Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE
Baxter Healthcare Limited
B05XA03
SODIUM CHLORIDE
0.9 %w/v
Intravenous Inf Solution
Product subject to prescription which may not be renewed (A)
sodium chloride
Marketed
1983-04-01
Sodium Chloride Intravenous Infusion BP 0.9% w/v 1 PACKAGE LEAFLET: INFORMATION FOR THE USER Read all of this leaflet carefully before you are given 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 nurse. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. This medicine is called Sodium Chloride Intravenous Infusion BP 0.9% w/v (Viaflex container), but will be referred to as Sodium 0.9 Infusion throughout the remainder of this leaflet. What is in this leaflet 1. What Sodium 0.9 Infusion is and what it is used for 2. What you need to know before you are given Sodium 0.9 Infusion 3. How you will be given Sodium 0.9 Infusion 4. Possible side effects 5. How to store Sodium 0.9 Infusion 6. Contents of the pack and other information 1. What Sodium 0.9 Infusion Is And What It Is Used For Sodium 0.9 Infusion is a solution of sodium chloride in water. Sodium chloride is a chemical substance (often called “salt”) found in the blood. Sodium 0.9 Infusion is used to treat: • a loss of body water (dehydration) • a loss of sodium from the body (sodium depletion) Situations that may cause sodium chloride and water loss include: • when you cannot eat or drink, due to illness or after surgery • pronounced sweating due to high fever • extensive skin loss, as can occur in severe burns. Sodium 0.9 infusion may also be used to deliver or to dilute other medicines for infusion. 2. What You Need to Know Before You Are Given Sodium 0.9 Infusion Do NOT receive Sodium 0.9 Infusion if you are suffering from any of the following conditions • higher levels of chloride in the blood than normal (hyperchloraemia) • higher levels of sodium in the blood than normal (hypernatraemia). • your blood is being pumped slower than normal (heart failure) • severely reduced kidney function • fluid build up in your b Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sodium Chloride Intravenous Infusion BP 0.9% w/v (viaflex container). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each litre contains 9.0 g (0.9% w/v) sodium chloride. This provides 150 mmol/l Sodium and 150 mmol/l Chloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Infusion. Clear, colourless solution, free from visible particles. pH: 4.0-7.0. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in prophylactic and replacement therapy requiring the use of sodium chloride or as a vehicle for the reconstitution and administration of intravenous medications. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults, older people and children:_ Doses may be expressed in terms of mEq or mmol of sodium, mass of sodium, or mass of sodium salt (1 g NaCl = 394 mg, 17.1 mEq or 17.1 mmol of Na and Cl). The dosage, rate and duration of administration is to be individualised as determined by several factors including age, weight, clinical condition, concomitant treatment and in particular the patient's hydration state, clinical and laboratory response to treatment. Fluid balance and plasma electrolyte concentrations must be monitored during treatment. Recommended dosage The recommended dosage for treatment of isotonic extracellular dehydration and sodium depletion is: • For adults : 500 ml to 3 litres/24h • For babies and children: 20 to 100 ml per 24h and per kg of body weight, depending of the age and the total body mass. 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 % is used as a diluent for injectable preparations of other drugs, the dosage and the infusion rate will also be dictated by the nature and the dose regimen of the prescribed drug. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Đọc toàn bộ tài liệu