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Afluria (Influenza Virus Vaccine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

AFLURIA® is an inactivated influenza virus vaccine indicated for active immunization of persons ages 6 months and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

This indication is based on the immune response elicited by AFLURIA; there have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with AFLURIA (see Clinical Studies [14] ).

DOSAGE AND ADMINISTRATION

Prior to Administration

AFLURIA should be inspected visually for particulate matter and discoloration prior to administration (see Description [11] ), whenever suspension and container permit. If either of these conditions exists, the vaccine should not be administered. Any vaccine that has been frozen or is suspected of being frozen must not be used.

Administration

When using a preservative-free, single-dose syringe, shake the syringe thoroughly and administer the dose immediately.

When using the multi-dose vial, shake the vial thoroughly before withdrawing each dose, and administer the dose immediately. Between uses, store the vial at 2—8C (36—46F) (see How Supplied/Storage and Handling [16] ). Once the stopper has been pierced, the vial must be discarded within 28 days.

Children

Children 6 months through 35 months of age not previously vaccinated with an influenza vaccine, or vaccinated for the first time last season with only one dose, should receive two 0.25 mL doses: one on day 1 followed by another approximately 4 weeks later. Children 6 months through 35 months of age given two doses of any influenza vaccine last season, or at least one dose two or more years ago, should receive only one 0.25 mL dose.1

Children 36 months through 8 years of age not previously vaccinated with an influenza vaccine, or vaccinated for the first time last season with only one dose, should receive two 0.5 mL doses: one on day 1 followed by another approximately 4 weeks later. Children 36 months through 8 years of age given two doses last season, or at least one dose two or more years ago, should receive only one 0.5 mL dose.1

Children 9 years of age and older should receive a single 0.5 mL intramuscular dose.1

The preferred sites for intramuscular injections are the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in toddlers and young children.

Adults

AFLURIA should be administered as a single 0.5 mL intramuscular injection, preferably in the deltoid muscle of the upper arm.

DOSAGE FORMS AND STRENGTHS

AFLURIA is a sterile suspension for intramuscular injection (see Description [11] ).

AFLURIA is supplied in two presentations:

  • 0.5 mL single-dose, pre-filled syringe, no preservative.
  • 5 mL multi-dose vial. Thimerosal, a mercury derivative, is added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied NDC Number
Package of ten 0.5 mL single-dose, prefilled syringes without needles 33332-010-01
Package of one 5 mL multi-dose vial, which contains ten 0.5 mL doses 33332-110-10

Store refrigerated at 2—8C (36—46F). Do not freeze. Protect from light. Do not use AFLURIA beyond the expiration date printed on the label.

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