SUMMARY OF PRODUCT potential should be carried out during the first (about 10) days
following the onset of menses.
CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
PoltechDTPA 13.25 mg
Kit for radiopharmaceutical preparation
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial contains:
sodium diethylenetriaminepentaacetate monohydrate (DTPA) 13.25 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
Lyophilisate for solution for injection.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
The kit for the preparation 99mTc-DTPA is intended for renal scinti-
graphic imaging (dynamic renal scintigraphy for GFR measurement
of each kidney and evaluation of urinary flow disorders) and for the
cerebral angiography and brain scanning.
4.2 Posology and method of administration
The radiopharmaceutical 99mTc-DTPA is administered intravenously
after labelling with sterile, oxidant-free eluate from a radionuclide
generator 99Mo/99mTc, in accordance with the labelling instructions.
The activity recommended for examination of a single adult
patient ranges from 74 to 370 MBq for kidneys examination and
370-555 MBq for brain examination. Technetium-99m in 5 ml of
eluate of sodium pertechnetate-99mTc (eluate from a radionuclide
generator 99Mo/99mTc) with activity of 740-1500 MBq may be used
for labelling of one kit vial. This amount is sufficient to perform the
examination in several adult patients.
4.3 Contraindications
The preparation should not be administered to pregnant or
breastfeeding women. This medicinal product may be administered
to women of childbearing potential during the first 10 days of the
menstrual cycle. Breast-feeding should be interrupted for 3 days
after examination.
4.4 Special warnings and precautions for use
The radiopharmaceuticals may be used only by authorized persons.
Safety precautions for careful handling this radiopharmaceutical
should be observed. Ensure protection of the staff and patients
against unnecessary exposure to ionising radiation. Permit to store
and administer radiopharmaceuticals depends on specified local
standards and regulations for radioactive materials.
The content of the kit vial is intended for preparation of
radiopharmaceutical 99mTc-DTPA and may be administered to a
patient only after completion of labelling procedure.
There are no data on safety and efficacy of the radiopharmaceutical
in children under 18 years of age.
An adequate hydration of a patient and frequent voiding are
necessary to minimize radiation dose to the bladder.
The exposure to radiation can be increased in patients with renal
insufficiency. This should be considered in the calculation of the
dose to be administered.
4.5 Interactions with other medicinal products and other
forms of interactions
No data.
4.6 Fertility, pregnancy and lactation
When it is necessary to administer radiopharmaceuticals to women
of childbearing potential, information should always be sought about
pregnancy. Pregnancy should be excluded in any women who has
had menstrual cycle disturbances. Any woman who has missed a
period should be assumed to be pregnant until proven otherwise.
Examinations using radiopharmaceuticals in women of childbearing
Breastfeeding should be interrupted following administration of
the first dose of radiopharmaceutical product due to potential risk
for the child. It can be restarted when radiation dose potentially
administered to the child during breastfeeding and contact with
mother is within the range of approved standards. Where uncertainty
exists it is important to minimize the radiation exposure during
examinations. Alternative techniques which do not involve ionising
radiation should be considered.
4.7 Effects on ability to drive and use machines
The radiopharmaceutical has no influence on ability to drive and
use machines.
4.8 Undesirable effects
The exposure to radiation should be substantiated by benefits
resulting from the performed test. The administered radioactivity
should be adjusted in order to achieve the desired diagnostic
effect and possibly lower the radiation dose to the patient. The
exposure to ionising radiation is linked with the risk of cancer
induction and potential for hereditary defects. For diagnostic
nuclear medicine investigations the current statistical evidence
suggests that the radiation doses related to the examinations
are very low and therefore the frequency of these adverse
effects is low.
According to the literature data (J.Nucl.Med., 1996, 37, 185-192,
1064-1067), after the intravenous administration of the radiophar-
maceutical 99mTc-DTPA the following adverse reactions have been
reported sporadically: fever, nausea, vomiting, flushing, erythema,
pruritus, urticaria, headache, hypertension, aseptic meningitis.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued monitoring
of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions
via Pharmacovigilance Department of the Office for Registration of
Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw, Poland
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: adr@urpl.gov.pl
4.9 Overdose
The risk of overdose in case of diagnostic doses can be neglected.
However, in the event of overdose, the dose absorbed to the patient
should be reduced where possible by increasing the elimination of
the radionuclide from the body by forced diuresis and administration
of liquids.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: diagnostic radiopharmaceutical
ATC code: V09CA01
5.2 Pharmacokinetic properties
PoltechDTPA is intended for technetium-99mTc labelling. Approxi-
mately 90% of the injected dose is eliminated to the urine within
the first 24 hours mainly by glomerular filtration. The prepara-
tion is not taken up by other organs. Following intravenous ad-
ministration, the preparation diffuses towards the extravascular
space. It does not cross the normal blood-brain barrier.
No resorption of the compound has been demonstrated.
5.3 Preclinical safety data
Very low toxicity of the complex (LD50 = 235 mg/kg b.w.) allows safe
administration of diagnostic doses. No immunization effects were
observed in patients.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Stannous chloride dihydrate
Sodium chloride
Nitrogen
6.2 Incompatibilities
No data. Absorbed dose per unit of administered activity
6.3 Shelf life [mGy/MBq]
Shelf life of the kit is 1 year.
Organ Adults 15 years 10 years 5 years 1 year
The radiolabelled product should be administered within 6 hours of
preparation. Radiochemical purity and stability data of preparation Adrenals 1.3E-03 1.7E-03 2.6E-03 3.8E-03 7.0E-03
refer to this time at a temperature below 25°C. Bladder 6.2E-02 7.8E-02 9.7E-02 9.5E-02 1.7E-01
6.4 Special precautions for storage Bone surfaces 2.3E-03 2.8E-03 4.0E-03 5.5E-03 9.9E-03
Store in a refrigerator (2°C- 8°C). Brain 8.4E-04 1.0E-03 1.7E-03 2.7E-03 4.8E-03
During transportation (not longer than 7 days) up to 35°C. Breast 7.1E-04 9.0E-04 1.3E-03 2.1E-03 4.0E-03
Expiry date is given on the label. Gall bladder 1.5E-03 2.0E-03 3.6E-03 4.6E-03 6.0E-03
Shelf life after reconstitution and labelling with sodium pertechnetate Gastrointestinal tract
(99mTc) solution: up to 6 hours at a temperature below 25°C in a
Stomach 1.3E-03 1.6E-03 2.7E-03 3.7E-03 6.7E-03
suitable radiation lead shield.
Small intestine 2.5E-03 3.1E-03 4.5E-03 5.7E-03 9.8E-03
Storage should be in accordance with national regulations for
radioactive materials. Colon 3.0E-03 3.8E-03 5.4E-03 6.4E-03 1.1E-02
(ULI 2.1E-03 2.7E-03 4.0E-03 5.4E-03 9.0E-03)
6.5 Nature and contents of container
(LLI 4.3E-03 5.3E-03 7.3E-03 7.7E-03 1.3E-02)
10 ml multi-dose glass vials sealed with a rubber stopper and
aluminium cap in cardboard box. Heart 1.1E-03 1.4E-03 2.1E-03 3.2E-03 5.8E-03
3 vials Kidneys 3.9E-03 4.7E-03 6.7E-03 9.6E-03 1.7E-02
6 vials Liver 1.2E-03 1.5E-03 2.4E-03 3.5E-03 6.3E-03
6.6 Special precautions for disposal and other handling Lungs 9.9E-04 1.3E-03 1.9E-03 2.9E-03 5.3E-03
This radiopharmaceutical may be received, used and administered Muscles 1.6E-03 2.0E-03 2.8E-03 3.7E-03 6.7E-03
only by authorized persons in designated clinical settings. Its Oesophagus 1.0E-03 1.3E-03 1.9E-03 2.9E-03 5.3E-03
receipt, storage, use, transfer and disposal are subject to the Ovaries 4.2E-03 5.3E-03 6.9E-03 7.8E-03 1.3E-02
regulations and/or appropriate licenses of the local competent
Pancreas 1.4E-03 1.8E-03 2.7E-03 4.0E-03 7.2E-03
official organizations. Radiopharmaceuticals should be prepared
by the user in a manner which satisfies both radiation safety Red marrow 1.4E-03 1.8E-03 2.6E-03 3.3E-03 5.6E-03
and pharmaceutical quality requirements. Appropriate aseptic Skin 8.5E-04 1.0E-03 1.6E-03 2.3E-03 4.3E-03
precautions should be taken, complying with the requirements for Spleen 1.2E-03 1.6E-03 2.4E-03 3.6E-03 6.6E-03
pharmaceuticals. Testes 2.9E-03 4.0E-03 6.0E-03 6.9E-03 1.3E-02
Thymus 1.0E-03 1.3E-03 1.9E-03 2.9E-03 5.3E-03
7. MARKETING AUTHORISATION HOLDER
Thyroid 1.0E-03 1.3E-03 2.0E-03 3.2E-03 5.8E-03
National Centre for Nuclear Research
Uterus 7.9E-03 9.5E-03 1.3E-02 1.3E-02 2.2E-02
Andrzej Sołtan 7, 05-400 Otwock, Poland
Phone: +48 22 7180700 Remaining organs 1.7E-03 2.0E-03 2.8E-03 3.7E-03 6.4E-03
Fax: +48 22 7180350 Effective dose
e-mail: polatom@polatom.pl [mSv/MBq] 4.9E-03 6.2E-03 8.2E-03 9.0E-03 1.6E-02
Bladder wall contributes up to 57% of the effective dose.
8. MARKETING AUTHORISATION NUMBER
R/3453 The effective dose if bladder is emptied 0.5 or 1 hour after administration.
1 hour 3.8E-03 4.8E-03 6.5E-03 7.7E-03 1.4E-02
9. DATE OF FIRST AUTHORISATION/
30 minutes 4.1E-03 5.3E-03 7.0E-03 7.9E-03 1.4E-02
RENEWAL OF THE AUTHORISATION
Date of first authorization: 16.05.1989
Date of latest renewal: 27.08.2013 - Shake the contents of the vial until complete dissolution of the
powder (about 2 min.). Keep the vial in the shield all the time.
10. DATE OF APPROVAL/REVISION OF THE TEXT - The received solution is a ready-to-use solution for injection.
27.08.2013 The 99mTc-DTPA preparation should be used within 6 hours after
completion of labelling procedure.
11. DOSIMETRY Regulations for safety of work at exposure to ionising radiation
The projected radiation doses to organs and tissues of a patient should be strictly observed during preparation and administration
after intravenous injection of 99mTc-DTPA are given in the table. of radiopharmaceutical.
These data are adopted from ICRP 80: Annals of the ICRP,
Radiation dose to Patients from Radiopharmaceuticals. Addendum Instruction for quality control of radiopharmaceutical 99mTc-DTPA
2 to ICRP 53. 1998 p. 59. Radiochemical purity measurement: by Thin Layer Chromatography
– two chromatographic systems according to Ph.Eur. Monograph
12. INSTRUCTIONS FOR PREPARATION 0642
OF RADIOPHARMACEUTICALS 1. ITLC-SG plates, developing solution: 0.9% sodium chloride
PoltechDTPA is designed for labelling with 99m-technetium as Under these conditions:
eluate of sodium pertechnetate-99mTc obtained from the 99Mo/99mTc - 99mTc colloidal forms remain at the origin.
generator. The labelling procedure should be performed in the - 99mTc-DTPA complex and free, unbound pertechnetate 99mTcO4-
work station protected against ionising radiation and using method migrate with solvent front.
ensuring sterility of the preparation. 2. ITLC-SG plates, developing solution: methylethyl ketone (MEK).
Under these conditions:
Labelling procedure: - free, unbound pertechnetate 99mTcO4- migrates with the solvent
- Place the kit vial containing the lyophilisate in an appropriate front;
radioprotective shield. - 99mTc-DTPA complex and 99mTc colloidal forms remain at the origin.
- Using a syringe inject (by piercing the rubber stopper) about 5 ml of
eluate of sodium pertechnetate 99mTc (or eluate with desired activity
pre-diluted with sterile saline) into the vial containing lyophilized
DTPA.
- Using the same syringe relieve the excess of pressure in the vial
by withdrawing the equivalent volume of gas.