DIPEPTIVEN 200 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

PACKAGE LEAFLET:INFORMATION FOR THE USER

Dipeptiven 200 mg/ml concentrate for solution for infusionAlanine-glutamine

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Tell your doctor or pharmacist if you notice any side effects not listed in this leaflet.

Contents of the pack:

1. What is DIPEPTIVEN and what is it used for
2. What you need to know before you use DIPEPTIVEN
3. How to use DIPEPTIVEN
4. Possible side effects
5. Storage of DIPEPTIVEN
6. Further information

1. What is DIPEPTIVEN and what is it used for

DIPEPTIVEN is a concentrated solution for infusion. It comes in glass vials of 50 ml and 100 ml. It belongs to the group of medicines called parenteral nutrition solutions.

DIPEPTIVEN is indicated as part of a clinical nutrition regimen in patients with hypercatabolic and/or hypermetabolic states. It should be administered together with parenteral or enteral nutrition or a combination of both.

2. What you need to know before you use DIPEPTIVEN

Do not use DIPEPTIVEN:

• If you are allergic (hypersensitive) to the active substance or any of the other ingredients of Dipeptiven.
• If you have severe renal impairment (creatinine clearance < 25 ml/min)
• If you have severe hepatic impairment
• If you have severe metabolic acidosis
• If you are in circulatory shock
• If you have hypoxia - a condition where the oxygen level is low
• If you have multi-organ failure – a condition where two or more organs are not functioning normally

Your doctor should check this.

Your doctor or healthcare professional should check before use that the solution is clear and free of particles.

Be careful with DIPEPTIVEN:

• Liver function parameters should be regularly monitored if you have compensated hepatic insufficiency.

• Special attention should be paid to serum osmolarity, serum electrolyte levels, water balance, acid-base balance, liver function tests (alkaline phosphatase, ALT, AST, bilirubin) and possible symptoms of hyperammonemia.

Using other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

No interactions with other medicines have been described.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

DIPEPTIVEN should not be administered during pregnancy and breastfeeding.

Driving and using machines

Not applicable

3. How to use DIPEPTIVEN

Dipeptiven will be administered to you in the hospital.

You will receive Dipeptiven by infusion (drip by intravenous route). The volume and interval of the infusion will depend on your needs. Your doctor will decide what dose you should receive.

It is recommended to perform the infusion with a Dipeptiven solution at room temperature.

Ask your doctor or pharmacist if you have any further questions about the use of this product.

If you use more DIPEPTIVEN than you should:

If you are given more DIPEPTIVEN than you should, the administration of the medicine should be stopped immediately.

Chills, nausea, and vomiting may occur if the infusion rate is exceeded.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, Phone: 91-5620420.

4. Possible side effects

Like all medicines, Dipeptiven can cause side effects, although not everybody gets them.

However, to date, no side effects have been described for DIPEPTIVEN.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

You can also report them directly through the national reporting system included in Annex V*. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of DIPEPTIVEN

Keep out of the reach and sight of children.

Your doctor and hospital pharmacist are responsible for the correct storage, use, and disposal of Dipeptiven.

Do not store above 25°C.

Do not use Dipeptiven after the expiry date stated on the packaging.

The expiry date is the last day of the month stated.

The solution should be clear and colorless. Do not administer otherwise.

Any unused portion of the solution should be discarded after treatment.

Medicines should 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. FURTHER INFORMATION

Composition of Dipeptiven

1 ml contains:

Alanine-glutamine 200 mg (= 82.0 mg alanine, 134.6 mg glutamine)

The other ingredients are: water for injections q.s.

Appearance and packaging

Dipeptiven is a clear solution that comes in glass vials.

It is available in pack sizes of 50 and 100 ml.

Not all pack sizes may be marketed.

Marketing authorisation holder

Fresenius Kabi Deutschland GmbH

Else-Kröner-Strasse, 1

D-61352 Bad Homburg

Germany

Local representative

Fresenius Kabi España, S.A.U.

Marina 16-18

08005-Barcelona

Manufacturer

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

8055 Graz

Austria

This leaflet was last revised in June 2023.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

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This information is intended only for healthcare professionals:

This medicine will always be administered by specialized personnel. It will be administered by infusion after mixing with a compatible infusion solution.

The solution should be clear and colorless. Do not administer otherwise.

The contents of each vial of Dipeptiven are for single use only. Any unused portion should be discarded.

Special warnings and precautions for use

For safe administration, the maximum dose of Dipeptiven should not exceed 2.5 ml (corresponding to 0.5 g of N(2)-L-alanyl-L-glutamine) per kg body weight and day.

Dipeptiven should only be used as part of clinical nutrition, and its dosage is limited by the amount of proteins/amino acids provided by nutrition. If the clinical condition does not allow nutrition (e.g., circulatory shock, hypoxia, unstable critical patients, severe metabolic acidosis), Dipeptiven should not be administered.

The oral/enteral intake of formulas supplemented with glutamine in combination with parenteral nutrition should be taken into account for the calculation of the prescribed dose of Dipeptiven.

After intravenous infusions of the product, urticaria may develop even without allergies to the components of the solution. One reason could be cold urticaria caused by cold infusions. Therefore, it is recommended to perform the infusion with a Dipeptiven solution at room temperature.

It is advisable to regularly monitor liver function parameters in patients with compensated hepatic insufficiency.

Electrolytes, serum osmolarity, water balance, acid-base balance, creatinine clearance, urea, as well as liver function tests (alkaline phosphatase, ALT, AST) and possible symptoms of hyperammonemia should be monitored.

Since there are currently no sufficient data on the administration of DIPEPTIVEN to pregnant or breastfeeding women and children, the administration of the preparation to these patient groups is not recommended.

Experience with the use of Dipeptiven for periods longer than nine days is limited.

The choice of a peripheral or central vein depends on the final osmolarity of the mixture. The generally accepted limit for peripheral infusion is approximately 800 mosm/l, but it varies considerably with the age and general condition of the patient and the characteristics of the peripheral veins.

Posology and method of administration

1.5 - 2.5 ml of Dipeptiven per kg body weight (equivalent to 0.3 - 0.5 g N(2)-L-alanyl-L-glutamine per kg body weight). This corresponds to 100 to 175 ml of Dipeptiven for a patient with a body weight of 70 kg.

Maximum daily dose: 2.5 ml, equivalent to 0.5 g of N(2)-L-alanyl-L-glutamine) of Dipeptiven per kg body weight.

The maximum daily dose of 0.5 g N(2)-L-alanyl-L-glutamine per kg body weight should be administered in combination with at least 1.0 g of amino acids/proteins per kg body weight and day. Including the amino acids provided by Dipeptiven, this results in a daily dose of at least 1.5 g of amino acids/proteins per kg body weight.

The following adjustments are examples for the supply of Dipeptiven and amino acids as a solution for parenteral nutrition, and/or proteins as an enteral nutrition formula:

Amino acid/protein requirement 1.2 g/kg body weight per day:

0.8 g amino acids/proteins + 0.4 g N(2)-L-alanyl-L-glutamine per kg body weight

Amino acid/protein requirement 1.5 g/kg body weight per day:

1.0 g amino acids/proteins + 0.5 g N(2)-L-alanyl-L-glutamine per kg body weight

Amino acid/protein requirement 2 g/kg body weight per day:

1.5 g amino acids/proteins + 0.5 g N(2)-L-alanyl-L-glutamine per kg body weight

Dipeptiven is a concentrated infusion solution that is not designed for direct administration.

Patient with total parenteral nutrition

The infusion rate depends on the infusion rate of the vehicle 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 vehicle solution or a perfusion regimen containing amino acids before administration. Dipeptiven can be diluted with a 0.9% sodium chloride solution or a 5% glucose solution.

Patient with total enteral nutrition

Dipeptiven is infused continuously over 20-24 hours a day. For peripheral venous infusion, Dipeptiven is diluted to achieve an osmolarity ≤ 800 mosmol/l (e.g., 100 ml of Dipeptiven + 100 ml of 0.9% sodium chloride).

Patient with combined parenteral and enteral nutrition

The total daily dose of Dipeptiven should be administered with parenteral nutrition, i.e., mixed with a compatible amino acid solution or a perfusion regimen containing amino acids before administration.

The infusion rate depends on the infusion rate of the vehicle solution and should be adjusted according to the proportions of enteral and parenteral nutrition.

Maximum infusion rate

When adding Dipeptiven to parenteral nutrition mixtures, the maximum infusion rate should be adjusted depending on the maximum infusion rate of the other nutrients.

If Dipeptiven is administered alone, clinical studies have shown that a dose of 0.5 g of Dipeptiven/kg/day can be safely administered via a peripheral vein over 4 hours. This corresponds to 0.125 g/kg/hour (0.625 ml/kg/hour). If administered as part of total parenteral nutrition and representing 30% of the total amino acid load, the maximum infusion rate corresponds to 0.030 g/kg/hour.

Duration of administration

The duration of use should not exceed 3 weeks.

Incompatibilities

When mixing with a vehicle solution, it is essential to ensure injection under hygienic conditions, thorough mixing, and compatibility.

No other medicines should be added to the mixture.

DIPEPTIVEN should not be stored after the addition of other components.

The product should be used immediately after opening the vial.

Instructions for use and handling

DIPEPTIVEN is a concentrated infusion solution that is not designed for direct administration. The addition of the concentrate to the vehicle solution before administration should be performed under aseptic conditions. DIPEPTIVEN is infused with the vehicle solution. For more details, see "Posology and method of administration".

Unused parts of the solution should be discarded.