Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy
B05XA31
IODINE 1.96 µg/ml SELENIUM 7 µg/ml ZINC 500 µg/ml COPPER 40 µg/ml MAGNESIUM 1 µg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
IODINE 1.96 µg/ml SELENIUM 7 µg/ml ZINC 500 µg/ml COPPER 40 µg/ml MAGNESIUM 1 µg/ml
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2023-04-25
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Kidtrayze 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 or nurse. - If your child gets any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Kidtrayze is and what it is used for 2. What you need to know before you use Kidtrayze 3. How to use Kidtrayze 4. Possible side effects 5. How to store Kidtrayze 6. Contents of the pack and other information 1. WHAT KIDTRAYZE IS AND WHAT IT IS USED FOR Kidtrayze is a mixture of trace elements given into the blood by a drip (intravenous infusion). Kidtrayze contains five trace elements (zinc, copper, manganese, selenium, and iodine) in very small amounts which are normally absorbed from food. These trace elements are necessary for a normal body function. Kidtrayze is used to meet the basic requirements of trace elements for preterm and term neonates, infants, children, and adolescents who cannot eat or absorb enough food through tube feeding and thus need food infused through their vein (called intravenous nutrition or parenteral nutrition). Kidtrayze is added to parenteral nutrition containing all the nutrients the body needs. 2. WHAT YOU NEED TO KNOW BEFORE USE OF KIDTRAYZE DO NOT USE KIDTRAYZE IF YOUR CHILD: - is allergic (hypersensitive) to the active substances or any of the other ingredients of this medicine (listed in section 6) - has Wilson’s disease. WARNINGS AND PRECAUTIONS Talk to your doctor before using Kidtrayze if your child has : - kidney problems - liver problems - reduced biliary excretion - thyroid problems (hyperthyroidism) Blood levels of trace elements will be monitored regularly by your doctor during treatment. Your doctor will adapt the dosage of Kidtrayze accordingly. CHILDREN AND Perskaitykite visą dokumentą
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. N AME OF THE M EDICINAL P RODUCT Kidtrayze concentrate for solution for infusion 2. Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Kidtrayze composition quantities of trace elements salts per ml and per 10 ml ampoule: KIDTRAYZE 1 ml 1 ampoule (10 ml) Zinc chloride 1042 micrograms 10420 micrograms Copper chloride dihydrate 107.4 micrograms 1074 micrograms Manganese chloride tetrahydrate 3.600 micrograms 36.00 micrograms Sodium selenite 15.33 micrograms 153.3 micrograms Potassium iodide 2.567 micrograms 25.67 micrograms The active ingredients in 1 ml of Kidtrayze correspond to: Zinc (Zn) 7.64 micromol 500 micrograms Copper (Cu) 0.630 micromol 40.0 micrograms Manganese (Mn) 0.0182 micromol 1.00 micrograms Selenium (Se) 0.0887 micromol 7.00 micrograms Iodine (I) 0.0155 micromol 1.96 micrograms For the full list of excipients, see section 6.1. 3. P HARMACEUTICAL F ORM Concentrate for solution for infusion. Clear solution, almost colourless. • Osmolality: approx. 40 mosm/kg water • pH: 2.0 4. C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Kidtrayze is indicated in preterm and term neonates, infants, children, and adolescents in need of intravenous nutrition to supply the basal requirements of trace elements. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Preterm neonates: _ A recommended maximum daily dose of 1.0 mL Kidtrayze per kg body weight covers basal requirements of the included trace elements. _Term neonates, infants, and children weighing less than 20 kg: _ A recommended maximum daily dose of 0.5 mL Kidtrayze per kg body weight covers basal requirements of the included trace elements. Page 2 of 7 _Children weighing more than 20 kg and adolescents_ : A recommended maximum daily dose of 10 mL Kidtrayze covers basal requirements of the included trace elements. The following trace element amounts are contained in 0.5 ml, 1.0 ml, and 10 ml Kidtrayze: 0.5 ml 1.0 ml 10 ml Zn 250 micrograms 500 micrograms 5000 micrograms Cu 20.0 micrograms 40.0 micrograms 400 Perskaitykite visą dokumentą