Product overview
Type
BCG
Commercial Name
BCG Vaccine
Manufacturer
Serum Institute of India Pvt. Ltd.
Responsible NRA
Central Drugs Standard Control Organization
Country
India
URL
Prequalification
Prequalification Status
Current
Product description
Pharmaceutical Form
Lyophilised active component to be reconstituted with excipient diluent before use
Presentation
Vial
Number of Doses
20
Diluent
0.9% Sodium Chloride
Route of Administration
Intradermal
Shelf Life
24 months
Storage Temperature
2-8°C
Vaccine Vial Monitor
Type 14
Secondary Packaging
Carton of 50 vials (active)[Dimensions 18.5x9.5x5.0 cm] + carton of 50 ampoules of diluent [Dimensions 14.5x6.0x7.2 cm]
Tertiary Packaging
Box of 24 cartons of 50 vials (1200 vials) [dimensions 60x48x36 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
vaccine: 1.757 (0.1 ml dose)/ 0.878 (0.05 ml dose); diluent 1.2528 (0.1 ml dose)/ 0.6264 (0.05 ml) cm3/dose (in secondary packaging)