Страна: Тайвань
Язык: китайский
Источник: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
TEMOZOLOMIDE
美商默沙東藥廠股份有限公司台灣分公司 台北市信義區信義路五段106號12樓 (86683720)
L01AX03
凍晶注射劑
TEMOZOLOMIDE (1004002000) MG
小瓶裝;;盒裝
製 劑
限由醫師使用
BAXTER ONCOLOGY GMBH KANTSTR. 2, 33790 HALLE/WESTFALEN, GERMANY DE
temozolomide
新診斷的多形神經膠母細胞瘤,與放射治療同步進行,然後作為輔助性治療。給予標準治療後復發性或惡化之惡性神經膠質瘤,例如:多形神經膠母細胞瘤或退行性星狀細胞瘤。
註銷日期: 2014/12/25; 註銷理由: 自請註銷; 有效日期: 2015/07/28; 英文品名: Temodal Powder for solution for infusion
已註銷
2010-07-28
TEMODAL ® POWDER FOR SOLUTION FOR INFUSION 1. NAME OF THE MEDICINAL PRODUCT Temodal 2.5 mg/ml powder for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100 mg of temozolomide. After reconstitution, 1 ml solution for infusion contains 2.5 mg temozolomide. Excipient: Each vial contains 2.4 mmol sodium. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion. White powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Temodal is indicated for the treatment of: - patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and then as adjuvant treatment. - patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Temodal should only be prescribed by physicians experienced in the oncological treatment of brain tumours. Anti-emetic therapy may be administered (see section 4.4). Posology Adult patients with newly-diagnosed glioblastoma multiforme Temodal is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (adjuvant phase). Concomitant phase TMZ is administered at a dose of 75 mg/m 2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions). No dose reductions are recommended, but delay or discontinuation of TMZ administration should be decided weekly according to haematological and nonhaematological toxicity criteria. TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met: -absolute neutrophil count (ANC) ≥ 1.5 x 10 9 /l -thrombocyte count ≥ 100 x 10 9 /l -common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia,nausea and vomiting). During treatment a complete blood count should be obtained weekly. TMZ administration should be tempora Прочитать полный документ