"The U.S. Food and Drug Administration announced today that it has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the six manufacturers licensed to produce and distribute influenza vaccine for the United "...
(Influenza Vaccine) Influenza Virus Vaccine, for Intramuscular Injection
- Patient Information:
Details with Side Effects
FLULAVAL, Influenza Virus Vaccine, for intramuscular injection, is a trivalent, splitvirion, inactivated influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens' eggs. Each of the influenza viruses is produced and purified separately. The virus is inactivated with ultraviolet light treatment followed by formaldehyde treatment, purified by centrifugation, and disrupted with sodium deoxycholate.
FLULAVAL is a sterile, translucent to whitish opalescent suspension in a phosphatebuffered saline solution that may sediment slightly. The sediment resuspends upon shaking to form a homogeneous suspension.
FLULAVAL has been standardized according to USPHS requirements for the 2013-2014 influenza season and is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5mL dose in the recommended ratio of 15 mcg HA of each of the following 3 strains: A/California/7/2009 NYMC X-179A (H1N1), A/Texas/50/2012 NYMC X-223A (H3N2) (an A/Victoria/361/2011-like virus), and B/Massachusetts/2/2012 NYMC BX-51B.
Thimerosal, a mercury derivative, is added as a preservative. Each 0.5-mL dose contains 50 mcg thimerosal ( < 25 mcg mercury). Each 0.5-mL dose may also contain residual amounts of ovalbumin ( ≤ 0.3 mcg), formaldehyde ( ≤ 25 mcg), and sodium deoxycholate ( < 50 mcg) from the manufacturing process. Antibiotics are not used in the manufacture of this vaccine.
The vial stoppers are not made with 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.
Additional Flulaval Information
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