Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
ZINC CHLORIDE ; CUPRIC CHLORIDE DIHYDRATE ; MANGANESE CHLORIDE TETRAHYDRATE ; SODIUM SELENITE PENTAHYDRATE ; SODIUM FLUORIDE ; POTASSIUM IODIDE
Fresenius Kabi Limited
B05XA31
ZINC CHLORIDE ; CUPRIC CHLORIDE DIHYDRATE ; MANGANESE CHLORIDE TETRAHYDRATE ; SODIUM SELENITE PENTAHYDRATE ; SODIUM FLUORIDE ; POTASSIUM IODIDE
%v/v
Solution for Infusion
Product subject to prescription which may not be renewed (A)
electrolytes in combination with other drugs
Marketed
1995-11-13
562 660 15816012H.indd 1 2016-06-03 14:50:57 15816012H.indd 2 2016-06-03 14:50:57 Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Peditrace concentrate for solution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Concentrate for solution for infusion A sterile, clear, colourless solution for addition to certain infusion fluids. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Peditrace is intended to meet the basal requirements for trace elements during intravenous nutrition of infants and children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Paediatric population_ The basal requirements for infants and children of the included trace elements are met by 1 ml of Peditrace per kg body weight per day to a maximum daily dose of 15 ml. A daily dose of 15 ml Peditrace should also meet the basic needs of trace elements in children weighing 15-40 kg. Above 40 kg the adult preparation Additrace should be used. Method of administration Peditrace should not be given undiluted. Each 1 ml of Peditrace contains: Zinc chloride 521 micrograms Copper chloride 2H 2 O 53.7 micrograms Manganese chloride 4H 2 O 3.60 micrograms Sodium selenite anhydrous 4.38 micrograms Sodium fluoride 126 micrograms Potassium iodide 1.31 micrograms The active ingredients in 1 ml correspond to: Zinc 250 micrograms 3.82 micromol Copper 20 micrograms 0.315 micromol Manganese 1 micrograms 18.2 nmol Selenium 2 micrograms 25.3 nmol Flouride 57 micrograms 3.0 micromol Iodine 1 micrograms 7.88 nmol For the full list of excipients, see section 6.1. 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_ _ Прочитайте повний документ