Země: Evropská unie
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
docetaxel
Sun Pharmaceutical Industries Europe B.V.
L01CD02
docetaxel
Antineoplastic agents
Stomach Neoplasms; Adenoma; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Prostatic Neoplasms
Breast cancerDocetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.Docetaxel 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 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 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 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 is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.Docetaxel 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 in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Gastric adenocarcinomaDocetaxel 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 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: 1
Withdrawn
2010-05-10
Medicinal product no longer authorised 86 B. PACKAGE LEAFLET Medicinal product no longer authorised 87 PACKAGE LEAFLET: INFORMATION FOR THE USER DOCEFREZ 20 MG POWDER AND SOLVENT FOR 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 nurse. - 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 nurse. IN THIS LEAFLET : 1. What Docefrez is and what it is used for 2. Before you use Docefrez 3. How to use Docefrez 4. Possible side-effects 5. How to store Docefrez 6. Further information 1. WHAT DOCEFREZ IS AND WHAT IT IS USED FOR Docefrez contains the active substance docetaxel. Docetaxel, derived from yew-tree needles, belongs to a group of anti-cancer medicines called taxanes. Docefrez is used, either alone or in combination with other medicines, for the treatment of the following kinds of cancer: - advanced breast cancer, alone or with doxorubicin, or trastuzumab, or capecitabine - early breast cancer with or without lymph node involvement, with doxorubicin and cyclophosphamide - non-small cell lung cancer (NSCLC), alone or with cisplatin - prostate cancer, with prednisone or prednisolone - metastatic gastric cancer, with cisplatin and 5-fluorouracil - head and neck cancer, with cisplatin and 5-fluorouracil. 2. BEFORE YOU USE DOCEFREZ DO NOT USE DOCEFREZ - if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docefrez - if your number of white blood cells is too low - if you have severe liver disease - TAKE SPECIAL CARE WITH DOCEFREZ Tell your doctor if you have: - heart problems - liver problems - kidney problems Before each Docefrez dose, you will have blood tests to check that your blood cell counts and liver function are adequate. USING OTHER MEDICINES Medicinal product no longer authorised 88 Please tell your doctor or nurse if Přečtěte si celý dokument
Medicinal product no longer authorised 1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Docefrez 20 mg powder and solvent for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose vial of powder contains 20 mg docetaxel (anhydrous). After reconstitution, 1 ml of concentrate contains 24 mg docetaxel. Excipients: the solvent contains 35.4% (w/w) ethanol. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for concentrate for solution for infusion. White lyophilised powder. The solvent is a viscous, clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Breast cancer Docetaxel 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 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 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 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 in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Přečtěte si celý dokument