Dipeptiven

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-glutaminum

Read the Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

• Keep this Leaflet, so you can Read it Again if you Need to.
• If you have any Further Questions, Ask your Doctor, Pharmacist, or Nurse.
• This Medicinal Product has been Prescribed for you Personally. Do not Pass it on to Others. It may Harm them, even if their Symptoms are the Same as yours.
• If you Experience any Side Effects, including those not Listed in this Leaflet, Tell your Doctor, Pharmacist, or Nurse. See Section 4.

Table of Contents of the Leaflet

• 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. Contents of the Packaging 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

Do not Use the Medicinal Product:

• if you have Liver or Kidney Function Disorders;
• if you have Metabolic Acidosis - low Blood pH;
• if you are Allergic to the Active Substance or to any of the other Ingredients of this Medicinal Product (listed in Section 6);
• if you are 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, Discuss it with your Doctor or Nurse.
For Patients Receiving Dipeptiven, the Doctor may Order Regular Blood Tests to Check the Patient's Health and Confirm the Proper Effect of Dipeptiven. Experience with the Use of Dipeptiven for a Period Longer than Nine Days is Currently Limited.

Dipeptiven and other Medicinal Products

Tell your Doctor or Pharmacist about all Medicinal Products you are Currently Taking or have Recently Taken, as well as any Medicinal Products you Plan to Use.

Pregnancy and Breastfeeding

If you are Pregnant or Breastfeeding, Think you may be Pregnant, or Plan to have a Child, Consult your Doctor or Pharmacist before Using this Medicinal Product.
Do not Use this Medicinal Product during Pregnancy and Breastfeeding.

Driving and Using Machines

Dipeptiven has no Influence 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 Body Weight in Kilograms and the Ability to Break down Nutrients and the Need for Amino Acids.
The Doctor Decides on the Size of the Dose Used in 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 Chance of Administering a Higher Dose than Recommended. However, if you Think you have Received a Higher Dose of Dipeptiven than Recommended, Inform your Doctor or Nurse Immediately. Symptoms of Overdose may include Chills, Nausea, and Vomiting.
If you have any Further Questions about the Use of this Medicinal Product, Consult your Doctor or Nurse.

4. Possible Side Effects

None are Known if the Medicinal Product is Administered According to the Recommendations.

Reporting Side Effects

If you Experience any Side Effects, including those not Listed in this Leaflet, Tell your Doctor, Pharmacist, or Nurse. Side Effects can be Reported Directly to the Department of Adverse Reaction Monitoring of Medicinal Products 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

Store the Medicinal Product out of Sight and Reach of Children.

The Doctor or Nurse is Responsible for Ensuring the Proper Storage, Use, and Disposal of Dipeptiven.
Store at a Temperature below 25°C. Store in the Original Packaging.
Any Unused Remainder 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 Month Stated.
Medicinal Products should not be Disposed of via Wastewater or Household Waste. Ask your Pharmacist how to Dispose of Medicinal Products that are no Longer Needed. This will Help Protect the Environment.

6. Contents of the Packaging 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 what the Packaging Contains

Dipeptiven is a Clear, Colorless Solution. The Packaging of the Medicinal Product is a Type II Colorless Glass Bottle with a Rubber Stopper and a Hanging Loop in a Cardboard Box.
Packaging Size: 100 ml.
For more Detailed Information, Contact the Marketing Authorization Holder or the Parallel Importer.

Marketing Authorization Holder in Bulgaria, the 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in Bulgaria, the Country of Export:20020591

Parallel Import Authorization Number: 265/23

Date of Approval of the Leaflet: 24.11.2023

[Information about the Registered Trademark]

Information Intended for Healthcare Professionals Only:

Warnings and Precautions for Use

Regular Monitoring of Liver Function Parameters is Recommended in Patients with Stabilized Liver Failure.
Monitor the Electrolyte Concentration in Serum, Serum Osmolality, Water Balance, Acid-Base Balance, Liver Function Tests (Alkaline Phosphatase, AlAT, AspAT), and potential Symptoms of Hyperammonemia.
The Choice of Peripheral or Central Vein Depends on the Final Osmolality of the Mixture.
Generally, an Osmolality of around 800 mOsm/l is Considered the Upper Limit for Peripheral Infusion, but this Value Varies Greatly Depending on the Patient's Age and General 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

Infusion Solution Obtained by Mixing Dipeptiven with a 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, do not Exceed the Maximum Daily Dose of 2 g of Amino Acids/Proteins per Kilogram of Body Weight. 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 over 20-24 Hours per Day.
When Used in 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 Use
The Duration of Use should not Exceed 3 Weeks.

Disposal of the Medicinal Product

Check the Container and Solution before Use. Use only a Clear Solution, Free from Particulate Matter, from an Undamaged Container. For Single Use only. Any Unused Remainder of the Medicinal Product is not Suitable for Further Use.

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

Use the Medicinal Product Immediately after Opening the Bottle.
Do not Store Dipeptiven after Mixing it with other Ingredients.