Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Potassium chloride; Sodium chloride
Fresenius Kabi Limited
B05BB; B05BB01
Potassium chloride; Sodium chloride
0.3% w/v + 0.9% w/v percent weight/volume
Solution for infusion
Product subject to prescription which may not be renewed (A)
Solutions affecting the electrolyte balance; electrolytes
Not marketed
2014-11-03
CORES: COLOURS CÓDIGO: _CODE_ VERSÃO: _VERSION_ FICHA TÉCNICA: _TECHNICAL SHEET_ DESIGNAÇÃO: _NAME_ PROVA: _PROOF_ ELABORADO POR: _MADE BY_ DATA: _DATE_ ESCALA: _SCALE_ Anexo 6.00 do PT.G.087 This medicinal product is authorised in the Member States of the EEA under the following names: THIS LEAFLET WAS LAST REVISED IN 07/2014 9 10 from visible particles. It is available in 500 ml and 1000 ml polyethylene bottles (KabiPac) closed with a polyolefin cap containing a polyisoprene rubber stopper. It is supplied in packs of 10 bottles. Not all pack sizes may be marketed. MARKETING AUTHORISATION HOLDER AND MANUFACTURER MARKETING AUTHORISATION HOLDER Fresenius Kabi Limited, Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire, WA7 1NT, UK MANUFACTURER Fresenius Kabi Deutschland GmbH Freseniusstraße 1, D-61169 Friedberg, Germany POTASSIUM CHLORIDE 0.15% W/V & SODIUM CHLORIDE 0.9% W/V SOLUTION FOR INFUSION 0xxxxx1/00 V001 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 & Sodium Chloride 0.9% 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 & Sodium Chloride 0.9% w/v 3. How Potassium Chloride 0.15% w/v & Sodium Chloride 0.9% w/v is given 4. Possible side effects 5. How to store Potassium Chloride 0.15% w/v & Sodium Chloride 0.9% w/v 6. Contents of the pack and other information 1. WHAT POTASSIUM CHLORIDE 0.15% W/V & SODIUM CHLORIDE 0.9% W/V IS AND WHAT IT IS USED FOR Potassium Chloride 0.15% w/v & Sodium Chloride 0.9% w/v is a solution of potassium chloride and sodium chloride in water. Potassium chloride and sodium chloride are chemicals (often called ‘salts’) th Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Potassium Chloride 0.3% w/v & Sodium Chloride 0.9% w/v Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Potassium Chloride 3.00 g/l Sodium Chloride 9.00 g/l Each ml contains 3.00 mg potassium chloride and 9.00 mg sodium chloride. Each 500 ml bottle contains 1.50 g potassium chloride and 4.5 g sodium chloride. Each 1000 ml bottle contains 3.00 g potassium chloride and 9.00 g sodium chloride. mmol/l: K + : 40 Na + : 154 Cl - : 194 For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion Clear and colourless solution, free from visible particles Osmolarity: 388 mOsm/l (approx.) pH: 4.5 – 7.0 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Potassium Chloride 0.3% w/v & Sodium Chloride 0.9% w/v 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 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 + = 23 mg 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 (acid-base balance) conditions of the patient, concomitant therapy and in particular the patient's hydration state. General posology The recommended dosage for treatment of isotonic fluid depletion (extracellular dehydration) by means of any intravenous solution is: - for adults: 500 ml to 3 litres/24 h - for babies and children: 20 to 100 ml per 24 h and per kg of body weight, depending of the age and the total body mass. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Les hele dokumentet