Israel - English - Ministry of Health
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of Peditrace contains:
Copper Chloride 2H
Manganese Chloride 4 H
0 3.60 µg
Sodium Selenite anhydrous 4.38 µg
The active ingredients in 1 ml correspond to
38 mosm/kg water
Concentrate for solution for infusion.
4 CLINICAL PARTICULARS
Peditrace is indicated to meet the basal requirement of trace elements during intravenous
nutrition of infants and children.
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.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section
Special warnings and precautions for use
Administration should be carried out under specialist surveillance, especially in patients
with pre-existing imbalances, in renal failure or in hepatic disease. Peditrace should be
used with caution in conditions where excretion in the bile is reduced, particularly when
cholestatic liver disease is present and/or when urinary excretion is markedly reduced.
Patients with such conditions require careful biochemical monitoring as the excretion of
trace elements may also be significantly decreased.
Patients requiring long term total parenteral nutrition (TPN) (defined as longer than one
month) should have a baseline whole blood or serum manganese level within or below
the normal range and normal liver function before receiving Peditrace.
Manganese levels and liver function should be monitored regularly (monthly) while the
patient is maintained on Peditrace.
Peditrace should be stopped if manganese levels rise into the potentially toxic range
(please refer to appropriate reference ranges for the testing laboratory), or if cholestasis
Interactions with other Medicaments and other forms of Interaction
No interactions with other drugs have been observed.
Fertility, pregnancy and lactation
Effects on ability to drive and use machines
Impaired renal or hepatic excretion may lead to chronic overdose of one or more trace
Reporting of suspected adverse reactions
Side effects can be reported to the Ministry of Health by clicking on the link “Report Side
Effects of Drug Treatment” that appears on the homepage of the Ministry of Health’s
website (www.health.gov.il) which links to an online form for reporting side effects, or
by following this link: https://sideeffects.health.gov.il
and by emailing the Registration
Holder's Patient Safety Unit at: email@example.com
In recommended doses Peditrace supplies trace elements at the level of normal daily
Acute overdose of these trace elements is unlikely to be hazardous.
Chronic overdose of manganese has been recorded as causing Parkinsonism and
Chronic overdosage may very rarely occur secondary to an unsuspected idiosyncratic
deficiency in metabolism or excretion for a specific trace element. In this case, signs
may be observed such as nail dystrophy with insidious onset of symptoms secondary to
haematological changes or tissue deposition. Diagnosis would be confirmed by
biochemical and haematological tests and treatment should be withdrawal of Peditrace.
Pharmacotherapeutic group: Combination of electrolytes, Electrolytes in combination
with other drugs
ATC code: B05XA30, B05XA31
Peditrace is a concentrated trace element solution formulated to cover the requirements
of neonates and infants receiving total parenteral nutrition. Potassium magnesium and
calcium are not included in the formulation as individual requirements vary from patient
The trace elements in Peditrace, infused in physiological amounts, should be utilised in
the same way as elements absorbed from an oral diet. Copper and manganese are
normally excreted via the bile, whereas selenium and zinc (especially in patients
receiving intravenous nutrition) are mainly excreted via the urine.
No pharmacokinetic studies with Peditrace have been performed.
5.3. Preclinical Safety Data
No toxic effects were observed during the pre-clinical studies.
List of excipients
Water for injections
Do not add drugs with Peditrace to infusion solution unless the compatibility profile
Do not add Peditrace to infusion solutions other than those recommended unless the
compatibility profile is satisfactory.
The expiry date of the product is indicated on the packaging materials.
Special Precautions for Storage
Do not freeze. Store below 25°C.
Nature and Contents of Container
Polypropylene plastic vial with rubber stopper.
Pack sizes: 10 x 10 ml
Special precautions for disposal
Additions should be made aseptically.
Up to 6 ml Peditrace can be added to 100 ml Vaminolact, Vamin 9 Electrolyte Free,
Vamin 14 Electrolyte Free or glucose solution (50-500 mg/ml).
The infusion time should not be less than 8 hours. The infusion should be given at a very
When additions are made to an infusion solution, the infusion should be completed within
24 hours from preparation to prevent microbiological contamination. The left-over
contents of opened bottles/vials/ampoules should be discarded and not kept for later use.
Fresenius Kabi AB, Uppsala, Sweden
Cure Medical & Technical Supply Ltd, Hashiloach 6, P.O.B. 3340, Petach Tikva.
9 REGISTRATION NUMBER(S)
The content of this leaflet was revised in October 2020.