Fluzone High-Dose 60/60/60 injectable suspension

Fluzone High-Dose (Sanofi Pasteur), manufactured drug form of Influenza a virus a/california/7/2009 x-179a (h1n1) antigen (formaldehyde inactivated), influenza a virus a/victoria/210/2009 x-187 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/brisbane/60/2008 antigen (formaldehyde inactivated), 60ug/0.5mL influenza a virus a/california/7/2009 x-179a (h1n1) antigen (formaldehyde inactivated) ; 60ug/0.5mL influenza a virus a/victo... More

Available in:

NDC Product ID:

  • 49281-387

Manufacturer:

Manufactured drug form

Manufactured form of:

Label date:

  • Nov 4, 2010

Label link:

Label sections:

Section name Section URI Prominent warning Highlight text Section LOINC code
  • Recent Major Changes Section
  • No
  • 43683-2
  • 1. Indications And Usage
  • No
  • Fluzone is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. (1) Fluzone High-Dose is an inactivated influenza virus vaccine indicated for active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. (1) This indication is based on the immune response elicited by Fluzone High-Dose; there have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose.
  • 34067-9
  • 2. Dosage And Administration
  • No
  • 34068-7
  • 3. Dosage Forms And Strengths
  • No
  • Fluzone Sterile suspension for intramuscular injection supplied in four presentations: Prefilled syringe, 0.25 mL, pediatric dose, distinguished by a pink syringe plunger rod (3) Prefilled syringe, 0.5 mL, distinguished by a clear syringe plunger rod (3) Single-dose vial, 0.5 mL (3) Multi-dose vial, 5 mL, for 6 months of age and older, contains thimerosal as a preservative. (3, 11) Each 0.25 mL dose is formulated to contain a total of 22.5 mcg (7.5 mcg of each strain) of influenza virus hemagglutinin and each 0.5 mL dose is formulated to contain a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin. (3, 11) Fluzone High-Dose Sterile suspension for intramuscular injection supplied in prefilled syringes, 0.5 mL, distinguished by a gray syringe plunger rod. (3) Each 0.5 mL dose is formulated to contain a total of 180 mcg (60 mcg of each strain) of influenza virus hemagglutinin. (3, 11)
  • 43678-2
  • 4. Contraindications
  • No
  • Hypersensitivity to egg proteins or life-threatening reactions after previous administration of any influenza vaccine. (4, 11)
  • 34070-3
  • 5. Warnings And Precautions
  • No
  • If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give Fluzone or Fluzone High-Dose should be based on careful consideration of the potential benefits and risks. (5.1) The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals. (5.3)
  • 43685-7
  • 6. Adverse Reactions
  • No
  • Fluzone Most common (≥10%) injection-site reactions were injection site tenderness, pain, swelling and arm stiffness. (6) Most common (≥10%) systemic adverse events were headache and myalgia. (6) Fluzone High-Dose Most common (≥10%) injection-site reactions were injection site pain and erythema. (6) Most common (≥10%) systemic adverse events were myalgia, malaise, and headache. (6) To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 at 1-800-822-2463 (1-800-VACCINE) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
  • 34084-4
  • 8. Use In Specific Populations
  • No
  • Fluzone Safety and effectiveness of Fluzone have not been established in pregnant women, nursing mothers, or children <6 months of age. (8.1, 8.3, 8.4) Fluzone High-Dose Safety and effectiveness of Fluzone High-Dose have not been established in pregnant women, nursing mothers, or individuals <65 years of age. (8.1, 8.3, 8.4)
  • 43684-0
  • 11. Description
  • No
  • 34089-3
  • 12. Clinical Pharmacology
  • No
  • 34090-1
View entire collection »

Discontinued:

  • Yes

Marketing start date:

  • Jul 23, 2010

Marketing end date:

  • Jun 30, 2011

FDA application number:

  • BLA103914
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