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ROTAVAC 5D®

Product overview

Type
Rotavirus (live, attenuated)
Commercial Name
ROTAVAC 5D®
Manufacturer
Bharat Biotech International 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
Oral
Shelf Life
24 months
Storage Temperature
2-8°C
Vaccine Vial Monitor
Type 7
Secondary Packaging
Multi pack of 25 vials (125 doses) [Dimensions: 11.5 x 11.5 x 4.0 cm]
Tertiary Packaging
Box containing 32 multi packs of 25 vials (800 vials/4000 doses) [Dimensions: 47.5 x 24.0 x 18.5 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
4.2 cm3/dose (in secondary packaging)

Attachments

Container Photo
VPSAR (Vaccine Public Summary Assessment Report)
Package Insert