Trace Elements Injection 4
FDA Drug Information • Also known as: Multrys, Tralement
- Brand Names
- Multrys, Tralement
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION 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. It contains no preservative. Each single-dose vial contains 1 mL and each multiple-dose vial contains 10 mL. *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. Sulfuric acid may be added to adjust pH between 1.5 and 3.5. Zinc sulfate exists as a heptahydrate. The structural formula is: Molecular formula: ZnSO 4
What Is Trace Elements Injection 4 Used For?
1 INDICATIONS AND USAGE 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 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. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Single-dose vial amd multiple-dose vial . Not for direct intravenous infusion. ( 2.1 ) See full prescribing information for information on preparation, administration and general dosing considerations. ( 2.1 , 2.2 , 2.3 , 2.4) Recommended Dosage Each mL of Tralement provides zinc 3 mg, copper 0.3 mg, manganese 55 mcg, and selenium 60 mcg. ( 2.5 ) Adults and Pediatric Patients Weighing at Least 50 kg : The recommended dosage of Tralement is 1 mL per day added to parenteral nutrition. Tralement is not recommended for patients who may require a lower dosage of one or more of the individual trace elements. ( 2.5 ) Pediatric Patients Weighing 10 kg to 49 kg : The recommended dosage of Tralement based on body weight is 0.2 mL to 0.8 mL per day added to parenteral nutrition. 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. For complete dosing information see table in the full prescribing information. ( 2.4 , 2.5 ) Monitor trace element concentrations in blood during long-term administration of parenteral nutrition. ( 2.5 ) 2.1 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 )] . 2.2 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. 2.3 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...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following adverse reactions were identified in clinical studies or post-marketing reports. Given that some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions with other components of parenteral nutrition solutions :
Contraindications
4 CONTRAINDICATIONS Tralement is contraindicated in patients with hypersensitivity to zinc or copper [ see Warnings and Precautions ( 5.7 )]. Hypersensitivity to zinc or copper ( 4, 5.7 )
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary Administration of the recommended dose of Tralement in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Deficiency of trace elements may result in adverse pregnancy and fetal outcomes (see Clinical Considerations). Animal reproduction studies have not been conducted with Tralement or with the individual trace elements. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo-Fetal Risk Deficiencies of trace elements, including zinc, copper, manganese, and selenium are associated with adverse pregnancy and fetal outcomes. Pregnant women have an increased metabolic demand for trace elements. Parenteral nutrition with Tralement should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake.
Overdosage
10 OVERDOSAGE There is no information on overdos Management of overdosage is supportive care based on presenting signs and symptoms. Obtain blood samples for laboratory testing of the individual trace elements and ceruloplasmin for copper. Zinc Acute zinc toxicity was reported in an infant who received an inadvertent 1,000-fold overdose of zinc in parenteral nutrition that led to cardiac failure and death. Zinc toxicity in adult patients receiving 17 to 400-fold the recommended dosage in parenteral nutrition for 2.5 to 60 days reported signs and symptoms including vomiting, diarrhea, hyperamylasemia, thrombocytopenia, and anemia. The zinc serum concentration was 2 to 30-fold the upper end of the reported range in healthy subjects in these cases. Copper Acute copper toxicity was reported in patients with oral, intravenous, or subcutaneous administration. Clinical manifestations included metallic taste, nausea, vomiting, abdominal pain, and multi-organ failure involving kidney, liver, blood, and cardiovascular systems. Chelating agents can be used for treatment of acute toxicity. Long-term administration of parenteral copper above recommended dosage may result in significant accumulation of copper in the liver, brain, and other tissues with possible organ damage [see Warnings and Precautions ( 5.4 ) ]. Manganese Acute manganese toxicity was reported in adult patients following infusion of manganese more than 10,000-fold the recommended dosage and after use of dialysis fluid contaminated with manganese. Signs and symptoms included skin flushing, acute pancreatitis, elevated whole blood manganese concentrations, and MRI evidence of brain accumulation of manganese. Chronic infusion and oral intake of manganese above recommended dosage have resulted in neuropsychiatric symptoms and MRI evidence of brain accumulation of manganese [see Warnings and Precautions ( 5.3 ) ]. Selenium Acute selenium toxicity was reported with oral overdosage of greater than 1 g/day. Symptoms...
How Supplied
16 HOW SUPPLIED Tralement (trace elements injection 4*, USP) is a clear, colorless to slightly blue solution supplied as follows: NDC 0517-9305-01 1 mL single-dose vial NDC 0517-9305-25 Packaged in trays containing 25 vials per tray *Each mL of Tralement contains zinc 3 mg, copper 0.3 mg, manganese 55 mcg, and selenium 60 mcg. Vial closure is not made with natural rubber latex. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Store admixed solution at 2ºC to 8ºC (36ºF to 46ºF) [see Dosage and Administration ( 2.3 )].
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.