Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GLUCOSE ANHYDROUS SODIUM CHLORIDE SODIUM LACTATE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE
Fresenius Medical Care Deutschland GmbH
GLUCOSE ANHYDROUS SODIUM CHLORIDE SODIUM LACTATE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE
Solution for Dialysis
Product subject to prescription which may not be renewed (A)
Withdrawn
2013-04-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gambrosol trio 10, solution for peritoneal dialysis 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Gambrosol trio 10 is filled in a three-compartment bag. Two smaller compartments (A and B) each contain 50% glucose solution and sodium chloride (NaCl) and a larger third compartment (C) the electrolyte solution. After breaking the frangible pin between compartments A and C and thoroughly mixing the two fluids a PD solution containing 1.5% glucose will be produced. Similarly mixing the contents of compartments B and C will produce a PD solution containing 2.5% glucose. Finally by breaking both frangible pins and mixing the contents of all three compartments will produce a solution containing 3.9% glucose. _BEFORE RECONSTITUTION_ _AFTER RECONSTITUTION_ The glucose compartments A or/and B are mixed with the electrolyte compartment C to give the following reconstituted solutions: _ELECTROLYTE CONTENT PER EACH 1000 ML OF RECONSTITUTED SOLUTION:_ _EACH 1000 ML CONTAINS:_ GLUCOSE COMPARTMENTS A AND B ACTIVE INGREDIENTS: Glucose anhydrous 500.0 g _(as glucose monohydrate_ _550.0 g)_ Sodium chloride 5.38 g ELECTROLYTE COMPARTMENT C ACTIVE INGREDIENTS: Sodium chloride 5.38 g Sodium lactate S-(+) anhydrous 4.72 g _(as 60% m/m solution)_ _(7.87 g)_ Calcium chloride dihydrate 0.271 g Magnesium chloride hexahydrate 0.054 g Mix compartments A and C Reconstituted solution 10L (Light) Mix compartments B and C Reconstituted solution 10M (Medium) Mix compartments A, B and C Reconstituted solution 10H (High) RECONSTITUTED SOLUTION MMOL/L L M H Sodium Na + 133 132 131 mmol/l Calcium Ca ++ 1.79 1.75 1.70 mmol/l Magnesium Mg ++ 0.26 0.25 0.24 mmol/l Chloride Cl - 96.2 96.0 96.0 mmol/l Lactate 41 40 39 mmol/l Glucose 85 139 215 mmol/l IRISH MEDICINES BOARD _____________________ Read the complete document