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BCG Vaccine

Product overview

Vaccine type
BCG
Commercial Name
BCG Vaccine
Manufacturer
GreenSignal Bio Pharma Pvt Limited
Manufacturer Country
India
Responsible NRA
Central Drugs Standard Control Organization
Country
India

Prequalification

Effective Date

Product description

Pharmaceutical Form
Lyophilised active component to be reconstituted with excipient diluent before use
Presentation
Vial + Ampoule
Number of Doses
20
Diluent
0.9% Sodium Chloride
Route of Administration
Intradermal
Shelf Life
24 months
Storage Temperature
2 °C to 8 °C. Protected from direct light
Vaccine Vial Monitor
Type 14
Secondary Packaging
VACCINE: Box of 50 vials (1000 doses). Dimensions: 4.8 x 8.5 x 17.5 cm. DILUENT: Box of 50 ampoules (1000 doses) Dimensions: 5.7 x 6 x 12 cm.
Tertiary Packaging
VACCINE: Carton containing 24 boxes of 50 vials (1200 vials/24000 doses) Dimensions: 38 x 47 x 53.5 cm. DILUENT: Carton containing 24 boxes of 50 ampoules (1200 apoules/24000 doses) Dimensions: 19.8 x 25.5 x 26.5 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: 1.43 (0.1 mL dose) / 0.71 (0.05 mL dose). DILUENT: 0.82 (0.1mL dose) / 0.41 (0.05 mL dose) cm3/dose (in secondary packaging)

Attachments

Package Insert
WHO Public Assessment Report - WHOPAR