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FLUCELVAX® is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine
FLUCELVAX is approved for use in persons 18 years of age and older.
There is currently no drug history available for this drug.
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.