Id Biomedical Corporation Of Quebec

For intramuscular injection only.

2.1 Dosage and Schedule

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

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.

2.2 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 Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial.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 2º and 8ºC (36º and 46ºF). 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.