Leukeran

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Chlorambucil 2mg (+ 5% manufacturing overage)

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Chlorambucil 2 mg (+ 5% manufacturing overage)

Dosage:

2 mg

Pharmaceutical form:

Tablet

Composition:

Active: Chlorambucil 2mg (+ 5% manufacturing overage) Excipient: Colloidal silicon dioxide Ethanol Lactose monohydrate Microcrystalline cellulose Opadry brown 05B26836 Purified water Stearic acid

Units in package:

Bottle, glass, 25 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Ampac Fine Chemicals LLC

Product summary:

Package - Contents - Shelf Life: Bottle, glass, - 25 tablets - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

1969-12-31

Patient Information leaflet

LEUKERAN (NZ) – Consumer Medicine Information 
Page 1 of 3 
LEUKERAN
®

_chlorambucil tablets 2 mg _
________________________________________________________________________________________ 
CONSUMER MEDICINE INFORMATION (CMI) 

WHAT IS IN THIS LEAFLET 

This leaflet answers some common 
questions about LEUKERAN tablets. 
It does not contain all the available 
information. It does not take the 
place of talking to your doctor or 
pharmacist. 

All medicines have risks and 
benefits. Your doctor has weighed 
the expected benefits of you taking 
LEUKERAN against the risks this 
medicine could have for you. 

If you have any concerns about 
taking this medicine, ask your 
doctor or pharmacist. 

KEEP THIS LEAFLET WITH YOUR 
MEDICINE.  

You may need to read it again. 

WHAT LEUKERAN IS 
USED FOR 

LEUKERAN contains the active 
ingredient chlorambucil which 
belongs to a group of medicines 
called anti-neoplastic agents. Within 
this group, LEUKERAN belongs to 
a class of medicines called 
alkylating agents. 

LEUKERAN is used to treat 
Hodgkin’s disease, certain forms of 
non-Hodgkin’s lymphoma, chronic 
lymphocytic leukaemia, 
Waldenstrom’s macroglobulinaemia, 
advanced ovarian cancer and a 
proportion of patients with 
advanced breast cancer. These are 
all types of cancer which happen 
when abnormal cells are formed 
and multiply uncontrollably, 
crowding out and interfering with 
the vital functions of normal healthy 
cells. 

LEUKERAN works by stopping the 
growth of cancer cells. 

_USE IN CHILDREN _

LEUKERAN is sometimes used to 
treat children with Hodgkin’s 
disease or non-Hodgkin’s 
lymphoma. 

This medicine is often given in 
combination with other medicines 
used to treat the above conditions. 

ASK YOUR DOCTOR IF YOU HAVE ANY 
QUESTIONS ABOUT WHY LEUKERAN

Summary of Product characteristics

LEUKERAN – Data Sheet
Page 1 of 12
NEW ZEALAND DATA SHEET
1.
LEUKERAN
® TABLETS
chlorambucil tablets 2 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg of chlorambucil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
LEUKERAN tablet 2 mg is a brown, film-coated tablet that is round,
normal, biconvex, and engraved with “GX EG3” on one face and
“L” on
the other face.
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
•
Advanced ovarian adenocarcinoma.
Leukeran has a significant therapeutic effect on a proportion of
patients
with breast cancer.
4.2 DOSE AND METHOD OF 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 4-8 weeks.
LEUKERAN is usually included in combination therapy and a number
of regimes have been used.
LEUKERAN – Data Sheet
Page 2 of 12
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