"By Brenda Goodman, MA
WebMD Health News
Reviewed by Brunilda Nazario, MD
Feb. 26, 2015 -- It's no secret this year's flu shots didn't work as well as doctors had hoped. But the news got worse Thursday when the CDC revised "...
(Influenza Vaccine) for 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 2014-2015 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); 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: 9/11/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Flucelvax Information
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