Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Zinc gluconate; Copper gluconate; Manganese Gluconate; Potassium iodide; Sodium selenite
Laboratoire AGUETTANT
B05XA; B05XA31
Zinc gluconate; Copper gluconate; Manganese Gluconate; Potassium iodide; Sodium selenite
Unknown
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Electrolyte solutions; electrolytes in combination with other drugs
Marketed
2017-03-24
1 B. PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER JUNYELT, CONCENTRATE FOR SOLUTION FOR INFUSION (FOR PRETERM, AND TERM NEWBORNS, INFANTS AND CHILDREN) 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 JUNYELT, Concentrate for solution for infusion, but will be referred as JUNYELT throughout the whole leaflet. WHAT IS IN THIS LEAFLET 1. What JUNYELT is and what it is used for 2. What you need to know before you use JUNYELT 3. How to use JUNYELT 4. Possible side effects 5. How to store JUNYELT 6. Contents of the pack and other information 1. WHAT JUNYELT IS AND WHAT IT IS USED FOR JUNYELT is a concentrate for solution for infusion, especially designed for preterm and term newborns, infants and children. It contains five trace elements (zinc, copper, manganese, iodine, selenium), which are considered as essential because the body cannot produce them but needs them in very small quantities in order to function properly. Trace elements are normally provided by a balanced diet. JUNYELT is used to provide trace elements to preterm and term newborns, infants and children who cannot eat normally and need intravenous (into a vein) feeding. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE JUNYELT _ _ YOUR CHILD SHOULD NOT RECEIVE JUNYELT: if he/she is allergic (hypersensitive) to any of the ingredients of JUNYELT (See section 6 of this leaflet). if he/she suffers from Wilson’s disease (an inherited disorder where there is excessive amount of copper in the body). if he Прочитајте комплетан документ
Health Products Regulatory Authority 18 June 2021 CRN00C816 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Junyelt, Concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Composition of Junyelt expressed in quantities of salts per ampoule (10 ml) and per ml. Theoretical quantities of raw materials EXPRESSED IN ANHYDROUS JUNYELT For 1 ampoule (microgram/10 ml) For 1 ml (microgram) Zinc gluconate 6970 697.0 Copper gluconate 1428 142.8 Manganese gluconate 40.52 4.052 Potassium iodide 13.08 1.308 Sodium selenite 43.81 4.381 Content per ampoule of 10 ml JUNYELT Molar composition (micromol/10 ml) JUNYELT Weight composition (microgram/10 ml) Zinc (Zn) 15.30 1000 Copper (Cu) 3.15 200 Manganese (Mn) 0.091 5 Iodine (I) 0.079 10 Selenium (Se) 0.253 20 Content per ml JUNYELT Molar composition (micromol/ml) JUNYELT Weight composition (microgram/ml) Zinc (Zn) 1.53 100 Copper (Cu) 0.315 20 Manganese (Mn) 0.0091 0.5 Iodine (I) 0.0079 1 Selenium (Se) 0.0253 2 Each ml of solution contains 1.16 microgram equivalent to 0.0506 micromol of sodium. Each 10 ml ampoule contains 11.6 microgram equivalent to 0.506 micromol of sodium. Each ml of solution contains 0.31 microgram equivalent to 0.008 micromol of potassium. Each 10 ml ampoule contains 3.1 microgram equivalent to 0.08 micromol of potassium. For a full list of excipients, see section 6.1. Health Products Regulatory Authority 18 June 2021 CRN00C816 Page 2 of 6 3 PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless solution. Density 1.0 pH 2.7 to 3.3 Osmolality 15 mosmol/kg Osmolarity 15 mosmol/L 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Junyelt is used as part of the intravenous nutrition of preterm and term newborns, infants and children. It is intended to meet the basal requirements for trace elements. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology PRETERM, AND TERM NEWBORNS, INFANTS AND CHILDREN (WEIGHING 20 KG OR LESS): Basal requirements of the included trace elements are covered by Прочитајте комплетан документ