FLUZONE HIGH-DOSE (influenza a virus a/michigan/45/2015 x-275 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/sin

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Sanofi Pasteur Inc.

DCI (Dénomination commune internationale):

INFLUENZA A VIRUS A/Michigan/45/2015 X-275 ANTIGEN HEMAGGLUTININ ANTIGEN - UNII:116749898H)

Composition:

INFLUENZA A VIRUS A/Michigan/45/2015 X-275 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 60 ug in 0.5 mL

Mode d'administration:

INTRAMUSCULAR

indications thérapeutiques:

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

Descriptif du produit:

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.

Statut de autorisation:

Biologic Licensing Application

Résumé des caractéristiques du produit

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.
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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