FLUARIX, Influenza Virus Vaccine, for intramuscular injection, is a sterile colorless to 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 2011-2012 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/California/7/2009 NYMC X-181 (H1N1), A/Victoria/210/2009 NYMC X-187 (H3N2) (an A/Perth/16/2009-like virus), and B/Brisbane/60/2008.

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 may contain natural rubber latex. The rubber plungers do not contain latex.

Last reviewed on RxList: 1/10/2012
This monograph has been modified to include the generic and brand name in many instances.