Hepatitis B Vaccine (rDNA) (Paedriatic)
Hepatitis B vaccine (recombinant)
Product Details
WHO Product ID
FVP-P-133
Status
Prequalified
Date of prequalification
Vaccine type
Hepatitis B vaccine (recombinant)
Abbreviated Name
HepB
Commercial Name
Hepatitis B Vaccine (rDNA) (Paedriatic)
PQ Holder
Serum Institute of India Pvt. Ltd.
212/2 Off Soli Poonawala Road, Hadaspar
Pune,
Maharashtra
411 028
India
Responsible NRA
Central Drugs Standard Control Organization (CDSCO)
Product description
Pharmaceutical Form
Liquid: Ready to use
Presentation
Vial
Number of doses
1
Route of administration
Intramuscular
Vaccine Vial Monitor
Type 30
Multidose Vial Policy
Not applicable
Shelf life (months)
36 months
Storage temperature
2 - 8°C
Diluent
N/A
Preservative
Thiomersal
Preservative concentration
0.01%
Remarks
cold chain volume (cc)/dose is 17.575 (vial) and 12.18 (ampoule)Ampoule does not hold Vaccine Vial Monitor (VVM)
Product Packaging
Secondary Container
Tertiary Container
Component Packed
Active (Vaccine)
Total doses
50
Description
Carton of 50 vials (50 doses) [Dimensions: 18.5 x 9.5 x 5.0 (4 ml)]
Dimensions
18.5 x 9.5 x 5.0 cm
Cold Chain Volume (cm³/dose)
17.58
Component Packed
Active (Vaccine)
Total doses
50
Description
Carton of 50 vials (50 doses) [Dimensions: 18.5 x 9.5 x 4.0 (2 ml)]
Dimensions
18.5 x 9.5 x 4.0 cm
Cold Chain Volume (cm³/dose)
14.06
Component Packed
Active (Vaccine)
Total doses
50
Description
Carton of 50 ampoules (50doses)[Dimensions: 14.5 x 6.0 x 7.0 cm]
Dimensions
14.5 x 6.0 x 7.0 cm
Cold Chain Volume (cm³/dose)
12.18
