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Peditrace

Peditrace

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig
/
The Glory Medicina
Full Prescribing Info
Contents
Trace elements.
Description
Each 1-mL solution contains zinc chloride 521 mcg, copper chloride·2H20 53.7 mcg, manganese chloride·4H20 3.6 mcg, anhydrous sodium selenite 4.38 mcg, sodium fluoride 126 mcg, potassium iodide 1.31 mcg, HCl to pH 2 and water for injections to 1 mL.
Peditrace is a sterile solution containing trace elements for addition to amino acid solution or glucose solution (see Compatibility under Dosage & Administration) in the parenteral nutrition of premature and full-term infants and children.
The content of trace elements in Peditrace is as follows: See Table 1.

Click on icon to see table/diagram/image

Osmolality: 38 mOsmol/kg water. pH: 2.
Indications/Uses
Peditrace is intended to meet the basal requirement of trace elements during IV nutrition of infants and children.
Peditrace is a trace element additive solution for pediatric patients on total parenteral nutrition.
Dosage/Direction for Use
Peditrace must not be given undiluted.
The basal requirements for infants and children of the included trace elements are met by Peditrace 1mL/kg body weight/day to a maximum dose of 15 mL.
A daily dose of  Peditrace 15mL should also meet the basic needs of trace elements in children weighing >15 kg. Patients with increased losses or requiring prolonged IV nutrition should be monitored biochemically to confirm that requirements are being appropriately met.
Peditrace can be added to either an amino acid solution or glucose solution and given during a minimum infusion period of 8 hrs.
Some paediatric admixtures with Peditrace are tested and found compatible (see as follows).
The infusion should be given at a very slow rate and is best done with an appropriate pump or an automatic drop rate counter.
Compatibility: Up to 6 mL of Peditrace can be added to 100 mL of Vaminolact, Vamin 14 EF or glucose solution (50-500 mg/mL). When Peditrace is administered as an admixture (see Table 2) only admixtures in which compatibility has been documented are to be used.
The addition of Peditrace must be done aseptically. To minimize the risk of infection, the infusate should be used within 24 hrs.
Addition of other drugs must be avoided due to the risk of incompatibilities.
Admixtures compatible with Peditrace: See Table 2.

Click on icon to see table/diagram/image
The admixtures must be compounded using strict aseptic techniques and in aseptic working conditions to prevent bacterial contamination. These admixtures will remain stable when stored for up to 6 days at 5±3°C followed by 24 hrs at 25±5°C.
Contraindications
Wilson's disease.
Special Precautions
Peditrace should be used with caution when the excretion in bile is reduced, particularly in cholestatic liver disease or when the urinary excretion is markedly reduced. Such patients require careful biochemical monitoring.
Copper and manganese are normally excreted via the bile, whereas selenium and zinc (especially in patients receiving IV nutrition) are mainly excreted via the urine. If the treatment is continued for >4 weeks, control of manganese level is required.
Storage
Do not store above 25°C. Do not freeze.
MIMS Class
Parenteral Nutritional Products
ATC Classification
B05XA30 - combinations of electrolytes ; Belongs to the class of electrolyte solutions used in I.V. solutions.
Presentation/Packing
Form
Peditrace conc for soln for infusion
Packing/Price
10 mL x 10 × 1's
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