r injection. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
6.4 Special precautions for storage
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions of the diluted medicinal product, see section 6.3.
6.5 Nature and contents of container
4 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 100 mg of bevacizumab.
16 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 400 mg of bevacizumab.
Pack of 1 vial.
6.6 Special precautions for disposal and other handling
Avastin should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution.
The necessary amount of bevacizumab should be withdrawn and diluted to the required administration volume with sodium chloride 9 mg/ml (0.9%) solution for injection. The concentration of the final bevacizumab solution should be kept within the range of 1.4-16.5 mg/ml.
Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
Avastin is for single-use only, as the product contains no preservatives. Any unused product or waste material should be disposed of in accordance with local requirements.
No incompatibilities between Avastin and polyvinyl chloride or polyolefine bags or infusion sets have been observed.
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 2010
10. DATE OF REVISION OF THE TEXT
27 July 2011
LEGAL STATUS
POM
Detailed information on this product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu
