Product overview
Type
Rotavirus (live, attenuated)
Commercial Name
Rotavac
Manufacturer
Bharat Biotech International Limited
Responsible NRA
Central Drugs Standard Control Organization
Country
India
URL
Prequalification
Prequalification Status
Current
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
-20°C
Vaccine Vial Monitor
Type 2
Secondary Packaging
Carton of 25 vials (125 doses)[Dimensions: 4 x 11.5 x 11.5 cm]
Tertiary Packaging
Box of 32 cartons of 25 vials (4000 doses/800 vials)[Dimensions: 17.2 x 25.5 x 47 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
none
Cold Chain Volume
4.2 cm3/dose (in secondary packaging)