FLUZONE HIGH-DOSE QUADRIVALENT SOUTHERN HEMISPHERE (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/california/122/2022 (a/thailand/8/2022-like virus (h3n2) antigen (formaldehyde inactivated), influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated), and influenza b virus b/phuket/3073/2013 antigen- formaldehyde inactivated injection, suspension

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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/California/122/2022 SAN-022 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: N7CB2U8HAC) (INFLUENZA A VIRUS A/California/122/2022 SAN-022 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:8L9R8S52VV), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: B93BQX9789) (INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:9HB0XUS9TM), INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: FF9YP4D23C) (INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:CQV855H5FG)

Tilgængelig fra:

Sanofi Pasteur Inc.

Indgivelsesvej:

INTRAMUSCULAR

Terapeutiske indikationer:

Fluzone® High-Dose Quadrivalent Southern Hemisphere 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 Southern Hemisphere 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 Southern Hemisphere. Fluzone High-Dose Quadrivalent Southern Hemisphere and Fluzone High-Dose Quadrivalent are manufactured using the same process. Data in this section were obtained in studies with Fluzone High-Dose Quadrivalent. Fluzone High-Dose Quadrivalent Southern Hemisphere 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 Southern Hemisphere to establish whether there is a vaccine-associated risk with use of Fluzone High-Dose Quadrivalent in pregnancy. Fluzone High-Dose Quadrivalent Southern Hemisphere 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 Southern Hemisphere on the breastfed infant or on milk production/excretion. Safety and effectiveness of Fluzone High-Dose Quadrivalent Southern Hemisphere in children younger than 18 years of age have not been established. Safety, immunogenicity, and efficacy of Fluzone High-Dose Quadrivalent have been evaluated in adults 65 years of age and older [see Adverse Reactions (6.1) and Clinical Studies (14)].

Produkt oversigt:

Single-dose, prefilled syringe, without needle, 0.7 mL (NDC 49281-933-88) (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-933-50). Store Fluzone High-Dose Quadrivalent Southern Hemisphere 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.

Autorisation status:

Biologic Licensing Application

Produktets egenskaber

FLUZONE HIGH-DOSE QUADRIVALENT SOUTHERN HEMISPHERE- INFLUENZA A VIRUS
A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE
INACTIVATED), INFLUENZA A VIRUS
A/CALIFORNIA/122/2022 (A/THAILAND/8/2022-LIKE VIRUS (H3N2) ANTIGEN
(FORMALDEHYDE INACTIVATED),
INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE
INACTIVATED), AND INFLUENZA B VIRUS
B/PHUKET/3073/2013 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 SOUTHERN
HEMISPHERE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR FLUZONE HIGH-DOSE QUADRIVALENT SOUTHERN
HEMISPHERE.
FLUZONE HIGH-DOSE QUADRIVALENT (INFLUENZA VACCINE), SUSPENSION, FOR
INTRAMUSCULAR INJECTION
2024 FORMULA
INITIAL U.S. APPROVAL: 2019 (FLUZONE HIGH-DOSE QUADRIVALENT)
INDICATIONS AND USAGE
FLUZONE HIGH-DOSE QUADRIVALENT SOUTHERN HEMISPHERE 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 SOUTHERN HEMISPHERE 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 Southern Hemisphere 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 sol