Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Sodium chloride
Fresenius Kabi Deutschland GmbH
B05XA03
Sodium chloride
0.9 percent weight/volume
Solution for infusion
sodium chloride
Not marketed
2003-08-22
4750-2_Mise en page 1 11/09/15 16:24 Page1 Premature or term infants may retain an excess of sodium due to immature renal Do not throw away any medicines via wastewater or household waste. Ask your PACKAGE LEAFLET: INFORMATION FOR THE USER function. In premature or term infants, repeated infusions of sodium chloride should therefore only be given after determination of the serum sodium level. pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. - The physician should judge the incompatibility of an additive drug with the 0.9% sodium chloride solution by checking for any possible change in colour and/or possible formation of precipitate, insoluble complex or crystals. - Before adding any drug, check that the pH range in which it is effective is the same as that of 0.9% sodium chloride solution (pH = 4.5 – 7.0). - Please refer to the drug’s package insert. - When any drug is added to the 0.9% sodium chloride solution, the mixture must be administered immediately. INSTRUCTIONS FOR USE AND HANDLING Do not use unless the solution is clear and free from particles and the container is undamaged. Discard any damaged or partially used container. Use in aseptic conditions. Precautions when using bags: - do not use an air entry. - flush the infusion system in order to avoid any passage of air. - do not connect in series since the residual of the first container might be carried on by the solution coming from the second container, with the risk of air embolism. - for single use only; do not reconnect partially used container. 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT SODIUM CHLORIDE 0.9% SOLUTION FOR INFUSION CONTAINS The active substance is : Sodium chloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 g/l Sodium: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154 mmol/l Chloride: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154 mmol/l Osmolality: . . . . . . . . . . . . . . . . . . . . . . . 290 mosmol/k Citiți documentul complet
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 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 di Citiți documentul complet