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Focetria

Product overview

Type
Influenza, Pandemic (H1N1)
Commercial Name
Focetria
Manufacturer
Seqirus Vaccines Limited
Responsible NRA
CBER/FDA

Prequalification

Prequalification Status
Current: No Routine Production
Effective Date

Product description

Pharmaceutical Form
Liquid: ready to use
Presentation
Vial
Number of Doses
10
Diluent
Not Applicable
Route of Administration
Intramuscular
Shelf Life
12 months
Storage Temperature
2-8°C
Vaccine Vial Monitor
none
Secondary Packaging
Carton of 10 vials (100 doses) [Dimensions: 4.5 x 4.7 x 11.2 cm]
Tertiary Packaging
Inner carton holding 800 vials/8000 doses [Dimensions: 38 x 24 x 26 cm]
Multidose Vial Policy
Not Applicable.
Vaccine Preservative
thiomersal
Cold Chain Volume
2.36 cm3/dose (in secondary packaging)

Attachments

General
Package Insert