Dipeptiven

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Dipeptiven

200 mg/ml, concentrate for solution for infusion

N(2)-L-alanyl-L-glutaminum

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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Dipeptiven and what is it used for
• 2. Important information before using Dipeptiven
• 3. How to use Dipeptiven
• 4. Possible side effects
• 5. How to store Dipeptiven
• 6. Package contents and other information

1. What is Dipeptiven and what is it used for

Dipeptiven is a medicine containing a protein compound, administered intravenously as a component of clinical parenteral and/or enteral nutrition, along with salts, trace elements, and vitamins.

2. Important information before using Dipeptiven

When not to use Dipeptiven

Do not use the medicine:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6), symptoms of an allergic reaction may include high fever, chills, rash, or shortness of breath;
• if the patient has liver or kidney function disorders;
• if the patient has metabolic acidosis - a condition in which the blood has a low pH;
• if the patient is in circulatory shock - a condition in which blood flow is reduced;
• if the patient is hypoxic - a condition in which the oxygen level in the body is reduced;
• if the patient has multiple organ failure - a condition in which two or more organs do not function properly;
• if the patient is pregnant or breastfeeding.

Dipeptiven must be diluted before administration.Dipeptiven is added to another solution administered to the patient. The doctor or nurse will ensure the proper preparation of the solution with Dipeptiven before administering it to the patient.

Warnings and precautions

Before starting to use Dipeptiven, discuss it with your doctor or nurse. In patients using Dipeptiven, the doctor may order regular blood tests to check the patient's health and confirm the proper functioning of Dipeptiven. Experience with the use of Dipeptiven for more than nine days is limited.

Dipeptiven 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.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. The medicine should not be used during pregnancy and breastfeeding.

Driving and using machines

Dipeptiven has no effect on the ability to drive and use machines.

3. How to use Dipeptiven

This medicine is administered by infusion into a central or peripheral vein (intravenous drip). The dosage is determined by the doctor individually for each patient, depending on their body weight in kilograms and the ability to break down nutritional components and the need for amino acids. The doctor decides on the size of the dose used in a given patient.

Using a higher dose of Dipeptiven than recommended

The doctor or nurse will monitor the patient's condition during the infusion, so there is little likelihood of administering a higher dose than recommended. However, if the patient believes they have received a higher dose of Dipeptiven than recommended, they should immediately inform their doctor or nurse. Symptoms of overdose may include chills, nausea, and vomiting. In case of any further doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, Dipeptiven can cause side effects, although not everybody gets them. They are not known if the medicine is used as recommended.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 side effects, more information can be collected on the safety of the medicine.

5. How to store Dipeptiven

The medicine should be stored out of sight and reach of children.

The doctor or nurse is responsible for ensuring the proper storage, use, and disposal of Dipeptiven. Store below 25°C. After opening: use immediately. Store in the original packaging. 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 given month. Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Dipeptiven contains

100 ml of Dipeptiven contains: 20 g of N(2)-L-alanyl-L-glutamine (= 8.2 g L-alanine and 13.46 g L-glutamine). The other ingredient is water for injections.

What Dipeptiven looks like and what the package contains

Dipeptiven is a clear, colorless solution. The packaging of the medicine is a type II colorless glass bottle with a rubber stopper. Package size: 100 ml. For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Fresenius Kabi Deutschland GmbH, Else-Kroner-Strasse 1, D-61346 Bad Homburg v.d.H., Germany

Manufacturer:

Fresenius Kabi Austria GmbH, Hafnerstrasse 36, A-8055 Graz, Austria

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Bulgaria export permit number: 20020591

Parallel import permit number: 171/20

Date of leaflet approval: 23.06.2025

[Information on the trademark]

Information intended only for healthcare professionals:

Warnings and precautions for use

To ensure safe administration of Dipeptiven, do not exceed the maximum daily dose of 2.5 ml/kg body weight per day (equivalent to 0.5 g N(2)-L-alanyl-L-glutamine). Dipeptiven should be used only as part of clinical nutrition, and its dosage should be adjusted according to the amount of protein/amino acids required. If the patient's clinical condition does not allow for clinical nutrition (e.g., circulatory shock, hypoxia, unstable critically ill patients, severe metabolic acidosis), Dipeptiven should not be administered. When calculating the recommended dose of Dipeptiven, consider the amount of glutamine contained in oral/enteral products taken in combination with parenteral nutrition. It is recommended to regularly monitor liver function tests in patients with stabilized liver failure. Monitor serum electrolyte levels, serum osmolality, water balance, acid-base balance, creatinine clearance, urea levels, as well as liver function tests (alkaline phosphatase, ALT, AST) and potential symptoms of hyperammonemia. The choice of peripheral or central vein depends on the final osmolality of the mixture. Generally, an osmolality of approximately 800 mOsm/l is considered the upper limit for peripheral infusion, but this value varies greatly depending on the patient's age and overall condition, as well as the condition of the peripheral veins. Experience with the use of Dipeptiven for more than nine days is limited.

Dosage and administration

Infusion solution obtained after mixing Dipeptiven with a pharmaceutically compatible solution. Solutions with an osmolality above 800 mOsm/l should be administered into a central vein. Adult patients: Dipeptiven is used in parenteral or enteral nutrition, or in both parenteral and enteral nutrition. The dosage depends on the severity of the catabolic state and the need for amino acids/protein. During parenteral/enteral nutrition, do not exceed the maximum daily dose of 2 g amino acids/protein per kilogram body weight. In calculations, consider the content of alanine and glutamine in Dipeptiven. The proportion of amino acids from Dipeptiven should not exceed approximately 30% of the total amino acid/protein intake. Dipeptiven is a concentrate for solution for infusion and is not intended for direct administration. Patients receiving parenteral nutrition: The infusion rate depends on the type of carrier solution and should not exceed 0.1 g amino acids/kg body weight per hour. Dipeptiven should be mixed with a compatible amino acid solution or nutritional mixture containing amino acids before administration. Patients receiving enteral nutrition: Dipeptiven should be administered in continuous infusion lasting from 20 to 24 hours a day. During infusion into peripheral veins, Dipeptiven should be diluted to achieve an osmolality ≤ 800 mOsm/l (e.g., 100 ml Dipeptiven + 100 ml physiological saline solution). Patients receiving both enteral and parenteral nutrition: The total daily dose of Dipeptiven should be administered in parenteral nutrition, e.g., by mixing before administration with a compatible amino acid solution or nutritional mixture containing amino acids. The infusion rate depends on the type of carrier solution and should be adjusted according to the proportion of parenteral and enteral nutrition. Duration of use: The duration of use should not exceed 3 weeks.

Disposal of leftover medicine

Examine the container and solution before use. Use only a clear solution free from solid particles, from an undamaged container. For single use only. Unused leftover medicine is not suitable for further use.

Compatibility

The addition of the concentrate to the carrier solution should be performed under aseptic conditions, before administration to the patient. Ensure thorough mixing and pharmaceutical compatibility.

Shelf life

The medicine should be used immediately after opening the bottle.

Shelf life after mixing

Dipeptiven should not be stored after mixing with other components.