देश: सिंगापुर
भाषा: अंग्रेज़ी
स्रोत: HSA (Health Sciences Authority)
Docetaxel trihydrate 21.34mg/ml eqv Docetaxel
SANOFI-AVENTIS SINGAPORE PTE. LTD.
L01CD02
20mg/ml
INFUSION, SOLUTION CONCENTRATE
Docetaxel trihydrate 21.34mg/ml eqv Docetaxel 20mg/ml
INTRAVENOUS
Prescription Only
Sanofi-Aventis Deutschland GmbH
ACTIVE
2012-02-16
1. NAME OF THE MEDICINAL PRODUCT TAXOTERE 20 mg/1 ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel as trihydrate. One vial of 1 ml of concentrate contains 20 mg of docetaxel. Excipients: Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). The concentrate is a pale yellow to brownish-yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Breast cancer TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic breast carcinoma. 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). Non-small cell lung cancer TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer. OVARIAN CANCER: TAXOTERE is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of firstline or subsequent chemotherapy. Prostate cancer TAXOTERE in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma TAXOTERE in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer TAXOTERE in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patie पूरा दस्तावेज़ पढ़ें
SG/TAX/0623/SmPC1222 1 1. NAME OF THE MEDICINAL PRODUCT TAXOTERE 20 mg/1 ml concentrate for solution for infusion TAXOTERE 80 mg/4 ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TAXOTERE 20 MG/1 ML CONCENTRATE FOR SOLUTION FOR INFUSION: Each ml of concentrate contains 20 mg docetaxel as trihydrate. One vial of 1 ml of concentrate contains 20 mg of docetaxel. Excipient with known effect: Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg). For the full list of excipients, see section 6.1. TAXOTERE 80 MG/4 ML CONCENTRATE FOR SOLUTION FOR INFUSION Each ml of concentrate contains 20 mg docetaxel as trihydrate. One vial of 4 ml of concentrate contains 80 mg of docetaxel. Excipient with known effect: Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). The concentrate is a pale yellow to brownish-yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Breast cancer TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic breast carcinoma. 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). Non-small cell lung cancer TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic non- small cell lung cancer. Ovarian cancer TAXOTERE is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first line or subsequent chemotherapy. Prostate cancer TAXOTERE in combination with prednisone or prednisolone is indicated for पूरा दस्तावेज़ पढ़ें