PATIENT INFORMATION LEAFLET:INFORMATION FOR THE USER

Dipeptiven 200 mg/ml Concentrate for Solution for Infusion
Alanilglutamina

Read this leaflet carefully before you start using this medicine.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, ask your doctor or pharmacist.

-If you think you are having a severe side effect or if any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

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

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

Do not use DIPEPTIVEN:

-If you are allergic (hypersensitive) to the active ingredient or to any of the other components of Dipeptiven.

-If you have severe kidney impairment (creatinine clearance <25)

-If you have severe liver impairment

-If you have severe metabolic acidosis

• If you are experiencing circulatory shock
• If you have hypoxia - a state in which the oxygen level is low
• If you have multi-organ failure – a state in which two or more organs are not functioning normally

Your doctor must check this.

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

Be especially careful with DIPEPTIVEN:

-Regularly monitor liver function parameters if you have compensated liver insufficiency.

-Pay special attention to serum osmolarity, serum electrolyte levels, fluid balance, acid-base balance, liver function tests (alkaline phosphatase, ALT, AST, bilirubin) and possible symptoms of hyperammonemia.

Use of other medications

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

No interactions with other medications have been described.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

DIPEPTIVEN should not be administered during pregnancy and breastfeeding.

Driving and operating machines

Not applicable

Dipeptiven will be administered in the hospital.

You will receive Dipeptiven through infusion (drop by drop via intravenous route). The volume and interval of the infusion that you will be administered will depend on your requirements. Your doctor will decide what is the suitable dose that you should receive.

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

Consult your doctor or pharmacist if you have more doubts about the use of this product.

If you use more Dipeptiven than you should:

If you are administered more Dipeptiven than you should, the administration of the medication should be interrupted immediately.

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

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

Like all medications, Dipeptiven may produce adverse effects, although not everyone may experience them.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet.

You can also report them directly through thenational notification system included in theAppendix V.* By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of reach and sight of children.

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

Do not store at a temperature above 25°C.

Do not use Dipeptiven after the expiration date that appears on the packaging.

The expiration date is the last day of the month indicated.

The solution must be transparent and colorless. Do not administer otherwise.

Any remaining solution not used must be discarded after treatment.

Medicines should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. In this way, you will help protect the environment.

Composition of Dipeptiven

1 ml contains:

Alanilglutamine200 mg
(= 82.0 mg alanine, 134.6 mg glutamine)

The other components are: water for injection c.s.

Appearance of the product and contents of the container

Dipeptiven is a transparent solution that is packaged in glass bottles.

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

Not all container sizes may be marketed.

Marketing Authorization Holder

Fresenius Kabi Deutschland GmbH

Else-KrönerStrasse, 1

D-61352 Bad Homburg

Germany

Local Representative

Fresenius Kabi España, S.A.U.

Marina 16-18

08005-Barcelona

Responsible Person for Manufacturing

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

8055 Graz

Austria

This leaflet has been revised in June 2023.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

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This information is intended solely for medical professionals or healthcare professionals:

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

The solution must be transparent and colorless. Do not administer otherwise.

The contents of each container of Dipeptiven are for a single infusion. Any unused portion must be discarded.

Warnings and special 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-alanil-L-glutamine) per kg of body weight per day.

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

Oral/enteral intake of glutamine-supplemented formulas 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. A 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 liver insufficiency.

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

Since there is currently insufficient data on the administration of DIPEPTIVEN to pregnant women or breastfeeding women and children, administration of the preparation to these patient groups is not recommended.

The experience with the use of Dipeptiven for periods exceeding 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 a peripheral infusion is approximately 800 mosm/l, but it varies greatly with age and general condition of the patient and the characteristics of the peripheral veins.

Dosage and method of administration

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

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

The maximum daily dose of 0.5 g N(2)-L-alanil-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 per 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 parenteral nutrition solution and/or proteins as an enteral nutrition formula:

Requirement of amino acids/proteins 1.2 g/kg body weight per day:

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

Requirement of amino acids/proteins 1.5 g/kg body weight per day:

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

Requirement of amino acids/proteins 2 g/kg body weight per day:

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

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

Patients 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 must be mixed with a compatible amino acid solution or with a perfusion regimen containing amino acids before administration. Dipeptiven can be diluted with a 0.9% sodium chloride solution or with a 5% glucose solution.

Patients with total enteral nutrition

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

Patients 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 with 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 regulated depending on the maximum infusion rate of the other nutrients.

If Dipeptiven is administered alone, clinical studies have shown that it can be safely administered at a dose of 0.5 g of Dipeptiven/kg/day 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 represents 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 mixed with a vehicle solution, it is essential to ensure injection under hygienic conditions, a thorough mix, and compatibility.

No other medications 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 container.

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 "Dosage and method of administration".

Unused portions of the solution should be discarded.