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Influenza A (H1N1) 2009 Monovalent Vaccine - Package Insert

Influenza A (H1N1) 2009 Monovalent Vaccine - Package Insert

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Published by: Jonathan Robert Kraus (OutofMudProductions) on Aug 19, 2011
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05/25/2012

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Package insertInfluenza A (H1N1) 2009 MonovalentVaccine
 
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use InfluenzaA (H1N1) 2009 Monovalent Vaccine safely and effectively. See fullprescribing information for Influenza A (H1N1) 2009 Monovalent Vaccine.Influenza A (H1N1) 2009 Monovalent VaccineManufactured by CSL LimitedSuspension for Intramuscular InjectionInitial U.S. Approval: 2007----------------------------RECENT MAJOR CHANGES----------------------------
Indications and Usage (1) 11/2009Dosage and Administration (2.2) 11/2009
----------------------------INDICATIONS AND USAGE-----------------------------
Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenzavirus vaccine indicated for active immunization of persons ages 6 monthsand older against influenza disease caused by pandemic (H1N1) 2009virus. (1)
This indication is based on the immune response elicited by the seasonaltrivalent Influenza Virus Vaccine manufactured by CSL (AFLURIA).CSL’s Influenza A (H1N1) 2009 Monovalent Vaccine and AFLURIA aremanufactured by the same process. There have been no controlled clinicalstudies demonstrating a decrease in influenza disease after vaccinationwith AFLURIA. (14)
-------------------------DOSAGE AND ADMINISTRATION----------------------Based on currently available information, the vaccination regimen is asfollows:Children
6 months through 35 months of age
(0.25 mL dose, intramuscular injection):Two 0.25 mL doses approximately 4 weeks apart. (2.2)
 
36 months through 9 years of age
(0.5 mL dose, intramuscular injection):Two 0.5 mL doses approximately 4 weeks apart. (2.2)
 
10 years of age and older
 A single 0.5 mL dose for intramuscular injection. (2.2)
Adults
 
18 years of age and older:
A single 0.5 mL dose for intramuscular injection. (2.2)
 ------------------------DOSAGE FORMS AND STRENGTHS---------------------
Influenza A (H1N1) 2009 Monovalent Vaccine, a sterile suspension for intramuscular injection, is supplied in three presentations:
 
0.25 mL single-dose, pre-filled syringe, no preservative. (3)
 
0.5 mL single-dose, pre-filled syringe, no preservative. (3)
5 mL multi-dose vial containing ten doses. Thimerosal, a mercuryderivative, is added as a preservative; each 0.5 mL dose contains24.5 micrograms (mcg) of mercury. (3,11) --
-----------------------------CONTRAINDICATIONS-------------------------------
Hypersensitivity to eggs, neomycin, or polymyxin, or life-threateningreaction to previous influenza vaccination. (4,11)
------------------------WARNINGS AND PRECAUTIONS-------------------------
If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of  previous influenza vaccination, the decision to give Influenza A (H1N1)2009 Monovalent Vaccine should be based on careful consideration of the potential benefits and risks. (5.1)
Immunocompromised persons may have a diminished immune responseto Influenza A (H1N1) 2009 Monovalent Vaccine. (5.2)
------------------------------ADVERSE REACTIONS----------------------------
Adverse reactions information is based on studies conducted with seasonaltrivalent Influenza Virus Vaccine manufactured by CSL (AFLURIA).
 
In adults, the most common (
10%) local (injection-site) adversereactions were tenderness, pain, redness, and swelling. The mostcommon (
10%) systemic adverse reactions were headache, malaise, andmuscle aches. (6)
 
In children, the most common (
10%) local (injection-site) adversereactions were pain, redness, and swelling. The most common (
10%)systemic adverse reactions were irritability, rhinitis, fever, cough, loss of appetite, vomiting/diarrhea, headache, muscle aches and sore throat. (6)
To report SUSPECTED ADVERSE REACTIONS, contact CSLBiotherapies at 1-888-435-8633 or VAERS at 1-800-822-7967 orwww.vaers.hhs.gov.------------------------------DRUG INTERACTIONS----------------------------
Do not mix with any other vaccine in the same syringe or vial. (7.1)
 
Immunosuppressive therapies may diminish the immune response toInfluenza A (H1N1) 2009 Monovalent Vaccine. (7.2)
-
----------------------USE IN SPECIFIC POPULATIONS---------------------
Information is based on studies conducted with seasonal trivalent InfluenzaVirus Vaccine manufactured by CSL (AFLURIA).
 
 
Safety and effectiveness of Influenza A (H1N1) 2009 MonovalentVaccine have not been established in pregnant women or nursing mothersand in the pediatric population below 6 months of age. (8.1,8.3,8.4)
 
Antibody responses were lower in geriatric subjects than in younger subjects. (8.5)
See 17 for PATIENT COUNSELING INFORMATION.Revised: 11/2009 ____________________________________________________________________________________________________________________________________ 
 
 
Package insertInfluenza A (H1N1) 2009 MonovalentVaccine
 
FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION
2.1 Prior to Administration2.2 Administration
 3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS
5.1 Guillain-Barré Syndrome (GBS)5.2 Altered Immunocompetence5.3
 
Preventing and Managing Allergic Reactions5.4
 
Limitations of Vaccine Effectiveness
6 ADVERSE REACTIONS
 6.1 Overall Adverse Reactions6.2 Safety Experience from Clinical Studies6.3 Postmarketing Experience6.4 Other Adverse Reactions Associated With InfluenzaVaccination
7 DRUG INTERACTIONS
7.1 Concurrent Use With Other Vaccines7.2 Concurrent Use With Immunosuppressive Therapies
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy8.3 Nursing Mothers8.4 Pediatric Use8.5 Geriatric Use
11 DESCRIPTION12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Immunogenicity in the Adult and Geriatric Populations14.2 Immunogenicity in a Pediatric Population
15 REFERENCES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribinginformation are not listed.
 
 
Influenza A (H1N1) 2009Monovalent Vaccine
 
Package insertFULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccineindicated for active immunization of persons ages 6 months and older against influenzadisease caused by pandemic (H1N1) 2009 virus.This indication is based on the immune response elicited by the seasonal trivalentInfluenza Virus Vaccine manufactured by CSL (AFLURIA
®
). CSL’s Influenza A (H1N1)2009 Monovalent Vaccine and AFLURIA are manufactured by the same process. Therehave been no controlled clinical studies demonstrating a decrease in influenza diseaseafter vaccination with AFLURIA (
).
2 DOSAGE AND ADMINISTRATION2.1 Prior to Administration
Influenza A (H1N1) 2009 Monovalent Vaccine should be inspected visually for  particulate matter and discoloration prior to administration (
),whenever suspension and container permit. If either of these conditions exists, thevaccine should not be administered. Any vaccine that has been frozen or is suspected of  being frozen must not be used.
2.2 Administration
When using a preservative-free, single-dose syringe, shake the syringe thoroughly andadminister the dose immediately.When using the multi-dose vial, shake the vial thoroughly before withdrawing each dose,and administer the dose immediately. Between uses, store the vial at 2
8
°
C (36
46
°
F)(
). Once the stopper has been pierced, thevial must be discarded within 28 days.Clinical studies are ongoing with Influenza A (H1N1) 2009 Monovalent Vaccine todetermine the optimal dosage, number of doses and schedule.

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