July 26, 2016
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Influenza A H1N1 Monovalent Vaccine

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Influenza A H1N1 Monovalent Vaccine

Indications
Dosage
How Supplied

INDICATIONS

Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons ages 6 months and older against influenza disease caused by pandemic (H1N1) 2009 virus.

This indication is based on the immune response elicited by the seasonal trivalent Influenza Virus Vaccine manufactured by CSL (AFLURIA®). CSL's Influenza A (H1N1) 2009 Monovalent Vaccine and AFLURIA are manufactured by the same process. There have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with AFLURIA (Clinical Studies).

DOSAGE AND ADMINISTRATION

Prior To Administration

Influenza A (H1N1) 2009 Monovalent Vaccine 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 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 -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.

Clinical studies are ongoing with Influenza A (H1N1) 2009 Monovalent Vaccine to determine the optimal dosage, number of doses and schedule.

Available data show that children 9 years of age and younger are largely serologically na´ve to the pandemic (H1N1) 2009 virus.1 Based upon these data Influenza A (H1N1) 2009 Monovalent Vaccine should be administered as follows:

Children

Children 6 months through 35 months of age should receive two 0.25 mL doses approximately 4 weeks apart.2

Children 36 months through 9 years of age should receive two 0.5 mL doses approximately 4 weeks apart.2

Children 10 years of age and older should receive a single 0.5 mL intramuscular dose.2

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

Persons 18 years of age and older should receive a single 0.5 mL intramuscular injection, preferably in the deltoid muscle of the upper arm.

HOW SUPPLIED

Dosage Forms And Strengths

Influenza A (H1N1) 2009 Monovalent Vaccine is a sterile suspension for intramuscular injection (see DESCRIPTION).

Influenza A (H1N1) 2009 Monovalent Vaccine is supplied in three presentations:

  • 0.25 mL single-dose, pre-filled syringe, no preservative.
  • 0.5 mL single-dose, pre-filled syringe, no preservative.
  • 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

How Supplied  NDC Number 
Package of ten 0.25 mL single-dose, prefilled syringes without needles  33332-519-25 
Package of ten 0.5 mL single-dose, prefilled syringes without needles  33332-519-01 
Package of one 5 mL multi-dose vial, which contains ten 0.5 mL doses  33332-629-10 

The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial contain no latex.

Store refrigerated at 2-8°C (36-46°F). Do not freeze. Protect from light. Do not use Influenza A (H1N1) 2009 Monovalent Vaccine beyond the expiration date printed on the label.

Manufactured by: CSL Limited, Parkville, Victoria, 3052, Australia, US License No. 1764. Distributed by: CSL Biotherapies Inc., King of Prussia, PA 19406, USA. Revised: Nov 2009

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/30/2015

Indications
Dosage
How Supplied

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