国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
GLUCOSE MONOHYDRATE POTASSIUM CHLORIDE
Baxter Healthcare Limited
0.3/5.0 %w/v
Intravenous Inf Solution
1983-04-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 0.3% w/v Potassium Chloride and 5.0% w/v Glucose Intravenous Infusion BP. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Potassium Chloride: 3.0 g/L Glucose (as Monohydrate): 50.0 g/L mmol/l: K + : 40, Cl - : 40 For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Clear solution, free from visible particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For prophylactic and replacement therapy requiring the use of glucose and potassium chloride. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE The dosage is dependant upon the age, weight and clinical condition of the patients and must be decided on an individual basis. ADMINISTRATION Intravenous. 4.3 CONTRAINDICATIONS Use in patients with severe impairment of renal function. Use in hyperkalaemia such as is associated with adrenal insufficiency or severe renal insufficiency. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Administration should be carried out only under specialist surveillance. Plasma electrolyte levels should be carefully monitored during use, especially in patients with pre-existing imbalances, in renal failure or in hepatic disease. Venous irritation and thrombophlebitis may occur at the injection site. This fluid should be administered with great care to patients with diabetes mellitus or renal insufficiency. Potassium replacement therapy is critical and must be guided by measurement of plasma levels and ECG. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/06/2009_ _CRN 2067210_ _page number: 1_ Potassium replacement should be used with extreme caution in patients with cardiac disease, renal dysfunction, digitalisation or hep 完全なドキュメントを読む