Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
sevelamer
Sanofi B.V.
V03AE02
sevelamer
All other therapeutic products
Renal Dialysis; Hyperphosphatemia
Renagel is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 - dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Revision: 36
Authorised
2000-01-28
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE USER RENAGEL 400 MG FILM-COATED TABLETS sevelamer hydrochloride 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 further questions, ask your doctor or pharmacist. - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Renagel is and what it is used for 2. What you need to know before you take Renagel 3. How to take Renagel 4. Possible side effects 5. How to store Renagel 6. Contents of the pack and other information 1. WHAT RENAGEL IS AND WHAT IT IS USED FOR Renagel contains sevelamer as the active ingredient. It binds phosphate from food in the digestive tract and so reduces serum phosphate levels in the blood. Renagel is used to control the levels of phosphate in the blood of adult kidney failure patients on haemodialysis or peritoneal dialysis treatment. Adult patients whose kidneys have failed and who are undergoing haemodialysis or peritoneal dialysis are not able to control the level of serum phosphate in their blood. The amount of phosphate then rises (your doctor will call this hyperphosphataemia). Increased levels of serum phosphorus can lead to hard deposits in your body called calcification. These deposits can stiffen your blood vessels and make it harder for blood to be pumped around the body. Increased serum phosphorus can also lead to itchy skin, red eyes, bone pain and fractures. Renagel may be used with other medicines which include calcium or vitamin D supplements to control the development of renal bone disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RENAGEL DO NOT TAKE RENAGEL: • if you have low levels of phosphate in yo Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Renagel 400 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg sevelamer hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) The off-white, oval tablets are imprinted with “Renagel 400” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Renagel is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D 3 or one of its analogues to control the development of renal bone disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Starting dose_ The recommended starting dose of sevelamer hydrochloride is 2.4 g, 3.6 g or 4.8 g per day based on clinical needs and serum phosphorus level. Renagel must be taken three times per day with meals. Serum phosphate level in patients not on phosphate binders Starting dose of Renagel 400 mg tablets 1.76 – 2.42 mmol/L (5.5-7.5 mg/dl) 2 tablets, 3 times per day 2.42- 2.91 mmol/L (7.5-9 mg/dl) 3 tablets, 3 times per day > 2.91 mmol/L 4 tablets, 3 times per day For patients previously on phosphate binders, Renagel should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses. _Titration and maintenance _ Serum phosphate levels should be closely monitored and the dose of sevelamer hydrochloride titrated by 0.4 g or 0.8 g three times per day (1.2 g/day or 2.4 g/day) increments with the goal of lowering serum phosphate to 1.76 mmol/L (5.5mg/dl) or less. Serum phosphate should be tested every two to three weeks until a stable serum phosphate level is reached and on a regular basis thereafter. _ _ The dose range may vary between 1 and 10 tablets per meal. The average actual daily dose used in the chronic phase of a one year clinical st Прочетете целия документ