- 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