Advertisement

Topics

TRACE ELEMENTS INJECTION 4, USP | Trace Elements 4 [American Regent, Inc.] | BioPortfolio

12:34 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

PEDIATRIC

FOR IV USE AFTER DILUTION

Rx Only

TRACE ELEMENTS INJECTION 4, USP PEDIATRIC is a sterile, nonpyrogenic solution containing four Trace Elements for use as an additive for Total Parenteral Nutrition (TPN).

Each mL provides: Zinc 0.5 mg, Copper 0.1 mg, Manganese 30 mcg, and Chromium 1 mcg. Each mL contains: Zinc Sulfate Heptahydrate 2.2 mg (equivalent to 0.5 mg Zinc), Cupric Sulfate Pentahydrate 0.4 mg (equivalent to 0.1 mg Copper), Manganese Sulfate Monohydrate 92.3 mcg (equivalent to 30 mcg Manganese), Chromic Chloride Hexahydrate 5.12 mcg (equivalent to 1 mcg Chromium), and Water for Injection q.s. pH may be adjusted with Sulfuric Acid and/or Sodium Hydroxide. 0.9% Benzyl Alcohol is added as an antimicrobial preservative.

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, a cuproenzyme.

Providing copper during TPN prevents development of the following deficiency symptoms: leukopenia, neutropenia, anemia, depressed ceruloplasmin levels, impaired transferring 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, an activator of 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.

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.

TRACE ELEMENTS INJECTION 4, USP PEDIATRIC should not be given undiluted by direct injection into a peripheral vein because of the potential of infusion phlebitis.

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 TRACE ELEMENTS INJECTION 4, USP PEDIATRIC 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 Category C: Safety for use in pregnancy has not been established. Use of Multiple Trace Elements 4, USP in women of childbearing potential requires that anticipated benefits be weighed against possible hazards.

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 level are considered unlikely to occur.

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; such symptoms have been reported with a serum copper level of 286 mcg/dL. 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.

Do not use syringes, needles, or intravenous sets containing aluminum parts that may come in contact with TRACE ELEMENTS INJECTION 4, USP PEDIATRIC, for preparation or administration. Aluminum reacts and dissolves in acid media.

Each mL of the solution provides Zinc 0.5 mg, Copper 0.1 mg, Manganese 30 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 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, 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 TRACE ELEMENTS - 4 to parenteral nutrition solutions under a laminar flow hood is recommended. The trace elements present in TRACE ELEMENTS - 4 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° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

TRACE ELEMENTS INJECTION 4, USP PEDIATRIC

Each mL provides: Zinc 0.5 mg, Copper 0.1 mg, Manganese 30 mcg, and Chromium 1 mcg.

NDC 0517-9310-25           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

IN9310Rev. 8/18

Container NDC 0517-9310-25 TRACE ELEMENTS INJECTION 4, USPPEDIATRIC

10 mL MULTIPLE DOSE VIAL

FOR IV USE AFTER DILUTION

Rx Only

AMERICANREGENT, INC. SHIRLEY, NY  11967

Carton

TRACE ELEMENTS INJECTION 4, USPPEDIATRIC

NDC 0517-9310-2525 x 10 mLMULTIPLE DOSE VIALS

FOR IV USE AFTER DILUTION

Rx Only

Each mL provides: zinc 0.5 mg, copper 0.1 mg, manganese 30 mcg, and chromium 1 mcg. Each mL contains: zinc Sulfate (heptahydrate) 2.2 mg, cupric sulfate (pentahydrate) 0.4 mg, manganese sulfate (monohydrate) 92.3 mcg, chromic chloride (hexahydrate) 5.12 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

Manufacturer

American Regent, Inc.

Active Ingredients

Source

Drugs and Medications [38 Associated Drugs and Medications listed on BioPortfolio]

Peditrace [fresenius kabi usa, llc]

Peditrace

Addamel n [fresenius kabi usa, llc]

Addamel N

Multitrace -4 pediatric [american regent, inc.]

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

Multitrace-4 [american regent, inc.]

MULTITRACE -4 (TRACE ELEMENTS INJECTION 4, USP)

Multitrace -4 [american regent, inc.]

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

Clinical Trials [395 Associated Clinical Trials listed on BioPortfolio]

Study of Systemic Impact of Trace Elements Release by Implantable Medical Devices. Identification of Biomarkers of Systemic Inflammation

The main objective of this study is to evaluate the systemic impact of salting out of trace elements (TE) by metallic and nonmetallic implantable medical devices (IMD) and in particular th...

Examining the Link Between Trace Elements and Cardiovascular Disease Risk Factors in Young Adults

Cardiovascular disease (CVD) affects millions of people in the United States; each year, more people die from CVD than from any other disease. There are many dietary and lifestyle factors ...

Evaluation of Toxic Metals, Trace Elements and Total Antioxidant Activity in Children With Recurrent Wheezing

The purpose of this study is to evaluate hair trace elements and toxic metals and plasma total antioxidant activity in children with recurrent wheezing and to evaluate whether these toxic ...

Intradialytic Parenteral Nutrition in Hemodialysis Patients

Malnutrition is a major cause of death in chronic hemodialysis patients. Primary treatment of malnutrition in these patients is dietetic counseling, additional enteral nutrition and occasi...

Content, Bioavailability and Health Effects of Trace Elements and Bioactive Components in Organic Agricultural Systems

Trace elements, bioactive secondary metabolites and vitamins are among the most important quality parameters in plants. Yet, very little information is available on their content, bioavail...

PubMed Articles [2732 Associated PubMed Articles listed on BioPortfolio]

Chemometric characterization of the trace element profile of raw meat from Rubia Gallega x Holstein Friesian calves from an intensive system.

This study was conducted to compare the essential and toxic element content of seven veal cuts: shoulder clod (SC), inside round (IR), eye of round (ER), bottom round (BR), heel of round (HR), knuckle...

Serum trace elements in insulin-dependent and non-insulin-dependent diabetes: a comparative study.

Diabetes mellitus is associated with imbalance in body trace elements. The aim of the current investigation was to compare the levels of trace elements (Zn, Mg, Mn, Cu, Na, K, Fe, Ca, Cr, and Se) in i...

Change of the Levels of Trace Elements and Heavy Metals in Threatened Abortion.

This study aimed to investigate the impact of changes in the levels of trace elements and heavy metals in threatened abortion. Threatened abortion is a common complication in early pregnancy. Previous...

Differential release of sewage sludge biochar-borne elements by common low-molecular-weight organic acids.

Biochar materials originated from sewage sludge may contain elevated levels of potentially toxic elements. There was a lack of information on the mobility of biochar-borne elements, as driven by low-m...

Quantification of Trace Elements in Different Dokha and Shisha Tobacco Products using EDXRF.

The present study aims to quantify trace metals in different dokha (medwakh) and shisha tobacco products available in local markets. Recent research has shown that these products have higher amounts o...

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...


Drugs and Medication Quicklinks


Searches Linking to this Drug Record