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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 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.

DOSAGE AND ADMINISTRATION

Preparation for Administration

Inspect Influenza A (H1N1) 2009 Monovalent Vaccine syringes and vials visually for particulate matter and/or discoloration prior to administration. If either of these conditions exist, the vaccine should not be administered.

Shake the syringe and single-dose vials well before administering the vaccine and shake the multi-dose vial each time before withdrawing a dose of vaccine.

Recommended Dose and Schedule

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 naive 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 through 35 months of age should receive two 0.25 mL intramuscular doses approximately 1 month apart. (1)

Children 36 months through 9 years of age should receive two 0.5 mL intramuscular doses approximately 1 month apart. (1)

Children 10 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.

The vaccine should not be injected into the gluteal region or into areas where there may be a major nerve trunk.

Adults

Persons 18 years of age and older should receive a single 0.5 mL intramuscular dose.

In adults, the preferred site for intramuscular injection is the deltoid muscle.

The vaccine should not be injected into the gluteal region or into areas where there may be a major nerve trunk.

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 4 presentations:

  1. Prefilled syringe, 0.25 mL, no preservative, for 6 through 35 months of age; distinguished by a pink syringe plunger rod;
  2. Prefilled syringe, 0.5 mL, no preservative, for 36 months of age and older;
  3. Single-dose vial, 0.5 mL, no preservative, for 36 months of age and older;
  4. Multi-dose vial, 5 mL, for 6 months of age and older, contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose contains 25 micrograms (mcg) mercury.

How Supplied

Single-dose prefilled syringe, without needle, 0.25 mL, package of 10 prefilled syringes per carton – Product No. NDC 49281-650-25.

Single-dose prefilled syringe, without needle, 0.25 mL, package of 25 prefilled syringes per carton – Product No. NDC 49281-650-70.

Single-dose prefilled syringe, without needle, 0.5 mL, package of 10 prefilled syringes per carton – Product No. NDC 49281-650-50.

Single-dose prefilled syringe, without needle, 0.5 mL, package of 25 prefilled syringes per carton – Product No. NDC 49281-650-90.

Single-dose vial, 0.5 mL, package of 10 vials per carton – Product No. NDC 49281-650-10.

Multi-dose vial, 5 mL, one vial per carton. The vial contains ten 0.5 mL doses – Product No. NDC 49281-640-15.

Vial stoppers and syringe plungers do not contain latex.

Storage and Handling

Store all Influenza A (H1N1) 2009 Monovalent Vaccine presentations refrigerated at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Discard if vaccine has been frozen.

Between uses, return the multi-dose vial to the recommended storage conditions at 2 to 8C (35 to 46F).

Do not use after the expiration date shown on the label.

Manufactured by: Sanofi Pasteur Inc. Swiftwater PA 18370 USA. Product information as of September 2009.

Last reviewed on RxList: 11/5/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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