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Flulaval

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Flulaval

Flulaval

INDICATIONS

FLULAVAL® is indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. FLULAVAL is approved for use in persons 3 years of age and older.

DOSAGE AND ADMINISTRATION

For intramuscular injection only.

Dosage and Schedule

The dose and schedule for FLULAVAL are presented in Table 1.

Table 1: FLULAVAL: Dosing

Age Vaccination Status Dose and Schedule
3 through 8 years of age Not previously vaccinated with influenza vaccine Two doses (0.5-mL each) at least 4 weeks apart
Vaccinated with influenza vaccine in a previous season One or two dosesa (0.5-mL each)
9 years of age and older Not applicable One 0.5-mL dose
a One dose or two doses (0.5-mL each) depending on vaccination history as per the annual Advisory Committee on Immunization Practices (ACIP) recommendation on prevention and control of influenza with vaccines. If two doses, administer each 0.5-mL dose at least 4 weeks apart.

Administration Instructions

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.

Use a sterile needle and sterile syringe to withdraw the 0.5-mL dose from the multi-dose vial and administer intramuscularly. A sterile syringe with a needle bore no larger than 23 gauge is recommended for administration. It is recommended that small syringes (0.5 mL or 1 mL) be used to minimize any product loss. Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial.

The preferred site for intramuscular injection is the deltoid muscle of the upper arm. Do not inject in the gluteal area or areas where there may be a major nerve trunk.

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.

Do not administer this product intravenously, intradermally, or subcutaneously.

HOW SUPPLIED

Dosage Forms And Strengths

FLULAVAL is a suspension for injection available in 5-mL multi-dose vials containing ten 0.5-mL doses.

Storage And Handling

FLULAVAL is supplied in a 5-mL multi-dose vial containing 10 doses (0.5-mL each).

NDC 19515-890-02 Vial (containing 10 doses) in Package of 1: NDC 19515-890-07.

Once entered, a 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.

Manufactured by ID Biomedical Corporation of Quebec, Quebec City, QC, Canada, US License 1739. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709

Last reviewed on RxList: 11/25/2013
This monograph has been modified to include the generic and brand name in many instances.

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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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