Dipeptiven

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Dipeptiven, 200 mg/ml, concentrate for solution for infusion
N(2)-L-alanyl-L-glutamine
Please read the following information carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Dipeptiven is and what it is used for
2. Important information before using Dipeptiven
3. How to use Dipeptiven
4. Possible side effects
5. How to store Dipeptiven
6. Contents of the pack and other information

1. What Dipeptiven is and what it is used for

Dipeptiven is a medicinal product containing a protein compound, administered intravenously as a component of parenteral and (or) enteral clinical nutrition, together with electrolytes, trace elements, and vitamins.

2. Important information before using Dipeptiven

When not to use Dipeptiven
Do not use the medicine:

• if the patient has liver or kidney function disorders;
• if the patient has metabolic acidosis - low blood pH;
• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• 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 proper preparation of the solution
containing Dipeptiven before administering it to the patient.
Warnings and precautions
Before starting treatment with Dipeptiven, discuss this with the doctor or nurse.
In patients receiving Dipeptiven, the doctor may order regular blood tests
to monitor health status and confirm the proper effect of Dipeptiven.
Experience with the use of Dipeptiven for periods longer than nine days is currently limited.
Dipeptiven and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient intends to take.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy and while breastfeeding.
Driving and operating machinery
Dipeptiven has no influence on the ability to drive or operate machinery.

3. How to use Dipeptiven

This medicine is administered as an intravenous infusion into a central or peripheral vein (intravenous drip).
The dosage is individually determined by the doctor for each patient depending on body weight
calculated per kilogram, metabolic capacity for nutrients, and amino acid requirements.
The doctor decides the dose to be administered to a given patient.
Use of a higher than recommended dose of Dipeptiven
The doctor or nurse will monitor the patient's condition during the infusion; therefore, the likelihood of administering a higher than recommended dose is low. However, if the patient believes they have received a higher than recommended dose of Dipeptiven, they should immediately inform the doctor or nurse. Symptoms of overdose may include chills, nausea, and vomiting.
If there are any further doubts regarding the use of this medicine, consult a doctor or nurse.

4. Possible adverse reactions

Not known if the medicinal product is administered according to recommendations.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the package leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to 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, telephone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting adverse reactions, additional information on the safety of the medicinal product can be collected.

5. How to store Dipeptiven

Keep this medicine out of sight and reach of children.
Your doctor or nurse is responsible for ensuring the proper storage, use, and disposal of Dipeptiven.
Do not store above 25°C. Store in the original packaging.
Any unused portion of the medicine must not be used later.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Dipeptiven contains
50 ml of Dipeptiven solution contains:
10 g N(2)-L-alanyl-L-glutamine (= 4.1 g L-alanine and 6.73 g L-glutamine).
The other component is water for injections.

What Dipeptiven looks like and contents of the pack
Dipeptiven is a clear, colourless solution. The medicinal product is packed in a 50 ml colourless glass bottle (type II) closed with a rubber stopper, placed in a cardboard box.

For further information, please contact the responsible entity or the parallel importer.

Marketing Authorisation Holder in Greece, the country of export:
Fresenius Kabi Hellas AE
L. Mesogeion 354
153 41 Agia Paraskevi, Attica
Greece

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

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Number in Greece, the country of export: 16113/05-03-2012
Parallel Import Licence Number: 414/22

Information intended exclusively for medical professionals:

Warnings and precautions for use
Regular monitoring of liver function parameters is recommended in patients with stable liver insufficiency.
Serum electrolyte concentrations, serum osmolarity, fluid balance, acid-base balance, liver function tests (alkaline phosphatase, AlAT, AspAT), and potential symptoms of hyperammonemia should be monitored.
The choice between peripheral or central venous administration depends on the final osmolarity of the mixture.
An osmolarity of approximately 800 mOsm/l is generally considered the upper limit for peripheral infusion; however, this value varies significantly depending on the patient's age, general condition, and the status of peripheral veins.
Experience with the use of Dipeptiven for periods longer than nine days is currently limited.

Dosage and method of administration
The infusion solution is obtained by mixing Dipeptiven with a pharmaceutically compatible solution. Solutions with an osmolarity exceeding 800 mOsm/l should be administered via central vein.
Adults
Dipeptiven is used in parenteral nutrition, enteral nutrition, or in combined parenteral and enteral nutrition. Dosage depends on the severity of the catabolic state and the requirement for amino acids/protein.
During parenteral/enteral nutrition, the maximum daily dose of 2 g of amino acids/protein per kilogram of body weight should not be exceeded. The content of alanine and glutamine in Dipeptiven must be included in these calculations. The proportion of amino acids derived from Dipeptiven should not exceed approximately 30% of the total amino acid/protein intake.
Dipeptiven is a concentrate for preparing an infusion solution 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 of amino acids per kg of body weight per hour.
Dipeptiven must be mixed before administration with a compatible amino acid solution or a nutritive mixture containing amino acids.

Patients receiving enteral nutrition
Dipeptiven should be administered as a continuous infusion lasting 20–24 hours per day.
When administered via peripheral veins, Dipeptiven must be diluted to achieve an osmolarity ≤ 800 mOsm/l (e.g., 100 mL Dipeptiven + 100 mL physiological saline solution).

Patients receiving combined enteral and parenteral nutrition
The total daily dose of Dipeptiven should be administered as part of parenteral nutrition, for example by mixing it before administration with a compatible amino acid solution or nutritive mixture containing amino acids.
The infusion rate depends on the type of carrier solution and should be adjusted according to the ratio of parenteral to enteral nutrition.

Duration of use
The duration of use should not exceed 3 weeks.

Disposal of unused medication
The container and solution should be inspected before use. Use only a clear solution free from particulate matter and from an undamaged container. For single use only. Any unused medication residue must not be retained for later use.

Pharmaceutical incompatibilities
The addition of the concentrate to the carrier solution must be performed under aseptic conditions before administration to the patient. Adequate mixing and pharmaceutical compatibility must be ensured.

Storage conditions
The product should be used immediately after opening the bottle.
Do not store Dipeptiven after mixing with other components.