国家: 欧盟
语言: 英文
来源: EMA (European Medicines Agency)
daclizumab
Roche Registration Ltd.
L04AA08
daclizumab
Immunosuppressants
Graft Rejection; Kidney Transplantation
Zenapax is indicated for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation and is to be used concomitantly with an immunosuppressive regimen, including cyclosporine and corticosteroids in patients who are not highly immunised.
Revision: 8
Withdrawn
1999-02-26
Medicinal product no longer authorised 19 B. PACKAGE LEAFLET Medicinal product no longer authorised 20 PACKAGE LEAFLET: INFORMATION FOR THE USER Zenapax 5 mg/ml concentrate for solution for infusion Daclizumab 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 pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - 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 pharmacist. IN THIS LEAFLET: 1. What Zenapax is and what it is used for 2. Before you use Zenapax 3. How to use Zenapax 4. Possible side effects 5. How to store Zenapax 6. Further information 1. WHAT ZENAPAX IS AND WHAT IT IS USED FOR Daclizumab belongs to a group of medicines called immunosuppressants. These medicines help to suppress your body’s natural response to reject your transplanted organ. Daclizumab is a humanised monoclonal antibody produced in a murine NSO myeloma cell line using a glutamine synthetase (GS) expression system (NS_GSO) by recombinant DNA technology. Monoclonal antibodies are proteins which recognise and bind to other unique proteins in the body called antigens. Daclizumab binds to an antigen found on the surface of specific white blood cells called T lymphocytes. This activity suppresses the body’s natural immune response which otherwise might cause transplant rejection. Zenapax is used to prevent your body from rejecting transplanted kidneys. Zenapax is used together with other immunosuppressive drugs, including cyclosporine and corticosteroids. 2. BEFORE YOU USE ZENAPAX DO NOT USE ZENAPAX - if you are allergic (hypersensitive) to daclizumab or to any of the other ingredients of Zenapax. - if you are breast-feeding. Please read the section below on breast-feeding. TAKE SPECIAL CARE WITH ZENAPAX - if you have ever had an a 阅读完整的文件
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Zenapax 5 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Daclizumab*…………5 mg per 1 ml infusion One vial of 5 ml contains 25 mg of daclizumab* (5 mg/ml). * Recombinant humanized IgG1 anti-Tac antibody produced in a murine NSO myeloma cell line using a glutamine synthetase (GS) expression system (NS_GSO) by recombinant DNA technology Excipients: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear to slightly opalescent, colourless to slightly yellowish liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zenapax is indicated for the prophylaxis of acute organ rejection in _de novo_ allogenic renal transplantation and is to be used concomitantly with an immunosuppressive regimen, including cyclosporine and corticosteroids in patients who are not highly immunised. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Zenapax should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation. The recommended dose for Zenapax in adult and paediatric patients is 1 mg/kg. The volume of Zenapax containing the appropriate dose is added to 50 ml of sterile 0.9% saline solution and is administered intravenously over a 15 minute period. It may be given via a peripheral or central vein. Zenapax should initially be given within 24 hours before transplantation. The next and each subsequent dose should be given at intervals of fourteen days, for a total of five doses. Elderly Experience with Zenapax in elderly patients (older than 65 years) is limited because of the small number of older patients who undergo renal transplantation, but there is no evidence that elderly patients require a different dosage from younger patients. Patients with severe renal impairment No dosage adjustment is necessary for 阅读完整的文件