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
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1. NAME OF THE MEDICINAL PRODUCT
Alkeran 2mg Film-coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2mg melphalan.
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Flm-coated tablet.
White, film-coated round tablets engraved GXEH3 on one side and A on the other.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Melphalan tablets are indicated in the treatment of:
- multiple myeloma;
- advanced ovarian adenocarcinoma.
Melphalan tablets may be used in the treatment of:
-breast carcinoma: melphalan either alone or in combination with other drugs has a significant therapeutic effect in a proportion of patients suffering from advanced breast carcinoma.
Alkeran Tablets may be used in the management of polycythaemia vera.
4.2 Posology and method of administration
Oral administration in adults: The absorption of Alkeran after oral administration is variable. Dosage may need to be cautiously increased until myelosuppression is seen, in order to ensure that potentially therapeutic levels have been reached.
Multiple myeloma: A typical oral dosage schedule is 0.15mg/kg bodyweight/day in divided doses for 4 days repeated at intervals of six weeks. Numerous regimens have, however, been used and the scientific literature should be consulted for details.
The administration of oral Alkeran and prednisone may be more effective than Alkeran alone. The combination is usually given on an intermittent basis.
Prolonging treatment beyond one year in responders does not appear to improve results.
Advanced ovarian adenocarcinoma: A typical regimen is 0.2mg/kg bodyweight/day given orally in divided doses for 5 days. This is repeated every 4 to 8 weeks, or as soon as the bone marrow has recovered.
Carcinoma of the breast: Alkeran has been given orally at a dose of 0.15 mg/kg bodyweight or 6mg/m2 body surface area/day for 5 days and repeated every 6 weeks. The dose was decreased if bone marrow toxicity was observed.
Polycythaemia vera: For remission induction doses of 6 to 10mg daily for 5 to 7 days have been used, after which 2 to 4mg daily were given until satisfactory disease control was achieved. A dose of 2 to 6mg once per week has been used for maintenance therapy. In view of the possibility of severe myelosuppression if Alkeran is given on a continuous basis, it is essential that frequent blood |
