FLUCELVAX QUADRIVALENT (PRE-FILLED SYRINGE) (influenza a virus a/washington/19/2020 (h1n1) antigen (mdck cell derived, propiolac

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

INFLUENZA A VIRUS A/WASHINGTON/19/2020 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: 3YN85TU9MJ) (INFLUENZA A VIRUS A/WASHINGTON/19/2020 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:32SS7WU2J7), INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: 6ER9J3GB63) (INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:BUN3XFJ2B3),

Предлага се от:

Seqirus Inc.

Начин на приложение:

INTRAMUSCULAR

Терапевтични показания:

FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 6 months of age and older. [see Clinical Studies (14)] Do not administer FLUCELVAX QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine [see Description (11)] . Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are insufficient data for FLUCELVAX QUADRIVALENT in pregnant women to inform vaccine-associated risks in pregnancy. There were no developmental toxicity studies of FLUCELVAX QUADRIVALENT performed in animals. A developmental toxicity study has been performed in female r

Каталог на резюме:

FLUCELVAX QUADRIVALENT product presentations are listed in Table 11 below: Store this product refrigerated at 2°C to 8°C (36ºF to 46ºF). Between uses, return the multi-dose vial to the recommended storage conditions. Do not freeze. Protect from light. Do not use after the expiration date.

Статус Оторизация:

Biologic Licensing Application

Данни за продукта

FLUCELVAX QUADRIVALENT (PRE-FILLED SYRINGE) - INFLUENZA A VIRUS
A/WASHINGTON/19/2020 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE
INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) ANTIGEN
(MDCK CELL
DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/DARWIN/7/2019
ANTIGEN
(MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS
B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED,
PROPIOLACTONE
INACTIVATED) INJECTION, SUSPENSION
FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) - INFLUENZA A VIRUS
A/WASHINGTON/19/2020 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE
INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) ANTIGEN
(MDCK CELL
DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/DARWIN/7/2019
ANTIGEN
(MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS
B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED,
PROPIOLACTONE
INACTIVATED) INJECTION, SUSPENSION
SEQIRUS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUCELVAX
QUADRIVALENT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR FLUCELVAX
QUADRIVALENT.
FLUCELVAX QUADRIVALENT (INFLUENZA VACCINE)
SUSPENSION FOR INTRAMUSCULAR INJECTION
2021-2022 FORMULA
INITIAL U.S. APPROVAL: 2016
RECENT MAJOR CHANGES
Indications and Usage (1)
10/2021
Dosage and Administration (2.1)
10/2021
INDICATIONS AND USAGE
FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active
immunization for the prevention
of influenza disease caused by influenza virus subtypes A and types B
contained in the vaccine. (1)
FLUCELVAX QUADRIVALENT is approved for use in persons 6 months of age
and older. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR USE ONLY (2)
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.
(2)
AGE
DOSE
SCHEDULE
6 months through 8
years of age
One or two doses , 0.5 mL each
If 2 doses, administer at least 4
week