Immunization standards

BCG (10/20 dose vial)

Vaccine Trade Name: BCG Vaccine

Vaccine Type: BCG

Manufacturer: Serum Institute of India Ltd, India

Country of Manufacture: India

Date of prequalification: 29 May 2003

NRA of Record: CDSCO

Product Description

Pharmaceutical form: Lyophilized + Sodium Chloride 1 ml diluent

Presentation:10/ 20 dose vial + ampoule of diluent

Route of administration: intradermal
(0.05 mL dose for children under one year)
(0.1 mL dose for recipients over one year)

Vaccine Vial Monitor: Type 14

Shelf life: 24 months at 2 - 8 °C

Secondary Packaging: carton of 50 vials (active) + carton of 50 ampoules of diluent

Cold Chain volume per dose (cm3): 2.611 (0.1 mL dose)
1.305 (0.05 mL dose)

Preservative: None

Handling of opened multi-dose vials: 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.