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 (occurring 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 in food.
After intravenous administration, the trace elements in the medicine undergo similar processes to those from food.
Indications for use:
Peditrace is indicated for preterm infants, full-term newborns, and children requiring intravenous 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 administered 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).

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If treatment lasts longer than 4 weeks, your doctor may order a blood test to determine the manganese concentration.
In patients with excessive losses (e.g., blood, fluids) or requiring long-term intravenous nutrition, your doctor may order regular blood tests to determine the concentration of trace elements.
This is necessary to determine the body's need 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 interaction between Peditrace and other medicines has been found.

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 exclusively 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 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 in Peditrace.
After administration of the glucose solution containing Peditrace into peripheral veins, superficial vein thrombophlebitis (formation of inflammation and small blood clots, manifested by 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.
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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
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Peditrace

Store the medicine out of 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 month stated.
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
Cu
Mn
Se
F
I
μmol
μmol
nmol
nmol
μmol
nmol
The sodium and potassium content corresponds to:
sodium
potassium
250
20
1
2
57
1
μg
μg
μg
μg
μg
μg
3.82
0.315
18.2
25.3
3.00
7.88
μmol
nmol
70
0.31
μg
μg
3.05
7.88
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• 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 contents of the pack

The medicine is a concentrate for solution for infusion.
The packaging of the medicine is plastic 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 Ag. Paraskevi, Attica Greece

Manufacturer:

Fresenius Kabi Norge AS
Svinesundsveien 80
17 53 Halden
Norway

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Greece, the country of export:
297/8-11-2002
38032/10/18-04-2011

Parallel import authorization number: 813/12 Date of approval of the leaflet: 22.11.2022

[Information on the reserved trademark]
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Information intended exclusively for healthcare professionals:

Dosage and administration

Undiluted Peditrace must not be administered.
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.
Method of administration
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 tissues.

Preparation of the medicine for use

When mixing Peditrace with other medicines, aseptic rules must be followed.
Unused medicine is not suitable for further use.

Incompatibilities

Peditrace can be mixed or administered only with those medicines with which compatibility has been confirmed.
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 case where substances are added to the solution intended for infusion, the infusion should be completed within 24 hours of preparing the solution to avoid microbial contamination.
Unused contents of opened vials must be discarded, and it is not allowed to store them for further use.

Shelf life and storage conditions

After opening, the packaging cannot be stored.
Unused medicine is not suitable for further use.
Shelf life: 3 years.
Store in a temperature below 25°C. Do not freeze. Protect from light.

Disposal of unused medicine

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