Peditrace

Package leaflet: Information for the user

Warning! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Peditrace
concentrate for solution for infusion
Please read the entire leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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, fluorine, and iodine. The medicine is administered intravenously by infusion.
The amount of trace elements contained in the medicine is similar to that provided through nutrition.
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. It 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 (an inherited 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).

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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 blood tests to monitor trace element concentrations.
This is necessary to determine the body's requirements for these trace 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 this 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.
Peditrace 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 requirement for trace elements.
The duration of intravenous infusion should not be shorter than 8 hours.
The medicine must be administered very slowly.
Use of a higher than recommended dose of Peditrace
If a higher than recommended dose of Peditrace has been 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 everybody will experience them.
There are no reports of adverse reactions related to the trace elements contained in
Peditrace.
After intravenous administration of a glucose solution containing Peditrace, thrombophlebitis (inflammation and small blood clots characterized by palpable vein hardening, redness around the vein, pain and tenderness) has been observed. However, it cannot be determined whether this was caused by the administration of Peditrace or not.
Following 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.
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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
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Peditrace

Keep the 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 packaging. 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. Such measures help protect the environment.

6. Contents of the packaging and other information

What Peditrace contains

• The active substances 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

Which 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 of sodium and potassium correspond to:
sodium 70 μg 3.05 μmol
potassium 0.31 μg 7.88 nmol
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• Other components 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
Peditrace is a concentrate for solution for infusion.
The packaging consists of vials made of plastic material containing 10 ml of concentrate, packed 10 vials 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 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
Poland

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

Marketing Authorisation Number in Greece, country of export: 297/8-11-2002
38032/10/18-04-2011
Parallel Import Authorisation Number: 813/12
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Information intended exclusively for medical professionals:

Dosage and method of administration
Peditrace must not be administered undiluted.
Dosage must be individually determined by a physician for each patient depending on age, body weight, and trace element requirements.
Infants and children up to 15 kg
1 ml of Peditrace per kg of body weight per day.
The basic daily requirement of trace elements in children weighing over 15 kg is met by a 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 function disorders, there is an increased risk of tissue accumulation of trace elements.
Preparation of the medicinal product for use
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 administered only with those medicinal products with which compatibility has been confirmed.
Added medicinal products
No more than 6 ml of Peditrace may be added to 100 ml of Vaminolact, Vamin 14 Electrolyte-Free, or glucose solution (50–500 mg/ml).
Stability
When any substances are added to the infusion solution, the infusion must be completed within 24 hours after preparation to avoid microbiological contamination.
Any unused content of opened vials must be discarded and must not be stored for later use.
Shelf life and storage conditions
After opening, the packaging must not be stored.
Any unused portion of the medicinal product is unsuitable for further use.
Shelf life: 3 years.
Store below 25°C. Do not freeze. Protect from light.
Disposal of unused medicinal product
Any unused residues of the medicinal product or waste material must be disposed of in accordance with local regulations.
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