Leukeran

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

chlorambucil

Available from:

EXCELLA GmbH & Co.KG

INN (International Name):

chlorambucil

Dosage:

2mg

Pharmaceutical form:

tablets film-coated

Prescription type:

Prescription

Patient Information leaflet

Package Leaflet: Information for the user
LEUKERAN
®
2mg Film-coated Tablets
chlorambucil
Read all of this leaflet carefully before you start taking this
medicine because it
contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Leukeran is and what it is used for
2. What you need to know before you take Leukeran
3. How to take Leukeran
4. Possible side effects
5. How to store Leukeran
6. Contents of the pack and other information
1. What Leukeran is and what it is used for
Leukeran contains an active substance called chlorambucil which
belongs to a group of
medicines called cytotoxics (also called chemotherapy). This medicine
is used to treat certain
type of cancers affecting human blood and lymphatic system. Your
doctor will be able to explain
how Leukeran might help in your particular condition.
Leukeran is used in patients with:
- Hodgkin’s disease and Non-Hodgkin’s Lymphoma. Together, these
form a group of
diseases called lymphomas. They are cancers formed from cells of the
lymphatic system.
- Chronic lymphocytic leukaemia. A type of blood cancer where the bone
marrow
produces a large number of abnormal white blood cells.
- Waldenstrom’s macroglobulinaemia. A rare lymphoma associated with
an uncontrolled
increase of B-cells, a type of white blood cell, resulting in the
release of an abnormal protein
into the blood.
2. What you need to know before you take Leukeran
Do not take Leukeran if:
You are allergic to chlorambucil or any of the other ingredients of
this medicine (listed in
section 6).
Leukeran should not be used for the treatment of non-malignant cancer.
If you are not sure,

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
Leukeran-SPC clean.docx
2
1.
NAME OF THE MEDICINAL PRODUCT
Leukeran 2 mg Film-coated Tablets
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 a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (Tablet)
Brown, round, biconvex tablet, engraved on one side with“L”and
“GX EG3”on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Leukeran is indicated in the treatment of:
-
Hodgkin's disease;
-
Certain forms of non-Hodgkin's lymphoma;
-
Chronic lymphocytic leukaemia;
-
Waldenstrom'smacroglobulinaemia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
THE RELEVANT LITERATURE SHOULD BE CONSULTED FOR FULL DETAILS OF
THE TREATMENT SCHEDULES USED.
LEUKERAN IS AN ACTIVE CYTOTOXIC AGENT AND SHOULD ONLY BE
ADMINISTERED UNDER THE DIRECTION OF A SPECIALIST ONCOLOGY SERVICE
HAVING THE FACILITIES FOR REGULAR MONITORING OF CLINICAL
BIOCHEMICAL AND HAEMATOLOGICAL EFFECTS DURING AND AFTER
ADMINISTRATION.
Posology
_Hodgkin's disease_
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.
_Non-Hodgkin's lymphoma_
Leukeran-SPC clean.docx
3
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
non-Hodgkin'