Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

1. NAME OF THE MEDICINAL PRODUCT

 Leukeran 2mg Film-coated Tablets
 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each tablet contains 2mg of the active ingredient chlorambucil.

Each tablet also contains 67.65mg of lactose.

For a full list of excipients, see 6.1.

3. PHARMACEUTICAL FORM

 Film-coated tablet (Tablet)

Brown, film-coated, round, biconvex tablets engraved 'GX EG3' on one side and 'L' 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 administered orally.

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:-

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 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 fall