Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE POTASSIUM CHLORIDE SODIUM LACTATE GLUCOSE
Gambro Lundia AB
Unknown
2004-11-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kalilactasol, solution for haemofiltration and haemodialysis 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for haemofiltration and haemodialysis. Clear solution with a slightly yellow colour. pH of the solution: 4.5 – 6.5 Theoretical Osmolarity: 301.6 mOsm/l 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a substitution solution in continuous haemofiltration and haemodiafiltration and as dialysis solution in continuous haemodialysis and haemodiafiltration for acute renal failure and in cases of drug poisoning with dialysable or filterable substances. Kalilactasol is particularly indicated in patients who have a tendency to hyperkalaemia. Sodium Chloride 5.961 g/l Calcium Chloride (Dihydrate) 0.257 g/l Magnesium Chloride (Hexahydrate) 0.152 g/l Potassium Chloride 0.149 g/l Sodium Lactate solution 60% w/w 7.471 g/l corresponding to Sodium Lactate anhydrous 4.483 g/l Glucose Anhydrous 1.100 g/l (in Glucose Monohydrate 1.210 g/l) Kalilactasol solution contains glucose anhydrous 1.1g/litre and in mmol per litre: Sodium 142.00 Chloride 109.00 Potassium 2.00 Calcium 1.75 Magnesium 0.75 Lactate 40.00 For a full list of excipients, see section 6.1 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/03/2012_ _CRN 2099824_ _page number: 1_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Kalilactasol is administered into the venous return of the patient. Kalilactasol, when used as a substitution solution, is administered into the circuit before (pre-dilution) or after the hemofilter (post-dilution). The volume of the solution administered will depend upon the fluid balance of the individual patient, the target fluid balance to be achieved and the amount Read the complete document