| Novartis Vaccines and Diagnostics Limited BLA 1750 April 2009 Page 1 of 20 Influenza Virus Vaccine Fluvirin® 2009-2010 FORMULA HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FLUVIRIN® (Influenza Virus Vaccine) safely and effectively. See full prescribing information for FLUVIRIN®. FLUVIRIN® (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2009-2010 Formula Initial US Approval: 1988 INDICATIONS AND USAGE FLUVIRIN® is an inactivated influenza virus vaccine indicated for active immunization of persons 4 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine (1). FLUVIRIN® is not indicated for children less than 4 years of age because there is evidence of diminished immune response in this age group (8.4). DOSAGE FORMS AND STRENGTHS FLUVIRIN®, a sterile suspension for intramuscular injection, is supplied in two presentations: Prefilled 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 a preservative. (3,11) Each 0.5-mL dose contains 15 micrograms (mcg) of influenza virus hemagglutinin (HA) from each of the following 3 viruses: A/Brisbane/59/2007, IVR-148 (H1N1); A/Uruguay/716/2007, NYMC X-175C (H3N2) (an A/Brisbane/10/2007-like virus); and B/Brisbane/60/2008. (3, 11) CONTRAINDICATIONS History of systemic hypersensitivity reactions to egg proteins, or any other component of FLUVIRIN®, or life-threatening reactions to previous influenza vaccinations. (4.1, 11) WARNINGS AND PRECAUTIONS If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUVIRIN® should be based on careful consideration of the potential benefits and risks. (5.1) Immunocompromised persons may have a reduced immune response to FLUVIRIN®. (5.2) USE IN SPECIFIC POPULATIONS Safety and effectiveness of FLUVIRIN® have not been established in pregnant women, nursing mothers or children less than 4 years of age. (8.1, 8.3, 8.4) Antibody responses were lower in the geriatric population than in younger subjects. (8.5) |
| Influenza Virus Vaccine Fluvirin® 2009-2010 FORMULA |