Riik: Taiwan
keel: hiina
Allikas: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
DOCETAXEL
賽諾菲股份有限公司 台北市信義區松仁路3號7樓 (97168356)
L01CD02
注射劑
DOCETAXEL (1013000200) MG
盒裝;;小瓶附溶液;;小瓶
製 劑
限由醫師使用
AVENTIS PHARMA (DAGENHAM) DAGEHAM,ESSEX RM10 7XS,ENGLAND GB
docetaxel
乳癌、非小細胞肺癌、前列腺癌、胃腺癌、頭頸癌。
註銷日期: 2018/08/08; 註銷理由: 自請註銷; 有效日期: 2018/01/19; 英文品名: TAXOTERE CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION
已註銷
1998-01-19
1. NAME OF THE MEDICINAL PRODUCT TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose vial of TAXOTERE 20 mg/0.5 ml concentrate contains docetaxel which is a trihydrate corresponding to 20 mg of docetaxel (anhydrous). The viscous solution contains 40 mg/ml docetaxel (anhydrous). Excipient: Each single-dose vial of solvent contains 13% (w/w) ethanol 95% in water for injection. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate and solvent for solution for infusion. The concentrate is a clear viscous, yellow to brown-yellow solution. The solvent is a colourless solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Breast cancer TAXOTERE in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: ˙ operable node-positive breast cancer ˙ Operable node-negative breast cancer For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer (see section 5.1). TAXOTERE in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. TAXOTERE monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. TAXOTERE in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease. TAXOTERE in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy Lugege kogu dokumenti