Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Calcium polystyrene sulphonate
Sanofi-Aventis Ireland Limited T/A SANOFI
V03AE; V03AE01
Calcium polystyrene sulphonate
99.934 percent weight/weight
Powder for oral/rectal suspension
Product subject to prescription which may be renewed (B)
Drugs for treatment of hyperkalemia and hyperphosphatemia; polystyrene sulfonate
Marketed
1983-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER CALCIUM RESONIUM® 99.934% W/W POWDER FOR ORAL OR RECTAL SUSPENSION calcium polystyrene sulfonate Is this leaflet hard to see or read? Phone 01 403 5600 for help READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, nurse or pharmacist. This medicine is only for you. 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Calcium Resonium is and what it is used for 2. What you need to know before you are given Calcium Resonium 3. How Calcium Resonium is given 4. Possible side effects 5. How to store Calcium Resonium 6. Content of the pack and other information 1. WHAT CALCIUM RESONIUM IS AND WHAT IT IS USED FOR Calcium Resonium contains a medicine called calcium polystyrene sulfonate. This belongs to a group of medicines called ‘ion exchange resins’. Calcium Resonium is used to treat something called ‘hyperkalaemia’. This is when there is too much potassium in your blood. It works by removing this extra potassium to bring your levels back to normal. It is often given to people who have kidney problems and people on dialysis. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CALCIUM RESONIUM DO NOT USE CALCIUM RESONIUM IF: × You are allergic (hypersensitive) to calcium polystyrene sulphonate or any of the other ingredients in this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue × You have been told that you have a low level of potassium in your blood × You have been told you have problems that result in high levels of calcium in your body such as Lue koko asiakirja
Health Products Regulatory Authority 14 December 2023 CRN00DTSF Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calcium Resonium 99.934 % Powder for oral or rectal suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Calcium polystyrene sulphonate 99.934 % w/w For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for oral or rectal suspension. A buff-coloured, fine powder for oral or rectal suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Calcium Resonium is an ion-exchange resin that is recommended for the treatment of hyperkalaemia associated with anuria or severe oliguria. It is also used to treat hyperkalaemia in patients requiring acute dialysis and in patients on regular haemodialysis or on prolonged peritoneal dialysis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage recommendations detailed below are a guide only; the precise requirements should be decided on the basis of regular serum electrolyte determinations. _Adults, including the elderly_ Oral: The usual dose is 15g, 3 to 4 times a day. The resin is given by mouth in a little water, or it may be made into a paste with some sweetened vehicle. Administer Calcium Resonium at least 3 hours before or 3 hours after other oral medications. For patients with gastroparesis, a 6-hour separation should be considered1 (see Section 4.4 and Section 4.5). Rectal: In cases where vomiting may make oral administration difficult, the resin may be given rectally as a suspension of 30g resin in 100ml 2% methylcellulose 450 BP (medium viscosity) and 100ml of water, as a daily retention enema. In the initial stages administration by this route as well as orally may help to achieve a more rapid lowering of the serum potassium level. The enema should, if possible, be retained for at least nine hours, then the colon should be irrigated to remove the resin. If both routes are used initially it is probably unnecessary to continue rectal administration once the oral resin reached the rectum. _Paed Lue koko asiakirja