Země: Irsko
Jazyk: angličtina
Zdroj: 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
2009-08-28
Package leaflet: Information for the user SODIUM CHLORIDE 0.9% W/V SOLVENT FOR PARENTERAL USE Sodium chloride 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 or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Sodium Chloride is and what it is used for 2. What you need to know before you use Sodium Chloride 3. How to use Sodium Chloride 4. Possible side effects 5. How to store Sodium Chloride 6. Contents of the pack and other information 1. What Sodium Chloride is and what it is used for Sodium Chloride is indicated as a solvent of medicines that should be administered intravenously, intramuscularly or subcutaneously as a support of the addition of medicines. 2. What you need to know before you use Sodium Chloride Do not use Sodium Chloride - If you have had some allergic or unusual reaction to sodium chloride. - If you have a high concentration of sodium in your blood (hypernatremia) - If you have an increase of muscle tone (hypertonia) - If you suffer from cardiac insufficiency (incapability of the heart to pump the necessary amount of blood) - If you have some heart, liver or kidney disorder and if you suffer from an accumulation of water (oedema) in your body - If you have a severe high blood pressure (severe hypertension) - If you have an excess of acidity in your blood (metabolic acidosis) Warnings and precautions Talk to your doctor or nurse before using Sodium Chloride. - Once opened the solutions should be used immediately. - In case of subcutaneous administration do not add any supplement, since isotonia would change. - Do not use Přečtěte si celý dokument
Health Products Regulatory Authority 01 May 2019 CRN008S7Q Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sodium Chloride 0.9% w/v Solution for Infusion, polyethylene bottle 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. Health Products Regulatory Authority 01 May 2019 CRN008S7Q Page 2 of 5 4.3 CONTRAINDICATIONS This medicine should not be administr Přečtěte si celý dokument