Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
POTASSIUM CHLORIDE SODIUM CHLORIDE GLUCOSE MONOHYDRATE
Baxter Healthcare Limited
POTASSIUM CHLORIDE SODIUM CHLORIDE GLUCOSE MONOHYDRATE
0.15/0.18/ %w/v
Intravenous Inf Solution
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-10-18
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 0.15% w/v Potassium Chloride, 0.18% w/v Sodium Chloride and 4% w/v Glucose Intravenous Infusion BP, Viaflex Container 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substances Potassium Chloride 0.15 % w/v Sodium Chloride 0.18 % w/v Anhydrous Glucose 4.0 % w/v (as Glucose Monohydrate) 4.4 % w/v Equivalent to: mmol/L Potassium 20 Sodium 30 Chloride 50 For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Clear, colourless solution, free from visible particles. pH: 3.5 - 5.5 Osmolarity: 322 mOsm/l 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the restoration and maintenance of fluid, calorie and sodium, potassium and chloride balance where the oral route of administration is not feasible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE Dosage of product is dependent upon the age, weight, clinical state and degree of deficiency of the patient and must be determined on an individual basis. ADMINISTRATION Intravenous. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 09/06/2009_ _CRN 2067156_ _page number: 1_ 4.3 CONTRAINDICATIONS o Use of a solution which is cloudy, contains sediment or is in any way unusual. o Use in patients with fluid and sodium retention, congestive heart failure, or severe impairment of renal function. o Use in the presence of dehydration without fluid replacement. o Use in hyperkalaemia such as is associated with adrenal insufficiency or severe renal insufficiency. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE o Plasma electrolyte levels should be carefully monitored during use, especially in patients with pre-existing imbalances, in renal failure or in hepatic disease. o Belgenin tamamını okuyun