Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Sevelamer carbonate
Asumed Biotech Sdn. Bhd.
Sevelamer carbonate
180 Tablets
Chen Ho Pharmaceutical Co., Ltd. Sinying Plant
_Consumer Medication Information Leaflet_ _(RiMUP) _ SEVELA FILM-COATED TABLET 800MG _Sevelamer Carbonate 800mg _ _ _ _ _ 1 WHAT IS IN THIS LEAFLET a) What Sevela is used for b) How Sevela works c) Before you use Sevela d) How to use Sevela e) While you are using it f) Side effects g) Storage and Disposal of Sevela h) Product Description i) Manufacturer and Product Registration Holder j) Date of revision k) Serial Number WHAT SEVELA IS USED FOR The name of your medicine is Sevela Tablet 800mg (called “Sevela’ in this leaftlet). Sevela contains a medicine called Sevelamer Carbonate. Sevela is a phosphate binder to be used for the control of serum phosphorus in adults receiving haemodialysis or peritoneal dialysis, or with chronic kidney disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l. Sevela 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. HOW SEVELA WORKS Sevela is a prescription medication containing Sevelamer carbonate. It binds phosphate from food in the digestive tract and so reduces serum phosphorus levels in the bloods. BEFORE YOU USE SEVELA WHEN YOU MUST NOT USE IT: Do not use this product if you have bowel obstruction or you are allergic to _ _ sevelamer carbonate, sevelamer hydrochloride, or any other ingredients in this medication. (Please refer to product description) PREGNANCY AND LACTATION Do not take Sevela if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take Sevela if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. _ _ BEFORE YOU START USE IT: Before taking Sevela your doctor needs to know if you have any other medical condition that you may have, including swallowing problems, problems with motility (movement) in your stomach and bowel, being sick frequently, active inflammation of the bowel, have undergone major surgery on your stomach or bow Prečítajte si celý dokument
COMPOSITION Each capsule contains: Sevelamer Carbonate 800mg PRODUCT DESCRIPTION Off-white to white oval shaped film-coated tablet, “CH86”on single side. PHARMACODYNAMICS Pharmacotherapeutic group: All other therapeutic products, drugs for treatment of hyperkalemia and hyperphosphataemia. ATC code: V03AE02. _Mechanism of action _ Sevela contains sevelamer, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. Sevelamer contains multiple amines separated by one carbon from the polymer backbone which become protonated in the stomach. These protonated amines bind negatively charged ions such as dietary phosphate in the intestine. _Pharmacodynamic effect _ By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer lowers the phosphorus concentration in the serum. Regular monitoring of serum phosphorus levels is always necessary during phosphate binder administration. PHARMACOKINETICS Pharmacokinetic studies have not been carried out with sevelamer carbonate. Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, is not absorbed from the gastrointestinal tract. In addition, the potential absorption and accumulation of sevelamer during long-term chronic treatment (> one year) cannot be totally excluded. INDICATION Sevelamer carbonate is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer carbonate 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 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. RECOMMENDED DOSE Because of the rapid disintegration of the carbonate salt tablet and its rapid reaction with the hydrochloric acid in the stomach, the dosing of Sevelamer carbonate is Prečítajte si celý dokument