![]() ![]() Use parenteral nutrition solutions containing Tralement promptly after mixing.Discard if any precipitates are observed.Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the admixed emulsion. The emulsion has not separated, if lipid emulsion has been added.Precipitates have not formed during mixing or addition on additives.Inspect the final parenteral nutrition solution containing Tralement to ensure that:.An interaction may occur between cupric ion and ascorbic acid therefore, multivitamin additives should be added to the admixed parenteral nutrition solution shortly before infusion.For introducing additives to the parenteral nutrition container, use aseptic technique. Because additives may be incompatible, evaluate all additions to the parenteral nutrition container for compatibility and stability of the resulting preparation.Transfer Tralement to the parenteral nutrition container after the admixture of amino acids, dextrose, lipid emulsion (if added), and electrolytes solutions is prepared.Inspect Tralement single-dose vial for particulate matter.Preparation Instructions For Admixing Using A Parenteral Nutrition Container Inspect the parenteral nutrition solution containing Tralement for particulate matter before admixing, after admixing, and prior to administration.The key factor in the preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients. Add Tralement to the parenteral nutrition solution in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).Prior to administration, Tralement must be prepared and used as an admixture in parenteral nutrition solution. Tralement is not for direct intravenous infusion.Preparation And Administration Instructions Solutions with osmolarity of 900 mOsmol/L or greater must be infused through a central catheter. The choice of a central or peripheral venous route should depend on the osmolarity of the final infusate. The final parenteral nutrition solution is for intravenous infusion into a central or peripheral vein. Prior to administration, Tralement must be transferred to a separate parenteral nutrition container, diluted and used as an admixture in parenteral nutrition solution. It is not for direct intravenous infusion. Tralement is supplied as a single-dose vial for admixture use only. DOSAGE AND ADMINISTRATION Important Administration Information Tralement™ is indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Tralement contains no more than 6,000 mcg/L of aluminum. The structural formula of selenious acid is: Manganese sulfate exists as a monohydrate. The structural formula is:Ĭupric sulfate exists as a pentahydrate. Sulfuric acid may be added to adjust pH between 1.5 and 3.5. *Each mL contains zinc 3 mg (equivalent to zinc sulfate 7.41 mg), copper 0.3 mg (equivalent to cupric sulfate 0.75 mg), manganese 55 mcg (equivalent to manganese sulfate 151 mcg), selenium 60 mcg (equivalent to selenious acid 98 mcg), and water for injection. It contains no preservative.Įach single-dose vial contains 1 mL. Tralement™ (trace elements injection 4*, USP) is a sterile, non-pyrogenic, clear, and colorless to slightly blue solution, intended for use as a combination of four trace elements and an additive to intravenous solutions for parenteral nutrition. adverse reactions with the use of trace elements administered parenterally or by other routes of administration (neurologic toxicity with manganese, hepatic accumulation of copper and manganese, and hypersensitivity reactions with zinc and copper).adverse reactions with other components of parenteral nutrition solutions ( pulmonary embolism due to pulmonary vascular precipitates, vein damage and thrombosis, aluminum toxicity) and.Tralement (trace elements injection 4) is a combination of trace elements ( zinc sulfate, cupric sulfate, manganese sulfate and selenious acid) indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. ![]()
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