Tracutil

• Read the entire instruction leaflet before using the medicine.
• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you need advice or further information.
• This medicine has been prescribed for a specific individual and should not be passed on to others, as it may harm them even if their symptoms are the same.

Tracutil concentrate for solution for infusion
Excipients: hydrochloric acid 6 M, water for injections

Highest theoretical osmolarity: approx. 90 mOsm/l
pH 1.7 – 2.3
Packaging:
5 vials of 10 ml
50 vials of 10 ml
Marketing Authorization Holder Manufacturer
B. Braun Melsungen AG B. Braun Melsungen AG
Carl-Braun-Straße 1 Mistelweg 2-6
34212 Melsungen 12357 Berlin
Germany Germany

Leaflet Contents

1. What Tracutil is and what it is used for
2. Before you use Tracutil
3. How to use Tracutil
4. Possible side effects
5. How to store Tracutil
6. Further information

1. What Tracutil is and what it is used for

Medicinal product form
Concentrate for solution for infusion in glass vials; content: 10 ml.
Therapeutic indications
Component added to intravenous solutions for the supplementation of trace elements.
Indications
Tracutil is used as a component of parenteral nutrition providing trace elements for adult patients.

2. Before using Tracutil

Contraindications
Tracutil must not be administered to newborns, infants, and children (due to the lack of specific studies).
Severe cholestasis, i.e. impaired bile secretion (characteristic results of certain blood laboratory tests: serum bilirubin concentration > 140 mmol/l and increased activity of gamma-glutamyltransferase and alkaline phosphatase).
Hypersensitivity to any of the components of Tracutil.
Wilson's disease (copper metabolism disorder) and iron storage disorders (e.g. hemosiderosis or hemochromatosis).

Warnings and precautions
In case of prolonged parenteral nutrition, blood manganese levels should be monitored. If excessive accumulation of manganese is detected, dose reduction or discontinuation of Tracutil infusion may be necessary. The treating physician will order appropriate blood laboratory tests.
Tracutil should be used with caution in patients with impaired liver function, which may interfere with biliary excretion of manganese, copper, and zinc, leading to their accumulation and overdose.
The product should also be used with caution in patients with renal insufficiency, which may significantly limit the excretion of certain trace elements (selenium, fluoride, chromium, molybdenum, and zinc).
To prevent iron overload, which primarily affects patients with impaired liver function and those receiving blood transfusions, serum ferritin levels should be measured at regular intervals.
Patients receiving long- and medium-term parenteral nutrition often develop deficiencies in zinc and selenium. In such cases, especially when hypercatabolism is present due to extensive injuries, major surgery, burns, etc., the dose should be adjusted as needed and additional supplementation of deficient trace elements should be provided.
Tracutil should be administered cautiously in patients with diagnosed hyperthyroidism or iodine sensitivity, particularly when other medicinal products containing iodine are administered concomitantly (e.g. antiseptic agents containing iodine).
Chromium deficiency leads to reduced glucose tolerance; glucose tolerance improves with chromium supplementation. In diabetic patients receiving insulin, relative insulin overdose may occur, leading to hypoglycemia. Therefore, blood glucose levels should be monitored and insulin doses adjusted as necessary.

Pregnancy and breastfeeding
Before using any medication, consult a physician.
There are no data available on the safety of Tracutil during pregnancy and lactation. Therefore, this product should not be used during pregnancy and breastfeeding unless the expected benefits have been weighed against the potential risks.

Driving and operating machinery
Not applicable – the medication is administered to patients undergoing hospital treatment.

Use with other medicinal products
Tracutil must not be added to alkaline solutions with high buffering capacity, e.g. sodium bicarbonate solutions.
Do not add to fat emulsions.
The degradation of vitamin C in infusion solutions is accelerated in the presence of trace elements.
Tracutil should be diluted by adding at least 250 milliliters of 5%, 10%, 20%, 40%, or 50% glucose solution or an electrolyte solution, e.g. 0.9% sodium chloride or Ringer's solution.
The addition of the diluent should be performed under strictly aseptic conditions.
Tracutil must not be used as a diluent for other medications.
Compatibility with solutions administered simultaneously through a common access line should be verified.
Administration should be completed within 24 hours.
Tracutil must not be added directly to inorganic phosphate solutions (additive to nutritional mixtures). When adding to complete nutritional mixtures containing inorganic phosphates, consultation with the manufacturer is recommended.
Complete information on incompatibilities is not available. Further information may be obtained from the manufacturer.

3. How to use Tracutil

Dosage and method of administration
For adults only.
Recommended dosage regimen
The recommended daily dose for patients with basic requirements is 10 ml (1 ampoule).
For patients with moderately increased requirements, the daily dose may be increased to
20 ml (2 ampoules), with simultaneous monitoring of trace element status.
In cases of significantly increased demand for trace elements (e.g. extensive burns,
severe hypercatabolism in patients with multiple injuries), higher doses may be required.
Dosage in patients with impaired liver and/or kidney function should be determined individually.
Such patients may require reduced doses.
Administration may continue throughout the entire period of parenteral nutrition.

Method of administration
The trace element concentrate Tracutil must be administered intravenously only after dilution
by adding to at least 250 ml of an appropriate infusion solution, such as:

• glucose solutions (e.g. 5% or 10%),
• electrolyte solutions (e.g. 0.9% sodium chloride, Ringer's solution).
  Compatibility must be checked before adding to other infusion solutions.
  The infusion of the ready-to-use mixture should last no less than 6 hours and must be completed within 24 hours.

Note:
Diarrhea may lead to increased intestinal loss of zinc. In such cases, serum concentrations should be monitored.
Deficiencies of individual trace elements should be corrected by specific supplementation.

In case of overdose
Overdose of Tracutil is highly unlikely, as the amount of trace elements in one ampoule is considerably lower than known toxic levels. In case of suspected overdose, administration of the product should be discontinued. Overdose can be confirmed by appropriate laboratory tests.

4. Possible adverse reactions

Like all medicines, Tracutil can cause adverse reactions, although not everyone will experience them.
Life-threatening anaphylactic reactions to parenterally administered iron have been reported.
Iodine may cause allergic reactions.

Warning
The patient should inform their doctor or pharmacist if severe or any other adverse reactions not described in this leaflet occur.

Reporting suspected adverse reactions
After a medicinal product has been authorized, it is important to report suspected adverse reactions. This enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report all suspected adverse reactions through the Department of Monitoring Adverse Drug Reactions at 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 adverse reactions helps collect further information on the safety of this medicine.

5. Storage of Tracutil Medicinal Product

Store below 25°C and protect from light.
Expiry date
Do not use this product after the expiry date stated on the label.
Instructions for use and handling
Tracutil must be diluted by adding at least 250 millilitres of 5%, 10%, 20%, 40%, or 50% glucose solution, or electrolyte solutions such as 0.9% sodium chloride or Ringer's solution.
The diluent should be added under strictly aseptic conditions.
Tracutil must not be used as a diluent for other medicinal products.
Compatibility with other solutions administered simultaneously through a common infusion line must be verified.
Administration should be completed within 24 hours.
Tracutil must not be added directly to inorganic phosphate solutions (additive to parenteral nutrition mixtures). When adding to complete nutritional mixtures containing inorganic phosphates, consult the manufacturer.
Complete information on incompatibilities is not available. Further information may be obtained from the manufacturer.
Storage period after first opening of the container
Storage period after dilution or reconstitution according to instructions
The chemically and physically confirmed stability of the solution during use is 24 hours at 25°C.
From a microbiological point of view, the product should be used immediately. If the product is not used immediately, responsibility for the storage duration and conditions prior to use lies with the healthcare personnel administering the product. The storage time should not exceed 24 hours at 2–8°C, unless dilution was performed under controlled, validated aseptic conditions.

6. Other information

For more detailed information, please contact the representative of the marketing authorisation holder:
Poland
Aesculap Chifa Sp. z o.o.
Tysiąclecia 14 Street
64-300 Nowy Tomyśl
tel. (0-61) 44 20 100
Date of preparation of the leaflet: 2023-04-21