Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Potassium chloride; Glucose monohydrate; Sodium chloride
MACO PHARMA
B05BB; B05BB02
Potassium chloride; Glucose monohydrate; Sodium chloride
0.15 0.18 4 percent weight/volume
Solution for infusion
Product subject to prescription which may not be renewed (A)
Solutions affecting the electrolyte balance; electrolytes with carbohydrates
Marketed
2005-12-02
NTS124A-01/2019 PACKAGE LEAFLET: INFORMATION FOR THE USER POTASSIUM CHLORIDE 0.15% W / V SODIUM CHLORIDE 0.18% W / V GLUCOSE 4% W / V SOLUTION FOR INFUSION POTASSIUM CHLORIDE, SODIUM CHLORIDE AND GLUCOSE ANHYDROUS READ ALL OF THIS LEAFLET CAREFULLY BEFORE BEING GIVEN 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 0.18%w/v Glucose 4%w/v Solution for Infusion is and what it is used for 2. What you need to know before you are given Potassium Chloride 0.15%w/v Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for Infusion 3. How Potassium Chloride 0.15%w/v Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for Infusion is given 4. Possible side effects 5. How to store Potassium Chloride 0.15%w/v Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for Infusion 6. Contents of the pack and other information 1. WHAT POTASSIUM CHLORIDE 0.15% W / V SODIUM CHLORIDE 0.18% W / V GLUCOSE 4% W / V SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR Potassium Chloride 0.15%w/v Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for Infusion is a clear colourless to faintly straw-coloured solution of potassium chloride, sodium chloride and glucose 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, and are involved in nerve signals and muscle contractions. Glucose is a simple sugar which provides a source of energy. The solution is given to help restore the normal salt balance, to add water to tissues which are dehydrated and to provide energy. The solution may be given alone but may be given with other medicines added. You will be given Potassiu Přečtěte si celý dokument
Health Products Regulatory Authority 16 January 2019 CRN008TZW Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Potassium Chloride 0.15%w/v Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Component Per 500 ml Per 1000 ml Potassium chloride 0.75 g K+ 10 mmol 1.5 g K+ 20 mmol Sodium chloride 0.9 g Na+ 15 mmol 1.8 g Na+ 30 mmol Cl- 25 mmol Cl- 50 mmol Glucose monohydrate Equivalent to 20 g anhydrous glucose 111 mmol Equivalent to 40 g anhydrous glucose 222 mmol Osmolality approx. 330 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 correction and maintenance of fluid, potassium, sodium and chloride ion balance and as a source of energy, where oral administration is not feasible. 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. Health Products Regulatory Authority 16 January 2019 CRN008TZW Page 2 of 10 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 The infusion rate should not exceed the patient’s glucose oxidation capacities in order to avoid hyperglycaemia. Therefore the maximum dose ranges from 5mg/kg/min for adults to 10-18 mg/kg/min for babies and children depending on age and total body mass. _POSOLOGY Přečtěte si celý dokument