Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
POTASSIUM CHLORIDE ; SODIUM CHLORIDE ; GLUCOSE MONOHYDRATE
Baxter Healthcare Limited
B05BB02
POTASSIUM CHLORIDE ; SODIUM CHLORIDE ; GLUCOSE MONOHYDRATE
0.3/0.18/4 %w/v
Solution for Infusion
Product subject to prescription which may not be renewed (A)
electrolytes with carbohydrates
Marketed
2008-04-11
EUROPEAN LABELLING CENTRE ARTWORK APPROVAL 2nd DRAFT DATE 05 September 2013 RA TO APPROVE LAYOUT AND FORMAT PLANT APPROVAL HALLE ONLY Country N/A Name N/A Signature N/A Date N/A RA Proofreading Checklist Product Information proofread as per RA SOP CE-RAPV-009 Product name,strength,composition (API & excipients) Compliance with National Regulations Consistency check with all figures cited in the product information Barcodes, Symbols and Re- imbursement Information Storage Conditions and Shelf-Life 1a PACKAGE LEAFLET: INFORMATION FOR THE USER Active substances: potassium chloride, sodium chloride and glucose monohydrate b Read all of this leaflet carefully before you are 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. Throughout this leaflet, Potassium Chloride 0.3% w/v and Sodium Chloride 0.18% w/v in Glucose 4% w/v Intravenous Infusion BP will be called Potassium chloride, Sodium chloride & Glucose Infusion What is in this leaflet: 1. What Potassium chloride, Sodium chloride & Glucose Infusion is and what it is used for 2. What you need to know before you are given Potassium chloride, Sodium chloride & Glucose Infusion 3. How you will be given Potassium chloride, Sodium chloride & Glucose Infusion 4. Possible side effects 5. How to store Potassium chloride, Sodium chloride & Glucose Infusion 6. Content of the pack and other information 1. What Potassium chloride, Sodium chloride & Glucose Infusion is and what it is used for Potassium chloride, Sodium chloride & Glucose Infusion is a solution of potassium chloride, sodium chloride and glucose monohydrate in water. Potassium chloride and sodium chloride are chemicals (often called “salts”) found in the blood. It is used to prevent and treat the following conditions: • if you do not have enoug Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Potassium Chloride 0.3% w/v and Sodium Chloride 0.18% w/v in Glucose 4% w/v Intravenous Infusion BP (Viaflo Container) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substances: Potassium Chloride 0.30 % w/v Sodium Chloride 0.18 % w/v Glucose Monohydrate 4.4 % w/v _(equivalent to anhydrous glucose 4.0%w/v)_ Equivalent to: mmol/L Potassium 40 Sodium 30 Chloride 70 For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Clear, colourless solution, free from visible particles. pH: 3.5 – 5.5 Osmolarity: 362mOsm/l 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention and treatment of potassium, sodium and chloride depletion due to a loss of gastrointestinal fluid (vomiting, diarrhoea, surgical drainage, gastric suction, small intestinal bypass procedure, or small bowel fistula), a chronic abuse of laxative, malabsorption syndromes, mucus secreting villous adenoma of the small intestine, or renal salt-losing conditions (renal disorders, overuse of diuretics), particularly in cases (e.g. starvation) where a source of energy is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults, the Elderly and Children_ The dosage depends on the age, weight, clinical and biological conditions of the patient and concomitant therapy. Typical doses of potassium for the prevention of hypokalaemia may be up to 50 mmol daily and similar doses may be adequate in mild potassium deficiency. In severe acute hypokalaemia, up to 20 mmol of potassium in 500 ml over 2 to 3 hours under ECG control. Patients with renal impairment should receive lower doses. The maximum recommended dose of potassium is 2 to 3 mmol/kg/24h. The rate should not exceed 10 to 40 mmol/h to avoid hyperkalaemia. For peripheral infusions, potassium concentration should be less than 60 mmol/l to avoid pain. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Citiți documentul complet