Vaxzevria
Product Overview
Type: COVID-19 Vaccine (ChAdOx1-S ([recombinant])
INN: N/A
Trade name: Vaxzevria
EUL holder: AstraZeneca AB
Country: Sweden
Responsible NRA: European Medicines Agency (EMA)
Country: The Netherlands
WHO EUL recommendation
Effective date: 15 April 2021
Product description
Pharmaceutical Form: Suspension for injection
Presentation: 5 mL vial and 6 mL vial
Number of doses: 8 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 ten 5mL vials (80 doses). Dimensions: 8.1 x 4.1 x 10.6 cm. b. Carton of ten 10R vials (100 doses). Dimensions: 13.5 x 5.5 x 5.5 cm. c. Carton of ten 6mL vials (100 doses). Dimensions: 14.5 x 6.8 x 5.1 cm. d. Carton of ten 5mL vials (100 doses). Dimensions: 13.2 x 5.7 x 5.0 cm. |
|
Tertiary Packaging: |
a. 24 secondary packaged cartons containing 10 vials per carton (240 vials /1920 doses) Dimensions: 26.2 x 22.8 x 18.8 cm b. 16 secondary packaged cartons containing 10 vials per carton (160 vials /1600 doses) Dimensions: 29.0 x 25.0 x 13.1 cm c. 24 secondary packaged cartons containing 10 vials per carton (240 vials /2400 doses) Dimensions: 31.0 x 21.8 x 22.8 cm d. 24 secondary packaged cartons containing 10 vials per carton (240 vials /2400 doses) Dimensions: 24.8 x 28.8 x 18.0 cm |
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Cold Chain Volume in secondary packaging: |
a. 4.40 cm3/dose b. 4.08 cm3/dose c. 5.03 cm3/dose d. 3.76 cm3/dose |
Product Characteristics and Package Leaflet
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