AFLURIA QUADRIVALENT (influenza a virus a/victoria/2454/2019 ivr-207 (h1n1) antigen (propiolactone inactivated), influenza a vir

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

INFLUENZA A VIRUS A/VICTORIA/2454/2019 IVR-207 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: YTL6A60F5I) (INFLUENZA A VIRUS A/VICTORIA/2454/2019 IVR-207 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:540GM6LL7U), INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: OAT4H11ZT6) (INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:PC99FHQ5W6), INFLUENZA B VIRUS B/VICTORIA/705/2018 BV

Dostupné z:

Seqirus Pty Ltd.

Spôsob podávania:

INTRAMUSCULAR

Terapeutické indikácie:

AFLURIA® QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. AFLURIA QUADRIVALENT is approved for use in persons 6 months of age and older. AFLURIA QUADRIVALENT is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine (see Description [11]) . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AFLURIA QUADRIVALENT during pregnancy. Women who are vaccinated with AFLURIA QUADRIVALENT during pregnancy are encouraged to enroll in the registry by calling 1-855-358-8966 or sending an email to Seqirus at [e-mail]. Risk summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated ba

Prehľad produktov:

Each product presentation includes a package insert and the following components:

Stav Autorizácia:

Biologic Licensing Application

Súhrn charakteristických

AFLURIA QUADRIVALENT- INFLUENZA A VIRUS A/VICTORIA/2454/2019 IVR-207
(H1N1) ANTIGEN
(PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019
IVR-208 (H3N2) ANTIGEN
(PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018
BVR-11 ANTIGEN (PROPIOLACTONE
INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN
(PROPIOLACTONE
INACTIVATED) INJECTION, SUSPENSION
SEQIRUS PTY LTD.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AFLURIA QUADRIVALENT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AFLURIA
QUADRIVALENT.
AFLURIA QUADRIVALENT, INFLUENZA VACCINE
SUSPENSION FOR INTRAMUSCULAR INJECTION
2020-2021 FORMULA
INITIAL U.S. APPROVAL (AFLURIA QUADRIVALENT): 2016
RECENT MAJOR CHANGES
Dosage and Administration (2)
08/2020
INDICATIONS AND USAGE
AFLURIA QUADRIVALENT is an inactivated influenza vaccine indicated for
active immunization against influenza
disease caused by influenza A subtype viruses and type B viruses
contained in the vaccine. (1)
AFLURIA QUADRIVALENT is approved for use in persons 6 months of age
and older. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR INJECTION ONLY, BY NEEDLE AND SYRINGE (6 MONTHS AND
OLDER) OR BY PHARMAJET
STRATIS
NEEDLE-FREE INJECTION SYSTEM (18 THROUGH 64 YEARS). (2)
1 or 2 doses depends on vaccination history as per Advisory Committee
on Immunization Practices annual recommendations on
prevention and control of influenza with vaccines. (2)
AG E
DO SE
SC HE DULE
6 months through 35 months
One or two doses , 0.25 mL each
If 2 doses, administer at least 1 month apart
36 months through 8 years
One or two doses , 0.5 mL each
If 2 doses, administer at least 1 month apart
9 years and older
One dose, 0.5 mL
Not Applicable
DOSAGE FORMS AND STRENGTHS
AFLURIA QUADRIVALENT is a suspension for injection supplied in three
presentations:
0.25 mL pre-filled syringe (single dose) (3, 11)
0.5 mL pre-filled syringe (single dose) (3, 11)
5 mL multi-dose vial (0.25 mL or 0.5 mL doses) (3, 11)
CONT