Country: Ireland
Language: English
Source: 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
License 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 ________________________________ Read the complete document