FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE (influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) antigen (formaldehyde inactivated)

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 9G0XU62HKP) (INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:ND5Y3FDI9P), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANT

Disponible des:

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 rece

Resumen del producto:

Single-dose, prefilled syringe (pink plunger rod), without needle, 0.25 mL (NDC 49281-181-00) (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-181-25). Single-dose, prefilled syringe (clear plunger rod), without needle, 0.5 mL (NDC 49281-320-88) (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-320-50). Multi-dose vial, 5 mL (NDC 49281-336-78) (not made with natural rubber latex). Supplied as package of 1 (NDC 49281-336-15). A maximum of ten doses can be withdrawn from the multi- dose vial.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.

Estat d'Autorització:

Biologic Licensing Application

Fitxa tècnica

FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE- INFLUENZA A VIRUS
A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED),
INFLUENZA A VIRUS A/SOUTH
AUSTRALIA/34/2019 IVR-197 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED),
INFLUENZA B VIRUS
B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), AND INFLUENZA B
VIRUS
B/WASHINGTON/02/2019 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
HE MISPHE RE .
FLUZONE QUADRIVALENT (INFLUENZA VACCINE)
SUSPENSION FOR INTRAMUSCULAR INJECTION
2020 FORMULA
INITIAL U.S. APPROVAL: 2013 (FLUZONE QUADRIVALENT)
RECENT MAJOR CHANGES
Dosage and Administration (2.1)
01/2019
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)
AG E
VACCINATION STATUS
DO SE
SC HE DULE
"-" 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
ye ars
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
olde r
-
One 0.5 mL dose
-
DOSAGE FORMS AND STRENGTHS
Suspension for injec