Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling
HALAVEN is a cytotoxic anticancer medicinal product and, as with other toxic compounds, caution should be exercised in its handling. The use of gloves, goggles, and protective clothing is recommended. If the skin comes into contact with the solution it should be washed immediately and thoroughly with soap and water. If it contacts mucous membranes, the membranes should be flushed thoroughly with water. HALAVEN should only be prepared and administered by personnel appropriately trained in handling of cytotoxic agents. Pregnant staff should not handle HALAVEN.

Using aseptic technique HALAVEN can be diluted up to 100 ml with sodium chloride 9 mg/ml (0.9%) solution for injection. It must not be mixed with other medicinal products and should not be diluted in glucose 5% infusion solution.

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

7. Marketing authorisation holder
Eisai Europe Ltd

European Knowledge Centre

Mosquito Way

Hatfield

Hertfordshire

AL10 9SN

United Kingdom

8. Marketing authorisation number(s)
EU/1/11/678/001-002

9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 17 March 2011

10. Date of revision of the text
06/2014

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