देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
DOCETAXEL ANHYDROUS
Alfred E Tiefenbacher (GmbH & Co. KG)
80 10 Milligram
Concentrate for Soln for Inf
2011-08-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Docefim 80 mg/4 ml concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel anhydrous. One vial of 4 ml of concentrate contains 80 mg of docetaxel. Excipients: Each vial of 4 ml of concentrate contains 2.26 ml of ethanol 96% (1.83 g). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. The concentrate is a clear viscous, colourless to brownish-yellow sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BREAST CANCER Docefim 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). Docefim 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. Docefim 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. Docefim 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. Docefim in combination with capecitabine is indicated for the treatment of pati पूरा दस्तावेज़ पढ़ें