"The U.S. Food and Drug Administration today announced that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the preve"...
DOSAGE AND ADMINISTRATION
FOR INTRANASAL ADMINISTRATION BY A HEALTHCARE PROVIDER.
Administer FluMist Quadrivalent according to the following schedule:
|2 years through 8 years||1 or 2 dosesa,||If 2 doses, administerat least 1 month apart|
|0.2 mLb each|
|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
b Administer as 0.1 mL per nostril.
“-” indicates information is not applicable
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).
Note: Active inhalation (i.e., sniffing) is not required by the patient during vaccine administration.
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.Carton containing 10 intranasal sprayers: NDC 66019-303-10
Single intranasal sprayer: NDC 66019-303-01
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.
Keep FluMist Quadrivalent sprayer in outer carton in order to protect from light.
A single temperature excursion up to 25°C (77°F) 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, U.S. Government License No. 1799. Revised: July 2016.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/20/2016
Additional FluMist Information
FluMist - User Reviews
FluMist User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
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.
Find out what women really need.