Immunization standards

Meningococcal A conjugate 10 dose presentation

Vaccine Trade Name: MenAfriVac

Vaccine Type: Meningococcal A conjugate

Manufacturer: Serum Institute of India Ltd, India

Country of Manufacture: India

Date of prequalification: 23 June 2010

NRA of Record: CDSCO

Product Description

Pharmaceutical form: lyophilised

Presentation: 10 dose vial (active) + 10 dose ampoule (diluent)

Route of administration: intramuscular

Vaccine Vial Monitor: Type 30

Shelf life:
36 months at 2 - 8 °C (active)
60 months at 25°C (diluent)

Secondary Packaging: carton of 50 vials (active) + carton of 50 ampoules (diluent)

Cold Chain volume per dose (cm3): 2.6

Preservative: Thiomersal, 0.01%.

Handling of opened multi-dose vials: 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.

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 .

Last update:

6 November 2015 09:33 CET