Peditrace 1 mL Intravenous solution

PEDITRACE is indicated to meet the basal requirement of trace elements during intravenous nutrition of premature and full term infants.

Posology
The basal requirements for infants (<15 kg in weight) of the included trace elements are met by 1 mL of PEDITRACE per kg body weight per day to a maximum dose of 15 mL. The efficacy of a daily dose of 15 mL PEDITRACE in children weighing more than 15 kg has not been established and regular monitoring of trace element plasma levels is recommended. Up to 6 mL PEDITRACE can be added to 100 mL of a glucose solution (50 u2013 500 mg/mL) and given during a minimum infusion period of 8 hours. The infusion should be given at a very slow rate and is best done with an appropriate pump or an automatic drop rate counter.
Method of administration
Intravenous infusion. PEDITRACE must not be given undiluted. For instructions on dilution of the product before administration, see section 6.6.

PEDITRACE is contraindicated in:
u2022 Patients with hypersensitivity to any of the active ingredients or to the excipients in PEDITRACE (see section 6.1).
u2022 Persons allergic to iodine.
u2022 Wilsonu2019s disease.
u2022 This supplement should be withheld when cholestatic liver disease is present.

The safety of PEDITRACE in patients with renal or hepatic impairment has not been established. PEDITRACE should be used with caution in patients with impaired biliary and/or renal function. Considerable caution is required in administering PEDITRACE solution to patients with impaired biliary excretion, or compromised liver function, as copper and manganese are normally excreted via the bile. PEDITRACE should also be used with caution in patients with biochemical or clinical evidence of liver dysfunction. Lower dosages should be given when there is impaired renal function. Such patients require careful biochemical monitoring. Selenium and zinc are mainly excreted via the urine. 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 that the requirements are being met appropriately.

PEDITRACE contains sodium and potassium
PEDITRACE contains less than 1 mmol sodium (23 mg) per 10 mL solution, i.e., essentially u2018sodium-freeu2019. PEDITRACE contains less than 1 mmol potassium (39 mg) per 10 mL solution, i.e., essentially u2018potassium-freeu2019.

Concurrent administration of zinc salt with penicillamine might diminish the effect of penicillamine. Corticosteroids in excess, increase urinary copper excretion.

Pregnancy
No data available.
Breastfeeding
No data available.
Fertility
No data available.

No data available.

Tabulated list of adverse reactions
System organ class Frequency unknown (cannot be estimated from the available data)
Immune system disorders Allergic reactions - may include urticaria, angioedema, cutaneous haemorrhage or purpuras, fever, arthralgia, lymphadenopathy and eosinophilia.
Endocrine disorders Goitre, hypothyroidism, hyperthyroidism.
Vascular disorders Superficial thrombophlebitis has been observed when glucose containing PEDITRACE was administered. However, it is not possible to deduce whether this reaction is attributable to the trace elements infusion or not.
General disorders and administration site conditions Prolonged administration of iodine may lead to iodism.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website. Healthcare providers are asked to report any suspected adverse drug reactions to the Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicines regulatory authority in the country where the product is marketed.

Chronic excessive exposure to manganese is associated with severe extrapyramidal neurological disease. Iodine excess may cause hypothyroidism. Prolonged use of zinc may lead to copper deficiency and anaemia. Selenium toxicity may lead to weakness, anorexia, tremors and sweating. In patients with impaired renal or biliary function, there is an increased risk for accumulation of trace elements. In case of a chronic overload of iron there is a risk of haemosiderosis, which can be treated by venesection in severe and rare cases. Treatment is symptomatic and supportive. When overdosage occurs treatment should be withdrawn.