Influenza vaccine (patient information)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Mohamed Moubarak, M.D. [2]
(Patient Information)
See FDA-approved patient labeling (Patient Information Sheet).
Inform the vaccine recipient of the potential benefits and risks of vaccination with 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.
Manufactured by Protein Sciences Corporation (Meriden, CT)
US license 1795
Distributed by Protein Sciences Corporation
Flublok is a registered trademark of Protein Sciences Corporation.
Patient Information Sheet Flublok® Influenza Vaccine
Read this information sheet carefully before getting Flublok vaccine. This summary is not intended to take the place of talking with your healthcare provider. If you have questions or would like more information, please talk with your healthcare provider.
What is Flublok vaccine?
Flublok is a vaccine given by injection (shot) to prevent influenza illness (flu). Flublok vaccine is for people who are 18 - 49 years of age. Flublok vaccine may not protect all people who receive the vaccine.
Who should not get Flublok vaccine? You should not get Flublok vaccine if you:
Ever had a severe allergic reaction to any of the ingredients in Flublok vaccine (listed below) Are younger than 18 years of age or older than 49 years of age.
Tell your healthcare provider if you have or have had:
Guillain Barré Syndrome (severe muscle weakness) after getting a flu shot Problems with your immune system as your immune response may be reduced
How is Flublok vaccine given? Flublok vaccine is given as a single injection (shot) into a muscle in your arm.
What are the possible side effects of Flublok vaccine? The most common side effects of Flublok vaccine are:
pain, redness, bruising, and swelling where you get the shot headache tiredness muscle aches
These are not all of the possible side effects of Flublok vaccine. A list of other side effects is available from your healthcare professional.
Call your healthcare provider for advice about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov.
What are the ingredients in Flublok vaccine? Flublok vaccine contains three influenza proteins. Inactive ingredients include sodium chloride, sodium phosphate, and polysorbate 20. Flublok contains no preservatives, antibiotics, egg proteins, or latex.[1]
References
- ↑ "FLUBLOK (INFLUENZA VACCINE) INJECTION, SOLUTION [PROTEIN SCIENCES CORPORATION]". Text " accessdate" ignored (help)
Adapted from the FDA Package Insert.