Tralement Dosage

Important Administration Information

Tralement is supplied as a single-dose vial and multiple-dose vial for admixture use only. It is not for direct intravenous infusion. Prior to administration, Tralement must be transferred to a separate parenteral nutrition container, and used as an admixture in parenteral nutrition solution.

The final parenteral nutrition solution is for intravenous infusion into a central or peripheral vein. The choice of a central or peripheral venous route should depend on the osmolarity of the final infusate. Solutions with osmolarity of 900 mOsmol/L or greater must be infused through a central catheter [see Warnings and Precautions (5.2)].

Preparation and Administration Instructions

• Tralement is not for direct intravenous infusion. Prior to administration, Tralement must be prepared and used as an admixture in parenteral nutrition solution.
• 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). The key factor in the preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients.
• Inspect the parenteral nutrition solution containing Tralement for particulate matter before admixing, after admixing, and prior to administration.

Preparation Instructions for Admixing Using a Parenteral Nutrition Container

• Inspect Tralement single-dose vial and multiple-dose vial for particulate matter.
• Transfer Tralement to the parenteral nutrition container after the admixture of amino acids, dextrose, lipid emulsion (if added), and electrolytes solutions is prepared.
• Because additives may be incompatible, evaluate all additions to the parenteral nutrition container for compatibility and stability of the resulting preparation. Consult with pharmacist, if available. For introducing additives to the parenteral nutrition container, use aseptic technique.
• 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.
• Inspect the final parenteral nutrition solution containing Tralement to ensure that:
  o Precipitates have not formed during mixing or addition on additives.
  o The emulsion has not separated, if lipid emulsion has been added. Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the admixed emulsion.
  o Discard if any precipitates are observed.

Stability and Storage

• Single-dose vial. Discard unused portion.
• Multiple-dose vial: May puncture up to 20 times. Discard any unused portion after 28 days.
• Use parenteral nutrition solutions containing Tralement promptly after mixing. Any storage of the admixture should be under refrigeration from 2ºC to 8ºC (36ºF to 46ºF) and limited to a period of no longer than 9 days. After removal from refrigeration, use promptly and complete the infusion within 24 hours. Discard any remaining admixture.
• Protect the parenteral nutrition solution from light.

Overview of Dosing

• Prior to administration of parenteral nutrition solution containing Tralement, correct severe fluid, electrolyte, and acid-base disorders.
• The dosage of the final parenteral nutrition solution containing Tralement must be based on the concentrations of all components in the solution, the patient’s clinical condition, nutritional requirements, and the contribution of oral or enteral intake.
• For pediatric patients weighing 10 to 49 kg, Tralement does not provide the recommended daily dosage of zinc (in heavier patients in some weight bands), copper or selenium. Additional supplementation using single trace element products may be needed for these patients [see Dosage and Administration (2.5)].
• Monitor fluid and electrolyte status during treatment use of Tralement and adjust the parenteral nutrition solution as needed

2.5 Recommended Dosage and Monitoring in Adult and Pediatric Patients

Tralement is a fixed-combination product. Each mL of Tralement provides zinc 3 mg, copper 0.3 mg, manganese 55 mcg, and selenium 60 mcg.

Tralement is recommended only for patients who require supplementation with all four of the individual trace elements (i.e., zinc, copper, manganese and selenium).

Adults and Pediatric Patients Weighing at least 50 kg:
The recommended dosage of Tralement is 1 mL per day added to parenteral nutrition (zinc 3 mg/copper 0.3 mg/manganese 55 mcg/selenium 60 mcg). Tralement is not recommended for those patients who may require a lower dosage of one or more of the individual trace elements.

Pediatric Patients Weighing 10 kg to 49 kg:
The recommended dosage of Tralement by volume to be added to parenteral nutrition is based on body weight and ranges from 0.2 mL to 0.8 mL per day as shown in Table 1.

Use Additional Supplementation with Tralement
For pediatric patients weighing 10 kg to 49 kg, additional zinc (in heavier patients in some weight bands), copper and selenium may be needed to meet the recommended daily dosage of these trace elements, shown below. To determine the additional amount of supplementation that is needed, compare the calculated daily recommended dosage based on the body weight of the patient to the amount of each trace element provided by Tralement (Table 1) and other oral or enteral nutrition sources.

• Zinc: 50 mcg/kg/day (up to 3,000 mcg/day)
• Copper: 20 mcg/kg/day (up to 300 mcg/day)
• Selenium: 2 mcg/kg/day (up to 60 mcg/day)

Do not supplement Tralement with additional manganese. Accumulation of manganese in the brain can occur with long-term administration with higher than the recommended dosage of 1 mcg/kg/day (up to 55 mcg/day) [see Warnings and Precautions (].

Monitoring

• Monitor serum zinc, copper, and selenium concentrations and manganese whole blood concentrations during long-term administration of parenteral nutrition.
• Trace elements concentrations may vary depending on the assay used and the laboratory reference range. The collection, processing, and storage of the blood samples should be performed according to the laboratory’s sample requirements for analysis.
  
  o Zinc: In serum, the reported concentration range in healthy adults is 60 to 140 mcg/dL. Zinc concentrations in hemolyzed samples may be falsely elevated due to release of zinc from erythrocytes.
  o Copper: In serum, the reported concentration range in healthy adults is 70 to 175 mcg/dL; consider obtaining concentrations of ceruloplasmin along with serum copper.
  o Manganese: In whole blood, the reported concentration range in healthy adults is 4 to 16 mcg/L.
  o Selenium: In serum, the reported concentration range in healthy adults is 7 to 19 mcg/dL.