البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
epoetin delta
Shire Pharmaceutical Contracts Limited
B03XA
epoetin delta
Antianemic preparations
Kidney Failure, Chronic; Anemia
Dynepo is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult patients. It may be used in patients on dialysis and in patients not on dialysis.
Revision: 9
Withdrawn
2002-03-18
Medicinal product no longer authorised 102 B. PACKAGE LEAFLET Medicinal product no longer authorised 103 PACKAGE LEAFLET – INFORMATION FOR THE USER DYNEPO 1,000 IU/0.5 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE DYNEPO 2,000 IU/0.5ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE DYNEPO 3,000 IU/0.3ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE DYNEPO 4,000 IU/0.4ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE DYNEPO 5,000 IU/0.5 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE DYNEPO 6,000 IU/0.3 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE DYNEPO 8,000 IU/0.4 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE DYNEPO 10,000 IU/0.5ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE Epoetin delta READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Dynepo is and what it is used for 2. Before you take Dynepo 3. How to take Dynepo 4. Possible side effects 5. How to store Dynepo 6. Further information 1. WHAT DYNEPO IS AND WHAT IT IS USED FOR Epoetin delta is a human erythropoietin made by a technology process called gene-activation, which uses a human cell line. Epoetin delta is a hormone which stimulates the production of red blood cells in the bone marrow. Red blood cells are very important since they contain haemoglobin, a protein which distributes oxygen in your body. Dynepo is used for treating the symptoms of anaemia (which include tiredness, weakness and shortness of breath) associated with chronic renal failure in adult patients , Anaemia is a blood disorder characterised by a decrease in red blood cells. Dynepo may be used in patients on dialysis (a bl اقرأ الوثيقة كاملة
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Dynepo 1,000 IU/0.5 ml solution for injection in a pre-filled syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Pre-filled syringe containing 1,000 IU per 0.5 ml dose (2,000 IU/ml) of the active substance epoetin delta. Epoetin delta is produced in human cells (HT-1080) by gene-activation technology. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in a pre-filled syringe. Clear, colourless and waterlike. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dynepo is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult patients. It may be used in patients on dialysis and in patients not on dialysis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Dynepo should be initiated by physicians experienced in the treatment of anaemia associated with CRF.. The dosage of Dynepo must be adjusted individually to maintain the level of haemoglobin within the target range of 10 to 12g/dl. Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician’s evaluation of the individual patient’s clinical course and condition is necessary. Dynepo should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 12 g/dL (7.5 mmol/L). Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid puncture of peripheral veins. Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed. Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dL (6.2 mmol/l) to 12g/dL (7.5mmol/l). A sustained haemoglobin level of greater than 12 g/dL (7.5 mmol/l) should be avoided; guidance for appropriate dose adjus اقرأ الوثيقة كاملة