Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Potassium chloride; Sodium chloride
Baxter Healthcare Limited
B05BB; B05BB01
Potassium chloride; Sodium chloride
0.15/0.9 percent weight/volume
Solution for infusion
Product subject to prescription which may not be renewed (A)
Solutions affecting the electrolyte balance; electrolytes
Not marketed
2007-11-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Potassium Chloride 0.15% w/v & Sodium Chloride 0.9% w/v Solution for Infusion - BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Potassium Chloride 1.50 g/l Sodium Chloride 9.00 g/l Each ml contains 1.50 mg Potassium Chloride and 9.00 mg Sodium Chloride. mmol/l: K + : 20 Na + : 154 C1 - : 174 For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Clear solution, free from visible particles. Osmolarity: 348 mOsm/L (approx.) pH: 4.5 – 7.0 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Potassium Chloride 0.15 % w/v & Sodium Chloride 0.9% w/v Solution for Infusion is indicated for the prevention and treatment of potassium depletion and/or hypokalaemia, in sodium chloride and water-losing conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, the Elderly_,_ Adolescents and Children Doses may be expressed in terms of mEq or mmol of each cation, mass of each cation, or mass of each cation salt: - for sodium 1 g NaCl = 394 mg of Na + or 17.1 mEq or 17.1 mmol of Na + and Cl - 1 mmol Na + = 23mg Na + - for potassium 1 g KCl = 525 mg of K + or 13.4 mEq or 13.4 mmol of K + and Cl - 1 mmol K + = 39.1 mg K + The dosage of this solution depends on the age, weight, clinical and biological (acidbase balance) conditions of the patient, concomitant therapy and in particular the patient's hydration state. _Posology for prevention and treatment of potassium depletion_ - For Adults, the Elderly and Adolescents: H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Read the complete document