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(Influenza Virus Vaccine) for Intramuscular Injection
AGRIFLU, Influenza Virus Vaccine, for intramuscular injection is a trivalent inactivated influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens' eggs inoculated with an influenza virus suspension containing kanamycin and neomycin sulphate. Each of the influenza virus strains is harvested and clarified separately by centrifugation and filtration prior to inactivation with formaldehyde. The inactivated virus is concentrated and purified by zonal centrifugation. The surface antigens, hemagglutinin and neuraminidase, are obtained from the influenza virus particle by further centrifugation in the presence of cetyltrimethylammonium bromide (CTAB), a process which removes most of the internal proteins. The CTAB is removed from the vaccine preparation by subsequent purification steps.
AGRIFLU is a sterile clear aqueous suspension 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 virus strains recommended for the 2013/2014 influenza season: A/California/7/2009, NYMC X-181 (H1N1); A/Texas/50/2012, NYMC X-223 (H3N2); and B/Massachusetts/2/2012.
The 0.5 mL pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative.
The 5.0 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury.
Each 0.5 mL dose from the pre-filled syringe or multi-dose vial may contain residual amounts of egg proteins ( < 0.4 mcg), formaldehyde ( ≤ 10 mcg), polysorbate 80 ( ≤ 50 mcg), and CTAB ( ≤ 12 mcg). Each dose may also contain residual amounts of neomycin ( ≤ 0.02 mcg by calculation), kanamycin ( ≤ 0.03 mcg by calculation), and barium ( < 0.5 mcg by calculation), which are used during the initial stages of manufacture. The tip caps of the syringes may contain natural rubber latex. The syringe plunger and the multi-dose vial do not contain natural rubber latex.
Last reviewed on RxList: 8/25/2014
This monograph has been modified to include the generic and brand name in many instances.
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