Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Icodextrin; Sodium chloride; Sodium lactate; Magnesium chloride; Calcium chloride
Icodextrin 7.5%) APD solution for peritoneal dialysis 2.5litre single bags with luer connector (Vantive Ltd
n/a
Icodextrin; Sodium chloride; Sodium lactate; Magnesium chloride; Calcium chloride
75gram/1litre ; 5.4gram/1litre ; 4.5gram/1litre ; 51mg/1litre ; 257mg/1litre
Solution for peritoneal dialysis
Intraperitoneal
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: ; GTIN: 05413760441894 50085412574368
OBJECT 1 EXTRANEAL (ICODEXTRIN 7.5%) SOLUTION FOR PERITONEAL DIALYSIS Summary of Product Characteristics Updated 26-May-2016 | Baxter Healthcare Ltd 1. Name of the medicinal product EXTRANEAL (Icodextrin 7.5%) Solution for peritoneal dialysis 2. Qualitative and quantitative composition A sterile peritoneal dialysis fluid containing Icodextrin at a concentration of 7.5% w/v in an electrolyte solution. Icodextrin 75 g/L Sodium Chloride 5.4 g/L Sodium S-Lactate 4.5 g/L Calcium Chloride 0.257 g/L Magnesium Chloride 0.051 g/L Theoretical osmolarity: 284 (milliosmoles per litre) Theoretical osmolality: 301 (milliosmoles per kg) Electrolyte solution content per 1000 ml: Sodium 133 mmol/L Calcium 1.75 mmol/L Magnesium 0.25 mmol/L Chloride 96 mmol/L Lactate 40 mmol/L pH = 5 to 6 For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for peritoneal dialysis. Extraneal is a sterile, clear, colorless 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. 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 normal body size the instilled volume should Прочитать полный документ