PEDITRACE

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Peditrace

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml of Peditrace contains:

Active Ingredients

Quantity

Zinc Chloride

521 µg

Copper Chloride 2H

53.7 µg

Manganese Chloride 4 H

0 3.60 µg

Sodium Selenite anhydrous 4.38 µg

Sodium Fluoride

126 µg

Potassium Iodide

1.31 µg

The active ingredients in 1 ml correspond to

250 µg

3.82 µmol

20 µg

0.315 µmol

1 µg

18.2

nmol

2 µg

25.3

nmol

57 µg

3.00

µmol

1 µg

7.88

nmol

Product Properties

Osmolality:

38 mosm/kg water

3

PHARMACEUTICAL FORM

Concentrate for solution for infusion.

4 CLINICAL PARTICULARS

4.1

Therapeutic indications

Peditrace is indicated to meet the basal requirement of trace elements during intravenous

nutrition of infants and children.

4.2

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.

4.3

Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section

6.1.

Wilson’s disease.

4.4

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

develops.

4.5.

Interactions with other Medicaments and other forms of Interaction

No interactions with other drugs have been observed.

4.6

Fertility, pregnancy and lactation

Not relevant.

4.7

Effects on ability to drive and use machines

Not relevant.

4.8

Undesirable effects

Impaired renal or hepatic excretion may lead to chronic overdose of one or more trace

elements.

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: drugsafety@neopharmgroup.com

4.9. Overdose

In recommended doses Peditrace supplies trace elements at the level of normal daily

requirements.

Acute

Acute overdose of these trace elements is unlikely to be hazardous.

Chronic

Chronic overdose of manganese has been recorded as causing Parkinsonism and

psychosis.

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.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

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

to patient.

5.2.

Pharmacokinetic Properties

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.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Hydrochloric acid

Water for injections

6.2.

Incompatibilities

Do not add drugs with Peditrace to infusion solution unless the compatibility profile

is satisfactory.

Do not add Peditrace to infusion solutions other than those recommended unless the

compatibility profile is satisfactory.

6.3.

Shelf Life

The expiry date of the product is indicated on the packaging materials.

6.4.

Special Precautions for Storage

Do not freeze. Store below 25°C.

6.5.

Nature and Contents of Container

Polypropylene plastic vial with rubber stopper.

Pack sizes: 10 x 10 ml

6.6

Special precautions for disposal

Compatibility

Additions should be made aseptically.

Additions

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).

Infusion time

The infusion time should not be less than 8 hours. The infusion should be given at a very

slow rate.

Stability

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.

7

MANUFACTURER

Fresenius Kabi AB, Uppsala, Sweden

8

REGISTRATION HOLDER

Cure Medical & Technical Supply Ltd, Hashiloach 6, P.O.B. 3340, Petach Tikva.

9 REGISTRATION NUMBER(S)

104-30-28847

The content of this leaflet was revised in October 2020.