MULTITRACE-4- trace elements 4 injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP) (ZINC CATION - UNII:13S1S8SF37), CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L), MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANESE CATION (2+) - UNII:H6EP7W5457), CHROMIC CHLORIDE (UNII: KB1PCR9DMW) (CHROMIC CATION - UNII:X1N4508KF1)

Available from:

American Regent, Inc.

INN (International Name):

ZINC SULFATE HEPTAHYDRATE

Composition:

ZINC CATION 4.39 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, and chromium and to prevent depletion of endogenous stores of these trace elements and subsequent deficiency symptoms. MULTITRACE ® - 4 should not be given undiluted by direct injection into a peripheral vein because of the potential of infusion phlebitis. WARNINGS: 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 indicate

Product summary:

MULTITRACE ® - 4 (TRACE ELEMENTS INJECTION 4, USP) Each mL provides: Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg and Chromium 4 mcg. NDC 0517-7410-25              10 mL Multiple Dose Vial*              Packaged in boxes of 25 *Contains 0.9% benzyl alcohol as an antimicrobial preservative. AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN7410 Rev. 8/18

Authorization status:

unapproved drug other

Summary of Product characteristics

MULTITRACE-4- TRACE ELEMENTS 4 INJECTION, SOLUTION
AMERICAN REGENT, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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MULTITRACE -4 (TRACE ELEMENTS INJECTION 4, USP)
FOR IV USE AFTER DILUTION
RX ONLY
DESCRIPTION
MULTITRACE - 4 (TRACE ELEMENTS INJECTION 4, USP) is a sterile,
nonpyrogenic
solution containing four Trace Elements for use as an additive for
Total Parenteral Nutrition (TPN).
Each mL provides: Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg and
Chromium 4 mcg. Each mL
contains: Zinc Sulfate Heptahydrate 4.39 mg (equivalent to 1 mg Zinc);
Cupric Sulfate Pentahydrate 1.57
mg (equivalent to 0.4 mg Copper); Manganese Sulfate Monohydrate 0.308
mg (equivalent to 0.1 mg
Manganese); Chromic Chloride Hexahydrate 20.5 mcg (equivalent to 4 mcg
Chromium); and Water for
Injection, q.s. pH of the solution may be adjusted with sulfuric acid
and/or sodium hydroxide. 0.9%
Benzyl Alcohol is added as an antimicrobial preservative.
CLINICAL PHARMACOLOGY
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 as