देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Sodium chloride
Fresenius Kabi Deutschland GmbH
B05XA; B05XA03
Sodium chloride
0.9 percent weight/volume
Solution for infusion
Electrolyte solutions; sodium chloride
Marketed
2003-08-22
PACKAGE LEAFLET: INFORMATION FOR THE USER Sodium Chloride 0.9 % w/v Solution for Infusion READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Sodium Chloride 0.9 % Solution for Infusion is and what it is used for 2. What you need to know before you use Sodium Chloride 0.9 % Solution for Infusion 3. How to use Sodium Chloride 0.9 % Solution for Infusion 4. Possible side effects 5. How to store Sodium Chloride 0.9 % Solution for Infusion 6. Contents of the pack and other information 1. WHAT SODIUM CHLORIDE 0.9%SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR Sodium Chloride 0.9% is a sterile, colourless solution for infusion. It is used for the treatment of sodium depletion (deficiency), dehydration (water loss), hypovolaemia (sudden drop in volume of circulating blood) and as a solvent and carrier for other compatible drugs for parenteral administration of medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SODIUM CHLORIDE 0.9 % SOLUTION FOR INFUSION DO NOT USE SODIUM CHLORIDE 0.9 % SOLUTION FOR INFUSION: - if you have water/sodium retention situations, and in particular : o decompensated heart failure (heart can't pump enough blood throughout the body) o kidney failure with oliguria or anuria (decreased or absent production of urine). _ _ Furthermore, when Sodium Chloride 0.9 % Solution for Infusion is used as a carrier for other medicines, your doctor will consider contraindications related to the added medicinal product(s) before administering this medicine to you. Your doctor will explain this to you. WARNINGS AND PRECAUTIONS Sodium Chloride 0.9 % Solution for Infusion, will be used with caution if you suffer from: • high blood पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 01 March 2024 CRN00C8HJ Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sodium Chloride 0.9 % w/v solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium chloride: 9 g/l Each ml contains 9 mg sodium chloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Clear and non coloured solution_._ Sodium:..............................................................................154 mmol/l Chloride:.............................................................................154 mmol/l Osmolality:....................................................................... 290 mosmol/kg Osmolarity:....................................................................... 308 mosmol/l pH between 4.5 and 7.0. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicine is indicated in the following situations: - Treatment of sodium depletion. - Treatment of isotonic extracellular dehydration. - Treatment of hypovolaemia. - Vehicle or diluent of compatible drugs for parenteral administration of medicines. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION By intravenous infusion using sterile equipment and aseptic method. 1 g of sodium chloride corresponds to 394 mg or 17.1 mEq or17.1 mmolof sodium ion. The recommended dosage for treatment of isotonic extracellular dehydration and sodium depletion is: - FOR ADULTS : 500 ml to 3 Liters/24 h - FOR BABIES AND CHILDREN : 20 to 100 ml per 24 h and per kg of body weight, depending of the age and the total body mass. The infusion rate depends on the patient’s clinical condition. The recommended dosage when used as a vehicle or diluent ranges from 50 to 250 ml per dose of medicinal product to be administered. When Sodium Chloride 0.9 %, solution for infusion, is used as a diluent for injectable preparations of other drugs, the dosage and the infusion rate will be principally dictated by the nature and the dose regimen of the prescribed drug. 4.3 CONTRAINDICATIONS पूरा दस्तावेज़ पढ़ें