Multitrace-4 Concentrate

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.

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®- 4 CONCENTRATE 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 the 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.

Pregnancy

Pregnancy Category C: Safety for use in pregnancy has not been established. Use of MULTITRACE® - 4 CONCENTRATE in women of childbearing potential requires that anticipated benefits be weighed against possible hazards.

Each mL of the solution provides Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, and Chromium 10 mcg. The suggested dosage ranges for the four trace elements are:

ZINC

For the metabolically stable adult receiving TPN, the suggested intravenous dosage level is 2.5 to 4 mg zinc/day. An additional 2 mg zinc/day is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost, or an additional 17.1 mg zinc/kg of stool or ileostomy output is recommended. Frequent monitoring of zinc blood levels is suggested for patients receiving more than the usual maintenance dosage level of zinc. Normal plasma levels for zinc vary from approximately 88 to 112 mcg/100 mL.

For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day is suggested.

COPPER

For the metabolically stable adult receiving TPN, the suggested additive dosage level is 0.5 to 1.5 mg copper/day. For pediatric patients, the suggested additive dosage level is 20 mcg copper/kg/day. The normal plasma range for copper is approximately 80 to 160 mcg/100 mL.

MANGANESE

For the metabolically stable adult receiving TPN, the suggested additive dosage level for manganese is 0.15 to 0.8 mg/day. For pediatric patients, a dosage level of 2 to 10 mcg manganese/kg/day is recommended.

CHROMIUM

For the metabolically stable adult receiving TPN, the suggested additive dosage level is 10 to 15 mcg chromium/day. The metabolically stable adult with intestinal fluid loss may require 20 mcg chromium/day with frequent monitoring of blood levels as a guideline for subsequent administration. For pediatric patients, the suggested additive dosage level is 0.14 to 0.20 mcg/kg/day.

Periodic monitoring of plasma levels of Zinc, Copper, Manganese, and Chromium is suggested as a guideline for administration.

Aseptic addition of the solution to the TPN solution under a laminar flow hood is recommended. The trace elements present in the solution are physically compatible with the electrolytes and vitamins usually present in the amino acid/dextrose solution used for TPN.

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

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).

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. 10/10

Container 

NDC 0517-7210-25

MULTITRACE -4 CONCENTRATE
(TRACE ELEMENTS INJECTION 4, USP)

10 mL MULTIPLE DOSE VIAL

FOR IV USE AFTER DILUTION

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY  11967

Carton

MULTITRACE -4 CONCENTRATE
(TRACE ELEMENTS INJECTION 4, USP)

NDC 0517-7210-25
25 x 10 mL
MULTIPLE DOSE VIALS

FOR IV USE AFTER DILUTION

Rx Only

Each mL provides: Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, Chromium 10 mcg. Each mL contains: Zinc Sulfate (Heptahydrate) 22 mg, Cupric Sulfate (Pentahydrate) 3.93 mg, Manganese Sulfate (Monohydrate) 1.54 mg, Chromic Chloride (Hexahydrate) 51.3 mcg, Benzyl Alcohol 0.9% as an antimicrobial preservative, and Water for Injection q.s. pH may be adjusted with Sulfuric Acid and/or Sodium Hydroxide. Sterile, nonpyrogenic.Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).
Directions for Use: See Package Insert.

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

Rev. 11/05