Land: Europese Unie
Taal: Engels
Bron: EMA (European Medicines Agency)
sevelamer carbonate
Sanofi B.V.
V03AE02
sevelamer carbonate
All other therapeutic products
Hyperphosphatemia; Renal Dialysis
Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1.78 mmol/L.Sevelamer carbonate Winthrop should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Revision: 21
Authorised
2015-01-15
52 B. PACKAGE LEAFLET 53 PACKAGE LEAFLET: INFORMATION FOR THE USER SEVELAMER CARBONATE WINTHROP 800 MG FILM-COATED TABLETS sevelamer carbonate 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Sevelamer carbonate Winthrop is and what it is used for 2. What you need to know before you take Sevelamer carbonate Winthrop 3. How to take Sevelamer carbonate Winthrop 4. Possible side effects 5. How to store Sevelamer carbonate Winthrop 6. Contents of the pack and other information 1. WHAT SEVELAMER CARBONATE WINTHROP IS AND WHAT IT IS USED FOR Sevelamer carbonate Winthrop contains the active substance sevelamer carbonate. It binds phosphate from food in the digestive tract and so reduces serum phosphorus levels in the blood. This medicine is used to control hyperphosphataemia (high blood phosphate levels) in: • adult patients on dialysis (a blood clearance technique). It can be used in patients undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood); • patients with chronic (long-term) kidney disease who are not on dialysis and have a serum (blood) phosphorus level equal to or above 1.78 mmol/L. This medicine should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease. 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 b Lees het volledige document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Sevelamer carbonate Winthrop 800 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 800 mg sevelamer carbonate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). White to off-white oval tablet, engraved with “RV800” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD) not on dialysis with serum phosphorus ≥ 1.78 mmol/L. Sevelamer carbonate Winthrop should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 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 carbonate is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level. Sevelamer carbonate Winthrop must be taken three times per day with meals. Serum phosphorus level in patients Total daily dose of sevelamer carbonate to be taken over 3 meals per day 1.78 – 2.42 mmol/L (5.5 – 7.5 mg/dl) 2.4 g* > 2.42 mmol/L (> 7.5 mg/dl) 4.8 g* *Plus subsequent titrating, see section “Titration and maintenance” For patients previously on phosphate binders (sevelamer hydrochloride or calcium based), Sevelamer carbonate Winthrop should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses. _Titration and maintenance _ Serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated by 0.8 g three times per day (2.4 g/day) increments every 2-4 weeks until an acceptable serum phosphorus level is reached, with re Lees het volledige document