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- Patient Information:
Details with Side Effects
DOSAGE AND ADMINISTRATION
- For intramuscular use only
Dose and Schedule
The dose and schedule for Fluzone is presented in Table 1.
Table 1: Fluzone
|6 months through 35 months||One or two dosesa , 0.25 mL each||If 2 doses, administer at least 1 month apart|
|36 months through 8 years||One or two dosesa , 0.5 mL each||If 2 doses, administer at least 1 month apart|
|9 years and older||One dose, 0.5 mL||-|
|a1 or 2 doses depends on vaccination history
as per Advisory Committee on Immunization Practices annual recommendations on
prevention and control of influenza with vaccines.
“-” indicates information is not applicable
Inspect 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 single-dose 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 Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial.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 vaccine should not be combined through reconstitution or mixed with any other vaccine.
Dosage Forms And Strengths
Fluzone is a suspension for injection.
Fluzone is supplied in 4 presentations:
- Prefilled syringe (pink syringe plunger rod), 0.25 mL, for persons 6 months through 35 months of age.
- Prefilled syringe (clear syringe plunger rod), 0.5 mL, for persons 36 months of age and older.
- Single-dose vial, 0.5 mL, for persons 36 months of age and older.
- Multi-dose vial, 5 mL, for persons 6 months of age and older.
Single-dose, prefilled syringe, without needle, 0.25 mL (NDC 49281-113-00) (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-113-25).
Single-dose, prefilled syringe, without needle, 0.5 mL (NDC 49281-013-88) (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-013-50).
Single-dose vial, 0.5 mL (NDC 49281-013-58) (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-013-10).
Multi-dose vial, 5 mL (NDC 49281-392-78) (not made with natural rubber latex). The vial contains ten 0.5 mL doses. Supplied as package of one (NDC 49281-392-15).
Storage and Handling
Store all Fluzone presentations refrigerated at 2° to 8°C (35° to 46°F). DO NOT FREEZE.
Discard if vaccine has been frozen.
Between uses, return the multi-dose vial to the recommended storage conditions at 2° to 8°C (35° to 46°F).
Do not use after the expiration date shown on the label.
Manufactured by: Sanofi Pasteur Inc. Swiftwater, PA 18370 USA. Revised: April 2013
Last reviewed on RxList: 11/25/2013
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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