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Influenza A H1N1 Intranasal Vaccine

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Influenza A H1N1 Intranasal Vaccine

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.

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