देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Potassium chloride
Mercury Pharmaceuticals (Ireland) Ltd
A12BA; A12BA01
Potassium chloride
15 percent weight/volume
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Potassium; potassium chloride
Marketed
1988-11-18
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 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. The name of your medicine is Potassium Chloride 15% w/v Concentrate for Solution for Infusion, it will be referred to as Potassium Chloride Concentrate throughout the leaflet for ease here after . WHAT IS IN THIS LEAFLET: 1. What Potassium Chloride Concentrate is and what it is used for 2. What you need to know before you are given Potassium Chloride Concentrate 3. How you are given Potassium Chloride Concentrate 4. Possible side effects 5. How to store Potassium Chloride Concentrate 6. Contents of the pack and other information 1. WHAT POTASSIUM CHLORIDE CONCENTRATE IS AND WHAT IT IS USED FOR WHAT IT IS USED FOR Potassium Chloride Concentrate belongs to a group of medicines called electrolyte replacement solutions. Electrolytes are a group of chemicals and salts that are in the body fluids. Potassium Chloride Concentrate is used in patients needing additional amounts of potassium. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN POTASSIUM CHLORIDE CONCENTRATE YOU SHOULD NOT BE GIVEN POTASSIUM CHLORIDE CONCENTRATE IF : • you know that you are allergic to potassium chloride or any of the other ingredients in this medicine (listed in section 6) • you have high levels of potassium in your blood (hyperkalaemia)- your doctor will advice you. Make sure your doctor knows if you suffer from the above. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR NURSE BEFORE YOU ARE GIVEN POTASSIUM CHLORIDE CONCENTRATE IF YOU: • have a kidney disorder or if your adrenal glands are not working properly (your doctor will advise you) • h पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 14 August 2020 CRN009RLP Page 1 of 4 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 10 ml of solution contains 1.5 g of Potassium Chloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in patientS requiring supplemental potassium therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The goal of potassium replacement therapy is to elevate the plasma concentration of the ion to within the normal range. Dose per hour: The maximal rate of intravenous infusion is 20mmol/hour. Dose per day: Since the normal dietary intake of potassium is 50 to 100 mmol daily, it is rare that a larger amount is required during potassium replacement therapy. Method of administration For intravenous administration, after dilution. Before administering Potassium Chloride 15% w/v Concentrate for Solution for Infusion: 1. This solution must be diluted with not less than 50 times its volume of sodium chloride solution or other suitable diluent. 2. The solution should be carefully mixed with the infusion fluid. During administration: 1. The diluted injection should be administered by slow intravenous infusion at a maximal rate of 20 mmol of potassium per hour. 2. The ECG should be monitored continuously. 4.3 CONTRAINDICATIONS 1. Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 2. Potassium Chloride Concentrate (15%) should never be used undiluted. 3. Hyperkalaemia. Health Products Regulatory Authority 14 August 2020 CRN009RLP Page 2 of 4 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The diluted solution should always be given slowly as high blood concentrations of potassium may cause serious cardiac toxicity. Particular care is required when administering potassium to pati पूरा दस्तावेज़ पढ़ें