May 27, 2016
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"The U.S. Food and Drug Administration today approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu. The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in peopl"...



(influenza vaccine) Intramuscular Injection


FLUCELVAX (Influenza Vaccine), a vaccine for intramuscular injection, is a “subunit” influenza 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 2015-2016 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 (wild type) (an A/California/7/2009 (H1N1)pdm09-like virus);

A/South Australia/55/2014 (wild type) (an A/Switzerland/9715293/2013 (H3N2)-like virus); B/Utah/9/2014 (a B/Phuket/3073/2013-like virus).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: 10/15/2015
This monograph has been modified to include the generic and brand name in many instances.

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