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Fluarix

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Fluarix

FLUARIX
(Influenza Virus Vaccine)

Fluarix

DRUG DESCRIPTION

FLUARIX, Influenza Virus Vaccine, for intramuscular injection, is a sterile colorless and slightly opalescent suspension. FLUARIX is a vaccine prepared from influenza viruses propagated in embryonated chicken eggs. Each of the influenza viruses is produced and purified separately. After harvesting the virus-containing fluids, each influenza virus is concentrated and purified by zonal centrifugation using a linear sucrose density gradient solution containing detergent to disrupt the viruses. Following dilution, the vaccine is further purified by diafiltration. Each influenza virus solution is inactivated by the consecutive effects of sodium deoxycholate and formaldehyde leading to the production of a “split virus.” Each split inactivated virus is then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The vaccine is formulated from the 3 split inactivated virus solutions.

FLUARIX has been standardized according to USPHS requirements for the 2013-2014 influenza season and is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5-mL dose, in the recommended ratio of 15 mcg HA of each of the following 3 strains: A/Christchurch/16/2010 NIB-74XP (H1N1) (an A/California/7/2009-like virus), A/Texas/50/2012 NYMC X-223A (H3N2) (an A/Victoria/361/2011-like virus), and B/Massachusetts/2/2012 NYMC BX-51B.

FLUARIX is formulated without preservatives. FLUARIX does not contain thimerosal. Each 0.5-mL dose also contains octoxynol-10 (TRITON® X-100) ≤ 0.085 mg, α-tocopheryl hydrogen succinate ≤ 0.1 mg, and polysorbate 80 (Tween 80) ≤ 0.415 mg. Each dose may also contain residual amounts of hydrocortisone ≤ 0.0016 mcg, gentamicin sulfate ≤ 0.15 mcg, ovalbumin ≤ 0.05 mcg, formaldehyde ≤ 5 mcg, and sodium deoxycholate ≤ 50 mcg from the manufacturing process.

The tip caps of the prefilled syringes of FLUARIX may contain natural rubber latex; the plungers 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 Fluarix »

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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