FLUMIST QUADRIVALENT- influenza vaccine live intranasal spray

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

INFLUENZA A VIRUS A/NORWAY/31694/2022 (H1N1) LIVE (ATTENUATED) ANTIGEN (UNII: FV9FGC9YZW) (INFLUENZA A VIRUS A/NORWAY/31694/2022 (H1N1) LIVE (ATTENUATED) ANTIGEN - UNII:FV9FGC9YZW), INFLUENZA A VIRUS A/NORWAY/16606/2021 (H3N2) LIVE (ATTENUATED) ANTIGEN (UNII: L7Z42HP5RZ) (INFLUENZA A VIRUS A/NORWAY/16606/2021 (H3N2) LIVE (ATTENUATED) ANTIGEN - UNII:L7Z42HP5RZ), INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 LIVE (ATTENUATED) ANTIGEN (UNII: JV6ND6VMY5) (INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 LIVE (ATTENUATED)

제공처:

MedImmune, LLC

INN (국제 이름):

INFLUENZA A VIRUS A/SLOVENIA/2903/2015 LIVE ANTIGEN LIVE ANTIGEN - UNII:ESO7BC4H6F)

구성:

INFLUENZA A VIRUS A/SLOVENIA/2903/2015 (H1N1) LIVE (ATTENUATED) ANTIGEN 10000000 [FFU] in 0.2 mL

관리 경로:

NASAL

치료 징후:

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 (11)] . FluMist Quadrivalent is approved for use in persons 2 through 49 years of age. Do not administer FluMist Quadrivalent to persons who have had a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see Description (11)] including egg protein, or after a previous dose of any influenza vaccine. Do not administer FluMist Quadrivalent to children and adolescents through 17 years of age who are receiving aspirin therapy or aspirin-containing therapy because of the association of Reye’s syndrome with aspirin and wild-type influenza infection [see Drug Interactions (7.1)] . Risk Summary FluMist Quadrivalent is not absorbed systemically following intranasal administration and maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations Disease-Ass

제품 요약:

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 66019-310-10 Single intranasal sprayer: NDC 66019-310-01 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 NOT BE USED AFTER 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).

승인 상태:

Biologic Licensing Application

제품 특성 요약

FLUMIST QUADRIVALENT- INFLUENZA VACCINE LIVE INTRANASAL SPRAY
MEDIMMUNE, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUMIST QUADRIVALENT
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUMIST
QUADRIVALENT.
FLUMIST QUADRIVALENT (INFLUENZA VACCINE LIVE, INTRANASAL)
INTRANASAL SPRAY
2023-2024 FORMULA
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
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. (1, 11)
FluMist Quadrivalent is approved for use in persons 2 through 49 years
of age. (1)
DOSAGE AND ADMINISTRATION
For intranasal administration by a healthcare provider. (2)
*
†
AGE
DOSE
SCHEDULE
2 years through 8 years
1 or 2 doses ,
0.2 mL each
If 2 doses, administer at least 1
month apart
9 years through 49 years
1 dose, 0.2 mL
-
“-” indicates information is not applicable.
DOSAGE FORMS AND STRENGTHS
Each 0.2 mL dose is a suspension supplied in a single-dose pre-filled
intranasal sprayer. (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
The most common solicited adverse reactions (≥10% in vaccine
recipients and at least 5% greater than in
placebo recipients) reported after FluMist were runny nose or nasal
congestion (ages 2 years through 49
years), fever over 100°F (children ages 2 years through 6 years), and
sore throat (adults ages 18 years
through 49 years). Among children and adolescents 2 through 17 years
of age who received FluMist
Quadrivalent, 32% reported runny nose or nasal congestion and 7%
reported fever over 100°F. Among
adults 18 through 49 years of age who received FluMist Quadrivalent,
44% reported runny nose or nasal
congestion and 19% reported sore throat. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MEDIMMUNE AT
1-877-633-4411 OR
VAERS AT 1-800-822-7967 OR _HTTP://VAERS.HHS.GOV._
DRUG INTERACTIONS
®
®
®
1 or 2