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MICRO+ TE PEDIATRIC is a brand name for Zinc, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Micro+® TE Pediatric (5 trace elements) is indicated for use as a pediatric supplement to intravenous solutions given for Total Parenteral Nutrition (TPN) for patients requiring supplementation with all five trace elements. Its administration in TPN solutions helps to maintain plasma zinc, copper, manganese, selenium…
Verbatim from this product's HC label. Tap a section to expand.
e zinc, copper, manganese, selenium and iodine). Micro+® TE Pediatric is a fixed-combination product. Each ml of Micro+® TE Pediatric provides zinc 250 mcg, copper 20 mcg, manganese 1 mcg, selenium 2 mcg, and iodide 1 mcg.
Dosing for infants and children 20 kg or less:
The recommended dose of Micro+ TE Pediatric is 1 ml/kg/day. The suggested daily requirements of the five (5) trace elements in pediatric patients are listed below. Micro+® TE Pediatric _ Product Monograph Page 4 of 22 Zinc The recommended dose is 250 mcg zinc/kg/day for full-term infants (3 to 10 kg) and 50 mcg zinc/kg/day for children (10 to 40kg), up to a maximum of 5000 mcg zinc/day.
For preterm infants ( less than 3 kg): 400 mcg zinc/kg/day is recommended. Additional supplementation would be required to meet guideline recommendations. Patients should be monitored for zinc levels, and if needed, they should be supplemented with zinc from another source.
Micro+ TE Pediatric should not be used for this additional supplementation.
For children over 20 kg:
At a dose of 1 ml/kg/day of Micro+ TE Pediatric, the dose of zinc would be over the recommended daily maximum requirements. Micro+ TE Pediatric is only recommended to meet the higher needs associated with excessive gastrointestinal losses, sepsis, hypercatabolic states and burns, which require additional supplementation Copper The recommended daily dose is 20 mcg/kg/day for all children (less than 40 kg).
Manganese A dosage level of 1 mcg/kg/day with a maximum daily total dose of 15 mcg of manganese is recommended. Selenium The recommended daily dose is 2 mcg/kg/day for all children (less than 40 kg) Iodine Iodine is not recommended for routine daily dosing; Micro + TE Pediatric should only be used as per the Healthcare professional assessment of the patient’s iodine needs.
2 Dilution for intravenous use Micro+® TE Pediatric should be aseptically added to the amino acid/dextrose component of a TPN solution under a laminar flow hood. Micro+ TE Pediatric may only be added to medications and parenteral nutrition solutions for which compatibility has been shown.
Micro+® TE Pediatric is used as an additive to parenteral nutrition admixtures in compounded bags where data are available. 9% Sodium chloride (NaCl), 10% dextrose, 10% Travasol® Amino Acid and 20% Intralipid®. 9% NaCl or 10% Dextrose.
No adverse reactions have been reported for the amount of zinc, copper, manganese or selenium present in this product. The amounts are small and toxicity symptoms are not likely to occur at the suggested dosage level. However, adverse reactions have been reported for iodine.
Iodine and iodides can produce goitre and hypothyroidism as well as hyperthyroidism. Goiter and hypothyroidism have also occurred in infants born to mothers who had taken iodides during pregnancy. Iodine can give rise to allergic reactions which may include urticaria, angioedema, cutaneous hæmorrhage or purpuras, fever, arthralgia, lymphadenopathy, and eosinophilia.
Prolonged administration may lead to iodism, although some of the effects could be considered to be due to hypersensitivity. These include adverse effects on the mouth such as metallic taste, increased salivation, burning or pain, and coryza; there may be swelling and inflammation of the throat.
Eyes may be irritated and swollen. Pulmonary œdema may develop. Skin reactions include acneform or severe eruptions (iododerma). Other reported effects include gastrointestinal upsets and diarrhea. Symptomatic treatment may be required for allergic reactions and iodism, although symptoms usually subside rapidly when administration of iodine is discontinued.
1 Drug-Drug Interactions Interactions with other drugs have not been established. 2 Drug-food Interactions The drug is administered intravenously; therefore, there is no interaction with food. 3 Drug-Herb Interactions Interactions with herbal products have not been established.
4 Drug-Laboratory Test Interactions Interactions with laboratory tests have not been established.
e zinc, copper, manganese, selenium, and iodine). New guidelines do not recommend inclusion of iodine in trace elements solutions for pediatric patients weighing more than 3 kg. Therefore, Micro+ TE Pediatric should only be used in cases of demonstrated iodine deficiency.
e. zinc, copper, manganese, selenium or iodide). Micro+ TE Pediatric is a hypotonic solution which should be administered in admixtures only. If toxicity symptoms occur due to any one of the trace elements in Micro+ TE Pediatric, discontinue supplementation of TPN solutions immediately.
Do not give undiluted Micro+ TE Pediatric by direct injection into a peripheral vein because of the potential of infusion phlebitis. Occasional sensitization to iodine can result in anaphylactic shock. Patients should be evaluated for sensitivity to iodine before administration of Micro+ TE Pediatric.
Excess of manganese can lead to deposition in the basal ganglia of the brain and cause toxic Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous Concentrate, Sterile solution for intravenous infusion / Zinc 250 mcg/mL Copper 20 mcg/mL Selenium 2 mcg/mL Iodide 1 mcg/mL Manganese 1 mcg/mL Sulfuric acid and water for injection Micro+® TE Pediatric _ Product Monograph Page 9 of 22 events that manifest symptomatically as Parkinson-like signs and symptoms in addition to other neuropsychiatric symptoms.
Accumulation of manganese in the brain can occur with long-term administration when doses higher than the recommended 1 mcg/kg/day are used. Do not supplement the proposed drug product with additional manganese. Gastrointestinal The possibility of selenium retention should be considered in patients with renal dysfunction and/or gastrointestinal malfunction since selenium is eliminated in the urine and to a smaller extent in the feces.
Hepatic/Biliary/Pancreatic The possibility of copper and manganese retention should be a consideration in patients with biliary obstruction and caution should be exercised since copper and manganese are eliminated via the bile. Manganese and copper blood levels and liver function should be monitored regularly (monthly) in such patients.
Micro+® TE Pediatric is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Micro+® TE Pediatric (5 trace elements for injection) can also be co-administered with Magnesium sulfate (50%, USP) when diluted in 10% Dextrose. 9% Sodium chloride (NaCl), 10% dextrose, 10% Travasol® Amino Acid or 20% Intralipid® Micro+® TE Pediatric _ Product Monograph Page 5 of 22 After dilution, the solution must be used within 24 hours if store at room temperature or 48 hours if refrigerated (5 ± 3ºC).
Visually inspect parenteral drug products for particulate matter and discolouration prior to and after admixing and before administration whenever container and solution permit. See Storage, stability and Disposal. The vial is a single use vial.
Discard unused portion of the solution. 3 Administration Micro+® TE Pediatric must be diluted before use. , zinc, copper, manganese, selenium and iodine). e. zinc, copper, manganese, selenium or iodide). Routine monitoring of zinc, copper, manganese, selenium and iodine plasma levels is suggested as a guideline for administration.
For iodine, routine monitoring of thyroid function is also suggested. Zinc Normal plasma levels vary from approximately 68 to 136 mcg per 100 mL. Frequently monitor the blood zinc levels for those patients receiving more than the usual maintenance dosage level of zinc.
The dose in 1 mL of Micro+ TE Pediatric is below the recommended daily dose of zinc for preterm infants weighing 3 kg or less. The patients should be monitored for zinc level, and if needed, they should be supplemented with zinc from another source than Micro+ TE Pediatric Copper While the normal adult plasma levels range from 90 to 130 mcg/100 mL, the normal full-term newborn’s serum levels are about one-third of this.
These values were found to rise gradually during the first week of life, fall to below adult levels at two months of age, rise to within the adult range at three months of age, and to rise still higher above the adult range at eight months of age, at which levels the values persisted throughout the remainder of infancy.
Manganese Manganese is bound in both the serum and the erythrocytes. Normal human blood values have been recognized as 6 to 10 mcg/mL. Selenium The range for selenium blood levels has been reported as 78 to 157 ng/mL of plasma, and 70 to 229 ng/mL of whole blood.
60 mcg/100 mL. Thyroid function is a more realistic indicator of iodine requirements, with the protein-bound iodine (PBI) or butanol Micro+® TE Pediatric _ Product Monograph Page 6 of 22 extractable iodine (BEI) of the serum corresponding reasonably well with the level of thyroid activity; limits of normality have been placed at 3-8 mcg/100 mL of serum.
Iodine is not recommended for routine daily dosing in pediatric patients above 3 kg. Micro+ TE Pediatric should […]
Micro+ TE Pediatric should be stopped if manganese and copper levels rise to the potentially toxic range. Administration of copper to patients with cholestasis and or cirrhosis may cause accumulation hepatic of copper. Administration of copper to patients with Wilson disease (defect in the metabolism of copper transport) may cause both increased hepatic accumulation of copper and aggravation of the hepatocellular degeneration.
If the patient develops any signs or symptoms of hepatobiliary disease during administration of Micro+ TE Pediatric, verify the serum concentration of copper and ceruloplasmin as well as the concentration of manganese in whole blood.
The use of individual trace element products should be considered in these patients. Renal The possibility of zinc retention should be a consideration in patients with renal dysfunction and caution should be exercised since zinc is excreted via the kidneys.
The possibility of selenium retention should be considered in patients with renal dysfunction and/or gastrointestinal malfunction since selenium is eliminated in the urine and to a smaller extent in the feces. Because iodide is mostly eliminated in the urine, iodine may accumulate to toxic levels in patients with renal dysfunction.
Consideration should be given to other sources of iodine, such as topical disinfectants or coastal air, as iodine is absorbed through the skin and mucous membranes. 1 Pregnant and/or breastfeeding women Micro+ TE Pediatric is intended for use in children.
Animal reproduction studies or clinical investigations during pregnancy have not been carried out with Micro+ TE Pediatric. The Healthcare professionals should carefully consider the potential risks and benefits of each patient before prescribing this product.
2 Geriatrics Micro+ TE Pediatric is intended for use in children. The Healthcare professionals should carefully consider the potential risks and benefits of each patient before prescribing this product.