Vaxzevria
Product Overview
Type: COVID-19 Vaccine (ChAdOx1-S ([recombinant])
INN: N/A
Trade name: Vaxzevria
EUL holder: AstraZeneca AB
Country: Sweden
Responsible NRA: Health Canada
Country: Canada
WHO EUL Recommendation
Effective date: 27 August 2021
Product description
Pharmaceutical Form: Suspension for injection
Presentation: 6 mL vial
Number of doses: 10 doses (0.5 mL per dose)
Route of administration: Intramuscular
Age indication: 18 years and older
Shelf – life: 6 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
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Secondary Packaging: |
a. Carton of 10 vials (10 doses/vial) (100 doses/carton). Dimensions: 13.5 x 5.5 x 5.5 cm b. Carton of 10R vials (10 doses/10R or 6 mL vial) (100 doses/carton). Dimensions: 14.5 x 6.8 x 5.1 cm or 14.5 x 6.8 x 6.8 cm c. Carton of 10 vials /10 doses per vial) (100 doses/per carton). Dimensions: 4.5 x 11.1 x 10.6 cm d. Carton of 10 vials (80 doses/vial) (80 doses/carton). Dimensions: 8.1 x 4.1 x 10.6 cm e. Carton of 10 vials (10 doses/vial) (100 doses/carton). Dimensions: 13.7 x 5.3 x 5.3 cm |
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Tertiary Packaging: |
a. 16 secondary packaged cartons (160 vials /1600 doses). Dimensions: 29.0 x 25.0 x 13.1 cm b. 24 secondary packaged cartons (240 vials /2400 doses). Dimensions: 31.0 x 21.8 x 22.8 cm or 31.2 x 21 x 28.0 cm c. 24 secondary packaged cartons (240 vials /2400 doses). Dimensions: 18.6 x 22.8 x 18.3 cm d. 24 secondary packaged cartons (240 vials/1920 doses). Dimensions: 26.2 x 22.8 x 18.8 cm e. 24 secondary packaged cartons (240 vials /2400 doses). Dimensions: 29.5 x 23.5 x 18.7 cm |
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Cold Chain Volume in secondary packaging: |
a. 4.08 cm3/dose b. 5.03 or 6.70 cm3/dose c. 2.90 cm3/dose d. 4.40 cm3/dose e. 3.85 cm3/dose |