May 25, 2017
Recommended Topic Related To:


"Dec. 3, 2012 -- The U.S. flu season is here -- the earliest start since the "moderately severe" season of 2003.

Just as in 2003, the nasty H3N2 flu bug is causing most cases so far.

"This could be a bad flu year," warned CDC"...



How Supplied


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.


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
Aged 3 through 8 years 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)
Aged 9 years 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.

For the multi-dose vial, 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 Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial.

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.

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

FLULAVAL is a suspension for injection available in 0.5-mL prefilled TIP-LOK® syringes and 5-mL multi-dose vials containing 10 doses (each dose is 0.5 mL).

Storage And Handling

FLULAVAL is available in 0.5-mL single-dose disposable prefilled TIP-LOK syringes (packaged without needles) and in 5-mL multi-dose vials containing 10 doses (0.5-mL each).

NDC 19515-850-41 Syringe in Package of 10: NDC 19515-850-52
NDC 19515-845-01 Multi-Dose Vial (containing 10 doses) in Package of 1: NDC 19515-845-11

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. Once entered, a multi-dose vial should be discarded after 28 days.

Manufactured by ID Biomedical Corporation of Quebec, Quebec City, QC, Canada, US License 1739. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: June 2015

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

Last reviewed on RxList: 11/3/2015

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.

Living Better

Find the secrets to longer life.