Leaflet: information for the user

Empressin 40 U.I./2 ml concentrate for infusion solution

argipresina

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

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

1. What Empressin is and what it is used for

2. What you need to know before you start using Empressin

3. How to use Empressin

4. Possible side effects

5. Storage of Empressin

6. Contents of the pack and additional information

Empressin is an active substance produced artificially equivalent to the natural vasopressin hormone. It regulates the body's hydroelectrolyte balance and reduces urine excretion. Empressin is used in septic shock states when other suitable methods for achieving the desired blood pressure values established by the treating physician have failed.

No use Empressin:

-if you are allergic to ergotamine or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Special precautions are necessary for the use of Empressin:

-if used to increase blood pressure in cases of shock after using other methods. Administration should 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 disease in which a rapid increase in extracellular fluid represents a risk.

-if the patient has chronic nephritis.

Children and Adolescents

The use of Empressin in children and newborns is contraindicated.

Other Medications and Empressin

Empressin should be administered with caution along with carbamazepine, chlorpropamide, clofibrate, urea, fludrocortisone, or tricyclic antidepressants, as these drugs may increase the effect of Empressin. Empressin should be administered with caution along with demeclocycline, noradrenaline, lithium, heparin, or alcohol, as these substances may reduce its effects. The concomitant use of Empressin with medications that alter blood pressure may increase or decrease the elevation of blood pressure caused by Empressin. Inform your doctor or pharmacist if you are taking/using or have taken/used recently any other medication, including over-the-counter products.

Use of Empressin with Food and Beverages

Empressin should not be used in combination with alcohol.

Pregnancy and Breastfeeding

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

The transfer of Empressin to breast milk is unknown.

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

Consult your doctor or pharmacist before using any medication.

Driving and Operating Machines

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

Important Information about Certain Excipients of Empressin

This medication contains less than 1 mmol of sodium (23 mg) per dose, which is essentially “sodium-free”.

Empressin will be administered by a doctor.

Empressin will only be used in addition to conventional treatment. Initially, 0.01 U.I. of Empressin per minute will be administered via infusion. This dose may be increased every 15-20 minutes up to 0.03 U.I. 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-related conditions in children, infants, and newborns in the intensive care unit and operating room. The use of Empressin for this indication is not recommended in children and newborns.

If You Take More Empressin Than You Should

This medication will be administered by a doctor. If you believe you have been given too high a dose of this medication, speak immediately with your doctor.

If You Discontinue Treatment with Empressin

The discontinuation of treatment with this medication should be done gradually, meaning that treatment should not be stopped abruptly. If you believe treatment has been stopped too soon, speak immediately with your doctor. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

-abnormal heart rhythm

-chest tightness

-circulatory disorders in the myocardium, intestines, or fingertips

-peripheral vasoconstriction

-tissue death

-colics

-pallor around the mouth

-skin tissue death

Poorly frequent (may affect up to 1 in 100 patients):

-low sodium levels in the blood

-shaking

-dizziness

-headache

-decreased cardiac output

-potentially fatal change in heart rhythm

-cardiac arrest

-respiratory difficulty caused by bronchial constriction

-nausea

-vomiting

-flatulence

-intestinal tissue death

-sweating

-skin rash

-changes in certain blood test values

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

-intense allergic reaction, potentially fatal

Unknown (frequency cannot be estimated from available data):

-hyperhydration

-diabetes insipidus after treatment suspension.

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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Store in refrigerator (2°C - 8°C).

Do not use this medication after the expiration date that appears on the label and the box. The expiration date is the last day of the month indicated.

Once opened, dilute and use the product immediately.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Empressin

The active principle is argipressin.

A vial with 2ml of concentrate for solution for infusion contains argipressin acetate in an amount corresponding to 40U.I. of argipressin (which is equivalent to 133micrograms).

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

Aspect of the product and content of the package

Empressin is a transparent and colorless concentrate for solution for infusion.

Each package contains 5 or 10vials.

Only some package sizes may be marketed.

Holder of the marketing authorization

Orpha-Devel Handels und Vertriebs GmbH

Wintergasse 85/1B

3002 Purkersdorf

Austria

For more information about this medication, please contact the local representative of the marketing authorization holder:

AOP Orphan Pharmaceuticals Iberia S.L.U.

Calle de Cólquide nº6, Edif. Prisma – Portal 2, 1º F

28231, Las Rozas, Madrid

Spain

Responsible for manufacturing

AOP Orphan Pharmaceuticals GmbH

Leopold-Ungar-Platz 2,

1190 Vienna

Austria

This medication is authorized in the member states of the European Economic Area with the following names:

AustriaEmpesin 40 I.E./2 ml Konzentrat zur Herstellung einer Infusionslösung

BelgiumReverpleg 40 I.E./2 ml concentraat voor oplossing voor infusie

Bulgaria????????40 IU/2ml?????????????????????????????

CroatiaEmpressin 40 IU/2ml koncentrat za otopinu za infuziju

Czech RepublicEmbesin

GermanyEmpressin 40 I.E./2 ml Konzentrat zur Herstellung einer Infusionslösung

DenmarkEmpressin

EstoniaEmpesin

GreeceEmpressin 40 I.U./2 mlΠυκν?δι?λυμαγιαπαρασκευ?διαλ?ματοςπρος?γχυση

SpainEmpressin 40 U.I./2 ml concentrado para solución para perfusión

FinlandEmpressin 40 I.U./2 ml infuusiokonsentraatti, liuosta varten

FranceReverpleg 40 U.I./2 ml solution à diluer pour perfusion

HungaryEmbesyn 40 N.E./2 ml koncentrátum oldatos infúzióhoz

IrelandEmbesin 40 I.U./2 ml concentrate for solution for infusion

ItalyEmpressin 40 U.I./2 ml concentrato per soluzione per infusione

LithuaniaEmpesin 40 TV/ 2ml koncentratas infuziniam tirpalui

LuxembourgReverpleg 40 I.U./2 ml solution à diluer pour perfusion

LatviaEmpesin 40 SV/2 ml koncentrats infuziju škiduma pagatavošanai

NetherlandsEmpressine 40 I.E./2ml, concentraat voor oplossing voor infusie

NorwayEmpressin

PolandEmpesin

PortugalEmpressin, 40 U.I./2ml, concentrado para solução para perfusão

RomaniaReverpleg 40 U.I./2 ml concentrat pentru solutie perfuzabila

SwedenEmpressin 40 I.E./2 ml Koncentrat till infusionsvätska, lösning

SloveniaEmpesin 40 i.e./2 ml koncentrat za raztopino za infundiranje

SlovakiaEmbesin 40 IU/2 ml infúzny koncentrát

Last review date of this leaflet:11/2023

This information is intended solely for healthcare professionals:

Dosage and administration

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

Argipressin should be administered by continuous intravenous infusion of 0.01U.I. per minute using a pump or a mechanical infusion pump. Depending on the clinical response, the dose can be increased every 15-20minutes up to 0.03U.I. per minute. For intensive care patients, the desired blood pressure is usually 65-75mmHg. Argipressin should only be administered with conventional vasopressor treatment with catecholamines. Doses above 0.03U.I. per minute should only be administered as emergency treatment, as they may cause skin and intestinal necrosis and an increased risk of cardiac arrest (see section 4.4 of the SmPC). The duration of treatment should be chosen according to the individual clinical picture, but preferably should last at least 48hours. Argipressin treatment should not be discontinued abruptly, but should be gradually reduced according to the patient's clinical evolution. The overall duration of argipressin treatment will be at the discretion of the responsible physician.

Dilute a solution for infusion by dissolving 2ml of the concentrate in 48ml of sodium chloride 9mg/ml solution (0.9%) (which is equivalent to 0.8U.I. of argipressin per ml). The total volume after dilution should be 50ml.

Infusion rates according to recommended doses:

Pediatric population

Argipressin has been used for the treatment of vasodilatory shock in children and newborns in intensive care units and during surgical procedures. Since argipressin, compared to conventional treatment, did not show an improvement in survival and showed higher rates of adverse events, its use is not recommended in children and newborns.

Contraindications

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

Special warnings and precautions for use

This product should not be exchanged with other medications containing argipressin with different concentration units (e.g. preservative units, UP).

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

Argipressin should only be administered under close and continuous monitoring of hemodynamic and organic parameters.

Argipressin treatment should only be initiated if a sufficient perfusion pressure cannot be maintained despite adequate volume replacement and application of catecholamine vasopressors.

Argipressin should be used with special caution in patients with cardiovascular or vascular diseases. High doses of argipressin for other indications have been observed to cause intestinal and myocardial ischemia, intestinal and myocardial infarction, and reduced perfusion in the extremities.

It is very rare for argipressin to cause hyperhydration. Early recognition of initial signs of somnolence, lethargy, and headache is essential to prevent terminal coma and seizures.

Argipressin should be used with caution in cases of epilepsy, migraine, asthma, heart failure, or any condition in which a rapid increase in extracellular fluid can pose a risk to an already overburdened organism.

In the pediatric population, the risk-benefit ratio has not been demonstrated. The use of argipressin is not recommended for this indication in children and newborns (see section 5.1 of the SmPC).