Peditrace

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Peditrace
concentrate for solution for infusion
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse immediately. See section 4.

Table of Contents

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

1. What Peditrace is and what it is used for

Peditrace is a mixture of trace elements (present in the body in very small amounts), such as: zinc, copper, manganese, selenium, fluoride, and iodine. Peditrace is administered intravenously by infusion.
The amount of trace elements contained in the medicine is similar to that provided by food.
After intravenous administration, the trace elements in Peditrace undergo similar processes in the body as those derived from food.

Indications:
Peditrace is indicated in preterm infants, full-term newborns, and children requiring parenteral nutrition. Peditrace is administered to maintain or replenish trace element levels in the body. It meets the body's basic requirements for trace elements.

2. Important information before using Peditrace

When not to use Peditrace
Do not use the medicine:

• if the patient has Wilson's disease (a hereditary disorder of copper metabolism in the body leading to liver damage).

Warnings and precautions
Before starting treatment with Peditrace, discuss this with the doctor or nurse.
The medicine should be administered with caution if:

• the patient has disorders of bile secretion and (or) impaired kidney function, as excretion of trace elements may be significantly reduced,
• the patient has impaired liver function (especially with impaired bile secretion). If treatment lasts longer than 4 weeks, the doctor may order blood tests to determine manganese concentration. In patients with excessive losses (e.g. blood, fluids) or requiring long-term parenteral nutrition,

the doctor may order regular monitoring of blood levels of trace elements.
This is necessary to determine the body's requirement for these elements.
Peditrace and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
No interactions between Peditrace and other medicines have been reported.
Pregnancy and breastfeeding
This information does not apply to Peditrace, as the medicine is intended for use in children.
Driving and operating machinery
Not applicable.

3. How to use Peditrace

This medicine is administered exclusively by medical personnel.
The medicine must not be self-administered.
In case of any doubts, consult a doctor.
The dosage is determined individually by the doctor for each patient depending on age, body weight,
and requirements for trace elements.
The duration of intravenous infusion should not be shorter than 8 hours. The medicine must be administered very slowly.
Administration of a higher than recommended dose of Peditrace
If a higher than recommended dose of Peditrace is administered, inform the doctor or nurse immediately.
In patients with impaired biliary excretion or impaired kidney function, there is an increased risk of accumulation of trace elements in tissues.
In case of any further doubts regarding the use of this medicine, consult a doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
There are no reports of adverse reactions related to the trace elements contained
in the medicine Peditrace.
After intravenous administration of a glucose solution containing the medicine Peditrace, thrombophlebitis has been observed (inflammation and small blood clots, manifested by palpable vein hardening, redness around the vein, pain, and tenderness). However, it cannot be determined whether this was caused by the administration of Peditrace or not.
After local administration of iodine, some patients may experience allergic reactions. Peditrace contains potassium iodide. However, no adverse reactions have been observed after intravenous administration of iodides (including potassium iodide) at recommended doses.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Peditrace

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not freeze. Protect from light.
Once opened, the container must not be stored. Any unused portion of the medicine is not suitable
for further use.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Do not use this medicine if solid particles are observed in it.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Peditrace contains

• The active substances in the medicine are: zinc chloride, copper(II) chloride dihydrate, manganese(II) chloride tetrahydrate, sodium selenite pentahydrate, sodium fluoride, potassium iodide.

1 ml of concentrate contains:
zinc chloride 521 μg
copper(II) chloride dihydrate 53.7 μg
manganese(II) chloride tetrahydrate 3.60 μg
sodium selenite pentahydrate 6.66 μg
sodium fluoride 126 μg
potassium iodide 1.31 μg

This corresponds to:
Zn 250 μg 3.82 μmol
Cu 20 μg 0.315 μmol
Mn 1 μg 18.2 nmol
Se 2 μg 25.3 nmol
F 57 μg 3.00 μmol
I 1 μg 7.88 nmol

Contents corresponding to sodium and potassium:
sodium 70 μg 3.05 μmol
potassium 0.31 μg 7.88 nmol

• Other components: hydrochloric acid, water for injections.

The osmolality of the concentrate is: 38 mOsm/kg water, pH: 2.0.
What Peditrace looks like and contents of the pack
The medicine is a concentrate for solution for infusion.
The medicine is packed in polypropylene vials containing 10 ml of concentrate, packed 10 units per cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Greece, country of export:
Fresenius Kabi Hellas A.E.
L. Mesogeion 354, 15341
Agia Paraskevi, Attica, Greece
Manufacturer:
Fresenius Kabi Norge AS
Svinesundsveien 80, NO-1788 Halden, Norway
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76, 03-301 Warsaw, Poland
Marketing authorisation number in Greece, country of export: 38032/10/18-04-2011
Parallel import authorisation number: 365/19

Information intended exclusively for healthcare professionals:

Dosage and administration
Peditrace must not be administered without prior dilution.
Dosage is determined individually by the physician for each patient depending on age, body weight, and requirements for trace elements.
Infants and children up to 15 kg:
1 ml of Peditrace per kg body weight per day.
The basic requirement for trace elements in children weighing over 15 kg is met by a daily dose of 15 ml.
Method of administration
Intravenous infusion.
The infusion time should not be shorter than 8 hours. The infusion must be administered very slowly.

Overdose
In patients with impaired biliary excretion or renal dysfunction, there is an increased risk of tissue accumulation of trace elements.

Preparation of the medicinal product for administration
When mixing Peditrace with other medicinal products, aseptic techniques must be observed.
Any unused portion of the medicinal product is unsuitable for further use.

Pharmaceutical incompatibilities
Peditrace may be mixed or co-administered only with medicinal products with which compatibility has been confirmed.

Added medicinal products
To 100 ml of Vaminolact, Vamin 14 Electrolyte-Free, or glucose solution (50–500 mg/ml), no more than 6 ml of Peditrace may be added.

Stability
Whenever substances are added to an infusion solution, the infusion must be completed within 24 hours after preparation to avoid microbiological contamination.
The contents of opened vials that remain unused must be discarded and must not be stored for later use.
Data on stability and pharmaceutical compatibility with parenteral nutrition products are available upon request from the marketing authorization holder.

Storage conditions
After opening, the packaging must not be stored.
Any unused portion of the medicinal product is unsuitable for further use.
Store below 25°C. Do not freeze. Protect from light.

Disposal of unused medicinal product or waste
Any unused residues of the medicinal product or waste materials must be disposed of in accordance with local regulations.