"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 Virus Vaccine) Pre-filled Syringes
FLUVIRIN® is a trivalent, sub-unit (purified surface antigen) influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens' eggs inoculated with a specific type of influenza virus suspension containing neomycin and polymyxin. Each of the influenza virus strains is harvested and clarified separately by centrifugation and filtration prior to inactivation with betapropiolactone. 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 nonylphenol ethoxylate, a process which removes most of the internal proteins. The nonylphenol ethoxylate is removed from the surface antigen preparation.
FLUVIRIN® is a homogenized, sterile, slightly opalescent suspension in a phosphate buffered saline. FLUVIRIN® has been 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 of each of the following 3 viruses:
A/Christchurch/16/2010, NIB-74 (H1N1) (an A/California/7/2009-like virus); A/Texas/50/2012, NYMC X-223 (H3N2) (an A/Victoria/361/2011-like virus); and B/Massachusetts/2/2012.
The 0.5-mL prefilled syringe presentation is formulated without preservative. However, thimerosal, a mercury derivative used during manufacturing, is removed by subsequent purification steps to a trace amount ( ≤ 1 mcg mercury per 0.5-mL dose).
The 5-mL multidose vial formulation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5-mL dose from the multidose vial contains 25 mcg mercury.
Each dose from the multidose vial or from the prefilled syringe may also contain residual amounts of egg proteins ( ≤ 1 mcg ovalbumin), polymyxin ( ≤ 3.75 mcg), neomycin ( ≤ 2.5 mcg), betapropiolactone (not more than 0.5 mcg) and nonylphenol ethoxylate (not more than 0.015% w/v).
The tip caps of the FLUVIRIN® prefilled syringes may contain natural rubber latex. The multidose vial stopper and the syringe stopper/plunger do not contain 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 (Fluvirin )?
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.
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