Product overview
Type
Hepatitis B
Commercial Name
Hepatitis B Vaccine (rDNA) (Paediatric)
Manufacturer
Serum Institute of India Pvt. Ltd.
Responsible NRA
Central Drugs Standard Control Organization
Country
India
Prequalification
Prequalification Status
Current
Product description
Pharmaceutical Form
Liquid: ready to use
Presentation
Vial
Number of Doses
10
Diluent
Not Applicable
Route of Administration
Intramuscular
Shelf Life
36 months
Storage Temperature
2-8°C
Vaccine Vial Monitor
Type 30
Secondary Packaging
carton of 50 vials (500 doses) [Dimensions: 18.5 x 9.5 x 6.0 cm]
Tertiary Packaging
24 cartons of 50 vials (1200 vials/12000 doses) [dimensions: 60x48x41 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
0.005%
Cold Chain Volume
2.109 cm3/dose (in secondary packaging)
Attachments
