FluMist is a live attenuated influenza virus vaccine indicated for the active immunization of individuals 2-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

FOR INTRANASAL ADMINISTRATION BY A HEALTH CARE PROVIDER.

Dosing Information

FluMist should be administered according to the following schedule:

For children age 2 years through 8 years who have not previously received influenza vaccine, the recommended dosage schedule for nasal administration is one 0.2 mL dose (0.1 mL per nostril) followed by a second 0.2 mL dose (0.1 mL per nostril) given at least 1 month later.

For all other individuals, including children age 2-8 years who have previously received influenza vaccine, the recommended schedule is one 0.2 mL dose (0.1 mL per nostril).

FluMist should be administered prior to exposure to influenza. Annual revaccination with influenza vaccine is recommended.

Administration Instructions

Each sprayer contains a single dose of FluMist; approximately one-half of the contents should be administered into each nostril. 0.1 mL (i.e., half of the dose from a single FluMist sprayer) is administered into each nostril while the recipient is in an upright position. Insert the tip of the sprayer just inside the nose and rapidly depress the plunger until the dose-divider clip stops the plunger. The dose-divider clip is removed from the sprayer to administer the second half of the dose (0.1 mL) into the other nostril. Once FluMist has been administered, the sprayer should be disposed of according to the standard procedures for medical waste (e.g., sharps container or biohazard container).

Dosage Forms And Strengths

0.2 mL pre-filled, single-use intranasal spray.

Each 0.2 mL dose of FluMist is formulated to contain 10^6.5-7.5 FFU (fluorescent focus units) of each of three live attenuated influenza virus reassortants: A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004 [1].

Storage And Handling

FluMist is supplied for intranasal delivery in a package of 10 pre-filled, single-use sprayers. NDC 66019-105-01

Storage and Handling

Once FluMist has been administered, the sprayer should be disposed of according to the standard procedures for medical waste (e.g., sharps container or biohazard container).

FLUMIST SHOULD BE STORED IN A REFRIGERATOR BETWEEN 2-8°C (35-46°F) UPON RECEIPT AND UNTIL USE BEFORE THE EXPIRATION DATE ON THE SPRAYER LABEL.

DO NOT FREEZE.

The cold chain (2 to 8°C) must be maintained when transporting FluMist.

FluMist® is a registered trademark of MedImmune Vaccines, Inc. Manufactured by: MedImmune Vaccines, Inc. Gaithersburg, MD 20878. For other product information regarding FluMist, call 1-877-FLUMIST (358-6478). Issue Date: September 2007. FDA Rev date: 9/19/2007

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