Myleran Tablets 2mg

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Thành phần hoạt chất:

BUSULPHAN

Sẵn có từ:

Aspen Medical Products Malaysia Sdn Bhd

INN (Tên quốc tế):

BUSULPHAN

Các đơn vị trong gói:

25 Tablet Tablets

Sản xuất bởi:

Excella GmbH & Co.KG

Tờ rơi thông tin

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
MYLERAN TABLETS
Busulfan (2mg)
WHAT IS IN THE LEAFLET
1.
What MYLERAN Tablet is
used for
2.
How
MYLERAN
Tablet
works
3.
Before you use MYLERAN
Tablet
4.
How
to
use
MYLERAN
Tablet
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
MYLERAN Tablet
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
11.
Serial number
WHAT MYLERAN TABLET IS
USED FOR
MYLERAN Tablet is used to
treat certain blood disorders and
cancer of the blood.
Busulfan
is
used
for
certain
condition of:
-
Chronic myeloid leukaemia
- a disease that increases the
number of white blood cells.
This
can
cause
infections
and bleeding.
-
Polycythaemia
vera
-
a
disease which increases the
number of red cells in your
blood. This makes the blood
thicken
and
causes
blood
clots.
This
leads
to
headaches,
dizziness
and
shortness of breath.
-
Thrombocythaemia
-
a
disease
which
affects
platelets (blood cells which
help blood to clot). There
may
be
an
increase
in
platelets
-
which
causes
blood clots. Or the platelets
do
not
work
properly
-
which causes bleeding such
as
nose
bleeds,
bleeding
gums and bruising easily.
-
Myelofibrosis
-
a
disease
where bone marrow (where
blood
cells
are
made)
is
replaced
by
scar
(fibrous)
tissue. This causes red and
white blood cells to be made
wrongly.
This
can
cause
tiredness, bloated stomach,
bleeding, and bruising.
HOW
MYLERAN
TABLET
WORKS
MYLERAN Tablet contains a
medicine called busulfan. This
belongs to a group of medicines
called cytotoxics. It works by
reducing the amount of certain
types
of
blood
cells
in
your
body.
Ask your doctor if you have any
questions
about
why
this
medicine has been prescribed
for you. Your doctor may have
prescribed it for another reason.
BEFORE
YOU
USE
MYLERAN
TABLET
-
_When you must not take it _
Do not take MYLERAN Tablet
if you have an allergy to:
•
busulfan,
the
active
ingredient
•
any of the other ingredients
listed
at
the
end
of
this
leaflet
Do not take this medicine if you
are resi

Đặc tính sản phẩm

MYLERAN
BUSULFAN
QUALITATIVE AND QUANTITATIVE COMPOSITION
_MYLERAN_ tablets containing busulfan 2mg.
- 2mg tablets are white, film-coated, round, biconvex tablets engraved
“GX EF3” on one side
and “M” on the other.
PHARMACEUTICAL FORM
Tablets
CLINICAL INFORMATION
INDICATIONS
Busulfan is indicated for the palliative treatment of the chronic
phase of chronic myeloid
leukaemia.
Busulfan is effective in producing prolonged remission in
polycythaemia vera, particularly in
cases with marked thrombocytosis.
Busulfan may be useful in selected cases of essential thrombocythaemia
and myelofibrosis.
DOSAGE AND ADMINISTRATION
Busulfan 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 busulfan tablets,
this can be achieved by introducing one or more busulfan free days
between treatment days.
The tablets should not be divided (_see Instructions for
Use/Handling_).
•
OBESE PATIENTS
Dosing based on body surface area or adjusted ideal body weight should
be considered in the
obese (_see Pharmacokinetics_).
The relevant literature should be consulted for full details of
treatment schedules.
CHRONIC MYELOID LEUKAEMIA
POPULATIONS
•
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 busulfan 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
/l (typica