Riik: Iisrael
keel: heebrea
Allikas: Ministry of Health
SODIUM CHLORIDE
TEVA MEDICAL MARKETING LTD.
B05XA03
תמיסה לאינפוזיה
SODIUM CHLORIDE 0.9 %W/V
תוך-ורידי
מרשם נדרש
BAXTER HEALTHCARE LTD. U.K.
SODIUM CHLORIDE
2014-03-31
Sodium Chloride 0.9% Intravenous Infusion BP ME 03.2020 Notification SODIUM CHLORIDE 0.9% INTRAVENOUS INFUSION BP SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sodium Chloride 0.9% Intravenous Infusion BP 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium chloride: 9.0 g/l Each ml contains 9 mg sodium chloride. mmol/l: Na+ : 154 Cl-: 154. pH: 4.5 -7 For the full list of excipients: see section 6.1 3. PHARMACEUTICAL FORM Solution for infusion Clear solution, free from visible particles. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Sodium Chloride 0.9% intravenous infusion is indicated for: • Treatment of isotonic extracellular dehydration • Treatment of sodium depletion • Vehicle or diluent of compatible drugs for parenteral administration. 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 individualized as determined by several factors including age, weight, clinical condition, concomitant treatment and in Sodium Chloride 0.9% Intravenous Infusion BP ME 03.2020 Notification 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 Lugege kogu dokumenti