WHO recommendation Serum Institute of India Pvt Ltd - COVID-19 Vaccine (ChAdOx1-S [recombinant]) - COVISHIELD™
Product Overview |
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| Vaccine type: | COVID-19 Vaccine (ChAdOx1-S ([recombinant]) | ||
| Commercial name: | COVISHIELD™ | ||
| EUL holder: | Serum Institute of India Pvt. Ltd | ||
| Country: | India | ||
| URL: | https://www.seruminstitute.com/ | ||
| Manufacturing sites: | See box below "Manufacturing sites" | ||
| Responsible NRA: | Central Drugs Standard Control Organization | ||
| Country: | India | ||
| URL: | https://cdsco.gov.in/opencms/opencms/en/Home/ | ||
WHO Recommendation |
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| Effective date: | 15 February 2021 | ||
Product Description |
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| Pharmaceutical form: | Solution for injection | ||
| Presentation: | Vial | ||
| Number of doses: | 2 and 10 doses | ||
| Diluent: | Not applicable | ||
| Route of administration: | Intramuscular | ||
| Age indication: | Individuals aged 18 years and older | ||
| Shelf-life: | 9 months | at storage temperature: | 2°C to 8°C |
| Vaccine vial monitor: | None | ||
| Secondary packaging: | COVIDSHIELD-2dose: Carton holds 50 vaccine vials (100 doses) Dimensions: 18.5 x 9.5 x 4.0 cm COVIDSHIELD-10 dose: Carton holds 50 vaccine vials (500 doses) |
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| Tertiary packaging: | COVIDSHIELD-2dose: 6 secondary packaged cartons containing 50 vials per carton (300 vials /600 doses): Dimensions: 31.0 x 19.0 x 9.3 cm COVIDSHIELD-10 dose: 6 secondary packaged cartons containing 50 vials per carton (300 vials /3000 doses): Dimensions: 31.0 x 19.0 x 9.3 cm |
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| Cold chain volume: | 7.03 (2 dose vial) 2.109 (10 dose vial) |
cm3 (in secondary packaging) | |
| Preservative: | Not applicable | with concentration: | Not applicable |
| Handling of opened multidose-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. |