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Fluzone

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Fluzone

Fluzone
(Influenza Virus Vaccine) for Intramuscular Injection

Fluzone

DRUG DESCRIPTION

Fluzone (Influenza Virus Vaccine) for intramuscular injection is an inactivated influenza virus vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The viruscontaining 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 2013-2014 influenza season: A/California/07/2009 NYMC X-179A (H1N1), A/Texas/50/2012 X- 223A (H3N2) and B/Massachusetts/02/2012. The amounts of HA and other ingredients per dose of vaccine are listed in Table 6.

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
Other:
  Sodium phosphate-buffered isotonic sodium chloride solution QSb to appropriate volume QSb to appropriate volume
  Formaldehyde ≤ 50 mcg ≤ 100 mcg
  Octylphenol Ethoxylate ≤ 75 mcg ≤ 150 mcg
  Gelatin 0.05% 0.05%
Preservative
  Single-Dose Presentations None None
  Multi-Dose Presentation (Thimerosal) N/A 25 mcg mercury
aper United States Public Health Service (USPHS) requirement
bQuantity Sufficient
N/A 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...

Read All Potential Side Effects and See Pictures of Fluzone »

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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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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