FLUARIX QUADRIVALENT 2023/2024- influenza virus vaccine suspension

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: AU5C98U4BB) (INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:C46XJT9FQ9), INFLUENZA A VIRUS A/DARWIN/6/2021 IVR-227 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: F5QV7AF326) (INFLUENZA A VIRUS A/DARWIN/6/2021 IVR-227 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:N969QK7XD2), INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN

可用日期:

GlaxoSmithKline Biologicals SA

INN（国际名称）:

INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 ANTIGEN HEMAGGLUTININ ANTIGEN - UNII:LD80H821HF)

组成:

INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL

给药途径:

INTRAMUSCULAR

疗效迹象:

FLUARIX QUADRIVALENT is indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine [see Description (11)] . FLUARIX QUADRIVALENT is approved for use in persons aged 6 months and older. Do not administer FLUARIX QUADRIVALENT to anyone with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or following a previous administration of any influenza 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. Available data from a pregnancy registry do not suggest an increased risk of major birth defects and miscarriage in individuals who received FLUARIX QUADRIVALENT within 28 days prior to conception or during pregnancy (see D

產品總結:

FLUARIX QUADRIVALENT is available in 0.5-mL single-dose, disposable, prefilled TIP-LOK syringes (packaged without needles). NDC 58160-909-41 Syringe in Package of 10: NDC 58160-909-52 Store refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen. Store in the original package to protect from light.

授权状态:

Biologic Licensing Application

产品特点

FLUARIX QUADRIVALENT 2022/2023- INFLUENZA VIRUS VACCINE SUSPENSION
FLUARIX QUADRIVALENT 2023/2024- INFLUENZA VIRUS VACCINE SUSPENSION
GLAXOSMITHKLINE BIOLOGICALS SA
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUARIX QUADRIVALENT
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUARIX
QUADRIVALENT.
FLUARIX QUADRIVALENT (INFLUENZA VACCINE) INJECTABLE SUSPENSION, FOR
INTRAMUSCULAR USE
2023-2024 FORMULA
INITIAL U.S. APPROVAL: 2012
INDICATIONS AND USAGE
FLUARIX QUADRIVALENT is a vaccine indicated for active immunization
for the prevention of disease
caused by influenza A subtype viruses and type B viruses contained in
the vaccine. FLUARIX
QUADRIVALENT is approved for use in persons aged 6 months and older.
(1)
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR INJECTION ONLY. (2)
One dose or 2 doses (0.5‑mL each) depending on vaccination history
as per the annual Advisory
Committee on Immunization Practices (ACIP) recommendation on
prevention and control of seasonal
influenza with vaccines. If 2 doses, administer each 0.5‑mL dose at
least 4 weeks apart. (2.1)
AGE
VACCINATION STATUS
DOSE AND SCHEDULE
6 months through 8 years
Not previously vaccinated with
influenza vaccine
Two doses (0.5‑mL each) at least 4
weeks apart (2.1)
Vaccinated with influenza vaccine in a
previous season
One or 2 doses
(0.5‑mL each) (2.1)
9 years and older
Not applicable
One 0.5‑mL dose (2.1)
DOSAGE FORMS AND STRENGTHS
Suspension for injection supplied in 0.5‑mL single-dose prefilled
syringes. (3)
CONTRAINDICATIONS
History of severe allergic reactions (e.g., anaphylaxis) to any
component of the vaccine, including egg
protein, or following a previous dose of any influenza vaccine. (4,
11)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
•
•
•
•
a
a
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of
a prior influenza vaccine, the
decision to give FLUARIX QUADRIVALENT should be based on careful
consideration of potential
benefits