FLUAD influenza virus a/california/7/2009 x-181 (h1n1) antigen (formaldehyde inactivated) a/switzerland/9715293/2013 nib-88 (h3n

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 872508X6JG) (INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:5CL7878S2Q)

Tilgængelig fra:

Novartis Vaccines and Diagnostics Limited

INN (International Name):

INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 ANTIGEN HEMAGGLUTININ ANTIGEN - UNII:5CL7878S2Q)

Sammensætning:

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

Autorisation status:

Biologic Licensing Application

Produktets egenskaber

FLUAD- INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN
(FORMALDEHYDE INACTIVATED),
INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN
(FORMALDEHYDE INACTIVATED)
AND INFLUENZA B VIRUS B/BRISBANE/9/2014 ANTIGEN (FORMALDEHYDE
INACTIVATED) INJECTION, SUSPENSION
NOVARTIS VACCINES AND DIAGNOSTICS LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUAD™ SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR FLUAD.
FLUAD (INFLUENZA VACCINE, ADJUVANTED)
SUSPENSION FOR INTRAMUSCULAR INJECTION
2015-2016 FORMULA
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
FLUAD is an inactivated influenza vaccine indicated for active
immunization against influenza disease caused by influenza
virus subtypes A and type B contained in the vaccine. FLUAD is
approved for use in persons 65 years of age and older. (1)
Approval is based on the immune response elicited by FLUAD. Data
demonstrating a decrease in influenza disease after
vaccination with FLUAD are not available. (14)
DOSAGE AND ADMINISTRATION
A single 0.5 mL dose for intramuscular injection. (2.1)
DOSAGE FORMS AND STRENGTHS
Suspension for injection supplied in 0.5 mL single-dose pre-filled
syringes. (3)
CONTRAINDICATIONS
Severe allergic reaction to any component of the vaccine, including
egg protein, or after a previous dose of any influenza
vaccine. (4, 11)
WARNINGS AND PRECAUTIONS
If Guillain-Barré Syndrome (GBS) has occurred within six weeks of
previous influenza vaccination, the decision to give
FLUAD should be based on careful consideration of the potential
benefits and risks. (5.1)
The tip caps of the prefilled syringes contain natural rubber latex
which may cause allergic reactions in latex sensitive
individuals. (5.3)
ADVERSE REACTIONS
The most common (≥ 10%) local (injection site) adverse reactions
observed in clinical studies were injection site pain
(25%) and tenderness (21%). (6)
The most common (≥ 10%) systemic adverse reactions observed in
clinical studies