"The US Food and Drug Administration (FDA) has cleared the cobas Influenza A/B test for use on the cobas Liat System, according to manufacturer Roche.
It is the first Clinical Laboratory Improvement Amendments (CLIA)-waiv"...
Inform the vaccine recipient of the potential benefits and risks of Flublok.
Inform the vaccine recipient that:
- Flublok contains non-infectious proteins that cannot cause influenza.
- Flublok stimulates the immune system to produce antibodies that help protect against influenza viruses contained in the vaccine, but does not prevent other respiratory infections.
Instruct the vaccine recipient to report any adverse events to their healthcare provider and/or to the Vaccine Adverse Event Reporting System (VAERS).
Provide the vaccine recipient with the Vaccine Information Statements which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to vaccination. These materials are available free of charge at the Centers for Disease Control (CDC) website (www.cdc.gov/vaccines).
Inform the vaccine recipient that safety and efficacy have not been established in pregnant women.
Register women who receive Flublok while pregnant in the pregnancy registry by calling 1-888-855-7871.
Instruct the vaccine recipient that annual vaccination to prevent influenza is recommended.
Last reviewed on RxList: 5/7/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Flublok 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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