Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
COPPER CHLORIDE; MANGANESE AS CHLORIDE; POTASSIUM IODIDE; SODIUM FLUORIDE; SODIUM SELENITE ANHYDROUS; ZINC CHLORIDE
CURE MEDICAL & TECHNICAL SUPPLY
B05CB10
CONCENTRATE FOR SOLUTION FOR INFUSION
SODIUM FLUORIDE 126 MCG/ML; SODIUM SELENITE ANHYDROUS 4.38 MCG/ML; MANGANESE AS CHLORIDE 3.6 MCG/ML; COPPER CHLORIDE 53.7 MCG/ML; POTASSIUM IODIDE 1.31 MCG/ML; ZINC CHLORIDE 521 MCG/ML
I.V. INFUSION
Required
FRESENIUS KABI AB, SWEDEN
COMBINATIONS
Peditrace is indicated to meet the basal requirement of trace elements during intravenous nutrition of infants and children.
2022-01-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Peditrace 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of Peditrace contains: Active Ingredients Quantity Zinc Chloride 521 µg Copper Chloride 2H 2 0 53.7 µg Manganese Chloride 4 H 2 0 3.60 µg Sodium Selenite anhydrous 4.38 µg Sodium Fluoride 126 µg Potassium Iodide 1.31 µg The active ingredients in 1 ml correspond to Zn 250 µg 3.82 µmol Cu 20 µg 0.315 µmol Mn 1 µg 18.2 nmol Se 2 µg 25.3 nmol F 57 µg 3.00 µmol I 1 µg 7.88 nmol PRODUCT PROPERTIES Osmolality: 38 mosm/kg water pH: 2.0 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Peditrace is indicated to meet the basal requirement of trace elements during intravenous nutrition of infants and children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Peditrace must not be given undiluted. The recommended dose is 1 ml Peditrace/kg body weight/day for infants and children with a weight of up to 15 kg. The basic requirements of trace elements are covered by a daily dose of 15 ml to children weighing more than 15 kg. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Wilson’s disease. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Administration should be carried out under specialist surveillance, especially in patients with pre-existing imbalances, in renal failure or in hepatic disease. Peditrace should be used with caution in conditions where excretion in the bile is reduced, particularly when cholestatic liver disease is present and/or when urinary excretion is markedly reduced. Patients with such conditions require careful biochemical monitoring as the excretion of trace elements may also be significantly decreased. Patients requiring long term total parenteral nutrition (TPN) (defined as longer than one month) should have a baseline whole blood or serum manganese level within or below the normal range and normal liver function before receiving Peditrace. Man Baca dokumen lengkapnya