"The U.S. Food and Drug Administration today approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu. The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in peopl"...
(Influenza Virus Vaccine) Suspension for Intramuscular Injection
AFLURIA, Influenza Vaccine for intramuscular injection, is a sterile, clear, colorless to slightly opalescent suspension with some sediment that resuspends upon shaking to form a homogeneous suspension. AFLURIA is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs. Following harvest, the virus is purified in a sucrose density gradient using continuous flow zonal centrifugation. The purified virus is inactivated with beta-propiolactone, and the virus particles are disrupted using sodium taurodeoxycholate to produce a "split virion". The disrupted virus is further purified and suspended in a phosphate buffered isotonic solution.
AFLURIA is standardized according to USPHS requirements for the 2013-2014 influenza season and is formulated to contain 45 mcg hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA for each of the three influenza strains recommended for the 2013-2014 Northern Hemisphere influenza season: A/California/7/2009 (H1N1), NYMC X-181, A/Texas/50/2012 (H3N2), NYMC X-223 (an A/Victoria/361/2011-like strain), and B/Massachusetts/2/2012, NYMC BX-51B.
Thimerosal, a mercury derivative, is not used in the manufacturing process for the single dose presentations; therefore these products contain no preservative. The multi-dose presentation contains thimerosal, added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.
A single 0.5 mL dose of AFLURIA contains sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (1.5 mcg). From the manufacturing process, each 0.5 mL dose may also contain residual amounts of sodium taurodeoxycholate ( ≤ 10 ppm), ovalbumin ( ≤ 1 mcg), neomycin sulfate ( ≤ 3 nanograms [ng]), polymyxin B ( ≤ 0.5 ng), and beta-propiolactone ( ≤ 2 ng). The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial were not made with natural rubber latex.
What are the possible side effects of influenza virus injectable vaccine?
Influenza virus injectable (killed virus) vaccine will not cause you to become ill with the flu virus that it contains. However, you may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.
You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive influenza virus vaccine in the future, you will need to tell your doctor if the previous shot caused any side...
What are the precautions when taking influenza virus vaccine (Afluria)?
Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex, eggs/chicken products found in some brands, preservatives like thimerosal found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: any fever, uncontrolled seizures or other nervous system disorder (such as encephalopathy), bleeding disorders (such as hemophilia, thrombocytopenia), history of Guillain-Barre syndrome, immune system disorders (such as autoimmune disorders, radiation treatment), seizures (such as...
Last reviewed on RxList: 11/25/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Afluria Information
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