"Many of the projected 135-139 million doses of influenza vaccines being produced for this flu season for use in the U.S. are now available to consumers from six manufacturers licensed by the Food and Drug Administration (FDA).
(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 ß-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.
Additional Flucelvax Information
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