Land: Indonesien
Språk: indonesiska
Källa: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
MELPHALAN
GLAXO WELLCOME INDONESIA - Indonesia
MELPHALAN
2 MG
TABLET
DUS, BOTOL @ 25 TABLET SALUT SELAPUT
EXCELLA Gmbh - Germany
2017-03-03
Page 1 of 7 ALKERAN™ TABLETS MELPHALAN 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg melphalan. 2. PHARMACEUTICAL FORM Film-coated tablets. 3. CLINICAL PARTICULARS 3.1 INDICATIONS _ALKERAN_ tablets are indicated in the treatment of: • multiple myeloma; • advanced ovarian adenocarcinoma. _ALKERAN_ tablets may be used in the treatment of: • breast carcinoma: _ALKERAN_ either alone or in combination with other drugs has a significant therapeutic effect in a proportion of patients suffering from advanced breast carcinoma; • polycythaemia rubra vera: _ALKERAN_ is effective in the treatment of a proportion of patients suffering from polycythaemia vera. 3.2 DOSAGE AND ADMINISTRATION GENERAL _ALKERAN_ is a cytotoxic drug which falls into the general class of alkylating agents. It should be prescribed only by physicians experienced in the management of malignant disease with such agents. Since _ALKERAN_ is myelosuppressive, frequent blood counts are essential during therapy and the dosage should be delayed or adjusted if necessary ( _see Warnings and _ _Precautions_ ). 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 0.15 mg/kg bodyweight/day in divided doses for 4 days repeated at intervals of 6 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 0.2 mg/kg bodyweight/day orally for 5 days. This is repeated every 4 to 8 weeks, or as soon as the peripheral blood count has recovered. Page 2 of 7 CARCINOMA OF THE BREAST _ALKERAN Läs hela dokumentet