País: Israel
Idioma: anglès
Font: Ministry of Health
POTASSIUM CHLORIDE
LAPIDOT MEDICAL IMPORT AND MARKETING LTD
A12BA01
CONCENTRATE FOR SOLUTION FOR INFUSION
POTASSIUM CHLORIDE 14.9 G / 100 ML
I.V
Required
B.BRAUN MELSUNGEN AG, GERMANY
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
Treatment of potassium deficiency states when oral replacement is not feasable.
2015-02-28
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Potassium Chloride 14.9 % 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL of concentrate contains 0.149 g potassium chloride corresponding to 2 mmol K + and 2 mmol Cl – 1 ampoule (= 10 mL ampoule) contains 1.49 g potassium chloride corresponding to 20 mmol K + and 20 mmol Cl – For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless solution Theoretical osmolarity 3 995 mOsm/L pH 4.5-7.5 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS States of potassium deficiency when oral replacement is not feasible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Individualize dosage. Guide dosage and rate of infusion by ECG and serum electrolyte determinations. The potassium deficit is calculated according to the following formula: mmol potassium = kg body weight x 0.2 x 2 x [4.5 – current serum potassium (mmol/l)]. (Body weight x 0.2 represents the extracellular fluid volume.) _Maximum daily dose _ Not more than 2 – 3 mmol/kg body weight/day. _Maximum infusion rate _ Up to 20 mmol potassium per hour in adults (corresponding to 0.3 mmol potassium/kg body weight/hour). _Children_ IV infusion up to 3 mEq/kg/day. Adjust volume of administered fluids to body size. METHOD OF ADMINISTRATION Intravenously use. Use only diluted as an additive to infusion solutions. The potassium concentration in the infusion solution must not exceed 40 mmol/l. Suitable vehicle solutions are e.g. 5% or 10% glucose solutions, isotonic sodium chloride solution, Compound Sodium Lactate solution, or complete electrolyte solutions. Do not infuse rapidly. Adjust rate of administration according to tolerance. Use of the largest peripheral vein and a small bore needle is recommended. In addition to ECG effects, vein irritation may result when a potassium concentration greater than 40 mEq/l is infused. Concentrated potassium solutions are for IV admixtures only; do not use undiluted. Direct injection may b Llegiu el document complet