Important Safety Information: INDICATIONS AND USAGE


FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is approved for use in persons 65 years of age and older.


CONTRAINDICATIONS


Severe allergic reaction to any component of the vaccine, including egg protein, or after a previous dose of any influenza vaccine.


WARNINGS AND PRECAUTIONS


• If Guillain-Barré Syndrome (GBS) has occurred within six weeks of previous influenza vaccination, the decision to give FLUAD should be based on careful consideration of the potential benefits and risks.


• The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.


Please see accompanying US Full Prescribing Information for FLUAD


http://hcp.fluad.com/Common/docs/FLUAD_Package_Insert.pdf ADVERSE REACTIONS


• The most common (≥10%) local (injection-site) adverse reactions observed in clinical studies were injection site pain (25%) and tenderness (21%).


• The most common (≥10%) systemic adverse reactions observed in clinical studies were myalgia (15%), headache (13%), and fatigue (13%).


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