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Fluvirin (Influenza Virus Vaccine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

FLUVIRIN® is an inactivated influenza virus vaccine indicated for immunization of persons 4 years of age and older against influenza virus disease caused by influenza virus subtypes A and type B contained in the vaccine. [see DOSAGE FORMS AND STRENGTHS (3)]

FLUVIRIN® is not indicated for children less than 4 years of age because there is evidence of diminished immune response in this age group.

DOSAGE AND ADMINISTRATION

Preparation for Administration

Inspect FLUVIRIN® syringes and multidose vials visually for particulate matter and/or discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered.

Shake the syringe vigorously before administering the vaccine and shake the multidose vial preparation each time before withdrawing a dose of vaccine.

Between uses, return the multidose vial to the recommended storage conditions between 2 and 8C (36 and 46F). Do not freeze. Discard if the vaccine has been frozen.

A separate syringe and needle or a sterile disposable unit should be used for each injection to prevent transmission of infectious agents from one person to another. Needles should be disposed of properly and not recapped.

It is recommended that small syringes (0.5-mL or 1-mL) should be used to minimize any product loss.

Recommended Dose and Schedule

Children (4 to 17 years of age):

Children aged 4 to 8 years should receive 2 doses of vaccine if they have not been vaccinated previously at any time with any influenza virus vaccine. Children aged 4 to 8 years who received only 1 dose in their first year of vaccination in the previous season should receive 2 doses. FLUVIRIN® should be given as a 0.5-mL intramuscular injection on day 1 followed by another 0.5-mL intramuscular injection at least 4 weeks later. 2 doses are required for protection in these children. (15.3)

Children aged 4 to 8 years who have been vaccinated with two doses of any influenza virus vaccine in the previous season, or with one dose in the year prior to the previous season, should receive only one dose. (15.3)

Children aged 9 years and older should receive a single 0.5-mL intramuscular injection.

The needle size may range from 7/8 to 1 inches, depending on the size of the child's deltoid muscle, and should be of sufficient length to penetrate the muscle tissue. The anterolateral thigh can be used, but the needle should be longer, usually 1 inch.

Adults (18 years and older):

FLUVIRIN® should be administered as a single 0.5-mL intramuscular injection preferably in the region of the deltoid muscle of the upper arm.

The vaccine should not be injected in the gluteal region or areas where there may be a major nerve trunk. A needle of ≥1 inch is preferred because needles <1 inch might be of insufficient length to penetrate muscle tissue in certain adults.

DOSAGE FORMS AND STRENGTHS

FLUVIRIN® is a sterile suspension for intramuscular injection. Each 0.5-mL dose contains 15 mcg hemagglutinin from each of the following 3 influenza virus types: A/Brisbane/59/2007, IVR-148 (H1N1); A/Uruguay/716/2007, NYMC X-175C (H3N2) (an A/Brisbane/10/2007-like virus); and B/Brisbane/60/2008. [see DESCRIPTION]

FLUVIRIN® is available in two presentations:

  • Prefilled syringe, 0.5-mL. Thimerosal, a mercury derivative used during manufacture, is removed by subsequent purification steps to a trace amount (≤1 mcg mercury per 0.5-mL dose).
  • Multidose vial, 5-mL. Contains thimerosal, a mercury derivative, added as a preservative. Each 0.5-mL dose from the multidose vial contains 25 mcg mercury.

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

FLUVIRIN® is supplied as a 0.5-mL prefilled syringe, package of 10 syringes per carton. NDC 66521-112-02

FLUVIRIN® is supplied as a 5-mL multidose vial, individually packaged in a carton. NDC 66521-112-10

Storage and Handling

Store FLUVIRIN® refrigerated between 2 and 8C (36 and 46F).

Do not freeze. Discard if the vaccine has been frozen.

Store in the original package to protect from light.

Do not use after the expiration date.

Between uses, return the multidose vial to the recommended storage conditions.

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