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-glutamine
Please read the entire leaflet carefully before use, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor, pharmacist, or nurse.
If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents

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 administered intravenously, used as a component of parenteral (intravenous) and/or enteral 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 is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6); symptoms of an allergic reaction may include high temperature, chills, rash or shortness of breath;
if the patient has impaired liver or kidney function;
if the patient has metabolic acidosis – a condition in which blood pH is low;
if the patient is in circulatory shock – a condition in which blood flow is reduced;
if the patient is hypoxic – a condition in which oxygen levels in the body are reduced;
if the patient has multi-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
being 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.
Patients receiving Dipeptiven may require regular blood tests ordered by the doctor
to monitor health status and confirm the proper effect of Dipeptiven.
Experience with the use of Dipeptiven for longer 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 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 her doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy and while breastfeeding.
Driving and using machines
Dipeptiven has no effect 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 according to body weight
in kilograms, 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, 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 you have any further doubts regarding the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
They are not known when the medicine is administered according to recommendations.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting adverse reactions, additional information regarding the safety of the medicine can be collected.

5. How to store the medicine Dipeptiven

The medicine should be stored out of sight and reach of children.
The doctor or nurse is responsible for ensuring appropriate storage, use, and disposal of the medicine Dipeptiven.
Store below 25°C 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 packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will 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 medicine is packed in a transparent glass bottle within a cardboard box.
Pack size: 100 ml.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation Holder in Romania, country of export:
Fresenius Kabi AB
Rapsgatan 7
SE-751 74 Uppsala
Sweden

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 Romania, country of export: 6104/2014/02
Parallel import authorisation number: 79/21

Information intended exclusively for medical professionals:

Warnings and precautions for use
To ensure safe administration of Dipeptiven, the maximum daily dose of 2.5 ml/kg body weight (corresponding to 0.5 g of N(2)-L-alanyl-L-glutamine) must not be exceeded. Dipeptiven should be used exclusively as part of clinical nutrition, and dosing should be adjusted according to the required amount of protein/amino acids to be supplied. Dipeptiven must not be administered if the patient's clinical condition does not allow for clinical nutrition (e.g. circulatory shock, hypoxia, critically ill unstable patients, severe metabolic acidosis).
When calculating the recommended dose of Dipeptiven, the amount of glutamine contained in oral/enteral products administered concomitantly with parenteral nutrition should be taken into account.
Regular monitoring of liver function parameters is recommended in patients with stable liver insufficiency.
Serum electrolyte concentrations, serum osmolarity, fluid balance, acid-base balance, creatinine clearance, urea concentration, as well as liver function tests (alkaline phosphatase, ALT, AST) and potential signs 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 status of peripheral veins.
Experience with the use of Dipeptiven for periods longer than nine days is 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 a central vein.

Adult patients
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 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.

Parenterally fed patients
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.

Enterally fed patients
Dipeptiven should be administered by continuous infusion lasting 20 to 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 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 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.

Compatibility
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.

Shelf-life
The product should be used immediately after opening the vial.

Shelf-life after mixing
Dipeptiven must not be stored after mixing with other components.