Package leaflet: Information for the patient

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 carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it 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. This medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Dipeptiven is and what it is used for
Important information before using Dipeptiven
How to use Dipeptiven
Possible side effects
How to store Dipeptiven
Contents of the pack and other information

1. What Dipeptiven is and what it is used for

Dipeptiven is a protein-containing medicinal product used 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 impaired liver or kidney function;
if the patient has metabolic acidosis – low blood pH;
if the patient is allergic to the active substance or to any of the other components 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 administration to the patient.
Warnings and precautions
Before starting treatment with Dipeptiven, discuss this with the doctor or nurse.
The doctor may recommend regular blood tests for patients receiving Dipeptiven to monitor health status and confirm the proper effect of the medicine. Experience with the use of Dipeptiven for periods longer than nine days is currently limited.
Dipeptiven and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
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 by intravenous infusion into a central or peripheral vein (intravenous drip).
The dosage is determined individually by the doctor for each patient, based on body weight in kilograms, capacity to metabolize 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, 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 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 this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables further collection of information on the safety of using this medicinal product.
5. How to store Dipeptiven
Keep the medicinal product out of sight and reach of children.
The doctor or nurse is responsible for ensuring appropriate storage, use and disposal of Dipeptiven. Do not store above 25°C. After opening: use immediately. Store in the original packaging. Any unused portion of the medicinal product is not suitable for further use. Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicinal products must not be disposed of via the sewage system or household waste bins. Ask your pharmacist how to dispose of medicinal products no longer in use. Such measures will help protect the environment.

6. Contents of the package and other information

What Dipeptiven contains
50 ml of Dipeptiven contains:
10 g of N(2)-L-alanyl-L-glutamine (= 4.1 g of L-alanine and 6.73 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 packed in a colourless glass bottle of type II with a rubber stopper.
Pack size: 50 ml.
For further information, please contact the responsible party or the parallel importer.

Responsible party in Greece, 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

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

Authorisation number in Greece, country of export: 16113/05-03-2012
Parallel import authorisation number: 5/22

Information intended exclusively for medical professionals:

Warnings and precautions for use
Liver function parameters should be systematically monitored 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 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 a central vein.

Adults
Dipeptiven is used in parenteral or 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 must not be exceeded. The content of alanine and glutamine in Dipeptiven must be accounted for 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.
Dipeptiven must be mixed before administration with a compatible amino acid solution or a nutrient 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, e.g., by mixing it before administration with a compatible amino acid solution or a nutrient mixture containing amino acids.
The infusion rate depends on the type of carrier solution and should be adjusted according to the proportions of parenteral and enteral nutrition.

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

Disposal of unused 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 of the medicinal product 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
The product should be used immediately after opening the bottle.
Dipeptiven must not be stored after mixing with other components.