Страна: Израиль
Язык: английский
Источник: Ministry of Health
CHROMIUM CHLORIDE; COPPER GLUCONATE; FERROUS GLUCONATE; MANGANESE GLUCONATE; POTASSIUM IODIDE; SODIUM FLUORIDE; SODIUM MOLYBDATE; SODIUM SELENITE; ZINC GLUCONATE
REMEDIX CARE LTD
B05XA31
CONCENTRATE FOR SOLUTION FOR INFUSION
FERROUS GLUCONATE 7988.2 MCG / 10 ML; CHROMIUM CHLORIDE 30.45 MCG / 10 ML; SODIUM MOLYBDATE 42.93 MCG / 10 ML; SODIUM SELENITE 153.32 MCG / 10 ML; POTASSIUM IODIDE 170.06 MCG / 10 ML; SODIUM FLUORIDE 2099.5 MCG / 10 ML; MANGANESE GLUCONATE 445.69 MCG / 10 ML; COPPER GLUCONATE 2142.4 MCG / 10 ML; ZINC GLUCONATE 69700 MCG / 10 ML
I.V
Required
LABORATOIRE AGUETTANT, FRANCE
ELECTROLYTES IN COMBINATION WITH OTHER DRUGS
NUTRYELT is used as part of an intravenous nutrition regimen, to cover basal or moderately increased trace element requirements in parenteral nutrition. NUTRYELT is indicated in adults only
2019-08-08
1. NAME OF THE MEDICINAL PRODUCT NUTRYELT ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Composition of NUTRYELT expressed in quantities of salts per ampoule (10 ml) and per litre. Theoretical quantities of raw materials EXPRESSED IN ANHYDROUS NUTRYELT For 1 ampoule (µg/10 ml) For 1 litre (mg) Zinc gluconate 69700 6970.0 Copper gluconate 2142.4 214.24 Manganese gluconate 445.69 44.569 Sodium fluoride 2099.5 209.95 Potassium iodide 170.06 17.006 Sodium selenite 153.32 15.332 Sodium molybdate 42.93 4.293 Chromium chloride 30.45 3.045 Ferrous gluconate 7988.2 798. 82 Content per ampoule of 10 ml NUTRYELT NUTRYELT Molar composition (μmol /10 ml) Weight composition (μg /10 ml) Zn 153 10000 Cu 4.7 300 Mn 1.0 55 F 50 950 I 1.0 130 Se 0.9 70 Mo 0.21 20 Cr 0.19 10 Fe 18 1000 For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion Clearand and slightly yellow solution. Density 1.0 pH 2.6 to 3.2 Osmolality 60 to 100 mosm/kg Osmolarity 60 to 100 mosm/l 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS NUTRYELT is used as part of an intravenous nutrition regimen, to cover basal or moderately increased trace element requirements in parenteral nutrition. NUTRYELT is indicated in adults only. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology For adults only. The recommended daily dose in patients with basal to moderately increased requirements is one ampoule (10 ml) of NUTRYELT. In cases of significantly increased trace element requirements (such as extensive burns, patients in severe hypercatabolic state due to major trauma) 2 ampoules (20 ml) of NUTRYELT may be given per day, and monitoring of serum trace element level is recommended. In patients with renal, hepatic impairments or mild cholestasis the posology should be adapted (see section 4.4). _Paediatric population _ NUTRYELT is contraindicated in children and adolescents (see section 4.3). A specific paediatric product should be used for trace element supplementation in the paediatric population during parentera Прочитать полный документ