Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
docetaxel trihydrate
Hospira UK Limited
L01CD02
docetaxel
Antineoplastic agents
Stomach Neoplasms; Prostatic Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung
Breast cancerTaxespira 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.Taxespira 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.Taxespira 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.Taxespira 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.Taxespira 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 cancer Taxespira indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.Taxespira 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 Taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Gastric adenocarcinoma Taxespira 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 cancer Taxespira 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: 8
Withdrawn
2015-08-28
62 B. PACKAGE LEAFLET Medicinal product no longer authorised 63 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TAXESPIRA 20 MG/1 ML CONCENTRATE FOR SOLUTION FOR INFUSION TAXESPIRA 80 MG/4 ML CONCENTRATE FOR SOLUTION FOR INFUSION TAXESPIRA 120 MG/6 ML CONCENTRATE FOR SOLUTION FOR INFUSION TAXESPIRA 140 MG/7 ML CONCENTRATE FOR SOLUTION FOR INFUSION TAXESPIRA 160 MG/8 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, 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 Taxespira is and what it is used for 2. What you need to know before you use Taxespira 3. How to use Taxespira 4. Possible side effects 5. How to store Taxespira 6. Contents of the pack and other information 1. WHAT TAXESPIRA IS AND WHAT IT IS USED FOR The name of this medicine is Taxespira. 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. Taxespira 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, Taxespira 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, Taxespira could be administered in combination with doxorubicin and cyclophosphamide. For the treatment of lung cancer, Taxespira could be administered either alone or in combination with cisplatin. For the treatment of prostate cancer, Taxespira is administ Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Taxespira 20 mg/1 ml concentrate for solution for infusion Taxespira 80 mg/4 ml concentrate for solution for infusion Taxespira 120 mg/6 ml concentrate for solution for infusion Taxespira 140 mg/7 ml concentrate for solution for infusion Taxespira 160 mg/8 ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel (as trihydrate). 20mg/1 ml One vial of 1 ml of concentrate contains 20 mg docetaxel. 80mg/4 ml One vial of 4 ml concentration contains 80 mg docetaxel. 120mg/6 ml One vial of 6 ml concentration contains 120 mg docetaxel. 140mg/7 ml One vial of 7 ml concentration contains 140 mg docetaxel. 160mg/8 ml One vial of 8 ml concentration contains 160 mg docetaxel. Excipient with known effect 20mg/1 ml Each 1 ml vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg). 80mg/4 ml Each 4 ml vial of concentrate contains 2 ml of ethanol anhydrous (1580 mg). 120mg/6 ml Each 6 ml vial of concentrate contains 3 ml of ethanol anhydrous (2370 mg). 140mg/7 ml Each 7 ml vial of concentrate contains 3.5 ml of ethanol anhydrous (2765 mg). 160mg/8 ml Each 8 ml vial of concentrate contains 4 ml of ethanol anhydrous (3160 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. The concentrate is a pale yellow to brownish-yellow solution. Medicinal product no longer authorised 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Breast cancer Taxespira 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 canc Прочетете целия документ