Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
PACLITAXEL
Pharmachemie BV
6 Milligram
Concentrate for Soln for Inf
2006-05-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paclitaxel 6 mg/ml Concentrate for Solution for Infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate for solution for infusion contains 6 mg of paclitaxel. A vial of 5 ml contains 30 mg of paclitaxel. A vial of 16.7 ml contains 100 mg of paclitaxel. A vial of 25 ml contains 150 mg of paclitaxel. A vial of 50 ml contains 300 mg of paclitaxel. Also includes excipients: Ethanol anhydrous: 396 mg/ml Macrogolglycerol ricinoleate: 527 mg/ml For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colourless or slightly yellow viscous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _OVARIAN CARCINOMA_ In the first-line chemotherapy of ovarian cancer, Paclitaxel is indicated for the treatment of patients with advanced carcinoma of the ovary or with residual disease (>1 cm) after initial laparotomy, in combination with cisplatin. In the second-line chemotherapy of ovarian cancer, Paclitaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of standard, platinum containing therapy. _BREAST CARCINOMA_ In the adjuvant setting, Paclitaxel is indicated for the treatment of patients with node-positive breast carcinoma following anthracycline and cyclophosphamide (AC) therapy. Adjuvant treatment with Paclitaxel should be regarded as an alternative to extended AC therapy. Paclitaxel is indicated for the initial treatment of locally advanced or metastatic breast cancer either in combination with an anthracycline in patients for whom anthracycline therapy is suitable, or in combination with trastuzumab, in patients who over-express human epidermal growth factor receptor 2 (HER-2) at a 3+ level as determined by Citiți documentul complet