Peditrace

Package Leaflet: Information for the User

Peditrace

Concentrate for Solution for Infusion

Read the Package Leaflet Carefully Before Using the Medicinal Product

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet

• 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 medicinal product is administered by intravenous infusion. The amount of trace elements in the medicinal product is similar to the amount provided by food. After intravenous administration, the trace elements in the medicinal product undergo similar processes to those from food. Indications for use: Peditrace is indicated for preterm infants, full-term newborns, and children requiring parenteral nutrition. The medicinal product 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 medicinal product:

• if you have 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 medicinal product should be administered with caution if:

• you have bile secretion disorders and/or kidney function disorders, as the elimination of trace elements may be significantly reduced,
• you have liver function disorders (especially with impaired bile secretion).

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 parenteral 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 Medicinal Products

Tell your doctor or pharmacist about all the medicinal products you are taking or have recently taken, as well as any medicinal products you plan to take. No interaction between Peditrace and other medicinal products has been reported.

Pregnancy and Breast-Feeding

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 medicinal product is administered exclusively by medical personnel. Do not use the medicinal product yourself. If you have any doubts, ask your doctor. The dosage is determined by your 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 medicinal product should be administered very slowly.

Using More than the Recommended Dose of Peditrace

If you have used more than the recommended dose of the medicinal product, 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 medicinal product, ask your doctor or nurse.

4. Possible Side Effects

Like all medicinal products, 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 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 the recommended doses.

Reporting Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to Store Peditrace

Keep the medicinal product out of the sight and reach of children. Store in a temperature below 25°C. Do not freeze. The packaging should not be stored after opening. Unused medicinal product is not suitable for further use. Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Do not use this medicinal product if you notice any solid particles in it. Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Peditrace Contains

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

1 ml of the concentrate contains:
zinc chloride
copper(II) chloride dihydrate
manganese(II) chloride tetrahydrate
sodium selenite anhydrous
sodium fluoride
potassium iodide
521 μg
53.7 μg
3.60 μg
4.38 μg
126 μg
1.31 μg
This corresponds to:
Zn
Cu
Mn
Se
F
I
μmol
μmol
nmol
nmol
μmol
nmol
250
20
1
2
57
1
μg
μg
μg
μg
μg
μg
3.82
0.315
18.2
25.3
3.00
7.88
The sodium and potassium content corresponds to:
sodium
potassium
μmol
nmol

• 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 medicinal product is a concentrate for solution for infusion. The packaging of the medicinal product is a polypropylene vial containing 10 ml of the concentrate, packed in a cardboard box of 10.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi AB
S-751 74 Uppsala
Sweden

Manufacturer

HP Halden Pharma AS
Svinesundsveien 80
1788 Halden
Norway
For more detailed information, please contact the representative of the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89
Date of Last Revision of the Package Leaflet:01.03.2024
70
0.31
μg
μg
3.05
7.88

Information Intended for Healthcare Professionals Only:

Dosage and Administration

Undiluted Peditrace must not be administered. The dosage is determined by your 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 more than 15 kg is met by a daily dose of 15 ml. 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 Medicinal Product for Administration

When mixing Peditrace with other medicinal products, aseptic techniques should be followed. Unused medicinal product is not suitable for further use.

Incompatibilities

Peditrace can only be mixed or administered with medicinal products that have been proven to be compatible. Added medicinal products: Up to 100 ml of Vaminolact, Vamin 14 Electrolyte-Free, or glucose solution (50-500 mg/ml) can be added with no more than 6 ml of Peditrace. Stability: If any substances are added to the infusion solution, the infusion should be completed within 24 hours of preparation to avoid microbial contamination. Unused contents of opened vials should be discarded and not stored for further use. Data on stability and compatibility with medicinal products used for parenteral nutrition are available upon request from the representative of the marketing authorization holder.

Storage Conditions

The packaging should not be stored after opening. Unused medicinal product is not suitable for further use. Store in a temperature below 25°C. Do not freeze.

Disposal of Unused Medicinal Product

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