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Leukeran 2mg Film-coated TabletsChlorambucil(六)
2013-07-11 22:55:23 来源: 作者: 【 】 浏览:4483次 评论:0
- 8°C. Store in the original container.
 

6.5 Nature and contents of container

 Leukeran tablets are supplied in amber (Type III) glass bottles with a child resistant polypropylene/ HDPE closure containing 25 or 50 tablets.

Not all pack sizes may be marketed
 

6.6 Special precautions for disposal and other handling

 Safe handling of Leukeran tablets:-

The handling of Leukeran Tablets should follow guidelines for the handling of cytotoxic drugs according to prevailing local recommendations and/or regulations (for example, Royal Pharmaceutical Society of Great Britain Working Party on the Handling of Cytotoxic Drugs).

Provided the outer coating of the tablet is intact, there is no risk in handling Leukeran Tablets. Pregnant staff should not handle cytotoxic agents. Leukeran Tablets should not be divided.
 

7. MARKETING AUTHORISATION HOLDER

 Aspen Pharma Trading Limited

12/13 Exchange Place

I.F.S.C.

Dublin 1, Ireland

8. MARKETING AUTHORISATION NUMBER(S)

 PA 1691/7/1

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 1st April 1979/1st April 2009
 

10. DATE OF REVISION OF THE TEXT

 January 2011

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