This indication is based on immune response elicited by FLULAVAL, and there have been no controlled trials adequately demonstrating a decrease in influenza disease after vaccination with FLULAVAL.
Important Safety Information For FLULAVAL
- Do not administer FLULAVAL to anyone with known severe allergic reactions (eg, anaphylaxis) to any component of the vaccine including egg protein or to a previous dose of any influenza vaccination
- If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLULAVAL should be based on careful consideration of the potential benefits and risks
- If FLULAVAL is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons
- Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
- In comparator-controlled clinical trials with FLULAVAL, adverse events included pain, redness, and swelling at the injection site; headache; fatigue; and myalgia. (See Adverse Reactions section of the Prescribing Information for FLULAVAL for other potential adverse events)
- Vaccination with FLULAVAL may not result in protection in all vaccine recipients.
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