Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
POTASSIUM CHLORIDE ; SODIUM CHLORIDE
Maco Pharma (UK) Ltd
B05BB01
POTASSIUM CHLORIDE ; SODIUM CHLORIDE
0.3 0.9 %w/v
Solution for Infusion
Product subject to prescription which may not be renewed (A)
electrolytes
Marketed
2002-12-17
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. Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Potassium Chloride 0.3% w/v Sodium Chloride 0.9% w/v Solution for Infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Osmolality approx. 360 mOsmol/kg water. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion Sterile endotoxin-free solution, colourless to faintly straw coloured without visible particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For fluid replacement, and provision of potassium, sodium and chloride electrolytes in the prevention and treatment of hypokalaemia and potassium depletion. Medium for intravenous administration of medicinal products known to be compatible. 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 and sodium chloride 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 age, body weight, complementary treatment and clinical and biochemical status. Rapid infusion may be harmful. The rate of administration should not exceed 30mmol of potassium per hour. Typically 500ml is infused slowly over 2 to 3 hours, but the dose and rate of administration are subject to clinical and laboratory assessment in each case. A recommended maximum dose is 2 – 3 mmol potassium per kg body weight in 24 hours. Fluid balance, serum electrolytes and acid-base balance may need to be monitored before and during administration, with particular attention to serum sodium in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated with vasopressin agonist drugs, due to the risk of hospital acquired hyponatraemia (see sections 4.4, 4.5 and 4.8). Monitoring of serum sodium is particularly important for hypotonic fluids. Potass Lees het volledige document