Država: Kanada
Jezik: engleski
Izvor: Health Canada
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; ACETIC ACID; DEXTROSE
BAXTER CORPORATION
B05ZA
HEMODIALYTICS, CONCENTRATES
51.5G; 29.8G; 20.3G; 36.0G; 220.0G
SOLUTION
CALCIUM CHLORIDE 51.5G; POTASSIUM CHLORIDE 29.8G; MAGNESIUM CHLORIDE 20.3G; ACETIC ACID 36.0G; DEXTROSE 220.0G
HAEMODIALYSIS
1L
Ethical
HEMODIALYSIS SOLUTION
Active ingredient group (AIG) number: 0554851005; AHFS:
APPROVED
2013-10-18
Page 1 of 10 Prescribing Information SelectBag One PRESCRIBING INFORMATION SELECTBAG ONE Solution for Dialysis Baxter Corporation Mississauga, Ontario L5N 0C2 Canada Date of Revision: June 10, 2021 Submission Control No: 247855 Baxter, Gambro, BiCart Select and SelectBag are trademarks of Baxter International Inc., or its subsidiaries. Page 2 of 10 Prescribing Information SelectBag One SELECTBAG ONE DESCRIPTION The SelectBag One product is a low-density polyethylene (LDPE) container containing a highly concentrated dialysis concentrate of the minor electrolytes (e.g. KCI, CaCl 2 , MgCl 2 ) and acid needed in a bicarbonate- based dialysis fluid. When the product is attached to the specially designed container holder and the spike is inserted into the container, the concentrate is drawn out by the dialysis machine. The dialysis machine mixes the acidic concentrate with the sodium chloride concentrate and the sodium bicarbonate concentrate to produce a bicarbonate-based dialysis fluid. Free from bacterial endotoxins. INDICATIONS To be used in a bicarbonate dialysis treatment for patients suffering from acute renal failure, chronic renal failure or acute intoxication with dialysable substances. INTENDED USE The SelectBag One product is intended to be used as an acetic acid based concentrate together with the BiCart Select combi-pak for on-line preparation of haemodialysis, haemodiafiltration or haemofiltration fluids on compatible Gambro dialysis systems. SPECIFICATIONS CONTENTS 1000 mL dialysis concentrate Please refer to the product label for the exact composition. CAPACITY Diluted 1:200, 200 litres of dialysis fluid can be produced. REQUIREMENTS FOR MIXING The dialysis concentrate must be mixed with a pure sodium chloride concentrate and a pure sodium bicarbonate concentrate, on a specially adapted dialysis machine to obtain the final dialysis fluid composition. Please refer to page 6. Page 3 of 10 Prescribing Information SelectBag One As an example, when the SelectBag One AX 250 G concentrate is mixed with a dilu Pročitajte cijeli dokument