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.
GlaxoSmithKline Vaccines, a division of GlaxoSmithKline group, is the world's leading vaccine company and a leader in innovation. The company is active in vaccine research, development and production with over 30 vaccines approved and 20 more in development - both in the prophylactic and therapeutic fields. Headquartered in Belgium, GSK Vaccines has 14 manufacturing sites strategically positioned around the globe. In 2011, GSK Vaccines distributed 1.1 billion doses to 173 countries in both the developed and the developing world.
Through its accomplished and dedicated workforce, GSK Vaccines applies its expertise to the discovery of innovative vaccines that contribute to the health and well-being of people of all generations around the world.
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