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Flublok

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Flublok

Indications
Dosage
How Supplied

INDICATIONS

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.

Dosage

Administer Flublok as a single 0.5-mL dose.

Administration

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.

HOW SUPPLIED

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
[NDC 42874-014-01]

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 2014

Last reviewed on RxList: 5/7/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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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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