Product overview
Type
Influenza, seasonal (Quadrivalent)
Commercial Name
Fluzone Quadrivalent (labelled as FluQuadri in other markets)
Manufacturer
Sanofi Pasteur Inc.
Responsible NRA
US Food and Drug Administration- Office of Vaccine Research and Review
Country
United States of America
Prequalification
Prequalification Status
Current
Product description
Pharmaceutical Form
Liquid: ready to use
Presentation
Vial
Number of Doses
10
Diluent
Not Applicable
Route of Administration
Intramuscular
Shelf Life
<=18 months (June of year following manufacture)
Storage Temperature
2-8°C
Vaccine Vial Monitor
Type 2
Secondary Packaging
Carton of 1 vial (10 doses) [Dimensions 3.0 x 6.0 x 3.0 cm]
Tertiary Packaging
Box 100 of cartons (1000 vials/1000 doses) [Dimensions 14.3 x 30.6 x 16.5 cm]
Multidose Vial Policy
WHO recommends that opened vials of this vaccine may be kept for use in subsequent immunization sessions (up to a maximum of 28 days) provided the conditions outlined in the WHO Policy Statement: The use of opened multi-dose vials of vaccine in subsequent immunization sessions are met.
Vaccine Preservative
thiomersal
Vaccine Preservative Concentration
0.01%
Cold Chain Volume
5.4 cm3/dose (in secondary packaging)