July 2, 2015
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FluMist

"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"...

FluMist




Indications
Dosage
How Supplied

INDICATIONS

FluMist® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine [see DESCRIPTION].

Quadrivalent is approved for use in persons 2 through 49 years of age.

DOSAGE AND ADMINISTRATION

FOR INTRANASAL ADMINISTRATION BY A HEALTHCARE PROVIDER.

Dosing Information

Administer FluMist Quadrivalent according to the following schedule:

Age Dose Schedule
2 years through 8 years 1 or 2 dosesa, 0.2 mLb each If 2 doses, administer at least 1 month apart
9 years through 49 years 1 dose, 0.2 mLb -
a 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines.
b Administer as 0.1 mL per nostril.
“-” indicates information is not applicable

Administration Instructions

Each sprayer contains a single dose (0.2 mL) of FluMist Quadrivalent; administer approximately one half of the contents of the single-dose intranasal sprayer into each nostril (each sprayer contains 0.2 mL of vaccine). Refer to Figure 1 for step-by-step administration instructions. Following administration, dispose of the sprayer according to the standard procedures for medical waste (e.g., sharps container or biohazard container).

Figure 1

Administration Instructions -  Illustration

Do not inject or use a needle - Illustration

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

HOW SUPPLIED

Dosage Forms And Strengths

Each 0.2 mL dose is a suspension supplied in a single-dose pre-filled intranasal sprayer.

FluMist Quadrivalent is supplied in a package of 10 pre-filled, single-dose (0.2 mL) intranasal sprayers. The single-use intranasal sprayer is not made with natural rubber latex.

NDC 66019-301-10

Storage And Handling

The cold chain [2-8°C (35-46°F)] must be maintained when transporting FluMist Quadrivalent.

FLUMIST QUADRIVALENT SHOULD BE STORED IN A REFRIGERATOR BETWEEN 2-8°C (35-46°F) UPON RECEIPT. THE PRODUCT MUST BE USED BEFORE THE EXPIRATION DATE ON THE SPRAYER LABEL. DO NOT FREEZE.

A single temperature excursion up to 25°C for 12 hours has been shown to have no adverse impact on the vaccine. After a temperature excursion, the vaccine should be returned immediately to the recommended storage condition (2°C - 8°C) and used as soon as feasible. Subsequent excursions are not permitted.

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

Manufactured by: MedImmune, LLC, Gaithersburg, MD 20878, 1-877-633-4411. Issue Date: July 2014.

Last reviewed on RxList: 5/12/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

FluMist - User Reviews

FluMist User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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