"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 "...
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|
|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.|
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 Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial.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.
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 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/3/2015
Additional Flulaval 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.
Find the secrets to longer life.