Immunization standards

Diphtheria-Tetanus-Pertussis (whole cell)-Hepatitis B-Haemophilus influenzae type b (10 dose vial)

Vaccine Trade Name:

Vaccine Type: Diphtheria-Tetanus-Pertussis (whole cell)-Hepatitis B-Haemophilus influenzae type b

Manufacturer: Biological E Limited

Country of Manufacture: India

Date of prequalification: 31 August 2011

NRA of Record: CDSCO

Product Description

Pharmaceutical form: liquid + lyophilized

Presentation: 10 dose vial DTP-HepB (liquid) + 10 dose vial Hib (lyophilized)

Route of administration: intramuscular

Vaccine Vial Monitor: Type 14

Shelf life: 24 months at 2 - 8 °C

Secondary Packaging: One carton containing 15 vials of 10 dose DTwP-rHepB Vaccine and 15 vials of 10 dose Hib Vaccine

Cold Chain volume per dose (cm3): 7.8

Preservative: Thiomersal, 0.01% w/v.

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.

Remarks

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Last update:

14 March 2013 11:13 CET