Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Potassium chloride; Glucose monohydrate
Fresenius Kabi Limited
B05BB; B05BB02
Potassium chloride; Glucose monohydrate
0.15 + 5 percent weight/volume
Solution for infusion
intravenous route
500 ml and 1000 ml
Product subject to prescription which may not be renewed (A)
Blood substitutes and perfusion solutions; electrolytes with carbohydrates
Solutions affecting the electrolyte balance; electrolytes with carbohydrates
Prevention and treatment of potassium depletion and/or hypokalaemia in cases where supply of water and carbohydrates is required due to either restriction of the intake of fluids and electrolytes or depletion by normal routes
Not marketed
2015-09-11
2146969.PA0566_071_002.2de58705-8abd-4e8e-a243-80853e5d7ea1_12_.palen-KCl 0.15_Glucose5-dec2014-clean.150422.doc 1 PACKAGE LEAFLET: INFORMATION FOR THE USER POTASSIUM CHLORIDE 0.15% W/V & GLUCOSE 5% W/V SOLUTION FOR INFUSION potassium chloride, glucose (as monohydrate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Potassium Chloride 0.15% w/v & Glucose 5% w/v is and what it is used for 2. What you need to know before you are given Potassium Chloride 0.15% w/v & Glucose 5% w/v 3. How Potassium Chloride 0.15% w/v & Glucose 5% w/v is given 4. Possible side effects 5. How to store Potassium Chloride 0.15% w/v & Glucose 5% w/v 6. Contents of the pack and other information 1. WHAT POTASSIUM CHLORIDE 0.15% W/V & GLUCOSE 5% W/V IS AND WHAT IT IS USED FOR Potassium Chloride 0.15% w/v & Glucose 5% w/v is a solution of potassium chloride and glucose in water. Potassium chloride is a chemical substance (often called a ‘salt’) that occurs naturally in the blood. Glucose is one of the body’s sources of energy. This solution provides 200 kilocalories per litre. This medicine is used as a source of carbohydrates (sugar) in the prevention and treatment of: loss of potassium from the body (e.g. after treatment with certain diuretics [water tablets]) low level of potassium in the blood (hypokalaemia) in situations that may cause potassium chloride and water loss including: - when you cannot eat or drink, due to illness or after surgery - pronounced sweating due to high fever 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN POTASSIUM CHLORIDE 0.15% W/V & GLUCOSE 5% W/V _ _ YOU WILL NOT BE GIVEN POTASSIUM CHLORIDE 0.15% W/V & GLUCOSE 5% W/V if the level of p Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Potassium Chloride 0.15% w/v & Glucose 5% w/v Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 1.50 mg Potassium Chloride and 50.0 mg Glucose Each 500 ml bottle contains 0.75 g Potassium Chloride and 25 g Glucose Each 1000 ml bottle contains 1.50 g Potassium Chloride and 50 g Glucose mmol/l: K + : 20 Cl - : 20 For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion Clear solution, free from visible particles. pH 3.5 – 6.0 Osmolarity 318 mOsm/l 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention and treatment of potassium depletion and/or hypokalaemia in cases where supply of water and carbohydrates is required due to either restriction of the intake of fluids and electrolytes or depletion by normal routes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Doses may be expressed in terms of mEq or mmol of potassium, mass of potassium, or mass of potassium salt: 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 (acid-base balance) conditions of the patient, concomitant therapy and in particular the patient’s hydration state. _General posology_ The recommended dosage for the treatment of carbohydrates and fluid depletion is - for adults: 500 ml to 3 litres/24 h - for babies and children: 0 - 10 kg body weight: 100 ml/kg/24 h 10 - 20 kg body weight: 1000 ml + (50 ml/kg over 10 kg) /24 h > 20 kg body weight: 1500 ml + (20 ml/kg over 20 kg)/24 h The infusion rate should not exceed the patient’s glucose oxidation capacities in order to avoid hyperglycaemia. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Lees het volledige document