"The U.S. Food and Drug Administration announced today that it has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the six manufacturers licensed to produce and distribute influenza vaccine for the United "...
Provide the following information to the vaccine recipient or guardian:
- Inform of the potential benefits and risks of immunization with FLULAVAL.
- Educate regarding potential side effects, emphasizing that: (1) FLULAVAL contains non-infectious killed viruses and cannot cause influenza, and (2) FLULAVAL is intended to provide protection against illness due to influenza viruses only, and cannot provide protection against all respiratory illness.
- Inform that safety and efficacy have not been established in pregnant women. Register women who receive FLULAVAL while pregnant in the pregnancy registry by calling 1-888-452-9622.
- Give the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 prior to each immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).
- Instruct that annual revaccination is recommended.
Last reviewed on RxList: 11/3/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Flulaval Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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