Flulaval
2009-2010 Inactivated Influenza Vaccine »
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Flulaval
INDICATIONS
FLULAVAL® is indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLULAVAL is approved for use in persons 18 years of age and older.
This indication is based on immune response elicited by FLULAVAL, and there have been no controlled trials adequately demonstrating a decrease in influenza disease after vaccination with FLULAVAL [see Clinical Studies].
DOSAGE AND ADMINISTRATION
For intramuscular administration only.
Preparation for Administration
Shake the multi-dose vial vigorously each time before withdrawing a dose of vaccine. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.
Between uses, return the multi-dose vial to the recommended storage conditions, between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen. Once entered, a multi-dose vial, and any residual contents, should be discarded after 28 days.
It is recommended that small syringes (0.5-mL or 1-mL) be used to minimize any product loss.
Recommended Dose and Schedule
FLULAVAL should be administered as a single 0.5-mL injection by the intramuscular route preferably in the region of the deltoid muscle of the upper arm.
Do not administer this product intravenously, intradermally or subcutaneously.
HOW SUPPLIED
Dosage Forms And Strengths
FLULAVAL is a suspension available in 5-mL multi-dose vials containing 10 doses (each dose is 0.5 mL).
Storage And Handling
FLULAVAL is supplied in a 5-mL multi-dose vial containing ten 0.5-mL doses. Once entered, the multi-dose vial should be discarded after 28 days.
Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen. Store in the original package to protect from light.
NDC 19515-888-07 (package of 1 vial containing 10 doses)
Manufactured by ID Biomedical Corporation of Quebec, Quebec City, QC, Canada. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709. June 2011
Last reviewed on RxList: 1/10/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Flulaval 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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