{"effective_time":"20190103","id":"7e978288-501f-fc99-e053-2991aa0a7f28","openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Peditrace 10 mL Vial Label Peditrace™ 10 ml Concentrate for solution for infusion PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Peditrace 10 mL Vial Carton Panel 10 vials of 10 ml Peditrace™ Concentrate for solution for infusion vial-lyv1981 carton-lyv1981"],"set_id":"cd13f750-9d7b-4ac4-8433-1d2c20adb266","spl_medguide":["1 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of PEDITRACE contains: Active ingredients Quantity Zinc chloride 521 µg Copper chloride 2H 2 O 53.7 µg Manganese chloride 4H 2 O 3.60 µg Sodium selenite anhydrous 4.38 µg Sodium fluoride 126 µg Potassium iodide 1.31 µg The active ingredients in 1 ml of PEDITRACE 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 The contents of sodium and potassium correspond to Sodium 70 µg 3.05 µmol Potassium 0.31 µg 7.88 nmol For excipients, see 5.1. PRODUCT PROPERTIES • Osmolality 38 mosm/kg water • pH: 2.0 2 PHARMACEUTICAL FORM Concentrate for solution for infusion 3 CLINICAL PARTICULARS 3.1 Therapeutic indications PEDITRACE is indicated in premature and full-term infants and children needing intravenous nutrition to supply the basal requirements of trace elements. 3.2 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. 3.3 Contraindications Wilson’s Disease. 3.4 Special warnings and special precautions for use PEDITRACE should be used with caution in patients with impaired biliary and/or renal function, in whom the excretion of trace elements may be significantly decreased. PEDITRACE should also be used with caution in patients with biochemical or clinical evidence of liver dysfunction (especially cholestasis). If the treatment is continued for more than 4 weeks, checking of manganese levels is required. Patients with increased losses or requiring prolonged intravenous nutrition should be monitored biochemically to confirm the requirements are being met appropriately. 3.5 Interaction with other medicinal products and other forms of interac tion No interactions with other drugs have been observed. 3.6 Pregnancy and lactation Not applicable. 3.7 Effects on ability to drive and use machines Not applicable. 3.8 Undesirable effects No adverse effects related to the trace elements in PEDITRACE have been reported. Superficial thrombophlebitis has been observed when glucose containing PEDITRACE was given. However, it is not possible to deduce whether this reaction is attributable to the trace elements infusion or not. Allergic reactions to iodine may occur following topical application. No adverse reactions are known to occur as a consequence of using the recommended intravenous iodide dosage levels. 3.9 Overdose In patients with impaired renal or biliary function, there is an increased risk for accumulation of trace elements. 4 PHARMACOLOGICAL PROPERTIES 4.1 Pharmacodynamic properties PEDITRACE is a mixture of trace elements in amounts normally absorbed from the oral diet and should have no pharmacodynamic effect besides maintaining or repleting nutritional status. 4.2 Pharmacokinetic properties When infused intravenously the trace elements in PEDITRACE are handled in a similar way to trace elements from an oral diet. Individual trace elements will be taken up by tissues to different extents, depending on the requirement within each tissue to maintain or restore the concentration of each element for the metabolic requirement of that tissue. Copper and manganese are normally excreted via the bile, whereas selenium and zinc (especially in patients receiving intravenous nutrition) are mainly excreted via the urine. 4.3 Preclinical safety data The safety evaluation is based mainly on clinical experience and documentation. 5 PHARMACEUTICAL PARTICULARS 5.1 List of excipients Hydrochloric acid Water for injections 5.2 Incompatibilities PEDITRACE may only be added to or mixed with other medicinal products for which compatibility has been documented. See 5.6. 5.3 Shelf‑life 3 years. 5.4 Special precautions for storage Do not store above 25°C. Do not freeze. 5.5 Nature and content of container Vial for injection, polypropylene plastic. Pack size: 10 x 10 ml 5.6 Instructions for use and handling COMPATIBILITY Additions should be made aseptically. Additions Up to 6 ml PEDITRACE can be added to 100 ml Vaminolact, Vamin 9 Electrolyte Free, Vamin 14 Electrolyte Free or glucose solution (50-500 mg/ml). INFUSION TIME The infusion time should not be less than 8 hours. The infusion should be given at a very slow rate. STABILITY When additions are made to an infusion solution, the infusion should be completed within 24 hours from preparation to prevent microbiological contamination. The left-over contents of opened bottles/vials/ampoules should be discarded and not kept for later use."],"spl_product_data_elements":["Peditrace ZINC, COPPER, MANGANESE, SELENIUM, FLUORINE, and IODINE SODIUM POTASSIUM HYDROCHLORIC ACID ZINC CHLORIDE ZINC CATION CUPRIC CHLORIDE CUPRIC CATION MANGANESE CHLORIDE MANGANESE CATION (2+) SODIUM SELENITE SELENITE ION SELENITE ION SODIUM FLUORIDE FLUORIDE ION POTASSIUM IODIDE IODIDE ION"],"version":"2"}