Dipeptiven

Package leaflet: Information for the patient

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

• Keep this leaflet, so that it can be read again if necessary.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

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
Talk to your doctor or nurse before starting treatment with Dipeptiven.
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 longer than nine days is currently limited.
Dipeptiven and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned to be used.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child,
she should consult her 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 by infusion into a central or peripheral vein (intravenous infusion).
The dosage is determined individually by the doctor for each patient according to body weight
calculated per kilogram, the ability to metabolize nutrients, and the requirement
for amino acids.
The doctor decides the dose to be administered to a given patient.
Administration of a higher than recommended dose of Dipeptiven
The doctor or nurse will monitor the patient's condition during the infusion, so 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 the doctor or nurse.

4. Possible adverse effects

Not known when the medicinal product is administered according to recommendations.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects
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, tel.: + 48 22 49 21 301,
fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects enables the collection of further information on the safety of the medicinal product.

5. How to store Dipeptiven

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

6. Contents of the pack and other information

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

What Dipeptiven looks like and contents of the pack
Dipeptiven is a clear, colourless solution. The medicinal product is supplied in a colourless glass bottle of type II, fitted with a rubber stopper and a ring for hanging the bottle, packed in a cardboard box.
Pack size: 100 ml.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Bulgaria, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

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

Marketing Authorisation Number in Bulgaria, country of export: 20020591
Parallel Import Authorisation Number: 265/23

Information intended exclusively for medical professionals:

Warnings and precautions for use
It is recommended to systematically monitor liver function parameters 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 accepted as 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 must 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 amino acid/protein requirements.
During parenteral/enteral nutrition, the maximum daily dose of 2 g of amino acids/protein per kilogram of body weight must 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/kg body weight per hour.
Before administration, Dipeptiven must be mixed with a compatible amino acid solution or a nutritive mixture containing amino acids.

Patients receiving enteral nutrition
Dipeptiven should be administered by continuous infusion over 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 during 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 treatment
The duration of treatment should not exceed 3 weeks.

Disposal of unused medicinal product
The container and solution should be inspected before use. Use only clear solutions free from particulate matter and from undamaged containers. For single use only. Any unused portion must not be retained for later use.

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

Storage conditions
Dipeptiven should be used immediately after opening the vial.
Dipeptiven must not be stored after mixing with other components.