AFLURIA® is an inactivated influenza virus vaccine indicated for active immunization of persons ages 18 years 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).

Prior to Administration

AFLURIA® should be inspected visually for particulate matter and discoloration prior to administration (see DESCRIPTION), 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 the 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 2-8°C (36-46°F) (see How Supplied/Storage and Handling). Once the stopper has been pierced, the vial must be discarded within 28 days.

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. Each 0.5 mL dose contains 15 micrograms (mcg) of influenza virus hemagglutinin (HA) from each of the three influenza virus strains included in the vaccine (see DESCRIPTION).

AFLURIA® is supplied in two presentations:

• 0.5 mL preservative-free, single-dose, pre-filled syringe.
• 5 mL multi-dose vial containing ten doses. Thimerosal, a mercury derivative, is added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.

Storage And Handling

AFLURIA® is supplied as a 0.5 mL preservative-free, single-dose pre-filled syringe (packaged without needles) and as a 5 mL multi-dose vial containing ten 0.5 mL doses, with thimerosal, a mercury derivative, added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.

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

CSL Limited Parkville, Victoria, 3052, Australia. US License No. 1764. Distributed by: CSL Biotherapies Inc. King of Prussia, PA 19406 USA. FDA Rev date: 9/28/2007

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