Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DOCETAXEL
Ebewe Pharma Ges.m.b.H Nfg. KG
DOCETAXEL
10 Mg/Ml
Concentrate for Soln for Inf
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
AT/H/0254,5/001/II/014,12 final PL 20140206 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. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 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 Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Docetaxel Ebewe 10mg/ml concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of the concentrate for solution for infusion contains 10 mg docetaxel. Each vial of 2ml contains 20 mg docetaxel anhydrous (10 mg/ml). Each vial of 8 ml contains 80 mg docetaxel anhydrous (10 mg/ml). Each vial of 16ml contains 160mg docetaxel andhydrous (10mg/ml). Excipient: Each single-dose vial of concentrate for solution contains 27% (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 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 ov Read the complete document