MULTITRACE®– 5 CONCENTRATE (TRACE ELEMENTS INJECTION 5, USP) is a sterile nonpyrogenic CONCENTRATED solution containing five Trace Elements for use as an additive for Total Parenteral Nutrition (TPN).

Each mL Contains: Zinc Sulfate Heptahydrate 22 mg (equivalent to 5 mg Zinc); Cupric Sulfate Pentahydrate 3.93 mg (equivalent to 1 mg Copper); Manganese Sulfate Monohydrate 1.54 mg (equivalent to 0.5 mg Manganese); Chromic Chloride Hexahydrate 51.3 mcg (equivalent to 10 mcg Chromium); Selenious Acid 98 mcg (equivalent to 60 mcg Selenium); and Water for Injection q.s. pH of the solution may have been adjusted with Sulfuric Acid. The 10 mL Multiple Dose Vial contains 0.9% Benzyl Alcohol as an antimicrobial preservative.

ZINC has been identified as a cofactor for over 70 different enzymes, including alkaline phosphatase, lactic dehydrogenase and both RNA and DNA polymerase. Zinc facilitates wound healing, helps maintain normal growth rates, normal skin hydration and senses of taste and smell.

Providing zinc during TPN prevents development of the following deficiency symptoms: Parakeratosis, hypogeusia, anorexia, dysosmia, geophagia, hypogonadism, growth retardation and hepatosplenomegaly. At plasma levels below 20 mcg zinc/100 mL, dermatitis followed by alopecia has been reported for TPN patients.

COPPER is essential as a cofactor for serum ceruloplasmin, an oxidase necessary for proper formation of the iron carrier protein, transferrin. Copper also helps maintain normal rates of red and white blood cell formation. Scorbutic type bone changes seen in infants fed exclusively with copper-poor cow’s milk are believed due to decreased activity of ascorbate oxidase, a cuproenzyme.

Providing copper during TPN prevents development of the following deficiency symptoms: leukopenia, neutropenia, anemia, depressed ceruloplasmin levels, impaired transferrin formation and secondary iron deficiency.

MANGANESE is an activator for enzymes such as polysaccharide polymerase, liver arginase, cholinesterase and pyruvate carboxylase.

Providing manganese during TPN prevents development of the following deficiency symptoms: nausea and vomiting, weight loss, dermatitis, and changes in growth and color of hair.

CHROMIUM (trivalent) is part of glucose tolerance factor, an activator of insulin-mediated reactions. Chromium helps to maintain normal glucose metabolism and peripheral nerve function.

Providing chromium during TPN prevents development of the following deficiency symptoms: impaired glucose tolerance, ataxia, peripheral neuropathy and a confusional state similar to mild/moderate hepatic encephalopathy.

SELENIUM is part of glutathione peroxidase which protects cell components from oxidative damage due to peroxides produced in cellular metabolism.

Prolonged TPN support in humans has resulted in selenium deficiency symptoms which include muscle pain and tenderness. The symptoms have been reported to respond to supplementation of TPN solutions with selenium

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