"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) Intramuscular Injection
Fluzone (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton. X-100), producing a “split virus”. The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution.
Fluzone suspension for injection is clear and slightly opalescent in color.
Antibiotics are not used in the manufacture of Fluzone.
No presentation of Fluzone is made with natural rubber latex.
Fluzone is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2015-2016 influenza season: A/California/07/2009 X-179A (H1N1), A/Switzerland/9715293/2013 NIB-88 (H3N2), and B/Phuket/3073/2013 (B Yamagata lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 6. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 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 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury.
Table 6: Fluzone Ingredients
|Ingredient||Quantity (per dose)|
|Fluzone 0.25 mL Dose||Fluzone 0.5 mL Dose|
|Active Substance: Split influenza virus, inactivated strainsa:||22.5 mcg HA total||45 mcg HA total|
|A (H1N1)||7.5 mcg HA||15 mcg HA|
|A (H3N2)||7.5 mcg HA||15 mcg HA|
|B||7.5 mcg HA||15 mcg HA|
|Sodium phosphate-buffered isotonic sodium chloride||QSb to appropriate||QSb to appropriate|
|Formaldehyde||< 50 mcg||< 100 mcg|
|Octylphenol ethoxylate||< 75 mcg||< 150 mcg|
|Multi-dose presentation (thimerosal)||12.5 mcg mercury||25 mcg mercury|
|a per United States Public Health Service (USPHS)
b Quantity Sufficient
“-” Indicates information is not applicable
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...
Last reviewed on RxList: 11/3/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Fluzone Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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