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(Influenza Virus Vaccine) for Intramuscular Injection


FLUCELVAX (Influenza Virus Vaccine), a vaccine for intramuscular injection, is a “subunit” influenza virus vaccine prepared from virus propagated in Madin Darby Canine Kidney (MDCK) cells, a continuous cell line. These cells were adapted to grow freely in suspension in culture medium. The virus is inactivated with .-propiolactone, disrupted by the detergent cetyltrimethylammonium bromide and purified through several process steps. Each of the 3 virus strains is produced and purified separately then pooled to formulate the trivalent vaccine.

FLUCELVAX is a sterile, slightly opalescent suspension in phosphate buffered saline. FLUCELVAX is standardized according to United States Public Health Service requirements for the 2013-2014 influenza season and is formulated to contain a total of 45 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA of each of the following three influenza strains: A/Brisbane/10/2010 (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. Each dose of FLUCELVAX may contain residual amounts of MDCK cell protein ( ≤ 8.4 mcg), protein other than HA ( ≤ 120 mcg), MDCK cell DNA ( ≤ 10 ng), polysorbate 80 ( ≤ 1125 mcg), cetyltrimethlyammonium bromide ( ≤ 13.5 mcg), and β-propiolactone ( ≤ 0.5 mcg), which are used in the manufacturing process.

FLUCELVAX contains no preservative or antibiotics.

The tip caps of the pre-filled syringes may contain natural rubber latex.

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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