Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
POTASSIUM CHLORIDE; SODIUM CHLORIDE
Maco Pharma (UK) Ltd
B05BB01
POTASSIUM CHLORIDE; SODIUM CHLORIDE
0.15/0.9 %w/v
Solution for Infusion
Product subject to prescription which may not be renewed (A)
electrolytes
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. Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Potassium Chloride 0.15%w/v Sodium Chloride 0.9%w/v Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Osmolality approx. 322 mOsm/kg H2O. 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 prophylactic and replacement therapy requiring the use of sodium chloride and potassium. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intravenous infusion under medical supervision. 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:_ 0 – 10kg body weight: 100ml/kg/24h 10 – 20kg body weight: 1000ml + (50ml/kg over 10kg)/24h > 20kg body weight: 1500ml + (20ml/kg over 20kg)/24h Active Component Per 500ml Per 1000ml Potassium chloride 0.75 g K + 10 mmol 1.5g K + 20 mmol Sodium chloride 4.5 g Na + 75 mmol 9.0 g Na + 150 mmol Cl - 85mmol Cl - 170 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _2_ _/_ _0_ _5 Les hele dokumentet