MYLERAN TABLETS 2 MG

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

BUSULFAN

可用日期:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC代码:

L01AB01

药物剂型:

TABLETS

组成:

BUSULFAN 2 MG

给药途径:

PER OS

处方类型:

Required

厂商:

EXCELLA GMBH & CO.KG., GERMANY

治疗领域:

BUSULFAN

疗效迹象:

For the palliative treatment of the chronic granulocytic leukemia.

授权日期:

2014-06-30

资料单张

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
MYLERAN TABLETS 2 MG
ACTIVE INGREDIENT AND ITS QUANTITY:
Each tablet contains: Busulfan 2 mg
Inactive and allergenic ingredients in the preparation - see
section 2 “
Important information about some of the ingredients
in the medicine” and
section 6 “Further Information” in the
leaflet.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE. This leaflet contains concise information about the
medicine. If you have further questions, refer to the doctor
or pharmacist.
This medicine has been prescribed to treat your ailment. Do
not pass it on to others. It may harm them even if it seems to
you that their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Myleran Tablets 2 mg is intended for supportive therapy for
chronic granulocytic leukemia (also called chronic myeloid
leukemia).
THERAPEUTIC GROUP: The medicine belongs to a group of
antineoplastics and immunomodulators, alkyl sulfonates and
cytotoxic medicines (also called chemotherapy).
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• you are sensitive (allergic) to the active ingredient busulfan
or to any of the other ingredients contained in the medicine
(see section 6 “Further Information”).
• you have been treated with Myleran Tablets in the past
and the treatment was unsuccessful.
• you are breast-feeding.
Do not use the medicine if one or more of the aforementioned
conditions apply to you.
If you are uncertain, refer to a doctor or pharmacist before
taking the medicine.
SPECIAL WARNINGS REGARDING USE OF THE PREPARATION
BEFORE TREATMENT WITH MYLERAN TABLETS 2 MG, TELL THE
DOCTOR IF:
∙ you are undergoing, or have recently undergone,
radiotherapy.
∙ you suffer from an inherited blood problem called
thalassemia.
∙ you have ever had gout (painful and swollen joints caused by
accumulation of uric acid crystals). You may need treatment
for gout before com

产品特点

Page 1 of 12
_ _
SUMMARY OF PRODUCT
CHARACTERISTICS
1. NAME OF THE
MEDICINAL PRODUCT
Myleran Tablets 2 mg
2.
QUALITATIVE
AND
QUANTITATIVE COMPOSITION
Each 2 mg tablet contains 2 mg of the active substance
busulfan.
Excipient with known effect:
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated
tablet
Myleran tablets 2 mg are white, film-coated, round biconvex tablets
engraved "GX EF3" on
one side and "M" on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the palliative treatment of chronic granulocytic leukaemia (also
called chronic myeloid
leukaemia)
.
4.2
POSOLOGY
AND METHOD OF
ADMINISTRATION
General
The bioavailability of oral Busulfan shows large intra-individual
variations ranging from 47% to
103% (mean 80%) in adults and from 22% to 120% (mean 68%) in children
(see section 5.2).
There are other formulations available which may be more suitable for
paediatric patients.
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
busulfan
free days
between
treatment days. The tablets should not be divided (see section 6.6
_). _
_Obese_
_ _
_ _
Dosing based on body surface area or adjusted ideal body weight should
be considered
in the obese (see
section
5.2
).
The relevant literature should be consulted for full details of
treatment schedules.
Page 2 of 12
Chronic granulocytic leukaemia (also called chronic myeloid
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 section 4.4
_)._
The