MULTITRACE -4- trace elements 4 injection, solution, concentrate

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 22 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 CONCENTRATE should not be given undiluted by direct injection into a peripheral vein because of the potential of infusion phlebitis.

Product summary:

MULTITRACE ® - 4 CONCENTRATE (TRACE ELEMENTS INJECTION 4, USP) Each mL provides: Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, and Chromium 10 mcg. NDC 0517-7201-25                 1 mL Single Dose Vial                 Packaged in boxes of 25 NDC 0517-7210-25                 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 IN7201 Rev. 8/18

Authorization status:

unapproved drug other

Summary of Product characteristics

MULTITRACE -4- TRACE ELEMENTS 4 INJECTION, SOLUTION, CONCENTRATE
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 CONCENTRATE
(TRACE ELEMENTS INJECTION 4, USP)
FOR IV USE AFTER DILUTION
RX ONLY
DESCRIPTION
MULTITRACE® - 4 CONCENTRATE (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 5 mg, Copper 1 mg, Manganese 0.5 mg and
Chromium 10 mcg.
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); and
Water for Injection, q.s. pH of the solution may have been adjusted
with Sulfuric Acid and/or Sodium
Hydroxide. The 10 mL Multiple Dose Vial contains 0.9% Benzyl Alcohol
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 wi