COVISHIELD
Product Overview
Type: COVID-19 Vaccine (ChAdOx1-S ([recombinant])
INN: N/A
Trade name: COVISHIELD
EUL holder: Serum Institute of India Pvt. Ltd
Country: India
Responsible NRA: Central Drugs Standard Control Organization (CDSCO)
Country: India
WHO EUL recommendation
Effective date: 15 February 2021
Product description
Pharmaceutical Form: Suspension for injection
Presentation: 2 mL vial and 5 mL vial
Number of doses: 2 doses (0.5 mL per dose) and 10 doses (0.5 mL per dose)
Route of administration: Intramuscular
Age indication: 18 years and older
Shelf – life: 9 months Storage temperature: 2°C to 8°C
Vaccine Vial monitor (VVM): None
Preservative: None
Adjuvant: None
Diluent: None
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.
Packaging description
|
Secondary Packaging: |
a. Carton of 50 vials (2 doses/vial) (100 doses/carton). Dimensions: 18.5 x 9.5 x 4.0 cm b. Carton of 50 vials (10 doses/vial) (500 doses/carton). Dimensions: 18.5 x 9.5 x 6.0 cm |
|
Tertiary Packaging: |
a. 6 secondary packaged cartons (300 vials/600 doses). Dimensions: 31.0 x 19.0 x 9.3 cm b. 6 secondary packaged cartons (300 vials/3000 doses). Dimensions: 31.0 x 19.0 x 9.3 cm |
|
Cold Chain Volume in secondary packaging: |
a. 7.03 cm3/dose b. 2.109 cm3/dose |
Product characteristics and Package leaflet
WHO Package Leaflet for Health Workers