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None used on labelling for supply through UN agencies. Also marketed with labelled commercial name ComBE Five (Liquid).

Product overview

Vaccine type
Diphtheria-Tetanus-Pertussis (whole cell)-Hepatitis B-Haemophilus influenzae type b
Commercial Name
None used on labelling for supply through UN agencies. Also marketed with labelled commercial name ComBE Five (Liquid).
Manofacturer
Biological E. Limited
Responsible NRA
Central Drugs Standard Control Organization
Country
India

Prequalification

Prequalification Status
Current
Effective Date

Product description

Pharmaceutical Form
Liquid: ready to use
Presentation
Vial
Number of Doses
5
Diluent
Not Applicable
Route of Administration
Intramuscular
Shelf Life
30 months
Storage Temperature
2-8°C
Vaccine Vial Monitor
Type 14
Secondary Packaging
Carton of 48 vials [Dimensions 14.5x10.8x4.5 cm]
Tertiary Packaging
Box of 24 cartons of 48 vials ( 5760 doses) [Dimensions 58.5x47x39 cm]
Multidose Vial Policy
WHO recommends that opened vials of this vaccine may be kept for use in subsequent immunization sessions (up to a maximum of 28 days) provided the conditions outlined in the WHO Policy Statement: The use of opened multi-dose vials of vaccine in subsequent immunization sessions are met.
Vaccine Preservative
thiomersal
Vaccine Preservative Concentration
0.01%
Cold Chain Volume
2.9 cm3/dose (in secondary packaging)

Attachments

Container Photo
Package Insert