LEUKERAN TABLET 2 mg (Revised Formula)

Страна: Сінгапур

мова: англійська

Джерело: HSA (Health Sciences Authority)

Активний інгредієнт:

CHLORAMBUCIL

Доступна з:

DCH AURIGA SINGAPORE

Код атс:

L01AA02

Дозування:

2 mg

Фармацевтична форма:

TABLET, FILM COATED

Склад:

CHLORAMBUCIL 2 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

Prescription Only

Виробник:

Excella GmbH & Co. KG

Статус Авторизація:

ACTIVE

Дата Авторизація:

2001-10-11

інформаційний буклет

LEUKERAN™
Chlorambucil
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg of the active ingredient chlorambucil.
PHARMACEUTICAL FORM
Film-coated tablet.
CLINICAL PARTICULARS
INDICATIONS
LEUKERAN is indicated in the treatment of:

Hodgkin’s disease; 

certain forms of non-Hodgkin’s lymphoma; 

chronic lymphocytic leukaemia; 

Waldenstrom’s macroglobulinaemia.
DOSAGE AND ADMINISTRATION

THE RELEVANT LITERATURE SHOULD BE CONSULTED FOR FULL DETAILS OF THE 
TREATMENT SCHEDULES USED.

_LEUKERAN_ is administered orally.
• ADULTS
_ _
_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 to 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 _

Used as a single agent the usual dosage is 0.1 to 0.2 mg/kg/day for 4
to 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 
_LEUKERAN_ as a single agent and combination chemotherapy in patients
with 
advanced non-Hodgkin’s lymphocytic lymphoma.

_CHRONIC LYMPHOCYTIC LEUKAEMIA_

Treatment with _LEUKERAN_ is usually started after the patient has
developed 
symptoms or when there is evidence of impaired bone marrow function
(but not 
marrow failure) as indicated by the peripheral blood count. 

Initially _LEUKERAN_ is given at a dosage of 0.15 mg/kg/day until
the total leukocyte 
count has fallen to 10,000 per microlitre. Treatment may be resumed 4
weeks after 
the end of the first course and continued at a

Характеристики продукта

LEUKERAN™
Chlorambucil
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg of the active ingredient chlorambucil.
PHARMACEUTICAL FORM
Film-coated tablet.
CLINICAL PARTICULARS
INDICATIONS
LEUKERAN is indicated in the treatment of:
Hodgkin’s disease;
certain forms of non-Hodgkin’s lymphoma;
chronic lymphocytic leukaemia;
Waldenstrom’s macroglobulinaemia.
DOSAGE AND ADMINISTRATION
THE RELEVANT LITERATURE SHOULD BE CONSULTED FOR FULL DETAILS OF THE
TREATMENT SCHEDULES USED.
_LEUKERAN_ IS AN ACTIVE CYTOTOXIC AGENT FOR USE ONLY UNDER THE
DIRECTION
OF PHYSICIANS EXPERIENCED IN THE ADMINISTRATION OF SUCH AGENTS.
_LEUKERAN _is administered orally and should be taken daily on an
empty stomach (at
least one hour before meals or three hours after meals).
• ADULTS
_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 to 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_
Used as a single agent the usual dosage is 0.1 to 0.2 mg/kg/day for 4
to 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
_LEUKERAN _as a single agent and combination chemotherapy in patients
with_ _
advanced non-Hodgkin’s lymphocytic lymphoma.
_CHRONIC LYMPHOCYTIC LEUKAEMIA_
Treatment with _LEUKERAN_ is usually started after the patient has
developed
symptoms or when there is evidence of impaired bone marrow function
(but not
marrow failure) as indicated by the peripheral blood count.
Initially _ LEUKERAN_ is given at a dosage of 0.15 mg/kg/day until the
tot