MYLERAN TABLET 2 mg (Revised Formula)

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

BUSULPHAN

Available from:

A. MENARINI SINGAPORE PTE. LTD.

ATC code:

L01AB01

Dosage:

2 mg

Pharmaceutical form:

TABLET, FILM COATED

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Excella GmbH

Authorization date:

2002-02-28

Patient Information leaflet

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