Empressin 20 IU/ml concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Empressin 20UI/ml concentrate for solution for infusion

argipresin

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Empressin is and what it is used for
2. What you need to know before using Empressin
3. How to use Empressin
4. Possible side effects
5. How to store Empressin
6. Contents of the pack and other information

1. What Empressin is and what it is used for

Empressin is an artificially produced active substance equivalent to the natural hormone vasopressin. It regulates the body's water-electrolyte balance and reduces urinary excretion. Empressin is used in septic shock states when other appropriate methods to achieve the target blood pressure values established by the physician in charge of treatment have failed.

2. What you need to know before using Empressin

Do not use Empressin:

• if you are allergic to argipresin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Special precautions are required when using Empressin:

• if it is used to increase blood pressure in shock situations after other methods have been tried. Administration must be carried out under close monitoring of vital parameters.
• if used in patients with cardiovascular diseases.
• if administered to patients with epilepsy, migraine, asthma, heart failure, or with a condition where a rapid increase in extracellular fluid represents a risk.
• if the patient suffers from chronic nephritis.

Children and adolescents

The use of Empressin in children and newborns is contraindicated.

Other medicines and Empressin

Empressin should be administered with caution together with carbamazepine, chlorpropamide, clofibrate, urea, fludrocortisone, or tricyclic antidepressants, as these drugs may enhance the effect of Empressin. Empressin should be administered with caution together with demeclocycline, noradrenaline, lithium, heparin, or alcohol, as these substances may reduce its effects. Concomitant use of Empressin with medications that affect blood pressure may increase or decrease the blood pressure elevation caused by Empressin. Inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicine, including those obtained without a prescription.

Use of Empressin with food and drink

Empressin must not be used in combination with alcohol.

Pregnancy and breastfeeding

Empressin may cause uterine contractions and increased intrauterine pressure during pregnancy, and may reduce uterine perfusion. Empressin should not be used during pregnancy unless clearly necessary.

It is unknown whether Empressin is excreted in breast milk.

The use of Empressin during pregnancy and breastfeeding is not recommended.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

No studies have been conducted on the effects on the ability to drive or use machines.

Important information about certain excipients in Empressin

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially "sodium-free".

3. How to use Empressin

Empressin will be administered by a physician.

Empressin will only be used in addition to conventional treatment. Initially, 0.01 IU of Empressin per minute will be administered by infusion. This dose may be increased every 15–20 minutes up to 0.03 IU of Empressin per minute. Higher doses will only be used in emergency situations.

Empressin is administered as a prolonged infusion and must be diluted with a physiological solution.

Use in children and adolescents

Empressin has been used to treat certain shock conditions in children, infants, and neonates in intensive care units and in the operating room. However, the use of Empressin for this indication is not recommended in children and newborns.

If you are given more Empressin than you should

This medicine will be administered by a physician. If you think you have been given too high a dose of this medicine, speak to your doctor immediately.

If you stop treatment with Empressin

Discontinuation of treatment with this medicine should be done gradually, meaning that treatment should not be stopped abruptly. If you think that treatment has been stopped too soon, speak to your doctor immediately. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Frequent (may affect up to 1 in 10 patients):

• abnormal heartbeat
• chest tightness
• circulatory disorders in the myocardium, intestine, or fingertips
• peripheral narrowing of blood vessels
• tissue death
• cramps
• paleness around the mouth
• death of skin tissue

Uncommon (may affect up to 1 in 100 patients):

• low sodium levels in the blood
• tremor
• dizziness
• headache
• decreased cardiac output
• potentially fatal change in heartbeat
• breathing difficulty caused by narrowing of the airways
• nausea
• vomiting
• flatulence
• death of intestinal tissue
• sweating
• skin rash
• changes in certain blood test values

Rare (may affect up to 1 in 1000 patients):

• severe, potentially life-threatening allergic reaction

Unknown (frequency cannot be estimated from available data):

• hyperhydration
• diabetes insipidus after discontinuation of treatment.

Reporting of 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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Empressin

Keep this medicine out of the sight and reach of children.

Store in the refrigerator (2 °C - 8 °C).

Do not use this medicine after the expiry date stated on the label and carton. The expiry date is the last day of the month indicated.

Once opened, dilute and use the product immediately.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Empressin

The active substance is argipresin.

Empressin is presented in clear type I glass vials containing a sterile concentrate for infusion solution.

• 1 ml vial: clear type I glass vial (vial with a score mark)
• 2 ml vial: clear type I glass vial (vial with coloured break ring)

The other excipients are: sodium chloride, glacial acetic acid for pH adjustment, and water for injections.

Appearance of the product and contents of the pack

Empressin is a clear, colourless concentrate for infusion solution.

Pack sizes:

• 1 ml vial: packs of 10 vials
• 2 ml vial: packs of 5 or 10 vials

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Orpha-Devel Handels und Vertriebs GmbH
Wintergasse 85/1B
3002 Purkersdorf
Austria

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

AOP Orphan Pharmaceuticals Iberia S.L.U.
Calle de Cólquide nº6, Edif. Prisma – Portal 2, 1º F
28231, Las Rozas, Madrid
Spain

Manufacturer

AOP Orphan Pharmaceuticals GmbH
Leopold-Ungar-Platz 2
1190 Vienna
Austria

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany Empressin 20 IU/ml concentrate for solution for infusion
Austria Empesin 20 IU/ml concentrate for solution for infusion
Belgium Reverpleg 20 IU/ml concentrate for infusion solution
Bulgaria ???????? 20 IU/ml ?????????? ?? ?????????? ???????
Croatia Empressin 20 IU/ml concentrate for infusion solution
Denmark Empressin
Slovakia Embesin 20 IU/ml infusion concentrate
Slovenia Empesin 20 IU/ml concentrate for infusion solution
Spain Empressin 20 UI/ml concentrate for infusion solution
Estonia Empesin
Finland Empressin 20 IU/ml infusion concentrate, solution for infusion
France Reverpleg 20 UI/ml solution to be diluted for infusion
Greece Empressin 20 IU/ml Πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση
Hungary Embesyn 20 NE/ml koncentrátum oldatos infúzióhoz
Ireland Embesin
Italy Empressin 20 UI/ml concentrate for infusion solution
Latvia Empesin 20 SV/ml concentrate for infusion solution
Lithuania Empesin
Luxembourg Reverpleg 20 UI/ml solution to be diluted for infusion
Netherlands / Holland Empressine 20 IU/ml, concentrate for infusion solution
Poland Empesin
Portugal Empressin, 20 UI/ml, concentrate for infusion solution
Czech Republic Embesin
Romania Reverpleg 20 UI/ml concentrate for perfusable solution
Sweden Empressin 20 IE/ml concentrate for infusion fluid, solution

Date of the latest revision of this leaflet: 03/2026

This information is intended for healthcare professionals only:

Dosage and method of administration

Treatment with argipresin in patients with hypotension resistant to catecholamines should preferably be initiated within the first six hours after the onset of septic shock, or within three hours in patients receiving high doses of catecholamines (see section 5.1 of the Summary of Product Characteristics).

Argipresin must be administered by continuous intravenous infusion at a rate of 0.01 IU per minute using an infusion pump or mechanical infusion device. Depending on the clinical response, the dose may be increased every 15–20 minutes up to 0.03 IU per minute. For intensive care patients, the desired blood pressure is typically 65–75 mmHg. Argipresin must only be administered in combination with conventional vasopressor therapy with catecholamines. Doses exceeding 0.03 IU per minute should only be administered as emergency treatment, as they may cause cutaneous and intestinal necrosis and an increased risk of cardiac arrest (see section 4.4 of the Summary of Product Characteristics). The duration of treatment should be determined according to the individual clinical condition, but should preferably last at least 48 hours. Treatment with argipresin must not be discontinued abruptly, but should be tapered gradually according to the patient's clinical progress. The total duration of argipresin treatment will be at the discretion of the responsible physician.

Empressin concentrate must not be administered undiluted.

The solution must be inspected visually for particulate matter and discoloration prior to administration. Only clear, colourless solutions should be used.

Prepare an infusion solution by performing the following dilution:

• 1 ml vial: dilute 1 ml of concentrate with 24 ml of sodium chloride solution 9 mg/ml (0.9%) (resulting in 0.8 IU of argipresin per ml). The total volume after dilution should be 25 ml.
• 2 ml vial: dilute 2 ml of concentrate with 48 ml of sodium chloride solution 9 mg/ml (0.9%) (resulting in 0.8 IU of argipresin per ml). The total volume after dilution should be 50 ml.

Infusion rates according to recommended doses:

Pediatric population

Argipresin has been used for the treatment of vasodilatory shock in children and infants in intensive care units and during surgical procedures. Since argipresin, compared to conventional treatment, did not improve survival and showed higher rates of adverse events, its use is not recommended in children and infants.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the summary of product characteristics.

Special warnings and precautions for use

This product must not be interchanged with other medications containing argipresin with different concentration units (e.g., pressor units, PU).

Argipresin must not be administered as a rapid intravenous injection for the treatment of catecholamine-resistant shock.

Argipresin must only be administered under close and continuous monitoring of hemodynamic and organ function parameters.

Treatment with argipresin should only be initiated if adequate intravascular volume replacement and catecholaminergic vasopressors fail to maintain sufficient perfusion pressure.

Argipresin should be used with particular caution in patients with cardiac or vascular diseases. Administration of high doses of argipresin for other indications has been observed to cause intestinal and myocardial ischemia, myocardial and intestinal infarction, and reduced perfusion in the extremities.

Overhydration due to argipresin is very rare. Early signs such as somnolence, lethargy, and headache must be promptly recognized to prevent terminal coma and seizures.

Argipresin should be used with caution in patients with epilepsy, migraine, asthma, heart failure, or any condition in which a rapid increase in extracellular fluid volume could pose a danger to an already overloaded organism.

In the pediatric population, a positive risk-benefit ratio has not been demonstrated. The use of argipresin for this indication is not recommended in children and newborns (see section 5.1 of the summary of product characteristics).