ablets are supplied in amber glass bottles of 25 or 50 tablets with a child resistant closure.
Not all pack sizes may be marketed
6.6 Special precautions for disposal and other handling
The handling of Alkeran formulations should follow guidelines for the handling of cytotoxic drugs according to prevailing local recommendations
Pregnant staff should not handle cytotoxics. Protective clothing, including gloves should be worn.
Alkeran Tablets should not be divided.
Provided the outer coating of the tablet is intact, there is no risk in handling Alkeran Tablets.
Disposal:-
Alkeran Tablets should be destroyed in accordance with relevant local regulatory requirements concerning the disposal of cytotoxic drugs.
Adequate care should be taken in the disposal of waste material, including containers and any other contaminated material.
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 1691/4/2
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1st April 1999/ 1st April 2004
10. DATE OF REVISION OF THE TEXT
January 2011 |