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TEMO

Package(a):
CAPSULES: 5 x 5 mg.
Dosage(a):
To be given in fasting state. In patients previously untreated with chemotherapy: 200 mg/m² 1 x daily for 5 days per 28-day cycle. In patients previously treated with chemotherapy: Initial dose 150 mg/m² 1 x daily, increased in the second cycle to 200 mg/m² daily, providing the absolute neutrophil count (ANC) is > 1.5 x 10(9)/1 and the thrombocyte count is > 100 x 10(9)/1 on day 1 of the next cycle.
Children: 200 mg/m² 1 x daily for 5 days per 28-day cycle.
Patients previously treated with chemotherapy should receive an initial dose of 150 mg/m² 1 x daily for 5 days with escalation to 200 mg/m² 1 x daily at the next cycle if there is no hematological toxicity. See prescribing information for full details.
Prescribing Restrictions:     

Package(b):
CAPSULES: 5 x 20 mg.
Dosage(b):
To be given in fasting state. In patients previously untreated with chemotherapy: 200 mg/m² 1 x daily for 5 days per 28-day cycle. In patients previously treated with chemotherapy: Initial dose 150 mg/m² 1 x daily, increased in the second cycle to 200 mg/m² daily, providing the absolute neutrophil count (ANC) is > 1.5 x 10(9)/1 and the thrombocyte count is > 100 x 10(9)/1 on day 1 of the next cycle.
Children: 200 mg/m² 1 x daily for 5 days per 28-day cycle.
Patients previously treated with chemotherapy should receive an initial dose of 150 mg/m² 1 x daily for 5 days with escalation to 200 mg/m² 1 x daily at the next cycle if there is no hematological toxicity. See prescribing information for full details.
Prescribing Restrictions:     

Package(c):
CAPSULES: 5 x 100 mg.
Dosage(c):
To be given in fasting state. In patients previously untreated with chemotherapy: 200 mg/m² 1 x daily for 5 days per 28-day cycle. In patients previously treated with chemotherapy: Initial dose 150 mg/m² 1 x daily, increased in the second cycle to 200 mg/m² daily, providing the absolute neutrophil count (ANC) is > 1.5 x 10(9)/1 and the thrombocyte count is > 100 x 10(9)/1 on day 1 of the next cycle.
Children: 200 mg/m² 1 x daily for 5 days per 28-day cycle.
Patients previously treated with chemotherapy should receive an initial dose of 150 mg/m² 1 x daily for 5 days with escalation to 200 mg/m² 1 x daily at the next cycle if there is no hematological toxicity. See prescribing information for full details.
Prescribing Restrictions:      

Package(d):
CAPSULES: 5 x 250 mg.
Dosage(d):
To be given in fasting state. In patients previously untreated with chemotherapy: 200 mg/m² 1 x daily for 5 days per 28-day cycle. In patients previously treated with chemotherapy: Initial dose 150 mg/m² 1 x daily, increased in the second cycle to 200 mg/m² daily, providing the absolute neutrophil count (ANC) is > 1.5 x 10(9)/1 and the thrombocyte count is > 100 x 10(9)/1 on day 1 of the next cycle.
Children: 200 mg/m² 1 x daily for 5 days per 28-day cycle.
Patients previously treated with chemotherapy should receive an initial dose of 150 mg/m² 1 x daily for 5 days with escalation to 200 mg/m² 1 x daily at the next cycle if there is no hematological toxicity. See prescribing information for full details.
Prescribing Restrictions:      


Indications:
Treatment of malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. First line treatment of advanced metastatic malignant melanoma. Newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment.
Contra-Indications:
Hypersensitivity to any of the ingredients or to dacarbazine. Pregnancy and lactation. Severe myelosuppression.
Special Precautions:
In patients with recurrent malignant glioma who are in a poor performance status or have other severely debilitating diseases or infection, administer after weighing the potential benefits and risks to the patient. Patients who have experienced severe (grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy. Elderly, genotoxic effects. See prescribing information for full details.
Side Effects:
Loss of appetite, headache, nausea, constipation, vomiting, hair loss, rash, tiredness. See prescribing information for full details.
Drug Interactions:
See prescribing information for full details.