Fluzone

Fluzone

Fluzone Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Fluzone® is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine.

Fluzone is approved for use in persons 6 months of age and older.

History

There is currently no drug history available for this drug.

Other Information

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
IngredientQuantity
(per dose)
Fluzone
0.25 mL Dose
Fluzone
0.5 mL Dose
"-" Indicates information is not applicable
* per United States Public Health Service (USPHS) requirement † Quantity Sufficient
Active Substance: Split influenza virus, inactivated strains*:22.5 mcg HA total45 mcg HA total
  A (H1N1)7.5 mcg HA15 mcg HA
  A (H3N2)7.5 mcg HA15 mcg HA
  B7.5 mcg HA15 mcg HA
Other:
  Sodium phosphate-buffered isotonic sodium chloride solutionQS† to appropriate volumeQS† to appropriate volume
  Formaldehyde≤50 mcg≤100 mcg
  Octylphenol ethoxylate≤75 mcg≤150 mcg
  Gelatin0.05%0.05%
Preservative
  Single-dose presentations--
  Multi-dose presentation (thimerosal)12.5 mcg mercury25 mcg mercury

Fluzone Manufacturers


  • Sanofi Pasteur Inc.
    Fluzone (Influenza A Virus A/california/7/2009 X-179a (H1n1) Antigen (Formaldehyde Inactivated), Influenza A Virus A/switzerland/9715293/2013 Nib-88 (H3n2) Antigen (Formaldehyde Inactivated), And Influenza B Virus B/phuket/3073/2013 Antigen (Formaldehyde Inactivated)) Injection, Suspension [Sanofi Pasteur Inc.]
  • Sanofi Pasteur Inc.
    Fluzone (Influenza A Virus A/california/7/2009 X-179a (H1n1) Antigen (Formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (H3n2) Antigen (Formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (Formaldehyde Inactivated)) Injection, Suspension [Sanofi Pasteur Inc.]

Login To Your Free Account