Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
docetaxel
Zentiva k.s.
L01CD02
docetaxel
Antineoplastic agents
Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms
Breast cancerDocetaxel Winthrop 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.Docetaxel Winthrop 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 Winthrop 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 Winthrop 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.Docetaxel Winthrop in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small-cell lung cancerDocetaxel Winthrop is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Docetaxel Winthrop 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 Winthrop in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer.Gastric adenocarcinomaDocetaxel Winthrop 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 cancerDocetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Revision: 30
Withdrawn
2007-04-20
157 B. PACKAGE LEAFLET Medicinal product no longer authorised 158 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DOCETAXEL ZENTIVA 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, your 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 Zentiva is and what it is used for 2. What you need to know before you use Docetaxel Zentiva 3. How to use Docetaxel Zentiva 4. Possible side effects 5. How to store Docetaxel Zentiva 6. Contents of the pack and other information 1. WHAT DOCETAXEL ZENTIVA IS AND WHAT IT IS USED FOR The name of this medicine is Docetaxel Zentiva. 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 Zentiva 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 Zentiva 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 Zentiva could be administered in combination with doxorubicin and cyclophosphamide. - For the treatment of lung cancer, Docetaxel Zentiva could be administered either alone or in combination with cisplatin. - For the treatment of prostate cancer, Docetaxel Zentiva is administered in combination with prednisone or prednisolone. - For the treatment of metastatic gastric cancer, Docetaxel Zentiva is administered in combinat Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 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. 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. 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 Docetaxel Zentiva 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 Zentiva 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 Zentiva 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 Zentiva 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 Zentiva in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemot Прочетете целия документ