Fluzone
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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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.
| Ingredient | Quantity (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 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 | QS† to appropriate volume | QS† to appropriate volume |
| Formaldehyde | ≤50 mcg | ≤100 mcg |
| Octylphenol ethoxylate | ≤75 mcg | ≤150 mcg |
| Gelatin | 0.05% | 0.05% |
| Preservative | ||
| Single-dose presentations | - | - |
| Multi-dose presentation (thimerosal) | 12.5 mcg mercury | 25 mcg mercury |
Sources
Fluzone Manufacturers
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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.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Fluzone | Sanofi Pasteur Inc.
For intramuscular use only 2.1 Dose and ScheduleThe dose and schedule for Fluzone are presented in Table 1.
Table 1: Dose and Schedule for Fluzone Age Dose Schedule "-" Indicates information is not applicable * 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines 6 months through 35 months One or two doses*, 0.25 mL each If 2 doses, administer at least 1 month apart 36 months through 8 years One or two doses*, 0.5 mL each If 2 doses, administer at least 1 month apart 9 years and older One dose, 0.5 mL - 2.2 AdministrationInspect Fluzone visually for particulate matter and/or discoloration prior to administration. If either of these conditions exist, the vaccine should not be administered.
Before administering a dose of vaccine, shake the prefilled syringe or multi-dose vial. Withdraw a single dose of vaccine using a sterile needle and syringe. Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial.
The preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in persons ≥12 months through 35 months of age, or the deltoid muscle in persons ≥36 months of age. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.
Do not administer this product intravenously or subcutaneously.
Fluzone should not be combined through reconstitution or mixed with any other vaccine.
-
Sanofi Pasteur Inc.
Fluzone | Sanofi Pasteur Inc.
For intramuscular use only 2.1 Dose and ScheduleThe dose and schedule for Fluzone are presented in Table 1.
Table 1: Dose and Schedule for Fluzone Age Dose Schedule "-" Indicates information is not applicable * 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines 6 months through 35 months One or two doses*, 0.25 mL each If 2 doses, administer at least 1 month apart 36 months through 8 years One or two doses*, 0.5 mL each If 2 doses, administer at least 1 month apart 9 years and older One dose, 0.5 mL - 2.2 AdministrationInspect Fluzone visually for particulate matter and/or discoloration prior to administration. If either of these conditions exist, the vaccine should not be administered.
Before administering a dose of vaccine, shake the prefilled syringe or multi-dose vial. Withdraw a single dose of vaccine using a sterile needle and syringe. Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial.
The preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in persons ≥12 months through 35 months of age, or the deltoid muscle in persons ≥36 months of age. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.
Do not administer this product intravenously or subcutaneously.
Fluzone should not be combined through reconstitution or mixed with any other vaccine.
![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.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9a89671f-02c1-4f88-99b6-d5cb5654854f&name=fluzone-01.jpg)
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