Tracutil

PATIENT INFORMATION LEAFLET

• The contents of the leaflet should be read before using the medicine
• This leaflet should be kept in case it needs to be read again
• A doctor or pharmacist should be consulted if advice or additional information is needed
• This medicine has been prescribed specifically for one person and should not be given to others, as it may harm them, even if their symptoms are the same

Tracutilconcentrate for solution for infusion
Excipients: hydrochloric acid 6 M, water for injections
Maximum theoretical osmolality:
approx. 90 mOsm/l
pH
1.7 – 2.3

Packaging:

5 ampoules of 10 ml
50 ampoules of 10 ml

Marketing Authorisation Holder

Manufacturer

• B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen Germany B.Braun Melsungen AG Mistelweg 2-6 12357 Berlin Germany

Table of contents of the leaflet

• 1. What is Tracutil and what is it used for
• 2. Before using Tracutil
• 3. How to use Tracutil
• 4. Possible side effects
• 5. Storage of Tracutil
• 6. Other information

1. What is Tracutil and what is it used for

Medicinal form

Concentrate for solution for infusion in glass ampoules; contents: 10 ml

Therapeutic indications

Component added to intravenous solutions to supplement trace elements

Indications

Tracutil is used as a component of parenteral nutrition, providing trace elements for adult patients

2. Before using Tracutil

Contraindications

Tracutil should not be administered to newborns, infants, and children (due to the lack of specific studies)
Significant cholestasis, i.e., inhibition of bile secretion (characteristic laboratory test results: bilirubin concentration in serum > 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 defect) and iron storage disorders (e.g., hemosiderosis or hemochromatosis)

Warnings and precautions

In the case of long-term artificial nutrition, the concentration of manganese in the blood should be monitored. If excessive accumulation of manganese is found, it may be necessary to reduce the dose or discontinue the infusion of Tracutil. The attending physician will order the relevant laboratory tests
Tracutil should be used with caution in patients with liver function disorders, which may disrupt the excretion of manganese, copper, and zinc with bile, leading to their accumulation and overdose
The medicine should also be used with caution in patients with renal insufficiency, which may result in significant impairment of the excretion of certain elements (selenium, fluorine, chromium, molybdenum, and zinc)
To prevent iron overload, which mainly threatens patients with liver function disorders and patients receiving blood transfusions, the concentration of ferritin in serum should be determined at regular intervals
In patients receiving parenteral nutrition for a medium and long period, deficiencies of zinc and selenium often occur. In such cases, especially when there is hypercatabolism associated with extensive injuries, severe surgery, burns, etc., the dose should be adjusted and additional supplementation of the missing elements should be ensured if necessary
Tracutil should be administered with caution to patients with known hyperthyroidism or sensitivity to iodine, especially when other iodine-containing medicinal products are administered (e.g., iodine-containing antiseptics)
Chromium deficiency leads to decreased glucose tolerance; tolerance improves with chromium supplementation. In diabetic patients taking insulin, relative insulin overdose may occur, leading to hypoglycemia. Therefore, it is recommended to monitor blood glucose levels and adjust insulin doses if necessary

Pregnancy and breastfeeding

Before using any medicine, a doctor should be consulted
There are no data on the safety of using Tracutil during pregnancy and lactation. Therefore, this product should not be used during pregnancy and breastfeeding, unless the expected benefits outweigh the potential risks

Driving and using machines

Not applicable – the medicine is used in hospitalized patients

Interaction with other medicinal products

Tracutil should not be added to alkaline solutions with high buffering potential, e.g., sodium bicarbonate solutions
Should not be added to fat emulsions
The breakdown of vitamin C in infusion solutions is accelerated in the presence of trace elements
Tracutil should be diluted by adding at least 250 ml of a suitable infusion solution, such as glucose solutions (e.g., 5%, 10%, 20%, 40%, or 50%) or electrolyte solutions (e.g., 0.9% sodium chloride or Ringer's solution). The addition of the diluent should be carried out under strictly aseptic conditions
Tracutil should not be used as a diluent for other medicines
Compatibility with solutions administered simultaneously through a common inlet should be checked. The administration of the ready-to-use mixture should not be shorter than 6 hours and should be completed within 24 hours
Tracutil should not be added directly to inorganic phosphate solutions (addition to nutritional mixtures). When adding to complete nutritional mixtures containing inorganic phosphates, the manufacturer should be consulted
Full information on incompatibilities is not available. More information can be obtained from the manufacturer

3. How to use Tracutil

Dosage and 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 the trace element status
In cases of significantly increased requirements for trace elements (e.g., extensive burns, severe hypercatabolism in patients with multiple injuries), higher doses may be necessary
Doses for patients with liver and/or kidney function disorders should be determined individually. Such patients may require reduced doses
Administration can be continued throughout the period of parenteral nutrition
Administration method
Tracutil trace element concentrate should be administered intravenously only after dilution by adding at least 250 ml of a suitable infusion solution, such as glucose solutions (e.g., 5% or 10%) or electrolyte solutions (e.g., 0.9% sodium chloride or Ringer's solution). Before adding to other infusion solutions, compatibility should be checked. The infusion of the ready-to-use mixture should not be shorter than 6 hours and should be completed within 24 hours

• glucose solutions (e.g., 5% or 10%),
• electrolyte solutions (e.g., 0.9% sodium chloride or Ringer's solution)

Note:
Diarrhea may lead to increased loss of zinc through the gastrointestinal tract. In such cases, blood levels should be monitored
Deficiencies of individual trace elements should be corrected by specific supplementation

Overdose

Overdose of Tracutil is very unlikely, as the amount of trace elements in an ampoule is much lower than the known toxic values. If overdose is suspected, administration should be discontinued. Overdose can be confirmed by relevant laboratory tests

4. Possible side effects

Like all medicines, Tracutil can cause side effects, although not everybody gets them
There have been reports of life-threatening anaphylactic reactions to intravenous iron administration
Iodine may cause allergic reactions
Note
The patient should inform the doctor or pharmacist if they experience intensified or other side effects not described in this leaflet

Reporting suspected adverse reactions

After the medicinal product has been placed on the market, it is important to report suspected adverse reactions. This allows for the continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje 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 to gather more information on the safety of this medicine

5. Storage of Tracutil

Store below 25°C, protect from light

Shelf life

The product should not be used after the expiry date stated on the label

Instructions for use and handling

Tracutil should be diluted by adding at least 250 ml of glucose solution 5%, 10%, 20%, 40%, or 50%, or electrolyte solutions, e.g., 0.9% sodium chloride or Ringer's solution. The addition of the diluent should be carried out under strictly aseptic conditions. Tracutil should not be used as a diluent for other medicines. Compatibility with solutions administered simultaneously through a common inlet should be checked. Administration should be completed within 24 hours. Tracutil should not be added directly to inorganic phosphate solutions (addition to nutritional mixtures). When adding to complete nutritional mixtures containing inorganic phosphates, the manufacturer should be consulted. Full information on incompatibilities is not available. More information can be obtained from the manufacturer

Shelf life after first opening of the package

Shelf life after dilution or reconstitution according to the instructions

The confirmed period of chemical and physical 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, the responsibility for the storage time and conditions before use lies with the healthcare professional. The storage time should not exceed 24 hours at a temperature between 2°C and 8°C, unless the dilution was carried out under controlled, validated aseptic conditions

6. Other information

For more detailed information, please contact the representative of the marketing authorization holder:

Poland

Aesculap Chifa Sp. z o.o. ul. Tysiąclecia 14

64-300 Nowy Tomyśl tel. (0-61) 44 20 100

Date of preparation of the leaflet: 2023-04-21