Monitoring Blood Manganese Levels: Blood manganese levels should be regularly monitored in case of prolonged artificial nutrition. Dose reduction may be necessary. Stop NUTRYELT infusion if manganese levels rise into the potentially toxic range. The occurrence of neurological signs may represent manganese toxicity.
Use in Patients with Reduced Biliary Excretion: Use with caution in patients with reduced biliary excretion, as elimination of manganese, copper and zinc may be significantly decreased, leading to accumulation and overdose.
Use in Special Populations: Use with caution in patients with renal impairment, hepatic impairment, or mild cholestasis, as excretion of some trace elements (selenium, fluoride, chromium, molybdenum and zinc) may be significantly decreased.
Use in Patients Undergoing Medium to Long-Term Parenteral Nutrition: In patients undergoing medium to long-term parenteral nutrition, there is an increased occurrence of iron, zinc and selenium deficiency. In this circumstance, administration of supplemental iron, zinc, and/or selenium may be required.
General Monitoring: Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation.
Chromium deficiency leads to a decrease in glucose tolerance, which improves after chromium supplementation. As a consequence, in diabetic patients on insulin medication, relative overdose of insulin and consecutive hypoglycemia may occur. Therefore controls of the blood glucose levels are recommended and re-adjustment of the insulin doses may become necessary.
NUTRYELT should be given with caution in cases of manifest hyperthyroidism or sensitivity to iodine if other iodine containing medicinal products (e.g., iodine antiseptic) are administered concomitantly.
Effects on ability to drive and use machines: There is no information of the effects of NUTRYELT on the ability to drive or operate an automobile or other heavy machinery.
Use in Children: Safety and effectiveness in the pediatric population have not been established.