BCG Vaccine
BCG
Product Details
WHO Product ID
FVP-P-117
Status
Prequalified
Date of prequalification
Vaccine type
BCG
Abbreviated Name
BCG
Commercial Name
BCG Vaccine
PQ Holder
India
NRA of record
Central Drugs Standard Control Organization
Product description
Pharmaceutical Form
Lyophilised active component to be reconstituted with excipient diluent before use
Presentation
Vial
Number of doses
20
Route of administration
Intradermal
Vaccine Vial Monitor
Type 14
Shelf-life
24 months
Storage temperature
2 - 8°C
Diluent
Sodium chloride (0.9%)
Preservative
None
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.
Remarks
If a 0.05mL dose is recommended this presentation is indicated as 20 doses. If a 0.1mL dose is used this presentation is indicated as 10 doses.Cold chain volume (cc) per dose: 1.757 (0.1 ml dose) / 0.878 (0.05 ml dose) Vial 1.2528 (0.1 ml dose) / 0.6264 (0.05 dose) Ampoule
Product Packaging
Secondary Container
Tertiary Container
Component Packed
Active (Vaccine)
Total doses
50
Description
Carton of 50 vials (active)[Dimensions 18.5x9.5x5.0 cm]
Dimensions
18.5 x 9.5 x 5.0 cm
Cold Chain Volume (cm³/dose)
0.88
Component Packed
Diluent
Total doses
50
Description
Carton of 50 ampoules of diluent [Dimensions 14.5x6.0x7.2 cm]
Dimensions
14.5 x 6.0 x 7.2 cm
Cold Chain Volume (cm³/dose)
0.63
