Peditrace
Generic name: zinc, copper, manganese, selenium, fluorine, and iodine
Dosage form: injection, solution
Drug class:Intravenous nutritional products
Medically reviewed by Drugs.com. Last updated on Apr 21, 2022.
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1 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of Peditrace contains:
Active ingredientsQuantity
Zinc chloride 521 µg
Copper chloride 2H2O 53.7 µg
Manganese chloride 4H2O 3.60 µg
Sodium selenite anhydrous 4.38 µg
Sodium fluoride 126 µg
Potassium iodide 1.31 µg
The active ingredients in 1 ml of Peditrace correspond to
Zn 250 µg 3.82 µmol
Cu 20 µg 0.315 µmol
Mn 1 µg 18.2 nmol
Se 2 µg 25.3 nmol
F 57 µg 3.00 µmol
I 1 µg 7.88 nmol
The contents of sodium and potassium correspond to
Sodium 70 µg 3.05 µmol
Potassium 0.31 µg 7.88 nmol
For excipients, see 5.1.
PRODUCT PROPERTIES
• Osmolality 38 mosm/kg water
• pH: 2.0
2 PHARMACEUTICAL FORM
Concentrate for solution for infusion
3 CLINICAL PARTICULARS
3.1 Therapeutic indications
Peditrace is indicated in premature and full-term infants and children needing intravenous nutrition to supply the basal requirements of trace elements.
3.2 Posology and method of administration
Peditrace must not be given undiluted.
The recommended dose is 1 ml Peditrace/kg body weight/day for infants and children with a weight of up to 15 kg. The basic requirements of trace elements are covered by a daily dose of 15 ml to children weighing more than 15 kg.
3.3 Contraindications
Wilson’s Disease.
3.4 Special warnings and special precautions for use
Peditrace should be used with caution in patients with impaired biliary and/or renal function, in whom the excretion of trace elements may be significantly decreased.
Peditrace should also be used with caution in patients with biochemical or clinical evidence of liver dysfunction (especially cholestasis).
If the treatment is continued for more than 4 weeks, checking of manganese levels is required.
Patients with increased losses or requiring prolonged intravenous nutrition should be monitored biochemically to confirm the requirements are being met appropriately.
3.5 Interaction with other medicinal products and other forms of interaction
No interactions with other drugs have been observed.
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