País: Singapur
Idioma: anglès
Font: HSA (Health Sciences Authority)
BUSULPHAN
A. MENARINI SINGAPORE PTE. LTD.
L01AB01
2 mg
TABLET, FILM COATED
ORAL
Prescription Only
Excella GmbH
2002-02-28
MYLERAN™ Busulphan QUALITATIVE AND QUANTITATIVE COMPOSITION _MYLERAN_ tablets containing busulphan 2 mg are white, film-coated, round, biconvex tablets engraved “GX EF3”on one side and “M” on the other. PHARMACEUTICAL FORM Tablets. CLINICAL PARTICULARS INDICATIONS _MYLERAN_ is indicated for the palliative treatment of the chronic phase of chronic granulocytic leukaemia. _MYLERAN_ is effective in producing prolonged remission in polycythaemia vera, particularly in cases with marked thrombocytosis. _MYLERAN_ may be useful in selected cases of essential thrombocythaemia and myelofibrosis. DOSAGE AND ADMINISTRATION _MYLERAN_ tablets are usually given in courses or administered continuously. The dose must be adjusted for the individual patient under close clinical and haematological control. Should a patient require an average daily dose of less than the content of the available _MYLERAN_ tablets, this can be achieved by introducing one or more _MYLERAN_ free days between treatment days. The tablets should not be divided (_see Instructions for Use/Handling_). The relevant literature should be consulted for full details of treatment schedules. CHRONIC GRANULOCYTIC LEUKAEMIA • INDUCTION IN ADULTS Treatment is usually initiated as soon as the condition is diagnosed. The dose is 0.06 mg/kg/day, with an initial daily maximum of 4 mg, which may be given as a single dose. There is individual variation in the response to _MYLERAN_ and in a small proportion of patients the bone marrow may be extremely sensitive (_see Warnings and _ _Precautions_). The blood count must be monitored at least weekly during the induction phase and it may be helpful to plot counts on semilog graph paper. The dose should be increased only if the response is inadequate after three weeks. Treatment should be continued until the total leukocyte count has fallen to between 15 and 25 x 10 9 /1 (typically 12 to 20 weeks). Treatme Llegiu el document complet