देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
ZINC GLUCONATE, COPPER GLUCONATE, MANGANESE GLUCONATE, SODIUM FLUORIDE, POTASSIUM IODIDE, SODIUM SELENITE, FERROUS GLUCONATE, SODIUM MOLYBDATE 2H2O, CHROMIUM CHLORIDE 6H2O
Laboratoire AGUETTANT
B05XA31
ZINC GLUCONATE, COPPER GLUCONATE, MANGANESE GLUCONATE, SODIUM FLUORIDE, POTASSIUM IODIDE, SODIUM SELENITE, FERROUS GLUCONATE, SO
Concentrate for Soln for Inf
Product subject to prescription which may not be renewed (A)
electrolytes in comb with other drugs
Authorised
2016-01-15
PACKAGE LEAFLET: INFORMATION FOR THE USER SUPPLYELT, CONCENTRATE FOR SOLUTION FOR INFUSION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. The name of this medicinal product is SUPPLYELT, concentrate for solution for infusion, but will be referred as SUPPLYELT throughout the whole leaflet What is in this leaflet 1. What SUPPLYELT is and what it is used for 2. What you need to know before you use SUPPLYELT 3. How to use SUPPLYELT 4. Possible side effects 5. How to store SUPPLYELT 6. Contents of the pack and other information 1. WHAT SUPPLYELT IS AND WHAT IT IS USED FOR SUPPLYELT is a concentrate for solution for infusion. It contains 9 essential trace elements (iron, copper, manganese, zinc, fluorine, iodine, selenium, chromium, molybdenum). These trace elements are considered as essential because the body cannot produce them but needs them in very small quantities in order to function properly. SUPPLYELT is used to provide trace elements in adults needing intravenous (into a vein) feeding. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SUPPLYELT DO NOT USE SUPPLYELT: - if you are allergic (hypersensitive) to any of the ingredients of SUPPLYELT (See section 6 of this leaflet). - if your body weight is less than 40 kg. - if you have abnormally high level of any of the ingredients of the product in your blood. (If you have any doubt, ask your doctor). - if you have a pronounced cholestasis (yellowing of the skin or whites of the eyes caused by liver or blood problem). - if you have an excess of copper (Wilson´s disease) or पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Supplyelt Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Composition of Supplyelt expressed in quantities of salts per ampoule (10 ml) and per litre. Content per ampoule of 10 ml Fe 18 1000 For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, limpid 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 Theoretical quantities of raw materials EXPRESSED IN ANHYDROUS SUPPLYELT For 1 ampoule (microgram/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 Supplyelt Supplyelt Molar composition (micromol /10 ml) Weight composition (microgram /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 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _0_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _8_ _6_ _5_ _2_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Supplyelt is used as part of an intravenous nutrition regimen, to cover basal or moderately increased trace element requirements in parenteral nutrition. Supplyelt पूरा दस्तावेज़ पढ़ें