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Flulaval (Influenza Virus Vaccine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

FLULAVAL® is indicated for active immunization of adults (18 years of age and older) against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

This indication is based on immune response elicited by FLULAVAL, and there have been no controlled trials demonstrating a decrease in influenza disease after vaccination with FLULAVAL [see Clinical Studies].

DOSAGE AND ADMINISTRATION

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 8C (36 and 46F). 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.

The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk. A needle length of ≥1 inch is preferred because needles <1 inch might be of insufficient length to penetrate muscle tissue in certain adults.

Do not administer this product intravenously, intradermally or subcutaneously.

DOSAGE FORMS AND STRENGTHS

FLULAVAL is a suspension available in 5-mL multi-dose vials containing 10 doses.

HOW SUPPLIED/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 8C (36 and 46F). Do not freeze. Discard if the vaccine has been frozen. Store in the original package to protect from light.

NDC 19515-887-07 (package of 1 vial containing 10 doses)

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