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Influenza A H1N1 Intranasal Vaccine

"The U.S. Food and Drug Administration today approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu. The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in peopl"...

Influenza A H1N1 Intranasal Vaccine

Indications
Dosage
How Supplied

INDICATIONS

Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is indicated for the active immunization of individuals 2-49 years of age against influenza disease caused by pandemic (H1N1) 2009 virus.

DOSAGE AND ADMINISTRATION

FOR INTRANASAL ADMINISTRATION BY A HEALTH CARE PROVIDER.

Dosing Information

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

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 Live, Intranasal should be administered as follows:

Age Group Dosage Schedule
Children age 2 years through 9 years 2 doses (0.2 mL* each, approximately 1 month apart)
Children, adolescents and adults age 10 through 49 years 1 dose (0.2 mL*)
* Administer as 0.1 mL per nostril.

Each 0.2 mL dose is administered as 0.1 mL per nostril.

Administration Instructions

Each sprayer contains a single dose; approximately one-half of the contents should be administered into each nostril. Refer to the administration diagram (Figure 1) for step-by-step administration instructions. Once the vaccine has been administered, the sprayer should be disposed of according to the standard procedures for medical waste (e.g., sharps container or biohazard container).

Figure 1

Administration Instructions - Illustration

Note: Active inhalation (i.e., sniffing) is not required by the patient during vaccine administration

HOW SUPPLIED

Dosage Forms And Strengths

Pre-filled, single-dose intranasal sprayer containing 0.2 mL suspension [See DESCRIPTION].

Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is supplied for intranasal delivery in a package of 10 pre-filled, single-use sprayers.

NDC 66019-200-10

Storage and Handling

Once Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal has been administered, the sprayer should be disposed of according to the standard procedures for medical waste (e.g., sharps container or biohazard container).

INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE LIVE, INTRANASAL SHOULD BE STORED IN A REFRIGERATOR BETWEEN 2-8°C (35-46°F) UPON RECEIPT AND UNTIL USE. THE PRODUCT MUST BE USED BEFORE THE EXPIRATION DATE ON THE SPRAYER LABEL.

DO NOT FREEZE.

The cold chain (2 to 8°C) must be maintained when transporting Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal.

Manufactured by: MedImmune, LLC Gaithersburg, MD 20878. 1-877-633-4411. Issue Date: 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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