Country: ইউরোপীয় ইউনিয়ন
ভাষা: ইংরেজি
সূত্র: EMA (European Medicines Agency)
colestilan
Mitsubishi Pharma Europe Ltd
V03AE
colestilan
Drugs for treatment of hyperkalaemia and hyperphosphataemia
Hyperphosphatemia
Treatment of hyperphosphataemia in adult patients with chronic kidney disease stage 5 receiving haemodialysis or peritoneal dialysis.
Revision: 2
Withdrawn
2013-01-21
43 B. PACKAGE LEAFLET Medicinal product no longer authorised 44 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BINDREN 1 G FILM-COATED TABLETS colestilan This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What BindRen is and what it is used for 2. What you need to know before you take BindRen 3. How to take BindRen 4. Possible side effects 5. How to store BindRen 6. Contents of the pack and other information 1. WHAT BINDREN IS AND WHAT IT IS USED FOR BindRen contains the active substance colestilan. It is used to lower high blood phosphorus levels in adult patients undergoing dialysis due to poor kidney function. About high blood phosphorus levels (hyperphosphataemia) If your kidneys no longer function properly you may undergo dialysis, which replaces many of the functions of your kidneys. You have also been advised to follow a special diet to reduce the amount of phosphorus that your body takes from food. Sometimes, the dialysis and diet are not enough to stop the phosphorus in your blood rising to high levels, a condition referred to by your doctor as hyperphosphataemia. Keeping the phosphorus level in your blood low is important to maintain healthy bones and blood vessels and to prevent itchy skin, red eyes, bone pain or bone fractures. How BindRen works Colestil সম্পূর্ণ নথি পড়ুন
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT BindRen 1 g film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 g colestilan. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, oval shaped, film-coated tablet approximately 20.2 mm in length and 10.7 mm wide printed with “BINDREN” (in blue ink) on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BindRen is indicated for the treatment of hyperphosphataemia in adult patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended starting dose is 6-9 g per day (2-3 g three times daily). Patients previously on other phosphate binders who are switched to BindRen should start taking 6-9 g per day (2-3 g three times daily). _Dose titration _ Serum phosphorus concentrations should be monitored. If an acceptable serum phosphorus concentration is not achieved, the dose may be increased by 3 g per day (1 g three times daily) in 2-3 weekly intervals. The maximum daily dose of BindRen tested in clinical trials was 15 g per day (5 g three times daily). _Special populations _ _Elderly population _ Experience from clinical studies in patients above the age of 75 years is very limited. _ _ _Renal impairment _ BindRen is indicated for use in patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis. No data on the use of BindRen in pre-dialysis patients are available. _Severe hepatic impairment _ Patients with severe hepatic impairment were excluded from clinical studies. Therefore, the use of BindRen is not rec সম্পূর্ণ নথি পড়ুন