FLUZONE 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

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: FF9YP4D23C) (INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:FF9YP4D23C), 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)

Disponible desde:

Sanofi Pasteur Inc.

Vía de administración:

INTRAMUSCULAR

indicaciones terapéuticas:

Fluzone® 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. Fluzone Quadrivalent Southern Hemisphere is approved for use in persons 6 months of age and older. Do not administer Fluzone Quadrivalent Southern Hemisphere to anyone with a history of 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. Fluzone Quadrivalent Southern Hemisphere and Fluzone Quadrivalent are manufactured using the same process. Data in this section were obtained in studies with Fluzone Quadrivalent. Pregnancy Exposure Registry Sanofi Pasteur Inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes following vaccination with Fluzone Quadrivalent during pregnancy. Healthcare providers are encouraged to enroll women who receive Fluzone Quadrivalent during pregnancy in Sanofi Pasteur Inc.'s vaccination pregnancy registry by calling 1-800-822-2463. Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available data with Fluzone Quadrivalent use in pregnant women are insufficient to inform vaccine-associated risk of adverse developmental outcomes. A developmental and reproductive toxicity study was performed in female rabbits given a 0.5 mL/dose of Fluzone Quadrivalent prior to mating and during gestation (a single human dose is 0.5 mL). This study revealed no adverse effects to the fetus or pre-weaning development due to Fluzone Quadrivalent [see Animal Data (8.1)] . Data Animal Data: In a developmental and reproductive toxicity study female rabbits were administered a 0.5 mL/dose of Fluzone Quadrivalent by intramuscular injection 24 and 10 days before insemination, and on Days 6, 12, and 27 of gestation (a single human dose is 0.5 mL). There were no adverse effects on pre-weaning development or vaccine-related fetal malformations noted in this study. Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk Pregnant women are at increased risk of complications associated with influenza infection compared to non-pregnant women. Pregnant women who contract influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery. Risk Summary It is not known whether Fluzone Quadrivalent is excreted in human milk. Data are not available to assess the effects of Fluzone Quadrivalent on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Fluzone Quadrivalent and any potential adverse effects on the breastfed child from Fluzone Quadrivalent or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to the disease prevented by the vaccine. Safety and effectiveness of Fluzone Quadrivalent Southern Hemisphere in children below the age of 6 months have not been established. Safety and immunogenicity of Fluzone Quadrivalent were evaluated in adults 65 years of age and older. [See Clinical Studies (14.6).] Antibody responses to Fluzone Quadrivalent are lower in persons ≥65 years of age than in younger adults.

Resumen del producto:

Single-dose, prefilled syringe (clear plunger rod), without needle, 0.5 mL (NDC 49281-324-88) (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-324-50). Multi-dose vial, 5 mL (NDC 49281-398-78) (not made with natural rubber latex). Supplied as package of 1 (NDC 49281-398-15). A maximum of ten doses can be withdrawn from the multi-dose vial. Store all Fluzone Quadrivalent Southern Hemisphere presentations 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.

Estado de Autorización:

Biologic Licensing Application

Ficha técnica

FLUZONE 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 QUADRIVALENT
SOUTHERN HEMISPHERE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR FLUZONE
QUADRIVALENT SOUTHERN HEMISPHERE.
FLUZONE QUADRIVALENT (INFLUENZA VACCINE)
SUSPENSION FOR INTRAMUSCULAR INJECTION
2024 FORMULA
INITIAL U.S. APPROVAL: 2013 (FLUZONE QUADRIVALENT)
INDICATIONS AND USAGE
FLUZONE 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 QUADRIVALENT SOUTHERN HEMISPHERE is approved for use in
persons 6 months of age and
older. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR USE ONLY (2)
AGE
VACCINATION STATUS
DOSE
SCHEDULE
"-" Indicates information is not applicable
*
†
6 months
through
35
months
Not previously vaccinated with
influenza vaccine or unknown
vaccination history
Two doses, either 0.25 mL
or 0.5 mL
Administer at least 4 weeks apart
Previously vaccinated with
influenza vaccine
One or two doses , either
0.25 mL or 0.5 mL
If two doses, administer at least 4
weeks apart
36
months
through 8
years
Not previously vaccinated with
influenza vaccine or unknown
vaccination history
Two 0.5 mL doses
Administer at least 4 weeks apart
Previously vaccinated with
influenza vaccine
One or two 0.5 mL doses
If two doses, administer at least 4
weeks apart
9 years
and older
-
One 0.5 mL dose
-
DOSAGE FORMS AND STRENGTHS
Suspension for injection supplied in 2 presentations: prefilled
single-d