Diphtheria Tetanus Pertussis Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed
Diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Product Details
WHO Product ID
FVP-P-223
Status
Prequalified
Date of prequalification
Vaccine type
Diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Abbreviated Name
DTwP-HepB-Hib
Commercial Name
Diphtheria Tetanus Pertussis Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed
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 14
Multidose Vial Policy
Not applicable
Shelf life (months)
30 months
Storage temperature
2 - 8°C
Diluent
N/A
Preservative
Thiomersal
Preservative concentration
0.01%
Remarks
Feb 2016: Approval of variation to change vial size of single dose vial. For some time batches already filled in the old vial may be distributed. Due to the smaller available vial label space the location of the VVM has moved from the label to the flip-off cap.
Product Packaging
Secondary Container
Tertiary Container
Component Packed
Active (Vaccine)
Total doses
50
Description
Carton of 50 vials (50 doses) [Dimensions: 18.5x9.5x5] (old 40mm height)
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) (new 30mm height) [Dimensions: 18.5x9.5x4 cm]
Dimensions
18.5 x 9.5 x 4.0 cm
Cold Chain Volume (cm³/dose)
14.06
