Empesin

Package Leaflet: Information for the User

Empesin, 40 IU/2 mL, concentrate for solution for infusion
Argipressin

Read the package leaflet carefully before using the medicine, 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 or pharmacist.
• This medicine has been prescribed for you only. 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 package leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

1. What is Empesin and what is it used for

Empesin is a synthetic active substance corresponding to the natural hormone - vasopressin. It regulates the body's water economy and reduces urine excretion. Empesin is used in cases of septic shock, after unsuccessful use of other appropriate methods, in order to achieve the target blood pressure values set by the doctor.

2. Important information before using Empesin

When not to use Empesin

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

Warnings and precautions

Precautions are necessary when using Empesin:

• if it is used to increase blood pressure in cases of shock after using other methods. The administration of the medicine must be carried out under strict control of vital function parameters;
• if it is used in patients with cardiovascular diseases;
• if it is administered to patients with epilepsy, migraine, asthma, heart failure, or a condition where a sudden increase in extracellular water volume poses a risk;
• if the patient has chronic kidney inflammation.

Children and adolescents

It is not recommended to use Empesin in this indication in children and newborns.

Empesin and other medicines

Caution should be exercised when administering Empesin together with carbamazepine, chlorpropamide, clofibrate, urea, fludrocortisone, or tricyclic antidepressants, as they may enhance the effect of Empesin. Caution should be exercised when administering Empesin together with demeclocycline, noradrenaline, lithium compounds, heparin, or alcohol, as it may lead to a weakening of its effect. Concomitant use of Empesin with medicines that change blood pressure may increase or decrease the increase in blood pressure caused by Empesin. You should inform your doctor or pharmacist about all medicines you are taking or have recently taken, as well as about medicines you plan to take. This also applies to medicines that are available without a prescription.

Using Empesin with food and drink

Do not use Empesin in combination with alcohol.

Pregnancy and breastfeeding

Empesin may cause uterine contractions and increased intrauterine pressure during pregnancy and may reduce blood flow in the uterus. Do not use Empesin during pregnancy, unless it is absolutely necessary.
It is not known whether Empesin passes into human milk.
It is not recommended to use Empesin during pregnancy and breastfeeding.
Before taking any medicines, consult your doctor or pharmacist.

Driving and using machines

No studies have been conducted on the effect on the ability to drive and use machines.

Important information about some excipients of Empesin

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means the medicine is considered "sodium-free".

3. How to use Empesin

Empesin is administered by a doctor.
Empesin should only be used as an adjunct to usual treatment. Initially, 0.01 IU of Empesin per minute is administered as an infusion. The dose can be increased every 15-20 minutes to a maximum of 0.03 IU of Empesin per minute. Higher doses should only be used in emergency situations.
Empesin is administered as a long-term infusion and must be diluted with a physiological saline solution.

Use in children and adolescents

Empesin has been used to treat certain shock conditions in infants, young children, and older children in the intensive care unit and in the operating room. However, it is not recommended to use Empesin in this indication in children and newborns.

Using a higher dose of Empesin than recommended

This medicine is administered by a doctor. If you think you have been given too much Empesin, contact your doctor immediately.

Stopping the use of Empesin

Discontinuation of treatment with this medicine must be done gradually, which means that treatment should not be stopped abruptly. If you think that the treatment has been stopped too early, contact your doctor immediately. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Empesin can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):

• heart rhythm disorders,
• chest tightness,
• circulatory disorders in the heart muscle, intestines, or fingertips,
• peripheral vasoconstriction,
• tissue necrosis,
• abdominal cramps,
• pallor around the mouth,
• skin tissue necrosis.

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

• low sodium levels in the blood,
• tremors,
• dizziness,
• headache,
• reduced cardiac output,
• life-threatening changes in heart rhythm,
• circulatory arrest,
• breathing difficulties due to bronchospasm,
• nausea,
• vomiting,
• bloating,
• intestinal tissue necrosis,
• sweating,
• rash,
• changes in some blood test results.

Rare (may affect up to 1 in 1,000 people):

• severe, life-threatening allergic reaction.

Unknown (frequency cannot be estimated from available data):

• water poisoning,
• diabetes insipidus after withdrawal.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Empesin

Keep the medicine out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C).
Do not use this medicine after the expiry date stated on the label and carton after: EXP.
The expiry date refers to the last day of the month.
After opening, dilute and use immediately.
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. Contents of the pack and other information

What Empesin contains

• The active substance is argipressin. One ampoule containing 2 mL of concentrate for solution for infusion contains 40 IU of argipressin (corresponding to 133 micrograms), as argipressin acetate.
• The other ingredients are: sodium chloride, glacial acetic acid (for pH adjustment), water for injections.

What Empesin looks like and contents of the pack

Empesin is a clear, colorless concentrate for solution for infusion.
Each pack contains 5 or 10 ampoules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

AOP Orphan Pharmaceuticals GmbH
Leopold-Ungar-Platz 2
1190 Vienna
Austria
To obtain more detailed information about this medicine, please contact the local representative of the marketing authorization holder:
AOP Orphan Pharmaceuticals Poland Sp. z o.o.
office.pl@aoporphan.com
Tel. +48 22 542 81 80

This medicine has been authorized in the Member States of the European Economic Area under the following names:

Austria
Empesin 40 IU/2 ml Konzentrat zur Herstellung einer Infusionslösung
Belgium
Reverpleg 40 IU/2 ml concentraat voor oplossing voor infusie
Bulgaria
Емпресин 40 IU/2ml Концентрат за инфузионен разтвор
Croatia
Empressin 40 IU/ 2 ml koncentrat za otopinu za infuziju
Czech Republic
Embesin
Denmark
Empressin
Estonia
Empesin
Finland
Empressin 40 I.U./2 ml infuusiokonsentraatti, liuosta varten
France
Reverpleg 40 U.I./2ml solution á diluer pour perfusion
Greece
Empressin 40 I.U./2 ml Πυκνό διάλυμα για παρασκευή διαλύματος προς
έγχυση
Spain
Empressin 40 I.U./2 ml concentrado para solución para perfusión
Netherlands
Empressine 40 I.E./2ml, concentraat voor oplossing voor infusie
Ireland
Embesin
Lithuania
Empesin
Luxembourg
Reverpleg 40 I.U./2 ml solution à diluer pour perfusion
Latvia
Empesin 40 SV/2 ml koncentrāts infūziju šķīduma pagatavošanai
Germany
Empressin 40 I.E./2 ml Konzentrat zur Herstellung einer Infusionslösung
Norway
Empressin
Poland
Empesin
Portugal
Empressin 40 U.I./2ml concentrado para solução para perfusão
Romania
Reverpleg
Slovakia
Embesin 40 I.U./2 mL infúzny koncentrát
Slovenia
Empesin 40 I.E./2 ml koncentrat za raztopino za infundiranje
Sweden
Empressin 40 I.E./2 ml koncentrat till infusionsvätska, lösning
Hungary
Embesyn 40 N.E./2ml koncentrátum oldatus infúzióhoz
Italy
Empressin 40 U.I. /2 ml concentrato per soluzione per infusione

Date of last revision of the package leaflet:

Information intended for healthcare professionals only:

Dosage and administration

Treatment with argipressin in patients with catecholamine-resistant hypotension should be started within the first six hours of septic shock onset or within 3 hours of shock onset in patients receiving high doses of catecholamines (see section 5.1 SmPC). Argipressin should be administered as a continuous intravenous infusion at a dose of 0.01 IU per minute using an infusion pump/mechanical device. Depending on the clinical response, the dose can be increased every 15-20 minutes to 0.03 IU per minute. In intensive care unit patients, the usual target blood pressure is 65-75 mmHg. Argipressin should only be used as an adjunct to conventional vasopressor therapy with catecholamines. Doses above 0.03 IU per minute should only be used as rescue therapy, as this may cause intestinal and skin necrosis and increase the risk of circulatory arrest (see section 4.4 SmPC). The duration of treatment should be tailored to the individual clinical picture, but it is recommended to last at least 48 hours. Argipressin treatment should not be stopped abruptly. It should be done gradually, according to the patient's clinical condition. The total duration of argipressin treatment depends on the decision of the treating physician.
To prepare the infusion solution, dilute 2 mL of concentrate in 48 mL of sodium chloride 9 mg/mL (0.9%) solution (corresponding to 0.8 IU of argipressin per mL). The total volume after dilution should be 50 mL.
Infusion rate depending on the recommended doses:
Children and adolescents
Argipressin has been used to treat vasodilatory shock in children and infants in the intensive care unit and during surgery. Since argipressin compared to standard treatment did not lead to improved survival and showed higher rates of adverse events, its use in children and infants is not recommended.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 SmPC.

Special warnings and precautions for use

This product should not be used interchangeably with other medicinal products containing argipressin expressed in different units (e.g., Pressor Units P.U.).
Argipressin should not be administered as a bolus in the treatment of catecholamine-resistant shock.
Argipressin should only be administered under strict and continuous monitoring of hemodynamic and organ-specific parameters.
Treatment with argipressin should only be started if it is not possible to maintain sufficient perfusion pressure despite adequate volume substitution and administration of catecholaminergic vasopressors.
Particular caution should be exercised when using argipressin in patients with heart or vascular diseases. It has been reported that the administration of high doses of argipressin for other indications causes myocardial and intestinal ischemia, myocardial and intestinal infarction, and decreased perfusion of the limbs.
Argipressin may rarely cause water poisoning. Early signs of water poisoning, such as drowsiness, apathy, and headache, should be recognized in time to prevent terminal coma and convulsions.
Argipressin should be used with caution in patients with epilepsy, migraine, asthma, heart failure, or other conditions where a sudden increase in extracellular water volume may pose a risk.
In the pediatric population, a positive benefit-risk ratio has not been demonstrated. The use of argipressin in this indication is not recommended in children and newborns (see section 5.1 SmPC).