Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE GLUCOSE MONOHYDRATE SODIUM CHLORIDE SODIUM BICARBONATE
Fresenius Medical Care Deutschland GmbH
1.5% %w/v
Soln for Peritoneal Dialysis
2003-11-28
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT bica_Vera _1.5% Glucose, Solution for peritoneal dialysis 2 QUALITATIVE AND QUANTITATIVE COMPOSITION bica_Vera _1.5% glucose is delivered in a double chamber bag. One chamber contains the alkaline hydrogen carbonate solution; the other chamber contains the acidic glucose-based electrolyte solution. Mixing of both solutions by opening the median seam between the two chambers results in the ready-to-use solution. BEFORE RECONSTITUTION 1 litre of acidic glucose based electrolyte solution contains: active substances: Sodium chloride 11.57 g Calcium chloride dihydrate 0.5145 g Magnesium chloride hexahydrate 0.2033 g Glucose monohydrate 33.0 g (equivalent to glucose) 30.0 g Na + 198.0 mmol/l Ca 2+ 3.5 mmol/l Mg 2+ 1.0 mmol/l Chloride 209.0 mmol/l 1 litre of alkaline hydrogen carbonate solution contains: active substances: Sodium hydrogen carbonate 5.88 g Na + 70.0 mmol/l HCO 3 - 70.0 mmol/l AFTER RECONSTITUTION 1 litre of the ready-to-use solution contains: active substances: Sodium chloride 5.786 g Sodium hydrogen carbonate 2.940 g Calcium chloride dihydrate 0.2573 g Magnesium chloride hexahydrate 0.1017 g Glucose monohydrate 16.5 g (equivalent to glucose) 15.0 g Na + 134.0 mmol/l Ca 2+ 1.75 mmol/l Mg 2+ 0.5 mmol/l Chloride 104.5 mmol/l Hydrogen carbonate 34.0 mmol/l Glucose 83.25 mmol/l For excipients, see 6.1 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/09/2007_ _CRN 2041678_ _page number: 1_ 3 PHARMACEUTICAL FORM Solution for peritoneal dialysis Clear and colourless solution Theoretical osmolarity: 358 mosm/l pH 7.40 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS End-stage (decompensated) chronic renal failure of any origin treated with peritoneal dialysis. 4.2 POSOLOGY AND METHOD O Belgenin tamamını okuyun