Peditrace
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How to use 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.
- Country of registration
- Prescription requiredNo
- Marketing authorisation holder (MAH)Fresenius Kabi Hellas A.E.
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to PeditraceDosage form: Concentrate, -Active substance: electrolytes in combination with other drugsManufacturer: Fresenius Kabi Norge ASPrescription not requiredDosage form: Concentrate, (170.1 mg + 133.5 mg + 14 mg)/mlActive substance: electrolytes in combination with other drugsPrescription not requiredDosage form: Solution, 1 g/10 mlActive substance: calcium chlorideManufacturer: Demo S.A.Prescription required
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