Product overview
Type
BCG
Commercial Name
BCG Freeze Dried Glutamate vaccine
Manufacturer
Japan BCG Laboratory
Responsible NRA
Pharmaceutical and Medical Devices Agency
Country
Japan
Prequalification
Prequalification Status
Current
Product description
Pharmaceutical Form
Lyophilised active component to be reconstituted with excipient diluent before use
Presentation
Ampoule
Number of Doses
10
Diluent
0.9% Sodium Chloride
Route of Administration
Intradermal
Shelf Life
24 months
Storage Temperature
2-8°C
Vaccine Vial Monitor
Type 30
Secondary Packaging
Active: Carton of 100 amps. (1 000 doses)[Dimensions: 13.6 x 13.3 x 8 cm]; Diluent carton of 100 amps. (1 000 doses)[Dimensions: 13.6 x 13.3 x 6.6 cm]
Tertiary Packaging
Active: Box containing 4 000 amps. (40 000 doses)[Dimensions: 61 x 76 x 43 cm]; Diluent: box containing 5 000 amps. (50 000 doses)[Dimensions: 75 x 41 x 37 cm]
Multidose Vial Policy
WHO recommends that opened vials of this vaccine should be discarded 6 hours after opening or at the end of the immunization session, whichever comes first.
Vaccine Preservative
none
Cold Chain Volume
Active: 1.44 Diluent: 1.19 cm3/dose (in secondary packaging)
Attachments