Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
docetaxel
Mylan S.A.S.
L01CD02
docetaxel
Antineoplastic agents
Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Treatment of breast cancer, special forms of lung cancer (non-small-cell lung cancer), prostate cancer, gastric cancer, or head and neck cancer.
Revision: 6
Withdrawn
2012-01-31
129 B. PACKAGE LEAFLET Medicinal product no longer authorised 130 PACKAGE LEAFLET: INFORMATION FOR THE USER DOCETAXEL MYLAN 20 MG/1 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 or hospital pharmacist. - 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 Mylan 20 MG/1 ML is and what it is used for 2. What you need to know before you use Docetaxel Mylan 20 MG/1 ML 3. How to use Docetaxel Mylan 20 MG/1 ML 4. Possible side effects 5. How to store Docetaxel Mylan 20 MG/1 ML 6. Contents of the pack and other information 1. WHAT DOCETAXEL MYLAN 20 MG/1 ML IS AND WHAT IT IS USED FOR Docetaxel is a substance derived from the needles of yew trees. Docetaxel belongs to the group of anti-cancer medicines called taxoids. Docetaxel Mylan 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 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 could be administered in combination with doxorubicin and cyclophosphamide. - For the treatment of lung cancer, docetaxel could be administered either alone or in combination with cisplatin. - For the treatment of prostate cancer, docetaxel is administered in combination with prednisone or prednisolone. - For the treatment of metastatic gastric cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil. - For the treatment of head and neck cancer, docetaxe Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 20 mg/1 ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate for solution for infusion contains 20 mg of docetaxel (anhydrous). One vial of 1 ml of concentrate contains 20 mg of docetaxel. Excipient with known effect: Each ml of concentrate for solution for infusion contains 395 mg of ethanol anhydrous. One vial of 1 ml of concentrate contains 395 mg of ethanol anhydrous. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). The concentrate is pale yellow to brownish-yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Breast cancer Docetaxel Mylan 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 Mylan 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 Mylan 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 Mylan 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. Docetaxel Mylan in combination with capecitabine is indicated for the treatment of patient Izlasiet visu dokumentu