国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Potassium chloride
Fresenius Kabi Deutschland GmbH
B05XA; B05XA01
Potassium chloride
15 percent weight/volume
Concentrate for solution for infusion
Electrolyte solutions; potassium chloride
Not marketed
2010-07-16
1 PACKAGE LEAFLET: INFORMATION FOR THE USER POTASSIUM CHLORIDE 15% W/V CONCENTRATE FOR SOLUTION FOR INFUSION Potassium chloride 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 pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Potassium Chloride is and what it is used for 2. What you need to know before you use Potassium Chloride 3. How to use Potassium Chloride 4. Possible side effects 5. How to store Potassium Chloride 6. Contents of the pack and other information 1. WHAT POTASSIUM CHLORIDE IS AND WHAT IT IS USED FOR This product belongs to the group “Additives for intravenous solutions’: Electrolytic solutions” and it is dispensed under medical prescription. Potassium Chloride is indicated for the treatment of potassium deficiency in patients for whom dietary measures or oral medication are inadequate. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE POTASSIUM CHLORIDE DO NOT USE POTASSIUM CHLORIDE: You must not be given Potassium Chloride if you suffer from excess of potassium in the blood (hyperkalaemia). WARNINGS AND PRECAUTIONS Talk to your doctor before using Potassium Chloride. Potassium Chloride will be given by or under the direct supervision of your physician, who will take care for the following: - Direct injection of potassium chloride concentrates without appropriate dilution may cause instant death. - The administration should be slow (usually 10 mmol/h, not exceeding 20 mmol/h) and under control of cardiac activity. - Since adequate urine flow must be ensured 完全なドキュメントを読む
Health Products Regulatory Authority 17 April 2019 CRN008S1W Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Potassium Chloride 15% w/v Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of solution contains 150 mg of potassium chloride (15 % w/v) equivalent to 2 mmol potassium ions. Each 5 ml of solution contain 750 mg of potassium chloride (15 % w/v) equivalent to 10 mmol potassium ions. Each 10 ml of solution contain 1500 mg of potassium chloride (15 % w/v) equivalent to 20 mmol potassium ions. Each 20 ml of solution contain 3000 mg of potassium chloride (15 % w/v) equivalent to 40 mmol potassium ions. Ionic content: Cl – 2000 mEq/l or 2000 mmol/l K + 2000 mEq/l or 2000 mmol/l Theoretical osmolarity: 4000 mosm/l pH-value: 4.5 – 7.0 For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. A clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Potassium Chloride 15% w/v is indicated for the treatment of potassium deficiency in patients for whom dietary measures or oral medication are inadequate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION INTRAVENOUS ADMINISTRATION ONLY AFTER DILUTION Posology _Paediatric population_ The safety and efficacy of potassium chloride for paediatric patients has not been fully established. Currently available data are described in section 5.1. _Adults_ Normal dose for adults: Administer intravenously only after dilution in a suitable solution, up to a maximum concentration of 3 g/l of potassium chloride (or 40 mEq of potassium). For therapy of severe hypokalaemia or diabetic ketoacidosis higher concentrations may be necessary; in this case, the infusion should be into a high blood flow vein and continuous ECG monitoring is advisable. 1 g of potassium chloride corresponds to 13.4 mEq or 524 mg of potassium. Dose is dependent on results of serum electrolyte levels and acid-base-state. The potassium deficit is to be calculated via the fo 完全なドキュメントを読む