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Manufacturer # 70461030110
Brand Flucelvax® Quadrivalent 2017 - 2018
Manufacturer Seqirus USA Inc
Application Flu Vaccine
Container Type Multiple Dose Vial
Dosage Form Injection
Generic Drug Code 43475
NDC Number 70461-0201-02
Storage Requirements Requires Refrigeration
Strength 60 mcg / 0.5 mL
Type Intramuscular
User Indicated For People 4 Years of Age and Above
Volume 0.5 mL
Features
FLUCELVAX QUADRIVALENT is an inactivated vaccine
indicated for active immunization for the prevention of influenza
disease caused by influenza virus subtypes A and type B contained in the
vaccine
FLUCELVAX is approved for use in persons 4 years of age and older
FLUCELVAX QUADRIVALENT is standardized according to United States
Public Health Service requirements for the 2017-2018 influenza season
and is formulated to contain a total of 60 micrograms (mcg)
hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA
of each of the following four influenza strains:
A/Singapore/GP1908/2015 IVR-180 (H1N1) (an A/Michigan/45/2015-like
virus); A/Singapore/GP2050/2015 (H3N2) (an A/Hong Kong/4801/2014 – like
virus); B/Utah/9/2014 (a B/Phuket/3073/2013-like virus); B/Hong
Kong/259/2010 (a B/Brisbane/60/08-like virus)
FLUCELVAX QUADRIVALENT 5 mL multi-dose vial formulation contains no
antibiotics