Important Safety Information for FLUARIX
- Do not administer FLUARIX to anyone with known severe allergic reactions to egg proteins (a vaccine component) or a life-threatening reaction to previous administration of any influenza vaccine
- If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUARIX should be based on careful consideration of the potential benefits and risks
- The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals
- If FLUARIX 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 clinical trials with FLUARIX, the most common adverse events in adults included injection site pain and redness, muscle aches, fatigue, and headache. In children 5 years to <18 years of age, the most common adverse events were similar to those in adults but also included injection site swelling. In children 3 years to <5 years of age, the most common adverse events included pain, redness, and swelling at the injection site, irritability, drowsiness, and loss of appetite. (See Adverse Reactions section of the Prescribing Information for FLUARIX for other potential adverse events).
- Vaccination with FLUARIX may not result in protection in all vaccine recipients.