Meningococcal A Conjugate MenAfriVac
Group A meningococcal conjugate vaccine
Product Details
WHO Product ID
FVP-P-196
Status
Prequalified
Date of prequalification
Vaccine type
Group A meningococcal conjugate vaccine
Abbreviated Name
MenA
Commercial Name
Meningococcal A Conjugate MenAfriVac
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
Lyophilised active component to be reconstituted with excipient diluent before use
Presentation
Vial + Ampoule
Number of doses
10
Route of administration
Intramuscular
Vaccine Vial Monitor
Type 30
Multidose Vial Policy
WHO recommends that opened vials of this vaccine should be discarded 6 hours after opening or at the end of the immunization session, whichever comes first.
Shelf life (months)
36 months
Storage temperature
2 - 8°C
Diluent
Specific Meningococcal diluent
Preservative
Thiomersal
Preservative concentration
0.01%
Remarks
The MenAfriVac vaccine can be used in a controlled temperature chain (CTC) for up to four days at ambient temperatures not exceeding 40°C. A CTC is initiated immediately prior to administration provided that the vaccine has not reached its expiry date and the vaccine vial monitor is still valid. Unopened vaccine vials should be discarded at the end of the four days at 40°C. Reconstituted vaccine should be discarded within six hours. WHO recommends that CTC implementation only occur with appropriate planning training and guidance. For more information please contact vaccines@who.int .
Product Packaging
Secondary Container
Tertiary Container
Component Packed
Active (Vaccine)
Total doses
50
Description
Carton of 50 vials (active)(500 doses) [dimensions 18.5x9.5x6.0]
Dimensions
18.5 x 9.5 x 6.0 cm
Cold Chain Volume (cm³/dose)
2.11
Component Packed
Diluent
Total doses
50
Description
carton of 50 ampoules (diluent)[Dimensions 10.5x8.7x17.0]
Dimensions
10.5 x 8.7 x 17.0 cm
Cold Chain Volume (cm³/dose)
3.11
