Approved September 15, 2009

INFLUENZA A VIRUS VACCINE, H1N1, INACTIVATED
(FDA Category 1)

Inactivated influenza A H1N1 virus vaccine (CSL Limited, Novartis Vaccines and Diagnostics Limited, Sanofi Pasteur, Inc) induces antibodies that neutralize the influenza A H1N1 virus.

DOSING INFORMATION: The recommended dose of the inactivated influenza A H1N1 virus vaccine is two 0.25 milliliters (mL) intramuscular (IM) doses given approximately 1 month apart for patients 6 through 35 months of age, two 0.5 mL IM doses given approximately 1 month apart for patients 36 months through 9 years (yr) of age, and one 0.5 mL IM dose for patients 10 yr of age and older.

CAUTIONS: Contraindicated in patients with severe hypersensitivity to egg proteins or any other component of the vaccine or a history of a life-threatening reaction with previous administration of any influenza vaccine. The most common adverse reactions include malaise, headache, myalgia, and injection-site pain, swelling, and tenderness.

FDA APPROVED INDICATIONS: The inactivated influenza A H1N1 virus vaccine is indicated for active immunization of patients 6 months of age and older against influenza caused by the pandemic H1N1 virus.