BCG Freeze Dried Glutamate vaccine
BCG
Product Details
WHO Product ID
FVP-P-338
Status
Prequalified
Date of prequalification
Vaccine type
BCG
Abbreviated Name
BCG
Commercial Name
BCG Freeze Dried Glutamate vaccine
PQ Holder
Japan
NRA of record
Pharmaceutical and Medical Devices Agency (PMDA)
Product description
Pharmaceutical Form
Lyophilised active component to be reconstituted with excipient diluent before use
Presentation
Ampoule
Number of doses
10
Route of administration
Intradermal
Vaccine Vial Monitor
Type 30
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
This presentation is for 10 doses of 0.1 mL. This is the recommended dose of BCG vaccine for all recipients in PAHO region. The attached insert in Spanish only. Please see the other presentation entry for other language versions of the product insert.
Product Packaging
Secondary Container
Tertiary Container
Component Packed
Active (Vaccine)
Total doses
100
Description
Active: Carton of 100 amps. (1 000 doses)[Dimensions: 13.6 x 13.3 x 8 cm]
Dimensions
13.6 x 13.3 x 8.0 cm
Cold Chain Volume (cm³/dose)
1.45
Component Packed
Diluent
Total doses
100
Description
Diluent carton of 100 amps. (1 000 doses)[Dimensions: 13.6 x 13.3 x 6.6 cm]
Dimensions
13.6 x 13.3 x 6.6 cm
Cold Chain Volume (cm³/dose)
1.19
