AFLURIA- influenza a virus a/california/7/2009 x-181 (h1n1) antigen (propiolactone inactivated), influenza a virus a/texas/50/20

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: BH0R06YXFZ) (INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:MHG4XW7BIG), INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 IVR-175 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: 5087BPO79O) (INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 IVR-175 (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:9A68J3T9TE), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANT

Disponible desde:

bioCSL Pty Ltd.

Designación común internacional (DCI):

INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 ANTIGEN HEMAGGLUTININ ANTIGEN - UNII:MHG4XW7BIG)

Composición:

INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL

Vía de administración:

INTRAMUSCULAR

indicaciones terapéuticas:

AFLURIA® is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. AFLURIA is approved for use in persons 5 years of age and older. AFLURIA 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 Category B: A reproductive and developmental toxicity study has been performed in female rats at a dose approximately 265 times the human dose (on a mg/kg basis) and revealed no evidence of impaired female fertility or harm to the fetus due to AFLURIA. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, AFLURIA should be given to a pregnant woman only if clearly needed. In the reproductive and developmental toxicity study, the effect

Resumen del producto:

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

Estado de Autorización:

Biologic Licensing Application

Ficha técnica

AFLURIA- INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN
(PROPIOLACTONE INACTIVATED),
INFLUENZA A VIRUS A/TEXAS/50/2012 X-223 (H3N2) ANTIGEN (PROPIOLACTONE
INACTIVATED), AND INFLUENZA B
VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (PROPIOLACTONE
INACTIVATED) INJECTION, SUSPENSION
BIOCSL PTY LTD.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AFLURIA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AFLURIA.
AFLURIA, INFLUENZA VACCINE
SUSPENSION FOR INTRAMUSCULAR INJECTION
2015-2016 FORMULA
INITIAL U.S. APPROVAL: 2007
RECENT MAJOR CHANGES
Dosage and Administration (2)
08/2014
INDICATIONS AND USAGE
AFLURIA is an inactivated influenza vaccine indicated for active
immunization against influenza disease caused by
influenza virus subtypes A and type B present in the vaccine. (1)
AFLURIA is approved for use in persons 5 years of age and older. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR (IM) INJECTION ONLY, BY NEEDLE AND SYRINGE (5 YEARS
OF AGE AND OLDER) OR BY PHARMAJET
STRATIS NEEDLE-FREE INJECTION SYSTEM (18 THROUGH 64 YEARS OF AGE). A SINGLE
DOSE IS 0.5 ML. (2)
AG E
SC HE DULE
*
5 years through 8 years
One dose or two doses at least 1 month apart
9 years and older
One dose
DOSAGE FORMS AND STRENGTHS
AFLURIA is a suspension for injection supplied in two presentations:
0.5 mL pre-filled syringe (single dose) (3, 11)
5 mL multi-dose vial (ten 0.5 mL doses) (3, 11)
CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) to any component of the
vaccine including egg protein, or to a previous dose
of any influenza vaccine. (4, 11)
WARNINGS AND PRECAUTIONS
Administration of CSL's 2010 Southern Hemisphere influenza vaccine was
associated with increased rates of fever and
febrile seizures in children predominantly below the age of 5 years as
compared to previous years. Febrile events were
also observed in children 5 through 8 years of age. (5.1)
If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of
previous influenz