Riik: Euroopa Liit
keel: inglise
Allikas: EMA (European Medicines Agency)
docetaxel
Teva Pharma B.V.
L01CD02
docetaxel
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Prostatic Neoplasms
Breast cancerDocetaxel Teva Pharma 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.Non-small-cell lung cancerDocetaxel Teva Pharma is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Docetaxel Teva Pharma in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerDocetaxel Teva Pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Revision: 6
Withdrawn
2011-01-21
70 B. PACKAGE LEAFLET Medicinal product no longer authorised 71 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DOCETAXEL TEVA PHARMA 20 MG CONCENTRATE AND SOLVENT 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 Teva Pharma is and what it is used for 2. What you need to know before you use Docetaxel Teva Pharma 3. How to use Docetaxel Teva Pharma 4. Possible side effects 5. How to store Docetaxel Teva Pharma 6. Contents of the pack and other information 1. WHAT DOCETAXEL TEVA PHARMA IS AND WHAT IT IS USED FOR The name of this medicine is Docetaxel Teva Pharma. Docetaxel is a substance derived from the needles of yew trees. Docetaxel belongs to the group of anti-cancer medicines called taxoids. Docetaxel Teva Pharma has been prescribed by your doctor for the treatment of advanced breast cancer, special forms of lung cancer (non-small cell lung cancer) and prostate cancer: - For the treatment of advanced breast cancer, Docetaxel Teva Pharma could be administered alone. - For the treatment of lung cancer, Docetaxel Teva Pharma could be administered either alone or in combination with cisplatin. - For the treatment of prostate cancer, Docetaxel Teva Pharma is administered in combination with prednisone or prednisolone. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DOCETAXEL TEVA PHARMA YOU MUST NOT BE GIVEN DOCETAXEL TEVA PHARMA IF • you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel Teva Pharma • the number of white blood cells is too low • you have a severe liver disease. WARNINGS AND PRECAUTIONS Before each treatment with Docetaxel Lugege kogu dokumenti
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Docetaxel Teva Pharma 20 mg concentrate and solvent for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose vial of Docetaxel Teva Pharma concentrate contains 20 mg docetaxel (anhydrous). Each ml of concentrate contains 27.73 mg docetaxel. Excipients with known effect : Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate and solvent for solution for infusion. The concentrate is a clear viscous, yellow to brown-yellow solution. The solvent is a colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Breast cancer Docetaxel Teva Pharma 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. Non-small cell lung cancer Docetaxel Teva Pharma is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. Docetaxel Teva Pharma in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Teva Pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The use of docetaxel should be confined to units specialised in the administration of cytotoxic chemotherapy and it should only be administered under the supervision of a physician qualified in the use of anticancer chemotherapy (see section 6.6). Recommended dose For breast and non-small cell lung cancer, premedication consisting of an oral corticost Lugege kogu dokumenti