Leukeran tablets film-coated

País: Armênia

Língua: inglês

Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes ativos:

chlorambucil

Disponível em:

EXCELLA GmbH & Co.KG

Código ATC:

L01AA02

DCI (Denominação Comum Internacional):

chlorambucil

Dosagem:

2mg

Forma farmacêutica:

tablets film-coated

Unidades em pacote:

(25) glass bottle

Tipo de prescrição:

Prescription

Status de autorização:

Registered

Data de autorização:

2018-12-13

Folheto informativo - Bula

1
PACKAGE LEAFLET
2
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 yo

Características técnicas

1
SUMMARY OF PRODUCT CHARACTERISTICS
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's macroglobulinaemia.
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 SPC
2
Leukeran has been used as an alternative to nitrogen mustard with a
reduction in toxicity but
similar therapeutic results.
_Non-Hodgkin's lymphoma_
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's
lymphocytic lymphoma.
_Chronic