Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED MULTITRACE ® - 4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP) Each mL provides: Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg, and Chromium 1 mcg. NDC 0517-9203-25 3 mL Single Dose Vial Packaged in boxes of 25 AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN9203 Rev. 8/18; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container ND C 0517-9203-25 MULTITRACE -4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP) 3 mL SINGLE DOSE VIAL FOR IV USE AFTER DILUTION Rx Only AMERICAN REGENT, INC. SHIRLEY, NY 11967 Carton MULTITRACE -4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP) ND C 0517-9203-25 25 x 3 mL SINGLE DOSE VIALS FOR IV USE AFTER DILUTION - PRESERVATIVE FREE Rx Only Each mL provides: Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg and Chromium 1 mcg. Each mL contains: Zinc Sulfate (Heptahydrate) 4.39 mg, Cupric Sulfate (Pentahydrate) 0.4 mg, Manganese Sulfate (Monohydrate) 77 mcg, Chromic Chloride (Hexahydrate) 5.12 mcg and Water for Injection q.s. pH may be adjusted with Sulfuric Acid and/or Sodium Hydroxide. Sterile, nonpyrogenic. WARNING: DISCARD UNUSED PORTION - USE ONLY IF SOLUTION IS CLEAR. 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 3 mL Container Label Carton; Serialization Label Serialization Label
- HOW SUPPLIED MULTITRACE ® - 4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP) Each mL provides: Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg, and Chromium 1 mcg. NDC 0517-9203-25 3 mL Single Dose Vial Packaged in boxes of 25 AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN9203 Rev. 8/18
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container ND C 0517-9203-25 MULTITRACE -4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP) 3 mL SINGLE DOSE VIAL FOR IV USE AFTER DILUTION Rx Only AMERICAN REGENT, INC. SHIRLEY, NY 11967 Carton MULTITRACE -4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP) ND C 0517-9203-25 25 x 3 mL SINGLE DOSE VIALS FOR IV USE AFTER DILUTION - PRESERVATIVE FREE Rx Only Each mL provides: Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg and Chromium 1 mcg. Each mL contains: Zinc Sulfate (Heptahydrate) 4.39 mg, Cupric Sulfate (Pentahydrate) 0.4 mg, Manganese Sulfate (Monohydrate) 77 mcg, Chromic Chloride (Hexahydrate) 5.12 mcg and Water for Injection q.s. pH may be adjusted with Sulfuric Acid and/or Sodium Hydroxide. Sterile, nonpyrogenic. WARNING: DISCARD UNUSED PORTION - USE ONLY IF SOLUTION IS CLEAR. 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 3 mL Container Label Carton
- Serialization Label Serialization Label
Overview
MULTITRACE ® - 4 PEDIATRIC (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 0.1 mg, Manganese 25 mcg and Chromium 1 mcg. Each mL contains: Zinc Sulfate Heptahydrate 4.39 mg (equivalent to 1 mg Zinc); Cupric Sulfate Pentahydrate 0.4 mg (equivalent to 0.1 mg Copper); Manganese Sulfate Monohydrate 77 mcg (equivalent to 25 mcg Manganese); Chromic Chloride Hexahydrate 5.12 mcg (equivalent to 1 mcg Chromium); and Water for Injection, q.s. pH of the solution may have been adjusted with sulfuric acid and/or sodium hydroxide. Preservative Free.
Indications & Usage
This formulation is indicated for use as a supplement to intravenous solutions given for TPN for children up to 11 years of age. 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.
Dosage & Administration
Each mL of the solution provides Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg, and Chromium 1 mcg, and is administered intravenously only after dilution to a minimum of 1:200. The suggested dosage ranges for the four trace elements are: ZINC : For full term infants and children, 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 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 pediatric patients, a dosage level of 2 to 10 mcg manganese/kg/day is recommended. CHROMIUM : 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 MULTITRACE® - 4 PEDIATRIC to parenteral nutrition solutions under a laminar flow hood is recommended. The trace elements present in MULTITRACE® - 4 PEDIATRIC are physically compatible with the electrolytes and vitamins usually present in parenteral nutrition formulations. Do not directly mix ascorbic acid injection with copper or selenium containing parenteral products in the same syringe or vial, as this admixture may cause the formation of an insoluble precipitate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).
Warnings & Precautions
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 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.
Contraindications
MULTITRACE ® - 4 PEDIATRIC should not be given undiluted by direct injection into a peripheral vein because of the potential of infusion phlebitis.
Adverse Reactions
The amounts of ZINC, COPPER, MANGANESE, AND CHROMIUM in the solution are very small and toxicity symptoms due to these trace elements at suggested dosage levels are considered unlikely to occur.
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