jection. The concentration of the final bevacizumab solution should be kept within the range of 1.4 mg/ml to 16.5 mg/ml. In the majority of the occasions the necessary amount of Avastin can be diluted with 0.9 % sodium chloride solution for injection to a total volume of 100 mL.
Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
No incompatibilities between Avastin and polyvinyl chloride or polyolefine bags or infusion sets have been observed.
Avastin is for single-use only, as the product contains no preservatives. Any unused medicinal product or waste material should be disposed in accordance with local requirements.
7. Marketing authorisation holder
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
8. Marketing authorisation number(s)
EU/1/04/300/001 – 100 mg/4 ml vial
EU/1/04/300/002 – 400 mg/16 ml vial
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 12 January 2005
Date of latest renewal: 14 January 2015
10. Date of revision of the text
23 July 2015
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu
