MULTITRACE-4 NEONATAL- 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 6.6 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

MULTITRACE ® - 4 NEONATAL is indicated for use as a supplement to intravenous solutions given for TPN. Administration of MULTITRACE ® - 4 NEONATAL 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 NEONATAL should not be given undiluted by direct injection into a peripheral vein because of the potential of infusion phlebitis.

Product summary:

MULTITRACE ® - 4 NEONATAL (TRACE ELEMENTS INJECTION 4, USP) NDC 0517-6202-25             2 mL Single Dose Vial           Packaged in boxes of 25 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN6202 Rev. 8/18

Authorization status:

unapproved drug other

Summary of Product characteristics

MULTITRACE-4 NEONATAL- 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 NEONATAL (TRACE ELEMENTS INJECTION 4, USP)
FOR IV USE AFTER DILUTION
RX ONLY
DESCRIPTION
MULTITRACE - 4 NEONATAL (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 1.5 mg
Copper 0.1 mg
Manganese 25 mcg
Chromium 0.85 mcg
EACH ML CONTAINS:
Zinc Sulfate (Heptahydrate) 6.6 mg
Cupric Sulfate (Pentahydrate) 0.39 mg
Manganese Sulfate (Monohydrate) 77 mcg
Chromic Chloride (Hexahydrate) 4.36 mcg
Water for Injection q.s
pH (range 2.3-2.7) may be adjusted with Sulfuric Acid and/or Sodium
Hydroxide.
Zinc Sulfate is chemically designated ZnSO , a white crystalline
compound freely soluble in water.
Cupric Sulfate is chemically designated CuSO , a blue crystalline
compound very soluble in water.
Manganese Sulfate is chemically designated MnSO , a pale red, slightly
efflorescent compound soluble
in water. Chromic Chloride is chemically designated CrCl
, a greenish compound, soluble in water.
CLINICAL PHARMACOLOGY
ZINC is an essential nutritional requirement that serves as a cofactor
for more than 70 different
enzymes including carbonic anhydrase, alkaline phosphatase, lactic
dehydrogenase, and both RNA and
DNA polymerase. Zinc facilitates wound healing, helps maintain normal
skin hydration, and senses of
taste and smell.
Zinc resides in muscle, bone, skin, kidney, liver, pancreas, retina,
prostate, and particularly in the red and
white blood cells. Zinc binds plasma albumin α -macroglobulin, and
some plasma amino acids including
histidine, cysteine, threonine, glycine, and asparagine. Ingested zinc
is excreted mainly in the stool
(approximately 90%), and to a lesser extent in the urine and in
perspiration. Pr