Dipeptiven

Package Leaflet: Information for the Patient

Warning! The package leaflet must be kept. Information on the immediate packaging in a foreign language.

Dipeptiven

200 mg/ml, concentrate for solution for infusion

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

Before using the medicinal product, the patient must carefully read the package leaflet, as it contains important information for the patient.

• The patient should keep this package leaflet, so that they can read it again if necessary.
• In case of any doubts, the patient should consult a doctor, pharmacist, or nurse.
• This medicinal product has been prescribed to a specific person. It must not be given to others. The medicinal product may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

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

2. Important information before using Dipeptiven

When not to use Dipeptiven

The medicinal product must not be used:

• 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 medicinal product (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 the proper preparation of the solution with Dipeptiven before administering it to the patient.

Warnings and precautions

Before starting treatment with Dipeptiven, the patient should discuss it with their doctor or nurse.
For 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 a period longer than nine days is currently limited.

Dipeptiven and other medicinal products

The patient should inform their doctor or pharmacist about all medicinal products they are currently taking or have recently taken, as well as any medicinal products they plan to use.

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 medicinal product.
The medicinal product must 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 medicinal product 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 their ability to break down nutrients and their need for amino acids.
The doctor decides on the size of the dose used for 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 the use of this medicinal product, the patient should consult their doctor or nurse.

4. Possible side effects

None are known if the medicinal product is administered according to the recommendations.

Reporting side effects

If any side effects occur, including any side effects not listed in this package leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance of 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 side effects will help to gather more information on the safety of the medicinal product.

5. How to store Dipeptiven

The medicinal product should be stored out of sight and reach of children.

The doctor or nurse is responsible for ensuring the proper storage, administration, and disposal of Dipeptiven. Do not store above 25°C. After opening: use immediately. Store in the original packaging. Unused 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 specified month.
Medicinal products should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Dipeptiven contains

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

What Dipeptiven looks like and what the packaging contains

Dipeptiven is a clear, colorless solution. The packaging of Dipeptiven is a type II colorless glass bottle with a rubber stopper.
Package size: 50 ml.
To obtain more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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:

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
Greek marketing authorization number, country of export: 16113/05-03-2012

Parallel import authorization number: 5/22 Date of approval of the package leaflet: 11.01.2022

[Information on the trademark]

Information intended for healthcare professionals only:

Warnings and precautions for use

Regular monitoring of liver function parameters is recommended for patients with stabilized liver failure.
The patient's serum electrolyte levels, osmolality, water balance, acid-base balance, liver function tests (alkaline phosphatase, AlAT, AspAT), and potential symptoms of hyperammonemia should be monitored.
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 a period longer than nine days is currently limited.

Dosage and administration

The infusion solution obtained after mixing Dipeptiven with a pharmaceutically compatible solution. Solutions with an osmolality above 800 mOsm/l should be administered via a central vein.
Adults
Dipeptiven is used in parenteral nutrition 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/proteins.
During parenteral/enteral nutrition, the maximum daily dose of 2 g of amino acids/proteins per kilogram of body weight must not be exceeded. The calculations should take into account 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.
Patient on 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 should be mixed with a compatible amino acid solution or nutritional mixture containing amino acids before administration.
Patient on enteral nutrition
Dipeptiven should be administered in a continuous infusion lasting 20-24 hours a day.
During peripheral vein infusion, Dipeptiven should be diluted to achieve an osmolality ≤ 800 mOsm/l (e.g., 100 ml of Dipeptiven + 100 ml of physiological saline solution).
Patient on both enteral and parenteral nutrition
The total daily dose of Dipeptiven should be administered in parenteral nutrition, e.g., by mixing it 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 treatment
The treatment duration should not exceed 3 weeks.

Disposal of unused medicinal product

The container and solution should be inspected before use. Only use a clear solution, free from particles, from an undamaged container. For single use only. Unused medicinal product is not suitable for further use.

Pharmaceutical incompatibilities

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.

Storage conditions

The medicinal product should be used immediately after opening the bottle.
Dipeptiven must not be stored after mixing with other ingredients.