Peditrace Novum

Leaflet accompanying the packaging: patient information

Peditrace Novum, concentrate for solution for infusion

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Peditrace Novum and what is it used for
• 2. Important information before using Peditrace Novum
• 3. How to use Peditrace Novum
• 4. Possible side effects
• 5. How to store Peditrace Novum
• 6. Contents of the packaging and other information

1. What is Peditrace Novum and what is it used for

Peditrace Novum is a mixture of trace elements administered to the patient in a drip (intravenous infusion). Peditrace Novum contains five trace elements (zinc, copper, manganese, selenium, and iodine) in very small amounts, which are usually supplied with food. These trace elements are essential for the proper functioning of the body.
Peditrace Novum is indicated for use as a supplement to the basic requirement for trace elements in preterm infants, full-term newborns, infants, children, and adolescents who cannot consume or absorb sufficient amounts of food through enteral nutrition, and therefore need intravenous nutrition (called parenteral nutrition). Peditrace Novum is added to parenteral nutrition containing all the nutrients the body needs.

2. Important information before using Peditrace Novum

When not to use Peditrace Novum:

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

Warnings and precautions

Before starting treatment, discuss with your doctor if the child has:

• kidney function disorders;
• liver function disorders;
• reduced bile secretion;
• thyroid function disorders (hyperthyroidism).

During treatment, the doctor will regularly check the content of trace elements in the blood and adjust the dosage of Peditrace Novum accordingly.

Children and adolescents

Peditrace Novum is intended for preterm infants, full-term newborns, infants, children, and adolescents.

Peditrace Novum and other medicines

Tell your doctor about all medicines the child is taking or has recently taken, as well as any medicines planned for the child.

Pregnancy and breastfeeding

If the adolescent patient is pregnant or breastfeeding, parents or guardians should consult a doctor or pharmacist before using this medicine.

Peditrace Novum contains sodium and potassium

Peditrace Novum contains less than 1 mmol (23 mg) of sodium per 10 mL (1 ampoule), i.e., the medicine is considered "sodium-free".
Peditrace Novum contains less than 1 mmol (39 mg) of potassium per 10 mL (1 ampoule), i.e., the medicine is considered "potassium-free".

3. How to use Peditrace Novum

The medicine is administered by medical personnel in an intravenous infusion (drip into a vein).
Peditrace Novum must always be diluted before use in another solution for parenteral nutrition.
The dosage is determined by the doctor individually for each child, depending on their weight and health condition.
In the case of parenteral nutrition lasting more than 3 weeks, it is recommended to administer iron intravenously daily, and to add molybdenum in the case of parenteral nutrition lasting more than 4 weeks.

Using a higher dose of Peditrace Novum than recommended

It is unlikely that the child will receive too high a dose of Peditrace Novum, as the administration of the medicine will be controlled by medical personnel. However, if it is suspected that the child has received too high a dose of Peditrace Novum, inform the doctor.
In case of any further doubts related to the use of this medicine, consult a doctor or nurse.

4. Possible side effects

No side effects have been reported.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, tell the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Peditrace Novum

Store the medicine out of sight and reach of children.
Do not store above 25°C. Do not freeze.
Do not use this medicine if visible signs of deterioration are observed.
Do not use this medicine after the expiry date stated on the carton and ampoule label after: EXP. The expiry date refers to the last day of the specified month.
Shelf life after mixing
Stability after mixing has been demonstrated for up to 7 days at 2-8 °C, and then 48 hours at 20-25 °C, including the infusion time. From a microbiological point of view, the medicine should be used immediately. Otherwise, the user is responsible for the storage period during use and the storage conditions before use. This period should not exceed 24 hours at 2-8 °C.

6. Contents of the packaging and other information

What Peditrace Novum contains

The active substances of the medicine are:
which corresponds to (in 1 mL):
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
The other ingredients are: hydrochloric acid (to adjust pH), water for injections.

What Peditrace Novum looks like and what the pack contains

Peditrace Novum, concentrate for solution for infusion, is a clear, almost colorless solution available in 10 mL transparent polypropylene ampoules.
Pack size:
20 x 10 mL in a carton

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi AB
751 74 Uppsala
Sweden

Manufacturer

HP Halden Pharma AS
Svinesundsveien 80
1788 Halden
Norway
To obtain more detailed information about this medicine, contact the representative of the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet:01.03.2024
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Information intended for healthcare professionals only:

Special warnings and precautions for use

Peditrace Novum should be used with caution in patients with renal impairment, in whom the excretion of selenium, zinc, and iodine in the urine may be significantly reduced. In these patients, there is an increased risk of accumulation of trace elements in the body.
Peditrace Novum should be used with caution in patients with liver function disorders (especially cholestasis), in whom the excretion of copper and manganese may be reduced.
In patients with impaired bile secretion, there may be a reduction in the elimination of manganese, copper, and zinc. Clinical symptoms of accumulation of these trace elements may require a reduction in dosage or discontinuation of Peditrace Novum in these patients.
In patients with renal and liver function disorders or in the case of mild cholestasis, dose adjustment may be necessary.
Peditrace Novum should be used with caution in patients with hyperthyroidism. In these patients, iodine may exacerbate symptoms of hyperthyroidism (e.g., goiter).
There is no need to adjust the dose of Peditrace Novum when iodine is used in addition as an antiseptic product containing iodine.
Long-term parenteral nutrition
In patients receiving parenteral nutrition for a long period, there may be an accumulation of trace elements, especially manganese. If treatment is continued for more than 4 weeks, manganese levels should be monitored. The occurrence of neurological symptoms (e.g., restlessness, rapid eye movements) may indicate possible manganese overload, which may also result from certain disease states and parenteral nutrition. Manganese accumulation may require a reduction in dosage or discontinuation of Peditrace Novum.
In patients receiving parenteral nutrition for a long time, there may be a deficiency of trace elements, especially copper, zinc, and selenium. In this case, additional supplementation should be ensured.

Dosage

Preterm infants
The recommended maximum dose of 1.0 mL of Peditrace Novum per kilogram of body weight per day meets the basic requirement for the trace elements contained in this medicine.
Full-term newborns, infants, and children with a body weight below 20 kg
The recommended maximum dose of 0.5 mL of Peditrace Novum per kilogram of body weight per day meets the basic requirement for the trace elements contained in this medicine.
Children with a body weight above 20 kg and adolescents
The recommended maximum daily dose of 10 mL of Peditrace Novum meets the basic requirement for the trace elements contained in this medicine.
In 0.5 mL, 1.0 mL, and 10 mL of Peditrace Novum, the following amounts of trace elements are present:

If the patient receives parenteral nutrition for more than 3 weeks, it is also recommended to administer iron intravenously daily. If the patient receives parenteral nutrition for more than 4 weeks, it is also recommended to add molybdenum to the parenteral nutrition.

Method of administration

Undiluted Peditrace Novum must not be used. Peditrace Novum is administered in an intravenous infusion after dilution in a solution or emulsion for parenteral nutrition. The rate and duration of the infusion depend on the rate and duration of the infusion of the parenteral nutrition solution.
Peditrace Novum can only be mixed with nutritional medicinal products for which compatibility has been demonstrated, see "Compatibility" below.

Special precautions for disposal and preparation of the medicine

Before use, check that the concentrate for solution for infusion is clear and free from particles.
Compatibility
Dilute before use.
Peditrace Novum is used as an additive to parenteral nutrition mixtures for which compatibility data are available.
Compatibility data are available for the following medicinal products: Aminoven Infant 10%, Vaminolact, Vamin 14 Electrolyte-Free, Vamin 18 Electrolyte-Free, SMOFlipid, Intralipid 20%, Vitalipid N Adult, Vitalipid N Infant, Soluvit N, ADDIPHOS, and GLYCOPHOS in specified amounts in combination with glucose and electrolyte solutions of specified concentrations. Peditrace Novum can also be added to SmofKabiven and SmofKabiven EF with or without Vitalipid N Infant/Adult, Soluvit N, and electrolytes.
Available data confirm the possibility of adding the above-mentioned medicinal products in accordance with the following table:
Peditrace Novum must never be added directly to a fat emulsion due to destabilizing effects. It is recommended to mix the macronutrients (amino acid and glucose solution with or without fat emulsion) before adding micronutrients. All additions should be made under aseptic conditions.
Any unused medicine or waste material should be disposed of in accordance with local regulations.

Shelf life after mixing

Stability after mixing (see "Compatibility") has been demonstrated for up to 7 days at 2-8 °C, and then 48 hours at 20-25 °C, including the infusion time. From a microbiological point of view, the medicine should be used immediately. Otherwise, the user is responsible for the storage period during use and the storage conditions before use. This period should not exceed 24 hours at 2-8 °C.