JUNYELT CONCENTRATE FOR

Posology Preterm, and term newborns, infants and children (weighing 20 kg or less): Basal requirements of the included trace elements are covered by 1 mL of JUNYELT per kg body weight per day to a maximum daily dose of 20 ml.

Children (weighing more than 20 kg):

A daily dose of 20 ml JUNYELT should meet basal trace element requirements. JUNYELT should be supplemented with a single zinc injectable solution in case of administration to preterm infants to reach a total zinc parenteral intake of 450-500 μg/kg/day.

A daily iron infusion is recommended when preterm infants are receiving long term parenteral nutrition (> 3 weeks), and molybdenum add-on in case of parenteral nutrition > 4 weeks.

Method of administration Intravenous route:

JUNYELT is not intended to be administered in its current presentation. It should be diluted according to the final desired osmolarity. For instructions on dose adjustments in specific patient groups, see section

The following adverse reaction(s) have been reported during post-marketing experience of trace element solutions. The frequency is not known (cannot be estimated from the available data). System organ class (SOC) MedDRA Preferred Term GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain at the application site Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme. uk/yellowcard

4. 6. 3 Contraindications − Patients with known hypersensitivity to one of the actives substances and to the excipients. − In case of Wilson’s disease and if serum concentrations of any of the trace elements contained in JUNYELT are elevated.

4 Special warnings and precautions for use The solution should be used after an accurate control of the patient clinical and biological parameters. In paediatrics, individual trace element requirements may vary based on factors such as age, weight, underlying disease state and duration of parenteral nutrition.

Blood manganese levels should be regularly monitored in case of prolonged artificial nutrition. A dose reduction may be necessary or infusion of JUNYELT should be stopped if manganese levels rise into the potentially toxic range (please refer to appropriate reference ranges).

The occurrence of neurological signs must evoke the possibility of a manganese overdose. Particular attention must be paid when the product is given to patients with reduced biliary excretion, since this could interfere with the biliary elimination of manganese, copper and zinc, leading to accumulation and overdose.

Copper overdose must be considered in the presence of nausea, vomiting, gastralgia. In patients with hepatic impairments or mild cholestasis the posology should be adapted. Besides, in case of pronounced cholestasis blood copper levels and hepatobiliary parameters should be monitored.

JUNYELT should be used with caution in patients with impaired renal function, as excretion of some trace elements (selenium and zinc) may be significantly decreased, leading to accumulation and overdose. In patients with renal impairments, the posology should be adapted.

JUNYELT should be used with caution in patients with manifest hyperthyroidism. In patients undergoing medium to long-term parenteral nutrition, there is an increased frequency of copper, zinc and selenium deficiency. In such circumstances, when necessary, the dosage should be adapted with the use of an extra supply of solutions, which contain only these individual components.

Because of a risk of precipitation, drugs or electrolytes should not be added to JUNYELT before the later has been diluted. The compatibility profile of infusion solutions administered through the same line should be verified. No adjustment of JUNYELT is required in case of additional intake of iodine through iodine-based antiseptic.

− Patients with known hypersensitivity to one of the actives substances and to the excipients. − In case of Wilson’s disease and if serum concentrations of any of the trace elements contained in JUNYELT are elevated.