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Flublok is a vaccine indicated for active immunization against disease caused by influenza virus subtypes A and type B contained in the vaccine. Flublok is approved for use in persons 18 years of age and older. In persons 18 through 49 years of age, this indication is based on a controlled clinical study demonstrating a decrease in influenza disease after vaccination with Flublok. In persons 50 years of age and older, this indication is based on the immune response elicited by Flublok; data demonstrating a decrease in influenza disease in persons 50 years and older after vaccination with Flublok are not available. (see Clinical Studies)
DOSAGE AND ADMINISTRATION
For intramuscular injection only.
Administer Flublok as a single 0.5-mL dose.
Shake the single-dose vial gently before withdrawing the vaccine dose.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permits. If either of these conditions exists, the vaccine should not be administered.
The preferred site for injection is the deltoid muscle. Administration is by sterile needle and syringe.
Flublok should not be mixed with any other vaccine in the same syringe or vial.
Dosage Forms And Strengths
Flublok is a sterile solution supplied in single-dose vials, 0.5 mL.
Flublok is supplied as a single-dose, 0.5 mL vial in a 10 vial carton:
|Presentation||Carton NDC Number||Components and NDC Number|
|Single-Dose Vial||42874-014-10||Ten 0.5 mL single-dose vials
Storage And Handling
- Store refrigerated between 2° and 8°C (36° and 46°F).
- Do not freeze. Discard if product has been frozen.
- Protect vials from light
- Do not use after expiration date shown on the label.
Manufactured by Protein Sciences Corporation (Meriden, CT). Distributed by Protein Sciences Corporation. Revised: October 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/7/2015
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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