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Manufacturer # 70461012002
Brand Fluvirin® 2017 - 2018
Manufacturer Seqirus USA Inc
Application Flu Vaccine
Container Type Prefilled Syringe
Dosage Form Injection
Generic Drug Code 43471
NDC Number 70461-0120-02
Storage Requirements Requires Refrigeration
Strength 45 mcg / 0.5 mL
Type Intramuscular
User Indicated For People 4 Years of Age and Above
Volume 0.5 mL
Features
FLUVIRIN® is an inactivated influenza virus vaccine
indicated for active immunization of persons 4 years of age and older
against influenza disease caused by influenza virus subtypes A and type B
contained in the vaccine
FLUVIRIN® is a trivalent, sub-unit (purified surface antigen)
influenza virus vaccine prepared from virus propagated in the allantoic
cavity of embryonated hens' eggs inoculated with a specific type of
influenza virus suspension containing neomycin and polymyxin
FLUVIRIN® has been standardized according to USPHS requirements for
the 2017/2018 influenza season and is formulated to contain 45 mcg
hemagglutinin (HA) per 0.5-mL dose in the recommended ratio of 15 mcg HA
of each of the following 3 viruses:A/Singapore/GP1908/2015,IVR-180 (an
A/Michigan/45/2015 (H1N1)pdm09- like virus; A/Hong Kong/4801/2014, NYMC
X-263B (H3N2) (an A/Hong Kong/4801/2014- like virus); and
B/Brisbane/60/2008, wild type (a B/Brisbane/60/2008-like virus)
The 0.5-mL prefilled syringe presentation is formulated without
preservative
However, thimerosal, a mercury derivative used during manufacturing,
is removed by subsequent purification steps to a trace amount