"The U.S. Food and Drug Administration today approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu. The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in peopl"...
DOSAGE AND ADMINISTRATION
For intramuscular injection only.
Dosage And Schedule
Administer FLUCELVAXas 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.
Shake the syringe vigorously before administering. FLUCELVAX should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. [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.
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: 62577-613-01
Pre-filled syringe NDC number: 62577-613-11
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, Inc., 350 Massachusetts Avenue, Cambridge, MA USA 02139, 1-877-683-4732. Revised: March 2014
Last reviewed on RxList: 9/11/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Flucelvax 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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