FLUZONE QUADRIVALENT NORTHERN HEMISPHERE (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivate

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: WD5E5VYM2E) (INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:ERB9SJ9VMQ), INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: KJA387FHB2) (INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:6S4Y8A8UEY), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHY

Dostupné z:

Sanofi Pasteur Inc.

INN (Medzinárodný Name):

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

Zloženie:

INFLUENZA A VIRUS A/Michigan/45/2015 X-275 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug in 0.5 mL

Spôsob podávania:

INTRAMUSCULAR

Terapeutické indikácie:

Fluzone® Quadrivalent 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 is approved for use in persons 6 months of age and older. Do not administer Fluzone Quadrivalent 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. 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 popul

Prehľad produktov:

Single-dose, prefilled syringe (clear plunger rod), without needle, 0.5 mL (NDC 49281-423-88) (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-423-50). Multi-dose vial, 5 mL (NDC 49281-639-78) (not made with natural rubber latex). Supplied as package of 1 (NDC 49281-639-15). A maximum of ten doses can be withdrawn from the multi-dose vial. Store all Fluzone Quadrivalent 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.

Stav Autorizácia:

Biologic Licensing Application

Súhrn charakteristických

FLUZONE QUADRIVALENT NORTHERN HEMISPHERE- INFLUENZA A VIRUS
A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE
INACTIVATED),
INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE
INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN
(FORMALDEHYDE
INACTIVATED), AND INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN
(FORMALDEHYDE
INACTIVATED) INJECTION, SUSPENSION
FLUZONE QUADRIVALENT NORTHERN HEMISPHERE- INFLUENZA A VIRUS
A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE
INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2)
ANTIGEN
(FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013
ANTIGEN
(FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/WASHINGTON/02/2019
ANTIGEN
(FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION
FLUZONE QUADRIVALENT NORTHERN HEMISPHERE- INFLUENZA A VIRUS
A/MICHIGAN/45/2015 X-275 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE
INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016
IVR-186 (H3N2)
HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS
B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED),
INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE
INACTIVATED) INJECTION, SUSPENSION
FLUZONE QUADRIVALENT NORTHERN HEMISPHERE- INFLUENZA A VIRUS
A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED),
INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE
INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN
(FORMALDEHYDE
INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN
(FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION
FLUZONE QUADRIVALENT NORTHERN HEMISPHERE- INFLUENZA A VIRUS
A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE
INACTIVATED),
INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN
(FORMALDEHYDE
INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN
(FORMALDEHYDE
INACTIVATED), INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN
(FORMALDEHYDE
INACTIVATED) INJECTION, SUSPENSION
FLUZONE QUADRIVALENT NORTHERN HE