Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Calcium polystyrene sulfonate
Lexon (UK) Ltd
V03AE01
Calcium polystyrene sulfonate
999mg/1gram
Powder for oral or rectal suspension
Rectal; Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09020101; GTIN: 5037015023217
CALCIUM RESONIUM 99.934% W/W POWDER FOR ORAL/ RECTAL SUSPENSION (calcium polystyrene sulphonate) For oral or rectal administration after reconstitution. Calcium Cycle Ion Exchange Resin Flavoured powder form of calcium polystyrene sulphonate for removing excess potassium from the body. YOUR MEDICINE CONTAINS 99.934% W/W OF CALCIUM POLYSTYRENE SULPHONATE AS THE ACTIVE INGREDIENT. One level measuring spoon contains 15g of Calcium Resonium. Always read the leaflet attached before use and for details of dosage regime. Use as directed by your doctor. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Store in a dry place. Do not store above 25°C. The suspension should be prepared immediately before use. Do not store for longer than 24 hours after reconstitution. Procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. Manufactured by SANOFI-SYNTHELABO LIMITED, Edgefield Avenue - Fawdon, Newcastle Upon Tyne NE3 3TT United Kingdom. Calcium Resonium is a registered trademark of Sanofi-Synthelabo Inc. P Ref: 1399/040215/CL/01 ® 300G powder Base Label 210mm Front Cover 225mm PEEL HERE 300G powder CALCIUM RESONIUM 99.934% W/W POWDER FOR ORAL/ RECTAL SUSPENSION (calcium polystyrene sulphonate) For oral or rectal administration after reconstitution. Calcium Cycle Ion Exchange Resin Flavoured powder form of calcium polystyrene sulphonate for removing excess potassium from the body. YOUR MEDICINE CONTAINS 99.934% W/W OF CALCIUM POLYSTYRENE SULPHONATE AS THE ACTIVE INGREDIENT. One level measuring spoon contains 15g of Calcium Resonium. Always read the leaflet attached before use and for details of dosage regime. Use as directed by your doctor. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Store in a dry place. Do not store above 25°C. The suspension should be prepared immediately before use. Do not store for longer than 24 hours after reconstitution. Procured from within the EU and repackaged by the Product Licence Holder Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calcium Resonium 99.934% w/w Powder for Oral/Rectal Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle contains 99.934% w/w of the active substance Calcium Polystyrene Sulfonate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for Oral/Rectal Suspension Cream or light brown coloured, fine powder 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 dialysis and in patients on regular haemodialysis or on prolonged peritoneal dialysis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Calcium Resonium is for oral or rectal administration only. 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 three or four times a day. Each dose should be given as a suspension in a small amount of water or, for greater palatability, in syrup (but not fruit juices which contain potassium), in the ratio of 3 to 4ml per gram of resin. 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 considered (see sections 4.4 & 4.5). Rectal This route should be reserved for the patient who is vomiting or who has upper gastrointestinal tract problems, including paralytic ileus. It may be used simultaneously with the oral route for more rapid initial results or in patients with gastroparesis, who have other orally administered medications that are administered within 6 hours of Calcium Resonium. The resin may be given rectally as a suspension of 30g resin in 150ml of water or 10% dextrose, as a daily retention enema. In the initial stages administration by this route as well as orally Perskaitykite visą dokumentą