Country: Malta
Language: English
Source: Medicines Authority
DOCETAXEL
Ebewe Pharma GmbH Nfg. KG Mondseestrasse 11, 4866 Unterach, Austria
L01CD02
DOCETAXEL 10 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
DOCETAXEL 10 mg/ml
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2010-06-15
Page 1 of 11 PACKAGE LEAFLET: INFORMATION FOR THE USER DOCETAXEL EBEWE 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION docetaxel READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, hospital pharmacist or nurse. - If you get any side effects, talk to your doctor, hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Docetaxel Ebewe is and what it is used for 2. What you need to know before you use Docetaxel Ebewe 3. How to use Docetaxel Ebewe 4. Possible side effects 5. How to store Docetaxel Ebewe 6. Content of the pack and other information 1. WHAT DOCETAXEL EBEWE IS AND WHAT IT IS USED FOR The name of this medicine is Docetaxel Ebewe. Its common name is docetaxel. Docetaxel is a substance derived from the needles of yew trees. Docetaxel belongs to the group of anti-cancer medicines called taxoids. Docetaxel Ebewe has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: • for the treatment of advanced breast cancer, Docetaxel Ebewe could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine. • for the treatment of early breast cancer with or without lymph node involvement, Docetaxel Ebewe could be administered in combination with doxorubicin and cyclophosphamide. • for the treatment of lung cancer, Docetaxel Ebewe could be administered either alone or in combination with cisplatin. • for the treatment of prostate cancer, Docetaxel Ebewe is administered in combination with prednisone or prednisolone. • for the treatment of metastatic gastric cancer, Docetaxel Ebewe is administered in combination with cisplatin and 5-fluorouracil. • for the treatment of head and neck c Read the complete document
Page 1 of 48 1. NAME OF THE MEDICINAL PRODUCT Docetaxel Ebewe 10 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of the concentrate for solution for infusion contains 10 mg docetaxel. Each vial of 2 ml contains 20 mg docetaxel anhydrous (10 mg/ml). Each vial of 8 ml contains 80 mg docetaxel anhydrous (10 mg/ml). Each vial of 16 ml contains 160 mg docetaxel anhydrous (10 mg/ml). Excipient with known effect Each single-dose vial of concentrate for solution for infusion contains 34% (w/w) ethanol 96% _._ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colourless to pale _,_ yellow solution; pH 3.0 – 4.5, free from visible particles. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Breast cancer Docetaxel Ebewe 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). Docetaxel Ebewe 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. Docetaxel Ebewe 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. Docetaxel Ebewe in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Page 2 of 48 Docetaxel Ebewe in combination with capecitabine is indicated fo Read the complete document