Fluarix
FDA Approves Vaccines for the 2011-2012 Influenza Season »
"The U.S. Food and Drug Administration announced today that it has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the six manufacturers licensed to produce and distribute influenza vaccine for the United "...
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Fluarix
INDICATIONS
FLUARIX® is indicated for active immunization for the prevention of disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUARIX is approved for use in persons 3 years of age and older.
DOSAGE AND ADMINISTRATION
Preparation for Administration
Shake well before administration. 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.
Recommended Dose and Schedule
FLUARIX should be administered as an intramuscular injection preferably in the region of the deltoid muscle of the upper arm.
Children: Children 3 years to < 9 years of age previously unvaccinated or vaccinated for the first time last season with only one dose receive two 0.5 mL doses; each 0.5 mL dose is administered at least 4 weeks apart.
Children 3 years to < 9 years of age who have been previously vaccinated with 2 doses of any influenza vaccine receive only one 0.5 mL dose.
Children 9 years of age and older receive only one 0.5 mL dose.
Adults: Administer as a single 0.5 mL dose.
Do not administer this product intravenously, intradermally, or subcutaneously.
Do not inject in the gluteal area or areas where there may be a major nerve trunk.
HOW SUPPLIED
Dosage Forms And Strengths
FLUARIX is a suspension available in 0.5-mL single-dose prefilled TIP-LOK® syringes.
Storage And Handling
FLUARIX is supplied in 0.5-mL single-dose prefilled TIP-LOK syringes. The tip caps of the needleless prefilled syringes may contain natural rubber latex.
NDC 58160-878-52 (package of 10)
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 GlaxoSmithKline Biologicals, Dresden, Germany, a branch of SmithKline Beecham Pharma GmbH & Co. KG, Munich, Germany. Licensed by GlaxoSmithKline Biologicals, Rixensart, Belgium, US License 1617. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709. April 2011
Last reviewed on RxList: 1/10/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Fluarix 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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