国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
POTASSIUM CHLORATE ; GLUCOSE MONOHYDRATE
Maco Pharma (UK) Ltd
B05BB02
POTASSIUM CHLORATE ; GLUCOSE MONOHYDRATE
0.3/5 %w/v
Solution for Infusion
Product subject to prescription which may not be renewed (A)
electrolytes with carbohydrates
Marketed
2005-12-02
WHAT IS IN THIS LEAFLET 1. What Potassium Chloride 0.3%w/v Sodium Chloride 0.9%w/v Solution for Infusion is and what it is used for 2. What you need to know before you are given Potassium Chloride 0.3%w/v Sodium Chloride 0.9%w/v Solution for Infusion 3. How Potassium Chloride 0.3%w/v Sodium Chloride 0.9%w/v Solution for Infusion is given 4. Possible side effects 5. How to store Potassium Chloride 0.3%w/v Sodium Chloride 0.9%w/v Solution for Infusion 6. Contents of the pack and other information 1. WHAT POTASSIUM CHLORIDE 0.3%W/V SODIUM CHLORIDE 0.9%W/V SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR Potassium Chloride 0.3%w/v Sodium Chloride 0.9%w/v Solution for Infusion is a clear colourless to faintly straw-coloured solution of potassium chloride and sodium chloride in water. The solution is stored in a sealed flexible plastic bag. Potassium, sodium and chloride ions are important for maintaining the correct balance of fluid in and around the body’s cells and tissues. The solution is given to help restore the normal salt balance and to add water to tissues which are dehydrated. The solution may be given alone but may be given with other medicines added. You will be given Potassium Chloride 0.3%w/v Sodium Chloride 0.9%w/v Solution for Infusion in hospital by a doctor or nurse. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN POTASSIUM CHLORIDE 0.3%W/V SODIUM CHLORIDE 0.9%W/V SOLUTION FOR INFUSION YOU MUST NOT BE GIVEN this solution if you have: • an ALLERGY to potassium chloride or sodium chloride or any of the other ingredients • increased levels of POTASSIUM or SODIUM in the blood, or an increased blood volume WARNINGS AND PRECAUTIONS Talk to your doctor or nurse if you: • have HEART FAILURE, KIDNEY or ADRENOCORTICAL PROBLEMS, HIGH BLOOD PRESSURE, LIVER DISEASE, or OEDEMA (swelling) • are DEHYDRATED which may cause thirst, dry mouth, dark urine, irregular heartbeat, tiredness • have PRE-ECLAMPSIA of pregnancy • have severe TISSUE DESTRUCTION such as occurs after burns • are VERY YOUNG or ELDERLY. 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Potassium Chloride 0.3%w/v Glucose 5%w/v Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Osmolality approx. 370 mOsm/kg H 2 O. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion (Intravenous Infusion) Colourless to faintly straw-coloured solution without visible particles in bags, individually overwrapped. pH 3.5 - 6.5. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For prevention and treatment of potassium depletion and/or hypokalaemia in cases where supply of water and carbohydrates is required due to restriction of intake of fluids and electrolytes by normal routes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intravenous infusion under medical supervision. Single use only. The pathophysiological response to dehydration, to electrolyte loss and to potassium chloride and glucose infusion will vary with the age of the patient being treated and this should be taken into account during rehydration therapy. The volume of solution needed to replenish deficits varies with hydration state, age, body weight, complementary treatment and clinical and biochemical status. 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 + POSOLOGY _ADULTS:_ 500ml to 3000ml/24h _PAEDIATRIC POPULATION:_ Active Component Per 500ml Per 1000ml Potassium chloride 1.5g K+ 20 mmol Cl¯ 20 mmol 3.0g K+ 40 mmol Cl¯ 40 mmol Glucose monohydrate equivalent to 25.0g anhydrous glucose 139 mmol equivalent to 50.0g anhydrous glucose 278 mmol 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 阅读完整的文件