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

This indication is based on immune response elicited by FLUARIX, and there have been no controlled trials demonstrating a decrease in influenza disease after vaccination with FLUARIX (see CLINICAL PHARMACOLOGY).

The Advisory Committee on Immunization Practices (ACIP) has issued recommendations regarding the use of the inactivated influenza virus vaccine.³

Annual vaccination with the current vaccine is necessary because immunity declines during the year after vaccination. Vaccine prepared for a previous influenza season should not be administered to provide protection for the current season.³

FLUARIX IS NOT INDICATED FOR USE IN CHILDREN.

Concomitant Administration With Other Vaccines: There are insufficient data to assess the concurrent administration of FLUARIX with other vaccines.

Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration whenever solution and container permit. If either of these conditions exist, the vaccine should not be administered.

The prefilled syringe should be shaken well before administration.

Do NOT inject intravenously.

The dose of FLUARIX is a single 0.5 mL injection in adults. Injections of FLUARIX should be administered intramuscularly, preferably in the region of the deltoid muscle. 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. Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel.

STORAGE

Store FLUARIX refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen. Store in the original package to protect from light.

FLUARIX is supplied as a colorless to slightly opalescent suspension in prefilled syringes containing a 0.5-mL single dose.

Single-Dose Prefilled Disposable TIP-LOK® Syringes (packaged without needles) NDC 58160-874-46 (package of 5)

REFERENCES

3. Centers for Disease Control and Prevention. Prevention and control of influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2004;53(RR-6):1-44.

FLUARIX and TIP-LOK are registered trademarks of GlaxoSmithKline. TRITON is a registered trademark of Union Carbide Chemicals & Plastics Technology Corp. Manufactured by: Sächsisches Serumwerk (SSW), Dresden, Germany, a subsidiary of GlaxoSmithKline Biologicals, Rixensart, Belgium, US License 1617. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709. August 2007. FDA rev date: 7/24/2007

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