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Details with Side Effects
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|
|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.|
Shake the multi-dose vial vigorously each time before withdrawing a dose of vaccine. 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.
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 Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial.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 5-mL multi-dose vials containing ten 0.5-mL doses.
Storage And Handling
FLULAVAL is supplied in a 5-mL multi-dose vial containing 10 doses (0.5-mL each).
NDC 19515-890-02 Vial (containing 10 doses) in Package of 1: NDC 19515-890-07.
Once entered, a multi-dose vial should be discarded after 28 days. 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 ID Biomedical Corporation of Quebec, Quebec City, QC, Canada, US License 1739. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709
Last reviewed on RxList: 11/25/2013
This monograph has been modified to include the generic and brand name in many instances.
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.
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