国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
GLUCOSE SODIUM CHLORIDE SODIUM LACTATE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE ANHYDROUS
Baxter Healthcare Limited
13.6 Mg/Ml
Solution for Dialysis
1993-06-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dianeal PD4 Glucose 1.36 % w/v (13.6 mg/ml), Solution for peritoneal dialysis. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION MMOL/L For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Peritoneal Dialysis. A clear colourless to pale yellow, solution in PVC containers, which may have an integral administration set and drainage bag. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dianeal PD4 is indicated whenever peritoneal dialysis is employed, including: 1. Acute and chronic renal failure. 2. Severe water retention. 3. Electrolyte disorders. 4. Drug intoxication, when a more adequate therapeutic alternative is not available. Dianeal PD4 is particularly useful for the control of serum calcium and phosphate levels in renal failure patients receiving calcium or magnesium-containing phosphate binders. Anhydrous Glucose 1.36 % w/v 13.60 g/L or Glucose Monohydrate 1.50 % w/v 15.00 g/L Sodium Chloride 0.538 % w/v 5.38 g/L Sodium Lactate 0.448 % w/v 4.48 g/L Calcium Chloride Dihydrate 0.0184 % w/v 184.00 mg/L Magnesium Chloride Hexahydrate 0.0051 % w/v 51.00 mg/L Na + 132.00 Ca 2+ 1.25 Mg 2+ 0.25 Cl - 95.00 C 3 H 5 O 3 - 40.00 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/02/2012_ _CRN 2107266_ _page number: 1_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Administration_ DIANEAL PD4 is intended for intraperitoneal administration only. Not for intravenous administration. Peritoneal dialysis solutions may be warmed to 37°C to enhance patient comfort. However, only dry heat (for example, heating pad, warming plate) should be used. Solutions should not be heated in water due to an increased risk of contamination. Solutions should not be heated 完全なドキュメントを読む