FLULAVAL QUADRIVALENT 2023/2024- influenza virus vaccine suspension

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED) (UNII: A5PTS27URJ) (INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED) - UNII:9HA5C4XL36), INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED) (UNII: P483J7GX6D) (INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED) - UNII:GRN94TP8YV), INFLUENZA B VIRUS B/AUSTRIA/1359417/2021

から入手可能:

ID Biomedical Corporation of Quebec

INN（国際名）:

INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 ANTIGEN HEMAGGLUTININ ANTIGEN - UNII:23D1E6C9UI)

構図:

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

投与経路:

INTRAMUSCULAR

適応症:

FLULAVAL 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. FLULAVAL QUADRIVALENT is approved for use in persons aged 6 months and older. Do not administer FLULAVAL 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 dose 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. There are insufficient data on FLULAVAL QUADRIVALENT in pregnant women to inform vaccine-associated risks. A developmental toxicity study was performed in female rats administered FLULAVAL QUADRIVALENT prior to mating and during gestation and lactation p

製品概要:

FLULAVAL QUADRIVALENT is available in 0.5-mL single-dose, disposable, prefilled TIP-LOK syringes (packaged without needles). NDC 19515-814-41 Syringe in Package of 10: NDC 19515-814-52 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.

認証ステータス:

Biologic Licensing Application

製品の特徴

FLULAVAL QUADRIVALENT 2023/2024- INFLUENZA VIRUS VACCINE SUSPENSION
ID BIOMEDICAL CORPORATION OF QUEBEC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLULAVAL QUADRIVALENT
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLULAVAL
QUADRIVALENT.
FLULAVAL QUADRIVALENT (INFLUENZA VACCINE) INJECTABLE SUSPENSION, FOR
INTRAMUSCULAR USE
2023-2024 FORMULA
INITIAL U.S. APPROVAL: 2013
INDICATIONS AND USAGE
FLULAVAL 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. FLULAVAL
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 FLULAVAL QUADRIVALENT should be based on careful
consideration of the potential
benefits and risks. (5.1)
Syncope (fainting) can occur in