙüïÙčöÖćøéĞćđîĉî×ĂÜēøÙǰ(curative
or modifying the evolution or progression of the disease)
2) ĔßšÙĞćüŠćǰ“ðŜĂÜÖĆî” ĔîïćÜÖøèĊìĊęÝĞćđðŨîǰēé÷ĔĀšøąïčßĆéđÝîüŠćđðŨîÖćøðŜĂÜÖĆîĒïïðåöõĎöĉǰĀøČĂǰ
ìčêĉ÷õĎöĉ (primary or secondary) ĔĀšÿĂéÙúšĂÜÖĆïĀúĆÖåćîìćÜÖćøĒóì÷Ťǰ
3) ÖøèĊ÷ćìĊęĕöŠĔßŠ÷ćĀúĆÖĔîÖćøøĆÖþćǰĒêŠĂćÝĔĀšđóĉęöđêĉöđ×šćĕðĔîÖøąïüîÖćøøĆÖþćĀúĆÖǰ(đßŠîǰÖćø
ÙüïÙčöĂćĀćøǰÖćøñŠćêĆéǰÖćøđðúĊę÷îĒðúÜóùêĉÖøøöǰĀøČĂ÷ćĂČęîǰė) ēé÷ìĆęüĕðĀöć÷ëċÜ÷ćìĊęöĊ×šĂïŠÜĔßšÖĆïñĎšðśü÷ïćÜ
øć÷ìĊęĔßšüĉíĊÖćøøĆÖþćĀúĆ ÖĀøČĂ÷ćĀúĆÖøĆÖþćĒúšü÷Ć ÜĕöŠĕéšñúêćöìĊęêšĂÜÖćøĂćÝøąïč×šĂïŠ ÜĔßšÙČĂǰĔßš đðŨî÷ćđÿøĉ ö
(adjunct therapy) Āöć÷ëċÜǰ÷ćđĀúŠćîĊĚÝĞćđðŨîêšĂÜöĊÖøąïüîÖćøøĆÖþćĂČęîøŠüöéšü÷đÿöĂ đßŠîǰ(÷ćÙúć÷ÖúšćöđîČĚĂ)
ĔßšđðŨî÷ćđÿøĉöøŠüöÖĆïÖćøóĆÖñŠĂîǰÖć÷õćóïĞćïĆéǰĒúąÖćøøĆÖþćĂČęîǰĔîÖćøïøøđìćĂćÖćøđÝĘïÖúšćöđîČĚĂĒïï
đÞĊ÷ïóúĆîÝćÖēøÙ×ĂÜÖúšćöđîČĚĂēÙøÜøŠćÜǰmusculoskeletal condition, (÷ćúéĕ×öĆî) ĔßšđðŨî÷ćđÿøĉöĔîÖćø
ÙüïÙčöøąéĆïĕ×öĆîĔîđúČĂéøŠüöÖĆïÖćøÙüïÙčöĂćĀćøǰ
4) ĔîïćÜÖøèĊĂćÝöĊ×šĂ÷ÖđüšîđÖĊę÷üÖĆïÖćøøąïč×šĂïŠÜĔßšéšü÷ÙĞćüŠć “øĆÖþć” êćöÙüćöĀöć÷Ĕî×šĂ 2
đßŠîøąïč×šĂïŠÜĔßšüŠćǰĔßšøĆÖþćðøąÙĆïðøąÙĂÜ (supporting treatment) àċęÜĀöć÷ëċÜǰÖćøøĆÖþćđóČęĂÙÜÿõćóÙüćö
ÿöéčú÷Ť×ĂÜøŠćÜÖć÷ĔîĒÜŠ×ĂÜÿĆââćèßĊó (vital signs) ĒúąõćüąíĞćøÜéčúǰ(homeostasis) ĀøČĂĔîïćÜÖøèĊĂćÝ
øąïč×šĂïŠÜĔßšüŠćǰĔßšøŠüöĔîÖøąïüîÖćøøĆÖþć đßŠîǰĔßšøŠüöĔîÖøąïüîÖćøøĆÖþć pancreatic fistula àċęÜĀöć÷ëċÜǰ
ÖćøøĆÖþćìćÜ÷ćìĊęđðŨîÿŠüîĀîċęÜ×ĂÜÖćøøĆÖþćìĊęêšĂÜĔßšüĉíĊÖćøøĆÖþćĀúć÷üĉíĊøŠüöÖĆî
5) ×šĂöĎúêŠĂĕðîĊĚÝąêšĂÜðøćÖäĔîđĂÖÿćøÖĞćÖĆï÷ćõć÷ĔêšĀĆü×šĂǰ“×šĂïŠÜĔßš” ĀćÖÿćöćøëøąïčĕéšǰ
Ö. øąïčĔĀšìøćïüŠć÷ćîĊĚđðŨî÷ćđÿøĉöìĊęĔßšøŠüöÖĆïÖćøøĆÖþćĀúĆÖǰ(éĎ×šĂ 4)
×. ĀćÖöĊĀúĆÖåćîÿîĆïÿîčîðøąÿĉìíĉñúĒúąÙüćöðúĂéõĆ÷×ĂÜ÷ćđÞóćąïćÜÖúčŠöðøąßćÖøǰĔĀšøąïčĔĀš
ßĆéđÝîüŠć×šĂïŠÜĔßšîĆĚîĔßšÖĆïÖúčŠöðøąßćÖøĔéǰđßŠî
x ÖúčŠöñĎšðśü÷ìĊęöĊÙüćöøčîĒøÜ×ĂÜēøÙĔîøąéĆïêŠćÜǰėǰÖĆîǰđßŠîǰÙüćöøčîĒøÜîšĂ÷ǰÙüćöøčîĒøÜĔî
øąéĆïðćîÖúćÜǰ
x đóýǰ: ĀćÖñúĉêõĆèæŤîĆĚîöĊ×šĂïŠÜĔßšìĊęđÝćąÝÜđÞóćąïćÜđóýǰĔĀšøąïčđóýìĊęßĆéđÝîĕüšéšü÷
x ÖúčŠöĂć÷čǰ: ĀćÖñúĉêõĆèæŤîĆĚîöĊ×šĂïŠÜĔßšìĊęđÝćąÝÜđÞóćąïćÜÖúčŠöĂć÷čǰĔĀšøąïčßŠüÜĂć÷čìĊęßĆéđÝîĕüš
éšü÷ǰđßŠî
÷ć “Ö” öĊ×šĂïŠÜĔßšÖĆïđéĘÖǰĀøČĂüĆ÷øčŠîǰìĊęöĊĂć÷čêĆĚÜĒêŠǰ…. đéČĂî/...ðŘ
Ù. ëšćÖćøìéÿĂïđÞóćąöĊÙüćöÝĞćđðŨîÿĞćĀøĆïÖćøêĆéÿĉîĔÝđúČĂÖĔßš÷ćĀøČĂÖćøêĉéêćöñĎšðśü÷ǰ(đßŠîǰÖćø
ìéÿĂïÙüćöĕü×ĂÜđßČĚĂ) ĔĀšøąïčúĆÖþèą×ĂÜÖćøìéÿĂïéĆÜÖúŠćüǰ
Ü. ëšć×šĂïŠÜĔßšĒðøñĆîêćö×îćé÷ćĒúąøą÷ąđüúćÖćøĔßš ĔĀšøąïčøć÷úąđĂĊ÷éĕüšĔîĀĆü×šĂ×îćé÷ćĒúą
üĉíĊÖćøĔßš÷ć
Ý. ĀćÖ÷ćĔéöĊðŦâĀćéšćîÙüćöðúĂéõĆ÷ĔĀšÿĞćøĂÜǰ(reserve) ĕüšĔßšĔîÖøèĊìĊęÝĞćđðŨîǰ(đßŠîǰĔîøć÷ìĊęĕöŠ
ÿćöćøëĔßš÷ćĂČęîøĆÖþćĕéšǰĀøČĂÖøèĊìĊęĔßš÷ćĂČęîĒúšüĕöŠĕéšñú) ĔĀšøąïč×šĂÙüćöüŠć
“ÙüøÿĞćøĂÜ÷ćîĊĚĕüšĔßšĔîÖøèĊìĊęÝĞćđðŨîĒúąóĉÝćøèćÙüćöðúĂéõĆ÷×ĂÜ÷ćîĊĚĂ÷ŠćÜøĂïÙĂï”

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Þ. ĀćÖöĊđÜČęĂîĕ×ĔéìĊęêšĂÜïøøúčĀøČĂÖøąìĞćĔĀšÿĞćđøĘÝÖŠĂîìĊęÝąêĆéÿĉîĔÝĔßš÷ćĔîøą÷ą÷ćüǰ(đßŠîǰñĎšðśü÷êšĂÜ
êĂïÿîĂÜêŠĂ÷ćđöČęĂìéúĂÜĔßšĔîøą÷ąÿĆĚîÖŠĂîǰÝċÜÝąÿćöćøëĔßš÷ćĔîøą÷ą÷ćüêŠĂĕðĕéš) ĔĀšøąïčđÜČęĂîĕ×éĆÜÖúŠćüĕüš
éšü÷ǰĔîÖøèĊìĊę×šĂïŠÜĔßšĔîøą÷ąÿĆĚîĒúąøą÷ą÷ćüöĊÙüćöĒêÖêŠćÜÖĆîǰĔĀšøąïč×šĂïŠÜĔßšĔîĒêŠúąÖøèĊĒ÷ÖĂĂÖÝćÖÖĆî
Ă÷ŠćÜßĆéđÝîǰǰǰ
6) ÙĞćöćêøåćîéšćîÖćøüĉîĉÝÞĆ÷ǰÙČĂǰ“ĔßšüĉîĉÝÞĆ÷ǰ........”
7) ÙĞćìĊęĕöŠĂîčâćêǰđßŠîǰĔßšïĞćøčÜǰĔßšïĞćøčÜøŠćÜÖć÷
8) ĔîÖøèĊ÷ćìĊęöčŠÜĀöć÷ìĊęĔßšđÿøĉöÿćøĂćĀćø(nutrient supplement) ĔĀšĔßšÙĞćüŠćǰ“Ĕßšđÿøĉö… “ đßŠîǰ
üĉêćöĉîǰđÖúČĂĒøŠǰēðøêĊîǰÖøéĂąöĉēîǰđðŨîêšî
9) ÷ćìĊęöĊüĆêëčðøąÿÜÙŤîĂÖđĀîČĂÝćÖîĊĚĔĀšóĉÝćøèćđðŨîÖøèĊĕðǰđßŠîǰwater for injection, filler,
Öøąÿć÷÷ć đðŨîêšî
4.2 ×îćé÷ćĒúąüĉíĊÖćøïøĉĀćø÷ć (Posology and method of administration)

4.2.1 ×îćé÷ćìĊęĒîąîĞćǰ(Recommended dose)
1) ×îćé÷ćĔĀšøąïčêćö×šĂïŠÜĔßšìĊęĕéšøąïčĕüšĔîĀĆü×šĂǰ“4.1 ×šĂïŠÜĔßšĔîÖćøøĆÖþć” đìŠćîĆĚîǰēé÷øąïč
×îćé÷ćǰÙüćöëĊęĔîÖćøĔĀš÷ćǰĒúąøą÷ąđüúćĔîÖćøĔĀš÷ćìĊęđĀöćąÿö
2) øąïč ×îćé÷ćĔîñĎš ĔĀâŠĒúąüĆ÷ øčŠîǰÙüøøąïčéšü ÷ĀîŠ ü÷îĚĞ ćĀîĆ Öǰ(đßŠ îĔßš ÷ćĔî×îćéǰ500 öĉ úúĉÖøĆö)
öćÖÖüŠćìĊęÝąøąïčđðŨîÝĞćîüîđöĘéǰǰ(đßŠîǰĔßš÷ćĔî×îćéǰ1-2 đöĘé) ēé÷øąïčĕüšõć÷ĔêšĀĆü×šĂǰ×îćé÷ćĔîñĎšĔĀâŠĒúą
üĆ÷øčŠîǰêćöéšü÷ĀĆü×šĂ øą÷ąđüúćĔîÖćøĔĀš÷ć
3) ĀćÖĕéšøĆïĂîčöĆêĉĔĀšĔßš÷ćĔîđéĘÖǰĔĀšøąïč×îćé÷ćĔîđéĘÖĕüšĔîĀĆü×šĂǰ“×îćé÷ćĔîđéĘÖ” ēé÷øąïčđðŨî
×îćé÷ćêŠĂĀîŠü÷îĚĞćĀîĆÖêĆüǰ(ÖĉēúÖøĆö) ĀøČĂǰóČĚîìĊęñĉü×ĂÜøŠćÜÖć÷ǰ(êćøćÜđöêø) ĀøČĂßŠüÜĂć÷čêćöĀúĆÖåćî
ÖćøýċÖþćìćÜÙúĉîĉÖ
Āöć÷đĀêčǰÖøèĊìĊęêšĂÜÖćøĔßšÙĞćǰ“đéĘÖĒøÖđÖĉé/neonate” “đéĘÖìćøÖ/infant” “đéĘÖđúĘÖ/small children” ĀøČĂǰ
“đéĘÖēê/children” “üĆ÷øčŠî/adolescence” ĔĀšøąïčßŠüÜĂć÷čĕüšéšü÷đÿöĂéĆÜîĊĚǰ (ĂšćÜĂĉÜêćöǰThai National
Formulary 2008)
x đéĘÖĒøÖđÖĉé (Ăć÷čĕöŠëċÜ 1 đéČĂî)
x đéĘÖìćøÖǰ(Ăć÷č 1đéČĂî-ĕöŠëċÜ 12 đéČĂî)
x đéĘÖđúĘÖ (Ăć÷čǰ1ðŘ- ĕöŠëċÜ 6 ðŘ)
x đéĘÖēê (Ăć÷čǰ6ðŘ- ĕöŠëċÜ 12 ðŘ)
x üĆ÷øčŠîǰ(Ăć÷čǰ12 ðŘǰ- ĕöŠëċÜ 18 ðŘ)
4) øąïčøą÷ąđüúćĔîÖćøĔĀš÷ćõć÷ĔêšĀĆü×šĂǰøą÷ąđüúćĔîÖćøĔĀš÷ć
5) øąïč×îćé÷ćÿĎÜÿčéĔîñĎšðśü÷ÖúčŠöĂć÷čêŠćÜǰėǰĕéšĒÖŠǰñĎšĔĀâŠǰñĎšÿĎÜĂć÷čǰüĆ÷øčŠîǰĒúąđéĘÖǰĔîĀĆü×šĂǰ×îćé÷ć
ÿĎÜÿčéÿĞćĀøĆïñĎšðśü÷ÖúčŠöĂć÷čêŠćÜǰė
6) øąïč×îćé÷ćĔîñĎšðśü÷ÖúčŠöóĉđýþǰĕüšĔîĀĆü×šĂǰ“×îćé÷ćĔîñĎšðśü÷ÖúčŠöóĉđýþ” ēé÷öĊĀĆü×šĂ÷ŠĂ÷éĆÜîĊĚ
x ×îćé÷ćĔîñĎšÿĎÜĂć÷čǰ (ëšćĕöŠöĊĔĀšđ×Ċ÷îüŠćǰ“ĕöŠöĊ×šĂöĎú” )
x ×îćé÷ćĔîñĎšöĊÖćøìĞćÜćî×ĂÜĕêïÖóøŠĂÜ (ëšćĕöŠöĊĔĀšđ×Ċ÷îüŠćǰ“ĕöŠöĊ×šĂöĎú” )
x ×îćé÷ćĔîñĎšöĊÖćøìĞćÜćî×ĂÜêĆïïÖóøŠĂÜǰ (ëšćĕöŠöĊĔĀšđ×Ċ÷îüŠćǰ“ĕöŠöĊ×šĂöĎú” )
ÿĞćĀøĆïÖúčŠöĂČęîǰėǰìĊęêšĂÜðøĆï×îćé÷ćǰĔĀšøąïčĕüšêćöÙüćöđĀöćąÿöǰđßŠîǰ×îćé÷ćĔîÿêøĊöĊÙøøõŤǰ×îćé÷ć
ĔîÿêøĊøąĀüŠćÜĔĀšîöïčêøǰ×îćé÷ćĔîñĎšìĞćÖćøßĞćøąđúČĂéñŠćîĕêđìĊ÷öǰ×îćé÷ćĔîÖúčŠöìĊęöĊ÷ĊîđÞóćą (genetics

17
characteristics) đðŨîêšî ×šĂöĎú×îćé÷ćìĊęđðŨîÿćøøĆÜÿĊǰ(radiation dosimetry) êšĂÜøąïčĔĀšßĆéđÝîìĆĚÜ×îćé÷ć
×ĂÜñĎšðśü÷ĒúąñĎšĔĀš÷ć
7) ĔîÖøèĊìĊę÷ćǰ(ĀøČĂǰđöĒìïĂĕúêŤ) öĊÙŠćéĆßîĊĔîÖćøøĆÖþćĒÙïǰ(narrow therapeutic index) Ēúą
øąéĆïÙüćöđ×šö×šî×ĂÜ÷ćöĊÙüćöÿĞćÙĆâĔîìćÜÙúĉîĉÖǰĔĀšøąïčÖćøđòŜćêĉéêćöøąéĆïÙüćöđ×šö×šî×ĂÜ÷ćøąĀüŠćÜÖćø
øĆÖþćǰ(therapeutic drug concentration monitoring) đóČęĂðøĆï×îćé÷ć
8) øąïč×šĂöĎúĂČęîǰėǰìĊęßŠü÷ĔĀšÖćøĔßš÷ćđðŨîĕðĂ÷ŠćÜëĎÖêšĂÜǰđĀöćąÿöǰĒúąÿąéüÖǰđßŠîǰ“êćøćÜìĊęđðŨî
ĒîüìćÜĔîÖćøđìĊ÷ï×îćé÷ćêćöóČĚîìĊęñĉüøŠćÜÖć÷ĔîđéĘÖ“ ĀøČĂǰ“êćøćÜìĊęĒÿéÜĒîüìćÜĔîÖćøđìĊ÷ï×îćé÷ćÿĎÜÿčé
êćöîĚĞćĀîĆÖêĆüñĎšðśü÷” ĀøČĂ “ĒîüìćÜìĊęđĀöćąÿöĔîÖćøðøĆï×îćé÷ćǰ(titrating dosage)" đðŨîêšî ×šĂöĎú×îćé
÷ćêŠćÜǰėǰĂćÝĒÿéÜĔîøĎðêćøćÜđóČęĂÙüćöÿąéüÖĔîÖćøĂŠćîĒúąìĞćÙüćöđ×šćĔÝǰøüöìĆĚÜ×šĂÙüøðäĉïĆêĉÖøèĊìĊęĕöŠĕéš
ïøĉĀćø÷ćêćö×îćéìĊęĒîąîĞćǰđßŠîǰúČöøĆïðøąìćî÷ćǰđðŨîêšîǰǰǰǰǰǰǰ
4.2.2 üĉíĊÖćøïøĉĀćø÷ć (Mode of Administration)
Ùüøøąïč×šĂÙüøąüĆÜÿĞćÙĆâĔîÖćøđêøĊ÷öĀøČĂïøĉĀćø÷ćìĆĚÜ×ĂÜĒóì÷Ťǰó÷ćïćúǰÙîĕ×šǰñĎšéĎĒúǰĕüšĔîĀĆü×šĂîĊĚǰ
1) ĔĀšøąïčüŠćđðŨî÷ćøĆïðøąìćî ÷ćÞĊéǰ÷ćóŠîÝöĎÖǰ÷ćđĀîĘïǰ÷ćĀ÷ĂéêćǰĄúĄǰêćöøĎðĒïï×ĂÜÖćøĔĀš÷ćìĊę
đĀöćąÿö
2) ĀćÖđðŨî÷ćøĆïðøąìćî ĔĀšøąïčüŠćÙüøøĆïðøąìćîǰ÷ć×èąìšĂÜüŠćÜǰóøšĂöĂćĀćøǰĀøČĂǰßŠüÜđüúćĔéǰÝċÜ
ÝąđĀöćąÿö
3) ĀćÖđðŨî÷ćøĆïðøąìćî ĔĀšøąïčüŠćÙüøĀúĊÖđúĊę÷ÜĂćĀćøĀøČĂ÷ćĔéìĊęöĊñúêŠĂÖćøéĎéàċö÷ć
4) ĀćÖđðŨî÷ćìĊęĀšćöïéĀøČĂĒïŠÜǰĔĀšøąïč×šĂÙüøðäĉïĆêĉĕüšĔîĀĆü×šĂîĊĚ óøšĂöđĀêčñú
5) ĀćÖđðŨî÷ćÞĊéĔĀšøąïčǰüĉíĊÖćøÞĊéìĊęđĀöćąÿöǰëĎÖêšĂÜĒúąðúĂéõĆ÷ǰđßŠîǰinfusion ĕöŠêęĞćÖüŠćǰ1 ßĆęüēöÜǰǰǰ
øüöìĆĚÜǰøąïčüĉíĊÞĊéìĊęđðŨî×šĂĀšćöĀøČĂÙüøĀúĊÖđúĊę÷ÜǰǰǰđßŠîǰ“ĀšćöÞĊéĒïïǰIV push” Ĕî÷ć KCl iv
6) Ăíĉïć÷üĉíĊÖćøĔßš÷ćìĊęöĊüĉíĊÖćøĔßšóĉđýþĕüšēé÷úąđĂĊ÷éĔîĀĆü×šĂîĊĚǰđßŠîǰüĉíĊĔßš÷ćóŠî×÷ć÷ĀúĂéúö
7) ĂćÝöĊøĎððøąÖĂïĕéšêćöÙüćöđĀöćąÿöǰđßŠîǰøĎðĒÿéÜüĉíĊóŠî÷ć
8) ÙüøøąïčüĉíĊĔßš÷ćìĊęÙüøĔÿŠĔÝđðŨîóĉđýþÿĞćĀøĆï÷ćïćÜÖúčŠöǰïćÜßîĉéǰđßŠîǰ÷ćðäĉßĊüîąÙüøøĆïðøąìćîǰ
ÝîÙøïêćöøą÷ąđüúćĔîÖćøøĆÖþćēøÙǰ÷ćïćÜßîĉéĕöŠÙüøøĆïðøąìćîǰ×èąĂ÷ĎŠĔîìŠćîĂîǰ÷ćïćÜßîĉéÙüøđÙĊĚ÷ü
ÖŠĂîÖúČîǰ÷ćïćÜßîĉéĀšćöđÙĊĚ÷üǰ÷ćïćÜßîĉéÙüøéČęöîĚĞćêćööćÖǰėǰđðŨîêšî
9) ĔîĀĆü×šĂîĊĚêšĂÜöĊÖćøøąïčüĉíĊÖćøđêøĊ÷ö÷ćĂ÷ŠćÜßĆéđÝîđðŨîÖøèĊǰėĕðǰđßŠîǰÖćøđÝČĂÝćÜ÷ćǰÖćøđêøĊ÷ö÷ćǰ
(øüöìĆĚÜÙüćöđ×šö×šîÿčéìšć÷×ĂÜÿćøúąúć÷ǰđöČęĂđêøĊ÷öêćö×ĆĚîêĂîìĊęĕéšøąïčĕüšǰĀîŠü÷×ĂÜÿćøúąúć÷ÿčéìšć÷ÙüøĂ÷ĎŠ
ĔîøĎð×ĂÜöĉúúĉÖøĆö×ĂÜÿćøÿĞćÙĆâĂĂÖùìíĉĝêŠĂöĉúúĉúĉêø×ĂÜÿćøúąúć÷ÿčéìšć÷ǰđüšîĒêŠĀîŠü÷ĂČęîöĊÙüćöđĀöćąÿö
öćÖÖüŠć úĆÖþèąĒúąÿĊ×ĂÜ÷ćĀúĆÜñÿö) üĉíĊÖćøĔßš÷ćĔîĒêŠúąøĎðĒïï×ĂÜ÷ćǰ(đßŠîǰĂĆêøćÖćøĔĀš÷ćìćÜĀúĂéđúČĂé
éĞćêŠĂîćìĊ ×šĂöĎúÙüćöđ×šćÖĆîĕéš×ĂÜ÷ćđöČęĂñÿöÖĆï÷ćĀøČĂÿćøĂČęîǰēé÷øąïčđÞóćą×šĂöĎúìĊęÿĞćÙĆâ) üĉíĊÖćøđêøĊ÷ö÷ć
ìĊęĔĀšìćÜÿć÷ĂćĀćøǰđðŨîêšî ÿĞćĀøĆïüĉíĊÖćøđÖĘï÷ćĀúĆÜñÿöĒúšüĔĀšøąïč×šĂÙüćö “üĉíĊÖćøđÖĘï÷ćĀúĆÜñÿöǰĔĀšéĎĀĆü×šĂ
6.4.4”
10) ĔîÖøèĊ÷ćÞĊéĔĀšøąïčüŠćǰ“ÖŠĂîÞĊé÷ćÙüøêøüÝÿĂïéšü÷ÿć÷êćüŠćĕöŠöĊÿćøĂąĕøđÝČĂðîĒúąÿĊêšĂÜĕöŠ
đðúĊę÷î”
11) ĀćÖöĊ×šĂÙüøøąüĆÜĂČęîė øąĀüŠćÜÖćøïøĉĀćø÷ćǰđßŠîǰÖćøðŜĂÜÖĆîĒÿÜĔî×èąïøĉĀćø÷ćǰÖćøðŜĂÜÖĆî
ÙüćößČĚîǰđðŨîêšîǰĔĀšøąïčĕüšĔîĀĆü×šĂîĊĚ

18
4.3.1 øąïč×šĂĀšćöĔßšǰìĊęđðŨî absolute contraindication ĕüšĔîĀĆü×šĂîĊĚǰ×šĂĀšćöĔßšĔîÖøèĊîĊĚǰĀöć÷ëċÜǰĕöŠ
ĒîąîĞćĔĀšĔßš÷ćîĊĚĔîÖøèĊêŠćÜǰėǰìĊęøąïčĕüšđîČęĂÜÝćÖĂĆîêøć÷ÝćÖÖćøĔßš÷ćöĊöćÖÖüŠćðøąē÷ßîŤìĊęÝąĕéšøĆïǰ(the risk
clearly outweighs any possible therapeutic benefit) ÿŠüî×šĂĀšćöĔßšìĊęđðŨîǰrelative contraindication
ĔĀšÝĆéĕüšĔîĀĆü×šĂ “4.4 ÙĞćđêČĂîóĉđýþĒúą×šĂÙüøøąüĆÜĔîÖćøĔßš÷ć” đüšîĒêŠĕöŠÿćöćøëøąïčüĉíĊÖćøĔîÖćøøąöĆéøąüĆÜǰ
ĀøČĂðŜĂÜÖĆîĂĆîêøć÷ìĊęĂćÝđÖĉé×ċĚîǰàċęÜđðŨîĂĆîêøć÷ìĊęøčîĒøÜĀøČĂëċÜĒÖŠßĊüĉêǰĔĀšÝĆéđðŨîǰ“×šĂĀšćöĔßš” (éĎĀĆü×šĂǰ4.4.4)
4.3.2 ĔĀš×ċĚîêšîðøąē÷Ùéšü÷ÙĞćüŠć “ĀšćöĔßš” ĕöŠÙüø×ċĚîêšîðøąē÷Ùéšü÷ÙĞćüŠćǰ“ĕöŠÙüøĔßš” ĀćÖêšĂÜÖćø×ċĚîêšî
ðøąē÷Ùéšü÷ÙĞćüŠćǰ“ĕöŠÙüøĔßš” ÙüøîĞćĕðĔÿŠĕüšĔîĀĆü×šĂ “4.4 ÙĞćđêČĂîóĉđýþĒúą×šĂÙüøøąüĆÜĔîÖćøĔßš÷ć”
4.3.3 đ×Ċ÷î×šĂĀšćöĒ÷ÖđðŨîðøąđéĘîêŠćÜǰėǰĂ÷ŠćÜßĆéđÝîǰ×ċĚîïøøìĆéĔĀöŠìčÖǰėǰðøąđéĘî ĒúąÙüøĂíĉïć÷ĔĀš
đ×šćĔÝëċÜđĀêčñúĔîÖćøĀšćöĔßš÷ćéšü÷
4.3.4 ĀćÖđðŨî×šĂĀšćöĔßšìĊęöĊ×šĂ÷ÖđüšîĔîÖøèĊìĊęÝĞćđðŨîĀúĊÖđúĊę÷ÜĕöŠĕéšǰĔĀšøąïčĕüšĔĀšßĆéđÝîĔîĀĆü×šĂîĊĚüŠćÖøèĊĔé
ìĊęÝĆéđðŨî×šĂ÷ÖđüšîǰđßŠî ĀšćöĔßšēÙĕìøöĂÖàćēàúĔîìćøÖĂć÷čîšĂ÷ÖüŠćǰ6 ÿĆðéćĀŤǰ÷ÖđüšîÖøèĊøĆÖþćĀøČĂðŜĂÜÖĆî
ÖćøêĉéđßČĚĂ Pneumocystis carinii đðŨîêšî
4.3.5 ĂĆîêøÖĉøĉ÷ćøąĀüŠćÜ÷ćĔéìĊęÝĆéđðŨî contraindication ĔĀšøąïčĕüšĔîĀĆü×šĂîĊĚéšü÷ǰîĂÖđĀîČĂÝćÖÖćøøąïč
ĕüšĔîĀĆü×šĂǰ“4.5 ĂĆîêøÖĉøĉ÷ćÖĆï÷ćĂČęîėǰĀøČĂĂĆîêøÖĉøĉ÷ćĂČęîė”
4.3.6 ×šĂĀšćöĔßšĔéìĊęđÖĊę÷ü×šĂÜÖĆïñĎšðśü÷ÖúčŠöóĉđýþđßŠîǰÿêøĊöĊÙøøõŤǰÿêøĊøąĀüŠćÜĔĀšîöïčêøǰìćøÖĒøÖđÖĉéǰ
ñĎšÿĎÜĂć÷čǰñĎšðśü÷ēøÙêĆïǰñĎšðśü÷ēøÙĕêǰñĎšðśü÷ G6PD ĔĀšøąïčĕüšĔîĀĆü×šĂîĊĚéšü÷ǰîĂÖđĀîČĂÝćÖÖćøøąïčĕüšĔîĀĆü×šĂǰ“4.4
ÙĞćđêČĂîóĉđýþĒúą×šĂÙüøøąüĆÜĔîÖćøĔßš÷ć” ĀøČĂǰ“4.6 ÖćøĔßšĔîÿêøĊöĊÙøøõŤĒúąÿêøĊøąĀüŠćÜĔĀšîöïčêø”
4.3.7 ĔîÖøèĊìĊęöĊ×šĂĀšćöĔßšÝćÖêĆü÷ćĕöŠÿĞćÙĆâĔîÿĎêøêĞćøĆï ĔĀšøąïčđóĉęöđêĉöĔîĀĆü×šĂîĊĚĕüšéšü÷ǰ
4.4 ÙĞćđêČĂîóĉđýþĒúą×šĂÙüøøąüĆÜĔîÖćøĔßš÷ć (Special warning and precautions for use)

4.4.1 ÙĞćđêČĂîĔĀšøąïčĕüšÖŠĂî×šĂÙüøøąüĆÜ ēé÷ĂćÝĔÿŠĕüšĔîÖøĂïđóČęĂĔĀšđĀĘîđéŠîßĆéǰēé÷øąïčÙĞćđêČĂîêćö
ÖãĀöć÷ǰîĂÖÝćÖîĆĚîøąïčöćêøÖćøÿĞćÙĆâìĊęđÖĊę÷ü×šĂÜÖĆïÙüćöðúĂéõĆ÷ÝćÖÖćøĔßš÷ćǰĀøČĂðøąÿĉìíĉõćó×ĂÜ÷ć
4.4.2 ×šĂÙüøøąüĆÜǰĀöć÷ëċÜǰÖøèĊêŠćÜǰėǰìĊęÖćøĔßš÷ćĂćÝÖŠĂĔĀšđÖĉéĂĆîêøć÷ìĊęøšć÷ĒøÜêŠĂñĎšðśü÷ǰÝċÜêšĂÜóĉÝćøèć
đðŨîóĉđýþüŠćÙüøĔßš÷ćĔîÖøèĊîĆĚîǰėǰĀøČĂĕöŠǰĀćÖöĊÖćøĔßš÷ćéĆÜÖúŠćüêšĂÜĔßšéšü÷ÙüćöøąöĆéøąüĆÜ ēé÷öĊöćêøÖćøĀøČĂ
×šĂðäĉïĆêĉêŠćÜėǰìĊęßŠü÷ðŜĂÜÖĆîĀøČĂúéĂĆîêøć÷ÝćÖÖćøĔßš÷ćîĆĚîǰđßŠîǰöĊÖćøêøüÝêĉéêćöøąéĆï÷ćĔîđúČĂéđóČęĂðøĆï
×îćé÷ćĔĀšđĀöćąÿöøŠüöÖĆïÖćøđòŜćêĉéêćöĂćÖćøĒúąĂćÖćøĒÿéÜ×ĂÜñĎšðśü÷Ă÷ŠćÜĔÖúšßĉéǰđðŨîêšîǰìĆĚÜîĊĚĀćÖöĊÖćøĔßš
÷ćĀöć÷ëċÜñĎšĔßš÷ćêšĂÜðøąđöĉîĒúšüüŠćðøąē÷ßîŤìĊęĕéšøĆïöĊđĀîČĂÖüŠćĂĆîêøć÷ìĊęĂćÝđÖĉé×ċĚîǰĀćÖðøąđöĉîĒúšüóïüŠćǰ
ÙüćöÙčšöÙŠćĕöŠßĆéđÝîĀøČĂöĊìćÜđúČĂÖĂČęîĕöŠÙüøĔßš÷ćéĆÜÖúŠćü đßŠîǰ÷ćĔîǰpregnancy category D đðŨîêšî
4.4.3 ĔĀšøąïčöćêøÖćøĀøČĂ×šĂðäĉïĆêĉìĊęÙüøÖøąìĞćøŠüöéšü÷ǰĀćÖêšĂÜÖćøĔßš÷ćĔîĒêŠúąÖøèĊ×ĂÜ×šĂÙüøøąüĆÜǰ
đóČęĂĔĀšñĎšĔßš÷ćÿćöćøëúéÙüćöđÿĊę÷ÜÝćÖĂĆîêøć÷ìĊęĂćÝđÖĉé×ċĚîĕéš
4.4.4 ĀćÖĕöŠÿćöćøëøąïčöćêøÖćøĀøČĂ×šĂðäĉïĆêĉĔîÖćøĀúĊÖđúĊę÷ÜĂĆîêøć÷ìĊęĂćÝđÖĉé×ċĚîĕéš ĔĀšóĉÝćøèćîĞćǰ
“×šĂÙüøøąüĆÜ” îĆĚîǰĕðĕüšĔîǰ“×šĂĀšćöĔßš”
4.4.5 ×šĂÙüøøąüĆÜÙüø×ċĚîêšîðøąē÷ÙêŠćÜǰė éšü÷ÙĞćêŠĂĕðîĊĚǰ
“ĕöŠÙüøĔßš” ĀøČĂǰ“ĕöŠÙüøĔĀš” đöČęĂĒðúÝćÖÙĞćüŠć should not
“ĀúĊÖđúĊę÷Ü” đöČęĂĒðúÝćÖÙĞćüŠć avoid
“øąöĆéøąüĆÜÖćøĔßš” ĀøČĂǰ“Ĕßšéšü÷ÙüćöøąöĆéøąüĆÜ” đöČęĂĒðúÝćÖÙĞćüŠćǰuse with caution
“øąöĆéøąüĆÜÖćøĔßšĂ÷ŠćÜ÷ĉęÜ” ĀøČĂǰ“Ĕßšéšü÷ÙüćöøąöĆéøąüĆÜĂ÷ŠćÜ÷ĉęÜ” đöČęĂĒðúÝćÖÙĞćüŠćǰuse with extreme
caution
19
4.4.6 đ×Ċ÷îÙĞćđêČĂîĒúą×šĂÙüøøąüĆÜĒ÷ÖđðŨîðøąđéĘîêŠćÜǰėǰĂ÷ŠćÜßĆéđÝîǰ×ċĚîïøøìĆéĔĀöŠìčÖǰėǰðøąđéĘî ÿĞćĀøĆï
ñĎšðśü÷ÖúčŠöđÞóćą 7 ÖúčŠöǰ(ĀćÖöĊ×šĂöĎú) ĕéšĒÖŠǰđéĘÖǰñĎšÿĎÜĂć÷čǰñĎšðśü÷ēøÙêĆïǰñĎšðśü÷ēøÙĕêǰÿêøĊöĊÙøøõŤǰÿêøĊĔĀšîöïčêø
ĒúąĂĆîêøÖĉøĉ÷ć ìĊęìĞćĔĀšđÖĉéÙüćöĕöŠðúĂéõĆ÷ÝćÖÖćøĔßš÷ć
4.4.7 ÙüøĂíĉïć÷ĔĀšđ×šćĔÝëċÜđĀêčñúĔîÖćøđêČĂîǰøüöìĆĚÜđĀêčñúĔîĒêŠúą×šĂÙüøøąüĆÜ
4.5 ĂĆîêøÖĉøĉ÷ćÖĆï÷ćĂČęîėĀøČĂĂĆîêøÖĉøĉ÷ćĂČęîė (Interactions with other medicinal products and

other forms of interactions)
×šĂöĎúõć÷ĔêšĀĆü×šĂĂĆîêøÖĉøĉ÷ćÖĆï÷ćĂČęîêšĂÜöĊïìÿøčðēé÷÷ŠĂ×ĂÜ×šĂöĎú éĆÜ×šĂÖĞćĀîéêŠĂĕðîĊĚ
4.5.1 ĔĀšøąïčüŠć÷ćîĊĚđðŨî÷ćìĊęđöĒìïĂĕúêŤñŠćîøąïïĔéǰēé÷øąïčÿćøêĆĚÜêšîǰ(substrate) ĒúąǰêĆü÷Ćï÷ĆĚ Ü
đĂîĕàöŤìĊęĔßšĔîđöĒìïĂúĉàċöǰ(inhibitor) đßŠîǰĂĂđôîîćéøĊîǰđðŨîǰsubstrate øĂÜǰ(minor) ×ĂÜ CYP1A2, 2B6,
2D6 Ēúą 3A4 ÷Ćï÷ĆĚÜĂ÷ŠćÜĂŠĂîǰ(weak) êŠĂ CYP1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1 Ēúą 3A4
4.5.2 ĔĀšøąïč×šĂöĎúøć÷Öćø÷ćǰĀøČĂ ÖúčŠö÷ćǰĀøČĂ ĂćĀćøǰĀøČĂ ÿöčîĕóø ìĊęöĊĂĆîêøÖĉøĉ÷ćÖĆï÷ćîĊĚǰĀøČĂÙćéüŠć
ÝąöĊĂĆîêøÖĉøĉ÷ćǰìĆĚÜĔîìćÜìùþäĊĀøČĂìĊęöĊøć÷ÜćîÖćøđÖĉéĂĆîêøÖøĉ÷ć ēé÷øąïčđÞóćąÖøèĊìĊęöĊÙüćöÿĞćÙĆâìćÜÙúĉîĉÖ
àċęÜÙüøöĊÙĞćĒîąîĞćĒúą×šĂðäĉïĆêĉđóČęĂðŜĂÜÖĆîĀøČĂúéÖćøđÖĉéĂĆîêøÖĉøĉ÷ćîĆĚîėđóČęĂĔĀšđÖĉéÖćøĔßš÷ćĂ÷ŠćÜðúĂéõĆ÷
ĒúąöĊðøąÿĉìíĉõćóǰđßŠîǰĀšćöĔßšĀøČĂĀúĊÖđúĊę÷ÜÖćøĔßšøŠüöÖĆîǰÖćøđòŜćøąüĆÜÖćøĔßš÷ćǰðøĆïđðúĊę÷î×îćé÷ćǰđðŨîêšî
4.5.3 ĀćÖìøćïÖúĕÖ×ĂÜÖćøđÖĉéĂĆîêøÖĉøĉ÷ćêšĂÜïøø÷ć÷ĕüšēé÷ÿøčðǰÿĞćĀøĆïĂĆîêøÖĉøĉ÷ćìĊęđðŨî×šĂĀšćöĔßšĀøČĂ
×šĂÙüøøąüĆÜǰêšĂÜöćïøø÷ć÷ĔîĀĆü×šĂîĊĚđóĉęöđêĉö
4.5.4 ĔîÖøèĊìĊę÷ćöĊĂĆîêøÖĉøĉ÷ćøŠüöÖĆïÖćøìéÿĂïìćÜĀšĂÜðäĉïĆêĉÖćøàċęÜĂćÝìĞćĔĀšÖćøĒðúñúÙúćéđÙúČęĂîǰ
ĔĀšøąïčĒîüìćÜðäĉïĆêĉìĊęëĎÖêšĂÜĒúą×šĂÙüøøąüĆÜìĊęÝĞćđðŨîĕüšéšü÷
4.5.5 ĔîÖøèĊìĊę÷ćöĊĂĆîêøÖĉøĉ÷ćĒúšüđðŨîñúĔĀšđÖĉéñúĂĆîĕöŠóċÜðøąÿÜÙŤìĊęÿĞćÙĆâǰĔĀšöĊÖćøĂšćÜëċÜĔîĀĆü×šĂǰ“4.8
ĂćÖćøĕöŠóċÜðøąÿÜÙŤǰ(Undesirable effects)” éšü÷

ĔîĀĆü×šĂîĊĚðøąÖĂïéšü÷ĀĆü×šĂ÷ŠĂ÷ǰ3 ĀĆü×šĂÙČĂǰÿêøĊöĊÙøøõŤǰÿêøĊøąĀüŠćÜÙúĂéïčêøǰĒúąÿêøĊøąĀüŠćÜĔĀšîö
ïčêøǰ
4.6.1 ÿêøĊöĊÙøøõŤ : êšĂÜøąïč×šĂöĎúĔîĀĆü×šĂîĊĚìčÖÙøĆĚÜǰđüšîĒêŠĔîÖøèĊìĊę÷ćîĆĚîĕöŠéĎéàċöđ×šćÿĎŠøŠćÜÖć÷ĒúąĕöŠöĊ
×šĂöĎúüŠćìĞćĔĀšđÖĉéĂĆîêøć÷ìćÜĂšĂöêŠĂìćøÖĔîÙøøõŤĔĀšøąïčüŠćǰ“÷ćîĊĚĕöŠéĎéàċöđ×šćÿĎŠøŠćÜÖć÷ĒúąĕöŠöĊ×šĂöĎúüŠćìĞćĔĀš
đÖĉéĂĆîêøć÷ìćÜĂšĂöêŠĂìćøÖĔîÙøøõŤ” đîČĚĂĀćĔîĀĆü×šĂÿêøĊöĊÙøøõŤöĊéĆÜîĊĚ
1) ÖćøđÖĉéìćøÖüĉøĎðǰ(Teratogenic effects)
1.1) øąïč üŠć÷ćîĆĚî öĊÙüćöðúĂéõĆ ÷êŠ ĂÖćøĔßš ĔîÿêøĊöĊÙøøõŤ øąéĆï Ĕé ÖúŠćüÙČ ĂǰĔĀš øąïčǰ pregnancy
category êćöøĎðĒïï×ĂÜ÷ć ēé÷ĂšćÜĂĉÜ×šĂöĎúÝćÖ US pregnancy categories đðŨîúĞćéĆïĒøÖ ĀćÖĕöŠöĊ×šĂöĎú
×ĂÜǰUS pregnancy categories ĔĀšĂšćÜĂĉÜêćöǰADEC pregnancy categories (Australia) àċęÜÿČïÙšî×šĂöĎúĕéš
ÝćÖ https://www.ebs.tga.gov.au/ ēé÷øąïčüŠćđðŨîǰUS pregnancy categories ĀøČĂǰADEC pregnancy
categories ĔéǰóøšĂöìĆĚÜĔĀšøąïčÙĞćÝĞćÖĆéÙüćö×ĂÜǰpregnancy category îĆĚîėĕüšéšü÷
1.2) ĔîÖøèĊìĊęöĊÖćøĒïŠÜøąéĆïÙüćöđÿĊę÷Üêćöĕêøöćÿ×ĂÜÖćøêĆĚÜÙøøõŤĔĀšøąïčĕêøöćÿúÜĕðéšü÷
1.3) ĔîÖøèĊìĊęĕöŠöĊ×šĂöĎúĔĀšøąïčüŠćǰ“ĕöŠöĊ×šĂöĎúđóĊ÷ÜóĂĔîđøČęĂÜÙüćöðúĂéõĆ÷ĔîÖćøĔßš÷ćĔîÿêøĊöĊÙøøõŤ”
Āöć÷đĀêč
US Pregnancy Categories
x US Pregnancy Category A
20
ÖćøýċÖþćüĉÝĆ÷ßîĉéÙüïÙčöĔîÿêøĊêĆĚÜÙøøõŤøą÷ąĕêøöćÿ 1 ĕöŠóïÙüćöđÿĊę÷ÜêŠĂìćøÖĔîÙøøõŤǰ ĒúąĕöŠóï
ĀúĆÖåćîüŠćöĊÙüćöđÿĊę÷ÜĔîĕêøöćÿêŠĂėöć) ÝċÜöĊÙüćöđðŨîĕðĕéšêęĞćìĊęÖŠĂĔĀšđÖĉéĂĆîêøć÷êŠĂìćøÖĔîÙøøõŤ
x US Pregnancy Category B
Āöć÷ëċÜÖøèĊĔéÖøèĊĀîċęÜêŠĂĕðîĊĚ ÖćøýċÖþćĔîÿĆêüŤìéúĂÜĕöŠóïÙüćöđÿĊę÷ÜêŠĂôŘêĆÿĒêŠ÷ĆÜĕöŠöĊÖćøýċÖþć
üĉÝĆ÷ßîĉéÙüïÙčöĔîÿêøĊêĆĚÜÙøøõŤǰ ĀøČĂÖćøýċÖþćĔîÿĆêüŤìéúĂÜóïĂĆîêøć÷ïćÜðøąÖćø (îĂÖđĀîČĂĕðÝćÖ
ÙüćöÿćöćøëĔîÖćøÿČïóĆîíčŤúéúÜ) ĒêŠĕöŠĕéšøĆïÖćø÷Čî÷ĆîÝćÖÖćøýċÖþćüĉÝĆ÷ßîĉéÙüïÙčöĔîÿêøĊêĆĚÜÙøøõŤøą÷ąĕêø
öćÿ 1 (ĒúąĕöŠóïĀúĆÖåćîüŠćöĊÙüćöđÿĊę÷ÜĔîĕêøöćÿêŠĂėöć)
x US Pregnancy Category C
Āöć÷ëċÜÖøèĊĔéÖøèĊĀîċęÜêŠĂĕðîĊĚ ÖćøýċÖþćĔîÿĆêüŤìéúĂÜóïĂĆîêøć÷ïćÜðøąÖćø ĕéšĒÖŠÖĞćđîĉéìćøÖüĉøĎð
(teratogenic) êĆüĂŠĂîêć÷ (embrycidal) ĀøČĂĂČęîė ĒúąĕöŠöĊÖćøýċÖþćüĉÝĆ÷ßîĉéÙüïÙčöĔîÿêøĊêĆĚÜÙøøõŤǰĀøČĂ ĕöŠöĊ
ÖćøýċÖþćìĆĚÜĔîÿêøĊêĆĚÜÙøøõŤĒúąÿĆêüŤìéúĂÜ ÷ćĔîÖúčŠöîĊĚÝċÜÙüøĔßšđÞóćąđöČęĂðøąē÷ßîŤìĊęĂćÝĕéšøĆïÙčšöÙŠćÖĆïÙüćö
đÿĊę÷ÜìĊęĂćÝđÖĉé×ċĚîêŠĂìćøÖĔîÙøøõŤ
x US Pregnancy Category D
óïĀúĆÖåćîÝćÖðøąÿïÖćøèŤĔßšÖćøĔßš÷ćĔîöîčþ÷ŤüŠćöĊÙüćöđÿĊę÷ÜêŠĂìćøÖĔîÙøøõŤǰ ĒêŠÖćøĔßš÷ćîĆĚîÖĆï
ÿêøĊêĆĚÜÙøøõŤđðŨîðøąē÷ßîŤÝċÜĂćÝÝĞćêšĂÜ÷ĂöøĆïÙüćöđÿĊę÷ÜéĆÜÖúŠćü (đßŠîĔßš÷ćîĆĚîÖĆïõćüąìĊęĂćÝđðŨîĂĆîêøć÷ëċÜ
ßĊüĉêĀøČĂĔßšĔîēøÙøšć÷ĒøÜàċęÜ÷ćìĊęðúĂéõĆ÷ÖüŠćĕöŠÿćöćøëĔßšĕéšĀøČĂĔßšĕöŠĕéšñú)
x US Pregnancy Category X
ÖćøýċÖþćĔîÿĆêüŤìéúĂÜĀøČĂöîčþ÷ŤóïÙüćöñĉéðÖêĉêŠĂôŘêĆÿĀøČĂêŠĂìćøÖĔîÙøøõŤǰĀøČĂöĊĀúĆÖåćîëċÜÙüćö
đÿĊę÷ÜêŠĂìćøÖĔîÙøøõŤÝćÖðøąÿïÖćøèŤÖćøĔßš÷ćĔîöîčþ÷Ťǰ ĀøČĂìĆĚÜÿĂÜÖøèĊìĊęÖúŠćüöć ĒúąÙüćöđÿĊę÷ÜéĆÜÖúŠćü öĊ
öćÖÖüŠćðøąē÷ßîŤìĊęĂćÝĕéšøĆïĂ÷ŠćÜßĆéđÝî ÷ćĔîÖúčŠöîĊĚÝċÜĀšćöĔßšĔîÿêøĊêĆĚÜÙøøõŤĀøČĂÿêøĊìĊęĂćÝÝąêĆĚÜÙøøõŤ
ADEC Pregnancy Categories
x ADEC Pregnancy Category A
đðŨî÷ćìĊęöĊÖćøĔßšĔîÿêøĊêĆĚÜÙøøõŤĒúąÿêøĊĔîüĆ÷đÝøĉâóĆîíčŤÝĞćîüîöćÖ ēé÷ĕöŠóïĀúĆÖåćîìĊę÷Čî÷ĆîüŠć đóĉęö
ÙüćöëĊęĔîÖćøđÖĉéøĎðóĉÖćø (malformation) ĀøČĂñúđÿĊ÷ĂČęîė êŠĂìćøÖĔîÙøøõŤìĆĚÜìćÜêøÜĒúąìćÜĂšĂö
x ADEC Pregnancy Category B1
đðŨî÷ćìĊęöĊÖćøĔßšĔîÿêøĊêĆĚÜÙøøõŤĒúąÿêøĊĔîüĆ÷đÝøĉâóĆîíčŤÝĞćîüîĕöŠöćÖîĆÖ ēé÷ĕöŠóïĀúĆÖåćîìĊę÷Čî÷ĆîüŠćđóĉęö
ÙüćöëĊęĔîÖćøđÖĉéøĎðóĉÖćø (malformation) ĀøČĂñúđÿĊ÷ĂČęîė êŠĂìćøÖĔîÙøøõŤìĆĚÜìćÜêøÜĒúąìćÜĂšĂö ÖćøýċÖþć
ĔîÿĆêüŤìéúĂÜĕöŠðøćÖäĀúĆÖåćîìĊęĒÿéÜëċÜĂĆîêøć÷ìĊęđóĉęö×ċĚîêŠĂôŘêĆÿ
ÙüćöëĊęĔîÖćøđÖĉéøĎðóĉÖćø (malformation) ĀøČĂñúđÿĊ÷ĂČęîėǰêŠĂìćøÖĔîÙøøõŤìĆĚÜìćÜêøÜĒúąìćÜĂšĂö ĕöŠöĊ
ÖćøýċÖþćĔîÿĆêüŤìéúĂÜĀøČĂöĊÖćøýċÖþćìĊęĕöŠđóĊ÷ÜóĂ ĒêŠ×šĂöĎúđìŠćìĊęöĊĕöŠðøćÖäĀúĆÖåćîìĊęĒÿéÜëċÜĂĆîêøć÷ìĊę
đóĉęö×ċĚîêŠĂôŘêĆÿ
ÙüćöëĊęĔîÖćøđÖĉéøĎðóĉÖćø (malformation) ĀøČĂñúđÿĊ÷ĂČęîė êŠĂìćøÖĔîÙøøõŤìĆĚÜìćÜêøÜĒúąìćÜĂšĂö ÖćøýċÖþć
ĔîÿĆêüŤìéúĂÜóïĀúĆÖåćîìĊęĒÿéÜëċÜĂĆîêøć÷ìĊęđóĉęö×ċĚîêŠĂôŘêĆÿ ĒêŠóĉÝćøèćĒúšüđĀĘîüŠćĂĆîêøć÷êŠĂ ìćøÖĔîÙøøõŤ
÷ĆÜđðŨîìĊęîŠćÿÜÿĆ÷

21
x ADEC Pregnancy Category C
đðŨî÷ćàċęÜöĊùìíĉĝìćÜđõÿĆßüĉì÷ćĂĆîĕéšÖŠĂĔĀšđÖĉé ĀøČĂÿÜÿĆ÷üŠćĂćÝÖŠĂĔĀšđÖĉéĂĆîêøć÷êŠĂìćøÖĔîÙøøõŤĀøČĂ
ìćøÖĒøÖđÖĉéēé÷ĕöŠìĞćĔĀšđÖĉéøĎðóĉÖćø (malformation) ñúđÿĊ÷đĀúŠćîĊĚĂćÝĒÖšĕ×ĕéšǰÙüøĂŠćîøć÷úąđĂĊ÷éđóĉęöđêĉö
ÝćÖđĂÖÿćøÖĞćÖĆï÷ć
x ADEC Pregnancy Category D
đðŨî÷ćàċęÜĕéšÖŠĂĔĀšđÖĉé ĀøČĂÿÜÿĆ÷üŠćĂćÝÖŠĂĔĀšđÖĉé ĀøČĂÙćéüŠćĂćÝÖŠĂĔĀšđÖĉéøĎðóĉÖćø (malformation) ÖĆï
ìćøÖĔîÙøøõŤǰ ĀøČĂÖŠĂĔĀšđÖĉéĂĆîêøć÷ìĊęĕöŠĂćÝĒÖšĕ×ĕéšǰ ÷ćđĀúŠćîĊĚĂćÝöĊùìíĉĝìćÜđõÿĆßüĉì÷ćìĊęÖŠĂĔĀšđÖĉéĂĆîêøć÷
øŠüöéšü÷ ÙüøĂŠćîøć÷úąđĂĊ÷éđóĉęöđêĉöÝćÖđĂÖÿćøÖĞćÖĆï÷ć
x ADEC Pregnancy Category X
đðŨî÷ćìĊęöĊÙüćöđÿĊę÷ÜÿĎÜĔîÖćøìĞćĔĀšđÖĉéĂĆîêøć÷ Ă÷ŠćÜëćüøêŠĂìćøÖĔîÙøøõŤǰ ÝîìĞćĔĀšĕöŠÙüøĔßšĔîÿêøĊêĆĚÜ
ÙøøõŤĀøČĂÿêøĊìĊęÿÜÿĆ÷üŠćĂćÝÝąêĆĚÜÙøøõŤ
2) ñúìĊęĕöŠĔßŠìćøÖüĉøĎðǰ(Nonteratogenic effects)
øąïčñúĂČęîìĊęđÖĊę÷ü×šĂÜÖĆïðøąÿĉìíĉñúĒúąÙüćöðúĂéõĆ÷×ĂÜÖćøĔßš÷ćîĊĚĔîÿêøĊöĊÙøøõŤĀøČĂñúìĊęđÖĊę÷üÖĆï
ÖćøÿČïóĆîíčŤǰîĂÖÝćÖîĊĚĔĀšøąïčñúĂČęîǰėǰ×ĂÜ÷ćîĊĚêŠĂìćøÖĔîÙøøõŤĀøČĂìćøÖĒøÖđÖĉéǰ(đßŠîǰĂćÖćøëĂîǰĀøČĂõćüą
îĚĞćêćúĔîđúČĂéêęĞćǰđðŨîêšîǰ) àċęÜĂćÖćøđĀúŠćîĆĚîĂćÝđÖĉéÝćÖÖćøĔßš÷ćĂ÷ŠćÜđðŨîøą÷ąđüúćîćî×ĂÜÿêøĊöĊÙøøõŤ
4.6.2 ÿêøĊøąĀüŠćÜÙúĂéïčêøǰ(Labor and delivery)
ĀćÖ÷ćîĆĚîöĊÖćøĔßšĔîøąĀüŠćÜÖćøÙúĂéïčêøǰĕöŠüŠćÝąöĊÖćøøąïčĕüšĔî×šĂïŠÜĔßšĀøČĂĕöŠÖĘêćöǰĔîĀĆü×šĂîĊĚêšĂÜöĊ
ÖćøĂíĉïć÷ëċÜñú×ĂÜ÷ćìĊęöĊêŠĂöćøéćĒúąìćøÖǰǰøą÷ąđüúćĔîÖćøÙúĂéǰǰñúêŠĂÖćøĔßšđÙøČęĂÜöČĂĔîÖćøìĞćÙúĂéǰ
ĀøČĂÖćøßŠü÷ßĊüĉê ìćøÖĒøÖđÖĉ éǰǰîĂÖÝćÖîĆĚîĔĀšøąïčñ ú×ĂÜ÷ćêŠĂÖćøđÝøĉâđêĉïēêǰĒúąóĆçîćÖćø×ĂÜđéĘ ÖĔî
ĂîćÙêǰĀćÖĕöŠìøćï×šĂöĎúéĆÜÖúŠćüǰêšĂÜøąïčĔĀšßĆéđÝîüŠćǰ“ĕöŠöĊ×šĂöĎú”
4.6.3 ÿêøĊøąĀüŠćÜĔĀšîöïčêøǰ(Nursing mothers)
ÖøèĊ÷ćéĎéàċöđ×šćÿĎŠøŠćÜÖć÷ǰĔĀšøąïč×šĂöĎúÖćø×Ćï÷ćìćÜîĚĞćîöĒöŠĒúąñú×ĂÜ÷ćêŠĂïčêøǰĒúąøąïčÖćøđÖĉé
ĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęóïǰéĆÜîĊĚǰ
1) ëšć÷ćëĎÖéĎéàċöđ×šćÿĎŠøŠćÜÖć÷ĕéšĒúąëĎÖ×ĆïĂĂÖìćÜîĚĞćîöǰĔĀšøąïč×šĂÙüćöéĆÜêŠĂĕðîĊĚ
1.1) ĀćÖ÷ćöĊ ÖćøđÖĉ é ĂćÖćøĕöŠ óċÜ ðøąÿÜÙŤ ìĊęøš ć ÷ĒøÜ ĀøČ Ă÷ćîĆĚ îĂćÝìĞ ć ĔĀš đ Öĉ é đîČĚ ĂÜĂÖĔĀš øąïč üŠ ćǰ
“đîČęĂÜÝćÖ÷ćǰ[ßČęĂêĆü÷ćÿĞćÙĆâ] ìĞćĔĀšđÖĉéĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęøšć÷ĒøÜǰ(ĀøČĂđðŨî÷ćìĊęĂćÝìĞćĔĀšđÖĉéđîČĚĂÜĂÖ) Öćø
Ĕßš÷ćĔîøąĀüŠćÜÖćøĔĀšîöïčêøÙüøđúČĂÖüŠćÝąĀ÷čéÖćøĔßš÷ćîĊĚǰĀøČĂĀ÷čéÖćøĔĀšîööćøéćĒÖŠìćøÖēé÷ÙĞćîċÜëċÜ
ðøąē÷ßîŤ×ĂÜ÷ćìĊęöćøéćêšĂÜĔßš÷ć” ĀøČĂ
1.2) ĀćÖ÷ćĕöŠĕéšìĞćĔĀšđÖĉéĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęøšć÷ĒøÜǰ(éĎÙĞćÝĆéÙüćöĔîõćÙñîüÖǰ1) ĒúąĕöŠĕéšìĞćĔĀš
đÖĉéđîČĚĂÜĂÖǰĔĀšøąïčüŠćǰ“ÙüøøąüĆÜđöČęĂĔĀš÷ćǰ[ßČęĂêĆü÷ćÿĞćÙĆâ] êŠĂÿêøĊìĊęĔĀšîöïčêø”
2) ĀćÖ÷ćîĆĚîéĎéàċöìĆęüøŠćÜÖć÷ĒêŠĕöŠöĊ×šĂöĎúüŠć÷ćëĎÖ×ĆïĂĂÖìćÜîĚĞćîöǰĔĀšøąïčéĆÜîĊĚ
2.1) ĀćÖ÷ćìĞćĔĀšđÖĉéĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęøšć÷ĒøÜĀøČĂ÷ćîĆĚîđðŨîĂćÝìĞćĔĀšđÖĉéđîČĚĂÜĂÖĔĀšøąïčüŠćǰ“ĕöŠ
ìøćï×šĂöĎú÷ćđÖĊę÷üÖĆïÖćø×Ćï÷ćĂĂÖìćÜîĚĞćîöǰĒêŠđîČęĂÜÝćÖöĊ÷ćĀúć÷ßîĉéìĊęÿćöćøë×ĆïĂĂÖìćÜîĚĞćîöĕéšĒúą÷ćǰ
[ßČęĂêĆü ÷ćÿĞ ćÙĆ â] ìĞ ćĔĀšđ Öĉ éĂćÖćøĕöŠóċÜ ðøąÿÜÙŤìĊęøšć ÷ĒøÜǰ(ĀøČ ĂđðŨ î÷ćìĊę ĂćÝìĞćĔĀšđ Öĉé đîČĚĂÜĂÖ) ÖćøĔßš ÷ćĔî
øąĀüŠćÜÖćøĔĀšîöïčêøÙüøđúČĂÖüŠćÝąĀ÷čéÖćøĔßš÷ćîĊĚǰĀøČĂĀ÷čéÖćøĔĀšîööćøéćĒÖŠìćøÖēé÷ÙĞćîċÜëċÜðøąē÷ßîŤ×ĂÜ
÷ćìĊęöćøéćêšĂÜĔßš÷ć”

22
2.2) ĀćÖ÷ćĕöŠĕéšìĞćĔĀšđÖĉéĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęøšć÷ĒøÜǰĒúąĕöŠĕéšìĞćĔĀšđÖĉéđîČĚĂÜĂÖǰĔĀšøąïčüŠćǰ“ĕöŠ
ìøćï×šĂöĎú÷ćđÖĊę÷üÖĆïÖćø×Ćï÷ćĂĂÖìćÜîĚĞćîöǰĒêŠđîČęĂÜÝćÖöĊ÷ćĀúć÷ßîĉéìĊęÿćöćøë×ĆïĂĂÖìćÜîĚĞćîöĕéšÝċÜÙüø
øąüĆÜđöČęĂĔĀš÷ćǰ[ßČęĂêĆü÷ćÿĞćÙĆâ] êŠĂÿêøĊìĊęĔĀšîöïčêø”
Āöć÷đĀêč ĔîÖøèĊìĊę÷ćöĊñúêŠĂüĆ÷đÝøĉâóĆîíčŤĒúąÖćøÙčöÖĞćđîĉéĔĀšøąïč×šĂöĎúĕüšĔîĀĆü×šĂîĊĚéšü÷
4.7 ñúêŠĂÙüćöÿćöćøëĔîÖćø×Ćï×ĊęĒúąìĞćÜćîÖĆïđÙøČęĂÜÝĆÖø (Effects on ability to drive and use
machine)
ĔĀš óĉÝ ćøèć×š ĂöĎ úìćÜđõÿĆ ßóúýćÿêøŤǰøć÷ÜćîĂćÖćøĕöŠóċÜ ðøąÿÜÙŤ ǰ Ēúą/ĀøČ Ăøć÷ÜćîÖćøýċÖþćǰìĊę
đÖĊę÷ü×šĂÜÖĆïñú×ĂÜ÷ćîĊĚêŠĂÙüćöÿćöćøëĔîÖćø×Ćï×ĊęĒúąÖćøĔßšđÙøČęĂÜÝĆÖøǰĒúšüđúČĂÖøąïč×šĂÙüćö×šĂĔé×šĂĀîċęÜǰ
éĆÜêŠĂĕðîĊĚǰ
Ö) ĕöŠöĊñúĀøČĂǰĒìïĕöŠöĊñúêŠĂÖćø×Ćï×Ċę÷ćî÷îêŤĀøČĂÖćøĔßšđÙøČęĂÜÝĆÖøǰ
×) öĊñúîšĂ÷ĀøČĂðćîÖúćÜêŠĂÖćø×Ćï×Ċę÷ćî÷îêŤĀøČĂÖćøĔßšđÙøČęĂÜÝĆÖø
Ù) öĊñúöćÖêŠĂÙüćöÿćöćøëĔîÖćø×Ćï×Ċę÷ćî÷îêŤĀøČĂÖćøĔßšđÙøČęĂÜÝĆÖø
ĔîÖøèĊìĊęĕöŠÿćöćøëÿøčðüŠćĂ÷ĎŠĔî×šĂǰÖ) ×) ĀøČĂǰÙ) ĔĀšøąïč×šĂđìĘÝÝøĉÜđìŠćìĊęìøćïĕüšǰđßŠîǰ"÷ćîĊĚñŠćîǰblood
brain barrier öĊøąéĆï÷ćøšĂ÷úąǰ... ĒêŠĕöŠöĊøć÷ÜćîüŠć÷ćîĊĚìĞćĔĀšÜŠüÜĀøČĂđüĊ÷îýĊøþą" "ĕöŠöĊ×šĂöĎú"
Āöć÷đĀêč
(1) ÙüćöĀöć÷×ĂÜ×šĂöĎúìćÜđõÿĆßóúýćÿêøŤǰøć÷ÜćîĂćÖćøĕöŠóċÜðøąÿÜÙŤǰĒúą/ĀøČĂøć÷ÜćîÖćøýċÖþćǰìĊę
đÖĊę÷ü×šĂÜÖĆïñú×ĂÜ÷ćîĊĚêŠĂÙüćöÿćöćøëĔîÖćø×Ćï×ĊęĒúąÖćøĔßšđÙøČęĂÜÝĆÖøǰöĊéĆÜêŠĂĕðîĊĚ
- Ö) Āöć÷ëċÜǰĕöŠñŠćîǰblood brain barrier Ēúą/ĀøČĂǰĕöŠöĊǰpharmacodynamic effect ìĊęìĞćĔĀšÜŠüÜ
îĂîǰǰǰ(drowsiness) Ēúą/ĀøČĂǰđüĊ÷îýĊøþą(dizziness)
- ×) ĒúąǰÙ) ñŠćîǰblood brain barrier Ēúą/ĀøČĂöĊ pharmacodynamic effect ìĊęìĞćĔĀšÜŠüÜîĂî
(drowsiness) Ēúą/ĀøČĂǰđüĊ÷îýĊøþą(dizziness)
(2) ĔĀšóĉÝćøèćÝćÖÙüćößčÖđìŠćîĆĚîǰđîČęĂÜÝćÖøć÷ÜćîĕöŠĕéšÖúŠćüëċÜĂćÖćøÜŠüÜàċöĒúą/ĀøČĂĂćÖćøđüĊ÷îýĊøþąǰđßŠîǰ
ÜŠüÜöćÖ-îšĂ÷ǰđüĊ÷îýĊøþąöćÖ-îšĂ÷
(3) đöČęĂóĉÝćøèćëċÜÙüćößčÖǰÿćöćøëĒïŠÜĂĂÖöćêćöÙüćöĀöć÷×ĂÜ×šĂöĎúìćÜđõÿĆßóúýćÿêøŤǰøć÷ÜćîĂćÖćøĕöŠ
óċ ÜðøąÿÜÙŤ ǰ Ēúą/ĀøČ Ăøć÷ÜćîÖćøýċ ÖþćǰìĊę đ ÖĊę ÷ ü×š ĂÜÖĆ ï ñú×ĂÜ÷ćîĊĚ êŠ ĂÙüćöÿćöćøëĔîÖćø×Ć ï ×Ċę ĒúąÖćøĔßš
đÙøČęĂÜÝĆÖøĕéšǰéĆÜîĊĚ
- ×) Āöć÷ëċÜǰñúîšĂ÷ĀøČĂðćîÖúćÜ = common (êĆĚÜĒêŠǰ1:100 ĕöŠđÖĉîǰ1:10)
- Ù) Āöć÷ëċÜǰñúöćÖ = very common (êĆĚÜĒêŠǰ1:10 ×ċĚîĕð)

ĔĀšÝĆéìĞć×šĂöĎúĔîĀĆü×šĂĂćÖćøĕöŠóċÜðøąÿÜÙŤǰêćö×šĂÖĞćĀîééĆÜîĊĚ
4.8.1 ĔĀšøąïčĂćÖćøĕöŠóċÜðøąÿÜÙŤìĆĚÜĀöéìĊęóïĔîÖćøìéúĂÜìćÜÙúĉîĉÖǰÖćøýċÖþćĀúĆÜ÷ćĂĂÖÝĞćĀîŠć÷ǰ
ĀøČĂøć÷ÜćîĂćÖćøĕöŠóċÜðøąÿÜÙŤ×ĂÜñĎšðśü÷ĒêŠúąøć÷ǰĂćÖćøéĆÜÖúŠćüêšĂÜöĊđĀêčñúĂĆîÿöÙüøĔĀšÿÜÿĆ÷ĕéšüŠćđÖĉéÝćÖ
ÖćøĔßš÷ćǰēé÷ðøąđöĉîÝćÖĀúĆÖåćîìĊęéĊìĊęÿčéìĊęöĊĂ÷ĎŠĒúą×šĂđìĘÝÝøĉÜìĊęđÖĊę÷ü×šĂÜĔîÖćøðøąđöĉîëċÜÿćđĀêčǰÙüćöøčîĒøÜǰ
ĒúąÙüćöëĊę×ĂÜĂćÖćøéĆÜÖúŠćüǰìĆĚÜîĊĚÙüøøąïčĂćÖćøĕöŠóċÜðøąÿÜÙŤìčÖĂćÖćøìĊęöĊñúÖćøðøąđöĉîêĆĚÜĒêŠøąéĆïĂćÝÝą

23
ĔßŠǰ(Possible) ×ċĚîĕðĕüšĔîđĂÖÿćøÖĞćÖĆï÷ć2 ÖøèĊđðŨî÷ćßČęĂÿćöĆâĔĀšøąïčĂćÖćøĕöŠóċÜðøąÿÜÙŤêćöñúĉêõĆèæŤ
ĂšćÜĂĉÜĀøČĂ÷ćêšîĒïïĕüšĂ÷ŠćÜÙøïëšüî3
4.8.2 ĀćÖöĊ×šĂöĎúĔĀšøąïčÙüćöëĊę×ĂÜÖćøđÖĉéĂćÖćøĕöŠóċÜðøąÿÜÙŤĒêŠúąĂćÖćøđÿöĂǰÖćøøąïčÙüćöëĊęĂćÝ
øąïčđðŨîǰøšĂ÷úąǰđðŨî incidence ĀøČĂǰÙüćöëĊęĔîÖćøđÖĉé đßŠî common, rare đðŨîêšîǰēé÷đøĊ÷ÜÝćÖÙüćöëĊęĔî
ÖćøđÖĉéöćÖĕð÷ĆÜđÖĉéĕéšîšĂ÷ǰĒúąĔĀšöĊÙĞćÝĞćÖĆéÙüćö×ĂÜÙüćöëĊęéĆÜÖúŠćüÖĞćÖĆïĕüšéšü÷ǰéĆÜÙĞćĒîąîĞćéšćîúŠćÜǰÖćø
ĒÿéÜ×šĂöĎúĂćÖćøĕöŠóċÜðøąÿÜÙŤĂćÝĔßš ADR terminology ×ĂÜÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćđðŨî
óÝîćîčÖøößŠü÷ĒðúýĆóìŤéĆÜÖúŠćüđðŨîõćþćĕì÷
4.8.3 đîČĚĂĀćÙüøÖøąßĆïĒúąđÝćąÝÜǰĕöŠÙüøøąïč×šĂÙüćöđßĉÜÖúŠćüĂšćÜǰđßŠîǰ“÷ćîĊĚĕöŠìĞćĔĀšđÖĉéĂćÖćøĕöŠóċÜ
ðøąÿÜÙŤßîĉéĀîċęÜßîĉéĔé” ĀøČĂǰ×šĂÙüćöđßĉÜđðøĊ÷ïđìĊ÷ïÙüćöëĊę×ĂÜÖćøđÖĉéĂćÖćøĕöŠóċÜðøąÿÜÙŤÖĆï÷ćĂČęîǰđßŠîǰ
“ēé÷ìĆęüĕðñĎšðśü÷ÝąìîêŠĂ÷ćĕéšéĊ” “ēé÷ìĆęüĕðĂćÖćøĕöŠóċÜðøąÿÜÙŤÝćÖ÷ćîĊĚóïĕéšîšĂ÷” đðŨîêšî4
4.8.4 ēÙøÜÿøšćÜ×ĂÜđîČĚĂĀćĔîĀĆü×šĂîĊĚÙüøðøąÖĂïéšü÷ǰ3 ÿŠüîÙČĂǰ×šĂöĎúÿĞćÙĆâǰĒúą×šĂöĎúĂćÖćøĕöŠóċÜ
ðøąÿÜÙŤǰĒúą×šĂöĎúĂČęîėǰ
1) ×šĂöĎúÿĞćÙĆâǰ: ÿøčðĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęđðŨîĂĆîêøć÷ëċÜßĊüĉêǰ(fatal) ĕüšĔîêĂîêšî×ĂÜĀĆü×šĂîĊĚ
êćöéšü÷ÿøčðĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęđðŨîĂĆîêøć÷ìĞćĔĀšđÖĉéÙüćöóĉÖćøĀøČĂêšĂÜđ×šćøĆÖþćĔîēøÜó÷ćïćú (éĎÙĞćÝĆé
ÙüćöĔîõćÙñîüÖǰ1)
ĀćÖöĊ×šĂöĎúìĊęĂíĉïć÷ÖúĕÖÖćøđÖĉéĂćÖćøĕöŠóċÜðøąÿÜÙŤîĊĚĕéšĔĀšĂíĉïć÷ēé÷÷ŠĂĕüšéšü÷ǰóøšĂöđüúćìĊęĂćÝ
đÖĉé (onset) Ēúą/ĀøČĂøą÷ąđüúćìĊęÙÜĂ÷ĎŠ×ĂÜÖćøđÖĉéĂćÖćøîĆĚîėǰ(duration) ëšćĂćÖćøéĆÜÖúŠćüđÖĉé×ċĚîĕéšìĆĚÜÖúčŠö
÷ćĔĀšøąïčßČęĂÖúčŠö÷ćĕüšéšü÷
2) ĂćÖćøĕöŠóċÜðøąÿÜÙŤ
ĒîąîĞćĔĀšÝĞćĒîÖĂćÖćøĕöŠóċÜðøąÿÜÙŤêćöǰêćöÙüćöëĊęéĆÜîĊĚ
2.1) ĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęóïïŠĂ÷öćÖǰ(óïǰ1:10 ×ċĚîĕð) (very common)
2.2) ĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęóïïŠĂ÷ǰ(óïêĆĚÜĒêŠǰ1:100 ĒêŠĕöŠëċÜǰ1:10) (common)
2.3) ĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęóïĕöŠïŠĂ÷ǰ(óïêĆĚÜĒêŠǰ1:1000 ĒêŠĕöŠëċÜǰ1:100) (uncommon)
2.4) ĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęóïĕéšîšĂ÷ǰ(óïêĆĚÜĒêŠǰ1:10,000 ĒêŠĕöŠëċÜǰ1:1000) (rare)
2.5) ĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęóïĕéšîšĂ÷öćÖǰ(óïîšĂ÷ÖüŠćǰ1:10,000) (very rare)
2.6) ĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęĕöŠøĎšÙüćöëĊęĔîÖćøđÖĉéǰ
ēé÷ĔĀšđ×Ċ÷îĂćÖćøĕöŠóċÜðøąÿÜÙŤĔîĒêŠúąĀĆü×šĂ÷ŠĂ÷ǰ[2.1)-2.5)] đøĊ÷ÜêćöÙüćöëĊęìĊęđÖĉé×ċĚîǰ
Āöć÷đĀêč ĔîìćÜðäĉ ïĆ êĉ Ĕ Āš ø ąïč Ă ćÖćøĕöŠ óċ Ü ðøąÿÜÙŤ ē é÷Ĕßš đ ĂÖÿćøÖĞ ć ÖĆ ï ÷ć×ĂÜ÷ćêš î Ēïï×ĂÜǰstringent
regulatory authorities5 (đßŠîǰLabel Information US FDA Ēúą SPC ×ĂÜǰEU) đðŨîđÖèæŤǰÿĞćĀøĆïĂćÖćøìĊę
serious, very common Ēúąǰcommon ÙüøĒÿéÜ×šĂöĎúĔîǰUSP DI (ĀøČĂǰDrugDex Drug Evaluations
Monograph Ĕîåćî×šĂöĎú Micromedex) ĔĀšÙøï
2
European Commission. NOTICE TO APPLICANTS. A GUIDELINE ON SUMMARY OF PRODUCT CHARACTERISTICS, October 2005.
3
World Health Organization. “Review of Applications for Marketing Authorization of Multisource (Generic) Pharmaceutical Products”
in the Blue Book-Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products.
Spain; 2011:42.
4
European Commission. NOTICE TO APPLICANTS. A GUIDELINE ON SUMMARY OF PRODUCT CHARACTERISTICS, October 2005.
5
WHO. Guide on Submission of Documentation for Prequalification of Innovator Finished Pharmaceutical Products Approved by
Stringent Regulatory Authorities. 2010.
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3) ×šĂöĎúĂČęîėǰ
3.1) ĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęđðŨîñúēé÷êøÜÝćÖÖćøđÖĉéĂĆîêøÖĉøĉ÷ćǰĔĀšÖúŠćüĕüšĔîĀĆü×šĂîĊĚǰĒúąĂšćÜ
ëċÜĔîĀĆü×šĂ ”4.5 ĂĆîêøÖĉøĉ÷ćÖĆï÷ćĂČęîėĀøČĂĂĆîêøÖĉøĉ÷ćĂČęîė” éšü÷
3.2) ×šĂÙüøðäĉ ïĆêĉ ĔîÖćøĀúĊÖđúĊę÷ ÜĂćÖćøĕöŠ óċÜðøąÿÜÙŤ ǰ ĀøČ ĂÖćøðäĉ ïĆêĉ êîđöČęĂöĊ ĂćÖćøĕöŠ óċÜ
ðøąÿÜÙŤđÖĉé×ċĚîĒúšü
ĔĀšøąïč×šĂöĎúéĆÜêŠĂĕðîĊĚ
4.9.1 øąïč×îćé÷ćÿĎÜÿčéêŠĂüĆîìĊęñĎšðśü÷ĒêŠúąÖúčŠöĂć÷čÙüøĕéšøĆï
4.9.2 øąïč×îćé÷ćìĊęĂćÝđÖĉéóĉþ
4.9.3 øąïčĂćÖćøĒúąĂćÖćøĒÿéÜ×ĂÜÖćøĕéšøĆï÷ćđÖĉî×îćéßîĉéđÞĊ÷ïóúĆî
4.9.4 øąïčüĉíĊøĆÖþćÖøèĊđÖĉéóĉþĒïïđÞĊ÷ïóúĆî
4.9.5 øąïčĂćÖćøĒúąĂćÖćøĒÿéÜ×ĂÜÖćøĕéšøĆï÷ćđÖĉî×îćéßîĉéđøČĚĂøĆÜ
4.9.6 øąïčüĉíĊøĆÖþćÖøèĊđÖĉéóĉþĒïïđøČĚĂøĆÜǰ
ĀĆü×šĂìĊęǰ5 ÙčèÿöïĆêĉìćÜđõÿĆßüĉì÷ć (Pharmacological Properties)

ðøąÖĂïéšü÷ǰ3 ×šĂ÷ŠĂ÷éĆÜîĊĚ
ðøąÖĂïéšü÷ĀĆü×šĂ÷ŠĂ÷éĆÜîĊĚ
5.1.1 ÖúĕÖÖćøĂĂÖùìíĉĝ×ĂÜ÷ć
5.1.2 ÙüćöÿĆöóĆ î íŤ×ĂÜ×îćé÷ćǰÙüćöđ×š ö×šî ǰĀøČ ĂđüúćǰÖĆ ïÖćøêĂïÿîĂÜìćÜđõÿĆ ß óúýćÿêøŤ×ĂÜ÷ćǰ
(øüöìĆĚÜÖćøêĂïÿîĂÜìćÜÙúĉîĉÖĔîøą÷ąÿĆĚî)
5.1.3 ÖúĕÖÖćøđÖĉéóĉþ×ĂÜ÷ć
5.1.4 Ùüćöĕü×ĂÜđßČĚĂĔîðøąđìýĕì÷ǰ(ÖøèĊđðŨî÷ćêšćîÝčúßĊó)
ÙĞćĂíĉïć÷
1) đõÿĆßóúýćÿêøŤĔîìĊęîĊĚĀöć÷ëċÜǰÖúĕÖÖćøĂĂÖùìíĉĝ×ĂÜ÷ćĔîöîčþ÷ŤìĊęÿĂéÙúšĂÜÖĆï×šĂïŠÜĔßš×ĂÜ÷ćǰđðŨîÖćø
Ăíĉïć÷ēé÷ÿĆÜđ×ðǰĒÿéÜøć÷úąđĂĊ÷éĕüšĔîĀĆü×šĂ÷ŠĂ÷ǰÖúĕÖÖćøĂĂÖùìíĉĝ×ĂÜ÷ć
2) ĔîïćÜÖøèĊĂćÝøąïčÖúĕÖÖćøđÖĉéóĉþĀøČĂÖúĕÖÖćøđÖĉéĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęÿĞćÙĆâǰ(ëšćöĊ) ēé÷ĒÿéÜ
øć÷úąđĂĊ÷éĕüšĔîĀĆü×šĂ÷ŠĂ÷ǰÖúĕÖÖćøđÖĉéóĉþ×ĂÜ÷ć
3) ĀćÖđðŨî÷ćêšćîÝčúßĊóǰĔĀšøąïčøć÷ßČęĂđßČĚĂìĊę÷ćĂĂÖùìíĉĝĕéšĕüšĔîĀĆü×šĂ÷ŠĂ÷ǰÙüćöĕü×ĂÜđßČĚĂĔîðøąđìýĕì÷
ĒúąĔĀšøąïčđßČĚĂìĊęéČĚĂêŠĂ÷ćîĆĚîĔîðøąđìýĕì÷ǰ(in vitro) ĕüšéšü÷ǰēé÷éĎøć÷úąđĂĊ÷éêćö×šĂÖĞćĀîéđÞóćąǰ
4) ĀćÖĀĆü×šĂ÷ŠĂ÷ìĊęǰ5.1.2 Ēúą/ĀøČĂǰ5.1.3 ĕöŠìøćïǰĀøČĂǰĕöŠöĊ×šĂöĎúǰĔĀšøąïč×šćÜĔêšĀĆü×šĂîĆĚîüŠć “ĕöŠìøćï”
ĀøČĂ “ĕöŠöĊ×šĂöĎú” ĕüšéšü÷

25
đõÿĆßÝúîýćÿêøŤǰ(Pharmacokinetic properties) Āöć÷ëċÜÙčèÿöïĆêĉìćÜđõÿĆßÝúîýćÿêøŤ×ĂÜêĆü÷ćìĊę
ÿĆöóĆ î íŤ ÖĆï ×îćé÷ćìĊę ĒîąîĞ ćǰÙüćöĒøÜǰĒúąÿĎ ê øêĞ ćøĆ ï÷ćǰĀćÖĕöŠ öĊ×šĂöĎ úéĆ ÜÖúŠ ćü ĂćÝĒÿéÜ×š ĂöĎ ú đõÿĆ ß
ÝúîýćÿêøŤĔîÖćøïøĉĀćø÷ćéšü÷üĉíĊĂČęîǰøĎðĒïï÷ćĂČęî ĀøČĂ×îćé÷ćĂČęîĒìîĕéš öĊ×šĂÖĞćĀîéĔîÖćøĒÿéÜ×šĂöĎúéĆÜîĊĚ
5.2.1 ÙüøĒÿéÜ×š Ă öĎ ú óćøćöĉ đ êĂøŤ óČĚ î åćîéš ć îđõÿĆ ß ÝúîýćÿêøŤ ǰ đßŠ î ǰßĊ ü ðøĉ ö ćèÖćøĂĂÖùìíĉĝ
(bioavailability) ÖćøßĞćøą÷ć (clearance) ĒúąÙŠćÙøċęÜßĊüĉê (half-life) àċęÜÙüøøąïčđðŨîÙŠćđÞúĊę÷óøšĂöÙŠćÙüćö
Ēðøðøüî
5.2.2 ĀĆü×šĂ÷ŠĂ÷×ĂÜđõÿĆßÝúîýćÿêøŤ ìĊęĒÿéÜǰĀćÖđÖĊę÷ü×šĂÜÖĆïñúĉêõĆèæŤ÷ćîĆĚîėǰĕéšĒÖŠ
1) ×šĂöĎúđïČĚĂÜêšî×ĂÜñúĉêõĆèæŤ÷ćǰüŠćđðŨî÷ćēóø-éøĆÖǰ(pro-drug) ĀøČĂ÷ćìĊęÝąđðúĊę÷îĒðúÜĕðđðŨî
ÿćøđöĒìïĂĕúêŤìĊęöĊùìíĉĝ (active metabolites), ĕÙĒøúúĉêĊ (chirality), ĀøČĂÙüćöÿćöćøëĔîÖćøúąúć÷ǰđðŨîêšîǰ
2) úĆÖþèąìĆęüĕð×ĂÜÿćøĂĂÖùìíĉĝÝćÖÖćøïøĉĀćø÷ćøĎðĒïïîĊĚ
Ö. ÖćøéĎéàċö÷ć : ÷ćëĎÖéĎéàċöĕéšÿöïĎøèŤĀøČĂĕöŠÿöïĎøèŤ, ÙŠćßĊüðøĉöćèĂĂÖùìíĉĝÿĆöïĎøèŤĀøČĂÙŠćđðøĊ÷ïđìĊ÷ïÖĆï÷ć
ÞĊéǰ(absolute and/or relative bioavailability), ÷ćñŠćîđ×šćÿĎŠêĆïĒúąëĎÖìĞćúć÷ìĊęêĆïÖŠĂîđ×šćÿĎŠøąïïÖćø
ĕĀúđüĊ÷îēúĀĉêǰ(first pass effect), øą÷ąđüúćêĆĚÜĒêŠđøĉęöĔĀš÷ćÝîëċÜđüúćìĊęøąéĆï÷ćĔîóúćÿöćÿĎÜÿčéǰ(Tmax),
Ăĉìíĉóú×ĂÜĂćĀćøêŠĂÙŠćóćøćöĉđêĂøŤìĊęüĆéĕéšǰ(influence of food), ĔîÖøèĊ×ĂÜÖćøĔßš÷ćđÞóćąìĊęêšĂÜöĊ×šĂöĎúßĊüð
øĉöćèÖćøĂĂÖùìíĉĝ×ĂÜ÷ćìĊęëĎÖéĎéàċöđ×šćÿĎŠøŠćÜÖć÷éšü÷ǰ
×. ÖćøÖøąÝć÷÷ć : ÖćøÝĆïÖĆïēðøêĊîĔîóúćÿöć (plasma protein binding), ðøĉöćêøÖćøÖøąÝć÷êĆü×ĂÜ÷ćǰ
(volume of distribution), Ùüćöđ×šö×šî×ĂÜ÷ćĔîđîČĚĂđ÷ČęĂĒúą/ĀøČĂĔîóúćÿöćǰ(tissue and/or plasma
concentrations), ĀćÖ÷ćÖøąÝć÷÷ćĒïïǰmulti-compartment ĔĀšĒÿéÜ×šĂöĎúóùêĉÖøøöìĊę÷ćÖøąÝć÷Ēïï
Āúć÷ĀšĂÜǰ(multi-compartment) éšü÷
Ù. ÖćøđðúĊę÷îĒðúÜ÷ć : øąéĆï×ĂÜđöĒìïĂúĉàċö (degree of metabolism), ÿćøđöĒìïĂĕúêŤǰ(metabolites),
ÖćøĂĂÖùìíĉĝ×ĂÜđöĒìïĂĕúêŤ, đĂîĕàöŤìĊęđÖĊę÷ü×šĂÜĔî×ïüîÖćøđöĒìïĂúĉàċöǰ(enzymes involved in
metabolism), êĞćĒĀîŠÜìĊęđÖĉéđöĒìïĂúĉàċö (site of metabolism), ñúÖćøýċÖþćĂĆîêøÖĉøĉ÷ćēé÷ÖćøìéúĂÜîĂÖ
øŠćÜÖć÷ǰ(in vitro) üŠć÷ćöĊÙčèÿöïĆêĉĔîÖćøđĀîĊę÷üîĞćĀøČĂ÷Ćï÷ĆĚÜđĂîĕàöŤĔîøŠćÜÖć÷ìĊęĔßšĔî×ïüîÖćøđöĒìïĂúĉàċö
ĀøČĂĕöŠ
Ü. ÖćøÖĞćÝĆé÷ć : ÙŠćÙøċęÜßĊüĉêĔîÖćøÖĞćÝĆé÷ćǰǰÖćøßĞćøą÷ć (clearance) ìĆĚÜĀöéǰ ÙüćöĒðøðøüî×ĂÜøąĀüŠćÜ
ïčÙÙúǰĒúą/ĀøČĂĔîÙîđéĊ÷üÖĆî×ĂÜÙŠćÖćøÖćøßĞćøą÷ć (clearance) ìĆĚÜĀöéǰ inter/intra-subject variability in
total clearance ĂüĆ÷üąìĊę×Ćï÷ćĂĂÖìĆĚÜ÷ćìĊęĂ÷ĎŠĔîøĎðđéĉöĒúąĔîøĎðđöĒìïĂĕúêŤ
Ý. đõÿĆßÝúîýćÿêøŤđßĉÜđÿšîêøÜ/ĕöŠđðŨîđßĉÜđÿšîêøÜ (ëšćöĊ): ĔĀšøąïčüŠćđðŨîÙüćöÿĆöóĆîíŤĒïïĔéđöČęĂóĉÝćøèćêćö
×îćé÷ćĀøČĂđüúćǰëšćĀćÖÙüćöÿĆöóĆîíŤîĆĚîĕöŠđðŨîđßĉÜđÿšîêøÜÙüøöĊÖćøĂíĉïć÷đĀêčñúéšü÷
3) úĆÖþèą×ĂÜñĎšðśü÷ìĊęĒêÖêŠćÜÖĆî
Ö. ĔîÖøèĊìĊęñĎšðśü÷öĊðŦÝÝĆ÷ìĊęÿŠÜñúêŠĂđõÿĆßÝúîýćÿêøŤ×ĂÜ÷ćĂ÷ŠćÜöĊîĆ÷ÿĞćÙĆâìćÜÙúĉîĉÖǰĔĀšĒÿéÜÙüćöÿĆöóĆîíŤ
øąĀüŠćÜðŦÝÝĆ÷đĀúŠćîĆĚîĔîđßĉÜðøĉöćèǰđóĉęöđêĉöéšü÷ǰǰ
×. ðŦÝÝĆ÷êŠćÜǰėǰìĊęĂćÝöĊñúêŠĂđõÿĆßÝúîýćÿêøŤǰǰđßŠîǰĂć÷čǰđóýǰÖćøÿĎïïčĀøĊęǰÖćøđðúĊę÷îĒðúÜ÷ćìĊęđÖĊę÷ü×šĂÜÖĆï
óĆîíčÖøøöìĊęöĊÙüćöĀúćÖĀúć÷ĔîÖúčŠöðøąßćÖøêŠćÜǰėǰǰ(polymorphic metabolism) ÖćøöĊÿõćüąēøÙĂČęîøŠüöǰ
đßŠîǰõćüąïÖóøŠĂÜĀøČĂúšöđĀúü×ĂÜĕêǰêĆïǰøüöìĆĚÜøąéĆïÙüćöøčîĒøÜ×ĂÜÙüćöïÖóøŠĂÜîĆĚîǰė
26
ÙüøĔĀš×šĂöĎúñúÖćøüĉÝĆ÷óøĊÙúĉîĉÖ×ĂÜ÷ćîĊĚđÞóćąĔîÿŠüîìĊęßŠü÷ĔĀšÖćøÿĆęÜĔßš÷ćêćö×šĂïŠÜĔßšđðŨîĕðĂ÷ŠćÜ
ðúĂéõĆ÷ǰÙüøÿøčðñúÖćøüĉÝĆ÷ēé÷ïøø÷ć÷ĔĀšÖøąßĆïǰĒúąÙüøÿøčðñúÖćøðøąđöĉîÙüćöđÿĊę÷ÜêŠĂÿĉęÜĒüéúšĂö×ĂÜ
ñúĉêõĆèæŤ÷ćîĊĚĕüšéšü÷ǰĀćÖđÖĊę÷ü×šĂÜÖĆïĀĆü×šĂîĊĚ
ĀĆü×šĂìĊęǰ6 øć÷úąđĂĊ÷éìćÜđõÿĆßÖøøö (Pharmaceutical Particulars)

ðøąÖĂïéšü÷ǰ5 ĀĆü×šĂ÷ŠĂ÷éĆÜîĊĚ
ĔĀšøąïčøć÷ÖćøêĆü÷ćĕöŠÿĞćÙĆâǰēé÷êšĂÜøąïčßČęĂđðŨîõćþćĂĆÜÖùþǰĀøČĂĀćÖĔßšßČęĂõćþćĕì÷ĔĀšüÜđúĘïßČęĂ
õćþćĂĆÜÖùþ đßŠîǰǰēóüĉēéî (povidone) ĒöÖîĊđàĊ÷öÿđêĊ÷đøì (magnesium stearate) ēéÙĎđàìēàđéĊ÷ö
(docusate sodium)
ĔĀšøąïč×šĂöĎúÙüćöĕöŠđ×šćÖĆî×ĂÜ÷ćÖĆïñúĉêõĆèæŤĂČęîàċęÜöĊĒîüēîšöìĊęÝąîĞćöćĔßšñÿöÖĆîĀøČĂĔĀšøŠüöÖĆîǰēé÷
ĂćÝđðŨîÙüćöĕöŠđ×šćÖĆîìćÜÖć÷õćóĒúą/ĀøČĂìćÜđÙöĊǰÖøèĊđðŨî÷ćÞĊéÙüøøąïčëċÜõćßîąǰÿć÷ǰĀøČĂĂčðÖøèŤĔîÖćø
ïøĉĀćø÷ćêćöÙüćöđĀöćąÿö
ĔîÖøèĊìĊęĕöŠöĊ×šĂöĎúĔĀšøąïčüŠćǰ“ĕöŠöĊ×šĂöĎú”
ĕéšĒÖŠ Ăć÷č÷ćđöČęĂïøøÝčĔîõćßîąđóČęĂÝĞćĀîŠć÷ Ăć÷č÷ćĀúĆÜÝćÖìĊęñÿöđÝČĂÝćÜĒúšüêćöìĊęÖĞćĀîé Ăć÷č÷ć
ĀúĆÜÝćÖìĊęđðŗéĔßš÷ćÙøĆĚÜĒøÖ ēé÷êšĂÜĔĀšÿĂéÙúšĂÜÖĆï×šĂöĎúÙüćöÙÜÿõćó×ĂÜñúĉêõĆèæŤ÷ć
ĔĀšøąïč×šĂöĎúéĆÜîĊĚ
6.4.1 øąïčÿõćüąÖćøđÖĘïøĆÖþćĒúąĂć÷č×ĂÜ÷ćêćö×šĂöĎúñúÖćøýċÖþćÙüćöÙÜÿõćó×ĂÜ÷ćìĊę×ċĚîìąđïĊ÷î
êĞćøĆï÷ćĕüšǰǰ(øüöìĆĚÜøąïčÿõćüąÖćøđÖĘïøĆÖþćĔî×èą×îÿŠÜ÷ć)
6.4.2 øąïčüĉíĊđÖĘï÷ćĀúĆÜđðŗéĔßšĒúšüĒúąÿćöćøëđÖĘïĕéšÖĊęüĆî
6.4.3 ĔîÖøèĊìĊęöĊ×šĂöĎúđÞóćąàċęÜöĊÙüćöÿĞćÙĆâĔîÖćøđÖĘïøĆÖþć Öćø×îÿŠÜǰÖćøđêøĊ÷ö÷ćǰĀøČĂĀ÷ĉï÷ćǰđßŠîǰ
÷ćđÙöĊïĞćïĆéǰđðŨîêšîǰ
6.4.4 ĀćÖđðŨî÷ćÞĊéĀøČĂ÷ćìĊęêšĂÜñÿöÖŠĂîĔßš (reconstitute) êšĂÜøąïčüŠćđöČęĂđðŗéĔßšĒúšüĀøČĂñÿöĒúšü ĀćÖ
ĔßšĕöŠĀöéêšĂÜđÖĘïĂ÷ŠćÜĕøǰĂčèĀõĎöĉđìŠćĕøǰđÖĘïĕéšÖĊęüĆîǰÿĆÜđÖêĂ÷ŠćÜĕøüŠć÷ćđÿČęĂöÿõćóǰĀćÖĕöŠöĊ×šĂöĎúĔĀšøąïčüŠćǰ“Ĕßš
÷ćìĆîìĊĀúĆÜñÿö÷ćǰđîČęĂÜÝćÖĕöŠöĊ×šĂöĎúÙüćöÙÜÿõćó×ĂÜ÷ćìĊęñÿöĒúšü”

27
ĔĀšøąïč×šĂöĎúéĆÜîĊĚ
6.5.1 øąïč ē é÷ïøĉ þĆìñĎš ñ úĉ ê ĀøČ ĂñĎš îĞ ćÿĆę Ü ĄǰêćöÙüćöđĀöćąÿöìĊę ÿ ĂéÙúš ĂÜÖĆ ïÖćø×Ă×ċĚ îìąđïĊ ÷îĕüš ÖĆ ï
ÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰĒúąöĊÖćøÝĞćĀîŠć÷ÝøĉÜĀøČĂöĊĒñîĔîÖćøÝĞćĀîŠć÷ǰēé÷ĔĀšöĊĀîŠü÷ÙüćöĒøÜ
×ĂÜ÷ćÿĂéÙúšĂÜÖĆïĀĆü×šĂìĊęǰ2 ÿŠüîðøąÖĂïĒúąðøĉöćèêĆü÷ćÿĞćÙĆâ
6.5.2 øąïčúĆÖþèąïøøÝčõĆèæŤĒúą×îćéïøøÝč đßŠîǰïøøÝčĒñÜôĂ÷úŤÿĊđÜĉîǰĒñÜúąǰ10 đöĘéǰ
6.5.3 ×îćéïøøÝčêšĂÜÿĂéÙúšĂÜÖĆï×îćé÷ćêćö×šĂïŠÜĔßšĀøČĂöćêøåćîÖćøøĆÖþć
ĀĆü×šĂìĊę 7 ßČęĂñĎšøĆïĂîčâćêñúĉêĀøČĂîĞćĀøČĂÿĆę Ü÷ćĒñîðŦÝÝčïĆîđ×šćöćĔîøćßĂćèćÝĆÖø (Marketing
Authorization Holder)
ĔĀšøąïč×šĂöĎúĕéšĒÖŠǰßČęĂĒúąìĊęĂ÷ĎŠñĎšøĆïĂîčâćêĄ
ĀĆü×šĂìĊę 8 đú×ìąđïĊ÷îêĞćøĆï÷ć (Marketing Authorization Numbers)
ĔĀšøąïčđú×ìąđïĊ÷îêĞćøĆï÷ćǰêćöìĊęðøćÖäĔîĔïÿĞćÙĆâÖćø×ċĚîìąđïĊ÷îêĞćøĆï÷ć
ĀĆü×šĂìĊę 9 üĆîìĊęĕéšøĆïĂîčöĆêĉìąđïĊ÷îêĞćøĆï÷ć (Date of First Authorization/Renewal of the
Authorization)
ĔĀšøąïčüĆîìĊęǰđéČĂîǰðŘǰìĊęĕéšøĆïĂîčöĆêĉìąđïĊ÷îêĞćøĆï÷ć
ĀĆü×šĂìĊęǰ10 üĆîìĊęöĊÖćøĒÖšĕ×ðøĆïðøčÜđĂÖÿćø (Date of revision of the text)
ĔĀšøąïčüĆîìĊę đéČĂîǰðŘǰìĊęöĊÖćøĒÖšĕ×ēé÷øąïčđÞóćąüĆîìĊę đéČĂîǰðŘǰìĊęĒÖšĕ×úŠćÿčé
2. đĂÖÿćøÖĞćÖĆï÷ćĒïïǰPackage Insert
ĀĆü×šĂìĊęǰ1 ßČęĂñúĉêõĆèæŤǰ(Product Name)
éĎĀĆü×šĂìĊęǰ1 ßČęĂñúĉêõĆèæŤǰ(Name of the Medicinal Product) Ĕî×šĂÖĞćĀîé×ĂÜđĂÖÿćøÖĞćÖĆï÷ćĒïïǰ
SPC
ĀĆü×šĂìĊęǰ2 ßČęĂĒúąÙüćöĒøÜ×ĂÜêĆü÷ćÿĞćÙĆâ (Name and Strength of Active Ingredient (s))
éĎĀĆü×šĂìĊęǰ2 ÿŠüîðøąÖĂïĒúąðøĉöćèêĆü÷ćÿĞćÙĆâǰ(Qualitative and Quantitative Composition) Ĕî
×šĂÖĞćĀîé×ĂÜđĂÖÿćøÖĞćÖĆï÷ćĒïïǰSPC
ĀĆü×šĂìĊęǰ3 úĆÖþèą×ĂÜñúĉêõĆèæŤ (Product Description)
ĒÿéÜ×šĂÙüćöêćöøĎðĒïïéĆÜîĊĚǰ
<øĎðĒïï÷ć> <úĆÖþèąõć÷îĂÖìĊęđĀĘîĕéšéšü÷êćđðúŠćǰ>
ÿćøĂČęîėǰĔîêĞćøĆïǰ<øć÷ÖćøêĆü÷ćĕöŠÿĞćÙĆâ>
ēé÷öĊøć÷úąđĂĊ÷é×šĂÖĞćĀîéĔîĀĆü×šĂìĊę 3 úĆÖþèąĒúąøĎðĒïï÷ćìćÜđõÿĆßÖøøö (Pharmaceutical
Form) ĒúąĀĆü×šĂìĊęǰ6.1 øć÷ÖćøêĆü÷ćĕöŠÿĞćÙĆâ (List of excipients) ×ĂÜ×šĂÖĞćĀîé×ĂÜđĂÖÿćøÖĞćÖĆï÷ćĒïïǰ
SPC

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ĀĆü×šĂìĊęǰ4 đõÿĆßóúýćÿêøŤĒúąđõÿĆßÝúîýćÿêøŤǰ(Pharmacodynamics/Pharmacokinetics)
ÙüøĒÿéÜđîČĚĂĀćđðŨîǰ2 ×šĂ÷ŠĂ÷ÙČĂ
4.1 đõÿĆßóúýćÿêøŤ (Pharmacodynamics) éĎĀĆü×šĂìĊęǰ5.1 ÙčèÿöïĆêĉìćÜđõÿĆßóúýćÿêøŤ
(Pharmacodynamic Properties) ×ĂÜĀĆü×šĂìĊęǰ5 ÙčèÿöïĆêĉìćÜđõÿĆßüĉì÷ć (Pharmacological Properties)
Ĕî×šĂÖĞćĀîé×ĂÜđĂÖÿćøÖĞćÖĆï÷ćĒïïǰSPC
4.2 đõÿĆß ÝúîýćÿêøŤ (Pharmacokinetics) éĎ ĀĆü ×šĂìĊęǰ 5.2 ÙčèÿöïĆêĉ ìćÜđõÿĆ ßÝúîýćÿêøŤ
(Pharmacokinetic properties) ×ĂÜĀĆü×šĂìĊęǰ5 ÙčèÿöïĆêĉìćÜđõÿĆßüĉì÷ć (Pharmacological Properties) Ĕî
ÿĞćĀøĆï×šĂöĎúÙüćöðúĂéõĆ÷ÝćÖÖćøýċÖþćóøĊÙúĉîĉÖ (Preclinical Safety data) ĂćÝĒÿéÜĕüšĔîĀĆü×šĂîĊĚǰ
êćöĒîüìćÜĔîĀĆü×šĂìĊęǰ5.3 ×šĂöĎúÙüćöðúĂéõĆ÷ÝćÖÖćøýċÖþćóøĊÙúĉîĉÖ (Preclinical Safety data) ×ĂÜĀĆü×šĂìĊęǰ
5 ÙčèÿöïĆêĉìćÜđõÿĆßüĉì÷ć (Pharmacological Properties) Ĕî×šĂÖĞćĀîé×ĂÜđĂÖÿćøÖĞćÖĆï÷ćĒïïǰSPC
ĀĆü×šĂìĊęǰ5 ×šĂïŠÜĔßš (Indication)
éĎĀĆü×šĂ÷ŠĂ÷ìĊę 4.1 ×šĂïŠÜĔßš (Therapeutic Indication) Ĕî×šĂÖĞćĀîé×ĂÜđĂÖÿćøÖĞćÖĆï÷ćĒïïǰSPC
ĀĆü×šĂìĊęǰ6 ×îćé÷ćìĊęĒîąîĞćǰ(Recommended Dose)
éĎĀĆü×šĂìĊęǰ4.2.1 ×îćé÷ćìĊęĒîąîĞćǰ(Recommended dose) ×ĂÜĀĆü×šĂìĊęǰ4.2 ×îćé÷ćĒúąüĉíĊÖćø
ïøĉĀćø÷ć (Posology and method of administration) Ĕî×šĂÖĞćĀîé×ĂÜđĂÖÿćøÖĞćÖĆï÷ćĒïïǰSPC
ĀĆü×šĂìĊęǰ7 üĉíĊÖćøĔßš÷ć (Mode of Administration)
éĎĀĆü×šĂìĊęǰ4.2.2 üĉíĊÖćøïøĉĀćø÷ć (Mode of Administration) ×ĂÜĀĆü×šĂìĊęǰ4.2 ×îćé÷ćĒúąüĉíĊÖćø
ïøĉĀćø÷ć (Posology and method of administration) Ĕî×šĂÖĞćĀîé×ĂÜđĂÖÿćøÖĞćÖĆï÷ćĒïïǰSPC ĒúąĔĀš
ĒÿéÜ×š Ă öĎ ú ÙüćöĕöŠ đ ×š ć ÖĆ î ×ĂÜ÷ćĕüš éš ü ÷ǰēé÷öĊ ×š Ă ÖĞ ć ĀîéêćöĀĆ ü ×š Ă ìĊę ǰ 6.2 ÙüćöĕöŠ đ ×š ć ÖĆ î ×ĂÜ÷ć
(Incompatibilities) Ĕî×šĂÖĞćĀîé×ĂÜđĂÖÿćøÖĞćÖĆï÷ćĒïïǰSPC
ĀĆü×šĂìĊęǰ8 ×šĂĀšćöĔßš (Contraindication)
éĎĀĆü×šĂìĊęǰ4.3 ×šĂĀšćöĔßš (Contraindication) Ĕî×šĂÖĞćĀîé×ĂÜđĂÖÿćøÖĞćÖĆï÷ćĒïïǰSPC
ĀĆü×šĂìĊęǰ9 ÙĞćđêČĂîĒúą×šĂÙüøøąüĆÜ (Warning and Precautions)
éĎĀĆü×šĂìĊęǰ4.4 ÙĞćđêČĂîóĉđýþĒúą×šĂÙüøøąüĆÜĔîÖćøĔßš÷ć (Special warning and precautions for
use) Ĕî×šĂÖĞćĀîé×ĂÜđĂÖÿćøÖĞćÖĆï÷ćĒïïǰSPC
ĀĆü×šĂìĊęǰ10 ĂĆîêøÖĉøĉ÷ćÖĆï÷ćĂČęîėǰ(Interactions with Other Medicaments)
éĎĀĆü×šĂìĊęǰ4.5 ĂĆîêøÖĉøĉ÷ćÖĆï÷ćĂČęîėĀøČĂĂĆîêøÖĉøĉ÷ćĂČęîė (Interaction with other medicinal
products and other forms of interactions) Ĕî×šĂÖĞćĀîé×ĂÜđĂÖÿćøÖĞćÖĆï÷ćĒïïǰSPC
ĀĆü×šĂìĊęǰ11 ÿêøĊöĊÙøøõŤĒúąÿêøĊøąĀüŠćÜĔĀšîöïčêø (Pregnancy and Lactation)
éĎĀĆü×šĂìĊęǰ4.6 ÖćøĔßšĔîÿêøĊöĊÙøøõŤĒúąÿêøĊøąĀüŠćÜĔĀšîöïčêø (Pregnancy and lactation) Ĕî

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ĀĆü×šĂìĊęǰ12 ĂćÖćøĕöŠóċÜðøąÿÜÙŤ (Undesirable Effects)
éĎĀĆü×šĂìĊęǰ4.8 ĂćÖćøĕöŠóċÜðøąÿÜÙŤ (Undesirable effects) ĒúąĀĆü×šĂìĊęǰ4.7 ñúêŠĂÙüćöÿćöćøëĔîÖćø
×Ćï×ĊęĒúąìĞćÜćîÖĆïđÙøČęĂÜÝĆÖøǰ(Effects on ability to drive and use machine) Ĕî×šĂÖĞćĀîé×ĂÜđĂÖÿćø
ÖĞćÖĆï÷ćĒïïǰSPC
ĀĆü×šĂìĊęǰ13 ÖćøĕéšøĆï÷ćđÖĉî×îćéĒúąüĉíĊÖćøøĆÖþć (Overdose and Treatment)
éĎĀĆü×šĂìĊęǰ4.9 ÖćøĕéšøĆï÷ćđÖĉî×îćé (Overdose) Ĕî×šĂÖĞćĀîé×ĂÜđĂÖÿćøÖĞćÖĆï÷ćĒïïǰSPC
ĀĆü×šĂìĊęǰ14 ÿõćüąÖćøđÖĘïøĆÖþć (Storage Condition)
éĎĀĆü×šĂìĊęǰ4.9 ÖćøĕéšøĆï÷ćđÖĉî×îćé (Overdose) Ĕî×šĂÖĞćĀîé×ĂÜđĂÖÿćøÖĞćÖĆï÷ćĒïïǰSPC
ĀĆü×šĂìĊęǰ15 øĎðĒïï÷ćĒúą×îćéïøøÝčìĊęöĊÝĞćĀîŠć÷ (Dosage Forms and Packaging Available)
éĎĀĆü×šĂìĊęǰ6.5 úĆÖþèąĒúąÿŠüîðøąÖĂï×ĂÜõćßîąïøøÝč (Nature and contents of container)
ÿĞćĀøĆïøĎðĒïï÷ćøąïčĔĀšÿĂéÙúšĂÜÖĆïĀĆü×šĂĂČęîėǰ
ĀĆü×šĂìĊęǰ16 ßČęĂĒúąìĊęĂ÷ĎŠ×ĂÜñĎšñúĉêĀøČĂîĞćĀøČĂÿĆęÜ÷ćĒñîðŦÝÝčïĆîđ×šćöćĔîøćßĂćèćÝĆÖø (Name and
Address of Manufacturer/Marketing Authorization Holder)
ĔĀšøąïč×šĂöĎúĕéšĒÖŠǰßČęĂĒúąìĊęĂ÷ĎŠñĎšøĆïĂîčâćêĄ
ĀĆü×šĂìĊęǰ17 üĆîìĊęöĊÖćøĒÖšĕ×ðøĆïðøčÜđĂÖÿćø (Date of Revision of Package Insert)
ĔĀšøąïčüĆîìĊęǰđéČĂîǰðŘǰìĊęöĊÖćøĒÖšĕ×ēé÷øąïčđÞóćąüĆîìĊęǰđéČĂîǰðŘǰìĊęĒÖšĕ×úŠćÿčé

30
ïììĊęǰ3
ĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîǰ
(Guideline for Development of Patient Information Leaflet: PIL)
đĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîđðŨîđÙøČęĂÜöČĂĔîÖćøÿČęĂÿćø×šĂöĎúóČĚîåćîìĊęÝĞćđðŨîĔîÖćøĔßš÷ćđóČęĂĔĀš
ñĎšðśü÷ÿćöćøëîĞć×šĂöĎúìĊęĕéšĕððäĉïĆêĉĔîÖćøĔßš÷ćĕéšĂ÷ŠćÜđĀöćąÿöǰëĎÖêšĂÜĒúąðúĂéõĆ÷ǰĀĆüĔÝÿĞćÙĆâĔîÖćøÝĆéìĞć
ÙČĂǰêšĂÜöčŠÜđÿîĂ×šĂöĎúìĊęßĆéđÝîüŠćñĎšðśü÷êšĂÜðäĉïĆêĉĂ÷ŠćÜĕøǰĒúąđĂÖÿćøÖĞćÖĆï÷ćêšĂÜöĊðøąÿĉìíĉõćóĔîÖćøĔĀš×šĂöĎúǰ
ēé÷ñŠćîÖćøĂĂÖĒïïöćđðŨîĂ÷ŠćÜéĊǰ×šĂöĎúìĊęîĞćđÿîĂêšĂÜëĎÖêšĂÜǰßĆéđÝîđĀöćąÿöĒÖŠñĎšðśü÷ǰÝĆéüćÜĔîêĞćĒĀîŠÜìĊę
ñĎšðśü÷ĀćóïĕéšÜŠć÷ǰĒúąÿćöćøëìĞćĔĀšñĎšðśü÷đÖĉéÙüćöđ×šćĔÝìĊęëĎÖêšĂÜǰ
ĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîÞïĆïîĊĚÝĆéìĞć×ċĚîēé÷ñŠćîÖøąïüîÖćøüĉÝĆ÷ĒúąóĆçîć
ĔĀš ÿ ĂéÙúš ĂÜÖĆ ï ïøĉ ïì×ĂÜðøąđìýĕì÷ǰēé÷Öćøðäĉ ïĆ êĉ ÖćøĒïïöĊ ÿŠ ü îøŠ ü öĒúąñŠ ćîÖćøìéÿĂïÖćøîĞ ćĕðĔßšǰ
ĒîüìćÜîĊĚöčŠÜĀöć÷ĔĀšñĎšøĆïĂîčâćêîĞćĕðĔßšĔîÖćø×ċĚîìąđïĊ÷îêĞćøĆï÷ćǰĂĊÖìĆĚÜĔßšĔîÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆï
ðøąßćßîöćêøåćîǰǰĂ÷ŠćÜĕøÖĘêćöǰñĎšìĊęĔßšðøąē÷ßîŤÝćÖđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîÙČĂñĎšðśü÷ĀøČĂñĎšïøĉēõÙǰ
ÝċÜÙüøìéÿĂïðøąÿĉìíĉõćóÖćøĔĀš×šĂöĎú×ĂÜđĂÖÿćøÖĞćÖĆï÷ćÖĆïñĎšïøĉēõÙ (user-testing) êćöÙüćöđĀöćąÿöǰ
ĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßî ĒîüìćÜÞïĆïîĊĚđðŨîĒîüìćÜÖćøÝĆéìĞćđĂÖÿćø
ÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîÞïĆïõćþćĕì÷đìŠćîĆĚî ðøąÖĂïéšü÷ǰ2 ÿŠüîǰÙČĂǰ
Ö. ×šĂÖĞćĀîéìĆęüĕðĔîÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßî
×. øć÷úąđĂĊ÷éĔîÖćøÝĆ éìĞćǰ“×šĂöĎ úđĂÖÿćøÖĞćÖĆï÷ćđóČęĂĔßšÿĞćĀøĆïÖćøìüîÿĂïēé÷ñĎšðøąđöĉî /
đÝšćĀîšćìĊę”
Ö. ×šĂÖĞćĀîéìĆęüĕðÿĞćĀøĆïÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßî
1. õćþćĒúąýĆóìŤìĊęĔßš
ĔĀšĔßšõćþćĕì÷đðŨîĀúĆÖĒúąĔßšêĆüđú×ĂćøïĉÖ ýĆóìŤĀøČĂ×šĂÙüćöìĊęĔßšêšĂÜÖøąßĆïǰđ×šćĔÝÜŠć÷ǰđĀöćąÿĞćĀøĆï
ðøąßćßîǰđßŠîǰĔßšÙĞćüŠćǰ“Öĉî” ĒìîÙĞćüŠćǰ“ìćî” “øĆïðøąìćî” ēé÷ìĆęüĕðĕöŠĒîąîĞćĔĀšĔßšýĆóìŤõćþćĂĆÜÖùþ
÷ÖđüšîĔîÖøèĊìĊęĂćÝìĞćĔĀšđÖĉéÙüćöÿĆïÿîǰĔĀšüÜđúĘïýĆóìŤõćþćĂĆÜÖùþĕüš
2. úĆÖþèą×ĂÜđĂÖÿćø
2.1 đĂÖÿćøÖĞćÖĆï÷ćìĊęĒîïĕðÖĆïñúĉêõĆèæŤ
đĂÖÿćøÖĞćÖĆï÷ćìĊęĒîïĕðÖĆïñúĉêõĆèæŤĔĀšÝĆéóĉöóŤéšü÷ĂĆÖþøÿĊêĆéÖĆïóČĚîÖøąéćþĂŠćîĕéšßĆéđÝî ĔîìčÖ
ĀîšćÖøąéćþ ĒúąĂĆÖþøìĊęóĉöóŤĒîąîĞćüŠćÙüøöĊ×îćéĕöŠđúĘÖÖüŠć Tahoma 11 points øą÷ąĀŠćÜøąĀüŠćÜĂĆÖþø
ÿćöćøëĂŠćîĕéšēé÷ÜŠć÷đìĊ÷ïđìŠćÖĆïÖćøĂŠćîĀîĆÜÿČĂóĉöóŤøć÷üĆî ēé÷ìĆęüĕðĒîąîĞćĔĀšÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆï
ðøąßćßîêćöøĎðĒïïéĆÜîĊĚ
1) ÖćøÝĆéđîČĚĂĀć
ĔĀšÝĆéìĞć×šĂöĎúĒîüîĂî (landscape) Ēïïǰ3 ÙĂúĆöîŤǰïîÖøąéćþ×îćéǰA4 (éĎêĆüĂ÷ŠćÜđĂÖÿćø ÖĞćÖĆï÷ć
ÿĞćĀøĆïðøąßćßîĔîõćÙñîüÖ 2)
2) óĉöóŤ×šĂÙüćöéšü÷êĆüĂĆÖþø Tahoma ìĊęđĀĘîßĆéĔîìčÖĀîšćǰÿĊêĆüĂĆÖþøêĆéÖĆïÿĊóČĚî ēé÷×îćéêĆüĂĆÖþøĔĀšéĎ
êćö×šĂÖĞćĀîéĔîĒêŠúąĀĆü×šĂ (éĎêĆüĂ÷ŠćÜēÙøÜøŠćÜđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîĔîõćÙñîüÖ 3)
ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙöǰ2556
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2.1) ÿŠüîêšî×ĂÜđĂÖÿćø : ßČęĂ÷ćǰÙüćöĒøÜǰøĎðĒïï÷ćǰĒúąßČęĂÖćøÙšć ÝĆéóĉöóŤéšü÷êĆüĂĆÖþø×îćéĕöŠîšĂ÷
ÖüŠćǰ14 đðŨîĂĆÖþøêĆüĀîćǰ(bold) Ă÷ĎŠÖċęÜÖúćÜĔîÖøĂïÿĊęđĀúĊę÷ö ÿŠüîĒøÖÿčé×ĂÜđĂÖÿćø
2.2) ĀĆü×šĂĔĀâŠìĆĚÜǰ6 ĀĆü×šĂ ÝĆéóĉöóŤ×šĂÙüćöéšü÷êĆüĂĆÖþøǰ×îćéĕöŠîšĂ÷ÖüŠćǰ14 đðŨîĂĆÖþøĀîćǰ(bold)
Ă÷ĎŠÖċęÜÖúćÜĔîÖøĂïÿĊęđĀúĊę÷ö
2.3) ĀĆü×šĂ÷ŠĂ÷ǰÝĆéóĉöóŤ×šĂÙüćöéšü÷êĆüĂĆÖþøǰ×îćéĕöŠîšĂ÷ÖüŠćǰ11 đðŨîĂĆÖþøêĆüĀîćǰ(bold) ēé÷ÝĆéßĉé
×Ăïàšć÷×ĂÜĀîšćÖøąéćþ
2.4) đîČĚĂĀćĔîĀĆü×šĂ÷ŠĂ÷ ÝĆéóĉöóŤ×šĂÙüćöéšü÷êĆüĂĆÖþøǰ×îćéĕöŠîšĂ÷ÖüŠćǰ11 ĂĆÖþøêĆüíøøöéćǰĀøČĂ
êĆüĀîćǰ×ċĚîĂ÷ĎŠÖĆï×šĂÖĞćĀîéĔîĒêŠúą×šĂ
2.5) ×šĂÙüćöøŠüöìšć÷đĂÖÿćøǰÝĆéóĉöóŤéšü÷éšü÷êĆüĂĆÖþø ×îćéĕöŠîšĂ÷ÖüŠć 11 Ēúą×šĂÙüćöĀĆü×šĂĔßš
ĂĆÖþøêĆüĀîćǰ(bold) ĔÿŠĔîÖøĂïÿĊęđĀúĊę÷ö ĒúąđîČĚĂĀćēé÷ìĆęüĕðĔĀšĂ÷ĎŠéšćîïîÿčé×ĂÜđĂÖÿćøǰĔîÿŠüî
ÙĂúĆöîŤéšćî×üćÿčé
2.6) ñĎšñúĉê/ñĎšîĞćđ×šć/ñĎšĒìîÝĞćĀîŠć÷ǰÝĆéóĉöóŤéšü÷éšü÷êĆüĂĆÖþøǰ×îćéĕöŠîšĂ÷ÖüŠć 11 ēé÷ĔĀšÝĆéüćÜ
êĞćĒĀîŠÜĂ÷ĎŠìšć÷ÿčé×ĂÜđĂÖÿćø
3) øĎðĀøČĂõćóðøąÖĂïêšĂÜöĊ×šĂÙüćöïøø÷ć÷øŠüöéšü÷đÿöĂ
×šĂÖĞćĀîé×šćÜêšîĂćÝðøĆïðøčÜĕéšêćöÙüćöđĀöćąÿöǰĒúąÙüøîĞćĕðìéÿĂïǰUser testing đóČęĂĔĀšĒîŠĔÝ

üŠćðøąßćßîÿćöćøëĂŠćîĂĂÖǰĀćÜŠć÷ǰĒúąđ×šćĔÝĕéšĂ÷ŠćÜëĎÖêšĂÜ
2.2 ×šĂöĎúđĂÖÿćøÖĞćÖĆï÷ćđóČęĂĔßšÿĞćĀøĆïÖćøìüîÿĂïēé÷ñĎšðøąđöĉî/đÝšćĀîšćìĊę
ÝĆéđêøĊ÷ö×šĂöĎúĒîüêĆĚÜǰ(portrait) ĒïïÙĂúĆöîŤđéĊ÷ü ìĆĚÜĔîøĎðđĂÖÿćø×îćéǰA4 ĒúąĒôŜö×šĂöĎúĂĉđúĘÖēìø
îĉÖÿŤǰĔî×šĂÙüćöĒêŠúąðøąē÷Ù×ĂÜđĂÖÿćøÖĞćÖĆï÷ćĔĀšĒÿéÜøć÷úąđĂĊ÷éÖćøĂšćÜĂĉÜ×šĂöĎúĔîđĂÖÿćøÖĞćÖĆï÷ćǰ
óøšĂöĒîïđĂÖÿćøĂšćÜĂĉÜĒÿéÜøć÷úąđĂĊ÷é×šĂöĎúĔĀšÙøïìčÖĀĆü×šĂĂ÷ŠćÜÿöïĎøèŤ ēé÷ĒîïÿĞćđîćđĂÖÿćøĂšćÜĂĉÜĔî
ÿŠüîìĊęđÖĊę÷ü×šĂÜǰĒúąĒôŜö×šĂöĎúĂĉđúĘÖēìøîĉÖÿŤöćðøąÖĂïÖćøóĉÝćøèćéšü÷
ÿĞćĀøĆïđĂÖÿćøÖĞćÖĆï÷ćìĊęĒîïĕðÖĆïñúĉêõĆèæŤĔĀšÿŠÜđðŨîđĂÖÿćøóøšĂöĒôŜö×šĂöĎúĂĉđúĘÖēìøîĉÖÿŤĔîüĆîìĊęøĆï
ĔïÿĞćÙĆâÖćø×ċĚîìąđïĊ÷îêĞćøĆï÷ćĀøČĂüĆîìĊęøĆïĂîčâćêĔĀšĒÖšĕ×ìąđïĊ÷îêĞćøĆï÷ćǰÖøèĊìĊę÷ĆÜĕöŠöĊÞïĆïÝøĉÜĔĀšÿŠÜđðŨîǰ
art work Ēìîĕéš
3. ÙčèúĆÖþèąìĆęüĕð×ĂÜđîČĚĂĀć
3.1 đîČĚĂĀć×ĂÜđĂÖÿćøÖĞćÖĆï÷ćêšĂÜßĆéđÝîüŠćñĎšðśü÷êšĂÜðäĉïĆêĉĂ÷ŠćÜĕøǰöĊÙüćöÿĂéÙúšĂÜÖĆï×šĂïŠÜĔßšĒúą
ñĎšðśü ÷ĀúĆÖìĊęĔßš÷ ć ēé÷đðŨ î×š ĂöĎ úìĊę öĊĒĀúŠ ÜĂš ćÜĂĉ ÜìĊę đßČę ĂëČ Ăĕéšǰ àċęÜêšĂÜĒîïđĂÖÿćøĂš ćÜĂĉÜìĊę ÿîĆ ïÿîčî đîČĚ ĂĀćĔî
đĂÖÿćøöćéšü÷đÿöĂ
đîČĚĂĀćĕöŠđðŨîúĆÖþèąÖćøēÛþèćÿøøóÙčèđóČęĂÿŠÜđÿøĉöÖćøĔßš÷ćǰĀšćöĔÿŠ×šĂöĎúìĊęĕöŠêøÜÖĆï×šĂđìĘÝÝøĉÜǰĀøČĂ
ÝÜĔÝĔĀšđÖĉéÙüćöđ×šćĔÝñĉé
ÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîÙüøóĉÝćøèćĒîüìćÜìĆęüĕðĔîÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćĒúą
ĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïïčÙúćÖøìćÜÖćøĒóì÷ŤðøąÖĂïéšü÷
3.2 ÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîĔĀšÙĞćîċÜëċÜüŠćñĎšðśü÷ÿćöćøëìĞćÙüćöđ×šćĔÝǰĒúąîĞć×šĂöĎú
ÝćÖđĂÖÿćøÖĞ ćÖĆ ï ÷ćĕðĔßš ǰ ĀøČ Ăðäĉ ïĆ êĉ Ă÷Š ćÜđĀöćąÿöĕéšĀ øČ ĂĕöŠ ǰ àċęÜđøĊ ÷ÖüŠ ćǰ“Consumer-focused” ĀøČ Ăǰ
“Performance-focused” ēé÷ĔĀšÙüćöÿĞćÙĆâĔîÖćøĔĀš×šĂöĎúìĊęñĎšðśü÷ÿćöćøëđ×šćĔÝĕéšÜŠć÷ǰĒúąîĞćĕðĔßšðäĉïĆêĉĕéš
Ýøĉ Ü ǰēé÷ĒîąîĞ ć ĔĀš îĞ ć đĂÖÿćøÖĞ ć ÖĆ ï ÷ćĕðñŠ ć îÖćøìéÿĂïÖćøĔĀš ×š Ă öĎ ú ×ĂÜđĂÖÿćøÖĞ ć ÖĆ ï ÷ćǰĀøČ Ă ǰUser-
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testing/Benchmarking ìĆĚÜîĊĚđóČęĂðøąđöĉîÖćøĔĀš×šĂöĎú×ĂÜđĂÖÿćøÖĞćÖĆï÷ćÖŠĂîìĊęÝąîĞćĕðĔĀšñĎšðśü÷ĔßšÝøĉÜǰüŠć
×šĂöĎúõć÷ĔîđĂÖÿćøÖĞćÖĆï÷ćîĆĚîÿćöćøëìĞćĔĀšđÖĉéÖćøĔßš÷ćìĊęëĎÖêšĂÜđĀöćąÿöǰĒúąðúĂéõĆ÷ĔîÖúčŠöñĎšðśü÷ĀøČĂĕöŠǰ
àċęÜðøąđöĉîĕéšÝćÖÖćøìĊęđĂÖÿćøÖĞćÖĆï÷ćÿćöćøëĔĀš×šĂöĎúìĊęñĎšðśü÷ÿćöćøëîĞćĕððäĉïĆêĉêĆüĕéšđĀöćąÿö ÿĞćĀøĆï
ÙĞćĒîąîĞćĔîÖćøìéÿĂïđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîõćþćĕì÷ǰàċęÜĕéšÝćÖÖćøüĉÝĆ÷ĒúąóĆçîćĔĀšđĀöćąÿöÖĆï
ïøĉïì×ĂÜðøąđìýĕì÷ǰöĊøć÷úąđĂĊ÷ééĆÜõćÙñîüÖ 4
đĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîÙüøÿćöćøëĔĀš×šĂöĎúĒÖŠñĎšðśü÷Ă÷ŠćÜßĆéđÝîìĆĚÜĔîĒÜŠ×ĂÜÖćøÝĆéüćÜĒúą
Ùüćöđ×šćĔÝ×ĂÜđîČĚĂĀćǰÿćöćøëìĞćĔĀšñĎšĂŠćîøĆïøĎšëċÜ×šĂöĎúÿĞćÙĆâ×ĂÜ÷ćĕéšĔîìĆîìĊĒöšÝąĂŠćîĒïïñŠćîė
3.3 ĔĀšÝĆéđîČĚĂĀćđðŨîǰ6 ĀĆü×šĂĔĀâŠǰđøĊ÷ÜêćöúĞćéĆï×ĂÜ×ĆĚîêĂîÖćøĔßš÷ćǰĕéšĒÖŠǰ÷ćîĊĚÙČĂĂąĕøǰ×šĂÙüøøĎš
ÖŠĂîĔßš÷ćǰüĉíĊĔßš÷ćǰ×šĂÙüøðäĉïĆêĉøąĀüŠćÜĔßš÷ćǰĂĆîêøć÷ìĊęĂćÝđÖĉéÝćÖ÷ćǰĒúąÙüøđÖĘï÷ćîĊĚĂ÷ŠćÜĕøǰēé÷êšĂÜøąïčßČęĂ
×ĂÜĀĆü×šĂĔĀâŠ ĀĆü×šĂ÷ŠĂ÷ Ēúąøć÷úąđĂĊ÷éĂČęîǰĔĀšÙøïëšüîêćöēÙøÜøŠćÜđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîǰ
(template) (õćÙñîüÖ 3)
3.4 ÝĆéìĞć×šĂöĎú÷ćĒ÷ÖêćöøĎðĒïïǰĒúąÙüćöĒøÜ×ĂÜ÷ćǰđüšîĒêŠǰëšćøüöÖĆîĒúšüĕöŠöĊñúêŠĂ×šĂïŠÜĔßšĒúą
ÙüćöðúĂéõĆ÷ÝćÖÖćøĔßš÷ć ÝċÜĂîčēúöĔĀšĔßšøŠüöÖĆîĕéšǰ
3.5 ÙĞćđêČĂî×ĂÜ÷ćêćöðøąÖćýÖøąìøüÜÿćíćøèÿč×ǰĔĀšÖøąÝć÷đîČĚĂĀćúÜêćöĀĆü×šĂ÷ŠĂ÷êŠćÜėêćö
ÙüćöđĀöćąÿöēé÷öĊđîČĚĂÙüćöÙøïëšüî
3.6 êšĂÜøąïč×šĂÙüćöêćöêćøćÜéšćîúŠćÜĔîđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîìčÖßîĉé
êćøćÜǰ×šĂÙüćöìĊęêšĂÜøąïčĔîđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîìčÖßîĉé
êĞćĒĀîŠÜ×ĂÜ×šĂÙüćö ×šĂÙüćö
ĔîđĂÖÿćøÖĞćÖĆï÷ć
đðŨî×šĂ÷ŠĂ÷ĒøÖǰĔîĀĆü×šĂǰ3.1 ×îćéĒúąüĉíĊĔßš x “ÙüøĔßš÷ćêćöÙĞćĒîąîĞć×ĂÜĒóì÷ŤĀøČĂđõÿĆßÖøđìŠćîĆĚî
đóøćą×îćéĒúąøą÷ąđüúćĔîÖćøĔßš÷ćîĊĚ×ċĚîÖĆïßîĉéĒúą
ÙüćöøčîĒøÜ×ĂÜēøÙ”
đðŨî×šĂ÷ŠĂ÷×ĂÜĀĆü×šĂëšćĔßš÷ćîĊĚđÖĉî×îćéìĊęĒîąîĞćǰÙüøìĞć x ĔĀšÿĆÜđÖêĂćÖćøĂ÷ŠćÜĔÖúšßĉéǰĀćÖöĊĂćÖćøñĉéðÖêĉìĊęøčîĒøÜǰ
Ă÷ŠćÜĕøǰ(×šĂǰ3.3) [(đßŠî ………) ëšćöĊ×šĂöĎúēðøéøąïčêĆüĂ÷ŠćÜĂćÖćøìĊęđÖĉé×ċĚîĕéš
/ Sign & Symptom of overdosage] ĔĀšøĊïîĞćÿŠÜ
ēøÜó÷ćïćúìĆîìĊ
đðŨî3×šĂ÷ŠĂ÷ĒøÖǰĔîĀĆü×šĂ 5.1 ĂćÖćøìĊęêšĂÜĀ÷čé÷ćĒúšüøĊï x ïüöìĊęĔïĀîšćǰđðúČĂÖêćǰøĉöòŘðćÖǰúöóĉþǰ
ĕðóïĒóì÷ŤìĆîìĊ x ĀîšćöČéǰđðŨîúöǰĒîŠîĀîšćĂÖǰĀć÷ĔÝúĞćïćÖǰ
x ñČę î ĒéÜǰêčŠ ö óĂÜǰñĉ ü ĀîĆ Ü Āúč é úĂÖǰöĊ ÝĚĞ ć êćöñĉ ü ĀîĆ Ü ĀøČ Ă
đúČĂéĂĂÖñĉéðÖêĉǰ
đðŨî×šĂ÷ŠĂ÷ĒøÖǰĔîĀĆü×šĂǰ6. ÙüøđÖĘï÷ćîĊĚĂ÷ŠćÜĕø x đÖĘï÷ćĕüšĔîõćßîąïøøÝčđéĉöêćöìĊęĕéšøĆïöć
Disclaimer ĔîÖøĂïÿĊęđĀúĊ÷ę öéšćîúŠćÜÿčé×ĂÜđĂÖÿćøǰ đĂÖÿćøîĊĚ đ ðŨ î ×š Ă öĎ ú ēé÷÷Š Ă ǰĀćÖöĊ ×š Ă ÿÜÿĆ ÷ ĔĀš ð øċ Ö þć
Ēóì÷ŤĀøČĂđõÿĆßÖø
4. đĂÖÿćøĂšćÜĂĉÜĀúĆÖ
đîČĚĂĀć×ĂÜđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîÙüøÝĆéìĞćÝćÖđĂÖÿćøĂšćÜĂĉÜ 2 ðøąđõìÙČĂ
1) ÖćøÝĆéìĞćēé÷ĂšćÜĂĉÜÝćÖđĂÖÿćøÖĞćÖĆï÷ćöćêøåćîÿĞćĀøĆïïčÙúćÖøìćÜÖćøĒóì÷ŤǰĀøČĂǰđĂÖÿćøÖĞćÖĆï
÷ć×ĂÜñúĉêõĆèæŤĂšćÜĂĉÜìĊęǰĂ÷. ÖĞćĀîé
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ÿćöćøëĔßšđĂÖÿćøÖĞćÖĆï÷ćöćêøåćîĀøČĂǰđĂÖÿćøÖĞćÖĆï÷ć×ĂÜñúĉêõĆèæŤĂšćÜĂĉÜìĊęǰĂ÷. đðŨîđĂÖÿćøĀúĆÖ
Ă÷ŠćÜĕøÖĘêćö ĒîąîĞćĔĀšÿČïÙšîǰPIL ìĊęĕéšøĆïĂîčöĆêĉÝćÖǰstringent regulatory authority ðøąÖĂïéšü÷đóČęĂßŠü÷ĔĀš
ÝĆéìĞćĕéšÜŠć÷×ċĚîǰēé÷đÞóćąðøąđìýìĊęöĊ×šĂÖĞćĀîéĔĀšìĞćǰuser testing đßŠî ÿĀøćßĂćèćÝĆÖøǰǰÿĀõćó÷čēøðǰǰ
ĂĂÿđêøđúĊ÷
2) ÖćøÝĆéìĞćēé÷ĔßšđĂÖÿćøĂšćÜĂĉÜĀúĆÖǰ
ĔîÖøèĊìĊęĕöŠöĊ×šĂöĎúêćö×šĂǰ1) ĔĀšÝĆéìĞćēé÷ĔßšđĂÖÿćøĂšćÜĂĉÜđøĊ÷ÜêćöúĞćéĆïÝćÖĒĀúŠÜĂšćÜĂĉÜǰ(ÞïĆïúŠćÿčé)
Ă÷ŠćÜîšĂ÷ 7 ĒĀúŠÜǰĔîìčÖĀĆü×šĂǰéĆÜîĊĚǰ
ßČęĂåćî×šĂöĎú
Ref 01 Patient Information Leaflet ×ĂÜ÷ćêšîĒïïǰÿČïÙšîÝćÖ
1.http://emc.medicines.org.uk/emc/industry (eMC), Ēúą
2.http://www.accessdata.fda.gov/scripts/cder/drugsatfda/(US FDA) Ēúą
3.http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01
ac058001d125 (EMA) Ēúą
4. http://www.mhra.gov.uk/Publications/PublicAssessmentReports/A-Zlisting/index.htm (MHRA) Ēúą
5. http://www.tga.gov.au/hp/information-medicines-pi.htm (TGA Australia)
Ref 02 Summary Product Characteristics/Package Insert ×ĂÜ÷ćêšîĒïïÿĞćĀøĆïïčÙúćÖøìćÜÖćøĒóì÷Ť ÿćöćøëÿČïÙšîĕéšÝćÖǰ
1.http://emc.medicines.org.uk/emc/industry (eMC)
2.http://www.accessdata.fda.gov/scripts/cder/drugsatfda/(US FDA)
3.http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01
ac058001d125 (EMEA)
4. http://www.mhra.gov.uk/Publications/PublicAssessmentReports/A-Zlisting/index.htm (MHRA)
5. http://www.tga.gov.au/hp/information-medicines-pi.htm (TGA Australia)
Ref 03 USPDI Advice for the patient Drug Information in Lay language ĀøČĂ www.medscape.com
Ref 04 åćî×šĂöĎúǰMicromedex (ÿČïÙšî×šĂöĎúĕéšìĊęĀšĂÜÿöčéÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ć)
Ref 05 đĂÖÿćøÖĞćÖĆï÷ćìĊę×ċĚîìąđïĊ÷îêĞćøĆï÷ćĔîðøąđìýĕì÷
Ref 06 Uptodate Patient Drug ĀøČĂǰDrug Information Handbook
Ref 07 ĒĀúŠÜ×šĂöĎúĂČęîǰđßŠî BNF, AHFS, Drug fact and comparison, Clinical Pharmacology (ĂćÝÿČïÙšîÝćÖǰMD
consult), Core Consumer Medicine Information (Core CMI) (http://medicinesaustralia.com.au/issues-information/core-
cmi/)
Āöć÷đĀêč ĀćÖĕöŠöĊ×šĂöĎúĔîđĂÖÿćøĂšćÜĂĉÜĒĀúŠÜĔéĔĀšøąïčüŠćĕöŠöĊ×šĂöĎúĔîđĂÖÿćøĂšćÜĂĉÜîĆĚîė
5. ×šĂÖĞćĀîéĀĆü×šĂ×ĂÜđĂÖÿćøÖĞćÖĆï÷ćõćþćĕì÷ÿĞćĀøĆïðøąßćßî
ĔîđĂÖÿćøÖĞćÖĆï÷ćĔĀšøąïč “ßČęĂ÷ćǰÙüćöĒøÜǰøĎðĒïï÷ćǰĒúąßČęĂÖćøÙšć” ĕüšĔîÿŠüîêšî×ĂÜđĂÖÿćø êćö
éšü÷ĀĆü×šĂĔîđĂÖÿćøÖĞćÖĆï÷ćǰ6 ĀĆü×šĂǰēé÷đøĊ÷ÜúĞćéĆïĀĆü×šĂǰ(ĀšćöÿúĆï) éĆÜîĊĚ
1. ÷ćîĊĚÙČĂ÷ćĂąĕø
1.1 ÷ćîĊĚöĊßČęĂÿćöĆâüŠćĂąĕøǰǰǰǰǰ
1.2 ÷ćîĊĚĔßšđóČęĂĂąĕø
1.3 ĔĀšøąïč×šĂöĎúÿĞćÙĆâĂČęîėǰ(êćöÙüćöÝĞćđðŨî)
2. ×šĂÙüøøĎšÖŠĂîĔßš÷ć
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2.1 ĀšćöĔßš÷ćîĊĚđöČęĂĕø
2.2 ×šĂÙüøøąüĆÜđöČęĂĔßš÷ćîĊĚ
3. üĉíĊĔßš÷ć
3.1 ×îćéĒúąüĉíĊĔßš
3.2 ĀćÖúČöÖĉî÷ćÙüøìĞćĂ÷ŠćÜĕø
3.3 ëšćÖĉî÷ćîĊĚđÖĉî×îćéìĊęĒîąîĞćǰÙüøìĞćĂ÷ŠćÜĕø
4. ×šĂÙüøðäĉïĆêĉøąĀüŠćÜĔßš÷ć
5. ĂĆîêøć÷ìĊęĂćÝđÖĉéÝćÖ÷ć
5.1 ĂćÖćøìĊęêšĂÜĀ÷čé÷ćĒúšüøĊïĕðóïĒóì÷ŤìĆîìĊ
5.2 ĂćÖćøìĊęĕöŠÝĞćđðŨîêšĂÜĀ÷čé÷ć ĒêŠëšćöĊĂćÖćøøčîĒøÜĔĀšĕðóïĒóì÷ŤìĆîìĊ
6. ÙüøđÖĘï÷ćîĊĚĂ÷ŠćÜĕø
Ēúąêćöéšü÷ “×šĂÙüćöøŠüöìšć÷đĂÖÿćøǰ(disclaimer)” “ñĎšñúĉê/ñĎšîĞćđ×šć/ñĎšĒìîÝĞćĀîŠć÷” “đĂÖÿćøîĊĚ
ðøĆïðøčÜÙøĆĚÜÿčéìšć÷đöČęĂ” êćöúĞćéĆï
Āöć÷đĀêč ÖćøÝĆéĀĆü×šĂêćö×šĂÖĞćĀîéîĊĚ÷ĆÜÙÜöĊđîČĚĂĀćÙøïëšüîÿĂéÙúšĂÜÖĆïĀĆü×šĂìĊęÖĞćĀîéĕüšêćö×šĂêÖúÜ×ĂÜ
ĂćđàĊ÷î (ACTD) ìĆĚÜǰ17 ĀĆü×šĂǰđóĊ÷ÜĒêŠÝĆéĀöüéĀöĎŠĔĀšÿćöćøëÿČęĂÿćøĔĀšðøąßćßîđ×šćĔÝĕéšÜŠć÷ǰîĂÖÝćÖîĆĚîǰ÷ĆÜ
ÿĂéÙúšĂÜÖĆïĒîüìćÜ×ĂÜÿĀõćó÷čēøðǰÿĀøĆåĂđöøĉÖćǰĒúąĂĂÿđêøđúĊ÷ǰøüöìĆĚÜǰĕéšñŠćîÖćøìéÿĂïđïČĚĂÜêšîĔî
ñĎšïøĉēõÙÙîĕì÷Ēúšüǰøć÷úąđĂĊ÷ééĆÜ êćøćÜĒÿéÜĀĆü×šĂĔîđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîǰđìĊ÷ïÖĆïǰACTD
êćøćÜ ĒÿéÜĀĆü×šĂĔîđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîǰđìĊ÷ïÖĆïǰACTD
ĀĆü×šĂĒúąúĞćéĆïǰPIL ìĊęÝąìĞć×ċĚî ĀĆü×šĂĒúąúĞćéĆïêćöĀöć÷đú××ĂÜǰACTD
ßČęĂ÷ćǰßČęĂÖćøÙšćǰøĎðĒïï÷ćǰĒúąÙüćöĒøÜ 1. Name of product
2. Description of product
4. Strength of the medicine
1.1 ÷ćîĊĚöĊßČęĂÿćöĆâüŠćĂąĕø 3. What is in the medicine?
1.2 ÷ćîĊĚĔßšđóČęĂĂąĕø 5. What is this medicine used for?
2. ×šĂÙüøøĎšÖŠĂîĔßš÷ć
2.1 ĀšćöĔßš÷ćîĊĚđöČęĂĕø 7. When should you not take this medicine?
2.2 ×šĂÙüøøąüĆÜđöČęĂĔßš÷ćîĊĚ 9. What other medicines or food should be avoided
whilst taking this medicine?
3. üĉíĊĔßš÷ć
3.1 ×îćéĒúąüĉíĊĔßš 6. How much & how often should you use this
medicine?
3.2 ĀćÖúČöÖĉî÷ćǰÙüøìĞćĂ÷ŠćÜĕø 10. What should you do if you miss a dose?
3.3 ëšćÖĉî÷ćîĊĚđÖĉî×îćéìĊęĒîąîĞćǰÙüøìĞćĂ÷ŠćÜĕø 12. Sign & symptom of over dosage?
13. What to do when you have taken more than the
recommended dosage?
4. ×šĂÙüøðãĉïĆêĉøąĀüŠćÜÖćøĔßš÷ć 15. Care that should be taken when taking this

medicine
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ĀĆü×šĂĒúąúĞćéĆïǰPIL ìĊęÝąìĞć×ċĚî ĀĆü×šĂĒúąúĞćéĆïêćöĀöć÷đú××ĂÜǰACTD
16. When should you consult your doctor?
5. ĂĆîêøć÷ìĊęĂćÝđÖĉéÝćÖ÷ćǰǰ
5.1 ĂćÖćøìĊęêšĂÜĀ÷čé÷ćĒúšüøĊïĕðóïĒóì÷ŤìĆîìĊ 8. Undesirable effects
5.2 ĂćÖćøìĊęĕöŠÝĞćđðŨîêšĂÜĀ÷čé÷ćǰĒêŠëšćöĊĂćÖćøøčîĒøÜ 16. When should you consult your doctor?
ĔĀšĕðóïĒóì÷ŤìĆîìĊ
6. ÙüøđÖĘï÷ćîĊĚĂ÷ŠćÜĕø 11. How should you keep this medicine?
ñĎšñúĉê/ñĎšîĞćđ×šć/ñĎšĒìîÝĞćĀîŠć÷ 14. Name/ logo of manufacturer, importer, or Marketing
Authorization Holder; MAH
ðøĆïðøčÜÙøĆĚÜúŠćÿčé 17. Date of revision of PIL
×. øć÷úąđĂĊ÷éĔîÖćøÝĆéìĞćǰ“×šĂöĎúđĂÖÿćøÖĞćÖĆï÷ćđóČęĂĔßšÿĞćĀøĆïÖćøìüîÿĂïēé÷ñĎšðøąđöĉî/
đÝšćĀîšćìĊę”
I.ÿŠüîêšî×ĂÜđĂÖÿćø: ßČęĂ÷ćǰÙüćöĒøÜǰøĎðĒïï÷ćǰĒúąßČęĂÖćøÙšć
(1) đðŨîÖćøøąïčǰßČęĂ÷ćǰÙüćöĒøÜǰøĎðĒïï÷ćǰĒúąßČęĂÖćøÙšćǰ
(2) ßČęĂ÷ć
x øąïčßČęĂÿćöĆâìćÜ÷ć (êćööćêøåćî INN ĒêŠǰĕöŠêšĂÜøąïčøĎðđÖúČĂ/đĂÿđìĂøŤ/ĕăđéøê ×ĂÜ÷ćǰ÷Öđüšî
đÖúČĂ/đĂÿđìĂøŤ/ĕăđéøê ìĊęĒêÖêŠćÜÖĆîîĆĚîöĊñúêŠĂ×šĂïŠÜĔßšĒúąÙüćöðúĂéõĆ÷ÝćÖÖćøĔßš÷ć) Ēúąøąïč
ßČęĂóšĂÜ×ĂÜ÷ćǰ(ëšćöĊ) êćöéšü÷ǰÙüćöĒøÜǰ(÷Öđüšî÷ćÿĎêøñÿöĕöŠêšĂÜøąïčÙüćöĒøÜ) Ēúą øĎðĒïï÷ć
x ĔîÖøèĊìĊęđðŨî÷ćÿĎêøñÿöǰĔĀšĔßšßČęĂÿćöĆâìćÜ÷ćìĊęđðŨîìĊęøĎšÝĆÖĀøČĂßČęĂÿćöĆâìćÜ÷ćÿĎêøñÿöìĊęöĊðøćÖã
đĂÖÿćøĂšćÜĂĉÜ đßŠîǰēÙĕìøöĂÖàćēàú üĉêćöĉîøüöǰđðŨîêšî
(3) ÙüćöĒøÜ
x øąïčĀîŠü÷×ĂÜðøĉöćè÷ćđðŨîõćþćĕì÷éšü÷ÙĞćđêĘöêćöøąïïđöêøĉÖĕöŠĔßšĂĆÖþø÷ŠĂ ĔîìčÖĀĆü×šĂ×ĂÜ
đĂÖÿćøÖĞćÖĆï÷ćǰǰđüšîĒêŠĔîĀĆü×šĂìĊęǰ1 ĂîčēúöĔĀšøąïčĀîŠü÷×ĂÜÙüćöĒøÜđðŨîÙĞć÷ŠĂìĊęđðŨîÿćÖúĕéš
ÿĞćĀøĆï÷ćßĊüüĆêëčĔĀšĔßšĀîŠü÷×ĂÜðøĉöćèêćöìĊęÿćÖú÷ĂöøĆïǰ
x ĕöŠÙüøđ×Ċ÷îêĆüđú×ìĊęöĊÝčéìýîĉ÷öēé÷ĕöŠÝĞćđðŨîǰđßŠîǰ3 öĉúúĉÖøĆö ĕöŠĔßŠǰ3.0 öĉúúĉÖøĆöǰĒúąĕöŠĔßŠǰ0.003
ÖøĆöǰǰĀćÖđðŨî×îćé÷ćêĆĚÜĒêŠǰ1 ÖøĆöǰÙüøøąïčĀîŠü÷đðŨîÖøĆöǰđßŠîǰ2 ÖøĆöǰĕöŠĔßŠǰ2000 öĉúúĉÖøĆöǰĔî
ÖøèĊ ìĊę×îćé÷ćêęĞ ćÖüŠ ćǰ1 ÖøĆ öǰÙüøøąïč Ā îŠ ü÷đðŨ î öĉ ú úĉÖøĆ ö ǰđßŠ î ǰ500 öĉ ú úĉÖøĆ öǰĕöŠ ĔßŠǰ 0.5 ÖøĆ öǰǰ
ÿĞćĀøĆï×îćé÷ćêęĞćÖüŠćǰ1 öĉúúĉÖøĆöǰÙüøøąïčĀîŠü÷đðŨîĕöēÙøÖøĆöǰđßŠîǰ300 ĕöēÙøÖøĆöǰĕöŠĔßŠǰ0.3
öĉúúĉÖøĆöǰǰëšćÝĞćđðŨîêšĂÜøąïčĀîŠü÷đðŨîìýîĉ÷öǰĒêŠĕöŠöĊêĆüđú×ĀîšćÝčéìýîĉ÷öǰÙüøđ×Ċ÷îđú×ýĎî÷ŤĀîšć
Ýčéìýîĉ÷öéšü÷ǰđßŠîǰ0.5 öĉúúĉÖøĆöǰĕöŠĔßŠǰ.5 öĉúúĉÖøĆö
x ÖøèĊ ñ úĉ ê õĆ è æŤ öĊ Ā úć÷ÙüćöĒøÜǰĔĀš ø ąïč ÙüćöĒøÜĒúąĀîŠ ü ÷ĕðĔîĒîüìćÜđéĊ ÷ üÖĆ î ǰđßŠ î ǰ250
öĉúúĉÖøĆöǰ500 öĉúúĉÖøĆö 750 öĉúúĉÖøĆöǰđðŨîêšîǰ(ĕöŠĔßŠđ×Ċ÷îđðŨîǰ250 öĉúúĉÖøĆöǰ0.5 ÖøĆö 750
öĉúúĉÖøĆöǰêćöúĞćéĆï)
x ÖøèĊìĊęđðŨî÷ćÝćÖÿöčîĕóøĒñîðŦÝÝčïĆî ĔĀšøąïčÙüćöĒøÜêćööćêøåćîìĊęøąïčĕüšĔîêĞćøć÷ćìĊęøĆåöîêøĊ
ðøąÖćýǰĀøČĂĒîüìćÜÖćøÙüïÙčöÙčèõćó×ĂÜ÷ćéĆÜÖúŠćüàċęÜđðŨîìĊę÷ĂöøĆïǰ
36
x øąïčĀîŠü÷ÙüćöĒøÜǰéšü÷×šĂÙüćöõćþćĕì÷ìĊęÖĞćĀîééĆÜøć÷úąđĂĊ÷éêŠĂĕðîĊĚ
ĀîŠü÷ ×šĂÙüćöìĊęÖĞćĀîé ĀîŠü÷ ×šĂÙüćöìĊęÖĞćĀîé
gram ÖøĆö liter úĉêø
milligram öĉúúĉÖøĆö milliliter öĉúúĉúĉêø
microgram ĕöēÙøÖøĆö microliter ĕöēÙøúĉêø
unit ÷Ďîĉê grain đÖøî
(4) øĎðĒïï÷ć
x ĒÿéÜøĎðĒïï÷ćìĊęđðŨîöćêøåćîêćöìĊęÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćÖĞćĀîéǰ
x øąïčøĎðĒïï÷ć éšü÷×šĂÙüćöõćþćĕì÷ìĊęÖĞćĀîééĆÜøć÷úąđĂĊ÷éêŠĂĕðîĊĚǰǰ
øĎðĒïï÷ć ×šĂÙüćöìĊęÖĞćĀîé øĎðĒïï÷ć ×šĂÙüćöìĊęÖĞćĀîé
Capsule ĒÙðàĎú Nasal drop Ā÷ĂéÝöĎÖ
Cream ÙøĊö Nasal spray óŠîÝöĎÖ
Ear drop Ā÷ĂéĀĎ Ointment ×ĊĚñċĚÜ
Emulsion ĂĉöĆúßĆî Rectal suppository đĀîĘïìüćø
Eye drop Ā÷Ăéêć Suspension îĚĞćĒ×üîêąÖĂî
Inhaler ÿĎéóŠîìćÜðćÖ Syrup îĚĞćđßČęĂö
Injection ÞĊé Tablet đöĘé
Liquid îĚĞć Vaginal tablet đöĘéÿĂéßŠĂÜÙúĂé
Lotion ēúßĆî Transdermal patch ĒñŠîĒðąñĉüĀîĆÜ
Oral spray ÷ćÿĎéóŠîìćÜðćÖ Oral paste ×ĊĚñċĚÜðŜć÷ðćÖ
Gel đÝú Granule ĒÖøîĎú
Effervescent Effervescent
đöĘéôĎś ñÜôĎś
tablet powder
Sublingual
÷ćđöĘéĂöĔêšúĉĚî Lozenge/Troche ÷ćĂöđöĘéĒ×ĘÜ
tablet
liniment ìćëĎîüé Pastille ÷ćĂöđöĘéîĉęö
Āöć÷đĀêč
(1) ×šĂöĎúÙüćöĒøÜĒúąøĎðĒïï÷ćĂČęîėǰîĂÖđĀîČĂÝćÖêĆüĂ÷ŠćÜìĊęÖĞćĀîéĔîêćøćÜĔĀšÿĂïëćöøć÷úąđĂĊ÷é
đóĉęöđêĉöÝćÖÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ć
(2) ÖøèĊǰøĎðĒïï÷ćìĊę÷ĆÜĕöŠöĊýĆóìŤïĆââĆêĉßĆéđÝîǰĀøČĂ÷ćìĊęöĊøĎðĒïïÙúšć÷ÖĆîǰàċęÜđöČęĂĒðúđðŨîõćþćĕì÷ĒúšüĂćÝ
ìĞ ć ĔĀš ÿĆ ï ÿîǰĔĀš ü ÜđúĘ ï ÙĞ ć õćþćĂĆ Ü Öùþ×ĂÜøĎ ð ĒïïîĆĚ î ĕéš ǰ ǰđßŠ î ǰðúéðúŠ Ă ÷Ēïïì÷Ă÷ǰ(sustained
release/extended release), ðúéðúŠĂ÷ĒïïÙüïÙčö (controlled release) đðŨîêšî
(5) ßČęĂÖćøÙšć
x øąïčßČęĂÖćøÙšćǰ
x ĔîÖøèĊ÷ćìĊęöĊĒêŠßČęĂÖćøÙšćõćþćĂĆÜÖùþìĊę÷Čęî×ĂĒÖšĕ×đðúĊę÷îĒðúÜđĂÖÿćøÖĞćÖĆï÷ćõćþćĕì÷ĒúąđðŨî
÷ćìĊęĕéšøĆïĔïÿĞćÙĆâÖćø×ċĚîìąđïĊ÷îêĞćøĆï÷ćÖŠĂîĒîüìćÜîĊĚĔĀšøąïčǰĔĀšüÜđúĘïõćþćĕì÷đðŨîÙĞćĂŠćîêćö
øćßïĆèæĉê÷ÿëćîǰđßŠîǰHexin (đăÖàĉî)
37
(6) ÖøèĊìĊę×ĂĔßšđĂÖÿćøÖĞćÖĆï÷ćÞïĆïđéĊ÷üÖĆî ĔĀšøąïčÙüćöĒøÜ×ĂÜ÷ćđøĊ÷ÜÖĆîĕüšÙĆęîéšü÷đÙøČęĂÜĀöć÷ÝčúõćÙǰ
đßŠîǰ20, 40 öĉúúĉÖøĆö ÖøèĊøĎðĒïï÷ćêŠćÜÖĆîĔĀšÙĆęîéšü÷ÙĞćüŠćǰ“ĀøČĂ” đßŠîǰđöĘéĀøČĂĒÙðàĎúǰǰēé÷ìĆęüĕðĕöŠĒîąîĞćĔĀš
ĔßšđĂÖÿćøÖĞćÖĆï÷ćÞïĆïđéĊ÷üÖĆîÖĆï÷ćìĊęöĊøĎðĒïï÷ćĒêÖêŠćÜÖĆîǰđßŠîǰ÷ćîĚĞćìĊęöčŠÜĀöć÷ĔĀšĔßšÖĆïđéĘÖǰĕöŠÙüøĔßšøŠüöÖĆï
÷ćđöĘéìĊęöčŠÜĀöć÷ÿĞćĀøĆïñĎšĔĀâŠ
1.1 ÷ćîĊĚöĊßČęĂÿćöĆâüŠćĂąĕøǰǰǰǰǰ
1) đðŨîÖćøøąïčßČęĂÿćöĆâìćÜ÷ćēé÷ĔßšßČęĂêćööćêøåćîǰInternational Nonproprietary Names (INNs)
(ëšćöĊđÖúČĂ/đĂÿđìĂøŤ/ĕăđéøêǰêšĂÜøąïčđÖúČĂ/đĂÿđìĂøŤ/ĕăđéøê) êćöéšü÷øĎðĒïïđÖúČĂ/đĂÿđìĂøŤ/ĕăđéøê
ĒúąÙüøüÜđúĘïõćþćĂĆÜÖùþĕüšéšü÷ êćöéšü÷ßČęĂÖúčŠö÷ćìĊęĒÿéÜëċÜÖćøĂĂÖùìíĉĝìĊęđ×šćĔÝĕéšÜŠć÷ǰđßŠîǰ÷ćúé
ĕ×öĆîǰ÷ćĒÖšĒóš đðŨîêšîǰ(ĒÿéÜÖúčŠö÷ćìĊęđðŨîöćêøåćîêćöìĊęÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ć
ÖĞćĀîé)
2) ĔĀšøąïč×šĂÙüćöéĆÜêŠĂĕðîĊĚ
x<ßČęĂÿćöĆâìćÜ÷ćõćþćĕì÷> ( <ßČęĂÿćöĆâìćÜ÷ćõćþćĂĆÜÖùþ> ) Ă÷ĎŠĔîÖúčŠöǰ< ßČęĂÖúčŠö÷ć >
đßŠîǰĂąìĂøŤüćÿĒììĉîǰĒÙúđàĊ÷öǰ(atorvastatin calcium) Ă÷ĎŠĔîÖúčŠö÷ćúéĕ×öĆî
Āöć÷đĀêč:
(1) ÖøèĊ÷ćÿĎêøñÿöĔĀšĒÝÖĒÝÜêĆü÷ćÿĞćÙĆâìčÖßîĉéóøšĂöÙüćöĒøÜ×ĂÜ÷ćìčÖêĆü
(2) ĔîÖøèĊìĊęßČęĂǰINN ĕöŠđðŨîìĊęøĎšÝĆÖǰĔĀšüÜđúĘïßČęĂÿćöĆâĂČęîĕüšìšć÷ßČęĂǰINNs ĒêŠĀćÖüŠćĕöŠöĊßČęĂǰINNs øąïčĕüšǰĔĀš
ĔßšßČęĂÿćöĆâìćÜ÷ćêćöìĊęÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćÖĞćĀîé ēé÷øąïčßČęĂĔĀšÙøïìĆĚÜøĎðĒïï×ĂÜđÖúČĂ
ĀøČĂđĂÿđìĂøŤĀøČĂĕăđéøêǰ×ĂÜ÷ćîĆĚîėǰđßŠî ĂąöĂÖàĉàĉúúĉîĕìøĕăđéøêǰĀøČĂǰĂąìĂøŤüćÿĒììĉîĒÙúđàĊ÷ö đðŨîêšî
(3) ßČęĂÿćöĆâìćÜ÷ćõćþćĕì÷ĔĀšđ×Ċ÷îêćöĀúĆÖđÖèæŤüĉíĊÖćøđ×Ċ÷î×ĂÜøćßïĆèæĉê÷ÿëćî
(4) ĀćÖĕöŠÿćöćøëøąïčÖúčŠö÷ćĕéšêćöÖúčŠöìćÜđõÿĆßüĉì÷ćǰĀøČĂÖúčŠö÷ćđðŨîìĊęđ×šćĔÝ÷ćÖêŠĂðøąßćßîǰÖĘĕöŠêšĂÜ
øąïčÖúčŠö÷ć
1.2 ÷ćîĊĚĔßšđóČęĂĂąĕø
1) øąïč×šĂïŠÜĔßš×ĂÜ÷ćǰēé÷êšĂÜđðŨî×šĂïŠÜĔßšìĊęöĊÙčèÿöïĆêĉêćöìĊęÖĞćĀîéĕüšĔîĀĆü×šĂìĊęǰ6 ×ĂÜĒîüìćÜìĆęüĕðĔî
ÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ć (Āîšćǰ5)
2) Ĕßš×šĂÙüćöõćþćĕì÷ìĊęđðŨîĔÝÙüćöÿøčðǰÖøąßĆïǰÿĆĚîĕéšĔÝÙüćöǰđ×šćĔÝÜŠć÷ĒúąđĀöćąÿĞćĀøĆïðøąßćßî (Ĕî
ÖøèĊìĊę×šĂïŠÜĔßšïćÜ×šĂïŠÜĔßšǰĀćÖøąïčĒúšüĕöŠđĀöćąÿöÖĆïðøąßćßîǰĂćÝêšĂÜðøĆïðøčÜ×šĂÙüćöéĆÜÖúŠćüĔĀš
đĀöćąÿöÖĆïðøąßćßîđóČęĂĕöŠĔĀšđÖĉéñúđÿĊ÷êŠĂÖćøĔßš÷ćĀøČĂÖćøøĆÖþć)
3) ĔĀšøąïč×šĂÙüćöéĆÜêŠĂĕðîĊĚ
x đóČęĂ ..<×šĂïŠÜĔßš>..
1.3 ĔĀšøąïč×šĂöĎúÿĞćÙĆâĂČęîėǰ(êćöÙüćöÝĞćđðŨî)
1) đðŨîÖćøøąïč×šĂöĎúđóĉęöđêĉöđÖĊę÷üÖĆïÖćøĔßš÷ćĂ÷ŠćÜÿöđĀêčñúǰĀøČĂ×šĂöĎúÿĞćÙĆâĂČęîėđÖĊę÷üÖĆïêĆü÷ćìĊęñĎšĔßšÙüø
ìøćïĒúąĕöŠÿćöćøëĔÿŠĕüšĔîĀĆü×šĂĂČęîĕéš đßŠî
- ÷ćðäĉßĊüîą (Antibiotics) ĂćÝøąïčüŠćǰ
“÷ćîĊĚĕöŠÿćöćøëøĆÖþćēøÙêĉéđßČĚĂÝćÖĕüøĆÿǰđßŠîǰĀüĆéǰĕ×šĀüĆéĔĀâŠǰĀúĂéúöĂĆÖđÿïđÞĊ÷ïóúĆîǰĕĂĀøČĂđÝĘïÙĂÝćÖ
đßČĚĂĕüøĆÿ”
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- ÷ćÿđêĊ÷øĂ÷éŤǰ(Steroids) ĂćÝøąïčüŠć
“ÖćøĔßš÷ćîĊĚĂćÝđÖĉéĂĆîêøć÷øčîĒøÜĕéšǰÝċÜêšĂÜÿĆęÜÝŠć÷ēé÷Ēóì÷ŤđìŠćîĆĚî”
2.×šĂÙüøøĎšÖŠĂîĔßš÷ć
2.1ĀšćöĔßš÷ćîĊĚđöČęĂĕø
1) đðŨîÖćøøąïč×šĂĀšćöĔßš×ĂÜ÷ćìĊęđðŨî Absolute Contraindication
2) øąïč×šĂĀšćöĔßšēé÷Ē÷ÖđðŨîðøąđéĘîêŠćÜǰėǰĂ÷ŠćÜßĆéđÝîǰ×ċĚîïøøìĆéĔĀöŠđöČęĂÝĞćđðŨî ēé÷øąïč×šĂĀšćöĔßšêćö
ĒîüìćÜêŠĂĕðîĊĚêćöÙüćöđĀöćąÿö
3) “đÙ÷Ēóš÷ćîĊĚǰĀøČĂ÷ćĂČęîĔîÖúčŠö XXX” [ëšćöĊÖúčŠö÷ć] (ĒÿéÜßČęĂÖúčŠö÷ćìĊęđðŨîöćêøåćîêćöìĊęÿĞćîĆÖÜćî
ÙèąÖøøöÖćøĂćĀćøĒúą÷ćÖĞćĀîé)
x “đöČęĂêĆĚÜÙøøõŤǰĀøČĂüćÜĒñîÝąêĆĚÜÙøøõŤǰđóøćąìĞćĔĀšđÖĉéĂĆîêøć÷øšć÷ĒøÜêŠĂìćøÖ” [ÖøèĊǰÝĆéĂ÷ĎŠĔî
pregnancy category X]
x “đöČęĂĂ÷ĎŠĔîøą÷ąĔĀšîöïčêøǰđóøćąìĞćĔĀšđÖĉéĂĆîêøć÷øšć÷ĒøÜêŠĂìćøÖ” [ÖøèĊöĊ×šĂöĎúüŠć ĀâĉÜĔĀšîöïčêø
ĀšćöĔßš÷ćîĊĚ]
x “đöČęĂêĆĚÜÙøøõŤǰüćÜĒñîÝąêĆĚÜÙøøõŤǰĀøČĂĂ÷ĎŠĔîøą÷ąĔĀšîöïčêøǰđóøćąìĞćĔĀšđÖĉéĂĆîêøć÷øšć÷ĒøÜêŠĂìćøÖ”
[ÖøèĊ÷ćÝĆéĂ÷ĎŠĔîǰpregnancy category X ĒúąǰöĊ×šĂöĎúüŠćǰĀâĉÜĔĀšîöïčêøĀšćöĔßš÷ćîĊĚ]
x ĀšćöĔßšǰxxx [ĔĀšøąïč×šĂĀšćöđÖĊę÷üÖĆïēøÙĀøČĂõćüąìĊęđðŨîǰAbsolute Contraindication]
x ĀšćöĔßšøŠüöÖĆïǰ....<÷ć>....<ĂćĀćø>....<ÿöčîĕóø>.... <ñúĉêõĆèæŤđÿøĉöĂćĀćø>…..[ÖøèĊ÷ćîĊĚöĊĂĆîêø
Öĉøĉ÷ćøŠüöÖĆïǰ÷ćǰĂćĀćøǰÿöčîĕóøǰĀøČĂǰñúĉêõĆèæŤđÿøĉöĂćĀćøǰìĊęÝĆéđðŨî Absolute
Contraindication]
2.2 ×šĂÙüøøąüĆÜđöČęĂĔßš÷ćîĊĚ
1) đðŨîÖćøøąïč×šĂÙüøøąüĆÜ×ĂÜ÷ćìĊęđðŨî warning/ precaution / caution/ relative contraindication
ĂČęîė ìĊęĕöŠĔßŠǰAbsolute Contraindication ëšćđðŨîǰAbsolute Contraindication ĔĀšøąïčĔî×šĂǰ2.1
ĀšćöĔßš÷ćîĊĚđöČęĂĕø
2) øąïč×šĂÙüøøąüĆÜ×ĂÜ÷ćēé÷Ē÷ÖđðŨîðøąđéĘîêŠćÜǰėǰĂ÷ŠćÜßĆéđÝîǰ×ċĚîïøøìĆéĔĀöŠđöČęĂÝĞćđðŨî ēé÷øąïč×šĂ
ÙüøøąüĆÜêćöĒîüìćÜêŠĂĕðîĊĚêćöÙüćöđĀöćąÿöǰ
x “ĀâĉÜöĊÙøøõŤÙüøøąöĆéøąüĆÜÖćøĔßš÷ćîĊĚ” [ÖøèĊ÷ćÝĆéĂ÷ĎŠĔî pregnancy category C]
x “ĀâĉÜöĊÙøøõŤĔĀšĀúĊÖđúĊę÷ÜÖćøĔßš÷ćîĊĚđóøćąĂćÝöĊĂĆîêøć÷êŠĂìćøÖĔîÙøøõŤĕéšǰĒêŠĒóì÷ŤĂćÝóĉÝćøèć
ÿĆęÜĔßš÷ćîĊĚǰĀćÖöĊđĀêčñúìćÜÖćøĒóì÷Ť” [ÖøèĊ÷ćÝĆéĂ÷ĎŠĔî pregnancy category D]
x “ĀâĉÜĔĀšîöïčêø ÙüøĀúĊÖđúĊę÷ÜÖćøĔßš÷ćîĊĚ” [÷Öđüšî÷ćïćÜêĆüìĊęöĊĀúĆÖåćîßĆéđÝîüŠćĔßšĕéšĂ÷ŠćÜ
ðúĂéõĆ÷ĀøČĂđðŨîöćêøåćîÖćøøĆÖþćÿĞćĀøĆïĀâĉÜĔĀšîöïčêøǰĕöŠêšĂÜøąïč]
x “øąöĆéøąüĆÜÖćøĔßš÷ćîĊĚĔîĀâĉÜöĊÙøøõŤĀøČĂĔĀšîöïčêøǰđîČęĂÜÝćÖĕöŠöĊ×šĂöĎú÷Čî÷ĆîÙüćöðúĂéõĆ÷” [Ĕî
ÖøèĊĕöŠöĊ×šĂöĎúéšćîÙüćöðúĂéõĆ÷ĔîĀâĉÜöĊÙøøõŤĀøČĂĔĀšîöïčêøǰÿĞćĀøĆïøĎðĒïï÷ćĒúąÙüćöĒøÜ
îĆĚîė]
x “ĀćÖìŠćîöĊõćüąêŠĂĕðîĊĚ“
<øąïč×šĂÙüøøąüĆÜìĊęđÖĊę÷üÖĆïēøÙǰĀøČĂõćüąìĊęêšĂÜøąüĆÜđìŠćîĆĚîǰēé÷đúČĂÖöćđÞóćąìĊęđĀĘîüŠćđĀöćąÿöǰ>
39
x “ĕöŠÙüøĔßš÷ćîĊĚøŠüöÖĆï÷ćǰĂćĀćøǰÿöčîĕóøǰĀøČĂñúĉêõĆèæŤđÿøĉöĂćĀćøïćÜßîĉé đóøćąĂćÝöĊñúêŠĂ
ÖćøøĆÖþćĀøČĂđÖĉéĂĆîêøć÷ĕéšǰđßŠîǰ....<÷ć>....<ĂćĀćø>....<ÿöčîĕóø>.... <ñúĉêõĆèæŤđÿøĉöĂćĀćø>”
[ĔĀšøąïč÷ćĀøČĂÖúčŠö÷ćǰĀøČĂĂćĀćøǰĀøČĂÿöčîĕóøǰĀøČĂĂćĀćøđÿøĉöïćÜßîĉéǰìĊęÙüøĀúĊÖđúĊę÷Üǰēé÷øąïč
đÞóćąøć÷ÖćøìĊęÿĞćÙĆâǰĒúąöĊÖćøĔßšĒóøŠĀúć÷Ĕîðøąđìýĕì÷ǰìĊęđÖĉéĂĆîêøÖĉøĉ÷ćÖĆï÷ćîĊĚēé÷öĊĀúĆÖåćî
ßĆéđÝîǰÙüćöøčîĒøÜöćÖ]
Āöć÷đĀêč:
ÙĞćĒîąîĞćĔîÖćøÝĆéìĞć×šĂöĎúĔîĀĆü×šĂǰ“×šĂÙüøøĎšÖŠĂîÖćøĔßš÷ć”
(1) Pregnancy category ĔĀšóĉÝćøèćêćöøĎðĒïï÷ć ēé÷ĂšćÜĂĉÜ×šĂöĎúÝćÖǰUS pregnancy categories đðŨî
úĞćéĆïĒøÖ ĀćÖĕöŠöĊ×šĂöĎú×ĂÜǰUS pregnancy categories ĔĀšĂšćÜĂĉÜêćöǰADEC pregnancy
categories (Australia) ĀøČĂǰhttps://www.ebs.tga.gov.au/
(2) ĔîÖøèĊìĊęöĊÖćøĒïŠÜøąéĆïÙüćöđÿĊę÷Üêćöĕêøöćÿ×ĂÜÖćøêĆĚÜÙøøõŤĔĀšøąïčĕêøöćÿúÜĕðéšü÷ǰđßŠîǰ
ibuprofen ĕêøöćÿìĊęǰ1,2 ÝąđðŨî pregnancy category B ĒêŠǰĕêøöćÿìĊęǰ3 ÝąđðŨî pregnancy
category D
aspirin ĕêøöćÿìĊęǰ1,2 ÝąđðŨî pregnancy category C ĒêŠǰĕêøöćÿìĊęǰ3 ÝąđðŨî pregnancy category D
ĔĀšøąïč×šĂÙüćöéĆÜîĊĚ
x ibuprofen : ĀâĉÜöĊÙøøõŤĔĀšĀúĊÖđúĊę÷ÜÖćøĔßš÷ćîĊĚĔîÖćøêĆĚÜÙøøõŤđéČĂîìĊęǰ7-9 đóøćąĂćÝöĊĂĆîêøć÷êŠĂ
ìćøÖĔîÙøøõŤĕéšǰĒêŠĒóì÷ŤĂćÝóĉÝćøèćÿĆęÜĔßš÷ćîĊĚǰĀćÖöĊđĀêčñúìćÜÖćøĒóì÷Ť
x aspirin : ĀâĉÜöĊÙøøõŤÙüøøąöĆéøąüĆÜÖćøĔßš÷ćîĊĚĔîÖćøêĆĚÜÙøøõŤđéČĂîìĊęǰ1-6 Ēúą ĀúĊÖđúĊę÷ÜÖćøĔßš÷ćîĊĚĔî
ÖćøêĆĚÜÙøøõŤđéČĂîìĊęǰ7-9 đóøćąĂćÝöĊĂĆîêøć÷êŠĂìćøÖĔîÙøøõŤĕéšǰĒêŠĒóì÷ŤĂćÝóĉÝćøèćÿĆęÜĔßš÷ćîĊĚǰĀćÖöĊ
đĀêčñúìćÜÖćøĒóì÷Ť
(3) ÖøèĊ÷ćîĚĞćǰëċÜĒöšÝąđðŨî÷ćÿĞćĀøĆïđéĘÖĒêŠñĎšĔĀâŠÖĘÿćöćøëĔßšĕéš ēé÷ĔĀšøąïčđÖĊę÷üÖĆïÙüćöđÿĊę÷ÜĔîĀâĉÜêĆĚÜÙøøõŤ
ĒúąĀâĉÜĔĀšîöïčêøǰĕüšĔîĀĆü×šĂǰ“×šĂÙüøøĎšÖŠĂîĔßš÷ć” éšü÷
3.üĉíĊĔßš÷ć
3.1 ×îćéĒúąüĉíĊĔßš
1) đðŨîÖćøøąïč×îćé÷ćêćö×šĂïŠÜĔßšǰĒúąüĉíĊĔßš÷ćĂ÷ŠćÜëĎÖêšĂÜ
2) ×îćé÷ćǰĔĀšøąïč×šĂÙüćöǰéĆÜîĊĚ
x“ÙüøĔßš÷ćêćöÙĞćĒîąîĞć×ĂÜĒóì÷ŤĀøČĂđõÿĆßÖøđìŠćîĆĚî đîČęĂÜÝćÖ×îćéĒúąøą÷ąđüúćĔîÖćøĔßš÷ćîĊĚ
×ċĚîÖĆïßîĉéĒúąÙüćöøčîĒøÜ×ĂÜēøÙ”
x×îćé÷ćêćö×šĂïŠÜĔßšîĆĚîėǰ
- ēé÷ìĆęüĕðĕöŠĒîąîĞćĔĀšøąïč×îćé÷ćǰ÷Öđüšî ÷ćÿćöĆâðøąÝĞćïšćîǰĒúą÷ćïøøÝčđÿøĘÝìĊęĕöŠĔßŠ÷ć
ĂĆîêøć÷ĀøČĂ÷ćÙüïÙčöóĉđýþ
- ĕöŠĒîąîĞćĔĀšøąïč×îćé×ĂÜ÷ćìĊęĔßšĔîēøÙìĊęêšĂÜĕéšøĆïÖćøéĎĒúÝćÖĒóì÷ŤđìŠćîĆĚîǰđßŠîǰ÷ćúéÙüćöéĆî
ēúĀĉêǰ÷ćÿĞćĀøĆïēøÙđïćĀüćîǰ÷ćïćÜßîĉéìĊęĒöšüŠćöĊßČęĂÿćöĆâìćÜ÷ćĒúąøĎðĒïï÷ćđéĊ÷üÖĆîÖĘêćöĒêŠ
öĊÙčèÿöïĆêĉĒêÖêŠćÜÖĆîĔîđõÿĆßÝúîýćÿêøŤĀøČĂßĊüÿööĎúǰđðŨîêšî
- Öćøøąïč×îćé÷ć: ĔĀšøąïč×îćé÷ćǰÙüćöëĊęĔîÖćøĔĀš÷ćǰĒúąøą÷ąđüúćĔîÖćøĔĀš÷ćìĊęđĀöćąÿöêćö×šĂ
ïŠÜĔßšĒúąÖúčŠöĂć÷č
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3) üĉíĊĔßš÷ćǰĔĀšøąïčéĆÜîĊĚ
- øąïčüĉíĊðäĉïĆêĉ đßŠîǰÖĉî÷ćĀúĆÜĂćĀćøìĆîìĊ Öĉî÷ćÖŠĂîĂćĀćøǰđÙĊĚ÷ü÷ćîĊĚÖŠĂîÖúČîǰđðŨîêšî
- ĀćÖđðŨî÷ćìĊęöĊüĉíĊÖćøĔßšĒïïóĉđýþǰđßŠî÷ćĀ÷Ăéêćǰ÷ćđĀîĘïǰ÷ćóŠîǰĔĀšĂíĉïć÷üĉíĊĔßšĔĀšßĆéđÝî
êĆüĂ÷ŠćÜǰÖćøđ×Ċ÷îüĉíĊĔßš÷ć
x ÖĉîÙøĆĚÜúą …… đöĘé
êĆüĂ÷ŠćÜ: ÖĉîÙøĆĚÜúą 2 đöĘéǰüĆîúąǰ2 ÙøĆĚÜǰĀúĆÜĂćĀćøǰđßšćǰđ÷Ęî
ÖĉîÙøĆĚÜúą ÙøċęÜǰđöĘéǰüĆîúąǰ3 ÙøĆĚÜǰĀúĆÜĂćĀćøǰđßšćǰÖúćÜüĆîǰđ÷Ęî
ÖĉîÙøĆĚÜúą 1 đöĘéǰüĆîúąǰ2 ÙøĆĚÜ óøšĂöĂćĀćøǰđßšćǰđ÷Ęî
ÖĉîÙøĆĚÜúą 2 đöĘéǰìčÖǰ12 ßĆęüēöÜ
x ĂöĔêšúĉĚîÙøĆĚÜúąǰ 1 đöĘéǰđöČęĂöĊĂćÖćøđÝĘïđÙšîĀîšćĂÖ
x ðŜć÷êć×šćÜìĊęđðŨîǰ üĆîúąǰ1 ÙøĆĚÜ ÖŠĂîîĂî
x óŠîĔêšúĉĚîǰĀøČĂÖøąóčšÜĒÖšöđüúćđÝĘïĀîšćĂÖ
x ñÿöîĚćĞ ëċÜ×ĊéÖĞćĀîé
x ìćñČęîÙĆî
x ìćïćÜǰėǰǰïøĉđüèìĊęđðŨî
x đĀîĘïìüćøĀîĆÖ/ßŠĂÜÙúĂéǰÙøĆĚÜúąǰǰ…. đöĘé
x ìćïøĉđüèßŠĂÜÙúĂéǰüĆîúą.....ÙøĆĚÜ
x Ā÷ĂéÝöĎÖ/ĀĎ/êć×šćÜìĊęđðŨîǰ….. Ā÷é
x óŠîÿĎéđ×šćÙĂÙøĆĚÜúąǰ…… ìĊ (ĔßšÖĆïǰmetered dose inhaler)
x ÿĎéđ×šćÙĂÙøĆĚÜúąǰ……. ìĊ (ĔßšÖĆïǰdry powder inhaler đßŠîǰturbuhaler, accuhaler)
x óŠîÝöĎÖ×šćÜìĊęđðŨî×šćÜúąǰ… ìĊǰǰǰ
êĆüĂ÷ŠćÜ: óŠîÝöĎÖìĆĚÜǰǰ2 ×šćÜǰǰ×šćÜúąǰ1 ìĊǰǰüĆîúąǰ2 ÙøĆĚÜǰđßšćǰǰđ÷Ęî
x ÞĊéĔêšñĉüĀîĆÜǰüĆîúą...ÙøĆĚÜǰÖŠĂîĂćĀćø... ÷Ďîĉê
êĆüĂ÷ŠćÜ: ÞĊéĔêšñĉüĀîĆÜǰüĆîúąǰ2 ÙøĆĚÜǰÖŠĂîĂćĀćøđßšćǰ10 ÷ĎîĉêǰÖŠĂîĂćĀćøđ÷Ęîǰ10 ÷Ďîĉê
x üĉíĊđĀîĘïßŠĂÜÙúĂé
1.úšćÜöČĂĔĀšÿąĂćé
2.ĒÖąÖøąéćþìĊęĀŠĂĂĂÖǰĒúšüÝčöŠ ĔîîĚĞćÿąĂćéóĂĔĀš÷ćßČĚîǰ(ðøąöćèǰ1-2 üĉîćìĊ) đóČęĂßŠü÷úéÖćøøąÙć÷đÙČĂÜ
3.îĂîĀÜć÷ēé÷ßĆîđ×Šć×ċĚîĒúąĒ÷Ö×ćĂĂÖ
4.ÿĂé÷ćđ×šćßŠĂÜÙúĂéĔĀšúċÖìĊęÿéč đìŠćìĊęÝąìĞćĕéšǰēé÷ĔßšîĉĚüßŠü÷éĆî÷ćđ×šćĕð
5.îĂîĔîìŠćđéĉöÿĆÖÙøĎŠǰĕöŠêęĞćÖüŠćǰ15 îćìĊǰÝîÖüŠć÷ćÝąúąúć÷ĀöéǰðÖêĉöĆÖÝąđĀîĘïÖŠĂîîĂîǰĂćÝĔßšÖøąéćþǰǰ
ßĞćøąàšĂîìïÖĆîĀúć÷ėǰßĉĚîǰĀøČĂñšćĂîćöĆ÷øĂÜìĊęÖćÜđÖÜĔîĕüš đóČęĂøĂÜøĆïÿŠüî×ĂÜ÷ćìĊęĂćÝĕĀúĂĂÖöć
x üĉíĊĔßš÷ćÿĎéóŠîÝöĎÖ
1.ëČĂĀúĂéóŠî÷ćĔîĒîüêĆĚÜǰđðŗéòćÙøĂïĀúĂéóŠî÷ćĂĂÖǰđ×÷ŠćĀúĂéĔîĒîüêĆĚÜǰ3-4 ÙøĆĚÜ
2.Āć÷ĔÝĂĂÖìćÜðćÖĔĀšÿčéđêĘöìĊę
3.ĔßšøĉöòŘðćÖĂöøĂïðćÖĀúĂéóŠî÷ćĔĀšÿîĉìǰĀøČĂĂšćðćÖĔĀšĀúĂéóŠî÷ćĂ÷ĎŠĀŠćÜÝćÖðćÖðøąöćèǰ3-4
đàîêĉđöêøǰĒúąĂšćðćÖđúĘÖîšĂ÷
4.Āć÷ĔÝđ×šćßšćėǰĒúąúċÖėǰìćÜðćÖóøšĂöÖĆïÖéìĊęóŠî÷ćǰ1 ÙøĆĚÜ
5.đĂćĀúĂéóŠî÷ćĂĂÖÝćÖðćÖǰĀčïðćÖĔĀšÿîĉìǰÖúĆĚîĀć÷ĔÝðøąöćèǰ10 üĉîćìĊǰĀøČĂĔĀšîćîìĊęÿčéđìŠćìĊęÝąîćîĕéš
6.ñŠĂîúöĀć÷ĔÝĂĂÖìćÜðćÖĀøČĂÝöĎÖßšćė
7.ÖøèĊêšĂÜóŠî÷ćĂĊÖÙøĆĚÜǰÙüøđüšîøą÷ąĀŠćÜÝćÖÙøĆĚÜĒøÖĂ÷ŠćÜîšĂ÷ǰ1- 2 îćìĊ
x ĀšćöĒïŠÜđöĘé÷ćĀøČĂïé÷ćîĊĚ
41
3.2 ĀćÖúČöÖĉî÷ćÙüøìĞćĂ÷ŠćÜĕøǰ(ðøĆïÖøĉ÷ćêćöüĉíĊĔßš÷ćǰđßŠîǰÖĉîǰóŠîǰđĀîĘïǰĀ÷ĂéǰìćǰĄúĄ)
1) đðŨîÖćøøąïčüĉíĊðäĉïĆêĉêĆüĔîÖøèĊìĊęñĎšĔßš÷ćúČöĔßš÷ć
2) ĔĀšĒîąîĞćüĉíĊðäĉïĆêĉêĆüêćöÙüćöđĀöćąÿöǰēé÷øąïčêćöđĂÖÿćøĂšćÜĂĉÜǰđßŠî
x “ĔĀšÖĉî÷ćìĆîìĊìĊęîċÖĕéšǰĒêŠëšćĔÖúšđüúć×ĂÜöČĚĂêŠĂĕðǰĔĀšøĂÖĉî÷ć×ĂÜöČĚĂêŠĂĕðǰĒúąĀšćöÖĉî÷ćđóĉęöđðŨîǰ
2 đìŠć”
x “Öĉî÷ćìĆîìĊìĊęîċÖĕéšǰĒêŠëšćúČöÖĉîđÖĉîǰ[x] ßĆęüēöÜĔĀšøĂÖĉî÷ć×ĂÜöČĚĂêŠĂĕðǰĒúąĀšćöÖĉî÷ćđóĉęöđðŨî 2
đìŠć”
x “ĔĀšÖĉî÷ćìĆîìĊìĊęîċÖĕéšǰĒêŠëšćđĀúČĂđüúćîšĂ÷ÖüŠćǰ[x] ßĆęüēöÜÖŠĂîëċÜöČĚĂêŠĂĕðǰĔĀšøĂÖĉî÷ć×ĂÜöČĚĂêŠĂĕðǰ
ĒúąĀšćöÖĉî÷ćđóĉęöđðŨîǰ2 đìŠć”
3) ÿĞćĀøĆï÷ćìĊęöĊüĉíĊĔßšđðŨîÖćøđÞóćąǰĀøČĂĕöŠđĀöćąÿöĔĀšñĎšðśü÷Ĕßš÷ćìĆîìĊìĊęîċÖĕéšǰđßŠîǰ÷ćÙčöÖĞćđîĉéßîĉé
øĆïðøąìćîǰ÷ć warfarin, steroids, methotrexate, ÷ćìĊęÖĉîüĆîđüšîüĆî, ÷ćìĊęÖĉîđéČĂîúąÙøĆĚÜǰđðŨîêšî ĔĀšøąïčüŠć
“ðøċÖþćĒóì÷ŤĀøČĂđõÿĆßÖøđöČęĂúČöÖĉî÷ćîĊĚ”
4) ĀćÖđðŨî÷ćìĊęĔßšđöČęĂöĊĂćÖćøǰ(÷ćǰPRN) ĕöŠêšĂÜöĊĀĆü×šĂ3.2
3.3 ëšćÖĉî÷ćîĊĚđÖĉî×îćéìĊęĒîąîĞć ÙüøìĞćĂ÷ŠćÜĕøǰ(ðøĆïÖøĉ÷ćêćöøĎðĒïï÷ćǰđßŠî ÖĉîǰóŠîǰđĀîĘïǰĀ÷Ăé ìćĄúĄ)
1) đðŨîÖćøøąïčĂćÖćøìĊęĂćÝđÖĉé×ċĚîĒúąüĉíĊðäĉïĆêĉêĆü ĔîÖøèĊìĊęñĎšĔßš÷ćĕéšøĆï÷ćđÖĉî×îćéìĊęøąïčĕüšĔî×šĂǰ3.1 ×îćé
ĒúąüĉíĊĔßš
2) ÷ćìčÖßîĉéĔĀšøąïč×šĂÙüćööćêøåćîǰéĆÜîĊĚ
x “ĔĀšÿĆÜđÖêĂćÖćøĂ÷ŠćÜĔÖúšßĉéǰĀćÖöĊĂćÖćøñĉéðÖêĉìĊęøčîĒøÜǰ[đßŠî ……… (ëšćöĊ×šĂöĎúēðøéøąïč
êĆüĂ÷ŠćÜĂćÖćøìĊęđÖĉé×ċĚîĕéš/Sign & Symptom of overdosage)] ĔĀšøĊïîĞćÿŠÜēøÜó÷ćïćúìĆîìĊ
4.×šĂÙüøðäĉïĆêĉøąĀüŠćÜĔßš÷ć
1) đðŨîÖćøøąïčüĉíĊÖćøðäĉïĆêĉêĆü×ĂÜñĎšĔßš÷ćĔîøąĀüŠćÜìĊęĕéšøĆï÷ćîĊĚ
2) ÿĞćĀøĆï÷ćìĆęüĕðǰĔĀšøąïč×šĂÙüøðäĉïĆêĉìĊęÿĞćÙĆâđóČęĂđÿøĉöñúÖćøøĆÖþćǰĀøČĂðŜĂÜÖĆîñú×šćÜđÙĊ÷ÜÝćÖ÷ćǰ
đßŠîǰ
x “ĀúĊÖđúĊę÷ÜÖćøÿĎïïčĀøĊęĒúąđÙøČęĂÜéČęöìĊęöĊĒĂúÖĂăĂúŤ”
x “øąöĆéøąüĆÜÖćø×Ćï×Ċę÷ćî÷îêŤǰĀøČĂìĞćÜćîđÖĊę÷üÖĆïđÙøČęĂÜÝĆÖøÖú ĀøČĂìĞćÜćîìĊęđÿĊę÷ÜêŠĂÖćøóúĆéêÖ
ÝćÖìĊęÿĎÜ”
x “ĀúĊÖđúĊę÷ÜÖćøĂ÷ĎŠÖúćÜĒééēé÷êøÜ”
x “ÙüïÙčöĂćĀćøĒúąĂĂÖÖĞćúĆÜÖć÷øąĀüŠćÜÖćøĔßš÷ćîĊĚ”
x “ĒÝšÜĒóì÷ŤĀøČĂìĆîêĒóì÷ŤüŠćÖĞćúĆÜĔßš÷ćîĊĚĀćÖêšĂÜÖćøñŠćêĆéĀøČĂìĞćôŦî”
x “óïĒóì÷Ť ê ćöîĆ é Ă÷Š ć ÜÿöęĞ ć đÿöĂǰđóČę Ă êĉ é êćöñúÖćøøĆ Ö þćĀøČ Ă ĂĆ î êøć÷ÝćÖ÷ć”
(đßŠîǰanticoagulant drug, statin)
3) ÿĞćĀøĆï÷ćêšćîÝčúßĊóǰ(Antimicrobial) îĂÖÝćÖ×šĂÙüøðäĉïĆêĉêćö×šĂǰ2. ĒúšüǰĔĀšøąïč ×šĂÙüćöéĆÜîĊĚ
éšü÷ĔîìčÖêĆü÷ć
x “ĔĀšÖĉî÷ćîĊĚêĉéêŠĂÖĆîìčÖüĆîÝîÙøïêćöÙĞćĒîąîĞć×ĂÜĒóì÷ŤǰĀøČĂđõÿĆßÖøǰĒöšĂćÖćøÝąéĊ×ċĚîĒúšüÖĘ
êćöǰöĉÞąîĆĚîđßČĚĂÝąéČĚĂ÷ć”
42
4) ÿĞćĀøĆï÷ćēøÙđøČĚĂøĆÜ îĂÖÝćÖ×šĂÙüøðäĉïĆêĉêćö×šĂǰ2. ĒúšüǰĔĀšøąïč ÿĂÜ×šĂÙüćö×šćÜúŠćÜîĊĚéšü÷ĔîìčÖêĆü
÷ć
x “ĀšćöĀ÷čé÷ćđĂÜǰĒúąĔĀšÖĉî÷ćîĊĚĂ÷ŠćÜêŠĂđîČęĂÜêćöÙĞćĒîąîĞć×ĂÜĒóì÷ŤǰĀøČĂđõÿĆßÖø”
x “óïĒóì÷ŤêćöîĆéĂ÷ŠćÜÿöęĞćđÿöĂǰđóČęĂêĉéêćöñúÖćøøĆÖþćĀøČĂĂĆîêøć÷ÝćÖ÷ć”
5. ĂĆîêøć÷ìĊęĂćÝđÖĉéÝćÖ÷ć
ÙüøøąïčĂĆîêøć÷ìĊęĂćÝđÖĉéÝćÖ÷ćēé÷Ē÷ÖđðŨîĀĆü×šĂêćöÙüćöøčîĒøÜǰēé÷ìĆęüĕðĒîąîĞćéĆÜîĊĚ
1) ĔĀšøąïčĂćÖćøĒóš÷ćêćöéšü÷ĂćÖćøĕöŠóċÜðøąÿÜÙŤøčîĒøÜđìŠćîĆĚîǰ
2) ĂćÖćøĒóš÷ćĔĀšĔßš×šĂÙüćöøŠüöǰéĆÜîĊĚ
x “ïüöìĊęĔïĀîšćǰđðúČĂÖêćǰøĉöòŘðćÖǰúöóĉþ”
x “ĀîšćöČéǰđðŨîúöǰĒîŠîĀîšćĂÖǰĀć÷ĔÝúĞćïćÖ”
x “ñČęîĒéÜǰêčŠöóĂÜǰñĉüĀîĆÜĀúčéúĂÖǰöĊÝĚĞćêćöñĉüĀîĆÜĀøČĂđúČĂéĂĂÖñĉéðÖêĉ”
3) ĂćÖćøĕöŠóċÜðøąÿÜÙŤßîĉéøčîĒøÜìĊęóïĔîđĂÖÿćøĂšćÜĂĉÜêĆĚÜĒêŠ 3 ĒĀúŠÜ×ċĚîĕðǰĒêŠëšćöĊđĂÖÿćøĂšćÜĂĉÜǰ2
ĒĀúŠÜǰĔĀšĔßšéčúóĉîĉÝ×ĂÜñĎšÝĆéìĞć×šĂöĎú
êĆüĂ÷ŠćÜ÷ćǰamoxicillin
x ïüöìĊęĔïĀîšćǰđðúČĂÖêćǰøĉöòŘðćÖǰúöóĉþǰ
x ĀîšćöČéǰđðŨîúöǰĒîŠîĀîšćĂÖǰĀć÷ĔÝúĞćïćÖǰ
x ñČęîĒéÜǰêčŠöóĂÜǰñĉüĀîĆÜĀúčéúĂÖǰ
x öĊÝĚĞćêćöñĉüĀîĆÜǰĀøČĂđúČĂéĂĂÖñĉéðÖêĉ
x êĆüđĀúČĂÜǰêćđĀúČĂÜǰðŦÿÿćüąđĀúČĂÜđ×šöñĉéðÖêĉǰ
x ðüéđÖøĘÜìšĂÜǰìšĂÜøŠüÜǰëŠć÷đðŨîîĚĞćǰĀøČĂëŠć÷đðŨîđúČĂéǰ
x ĕ×šÿĎÜĒúąđÝĘïÙĂĀúĆÜÖĉî÷ćîĊĚêĉéêŠĂÖĆîǰ10 üĆî×ċĚîĕðǰǰ
x öĊòŜć×ćüĔîðćÖǰ
x öĊêÖ×ćüǰĒúąĂćÖćøÙĆîĔîßŠĂÜÙúĂé
5.2 ĂćÖćøìĊęĕöŠÝĞćđðŨîêšĂÜĀ÷čé÷ć ĒêŠëšćöĊĂćÖćøøčîĒøÜĔĀšĕðóïĒóì÷ŤìĆîìĊ

ÙĞćĂíĉïć÷:
1) ĔĀšøąïčĂćÖćøĕöŠóċÜðøąÿÜÙŤ(ADR) ÝćÖ÷ćìĊęîĂÖđĀîČĂÝćÖ×šĂǰ5.1
2) ĔĀšøąïčĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęĕöŠøčîĒøÜêćöéčúóĉîĉÝ×ĂÜñĎšÝĆéìĞć×šĂöĎú đßŠî
x “ðćÖĒĀšÜ ÝöĎÖĒĀšÜ ÙĂĒĀšÜ êćĒĀšÜǰêćóøŠć”
x “ÜŠüÜàċöǰ îĂîĕöŠĀúĆïǰ òŦîøšć÷”
x “ÙúČęîĕÿšǰĂćđÝĊ÷î ðúć÷öČĂðúć÷đìšćđ÷ĘîǰðüéöüîìšĂÜ ìšĂÜñĎÖǰ ìšĂÜøŠüÜ”
x “Ă÷ćÖĂćĀćøđóĉęö×ċĚî îĚĞćĀîĆÖđóĉęö”
x “ðŦÿÿćüąĀøČĂĂčÝÝćøąöĊÿĊñĉéðÖêĉ đßŠîǰðŦÿÿćüąöĊÿĊÿšöĒéÜǰĂčÝÝćøąöĊÿĊéĞć”
Āöć÷đĀêč ×šĂĒîąîĞćĔîÖćøĔßš×šĂöĎúÝćÖđĂÖÿćøĂšćÜĂĉÜ
o ×šĂÙüćöìĊęóĉÝćøèćĔĀšđðŨîǰ5.1 đßŠîǰ
43
Stop taking your tablets and seek medical attention immediately
Side effects that you should report to your prescriber or health care professional as soon as
possible
Call your doctor right away if you notice any of these side effects
Reasons to call healthcare provider immediately
o ×šĂÙüćöìĊęóĉÝćøèćĔĀšđðŨîǰ5.2 đßŠîǰ
Side effects that usually do not require medical attention (report to your prescriber or
health care professional if they continue or are bothersome)
If you notice these less serious side effects, talk with your doctor
o ×šĂÙüćöìĊęĂćÝóĉÝćøèćĔĀšđðŨîǰ5.1 ĀøČĂǰ5.2 đßŠîǰ
Tell your doctors as soon as possible
6. đÖĘï÷ćîĊĚĂ÷ŠćÜĕø
1) ĔĀšøąïčüĉíĊÖćøđÖĘïøĆÖþć÷ćĂ÷ŠćÜëĎÖêšĂÜ éĆÜĒîüìćÜêŠĂĕðîĊĚêćöÙüćöđĀöćąÿö
x “đÖĘï÷ćĕüšĔîõćßîąïøøÝčđéĉöêćöìĊęĕéšøĆïöć” (×šĂÙüćöïĆÜÙĆï)
x øąïč×šĂÙüćöđÖĊę÷üÖĆïüĉíĊĔßš÷ćĔîĒêŠúąÙøĆĚÜĔĀšÿĂéÙúšĂÜÖĆïøĎðĒïï÷ćĒúąïøøÝčõĆèæŤǰđßŠî
- ĀćÖđðŨî÷ćđöĘéïøøÝčĒñÜǰĔĀšøąïčüŠćǰ
x “ĒÖą÷ćĂĂÖÝćÖĒñÜđöČęĂÝąÖĉîĔîĒêŠúąÙøĆĚÜđìŠćîĆĚî”
x ĀøČĂǰǰ“ĀšćöĒÖą÷ćÖŠĂîÖĉîđóøćą÷ćĂćÝđÿĊ÷ĕéš”
x ĀøČĂǰ"đÖĘï÷ćĕüšĔîõćßîąïøøÝčđéĉö"
- ĀćÖđðŨî÷ćđöĘéïøøÝč×üé ĔĀšøąïčüŠćǰ
x “Ā÷ĉï÷ćĂĂÖÝćÖ×üéđöČęĂÝąÖĉîĔîĒêŠúąÙøĆĚÜđìŠćîĆĚî”
x “đÖĘï÷ćĔîìĊęĒĀšÜ Ă÷ŠćĔĀšēéîĒÿÜēé÷êøÜ ēé÷ìĆęüĕðÙüøđÖĘïìĊęĂčèĀõĎöĉ [X] <ðøĆïêćö
ìąđïĊ÷î÷ć> ĂÜýćđàúđàĊ÷ÿ ĕöŠđÖĘï÷ćĔîìĊęøšĂîĀøČĂßČĚîǰđßŠîǰĔîøëǰĀšĂÜîĚĞćǰĀšĂÜÙøĆü”
x “đÖĘï÷ćîĊĚĕüšĔîêĎšđ÷ĘîǰĀšćöĒßŠĒ×ĘÜ” ĔîÖøèĊìĊęđðŨî÷ćìĊęêšĂÜđÖĘïĔîêĎšđ÷Ęî
x “đÖĘï÷ćìčÖßîĉéĔĀšóšîöČĂđéĘÖ”
x ÿĞćĀøĆï÷ćìĊęöĊĂć÷čÖćøĔßšÿĆĚîĀúĆÜÝćÖđðŗéĔßšĀøČĂñÿöĒúšü đßŠîǰ÷ćêćǰ÷ćßîĉéñÜĒĀšÜñÿöîĚĞćǰĔĀš
øąïčüĉíĊÖćøđÖĘïĒúąĂć÷čÖćøĔßš×ĂÜ÷ćĀúĆÜÝćÖđðŗéĔßšĀøČĂñÿöĒúšüĕüšéšü÷ (ðøĆïêćö×šĂöĎú
ÖćøýċÖþćÙüćöÙÜÿõćó×ĂÜ÷ć)
đßŠî Azithromycin dry powder for suspension “ñÿöĒúšüđÖĘïĔîêĎšđ÷Ęîĕéšǰ1 ÿĆðéćĀŤ”
II. ×šĂÙüćöøŠüöìšć÷đĂÖÿćøǰ(disclaimer)
1) øąïč×šĂÙüćöøŠüöĕüšĔîÖøĂïÿĊęđĀúĊę÷öéšćîúŠćÜÿčé×ĂÜđĂÖÿćøÖĞćÖĆï÷ć ēé÷ĒîąîĞćĔĀšÝĆéüćÜĔîÿŠüîÙĂúĆöîŤ
êøÜÖúćÜ ēé÷øąïč×šĂÙüćöéĆÜîĊĚ
“đĂÖÿćøîĊĚđðŨî×šĂöĎúēé÷÷ŠĂǰĀćÖöĊ×šĂÿÜÿĆ÷ĔĀšðøċÖþćĒóì÷ŤĀøČĂđõÿĆßÖø”
44
III. ñĎšñúĉê/ñĎšîĞćđ×šć/ñĎšĒìîÝĞćĀîŠć÷
1) đðŨîÖćøøąïč×šĂöĎúñĎšñúĉê/ñĎšîĞćđ×šć/ñĎšĒìîÝĞćĀîŠć÷ǰǰēé÷øąïč
x ßČęĂĒúąìĊęĂ÷ĎŠ×ĂÜïøĉþĆììĊęđÖĊę÷ü×šĂÜÖĆïñúĉêõĆèæŤ < ðøĆïêćöìąđïĊ÷î÷ć >
i. đÝšć×ĂÜñúĉêõĆèæŤǰøąïčßČęĂïøĉþĆìĒúąìĊęĂ÷ĎŠ
ii. ñĎšøĆïĂîčâćêĔîðøąđìýĕì÷ øąïčßČęĂïøĉþĆìĒúąìĊęĂ÷ĎŠ
iii. ñĎšÝĆéÝĞćĀîŠć÷Ĕîðøąđìýĕì÷ øąïčßČęĂïøĉþĆìĒúąìĊęĂ÷ĎŠ
IV.đĂÖÿćøîĊĚðøĆïðøčÜÙøĆĚÜÿčéìšć÷đöČęĂ
1) đðŨîÖćøøąïčǰüĆîǰđéČĂîǰðŘ (ó.ý.) ìĊęñĎšðøąÖĂïÖćøðøĆïðøčÜ×šĂöĎúÙøĆĚÜÿčéìšć÷ĒúąĕéšøĆïĂîčâćêÝćÖ
ÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ć
45
õćÙñîüÖ 1
Ùüćöøšć÷ĒøÜ×ĂÜĂćÖćøĕöŠóċÜðøąÿÜÙŤÝćÖćøĔßš÷ć
*
Ùüćöøšć÷ĒøÜ×ĂÜĂćÖćøĕöŠóċÜðøąÿÜÙŤÝćÖÖćøĔßš÷ćǰĒïŠÜđðŨî
1. ĕöŠøšć÷ĒøÜ ÖøèĊĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęđÖĉé×ċĚîĕöŠđ×šć×Šć÷ÖøèĊìĊęøąïčĔîĀĆü×šĂøšć÷ĒøÜ
2. øšć÷ĒøÜǰÖøèĊĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęđÖĉé×ċĚîđðŨîéĆÜîĊĚ
2.1 đÿĊ÷ßĊüĉêǰ(Death) đöČęĂöĊÖćøđÿĊ÷ßĊüĉêàċęÜĂćÝđðŨîñúöćÝćÖĂćÖćøĕöŠóċÜðøąÿÜÙŤÝćÖÖćøĔßš÷ćîĆĚîǰǰìĆĚÜîĊĚ
ÖćøđÿĊ÷ßĊüĉêĔîÖøèĊîĊĚĕöŠøüöëċÜÖćøìĊęìćøÖđÿĊ÷ßĊüĉê×èąêĆĚÜÙøøõŤǰ(ÖćøĒìšÜïčêø) ĂĆîđîČęĂÜöćÝćÖÙüćö
ñĉéðÖêĉöćĒêŠÖĞćđîĉéĀøČĂÖćøêĆĚÜÙøøõŤúšöđĀúü
2.2 ĂĆîêøć÷ëċÜßĊüĉêǰ(Life-threatening) đöČęĂñĎšðśü÷öĊÙüćöđÿĊę÷ÜÿĎÜêŠĂÖćøđÿĊ÷ßĊüĉêǰÝćÖĂćÖćøĕöŠóċÜ
ðøąÿÜÙŤÝćÖÖćøĔßš÷ćĀøČĂĂćÝöĊñúĔĀšñĎšðśü÷đÿĊ÷ßĊüĉêëšćĔßš÷ćîĆĚîĂ÷ŠćÜêŠĂđîČęĂÜ
2.3 êšĂÜđ×šćøĆïÖćøøĆÖþćĔîēøÜó÷ćïćúǰĀøČĂđóĉęöøą÷ąđüúćĔîÖćøøĆÖþćîćî×ċĚî
x êšĂÜđ×šćøĆïÖćøøĆÖþćĔîēøÜó÷ćïćúǰ(Hospitalization-initial) đöČęĂĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊę
đÖĉé×ċĚîîĆĚîđðŨîđĀêčĔĀšêšĂÜđ×šćøĆïÖćøøĆÖþćĔîēøÜó÷ćïćú
x ìĞ ć ĔĀš đ óĉę ö øą÷ąđüúćĔîÖćøøĆ Ö þćîćî×ċĚ î ǰ(Hospitalization-prolong) đöČę Ă ĂćÖćø
ĕöŠóċÜðøąÿÜÙŤìĊęđÖĉé×ċĚîîĆĚîǰđðŨîđĀêčĔĀšĔßšđüúćÖćøøĆÖþćĔîēøÜó÷ćïćú÷ćüîćî×ċĚîǰ(ÖøèĊñĎšðśü÷
êšĂÜÿĆÜđÖêÖćøèŤìĊęĀšĂÜÞčÖđÞĉîǰÙüøøąïčđðŨîêĆüđúČĂÖĂČęîǰđßŠîǰLife-threatening)
2.4 ÙüćöóĉÖćøǰ(Disability) đöČęĂĂćÖćøĕöŠóċÜðøąÿÜÙŤìĊęđÖĉé×ċĚîđðŨîñúĔĀšïčÙÙúéĆÜÖúŠćü
ĕöŠÿćöćøëéĞćøÜßĊüĉêêćöðÖêĉÿŠÜñúêŠĂÖćøđðúĊę÷îĒðúÜĒïïßĆęüÙøćüĀøČĂëćüøǰĀøČĂìĞćĔĀšđÖĉéÙüćö
đÿĊ÷Āć÷ǰĀøČĂÖćøìĞćúć÷êŠĂēÙøÜÿøšćÜǰĀîšćìĊę×ĂÜøŠćÜÖć÷ñĎšðśü÷ǰĀøČĂÙüćöÿćöćøëǰĒúąĀøČĂÙčèõćó
ßĊüĉê×ĂÜñĎšðśü÷ǰđßŠîǰêćïĂéǰĕêüć÷ǰđðŨîêšî
2.5 đðŨîđĀêčĔĀšđÖĉéÙüćöñĉéðÖêĉĒêŠÖĞćđîĉéǰ(Congenital anomaly) đöČęĂÿÜÿĆ÷üŠćñĎšðśü÷ĕéšøĆï÷ćÖŠĂî
ÖćøêĆĚÜÙøøõŤǰĀøČĂĔîøąĀüŠćÜÖćøêĆĚÜÙøøõŤĒúšüÿŠÜñúĔĀšđÖĉéÙüćöñĉéðÖêĉĒêŠÖĞćđîĉé×ĂÜìćøÖàċęÜđðŨîñú
×ĂÜĂćÖćøĕöŠóċÜðøąÿÜÙŤÝćÖÖćøĔßš÷ć
2.6 ĂČęîėǰđðŨîĂćÖćøøšć÷ĒøÜĂČęîėǰìĊęÿĞćÙĆâìćÜÖćøĒóì÷ŤǰàċęÜÿŠÜñúĔĀšñĎšðśü÷êšĂÜĕéšøĆïÖćøøĆÖþćéšü÷üĉíĊĂČęîǰ
đßŠîǰÖćøñŠćêĆéǰÖøèĊîĊĚøüöëċÜñĎšðśü÷àċęÜđÖĉéðŦâĀćÖćøĀć÷ĔÝêĉé×ĆéĂ÷ŠćÜøčîĒøÜĒúąêšĂÜøĆÖþćĔîĀšĂÜ
ÞčÖđÞĉîǰñĎšðśü÷đÖĉéĂćÖćøßĆÖǰĀöéÿêĉǰøąïïđúČĂéñĉéðÖêĉǰđðŨîêšî
*
ðøĆïðøčÜÝćÖÙĞćĒîąîĞćĔîÖćøÖøĂÖĒïïøć÷ÜćîđĀêčÖćøèŤĕöŠóċÜðøąÿÜÙŤÝćÖÖćøĔßšñúĉêõĆèæŤÿč×õćó×ĂÜýĎî÷ŤđòŜćøąüĆÜÙüćöðúĂéõĆ÷
éšćîñúĉêõĆèæŤÿč×õćó
46
õćÙñîüÖ 2
47
ѠѣєѠдоѧоѧјјѧь 500 єѧјјѧдіѤє
ньѧчѰзюоѬј
[нѪѷѠдѥізҖѥ]
1.ѕѥьѨѸзѪѠѕѥѠѣѳі 3. њѧыѨѲнҖѕѥ 5. ѠѤьшіѥѕъѨѷѠѥлѯдѧчлѥдѕѥ

1.1 ѕѥьѨѸєѨнѪѷѠѝѥєѤрњҕѥѠѣѳі 3.1 еьѥчѰјѣњѧыѨѲнҖ 5.1 ѠѥдѥіъѨѷшҖѠкўѕѫчѕѥ ѰјҖњіѨэѳюёэѰёъѕҙъѤьъѨ
x ѠѣєѠдоѧој ѧ јѧьѳъіѳѡѯчіш (Amoxicillin Trihydrate) x зњіѲнҖѕѥшѥєзѼѥѰьѣьѼѥеѠкѰёъѕҙўіѪѠѯѓѝѤнді x эњєъѨѲѷ эўьҖѥѯюјѪѠдшѥ іѧєѐҍюѥдјєёѧќ
ѯюҝьѕѥютѧнњѨ ьѣѠѕѬѲҕ ьдјѫє
ҕ ѯёььѧоѧјјѧь ѯъҕѥьѤѸь ѯьѪѠ
ѷ клѥдеьѥчѰјѣіѣѕѣѯњјѥѲьдѥіѲнҖѕѥьѨѸ x ўьҖѥєѪчѯюҝьјєѰьҕьўьҖѥѠдўѥѕѲлјѼѥэѥд
1.2 ѕѥьѨѸѲнҖѯёѪѷѠѠѣѳі еѩѸьдѤэньѧчѰјѣзњѥєіѫьѰікеѠкѱіз x яѪѷьѰчкшѫҕєёѠкяѧњўьѤкўјѫчјѠд
x ѲнҖіѤдќѥѱізшѧчѯнѪѸѠѰэзъѧѯіѨѕньѧчъѨѷѕѤкѳєҕчѪѸѠшҕѠѕѥьѨѸ x дѧьзіѤѸкјѣ1 ѰзюоѬј(500 єѧјјѧдіѤє) њѤьјѣ3 зіѤѸк x єѨлѸѼѥшѥєяѧњўьѤкўіѪѠѯјѪѠчѠѠдяѧчюдшѧ
ѯъҕѥьѤѸь дҕѠь ўіѪѠўјѤкѠѥўѥідѶѳчҖ x шѤњѯўјѪѠкшѥѯўјѪѠкюқѝѝѥњѣѯўјѪѠкѯеҖєяѧчюдшѧ
1.3 ѕѥьѨѸѳєҕѝѥєѥіщіѤдќѥѱізшѧчѯнѪѸѠлѥдѳњіѤѝѯнҕьўњѤч 3.2 ўѥдјѪєдѧьѕѥ зњіъѼѥѠѕҕѥкѳі x юњчѯдіѶкъҖѠкъҖѠкіҕњкщҕѥѕѯюҝььѸѼѥ ўіѪѠщҕѥѕѯюҝьѯјѪѠч
ѳеҖўњѤчѲўрҕўјѠчјєѠѤдѯѝэѯмѨѕэёјѤьѳѠўіѪѠѯлѶэзѠ x ѲўҖдѧьѕѥъѤьъѨъѨѷьѩдѳчҖѰшҕщѥҖ ѲдјҖѯњјѥеѠкєѪѸѠшҕѠѳюѲўҖ x ѳеҖѝѬкѰјѣѯлѶэзѠўјѤкдѧьѕѥьѨѸшѧчшҕѠдѤь 10 њѤьеѩѸьѳю
лѥдѯнѪѠѸ ѳњіѤѝ іѠдѧьѕѥеѠкєѪѠ Ѹ шҕѠѳю ѰјѣўҖѥєдѧьѕѥѯёѧѷєѯюҝь2 ѯъҕѥ x єѨѐґѥеѥњѲьюѥд
3.3 щҖѥдѧьѕѥьѨѯѸ дѧьеьѥчъѨѷѰьѣьѼѥ зњіъѼѥѠѕҕѥкѳі x єѨшдеѥњ ѰјѣѠѥдѥізѤьѲьнҕѠкзјѠч
2. еҖѠзњііѬҖдҕѠьѲнҖѕѥ x ѲўҖѝѤкѯдшѠѥдѥіѠѕҕѥкѲдјҖнч ѧ ўѥдєѨѠѥдѥіяѧчюдшѧъѨѷ 5.2 ѠѥдѥіъѨѷѳєҕлѼѥѯюҝьшҖѠкўѕѫчѕѥ Ѱшҕщѥ Җ єѨѠѥдѥі
іѫьѰікѲўҖіѨэьѼѥѝҕкѱікёѕѥэѥјъѤьъѨ іѫьѰікѲўҖѳюёэѰёъѕҙъѤьъѨ
2.1 ўҖѥєѲнҖѕѥьѨѸѯєѪѷѠѳі x зјѪѷьѳѝҖѠѥѯлѨѕьюњчъҖѠкюњчўѤњѯэѪѷѠѠѥўѥі
x ѯзѕѰёҖѕѥьѨѸ ўіѪѠѕѥѠѪѷьѲьдјѫє ҕ ѯёььѧоѧјјѧь ѰшҕщҖѥєѨѠѥдѥііѫьѰікѲўҖѳюёэѰёъѕҙъѤьъѨ
x ѯзѕѰёҖѕѥѲьдјѫҕєѯођѥѱіѝюѠіѧьеѤѸьіѫьѰік
4. еҖѠзњіютѧэѤшѧіѣўњҕѥкѲнҖѕѥ
2.2 еҖѠзњііѣњѤкѯєѪѷѠѲнҖѕѥьѨѸ 6. зњіѯдѶэѕѥьѨѸѠѕҕѥкѳі
x ўѥдъҕѥьєѨѓѥњѣшҕѠѳюьѨѸ x ѲўҖдѧьѕѥьѨѸшѧчшҕѠдѤьъѫдњѤьльзіэшѥє
- ѱізўѪч ѲўҖюіѩдќѥѰёъѕҙ ўіѪѠѯѓѝѤндідҕѠьѲнҖѕѥьѨѸ зѼѥѰьѣьѼѥеѠкѰёъѕҙ ўіѪѠѯѓѝѤндіѰєҖѠѥдѥілѣ x ѯдѶэѕѥѳњҖѲьѓѥньѣэіілѫѯчѧєшѥєъѨѷѳчҖіѤэєѥ
ѯёіѥѣѠѥлєѨѱѠдѥѝѰёҖѕѥьѨѸѳчҖкҕѥѕеѩѸьѰјѣѠѥлъѼѥѲўҖ чѨеѩѸьѰјҖњдѶшѥє єѧмѣьѤѸьѯнѪѠ
Ѹ лѣчѪѸѠѕѥ x ѰдѣѕѥѠѠдлѥдѰякѯєѪѠ ѷ лѣдѧьѲьѰшҕјѣзіѤѸкѯъҕѥьѤѸь
ѠѥдѥіѰёҖіѫьѰікѳчҖ x ѯдѶэѲьъѨѷѰўҖкѠѕҕѥѲўҖѱчьѰѝкѱчѕшікѱчѕъѤѷњѳю
x ѳєҕзњіѲнҖѕѥьѨѸіҕњєдѤэѕѥѠѥўѥіѝєѫьѳёіўіѪѠ зњіѯдѶэъѨѠ
ѷ ѫцўѓѬєѳ
ѧ єҕѯдѧь30 ѠкћѥѯојѯоѨѕѝ
яјѧшѓѤцфҙѯѝіѧєѠѥўѥіэѥкньѧч ѯёіѥѣѠѥлєѨяјшҕѠдѥі x ѳєҕѯдѶэѲьъѨѷіҖѠь ўіѪѠнѪѸьѯнҕьѲьіщўҖѠкьѸѼѥўҖѠкзіѤњ
іѤдќѥўіѪѠѯдѧчѠѤьшіѥѕѳчҖѯнҕь x ѯдѶэѕѥъѫдньѧчѲўҖёҖьєѪѠѯчѶд
- ѕѥзѫєдѼѥѯьѧчньѧчдѧь ѯёіѥѣѕѥьѨѸјчюіѣѝѧъыѧѓѥё
еѠкѕѥзѫєдѼѥѯьѧчлѩкѠѥлъѼѥѲўҖшѤѸкзііѓҙѳчҖ зњіѲнҖ
дѥізѫєдѼѥѯьѧчњѧыѠ
Ѩ ѪѷьіҕњєчҖњѕѲьіѣўњҕѥкѲнҖѕѥьѨѸ
- ѕѥѯєѱъѯъідѯош ѯёіѥѣѕѥьѨѸѠѥлѯёѧѷєёѧќеѠкѕѥ ѯѠдѝѥіьѨѸѯюҝьеҖѠєѬјѱчѕѕҕѠўѥдєѨеҖѠѝкѝѤѕѲўҖ
ѯєѱъѯъідѯошѳчҖ юіѩдќѥѰёъѕҙўіѪѠѯѓѝѤнді
яѬҖяјѧш/яѬҖьѼѥѯеҖѥ/яѬҖѰъьлѼѥўьҕѥѕ....................
48
шѤњѠѕҕѥкѯѠдѝѥідѼѥдѤэѕѥѝѼѥўіѤэюіѣнѥньѠѣєѠдоѧоѧјјѧь500 єѧјјѧдіѤєньѧчѰзюоѬј ѯѠдѝѥіьѨѸюіѤэюіѫкзіѤѸкјҕѥѝѫчѯєѪѷѠ......................
õćÙñîüÖ 3
49
нѪѷѠѝѥєѤръѥкѕѥXX (ѳєҕѲѝҕѯдјѪѠ) зњѥєѰікXX
іѬюѰээѕѥ
1. ѕѥьѨѸзѪѠѕѥѠѣѳі 3. њѧыѨѲнҖѕѥ 5. ѠѤьшіѥѕъѨѷѠѥлѯдѧчлѥдѕѥ

Ѹ ѨнѪѷѠѝѥєѤрњҕѥѠѣѳі
1.1 ѕѥьѨє 3.1 еьѥчѰјѣњѧыѨѲнҖ 5.1 ѠѥдѥіъѨѷшҖѠкўѕѫчѕѥѰјҖњіѨэѳюёэ
x іѥѕјѣѯѠѨѕч x іѥѕјѣѯѠѨѕч ѰёъѕҙъѤьъѨ
x іѥѕјѣѯѠѨѕч
1.2 ѕѥьѨѸѲнҖѯёѪѷѠѠѣѳі 3.2 ўѥдјѪє[њѧыѨѲнҖѕѥ] зњіъѼѥѠѕҕѥкѳі [ѕѥъѨѷѲнҖ
Җ єѨ
5.2 ѠѥдѥіъѨѷѳєҕлѼѥѯюҝьшҖѠкўѕѫчѕѥ Ѱшҕщѥ
Ѱээ PRN ѳєҕшҖѠкєѨўѤњеҖѠьѨѸ]
x іѥѕјѣѯѠѨѕч ѠѥдѥііѫьѰікѲўҖѳюѰёъѕҙъѤьъѨ
3.3 щҖѥдѧьѕѥьѨѯѸ дѧьеьѥчъѨѷѰьѣьѼѥзњіъѼѥѠѕҕѥкѳі
2. еҖѠзњііѬҖдҕѠьѲнҖѕѥ 4. еҖѠзњіютѧэѤшѧіѣўњҕѥкѲнҖѕѥ 6. зњіѯдѶэѕѥьѨѸѠѕҕѥкѳі
2.1 ўҖѥєѲнҖѕѥьѨѸѯєѪѷѠѳі x іѥѕјѣѯѠѨѕч x іѥѕјѣѯѠѨѕч

ѯѠдѝѥіьѨѸѯюҝьеҖѠєѬјѱчѕѕҕѠўѥдєѨеҖѠ
2.2 еҖѠзњііѣњѤкѯєѪѷѠѲнҖѕѥьѨѸ ѝкѝѤѕѲўҖюіѩдќѥѰёъѕҙўіѪѠѯѓѝѤнді
яѬҖяјѧш/яѬҖьѼѥѯеҖѥ/яѬҖѰъьлѼѥўьҕѥѕ................
ѯѠдѝѥіьѨѸюіѤэюіѫкзіѤѸкѝѫчъҖѥѕѯєѪѷѠ..............
50
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ĒîüìćÜÖćøìéÿĂïđĂÖÿćøÖĞć ÖĆï ÷ćÿĞć ĀøĆ ï ðøąßćßî
(USER TESTING GUIDELINE)
ÖćøìéÿĂïđĂÖÿćøÖĞćÖĆï÷ćđðŨîÖøąïüîÖćøĒúąđðŨîĀúĆÖåćîÿąìšĂîëċÜÙüćöĔÿŠĔÝ×ĂÜđÝšć×ĂÜñúĉêõĆèæŤĔîÖćøĔĀš×šĂöĎúĒÖŠñĎšïøĉēõÙǰ
đóČęĂĔĀšöĆęîĔÝüŠćđĂÖÿćøÖĞćÖĆï÷ćÿćöćøëÿČęĂÿćøĔĀšñĎšïøĉēõÙđ×šćĔÝĒúąĔĀš×šĂöĎúìĊęđðŨîðøąē÷ßîŤǰ ǰđĂÖÿćøÖĞćÖĆï÷ćìĊęöĊðøąÿĉìíĉõćóǰÙČĂ
đĂÖÿćøÖĞćÖĆï÷ćìĊęñĎšïøĉēõÙÿćöćøëĀć×šĂöĎúìĊęêšĂÜÖćøóïĕéšĂ÷ŠćÜøüéđøĘüǰĒúąÿćöćøëðäĉïĆêêĉ ćöĕéšĂ÷ŠćÜđĀöćąÿöǰǰđĂÖÿćøÖĞćÖĆï÷ćìĊę
ĕöŠöĊðøąÿĉìíĉõćóÿćöćøëÿŠÜñúĔĀšđÖĉéÖćøĔßš÷ćĂ÷ŠćÜĕöŠđĀöćąÿöǰìĞćĔĀšñĎšïøĉēõÙĕöŠĕéšøĆïðøąē÷ßîŤÿĎÜÿčéÝćÖÖćøĔßš÷ćĒúąĔîïćÜÖøèĊ
ĂćÝÖŠĂĔĀšđÖĉéĂĆîêøć÷ĀøČĂñúìĊęĕöŠêšĂÜÖćøêŠĂñĎšïøĉēõÙ
đðŨîÖćø÷ćÖìĊęÝąÙćéđéćüŠćñĎšïøĉēõÙÝąĔßšĀøČĂĂŠćîđĂÖÿćøÖĞćÖĆï÷ćĂ÷ŠćÜĕøǰđöČęĂĕéšøĆïđĂÖÿćøÖĞćÖĆï÷ćñĎšïøĉēõÙĒêŠúąÙîÝąöĊüĉíĊĂŠćîǰìĞć
Ùüćöđ×šćĔÝǰĀøČĂóùêĉÖøøöìĊęĒêÖêŠćÜÖĆîǰǰēé÷đîČĚĂĀćđĂÖÿćøÖĞćÖĆï÷ćÖĘöĊÙüćöàĆïàšĂîĒúąĒêÖêŠćÜÖĆîĔî÷ćĒêŠúąßîĉéǰÖćøĒðúđĂÖÿćø
ÖĞćÖĆï÷ćìĊęóĆçîćêćööćêøåćîÿćÖúǰđßŠîǰđöČęĂîĞćđĂÖÿćøÖĞćÖĆï÷ćàċęÜĕéšøĆïÖćøìéÿĂïöćđðŨîĂ÷ŠćÜéĊĒúšüĔîõćþćĂĆÜÖùþǰöćĒðúĔĀšđðŨî
õćþćĕì÷ÖĘĕöŠĂćÝ÷Čî÷ĆîĕéšüŠćñĎšïøĉēõÙÙîĕì÷ÝąöĊÙüćöđ×šćĔÝĒúąÿćöćøëĔßš÷ćĕéšđĀöćąÿöĔîúĆÖþèąđéĊ÷üÖĆîǰǰÖćøìéÿĂïĔîñĎšïøĉēõÙǰ
(User Testing) ÖŠĂîîĞćĕðĔßšÝąßŠü÷ĔĀšöĆęîĔÝüŠćđĂÖÿćøÖĞćÖĆï÷ćÿćöćøëìĞćĀîšćìĊęĕéšĂ÷ŠćÜöĊðøąÿĉìíĉõćóêćöÝčéöčŠÜĀöć÷
ÖćøìéÿĂïðøąÿĉìíĉõćóÖćøĔĀš×šĂöĎú×ĂÜđĂÖÿćøÖĞćÖĆï÷ćéšü÷üĉíĊìĊęđðŨîöćêøåćîÝąßŠü÷ßĊĚĔĀšđĀĘîëċÜÝčéïÖóøŠĂÜǰĀøČĂðøąđéĘîìĊęñĎšðśü÷
ĀøČĂÙîìĆęüĕðöĆÖĕöŠđ×šćĔÝĔîđĂÖÿćøÖĞćÖĆï÷ćǰÖćøìéÿĂïÝćÖöčööĂÜ×ĂÜñĎšĔßš×šĂöĎú÷ĆÜđðŨîüĉíĊìĊęĔĀšñĎšðśü÷ĀøČĂñĎšöĊēĂÖćÿĔßš÷ćöĊÿŠüîøŠüöĔî
×ĆĚîêĂîÖćøóĆçîćđĂÖÿćøÖĞćÖĆï÷ć ēé÷ĕöŠĔßŠÙĞćîċÜëċÜĒêŠđóĊ÷ÜđîČĚĂĀćìĊęêšĂÜÖćøĔĀšÝćÖöčööĂÜ×ĂÜïčÙúćÖøìćÜÖćøĒóì÷ŤđìŠćîĆĚî Öćø
ìéÿĂïđĂÖÿćøÖĞćÖĆï÷ćĔîñĎšïøĉēõÙÝąìĞćĔĀšđøćöĆęîĔÝĕéšüŠćđĂÖÿćøÖĞćÖĆï÷ćîĆĚîöĊðøąÿĉìíĉõćóđóĊ÷ÜóĂìĊęÝąÿČęĂÿćøÖĆïñĎšðśü÷ĕéšĂ÷ŠćÜ
đ×šćĔÝǰĒúñĎšðśü÷ÿćöćøëðäĉïĆêĉêćöĕéšĂ÷ŠćÜëĎÖêšĂÜêćöÿõćóÖćøĔßšÜćîÝøĉÜ
ÖćøìéÿĂïĔîñĎšïøĉēõÙǰ(User Testing) îĆïđðŨî×ĆĚîêĂîĀîċęÜõć÷ĔêšÖøąïüîÖćøóĆçîćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîǰĒúąìčÖÙøĆĚÜìĊę
öĊÖćøðøĆïđðúĊę÷îđĂÖÿćøÖĞćÖĆï÷ćÙüøìĞćÖćøìéÿĂïàĚĞćǰēé÷đÞóćąĔîðøąđéĘî/đîČĚĂĀćìĊęöĊÖćøđðúĊę÷îĒðúÜǰđóČęĂĔĀšöĆęîĔÝüŠćñĎšïøĉēõÙÝą
đ×šćĔÝĒúąðäĉïĆêĉêćöĕéšĂ÷ŠćÜđĀöćąÿöǰ
ĀúĆ Ö Öćø
ĀúĆÖÖćøóČĚîåćîìĊęêšĂÜìĞćÙüćöđ×šćĔÝÿĞćĀøĆïÖćøìéÿĂïđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßîǰéĆÜîĊĚ
x ÖćøìéÿĂïîĊĚđðŨîÖćøìéÿĂïđĂÖÿćøÖĞćÖĆï÷ćǰĕöŠĔßŠñĎšïøĉēõÙ
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øąéĆïĔéǰĒêŠĂ÷ĎŠìĊęđîČĚĂĀćĒêŠúąÿŠüîÿČęĂÿćøĕéšéĊđóĊ÷ÜĔéēé÷üĆéÝćÖÝĞćîüîñĎšĂŠćîìĊęđ×šćĔÝ
x ÖćøìéÿĂïîĊĚöĊđðŜćĀöć÷đóČęĂĀćÝčéïÖóøŠĂÜ×ĂÜđĂÖÿćøÖĞćÖĆï÷ć
×šĂöĎúìĊęñĎšìéÿĂïÙüøĔĀšÙüćöÿĞćÙĆâĒúąđðŨîðøąē÷ßîŤêŠĂÖćøóĆçîćđĂÖÿćøÖĞćÖĆï÷ćǰÙČĂǰ×šĂïÖóøŠĂÜĀøČĂÝčéìĊęđðŨîðŦâĀć×ĂÜ
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x ÖćøìéÿĂïîĊĚĕöŠĔßŠÖćøìéÿĂïüŠć÷ćĕéšñúĀøČĂĕöŠ
ÖćøìéÿĂïîĊĚĕöŠÿćöćøëïŠÜïĂÖđÖĊę÷üÖĆïñúÖćøĂĂÖùìíĉĝ×ĂÜ÷ćǰǰðøąÿĉìíĉõćóĔîÖćøĔĀš×šĂöĎú×ĂÜđĂÖÿćøÖĞćÖĆï÷ćÝąßŠü÷ĔĀš
ñĎšðśü÷ĕéšøĆïðøąē÷ßîŤÿĎÜÿčéÝćÖÖćøĔßš÷ćǰÿŠüîñú×ĂÜ÷ćÝąđðŨîøąéĆïĔé×ċĚîĂ÷ĎŠÖĆïÙčèÿöïĆêĉ×ĂÜ÷ćđĂÜǰǰñú×ĂÜÖćøìéÿĂï
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ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊęǰ3 ÖøÖãćÙöǰ2556
51
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ĀøČĂĕöŠĂ÷ŠćÜĕøǰǰđðŜćĀöć÷ÝċÜ ĕöŠĔßŠêšĂÜÖćøøĎšøąéĆïÙąĒîîÙüćöóċÜ óĂĔÝĀøČĂÙüćöøĎšÿċÖ×ĂÜñĎšïøĉēõÙêŠĂđĂÖÿćøÖĞćÖĆï÷ćǰ
đîČęĂÜÝćÖÙąĒîîÙüćöøĎšÿċÖöĆÖĕöŠĕéšĔĀš×šĂöĎúìĊęöĊøć÷úąđĂĊ÷éđóĊ÷ÜóĂÿĞćĀøĆïÖćøðøĆïðøčÜđĂÖÿćøÖĞćÖĆï÷ć
x ÖćøìéÿĂïîĊĚĕöŠÿćöćøëĒìîéšü÷üĉíĊÖćøüĆéøąéĆïÖćøĂŠćîĂĂÖǰ(Readability Testing)
øąéĆïÖćøĂŠćîĂĂÖđðŨîêĆüßĊĚüĆéøąéĆïÙüćö÷ćÖÜŠć÷×ĂÜõćþćìĊęĔßšǰðøąđöĉîēé÷ĂćýĆ÷ÿĎêøàċęÜöĆÖÙĞćîüèÝćÖÙüćö÷ćü×ĂÜÙĞć
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x ëćöĔĀšĂíĉïć÷đĀêčñú×ĂÜÖćøÖøąìĞćĀøČĂñúìĊęđÖĉéǰđßŠîǰìĞćĕöĀšćö×ĆïøëđöČęĂĔßš÷ć
2. ÿøšćÜĒïïÿĂïëćöìĊęðøąÖĂïéšü÷ÙĞćëćöǰ12-15 ×šĂ ÝĞćîüî×šĂÙĞćëćö×ċĚîÖĆïðøąđéĘîìĊęêšĂÜÖćøìéÿĂïǰĒêŠĕöŠÙüøÝąöĊÝĞćîüîöćÖ
đÖĉîĕðǰđóČęĂĕöŠĔĀšñĎšëĎÖìéÿĂïđÖĉéÙüćöđĀîČęĂ÷úšćēé÷øą÷ąđüúćĔîÖćøìéÿĂïĕöŠÙüøđÖĉîǰ30-35 îćìĊ
ÙĞćëćöÙüøöĊúĆÖþèąéĆÜîĊĚǰ
x ÙøĂïÙúčö×šĂöĎúÿĞćÙĆâìĊęñĎšðśü÷êšĂÜìøćïĒúąðäĉïĆêĉĕéšǰøüöìĆĚÜđîČĚĂĀćìĊęñĎšðśü÷ĂćÝđ×šćĔÝĕéš÷ćÖǰđßŠîǰßČęĂ÷ćǰüĉíĊĔßš÷ćǰüĉíĊÖćøđÖĘï
øĆÖþć÷ć ĂĆîêøć÷ÝćÖ÷ćǰđðŨîêšî
x ÿćöćøëßĊĚĔĀšđĀĘîëċÜ×šĂïÖóøŠĂÜ×ĂÜđĂÖÿćøÖĞćÖĆï÷ćĕéš
x ĕöŠĔßšõćþćìĊęßĊĚîĞćÖćøêĂïǰĀøČĂĔßšÙĞćđéĊ÷üÖĆïìĊęöĊĔîđĂÖÿćøÖĞćÖĆï÷ć
x ÙüøĔßšÙĞćëćöÿĆĚîėǰĒúąĔßšõćþćóĎéìĊęĔßšìĆęüĕð
x ĕöŠÙüøëćöÙĞćëćöðúć÷ðŗéìĊęÙĞćêĂïđðŨîǰ“ĔßŠ/ĕöŠĔßŠ”
x ó÷ć÷ćöĔßšÙĞćëćöðúć÷đðŗéìĊęêšĂÜĀćÙĞćêĂïÝćÖđĂÖÿćøÖĞćÖĆï÷ćǰÙĞćëćöúĆÖþèąîĊĚÝąßŠü÷ĔĀšìøćïüŠćñĎšĂŠćîđ×šćĔÝđîČĚĂĀćĔî
đĂÖÿćøÖĞćÖĆï÷ćĀøČĂëšćĔĀšìĞćêćöìĊęøąïčÝąöĊðŦâĀćĀøČĂĕöŠ
52
x ÙĞćëćöÙüøĔßšÙĞćóĎéìĊęßĆéđÝîǰĒúąöĊÙüøêĂïìĊęëĎÖđóĊ÷ÜÙĞćêĂïđéĊ÷ü
x ÙüøĀúĊÖđúĊę÷ÜÙĞćëćöìĊęëćöÙüćöÙĉéđĀĘîĀøČĂÙüćöøĎšÿċÖ
x úĞćéĆï×ĂÜ×šĂÙĞćëćöĕöŠÙüøđøĊ÷ÜĔîúĆÖþèąìĊęìĞćĔĀšĂćÿćÿöĆÙøÿćöćøëÙćéđéćêĞćĒĀîŠÜ×ĂÜÙĞćêĂïĔîđĂÖÿćøÖĞćÖĆï÷ćǰđßŠîǰ
ÖćøđøĊ÷ÜÙĞćëćöêćöúĞćéĆï×ĂÜđîČĚĂĀćĔîđĂÖÿćøÖĞćÖĆï÷ćÝąìĞćĔĀšĂćÿćÿöĆÙøÿćöćøëÙćéđéćĕéšüŠćÙĞćêĂï×šĂêŠĂĕðÝąđðŨîÿŠüî
êŠĂĕð×ĂÜđĂÖÿćøÖĞćÖĆï÷ćǰđðŨîêšî
x ÙüøđøĉęöëćöÝćÖÙĞćëćöìĊęĕöŠ÷ćÖđÖĉîĕð Ēúąêćöéšü÷ÙĞćëćöìĊęđÖĊę÷üÖĆï×šĂöĎúĀøČĂðøąđéĘîìĊęñĎšðśü÷êšĂÜìøćïǰÖŠĂîĔßš÷ćǰøąĀüŠćÜ
Ĕßš÷ćǰĒúąĀúĆÜĔßš÷ćǰēé÷ĒêŠúąÿŠüîĂćÝÝąöĊöćÖÖüŠćǰ1 ÙĞćëćöǰǰĀúĆÜÝćÖîĆĚîĂćÝÝąêŠĂéšü÷ÙĞćëćöđÖĊę÷üÖĆïðøąđéĘîĂČęîėìĊęÙüø
ìøćï
3. ìéúĂÜđïČĚĂÜêšîÖŠĂîÖćøìéÿĂïÝøĉÜǰ(Pilot Testing)
üĆêëčðøąÿÜÙŤ×ĂÜÖćøìéúĂÜđïČĚĂÜêšîǰÙČĂđóČęĂêøüÝÿĂïÙüćöđĀöćąÿöĒúąúĞćéĆï×ĂÜÙĞćëćöĔîĒïïìéÿĂïǰÖćøìéúĂÜđïČĚĂÜêšîîĊĚ
ÝąßŠü÷ĔĀšÿćöćøëðøĆïðøčÜÙĞćëćöĔîĒïïìéÿĂïǰ
ÖćøìéÿĂïĒïïÿĂïëćöÖŠĂîîĞćĕðĔßšÝøĉÜÙüøéĞćđîĉîÖćøǰéĆÜîĊĚ
x ìéúĂÜĔîÖúčŠöĂćÿćÿöĆÙø 2-6 Ùî àċęÜĂćÝđúČĂÖêćöÙüćöÿąéüÖĕéšǰđßŠîǰÙîĔÖúšêĆüǰĀøČĂđóČęĂî
x éĞćđîĉîÖćøĔîúĆÖþèąìĊęđĀöČĂîÖćøìéÿĂïÝøĉÜǰǰ
x ÿĆÜđÖêĔîðøąđéĘîêŠćÜėǰéĆÜîĊĚ
o ñĎšêĂïđ×šćĔÝÙĞćëćöêøÜÖĆïðøąđéĘîìĊęêšĂÜÖćøìéÿĂïǰ
o ĒêŠúąÙĞćëćööĊÙĞćêĂïĔîđîČĚĂĀćđĂÖÿćøÖĞćÖĆï÷ćǰ
o øą÷ąđüúćĔîÖćøìéÿĂïĕöŠîćîđÖĉîĕðǰ
x ĔîêĂîìšć÷ÙüøëćöĂćÿćÿöĆÙøëċÜ×šĂđÿîĂĒîąđóČęĂÝąßŠü÷ĔĀšÖćøìéÿĂïöĊðøąÿĉìíĉõćóöćÖ×ċĚîǰĕéšĒÖŠ
o ÙüćößĆéđÝî×ĂÜÙĞćĒîąîĞćĔîÖćøìéÿĂïǰǰ
o ÙüćößĆéđÝî×ĂÜ×šĂÙĞćëćöǰ
o ïøø÷ćÖćýĔîĀšĂÜìĊęìĞćÖćøìéÿĂïǰđßŠîǰÙüćöÿąéüÖÿïć÷ǰÙüćöđðŨîÖĆîđĂÜǰđðŨîêšî
4. ÙĆéđúČĂÖĂćÿćÿöĆÙøĀøČĂñĎšëĎÖìéÿĂïǰ
ÙčèúĆÖþèą×ĂÜĂćÿćÿöĆÙø
ĂćÿćÿöĆÙøĀøČĂñĎšëĎÖìéÿĂïĒêŠúąÙîÙüøöĊÙčèÿöïĆêĉǰéĆÜîĊĚ
x ÙüøöĊÙüćöđÿĊę÷ÜĔîúĆÖþèąđéĊ÷üÖúčŠöñĎšðśü÷ìĊęÝąĕéšøĆï÷ćîĆĚîė đßŠîǰñĎšÿĎÜĂć÷čǰđðŨîêšî
x ĕöŠĕéšđðŨîïčÙúćÖøìĊęöĊÙüćöđÖĊę÷ü×šĂÜÖĆï÷ćîĆĚîėǰēé÷êøÜǰđßŠîǰĒóì÷Ťǰó÷ćïćúǰĀøČĂǰđõÿĆßÖø
x ĂćÿćÿöĆ ÙøĕöŠ ÝĞ ć đðŨ îêš ĂÜđðŨ î ÖúčŠ ö ñĎš ðśü ÷ǰĒêŠ Ĕ îÖøèĊ ìĊęđ ðŨ î ÷ćìĊę öĊ ÖćøĔßš Ĕ îÖúčŠ ö đÞóćąǰĂćÝóĉ Ý ćøèćĔßš Ö účŠ ö ñĎš ðś ü÷đðŨ î
ĂćÿćÿöĆÙø
x ĕöŠĕéšĔßšđĂÖÿćøÖĞćÖĆï÷ćĔîÖćøìĞćÜćîǰĀøČĂßĊüĉêðøąÝĞćüĆî
x ÖćøìéÿĂïĔî÷ćìĊę öĊ Ö ćøĔßšĔ îÙîìĆę ü ĕðǰđßŠ î ǰ÷ćĒÖš ĕ ×š ǰ ÷ćĒÖš Ē óš ǰ ĂćÿćÿöĆ Ù øÙüøđðŨ î ñĎš ìĊę ĕ öŠ ĕ éš öĊ Ö ćøĔßš ÷ ćđðŨ î ðÖêĉ Ĕ î
ßĊüĉêðøąÝĞćüĆî ĒúąÙüøÙĆéđúČĂÖĂćÿćÿöĆÙøìĊęöĊøąéĆïÖćøýċÖþćóČĚîåćîǰđßŠîǰøąéĆïÖćøýċÖþćõćÙïĆÜÙĆïǰđîČęĂÜÝćÖëšćÖúčŠö
ÖćøýċÖþćîšĂ÷ÿćöćøëĔßšđĂÖÿćøÖĞćÖĆï÷ćĕéšĂ÷ŠćÜđĀöćąÿöǰÖćøĔßšđĂÖÿćøÖĞćÖĆï÷ćĔîðøąßćßîìĆęüĕðÖĘĕöŠîŠćÝąđÖĉéðŦâĀć
x ĕöŠđÙ÷ëĎÖìéÿĂïðøąÿĉìíĉõćóÖćøĔĀš×šĂöĎú×ĂÜđĂÖÿćøÖĞćÖĆï÷ćÞïĆïîĆĚîöćÖŠĂî
x ÙüøĀúĊÖ đúĊę ÷ÜÖćøÙĆé đúČ ĂÖĂćÿćÿöĆ ÙøêćöÙüćöÿąéüÖǰđßŠ îǰđóČęĂ îøŠ ü öÜćîǰĒêŠĂ ćÝĔßšđ ðŨ îĂćÿćÿöĆ ÙøĔîÖćøìéÿĂï
ĒïïìéÿĂïÖŠĂîÖćøìéÿĂïÝøĉÜ
53
ÝĞćîüîĂćÿćÿöĆÙø
x ÝĞćîüîĂćÿćÿöĆÙøĔîĒêŠúąøĂï×ĂÜÖćøìéÿĂïǰÙüøĔßšÝĞćîüîǰ10-11 Ùî
5. ×ĆĚîêĂîÖćøìéÿĂïđĂÖÿćøÖĞćÖĆï÷ć
x ìéÿĂïÖĆïĂćÿćÿöĆÙøìĊúąÙîĒ÷ÖÝćÖÖĆîǰđóČęĂúéĂĉìíĉóúÝćÖÖúčŠö
x đøĉęöÝćÖĔĀšĂćÿćÿöĆÙøĂŠćîđĂÖÿćøÖĞćÖĆï÷ćǰĀøČĂÿĞćøüÝđĂÖÿćøÖĞćÖĆï÷ć
x ĔîĒêŠúą×ĆĚîêĂî×ĂÜÖćøìéÿĂïǰîĂÖÝćÖÙĞćêĂïìĊęĂćÿćÿöĆÙøêĂïǰñĎšìéÿĂïêšĂÜÿĆÜđÖêĒúąïĆîìċÖÿĉęÜìĊęĂćÿćÿöĆÙøóĎéĀøČĂ
ìĞćǰđîČęĂÜÝćÖüĆêëčðøąÿÜÙŤ×ĂÜÖćøìéÿĂï×šĂöĎúđĀúŠćîĊĚÝąßŠü÷ĔĀšđĀĘî×šĂïÖóøŠĂÜ×ĂÜđĂÖÿćøÖĞćÖĆï÷ćĒúąßŠü÷ĔĀšÿćöćøë
ðøĆïðøčÜĔĀšđĀöćąÿöêŠĂĕðǰēé÷ÿĉęÜìĊęêšĂÜïĆîìċÖĀøČĂÿĆÜđÖêøąĀüŠćÜÖćøìéÿĂïǰĕéšĒÖŠ
o óùêĉÖøøöøąĀüŠćÜÖćøìéÿĂï
o üĉíĊÖćøĂŠćîđĂÖÿćøÖĞćÖĆï÷ćǰđßŠîǰÖćøìĆĚÜĀöéǰĀøČĂĂŠćî×šćöėǰđðŨîêšîǰ
o ÙĞćêĂïìĊęĂćÿćÿöĆÙøêĂïēé÷ĔßšÙĞćóĎé×ĂÜĂćÿćÿöĆÙøǰ
o üĉíĊÖćøêĂï×ĂÜĂćÿćÿöĆÙø
o üĉíĊÖćøĀćêĞćĒĀîŠÜ×ĂÜÙĞćêĂï
o ÙüćöÙĉéđĀĘî×ĂÜĂćÿćÿöĆÙø
x îĞćÙĞćêĂïĒúąïĆîìċÖìĊęĕéš×ĂÜĒêŠúą×šĂÙĞćëćööćĔĀšÙąĒîîđðŨîǰ2 ÿŠüîǰĕéšĒÖŠ
o ïĂÖêĞćĒĀîŠÜìĊęĂ÷ĎŠ×ĂÜÙĞćêĂïïîđĂÖÿćøÖĞćÖĆï÷ćëĎÖêšĂÜ Ēúą
o êĂïÙĞćëćöēé÷Ĕßš×šĂöĎúìĊęóïĔîđĂÖÿćøÖĞćÖĆï÷ćéšü÷õćþć×ĂÜêîđĂÜĂ÷ŠćÜëĎÖêšĂÜ
x øüïøüö×šĂöĎúđßĉÜÙčèõćóĒúąÙüćöÙĉéđĀĘîêŠćÜėìĊęïĆîìċÖĕüšǰđóČęĂüĉđÙøćąĀŤĀć×šĂïÖóøŠĂÜìĊęêšĂÜĒÖšĕ×
6. đĂÖÿćøÖĞćÖĆï÷ćìĊęñŠćîđÖèæŤÖćøìéÿĂïǰĂćÿćÿöĆÙøÝąêšĂÜÿćöćøë
x ïĂÖêĞćĒĀîŠÜìĊęĂ÷ĎŠ×ĂÜÙĞćêĂïïîđĂÖÿćøÖĞćÖĆï÷ćĕéšëĎÖêšĂÜ ĕöŠîšĂ÷ÖüŠćøšĂ÷úąǰ90 ÝćÖñĎšëĎÖìéÿĂïìĆĚÜĀöéǰĒúą
x êĂïÙĞćëćöēé÷Ĕßš×šĂöĎúìĊęóïĔîđĂÖÿćøÖĞćÖĆï÷ćéšü÷õćþć×ĂÜêîđĂÜĂ÷ŠćÜëĎÖêšĂÜǰĕöŠîšĂ÷ÖüŠćøšĂ÷úąǰ90 ÝćÖñĎšìĊęÿćöćøëĀć
ÙĞćêĂïĔîđĂÖÿćøÖĞćÖĆï÷ćóï
x đÖèæŤîĊĚĔßšóĉÝćøèćÿĞćĀøĆïĒêŠúą×šĂÙĞćëćöĒúąõćóøüö
7. ĔîÖøèĊìĊęñúÖćøìéÿĂïĕöŠñŠćîđÖèæŤÙąĒîîìĊęÖĞćĀîéǰĔĀšîĞć×šĂïÖóøŠĂÜìĊęóïĔîÖćøìéÿĂïÙøĆĚÜĒøÖöćéĞćđîĉîðøĆïðøčÜĒÖšĕ×
đĂÖÿćøÖĞćÖĆï÷ć
8. ìĞćÖćøìéÿĂïàĚĞćǰ(Repeat test) ēé÷ĔßšđĂÖÿćøÖĞćÖĆï÷ćìĊęĒÖšĕ×Ēúšüǰêćö×ĆĚîêĂîĔî×šĂǰ5 ĔîÖúčŠöñĎšìéÿĂïìĊęÙĆéđúČĂÖĔĀöŠĂĊÖ 10-
11 Ùîǰ
9. îĞćñúÖćøìéÿĂïöćĔĀšÙąĒîîĒúąüĉđÙøćąĀŤǰëšćĕöŠñŠćîĔĀšðøĆïĒÖšđĂÖÿćøÖĞćÖĆï÷ćǰĒúąìéÿĂïàĚĞćêćö×ĆĚîêĂîĔî×šĂ 5 ÝîÖüŠćÝą
ñŠćîđÖèæŤêćöìĊęÖĞćĀîéĕüšĔî×šĂ 6
10. đöČęĂñúÖćøìéÿĂïñŠćîđÖèæŤĒúšüǰĔĀšìĞćÖćøìéÿĂïÙøĆĚÜÿčéìšć÷ǰ(Final test) ĔîÖúčŠöĂćÿćÿöĆÙøĂĊÖǰ10-11 ÙîǰđóČęĂĔĀšđÖĉéÙüćö
öĆęîĔÝĔîñúÖćøìéÿĂïĔîÝĞćîüîĂćÿćÿöĆÙøìĊęđóĉęö×ċĚîǰǰ
11. îĞć×šĂöĎúÝćÖǰrepeat test (øĂïÿčéìšć÷) ĒúąǰFinal test öćøüöÖĆîǰÝąĕéš×šĂöĎúÝćÖÖćøêĂïĒïïÿĂïëćöÝćÖñĎšìéÿĂïǰ20-22
Ùî ēé÷ñúÖćøìéÿĂï 2 øĂïÿčéìšć÷êšĂÜĕéšÙąĒîîøüöÖĆîĕöŠîšĂ÷ÖüŠćøšĂ÷úąǰ80 éĆÜîĊĚ
x ïĂÖêĞćĒĀîŠÜìĊęĂ÷ĎŠ×ĂÜÙĞćêĂïïîđĂÖÿćøÖĞćÖĆï÷ćĕéšëĎÖêšĂÜ ĕöŠîšĂ÷ÖüŠćøšĂ÷úąǰ80 ÝćÖñĎšëĎÖìéÿĂïìĆĚÜĀöéǰĒúą
x êĂïÙĞćëćöēé÷Ĕßš×šĂöĎúìĊęóïĔîđĂÖÿćøÖĞćÖĆï÷ćéšü÷õćþć×ĂÜêîđĂÜĂ÷ŠćÜëĎÖêšĂÜǰĕöŠîšĂ÷ÖüŠćøšĂ÷úąǰ80 ÝćÖñĎšìĊęÿćöćøëĀć
ÙĞćêĂïĔîđĂÖÿćøÖĞćÖĆï÷ćóï
x đÖèæŤîĊĚĔßšóĉÝćøèćÿĞćĀøĆïĒêŠúą×šĂÙĞćëćöĒúąõćóøüö
54
Āöć÷đĀêč:
ÝĞćîüîĂćÿćÿöĆÙøìĊęĔßšĒîąîĞćĔĀšĔßšǰ11 ÙîǰêćöđÖèæŤñŠćî×ĂÜÖćøìéÿĂï
x êšĂÜĀćÙĞćêĂïóïĕöŠîšĂ÷ÖüŠćøšĂ÷úą 90 ×ĂÜĂćÿćÿöĆÙøĀøČĂñĎšëĎÖìéÿĂï
= 0.90*11 = 9.9 ÙîĀøČĂĕöŠîšĂ÷ÖüŠćǰ10 Ùî
x êĂïÙĞćëćöëĎÖêšĂÜĕöŠîšĂ÷ÖüŠćøšĂ÷úąǰ90 ×ĂÜñĎšĀćÙĞćêĂïóïǰ
= 0.9*0.9*11 = 8.91 ÙîĀøČĂĕöŠîšĂ÷ÖüŠćǰ9 Ùî
ëšćÝĞćîüîĂćÿćÿöĆÙøìĊęĔßšǰ10 ÙîǰêćöđÖèæŤñŠćî×ĂÜÖćøìéÿĂï
x êšĂÜĀćÙĞćêĂïóïĕöŠîšĂ÷ÖüŠćøšĂ÷úą 90 ×ĂÜĂćÿćÿöĆÙøĀøČĂñĎšëĎÖìéÿĂï
= 0.90*10 = 9.0 ÙîĀøČĂĕöŠîšĂ÷ÖüŠćǰ9 Ùî
x êĂïÙĞćëćöëĎÖêšĂÜĕöŠîšĂ÷ÖüŠćøšĂ÷úąǰ90 ×ĂÜñĎšĀćÙĞćêĂïóïǰ
= 0.9*0.9*10 = 8.1 Ùî ĀøČĂĕöŠîšĂ÷ÖüŠćǰ8 Ùî
55
êĆüĂ÷ŠćÜÙĞćëćöĔîĒïïìéÿĂïÙüćöđ×šćĔÝ×šĂöĎúĔîđĂÖÿćøÖĞćÖĆï÷ćĂąöĂÖàĉàĉúúĉî
ĀúĆÜÝćÖìĊęìŠćîĂŠćîđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆï÷ćĂąöĂÖàĉàĉúúĉîĒúšüǰÖøčèćêĂïÙĞćëćöđÖĊę÷üÖĆïđĂÖÿćøÖĞćÖĆï÷ćǰēé÷ßĊĚĔĀšđĀĘîüŠć
ÙĞćêĂï×ĂÜìŠćîîĆĚîĂ÷ĎŠìĊęĔéĔîđĂÖÿćøÖĞćÖĆï÷ćǰĒúąĂíĉïć÷ÙĞćêĂïêćöÙüćöđ×šćĔÝ
1. ÷ćîĊĚöĊßČęĂÿćöĆâìćÜ÷ćüŠćĂąĕø
2. ÷ćîĊĚĂ÷ĎŠĔîÖúčŠöĔé
3. ĀšćöĔßš÷ćîĊĚđöČęĂĒóš÷ćĔîÖúčŠöĔé
4. ÷ćîĊĚĔßšđóČęĂĂąĕø
5. ÷ćîĊĚêšĂÜÖĉîĂ÷ŠćÜĕø
6. ëšćöĊĂćÖćøïüöìĊęĔïĀîšćǰđðúČĂÖêćǰǰĒÿéÜëċÜĂćÖćøĂąĕøǰĒúąÙüøìĞćĂ÷ŠćÜĕø
7. ëšćöĊĂćÖćøìšĂÜøŠüÜëŠć÷đðŨîîĚĞćĒÿéÜëċÜĂćÖćøĂąĕøǰĒúąǰÙüøìĞćĂ÷ŠćÜĕø
8. ëšćöĊĂćÖćøÙúČęîĕÿšǰĂćđÝĊ÷îǰðüéìšĂÜǰðüéĀĆüǰĒÿéÜëċÜĂćÖćøĂąĕøǰĒúąÙüøìĞćĂ÷ŠćÜĕø
9. ìŠćîÙüøđÖĘïøĆÖþć÷ćîĊĚĂ÷ŠćÜĕø
10. ĀćÖìŠćîúČöÖĉî÷ćǰÙüøìĞćĂ÷ŠćÜĕø
11. ìĞćĕöĀšćöĔßš÷ćîĊĚĔîēøÙĀüĆéǰĕ×šĀüĆéĔĀâŠǰĀúĂéúöĂĆÖđÿïđÞĊ÷ïóúĆîǰǰĂĊÿčÖĂĊĔÿǰĕ×šđúČĂéĂĂÖǰĒúąêćĒéÜÝćÖđßČĚĂĕüøĆÿ
12. ìĞćĕö÷ćîĊĚĕöŠÙüøÖĉîÖĆï÷ćÙčöÖĞćđîĉé
13. ìĞćĕöêšĂÜøąüĆÜÖćøĔßš÷ćîĊĚÖĆïñĎšìĊęđðŨîēøÙõĎöĉĒóšĀøČĂēøÙĀČé
14. ìĞćĕöêšĂÜÖĉî÷ćĔĀšÙøïêćöÙĞćĒîąîĞć×ĂÜĒóì÷Ť
56

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ĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ć

(Guideline for Leaflet Development)

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ïììĊę 3 ĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćÿĞćĀøĆïðøąßćßî 31-45

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

2. ĀúĆÖÖãĀöć÷ (Legal basis)

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ĀĆü×šĂìĊęǰ2 ÿŠüîðøąÖĂïĒúąðøĉöćèêĆü÷ćÿĞćÙĆâ (Qualitative and quantitative composition)

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ĀĆü×šĂìĊę 3 úĆÖþèąĒúąøĎðĒïï÷ćìćÜđõÿĆßÖøøö (Pharmaceutical Form)

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

4.1 ×šĂïŠÜĔßš (Therapeutic Indication)

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

4.2 ×îćé÷ćĒúąüĉíĊÖćøïøĉĀćø÷ć (Posology and method of administration)

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

4.4 ÙĞćđêČĂîóĉđýþĒúą×šĂÙüøøąüĆÜĔîÖćøĔßš÷ć (Special warning and precautions for use)

4.5 ĂĆîêøÖĉøĉ÷ćÖĆï÷ćĂČęîėĀøČĂĂĆîêøÖĉøĉ÷ćĂČęîė (Interactions with other medicinal products and

4.6 ÖćøĔßšĔîÿêøĊöĊÙøøõŤĒúąÿêøĊøąĀüŠćÜĔĀšîöïčêø (Pregnancy and lactation)

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

4.8 ĂćÖćøĕöŠóċÜðøąÿÜÙŤ (Undesirable effects)

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ĀĆü×šĂìĊęǰ5 ÙčèÿöïĆêĉìćÜđõÿĆßüĉì÷ć (Pharmacological Properties)

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ĀĆü×šĂìĊęǰ6 øć÷úąđĂĊ÷éìćÜđõÿĆßÖøøö (Pharmaceutical Particulars)

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

ìšć÷ðøąÖćýÿĞćîĆÖÜćîÙèąÖøøöÖćøĂćĀćøĒúą÷ćǰđøČęĂÜǰĒîüìćÜÖćøÝĆéìĞćđĂÖÿćøÖĞćÖĆï÷ćǰúÜüĆîìĊǰę 3 ÖøÖãćÙö 2556

×šĂÖĞćĀîé×šćÜêšîĂćÝðøĆïðøčÜĕéšêćöÙüćöđĀöćąÿöǰĒúąÙüøîĞćĕðìéÿĂïǰUser testing đóČęĂĔĀšĒîŠĔÝ

4. ×šĂÙüøðãĉïĆêĉøąĀüŠćÜÖćøĔßš÷ć 15. Care that should be taken when taking this

5.2 ĂćÖćøìĊęĕöŠÝĞćđðŨîêšĂÜĀ÷čé÷ć ĒêŠëšćöĊĂćÖćøøčîĒøÜĔĀšĕðóïĒóì÷ŤìĆîìĊ

1.ѕѥьѨѸзѪѠѕѥѠѣѳі 3. њѧыѨѲнҖѕѥ 5. ѠѤьшіѥѕъѨѷѠѥлѯдѧчлѥдѕѥ

1. ѕѥьѨѸзѪѠѕѥѠѣѳі 3. њѧыѨѲнҖѕѥ 5. ѠѤьшіѥѕъѨѷѠѥлѯдѧчлѥдѕѥ

2. еҖѠзњііѬҖдҕѠьѲнҖѕѥ 4. еҖѠзњіютѧэѤшѧіѣўњҕѥкѲнҖѕѥ 6. зњіѯдѶэѕѥьѨѸѠѕҕѥкѳі

2.1 ўҖѥєѲнҖѕѥьѨѸѯєѪѷѠѳі x іѥѕјѣѯѠѨѕч x іѥѕјѣѯѠѨѕч

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