Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Icodextrin; Sodium chloride; Sodium (S) - lactate ; Calcium chloride; Magnesium chloride
Baxter Holding B.V.
B05DA
Icodextrin; Sodium chloride; Sodium (S) - lactate ; Calcium chloride; Magnesium chloride
Solution for peritoneal dialysis
Isotonic solutions
Marketed
1997-07-25
Health Products Regulatory Authority 21 January 2022 CRN00CRW7 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT EXTRANEAL Solution for peritoneal dialysis 2 QUALITATIVE AND QUANTITATIVE COMPOSITION A sterile peritoneal dial y sis fluid containing Ic odextri n at a concentration of 7 .5 % w/v in an electroly te solution. Icodextrin 75 g/L Sodium Chloride 5.4 g/L Sodium S-Lactate 4.5 g/L Calciu m Chloride 0.25 7g/L Magnesiu m Chloride0.05 1g/L Theoretical osm o larity : 284 (m illiosm oles per litre) Theoretical osm o lality : 301 (m illiosm oles per kg) Electroly te so lution co ntent per 100 0 m l: Sodium 133 mmol/L Calciu m 1.75mmol/L Magnesiu m0.25mmol/L Chloride 96 mmol/L Lactate 40 mmol/L pH = 5 to 6 For the full list of excipients, see se ction 6.1. 3 PHARMACEUTICAL FORM Solution for peritoneal dialysis. Extraneal is a sterile, clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Extraneal is recommended as a once daily replacement for a single glucose exchange as part of a continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) regimen for the treatment of chronic renal failure, particularly for patients who have lost ultrafiltration on glucose solutions, because it can extend time on CAPD therapy in such patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: Extraneal is recommended for use during the longest dwell period, i.e. in CAPD usually overnight and in APD for the long daytime dwell. • The mode of therapy, frequency of treatment, exchange volume, duration of dwell and length of dialysis should be initiated and supervised by the physician. _Adults_ By intraperitoneal administration limited to a single exchange in each 24 hour-period, as part of a CAPD or APD regimen. Health Products Regulatory Authority 21 January 2022 CRN00CRW7 Page 2 of 11 The volume to be instilled should be given over a period of approximately 10 to 20 minutes at a rate which the patient finds comfortable. For adult patients of norm Přečtěte si celý dokument