Product overview
Type
BCG
Commercial Name
BCG Vaccine
Manufacturer
BB- NCIPD Ltd. (Bul Bio-National Center of Infectious and Parasitic Diseases Ltd.)
Responsible NRA
Bulgarian Drug Agency
Country
Bulgaria
Prequalification
Prequalification Status
Current
Product description
Pharmaceutical Form
Lyophilised active component to be reconstituted with excipient diluent before use
Presentation
Ampoule
Number of Doses
20
Diluent
0.9% Sodium Chloride
Route of Administration
Intradermal
Shelf Life
36 months
Storage Temperature
2-8 °C and protected from light
Vaccine Vial Monitor
Type 30
Secondary Packaging
Active: Carton of 20 ampoules (400 doses)[Dimensions: 14.5 x 9.8 x 2.8 cm]; Diluent: Carton of 20 ampoules (400 doses)[Dimensions: 14.5 x 5.7 x 2.6 cm]
Tertiary Packaging
Active: Box containing 175 cartons of 20 ampoules ( 70 000 doses/ 3500 ampoules )[Dimensions: 58 x 58 x 53 cm]; Diluent: Box containing 175 cartons of 20 ampoules (70 000 doses/ 3500 ampoules)[Dimensions: 46 x 31 x 33 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: 0.99 Diluent: 0.53 cm3/dose (in secondary packaging)
Attachments
