Kidtrayze

Package leaflet: Information for the user

Kidtrayze concentrate for solution for infusion

Read this entire leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If the child experiences any side effects, including those not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of this leaflet

1. What Kidtrayze is and what it is used for
2. What you need to know before using Kidtrayze
3. How to use Kidtrayze
4. Possible side effects
5. How to store Kidtrayze
6. Contents of the pack and other information

1. What Kidtrayze is and what it is used for

Kidtrayze is a mixture of trace elements administered into the bloodstream by infusion (intravenous infusion). Kidtrayze contains five trace elements (zinc, copper, manganese, selenium and iodine) in very small amounts which are normally absorbed from food. These trace elements are necessary for normal body function.
Kidtrayze is used to meet the basic requirements of trace elements in term and preterm neonates, infants, children and adolescents who cannot eat or absorb sufficient food via tube feeding and therefore require food to be infused into their vein (called parenteral nutrition or intravenous nutrition). Kidtrayze is added to parenteral nutrition solutions containing all the nutrients the body needs.

2. What you need to know before using Kidtrayze

Do not use Kidtrayze if the child:

• is allergic (hypersensitive) to the active substances or to any of the other components of this medicine (listed in section 6)
• has Wilson's disease.

Warnings and precautions
Consult a doctor before using Kidtrayze if the child has:

• Kidney problems
• Liver problems
• Reduced biliary excretion
• Thyroid problems (hyperthyroidism)

The levels of trace elements in the blood will be monitored regularly by the doctor during treatment. The doctor will adjust the dosage of Kidtrayze accordingly.
Children and adolescents
Kidtrayze is intended for preterm and term newborns, infants, children, and adolescents.
Other medicines and Kidtrayze
Inform the doctor if the child is currently taking, has recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, consult your doctor before using Kidtrayze.
Kidtrayze contains sodium and potassium
Kidtrayze contains less than 1 mmol of sodium (23 mg) per 10 ml vial, i.e. essentially "sodium-free".
Kidtrayze contains less than 1 mmol of potassium (39 mg) per 10 ml vial, i.e. essentially "potassium-free".

3. How to use Kidtrayze

Kidtrayze will be administered to the child by intravenous infusion (into the bloodstream via an intravenous drip) by a healthcare professional. Kidtrayze will always be administered diluted in another solution for parenteral nutrition.
The doctor will determine the individual dose for the child based on body weight and function.
Daily iron infusion is recommended when parenteral nutrition is administered for more than 3 weeks, and molybdenum should be infused additionally when parenteral nutrition is administered for more than 4 weeks.
If more Kidtrayze is given than should be
It is unlikely that the child will receive an excessive amount of Kidtrayze, as the infusion will be monitored by a healthcare professional. If you think the child has received too much Kidtrayze, inform the doctor.
If you have any questions about the use of this medicine, consult the doctor or nurse.

4. Possible side effects

No side effects have been reported.
Reporting of suspected adverse reactions
If the child experiences any side effects, including those not listed in this leaflet, consult a doctor, pharmacist, or nurse.
You may also report side effects directly through the national reporting system available at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kidtrayze

Keep this medicine out of sight and reach of children.
Do not store above 25°C. Do not freeze.
Do not use this medicine if you notice any visible signs of deterioration.
Do not use this medicine after the expiry date stated on the carton and on the vial label
after EXP. The expiry date refers to the last day of that month.
Stability after reconstitution
Physico-chemical stability after reconstitution has been demonstrated for up to 7 days at 2°-8°C followed by 48 hours at 20-
25°C, including the duration of administration.
From a microbiological point of view, the product should be used immediately. If not used immediately, the storage time during use and the conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2-8°C.

6. Contents of the package and other information

What Kidtrayze contains
The active substances are:

The active substances in 1 ml of Kidtrayze correspond to:
Zinc (Zn) 7.64 micromoles 500 micrograms
Copper (Cu) 0.630 micromoles 40.0 micrograms
Manganese (Mn) 0.0182 micromoles 1.00 microgram
Selenium (Se) 0.0887 micromoles 7.00 micrograms
Iodine (I) 0.0155 micromoles 1.96 micrograms

Other components:
Hydrochloric acid (for pH adjustment)
Water for injections

Description of the appearance of Kidtrayze and contents of the pack
Kidtrayze, concentrate for solution for infusion, is clear and almost colourless. It is supplied in transparent polypropylene vials of 10 ml.

Pack sizes:
20 x 10 ml in a box

Marketing Authorisation Holder and Manufacturer
Responsible manufacturer for batch release:
HP Halden Pharma AS
Svinesundsveien 80
1788 Halden
Norway

Marketing Authorisation Holder:
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala – Verona
Italy

This medicinal product is authorised in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:

This leaflet was last reviewed on
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The following information is intended for medical or healthcare professionals only:
Special warnings and precautions for use
Kidtrayze should be used with caution in patients with impaired renal function, in whom excretion of selenium, zinc and iodine may be significantly reduced. There is an increased risk of trace element accumulation in these patients.

Kidtrayze should be used with caution in patients with hepatic dysfunction (especially cholestasis), in whom excretion of copper and manganese may be reduced.
In patients with impaired biliary excretion, elimination of manganese, copper and zinc may be reduced.
Clinical signs of trace element accumulation may require dose reduction or discontinuation of Kidtrayze in these patients.

Dose adjustments may be necessary in patients with impaired renal function and impaired hepatic function or mild cholestasis.

Kidtrayze should be used with caution in patients with hyperthyroidism. In these patients, iodine may exacerbate symptoms of hyperthyroidism (e.g. goitre).

No adjustment of Kidtrayze dosage is required in case of additional iodine intake from iodine-based antiseptics.

Long-term parenteral nutrition
In patients receiving long-term parenteral nutrition, accumulation of trace elements may occur, particularly of manganese. If treatment is continued for more than 4 weeks, manganese levels should be monitored. The appearance of neurological signs (e.g. anxiety, rapid eye movements) may indicate possible manganese overload, which may also result from certain medical conditions and parenteral nutrition. Manganese accumulation may require dose reduction or discontinuation of Kidtrayze.
In patients receiving long-term parenteral nutrition, deficiency of trace elements may occur, particularly of copper, zinc and selenium. In case of deficiency, these individual trace elements should be supplemented separately.

Dosage
Preterm neonates:
A recommended maximum daily dose of 1.0 ml of Kidtrayze per kg body weight meets the basic requirements of the included trace elements.

Term neonates, infants and children weighing less than 20 kg:
A recommended maximum daily dose of 0.5 ml of Kidtrayze per kg body weight meets the basic requirements of the included trace elements.

A recommended maximum daily dose of 10 ml of Kidtrayze meets the basic requirements of the included trace elements.

The following trace elements are contained in 0.5 ml, 1.0 ml, and 10 ml of Kidtrayze:

In addition to the trace elements contained in Kidtrayze, daily iron infusions are recommended if patients receive parenteral nutrition for more than 3 weeks. Addition of molybdenum to parenteral nutrition is recommended if patients receive parenteral nutrition for more than 4 weeks.
Method of administration
Kidtrayze must not be administered undiluted. Kidtrayze must be administered by intravenous infusion, diluted in a parenteral nutrition solution/emulsion. The rate and duration of infusion are determined by the rate and duration of infusion of the parenteral nutrition solution.
Kidtrayze may only be mixed with other nutrition products for which compatibility has been documented; see the section on compatibility below.
Special precautions for disposal and handling
Before use, visually inspect the concentrate for infusion solution to ensure it is clear and free from particles.
Compatibility
Dilute before use.
Kidtrayze is used as an additive to parenteral nutrition mixtures with which compatibility data are available.
Compatibility studies are available with the branded products Aminoven Infant, Vaminolact, Vamin 14 EF, Vamin 18 EF, SMOFlipid, Intralipid, Vitalipid N Adults, Vitalipid N Children, Soluvit N, Addiphos and Glycophos in defined quantities, combined with generic glucose and electrolytes at defined concentrations. Kidtrayze may also be added to SmofKabiven and SmofKabiven without electrolytes with or without Vitalipid N Children/Adults, Soluvit N and electrolytes.
Generated data support additions according to the summary table below:

Kidtrayze should never be added directly to a lipid emulsion due to destabilizing effects. It is recommended to first mix the macronutrients (amino acid solution and glucose, with or without lipid emulsion) before adding the micronutrients. Additions must be performed aseptically.
Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.
Stability after mixing
Stability after mixing
Physicochemical stability after mixing (see section on compatibility) has been demonstrated for up to 7 days at 2°-8°C followed by 48 hours at 20-25°C, including administration duration.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage time and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2-8°C.