Fluad is a trivalent inactivated influenza vaccine indicated for adults 65 years and older.Each 0.5 mL intramuscular injection contains at least 15 mcg of hemagglutinin (HA) of each influenza strain recommended for the current influenza season and the adjuvant MF59®.Fluad does not contain a preservative.The tip caps of the pre-filled syringes contain natural rubber latex. The syringe and syringe plunger stopper are not made with natural rubber latex.
Important Safety Information1
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. Approval is based on the immune response elicited by Fluad. Data demonstrating a decrease in influenza disease after vaccination with Fluad are not available.
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.
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%).