Dipeptiven

Package Leaflet: Information for the Patient

Dipeptiven, 200 mg/ml, Concentrate for Solution for Infusion

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

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

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor, Pharmacist, or Nurse.
• If You Experience Any Side Effects, Including Those Not Mentioned in this Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse. See Section 4.

Table of Contents of the Package 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 Pack 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 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 the Patient is Allergic to the Active Substance or to Any of the Other Ingredients of this Medicinal Product (Listed in Section 6), Symptoms of an Allergic Reaction May Include High Fever, Chills, Rash, or Shortness of Breath;
• If the Patient Has Liver or Kidney Function Disorders;
• If the Patient Has Metabolic Acidosis - a Condition in Which the Blood has a Low pH;
• If the Patient is in Circulatory Shock - a Condition in Which Blood Flow is Reduced;
• If the Patient is Hypoxemic - a Condition in Which the Oxygen Level in the Body is 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 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 to Use Dipeptiven, Discuss it with Your Doctor or Nurse. In Patients Receiving Dipeptiven, the Doctor May Order Regular Blood Tests to Check the Patient's Health and Confirm the Proper Action of Dipeptiven. Experience with the Use of Dipeptiven for a Period Longer than Nine Days is 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. This Medicinal Product Must Not be Used 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.

Use of a Higher Than Recommended Dose of Dipeptiven

The Doctor or Nurse Will Monitor the Patient's Condition During the Infusion, So the Risk 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 Questions About the Use of this Medicinal Product, Ask Your Doctor or Nurse.

4. Possible Side Effects

Like All Medicinal Products, this Medicinal Product Can Cause Side Effects, Although Not Everybody Gets Them. They are Not Known if the Medicinal Product is Used as Recommended.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Mentioned in this Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse. Side Effects Can be Reported Directly to the Department of Post-Marketing Surveillance 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. Side Effects Can Also be Reported to the Marketing Authorization Holder. By Reporting Side Effects, You Can Help Provide More Information on the Safety of this 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, Use, and Disposal of Dipeptiven. Store Below 25°C. Store in the Original Package. Unused Medicinal Product is Not Suitable for Further Use. Do Not Use this Medicinal Product After the Expiration Date Stated on the Package. The Expiration Date is the Last Day of the Specified Month. 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 Pack 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). 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 Pack Contains

Dipeptiven is a Clear, Colorless Solution. The Medicinal Product Packaging is a Type II Colorless Glass Bottle with a Rubber Stopper. Pack Sizes: 50 ml, 100 ml. Not All Pack Sizes May be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi Deutschland GmbH

• D - 61346 Bad Homburg v.d.H. Germany

Manufacturer

Fresenius Kabi Austria GmbH, Hafnerstrasse 36

• A - 8055 Graz Austria

For More Detailed Information, Please Contact the Representative of the Marketing Authorization Holder: Fresenius Kabi Polska Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw, Tel.: +48 22 345 67 89

Date of Last Revision of the Package Leaflet: -----------------------------------------------------------------------------------------------------------------

Information Intended Exclusively for Healthcare Professionals:

Warnings and Precautions for Use

To Ensure Safe Administration of Dipeptiven, Do Not Exceed the Maximum Daily Dose of 2.5 ml/kg Body Weight per Day (Equivalent to 0.5 g of N(2)-L-alanyl-L-glutamine). Dipeptiven Should be Used Only as Part of Clinical Nutrition, and its Dosage Should be Adjusted According to the Amount of Protein/Amino Acids Required to be Delivered. If the Patient's Clinical Condition Does Not Allow for Clinical Nutrition (e.g., Circulatory Shock, Hypoxemia, Unstable Patients in Critical Condition, Severe Metabolic Acidosis), Dipeptiven Should Not be Administered. When Calculating the Recommended Dose of Dipeptiven, Consider the Amount of Glutamine Contained in the Oral/Enteral Products Taken in Combination with Parenteral Nutrition. It is Recommended to Regularly Monitor Liver Function Parameters in Patients with Stabilized Liver Failure. Monitor Serum Electrolyte Concentrations, Serum Osmolality, Water Balance, Acid-Base Balance, Creatinine Clearance, Urea Concentration, as Well as Potential Symptoms of Hyperammonemia. The Choice of Peripheral or Central Vein Depends on the Final Osmolality of the Mixture. In General, 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 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 Limited.

Dosage and Administration

Infusion Solution Obtained After Mixing Dipeptiven with a Pharmaceutically Compatible Solution. Solutions with an Osmolality Exceeding 800 mOsm/l Should be Administered into a Central Vein. Adult Patients: Dipeptiven is Used in Parenteral 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/Protein. During Parenteral/Enteral Nutrition, Do Not Exceed the Maximum Daily Dose of 2 g of Amino Acids/Protein per Kilogram of Body Weight. In Calculations, Consider 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. 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 Should be Mixed with a Compatible Amino Acid Solution or Nutritional Mixture Containing Amino Acids Before Administration. Patients Receiving Enteral Nutrition: Dipeptiven Should be Administered in a Continuous Infusion Over 20 to 24 Hours per Day. During Infusion into Peripheral Veins, Dipeptiven Should be Diluted to Achieve an Osmolality ≤ 800 mOsm/l (e.g., 100 ml of Dipeptiven + 100 ml of Physiological Saline Solution). Patients Receiving Both Enteral and Parenteral Nutrition: The Total Daily Dose of Dipeptiven Should be Administered in Parenteral Nutrition, e.g., by Mixing it with a Compatible Amino Acid Solution or Nutritional Mixture Containing Amino Acids Before Administration. 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 Unused Medicinal Product

Examine the Container and Solution Before Use. Use Only a Clear Solution Free from Particulate Matter, from an Undamaged Container. For Single Use Only. Unused Medicinal Product is Not Suitable for Further Use. Compatibility: Addition of the Concentrate to the Carrier Solution Should be Done Under Aseptic Conditions, Before Administering it to the Patient. Ensure Thorough Mixing and Pharmaceutical Compatibility. Shelf-Life: The Medicinal Product Should be Used Immediately After Opening the Bottle. Shelf-Life After Mixing: Do Not Store Dipeptiven After Mixing it with Other Ingredients.