Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE
Mercury Pharmaceuticals (Ireland) Ltd
B05XA03
SODIUM CHLORIDE
0.9 %w/v
Solution for Injection
Product subject to prescription which may not be renewed (A)
Electrolyte solutions
Authorised
1988-06-01
PACKAGE LEAFLET: INFORMATION FOR THE USER SODIUM CHLORIDE 0.9% W/V SOLUTION FOR INJECTION This leaflet will provide you with important information about your medicine. Please read it carefully before your medicine is administered. The leaflet contains a summary but not all of the information about Sodium Chloride 0.9% w/v Solution for Injection. If you require any further information or if you are unsure about anything, ask your physician or pharmacist. ABOUT YOUR MEDICINE Sodium Chloride 0.9% w/v Solution for Injection is a clear, colourless sterile solvent for parenteral use. Each 1mI of this solvent contains 9mg of the active ingredient, sodium chloride. Each 1ml of sterile solution for injection contains 0.15millimoles of Na+ and Cl- ions. 2ml of sterile solution for injection contains 0.3millimoles of Na+ and Cl- ions. 5ml of sterile solution for injection contains 0.75millimoles of Na+ and Cl- ions. 10ml of sterile solution for injection contains 1.5millimoles of Na+ and Cl- ions. Other ingredients: Water for Injections and Hydrochloric Acid (for pH adjustment). _Pack sizes: _2ml, 5ml and 10ml in glass ampoules (packs of 10 ampoules). (Not all pack sizes may be marketed.) _Type of medicine: _Sodium Chloride 0.9% w/v Solution for Injection is an isotonic saline solution. Being isotonic means that the body cells bathed in the solution will neither shrink nor swell. _Holder of Product Authorisation:_ Mercury Pharmaceuticals (Ireland) Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland _Manufacturer: _Lomapharm Rudolf Lohmann GmbH KG, Langes Feld 5, 31860, Emmerthal, Germany. PA No.: 73/105/1 (2ml, 5ml and 10ml glass ampoules). USES Sodium Chloride 0.9% w/v Solution for Injection may be used to prevent or to treat certain types of salt and fluid imbalances that may occur in the body. The solution may be used to dilute or to prepare some drugs for use. It may also be used for irrigation (e.g. to wash out wounds). BEFORE YOU RECEIVE YOUR MEDICINE If Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sodium Chloride 0.9% w/v Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Chloride: 0.9% w/v Each ml contains 9 mg sodium chloride. Each 1ml of sterile solution for injection contains 0.15 millimoles of Na + and Cl - ions. Each 2ml of sterile solution for injection contains 0.3 millimoles of Na + and Cl - ions. Each 5ml of sterile solution for injection contains 0.75 millimoles of Na + and Cl - ions. Each 10ml of sterile solution for injection contains 1.5 millimoles of Na + and Cl - ions. (equivalent to 150 millimoles of Na + and Cl - per litre) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. (Injection) A clear colourless sterile aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in prophylactic and replacement therapy requiring the use of sodium chloride. Also for reconstitution and dilution of certain drugs and as an irrigant. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intravenous administration, or as appropriate to the reconstituted drug. In prophylaxis or replacement therapy of extracellular fluid deficits, the intravenous route should be used and the dose is dependent upon the age, weight, clinical state and degree of deficiency of the patient, and must be determined on an individual basis. 4.3 CONTRAINDICATIONS Administration in congestive heart failure, in conditions of severe impairment of renal function or in oedema with sodium retention. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Administration should be carried out under regular and careful supervision and should be discontinued if adverse reaction occurs. No other medication or substance should be added to this solution unless compatibility is known. The Læs hele dokumentet