Trace Elements 5

This formulation is indicated for use as a supplement to intravenous solutions given for TPN. Administration of the solution in TPN solutions helps to maintain plasma levels of zinc, copper, manganese, selenium and chromium and to prevent depletion of endogenous stores of these trace elements and subsequent deficiency symptoms.

MULTITRACE ® – 5 should not be given undiluted by direct injection into a peripheral vein because of the potential of infusion phlebitis.

Copper and Manganese are eliminated via the bile. In patients with severe liver dysfunction and/or biliary tract obstruction, decreasing or omitting copper and manganese supplements entirely may be necessary. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Before administering MULTITRACE ® – 5 in TPN solutions, the physician must assess the metabolic requirements for trace elements and disease state of the patient. Frequent determinations of serum levels of the various trace elements are suggested as a guideline for adjusting the dosage or completely omitting the solution. ZINC is eliminated via the intestine and kidneys. The possibility of retention should be considered in patients with malfunctioning excretory routes. COPPER and MANGANESE are eliminated via the bile, therefore the possibility of retention of these elements should be considered in patients with biliary obstruction. Ancillary routes of MANGANESE excretion, however, include pancreatic juice, or reabsorption into the lumen of duodenum, jejunum, or ileum. In assessing the contribution of CHROMIUM supplements to maintenance of normal glucose homeostasis, consideration should be given to the possibility that the patient may be diabetic, in which case oral or intravenous antidiabetic medication may be indicated. As SELENIUM is eliminated in urine and feces, SELENIUM supplements may be adjusted, reduced or omitted in renal dysfunction and/or gastrointestinal malfunction. In patients receiving blood transfusions, contribution from such transfusions should also be considered. Frequent selenium plasma level determinations are suggested as a guideline. In animals, SELENIUM has been reported to enhance the action of Vitamin E and decrease the toxicity of mercury, cadmium, and arsenic. Pregnancy Teratogenic Effects Pregnancy Category C: SELENIUM at high dosage levels (15-30 mcg/egg) has been reported to have adverse embryological effects among chickens. There are however no adequate and wellcontrolled studies in pregnant women. MULTITRACE ® – 5 should be used during pregnancy only if potential benefit justifies the potential risk to the fetus. Presence of SELENIUM in placenta and umbilical cord blood has been reported in humans.

The amounts of ZINC, COPPER, MANGANESE, CHROMIUM and SELENIUM in the solution are very small and toxicity symptoms due to these trace elements at suggested dosage levels are considered unlikely to occur.

Teratogenic Effects Pregnancy Category C: SELENIUM at high dosage levels (15-30 mcg/egg) has been reported to have adverse embryological effects among chickens. There are however no adequate and wellcontrolled studies in pregnant women. MULTITRACE ® – 5 should be used during pregnancy only if potential benefit justifies the potential risk to the fetus. Presence of SELENIUM in placenta and umbilical cord blood has been reported in humans.