FLUZONE HIGH-DOSE QUADRIVALENT NORTHERN HEMISPHERE (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: KJA387FHB2) (INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:6S4Y8A8UEY), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHY

Verfügbar ab:

Sanofi Pasteur Inc.

Verabreichungsweg:

INTRAMUSCULAR

Anwendungsgebiete:

Fluzone® High-Dose Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone High-Dose Quadrivalent is indicated for use in persons 65 years of age and older. A severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see Description (11)] , including egg protein, or to a previous dose of any influenza vaccine is a contraindication to administration of Fluzone High-Dose Quadrivalent. Fluzone High-Dose Quadrivalent is not approved for use in persons <65 years of age. There are limited human data on Fluzone High-Dose and no animal data available on Fluzone High-Dose Quadrivalent to establish whether there is a vaccine-associated risk with use of Fluzone High-Dose Quadrivalent in pregnancy. Fluzone High-Dose Quadrivalent is not approved for use in persons <65 years of age. No human or animal data are available to assess the effects of Fluzone High-Dose Quadrivalent on

Produktbesonderheiten:

Single-dose, prefilled syringe, without needle, 0.7 mL (NDC 49281-123-88) (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-123-65). Store Fluzone High-Dose Quadrivalent refrigerated at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Discard if vaccine has been frozen. Do not use after the expiration date shown on the label.

Berechtigungsstatus:

Biologic Licensing Application

Fachinformation

FLUZONE HIGH-DOSE QUADRIVALENT NORTHERN HEMISPHERE- INFLUENZA A
VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE
INACTIVATED),
INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE
INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN
(FORMALDEHYDE
INACTIVATED), AND INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN
(FORMALDEHYDE
INACTIVATED) INJECTION, SUSPENSION
SANOFI PASTEUR INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUZONE HIGH-DOSE
QUADRIVALENT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR FLUZONE HIGH-DOSE
QUADRIVALENT.
FLUZONE HIGH-DOSE QUADRIVALENT (INFLUENZA VACCINE), SUSPENSION, FOR
INTRAMUSCULAR INJECTION
2023-2024 FORMULA
INITIAL U.S. APPROVAL: 2019
RECENT MAJOR CHANGES
Warnings and Precautions (5.5)
11/2023
INDICATIONS AND USAGE
FLUZONE HIGH-DOSE 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)
FLUZONE HIGH-DOSE QUADRIVALENT is approved for use in persons 65 years
of age and older. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR USE ONLY
A single 0.7 mL dose for intramuscular injection in adults 65 years of
age and older (2.1)
DOSAGE FORMS AND STRENGTHS
Suspension for injection in prefilled syringe, 0.7 mL (3)
CONTRAINDICATIONS
Severe allergic reaction to any component of the vaccine, including
egg protein, or after previous dose of
any influenza vaccine (4)
WARNINGS AND PRECAUTIONS
If Guillain-Barré syndrome (GBS) has occurred within 6 weeks
following previous influenza vaccination, the
decision to give Fluzone High-Dose Quadrivalent should be based on
careful consideration of the potential
benefits and risks. (5.1)
ADVERSE REACTIONS
In adults ≥65 years of age, the most common (>10%) injection-site
reaction was pain (41.3%); the most
common solicited systemic adverse reactions were myalgia (22.7%),
headache (14.4%) and malaise
(13.2%). (6