LEUKERAN TABLETS 2 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

CHLORAMBUCIL

متاح من:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC رمز:

L01AA02

الشكل الصيدلاني:

TABLETS

تركيب:

CHLORAMBUCIL 2 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

EXCELLA GMBH & CO.KG., GERMANY

المجال العلاجي:

CHLORAMBUCIL

الخصائص العلاجية:

Leukeran is indicated in the treatment of Hodgkin's disease, indolent non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, and Waldenstrom's macroglobulinaemia

تاريخ الترخيص:

2019-03-31

نشرة المعلومات

PATIENT PACKAGE INSERT ACCORDING
TO PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a
doctor’s prescription only
LEUKERAN TABLETS 2 MG
THE ACTIVE INGREDIENT AND ITS QUANTITY:
Each tablet contains: Chlorambucil 2 mg
Inactive ingredients and allergens in the medicine –
see section 6 in the leaflet.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE
MEDICINE. This leaflet contains concise information
about the medicine.
If you have any further questions, refer to the doctor
or pharmacist.
This medicine is prescribed for you. Do not pass it on
to others. It may harm them even if it seems to you that
their illness is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Leukeran is used to treat Hodgkin’s disease, indolent
non-Hodgkin’s lymphoma, chronic lymphocytic
leukaemia and Waldenstrom’s macroglobulinaemia.
THERAPEUTIC GROUP: The medicine belongs to a
group of medicines called cytotoxics )also called
chemotherapy(, antineoplastic and immunomodulatory
agents,
Alkylating agents – nitrogen mustard analogues.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive )allergic( to the active ingredient
chlorambucil or to any of the other ingredients
contained in this medicine )see section 6(.
• You are breastfeeding.
If you are not sure, refer to the doctor before taking
the medicine.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
BEFORE TREATMENT WITH LEUKERAN, TELL THE DOCTOR IF:
• You were recently vaccinated or are planning to
receive a vaccine containing live organisms )see
the section regarding combining other medicines
with Leukeran(. Leukeran may cause your body to
be less capable of fighting infections.
• You are a potential candidate for a bone marrow
transplant )autologous stem cell transplantation(,
as prolonged use of the medicine may reduce the
number of stem cells.
• You are undergoing or have recently undergone
chemotherapy or radiotherapy.
• You have liver or kidney problems.
• You have a kidney problem )nephrotic syndrome(

خصائص المنتج

Page 1 of 9
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Leukeran Tablets 2 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg of the active ingredient chlorambucil.
Excipient(s) with known effect:
Each tablet also contains 67.65 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Brown, round, biconvex, film-coated tablets, one side engraved with
"L" and the other side engraved 'GX EG3'.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Leukeran
is
indicated
in
the
treatment
of
Hodgkin's
disease,
indolent
non-Hodgkin's
lymphoma,
chronic
lymphocytic leukaemia, and Waldenstrom's macroglobulinaemia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
THE RELEVANT LETERATURE SHOULD BE CONSULTED FOR FULL DETAILS OF THE
TREATMENT
SCHEDULES USED.
Chlorambucil is an active cytotoxic agent for use only under the
direction of physicians experienced in the
administration of such agents.
Posology
HODGKIN'S DISEASE
_Adults _
Used as a single agent in the palliative treatment of advanced
disease, a typical dosage is 0.2 mg/kg/day for 4-8
weeks.
Leukeran is usually included in combination therapy and a number of
regimes have been used.
Leukeran has been used as an alternative to nitrogen mustard with a
reduction in toxicity but similar therapeutic
results.
_Paediatric population _
_ _
Leukeran
_ _
may be used in the management of Hodgkin’s disease in children. The
dosage regimes are similar to
those used in adults.
Page 2 of 9
NON
-
HODGKIN'S
LYMPHOMA
_Adults _
Used as a single agent the usual dosage is 0.1-0.2 mg/kg/day for 4-8
weeks initially; maintenance therapy is then
given either by a reduced daily dosage or intermittent courses of
treatment.
Leukeran is useful in the management of patients with advanced diffuse
lymphocytic lymphoma and those who
have relapsed after radiotherapy.
There is no significant difference in the overall response rate
obtained with chlorambucil as a single agent and
combination chemotherapy in patients with advanced no