Product overview
Type
Rotavirus (live, attenuated)
Commercial Name
ROTASIIL®Thermo
Manufacturer
Serum Institute of India Pvt. Ltd.
Responsible NRA
Central Drugs Standard Control Organization
Country
India
URL
Prequalification
Prequalification Status
Current
Product description
Pharmaceutical Form
Lyophilised active component to be reconstituted with excipient diluent before use
Presentation
Two vial set (active + excipient)
Number of Doses
1
Diluent
Citrate bicarbonate buffer
Route of Administration
Oral
Shelf Life
30 months
Storage Temperature
25°C
Vaccine Vial Monitor
Type +250
Secondary Packaging
Active: Carton of 50 vials(50 doses) [Dimensions: 5.0 x 9.5 x 18.5 cm]; Diluent: Carton of 50 vials [Dimensions: 5.0 x 9.5 x 18.5 cm].
Tertiary Packaging
Active: Box containing 24 cartons of 50 vials (1200 vials/ 1200 doses) [Dimensions: 36 x 48 x 60 cm]; Diluent: Box containing 1200 vials/1200 doses [Dimensions: 24.6 x 32.5 x 40.5 cm].
Multidose Vial Policy
Not Applicable.
Vaccine Preservative
none
Cold Chain Volume
Active and diluent: 17.57 cm3/dose (in secondary packaging)
Attachments