FLUARIX®, Influenza Virus Vaccine for intramuscular use, is a sterile suspension 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 2007-2008 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/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004. 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. The vaccine is formulated without preservatives. Thimerosal is used at the early stages of manufacture and is removed by subsequent purification steps to a trace amount (≤ 1 mcg mercury per dose). Each dose may also contain residual amounts of hydrocortisone ≤ 0.0016 mcg, gentamicin sulfate ≤ 0.15 mcg, ovalbumin ≤ 1 mcg, formaldehyde ≤ 50 mcg, and sodium deoxycholate ≤ 50 mcg from the manufacturing process.

FLUARIX is supplied as a 0.5 mL dose in a prefilled syringe. FLUARIX, after shaking well, is colorless to slightly opalescent.

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