April 28, 2017
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How Supplied


FLUARIX® is indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine [see DESCRIPTION].

FLUARIX is approved for use in persons 3 years of age and older.


For intramuscular injection only.

Dosage And Schedule

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

Table 1: FLUARIX: 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 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.

Attach a sterile needle to the prefilled syringe and administer intramuscularly.

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.

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


Dosage Forms And Strengths

FLUARIX is a suspension for injection. Each 0.5-mL dose is supplied in single-dose prefilled TIP-LOK® syringes.

Storage And Handling

FLUARIX is supplied in 0.5-mL single-dose prefilled TIP-LOK syringes (packaged without needles).

NDC 58160-881-41 Syringe in Package of 10: NDC 58160-881-52

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.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 9/8/2014

How Supplied

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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