INFLUENZA A- H1N1 2009 MONOVALENT VACCINE injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: K9P8PVA2UG) (INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:K9P8PVA2UG)

Available from:

Novartis Vaccines and Diagnostics Ltd

INN (International Name):

INFLUENZA A VIRUS A/CALIFORNIA/7/2009-LIKE HEMAGGLUTININ ANTIGEN -LIKE HEMAGGLUTININ ANTIGEN - UNII:K9P8PVA2UG)

Composition:

INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL

Administration route:

INTRAMUSCULAR

Therapeutic indications:

Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for immunization of persons 4 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus. Influenza A (H1N1) 2009 Monovalent Vaccine should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (eggs or egg products), or to any component of Influenza A (H1N1) 2009 Monovalent Vaccine, or who has had a life-threatening reaction to previous influenza vaccinations [see DESCRIPTION (11)]. Novartis’ Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza Virus Vaccine (FLUVIRIN) are manufactured by the same process. Available information for FLUVIRIN is provided in this section. Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or FLUVIRIN. It is also not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or FLUVIRIN can cause fetal harm when administered to

Product summary:

Influenza A (H1N1) 2009 Monovalent Vaccine is supplied as a 0.5-mL prefilled single dose syringe, package of 10 syringes per carton. NDC 66521-200-02 Influenza A (H1N1) 2009 Monovalent Vaccine is supplied as a 5-mL multidose vial, individually packaged in a carton. NDC 66521-200-10 Store Influenza A (H1N1) 2009 Monovalent Vaccine refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze . Discard if the vaccine has been frozen. Store in the original package to protect from light. Do not use after the expiration date. Between uses, return the multidose vial to the recommended storage conditions.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE- INFLUENZA A (H1N1) 2009
MONOVALENT
VACCINE INJECTION, SUSPENSION
NOVARTIS VACCINES AND DIAGNOSTICS LTD
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INFLUENZA A (H1N1) 2009 MONOVALENT
VACCINE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
INFLUENZA A (H1N1) 2009 MONOVALENT
VACCINE.
INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE
MANUFACTURED BY NOVARTIS VACCINES AND DIAGNOSTICS LTD.
SUSPENSION FOR INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 2009
INDICATIONS AND USAGE
Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza
virus vaccine indicated for active immunization
of persons 4 years of age and older against influenza disease caused
by pandemic (H1N1) 2009 virus (1).
DOSAGE AND ADMINISTRATION
BASED ON CURRENTLY AVAILABLE INFORMATION THE VACCINATION REGIMEN IS AS
FOLLOWS:
CHILDREN 4 THROUGH 9 YEARS OF AGE: Two 0.5-mL intramuscular injections
approximately 1 month apart (2.2)
CHILDREN 10 THROUGH 17 YEARS OF AGE: A single 0.5-mL intramuscular
injection (2.2)
ADULTS 18 YEARS OF AGE AND OLDER: A single 0.5-mL intramuscular
injection (2.2)
DOSAGE FORMS AND STRENGTHS
Influenza A (H1N1) 2009 Monovalent Vaccine, a sterile suspension for
intramuscular injection, is supplied in two
pre se ntations:
Prefilled single dose syringe, 0.5-mL. Thimerosal, a mercury
derivative used during manufacture, is removed by
subsequent purification steps to a trace amount (≤ 1 mcg mercury per
0.5-mL dose) (3, 11)
Multidose vial, 5-mL. Contains thimerosal, a mercury derivative (25
mcg mercury per 0.5-mL dose). Thimerosal is
added as preservative. (3,11)
CONTRAINDICATIONS
History of systemic hypersensitivity reactions to egg proteins, or any
other component of Influenza A (H1N1) 2009
Monovalent Vaccine, or life-threatening reactions to previous
influenza vaccinations. (4, 11)
WARNINGS AND PRECAUTIONS
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of
prior influenza vaccine, the de