Multitrace -4 Pediatric
Trace Elements 4
American Regent, Inc.
Human Prescription Drug
NDC 0517-9203Multitrace -4 Pediatric also known as Trace Elements 4 is a human prescription drug labeled by 'American Regent, Inc.'. National Drug Code (NDC) number for Multitrace -4 Pediatric is 0517-9203. This drug is available in dosage form of Injection, Solution, Concentrate. The names of the active, medicinal ingredients in Multitrace -4 Pediatric drug includes Chromic Chloride - 5.12 ug/mL Cupric Sulfate - .4 mg/mL Manganese Sulfate - 77 ug/mL Zinc Sulfate Heptahydrate - 4.39 mg/mL . The currest status of Multitrace -4 Pediatric drug is Active.
Drug Information:
| Drug NDC: | 0517-9203 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Multitrace -4 Pediatric |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Trace Elements 4 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | American Regent, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution, Concentrate |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CHROMIC CHLORIDE - 5.12 ug/mL
CUPRIC SULFATE - .4 mg/mL
MANGANESE SULFATE - 77 ug/mL
ZINC SULFATE HEPTAHYDRATE - 4.39 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 09 Dec, 1993 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | American Regent, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1293464
1293466
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0305179203253
|
| UPC stands for Universal Product Code. |
| UNII: | KB1PCR9DMW
LRX7AJ16DT
W00LYS4T26
N57JI2K7WP
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Copper Absorption Inhibitor [EPC]
Decreased Copper Ion Absorption [PE]
Magnetic Resonance Contrast Activity [MoA]
Paramagnetic Contrast Agent [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0517-9203-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9203-25) / 3 mL in 1 VIAL, SINGLE-DOSE | 09 Dec, 1993 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Multitrace -4 pediatric trace elements 4 zinc sulfate heptahydrate zinc cation cupric sulfate cupric cation manganese sulfate manganese cation (2+) chromic chloride chromic cation sulfuric acid sodium hydroxide water
Indications and Usage:
Indications and 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.
Warnings:
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.
Dosage and Administration:
Dosage and 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 p
Read more...arenteral 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).
Contraindications:
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:
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.
Use in Pregnancy:
Pregnancy teratogenic effects pregnancy category c: safety for use in pregnancy has not been established. use of multitrace ® - 4 pediatric in women of childbearing potential requires that anticipated benefits be weighed against possible hazards.
Overdosage:
Overdosage symptoms of zinc overdose resulting from oral ingestion of zinc sulfate in large amounts have resulted in death. symptoms included nausea, vomiting, dehydration, electrolyte imbalances, dizziness, abdominal pain, lethargy and incoordination. single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemia patients without toxic manifestations. normal plasma levels for zinc vary from approximately 88 to 112 mcg/100 ml. plasma levels sufficient to produce symptoms of toxic manifestations are not known. calcium supplements may confer a protective effect against zinc toxicity. symptoms of copper toxicity reported in literature include prostration, behavior change, diarrhea, progressive marasmus, hypotonia, photophobia and peripheral edema. d-penicillamine has been reported effective as an antidote. manganese toxicity has not been reported in patients receiving tpn. neither have reports of manganese toxicity from excessive intake in foods and/or beverages been published. symptoms of chromium toxicity include nausea, vomiting, ulcers and gastrointestinal tract, renal and hepatic damage, and abnormalities of the central nervous system culminating in convulsions and coma. trivalent chromium administered intravenously to tpn patients has been shown to be nontoxic when given at dosage levels up to 250 mcg/day for two consecutive weeks.
Description:
Description 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.
Clinical Pharmacology:
Clinical pharmacology zinc has been identified as a cofactor for over 70 different enzymes, including carbonic anhydrase, 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 ascorbate oxidase,
Read more... a cuproenzyme. providing copper during tpn prevents development of the following deficiency symptoms: leukopenia, neutropenia, anemia, depressed ceruloplasmin levels, impaired transferrin formation and secondary iron deficiency. manganese is an activator for enzymes such as polysaccharide polymerase, liver arginase, cholinesterase and pyruvate carboxylase. providing manganese during tpn prevents development of the following deficiency symptoms: nausea and vomiting, weight loss, dermatitis, and changes in growth and color of hair. chromium (trivalent) is part of glucose tolerance factor, and activator insulin-mediated reactions. chromium helps to maintain normal glucose metabolism and peripheral nerve function. providing chromium during tpn prevents development of the following deficiency symptoms: impaired glucose tolerance, ataxia, peripheral neuropathy, and a confusional state similar to mild/moderate hepatic encephalopathy.
How Supplied:
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:
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