Peditrace

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Peditrace

Concentrate for solution for infusion

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

Peditrace is a mixture of trace elements (present in the body in very small amounts), such as zinc, copper, manganese, selenium, fluorine, and iodine. The medicine is administered by intravenous infusion.

The amount of trace elements in the medicine is similar to the amount provided by food.

After intravenous administration, the trace elements in the medicine undergo similar processes to those from food.

Indications for use:

Peditrace is indicated for premature infants, full-term newborns, and children who require parenteral nutrition. The medicine is administered to maintain or supplement the concentration of trace elements in the body. It meets the basic needs of the body 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 it with your doctor or nurse.

The medicine should be used with caution if:

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

the doctor may order regular blood tests to determine the concentration of trace elements. This is necessary to determine the body's needs for these elements.

Peditrace and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

No interactions between Peditrace and other medicines have been reported.

Pregnancy and breastfeeding

This information does not apply to Peditrace, as it is intended for use in children.

Driving and using machines

Not applicable.

3. How to use Peditrace

This medicine is administered only by medical personnel. The medicine must not be used by itself.

In case of doubts, consult your doctor.

The dosage is determined by the doctor individually for each patient, depending on age, body weight, and the need for trace elements.

The duration of intravenous infusion should not be less than 8 hours. The medicine should be administered very slowly.

Using a higher dose of Peditrace than recommended

If a higher dose of the medicine is used than recommended, tell your doctor or nurse immediately.

In patients with bile secretion disorders or kidney function disorders, there is an increased risk of accumulation of trace elements in the tissues.

If you have any further doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, Peditrace can cause side effects, although not everybody gets them.

There are no reports of side effects related to the trace elements contained in Peditrace.

After administration of a glucose solution containing Peditrace into peripheral veins, thrombophlebitis (formation of inflammation and small blood clots, manifesting as palpable hardening of the vein, redness around it, pain, and tenderness) has been observed. 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 side effects have been observed after intravenous administration of iodides (including potassium iodide) in recommended doses.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Peditrace

Keep the medicine out of the sight and reach of children.

Store in a temperature below 25°C. Do not freeze. Protect from light.

After opening, the packaging cannot be stored. Unused medicine is not suitable for further use.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.

Do not use this medicine if you notice any solid particles in it.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Peditrace contains

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

1 ml of the 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

The sodium and potassium content corresponds to:

sodium

70

μg

3.05

μmol

potassium

0.31

μg

7.88

nmol

• The other ingredients are: hydrochloric acid, water for injections.

The osmolality of the concentrate is: 38 mOsm/kg water, pH: 2.0.

What Peditrace looks like and what the pack contains

The medicine is a concentrate for solution for infusion.

The packaging of the medicine is polypropylene vials containing 10 ml of the concentrate, packed in 10 pieces in a cardboard box.

For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.

ul. Chełmżyńska 249, 04-458 Warsaw

Pharma Innovations Sp. z o.o.

ul. Jagiellońska 76, 03-301 Warsaw

Marketing authorization number in Greece, the country of export:38032/10/18-04-2011

Parallel import authorization number:365/19

Date of leaflet approval: 25.09.2024

[Information about the trademark]

Information intended exclusively for healthcare professionals:

Dosage and administration

Do not administer undiluted Peditrace.

The dosage is determined by the doctor individually for each patient, depending on age, body weight, and the need for trace elements.

Infants and children up to 15 kg:

1 ml of Peditrace per kg of body weight per day.

The basic need for trace elements in children weighing over 15 kg is met by a daily dose of 15 ml.

Administration method:

Intravenous infusion.

The duration of the infusion should not be less than 8 hours. The infusion should be performed very slowly.

Overdose

In patients with bile secretion disorders or kidney function disorders, there is an increased risk of accumulation of trace elements in the tissues.

Preparation of the medicine for use

When mixing Peditrace with other medicines, follow the rules of asepsis.

Unused medicine is not suitable for further use.

Pharmaceutical incompatibilities

Peditrace can be mixed or administered only with medicines that have been proven to be compatible.

Added medicines:

Up to 100 ml of Vaminolact, Vamin 14 Electrolyte-Free, or glucose solution (50-500 mg/ml), no more than 6 ml of Peditrace can be added.

Stability:

In the event that any substances are added to the infusion solution, the infusion should be completed within 24 hours of preparing the solution to avoid microbiological contamination.

Unused contents of opened vials should be discarded and not stored for further use.

Data on stability and pharmaceutical compatibility with medicines used for parenteral nutrition are available upon request from the marketing authorization holder.

Storage conditions

After opening, the packaging cannot be stored.

Unused medicine is not suitable for further use.

Store in a temperature below 25°C. Do not freeze. Protect from light.

Disposal of unused medicine

Any unused medicine or waste should be disposed of in accordance with local regulations.