Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
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)
Sanofi Pasteur Inc.
INTRAMUSCULAR
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)].
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.
Biologic Licensing Application
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 Läs hela dokumentet