Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: XW4JB03TI5) (INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:92XE6GHC89), INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 3NZW5ND3D6) (INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:K329YCD1N9), INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEH
Sanofi Pasteur Inc.
INFLUENZA A VIRUS A/Michigan/45/2015 X-275 ANTIGEN HEMAGGLUTININ ANTIGEN - UNII:116749898H)
INFLUENZA A VIRUS A/Michigan/45/2015 X-275 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 60 ug in 0.5 mL
INTRAMUSCULAR
Fluzone® High-Dose is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone High-Dose is approved 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. Fluzone High-Dose is not approved for use in persons <65 years of age. There are limited human data and no animal data available to establish whether there is a vaccine-associated risk with use of Fluzone High-Dose in pregnancy. Fluzone High-Dose 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 on the breastfed infant or on milk production/excretion. Safety and effectiveness of Fluzone High-Dose in persons <65 years of age have not bee
Single-dose, prefilled syringe, without needle, 0.5 mL (NDC 49281-405-88) (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-405-65). Store Fluzone High-Dose 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- INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16- 0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), AND INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A (A B/COLORADO/6/2017-LIKE VIRUS) ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION FLUZONE HIGH-DOSE- INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16- 0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), AND INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A (A B/COLORADO/6/2017-LIKE VIRUS) 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 SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUZONE HIGH-DOSE. FLUZONE HIGH-DOSE (INFLUENZA VACCINE) SUSPENSION FOR INTRAMUSCULAR INJECTION 2019-2020 FORMULA INITIAL U.S. APPROVAL: 2009 INDICATIONS AND USAGE FLUZONE HIGH-DOSE is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine. (1) FLUZONE HIGH-DOSE is approved for use in persons 65 years of age and older. (1) DOSAGE AND ADMINISTRATION FOR INTRAMUSCULAR USE ONLY A single 0.5 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 (gray plunger rod), 0.5 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 should be based on careful consideration of the potential benefits and risks. (5.1) ADVERSE REACTIONS In adults ≥65 years of age, the most Прочитать полный документ