Land: Israel
Språk: engelsk
Kilde: Ministry of Health
CALCIUM CHLORIDE DIHYDRATE; GLUCOSE AS MONOHYDRATE; MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUM CHLORIDE; SODIUM CARBONATE HYDROGEN; SODIUM CHLORIDE
FRESENIUS MEDICAL CARE ISRAEL P.B. LTD
B05XA30
SOLUTION FOR HEAMODIALYSIS/HAEMOFILTRATION
CALCIUM CHLORIDE DIHYDRATE 0.2205 G/L; GLUCOSE AS MONOHYDRATE 1 G/L; MAGNESIUM CHLORIDE HEXAHYDRATE 0.1017 G/L; POTASSIUM CHLORIDE 0.2237 G/L; SODIUM CARBONATE HYDROGEN 2.940 G/L; SODIUM CHLORIDE 6.136 G/L
I.V, HAEMODIALYSIS
Required
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH, GERMANY
COMBINATIONS OF ELECTROLYTES
COMBINATIONS OF ELECTROLYTES
multiBic 3 mmol/l potassium is indicated for intravenous use as substitution solution in haemofiltration and haemodiafiltration, and as dialysis solution in haemodialysis and haemodiafiltration.For use in patients - with acute kidney injury requiring continuous renal replacement therapy: continuous haemodialysis, haemofiltration or haemodiafiltration treatments. - with chronic kidney disease in whom a transient treatment is indicated, e.g. during the stay on an intensive care unit.- when continuous renal replacement therapy is indicated as part of the treatment of an intoxication with water soluble, filterable/dialyzable toxins.multiBic 3 mmol/l potassium is indicated in adults.
2012-01-31
1. NAME OF THE MEDICINAL PRODUCT MULTIBIC POTASSIUM-FREE MULTIBIC 2 MMOL/L POTASSIUM MULTIBIC 3 MMOL/L POTASSIUM MULTIBIC 4 MMOL/L POTASSIUM Note: this document presents the SmPCs for all four MULTIBIC strengths (potassium-free/2/3/4 mmol/l potassium) in one document, clearly indicating with grey-shaded titles the strength to which alternative text elements refer. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MULTIBIC potassium-free/2/3/4 mmol/l potassium is provided in a two- compartment bag with 4750 ml of an alkaline hydrogen carbonate solution in one compartment and 250 ml of an acidic electrolyte, glucose solution in the other compartment. BEFORE MIXING: 1000 ml solution contain: Acidic electrolyte, glucose solution (small compartment) MULTIBIC potassium- free MULTIBIC 2 mmol/l potassium MULTIBIC 3 mmol/l potassium MULTIBIC 4 mmol/l potassium Potassium chloride - 2.982 g 4.473 g 5.964 g Calcium chloride dihydrate 4.410 g 4.410 g 4.410 g 4.410 g Magnesium chloride hexahydrate 2.033 g 2.033 g 2.033 g 2.033 g Glucose monohydrate 22.00 g 22.00 g 22.00 g 22.00 g (Glucose) (20.00 g) (20.00 g) (20.00 g) (20.00 g) K + 0 mmol/l 40 mmol/l 60 mmol/l 80 mmol/l Ca 2+ 30 mmol/l 30 mmol/l 30 mmol/l 30 mmol/l Mg 2+ 10 mmol/l 10 mmol/l 10 mmol/l 10 mmol/l Cl - 82 mmol/l 122 mmol/l 142 mmol/l 162 mmol/l Glucose 111 mmol/l 111 mmol/l 111 mmol/l 111 mmol/l Alkaline hydrogen carbonate solution (large compartment) MULTIBIC potassium- free MULTIBIC 2 mmol/l potassium MULTIBIC 3 mmol/l potassium MULTIBIC 4 mmol/l potassium Sodium chloride 6.453 g 6.453 g 6.453 g 6.453 g Sodium hydrogen carbonate 3.104 g 3.104 g 3.104 g 3.104 g Na + 147 mmol/l 147 mmol/l 147 mmol/l 147 mmol/l Cl - 110 mmol/l 110 mmol/l 110 mmol/l 110 mmol/l HCO 3 - 37 mmol/l 37 mmol/l 37 mmol/l 37 mmol/l AFTER MIXING: 1000 ml of the ready-to-use solution contain: MULTIBIC potassium- free MULTIBIC 2 mmol/l potassium MULTIBIC 3 mmol/l potassium MULTIBIC 4 mmol/l potassium Potassium chloride - 0.1491 g 0.2237 g 0.2982 g Sodium chloride 6.136 g 6.136 g 6.136 g 6.136 g Sod Les hele dokumentet