Fluzone
FDA Approves Vaccines for the 2011-2012 Influenza Season »
"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 "...
Read the FDA Approves Vaccines for the 2011-2012 Influenza Season article »
Fluzone
Fluzone
(influenza virus) Vaccine
DRUG DESCRIPTION
Fluzone (Influenza Virus Vaccine) for intramuscular injection, Fluzone High-Dose (Influenza Virus Vaccine) for intramuscular injection, and Fluzone Intradermal (Influenza Virus Vaccine) for intradermal injection are inactivated influenza virus vaccines, 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. The Fluzone High-Dose and Fluzone Intradermal processes use an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration.
Fluzone, Fluzone High-Dose, and Fluzone Intradermal, suspensions for injection, are clear and slightly opalescent in color.
Antibiotics are not used in the manufacture of Fluzone, Fluzone High-Dose or Fluzone Intradermal.
The prefilled syringe tip caps of Fluzone and Fluzone High-Dose may contain natural rubber latex. Vial presentations of Fluzone and the Fluzone Intradermal microinjection system do not contain latex.
Fluzone, Fluzone High-Dose, and Fluzone Intradermal are standardized according to United States Public Health Service requirements and are formulated to contain HA of each of the following three influenza strains recommended for the 2011-2012 influenza season: A/California/07/2009 X-179A (H1N1), A/Victoria/210/2009 X-187 (an A/Perth/16/2009-like strain) (H3N2) and B/Brisbane/60/2008. The amounts of HA and other ingredients per dose of vaccine are listed in Table 8.
Table 8: Fluzone, Fluzone High-Dose, and Fluzone Intradermal
Ingredients
| Ingredient | Quantity (perdose) | |||
| Fluzone 0.25 mL Dose | Fluzone 0.5 mL Dose | Fluzone High-Dose 0.5 mL Dose | Fluzone Intradermal 0.1 mL Dose | |
| Active Substance: Split influenza virus, inactivated strainsa: | 22.5 mcg HA total | 45 mcg HA total | 180 mcg HA total | 27 mcg HA total |
| A (H1N1) | 7.5 mcg HA | 15 mcg HA | 60 mcg HA | 9 mcg HA |
| A (H3N2) | 7.5 mcg HA | 15 mcg HA | 60 mcg HA | 9 mcg HA |
| B | 7.5 mcg HA | 15 mcg HA | 60 mcg HA | 9 mcg HA |
| Other: | ||||
| Sodium phosphate-buffered isotonic sodium chloride solution | QSb to appropriate volume | QSb to appropriate volume | QSb to appropriate volume | QSb to appropriate volume |
| Formaldehyde | ≤ 50 mcg | ≤ 100 mcg | ≤ 100 mcg | ≤ 20 mcg |
| Octylphenol Ethoxylate | ≤ 75 mcg | ≤ 150 mcg | ≤ 250 mcg | ≤ 50 mcg |
| Gelatin | 0.05% | 0.05% | None | None |
| Preservative | ||||
| Single-Dose Presentations | None | None | None | None |
| Multi-Dose Presentation (Thimerosal) | N/A | 25 mcg mercury | N/A | N/A |
| a per United States Public Health
Service (USPHS) requirement. b Quantity Sufficient. N/A not applicable |
||||
Last reviewed on RxList: 1/11/2012
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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