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Flucelvax

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Flucelvax

INDICATIONS

FLUCELVAX® is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine

FLUCELVAX is approved for use in persons 18 years of age and older.

DOSAGE AND ADMINISTRATION

For intramuscular injection only.

Dosage and Schedule

Administer FLUCELVAX as a single 0.5 mL intramuscular injection preferably in the region of the deltoid muscle of the upper arm. Do not inject the vaccine in the gluteal region or areas where there may be a major nerve trunk.

Administration

Shake the syringe vigorously before administering. FLUCELVAX should be inspected visually for particulate matter and discoloration prior to administration. [see DESCRIPTION] If either condition exists, do not administer the vaccine. Do not use the vaccine if the contents have been frozen.

Attach a sterile needle to the pre-filled syringe and administer intramuscularly.

HOW SUPPLIED

Dosage Forms And Strengths

FLUCELVAX is a suspension for injection supplied in a 0.5 mL single-dose pre-filled Luer Lock syringe.

Storage And Handling

FLUCELVAX is supplied in a carton containing ten 0.5 mL single-dose syringes without needles:

Carton NDC number: 63851-612-01

Pre-filled syringe NDC number: 63851-612-11

The tip caps of the pre-filled syringes may contain natural rubber latex. The syringe and syringe plunger stopper are manufactured without natural rubber latex.

Store this product refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Do not use after the expiration date.

Manufactured by: Novartis Vaccines and Diagnostics GmbH, D-35006 Marburg, Germany. An Affiliate of: Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue, Cambridge, MA USA 02139, 1-877-683-4732. Revised: July 2013.

Last reviewed on RxList: 11/25/2013
This monograph has been modified to include the generic and brand name in many instances.

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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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