BCG Freeze Dried Glutamate vaccine
BCG
Product Details
WHO Product ID
FVP-P-67
Status
Prequalified
Date of prequalification
Vaccine type
BCG
Abbreviated Name
BCG
Commercial Name
BCG Freeze Dried Glutamate vaccine
PQ Holder
Japan BCG Laboratory (JBL)
1-5-21 Otsuka Bunkyo-ku
Tokyo,
112-0012
Japan
Responsible NRA
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
20
Route of administration
Intradermal
Vaccine Vial Monitor
Type 30
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.
Shelf life (months)
24 months
Storage temperature
2 - 8°C
Diluent
Sodium chloride (0.9%)
Preservative
None
Remarks
This presentation is for 20 doses of 0.05 mL (for children under 1 year) or 10 doses of 0.1 mL (for other recipients). This is the recommended dose of BCG vaccine outside the PAHO region. The attached insert is in English French Russian and Portuguese. The manufacturer adds the appropriate monolingual product insert depending on the destination country. For Spanish language text please see the other presentation entry for this vaccine.
Product Packaging
Secondary Container
Tertiary Container
Component Packed
Active (Vaccine)
Total doses
100
Description
Active: Carton of 100 ampoules (2 000 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)
0.72
Component Packed
Active (Vaccine)
Total doses
100
Description
Diluent:Carton of 100 ampoules (2 000 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)
0.6
