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Flulaval

"The U.S. Food and Drug Administration announced today that it has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the six manufacturers licensed to produce and distribute influenza vaccine for the United "...

Flulaval

FLULAVAL
(Influenza Vaccine) for Intramuscular Injection

DRUG DESCRIPTION

FLULAVAL, Influenza Vaccine, for intramuscular injection, is a trivalent, split-virion, inactivated influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens' eggs. Each of the influenza viruses is produced and purified separately. The virus is inactivated with ultraviolet light treatment followed by formaldehyde treatment, purified by centrifugation, and disrupted with sodium deoxycholate.

FLULAVAL is a sterile, opalescent, translucent to off-white suspension in a phosphatebuffered saline solution that may sediment slightly. The sediment resuspends upon shaking to form a homogeneous suspension.

FLULAVAL has been standardized according to USPHS requirements for the 2014-2015 influenza season and is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5mL dose in the recommended ratio of 15 mcg HA of each of the following 3 strains: A/California/7/2009 NYMC X-179A (H1N1), A/Texas/50/2012 NYMC X-223A (H3N2), and B/Massachusetts/2/2012 NYMC BX-51B.

The prefilled syringe is formulated without preservatives and does not contain thimerosal. Each 0.5-mL dose from the multi-dose vial contains 50 mcg thimerosal ( < 25 mcg mercury); thimerosal, a mercury derivative, is added as a preservative.

Each 0.5-mL dose of either presentation may also contain residual amounts of ovalbumin ( ≤ 0.3 mcg), formaldehyde ( ≤ 25 mcg), sodium deoxycholate ( ≤ 50 mcg), α-tocopheryl hydrogen succinate ( ≤ 240 mcg), and polysorbate 80 ( ≤ 665 mcg) from the manufacturing process. Antibiotics are not used in the manufacture of this vaccine.

The tip caps and plungers of the prefilled syringes are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex.

What are the possible side effects of influenza virus injectable vaccine?

Influenza virus injectable (killed virus) vaccine will not cause you to become ill with the flu virus that it contains. However, you may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive influenza virus vaccine in the future, you will need to tell your doctor if the previous shot caused any side...

Read All Potential Side Effects and See Pictures of Flulaval »

Last reviewed on RxList: 9/8/2014
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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