Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
SODIUM CHLORIDE
TEVA MEDICAL MARKETING LTD.
B05XA03
SOLUTION FOR INFUSION
SODIUM CHLORIDE 0.9 %W/V
I.V
Required
BAXTER HEALTHCARE LTD. U.K.
SODIUM CHLORIDE
SODIUM CHLORIDE
Treatment of isotonic extracellular dehydration. Treatment of sodium depletion. Vehicle or diluent of compatible drugs for parenteral administration.
2014-03-31
לע העדוה לע העדוה לע העדוה ( הרמחה ( הרמחה ( הרמחה עדימ עדימ עדימ ל ןולעב )תוחיטב ל ןולעב )תוחיטב ל ןולעב )תוחיטב אפור אפור אפור ןכדועמ( ןכדועמ( ןכדועמ( .102.50 .102.50 .102.50 ) ) ) ________ ךיראת JULY 9, 2015 ___ תילגנאב רישכת םש םושירה רפסמו _ SODIUM CHLORIDE 0.9% INTRAVENOUS INFUSION BP (VIAFLO®) CONTAINER 140 26 30794 00 ; 140 26 30794 01; 134 05 31396 00 לעב םש םושירה TEVA MEDICAL (MARKETING) LTD., HAORGIM ST 8, ASHDOD 77100 ה טורפל דעוימ הז ספוט דבלב תורמחה ! תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט INDICATION CONTRA- INDICATIONS POSOLOGY, DOSAGE & ADMINISTRA-TION The concentration and dosage, of sodium chloride solution for intravenous use is determined by several factors including the age, weight, and clinical condition, of the patient and in particular the patient's hydration state, clinical and laboratory response to treatment.. Serum-electrolyte concentrations should be carefully monitored. Recommended dosage The recommended dosage for treatment of isotonic extracellular dehydration and sodium depletion is: - for adults : 500 ml to 3 liters /24h - for babies and children : 20 to 100 ml per 24 h and per kg of body weight, depending on the age and the total body mass. The infusion rate depends on the patient clinical condition. Method of administration The solution is for administration by intravenous infusion The concentration and dosage, rate and duration of sodium chloride solution for intravenous use administration is to be individualized as determined by several factors including the age, weight, and clinical condition, concomitant treatment of the patient 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. Serum-electrolyte concentrations shoul Baca dokumen lengkap
Sodium Chloride 0.9% Intravenous Infusion BP Notification 06.2022 N.A 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 particular the patient's hydration state, clinical and laboratory response to treatment. Fluid balance and plasma electrolyte concentrations must be monitored during treatment. Sodium Chloride 0.9% Intravenous Infusion BP Notification 06.2022 N.A 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 Baca dokumen lengkap