Immunization standards

Diphtheria-Tetanus-Pertussis (whole cell)-Hepatitis B-Haemophilus influenzae type b (1 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: 1 dose vial DTP-HepB (liquid) + 1 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 24 vials of 1 dose DTwP-rHepB Vaccine and 24 vials of 1 dose Hib Vaccine

Cold Chain volume per dose (cm3): 29.36

Preservative: Thiomersal, 0.01% w/v.

Handling of opened multi-dose vials: N/A.

Remarks

An additional 1-dose mono carton packaging presentation holding one set of 2 vials of labeled DTwP-hepatitis B and Hib vaccine is available. This presentation occupies a cold chain volume of 34.7 cm3.

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Last update:

14 March 2013 11:13 CET