البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE ANHYDROUS SODIUM BICARBONATE POTASSIUM CHLORIDE GLUCOSE ANHYDROUS
Baxter Healthcare Limited
2 mMol.
Solution for Haemofiltration
2006-04-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Accusol 35 Potassium 2 mmol/l Solution for haemofiltration, haemodialysis and haemodiafiltration 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Equivalent to the following ionic composition: The 5000 ml of final solution results from mixing 3750 ml of solution ‘A’ with 1250 ml of solution ‘B’. The pH of the final solution is between 7.0 - 7.5. For a full list of excipients, see section 6.1. The number “35” in the name specifies the buffer concentration of the solution (bicarbonate = 35mmol/l.) 3 PHARMACEUTICAL FORM Solution for haemofiltration, haemodialysis and haemodiafiltration. COMPOSITION PER 1000 ML ACCUSOL 35 LARGE CHAMBER ‘A’ Calcium chloride dihydrate 0.343 g Magnesium chloride hexahydrate 0.136 g Sodium chloride 7.66 g Potassium chloride 0.199 g Glucose monohydrate 1.47 g SMALL CHAMBER ‘B’ Sodium bicarbonate 12.9 g FINAL SOLUTION AFTER MIXING PER 1000 ML ACCUSOL 35 Calcium chloride dihydrate 0.257 g Magnesium chloride hexahydrate 0.102 g Sodium chloride 6.14 g Potassium chloride 0.149 g Glucose anhydrous 1.0 g Sodium bicarbonate 2.94 g IONIC COMPOSITION OF FINAL SOLUTION PER 1000 ML ACCUSOL 35 Calcium (Ca ++ ) 1.75 mmol Magnesium (Mg ++ ) 0.5 mmol Sodium (Na + ) 140 mmol Potassium (K + ) 2 mmol Chloride (Cl - ) 111.5 mmol Glucose Anhydrous 5.55 mmol Bicarbonate (HCO 3 - ) 35 mmol Theoretical Osmolarity 296 MOSM/L IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/04/2011_ _CRN 2099091_ _page number: 1_ Accusol 35 is a sterile, non pyrogenic, clear and colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Accusol 35 is indicated for the treatment of acute and chronic renal failure, as substitution solution in haemofiltrat اقرأ الوثيقة كاملة