Influenza A (H1N1) 2009 Monovalent Vaccine

Influenza A (H1N1) 2009 Monovalent Vaccine is developed by Novartis Vaccines and Diagnostics Ltd. Given as suspension for Intramuscular Injection

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

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
• Children 10 through 17 years of age: A single 0.5-mL intramuscular injection
• Adults 18 years of age and older: A single 0.5-mL intramuscular injection

DOSAGE FORMS AND STRENGTHS
Influenza A (H1N1) 2009 Monovalent Vaccine, a sterile suspension for intramuscular injection, is supplied in two presentations:

• 0.5 mL preservative-free, single-dose, pre-filled syringe.

• Multidose vial, 5-mL. Contains thimerosal, a mercury derivative (25 mcg mercury per 0.5-mL dose). Thimerosal is added as preservative.

CONTRAINDICATIONS
• History of systemic hypersensitivity reactions to egg proteins,neomycin or polymixin or any other component of Influenza A (H1N1) 2009 Monovalent Vaccine, or life-threatening reactions to previous influenza vaccinations.

WARNINGS AND PRECAUTIONS
• If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give Influenza A (H1N1) 2009 Monovalent Vaccine should be based on careful consideration of the potential benefits and risks.
• Immunocompromised persons may have a reduced immune response to Influenza A (H1N1) 2009 Monovalent Vaccine.

ADVERSE REACTIONS
Adverse Reaction information is based on studies conducted with seasonal trivalent Influenza Virus Vaccine manufactured by Novartis (FLUVIRIN). Vial and Syringe leaflet text Page 1 of 20
Novartis Vaccines and Diagnostics Limited BLA 1750
September 2009
The most frequently reported adverse reactions are mild hypersensitivity reactions (such as rash), local reactions at the injection site, and influenza-like symptoms.

Reference:
www.fda.gov