6.6 Special precautions for disposal and other handling

Before administration, the XGEVA solution should be inspected visually. The solution may contain trace amounts of translucent to white proteinaceous particles. Do not inject the solution if it is cloudy or discoloured. Do not shake excessively. To avoid discomfort at the site of injection, allow the vial to reach room temperature (up to 25ºC) before injecting and inject slowly. Inject the entire contents of the vial. A 27 gauge needle is recommended for the administration of denosumab. Do not re-enter the vial.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/703/001

EU/1/11/703/002

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

13 July 2011

10. DATE OF REVISION OF THE TEXT

XGEVA is a registered trademark of Amgen Inc.

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.