国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Sodium chloride
Fresenius Kabi Deutschland GmbH
B05XA; B05XA03
Sodium chloride
0.9 %v/w
Solvent for parenteral use
Electrolyte solutions; sodium chloride
Marketed
2009-08-28
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 阅读完整的文件
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 solvent for parenteral use 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Composition per 100 ml: Electrolytes mmol/l mEq/l Sodium chloride 0.9 g Na + 154 154 Water for injections q.s.p. 100 ml Cl - 154 154 Each ml of solution contains 9 mg of sodium chloride Osmolarity: 308 mOsmol/L. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solvent for parenteral use. Clear and colourless solution, free or practically free from particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vehicle or diluent for parenteral administration of medicines for intravenous, intramuscular or subcutaneous route. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The amount to be used will depend on the concentration wanted for the administration of the medicine to be dissolved. Method of administration Intravenous, intramuscular or subcutaneous use. 4.3 CONTRAINDICATIONS Due to the indications of the product, contraindications depend on the medicine to be dissolved. In general, the administration of this product is contraindicated in the following situations: § Hypernatremia § Hypertonia § Cardiac insufficiency § Oedematous states in patients with cardiac, hepatic or renal disorders § Severe hypertension § Metabolic acidosis 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Once the container is opened the solution should be used immediately. In case of subcutaneous administration no supplement should be added, since isotonia would change. Health Products Regulatory Authority 01 May 2019 CRN008S7Q Page 2 of 5 Do not use the solution if it is not clear and without precipitates. Before adding the medicine to the ampoule compatibility between the substance to be administered and sodium chloride should be checked. Newborns, whether premature or not, can present too high sodium levels due to immaturity of renal function. Therefore, in newborns, whether pre 阅读完整的文件