Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE ANHYDROUS SODIUM BICARBONATE POTASSIUM CHLORIDE GLUCOSE ANHYDROUS
Baxter Healthcare Limited
4 mMol.
Solution for Haemofiltration
2006-04-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Accusol 35 Potassium 4 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 7.4. For excipients, see section 6.1. The number “35” in the name specifies the buffer concentration of the solution (bicarbonate = 35mmol/l.). 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 0.398 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 0.298 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 + ) 4 mmol Chloride (Cl - ) 113.5 mmol Glucose Anhydrous 5.55 mmol Bicarbonate (HCO 3 - ) 35 mmol Theoretical Osmolarity: 300 MOSM/L IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/04/2011_ _CRN 2099091_ _page number: 1_ 3 PHARMACEUTICAL FORM Solution for haemofiltration, haemodialysis and haemodiafiltration. 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 haemofiltration and haemodiafiltration, and Прочитајте комплетан документ