LEVOSIMENDAN KABI 2.5 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Levosimendan Kabi 2.5 mg/ml Concentrate for Solution for Infusion EFG

Read all of this 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.
• 1. If you have any further questions, ask your doctor or nurse.

• If you experience side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Levosimendan Kabi and what is it used for
2. What you need to know before you start using Levosimendan Kabi
3. How to use Levosimendan Kabi
4. Possible side effects

5 Storage of Levosimendan Kabi

1. Package Contents and Additional Information

1. What is Levosimendan Kabi and what is it used for

Levosimendan Kabi is presented as a concentrate that must be diluted before administration by intravenous infusion.

This medicine works by increasing the heart's pumping force and allowing the relaxation of blood vessels. Levosimendan will reduce pulmonary congestion and facilitate blood and oxygen circulation in your body. Levosimendan helps alleviate the respiratory difficulty of severe heart failure.

This medicine is indicated for the treatment of heart failure in people who continue to have difficulty breathing despite taking other medications to eliminate fluid from the body.

This medicine is indicated for adults.

2. What you need to know before you start using Levosimendan Kabi

Do not use Levosimendan Kabi

• If you are allergic to levosimendan or any of the other components of this medicine (listed in section 6).
• If you have low blood pressure or tachycardia (abnormally high heart rate).
• If you have severe kidney or liver damage.
• If you have a heart condition that makes it difficult for the heart to fill and empty.
• If your doctor has told you that you have had an arrhythmia called Torsades de Pointes.

Warnings and Precautions

Consult your doctor or nurse before starting to use this medicine

• If you have liver or kidney disease.
• If you have anemia and chest pain at the same time.
• If you have tachycardia, an abnormal heart rate, your doctor has told you that you have atrial fibrillation or have abnormally low potassium levels in your blood, your doctor should use this medicine with caution.

Children and Adolescents

Levosimendan should not be administered to children and adolescents under 18 years of age.

Other Medicines and Levosimendan Kabi

Tell your doctor if you are using, have recently used, or may need to use any other medicine.

If you have been given other intravenous heart medicines, the administration of this medicine may cause a drop in blood pressure.

Tell your doctor or nurse if you are taking isosorbide mononitrate, because the use of this medicine may increase the drop in blood pressure when standing up.

Pregnancy and Breastfeeding

If you have been given other intravenous heart medicines, the administration of levosimendan may cause a drop in blood pressure. It is not known if this medicine affects your baby.

It is not known if this medicine affects your baby.

Your doctor will have to decide if the benefit to you outweighs the possible risk to your baby.

Your doctor will have to decide whether the benefit to you outweighs the possible risk to your baby.

If this medicine is used during breastfeeding, it may pass into breast milk. You should not breastfeed while being treated with levosimendan to avoid possible cardiovascular side effects in the baby.

Levosimendan Kabi contains alcohol

This medicine contains 98% ethanol (alcohol), which corresponds to 3.925 mg of alcohol (anhydrous ethanol) in each 5 ml vial, equivalent to 99.2 ml of beer or 41.3 ml of wine.

This medicine is harmful to people with alcoholism.

The alcohol content should be taken into account in the case of pregnant or breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.

The amount of alcohol in this medicine may alter the effects of other medicines. The amount of alcohol in this medicine may impair your ability to drive or operate machinery.

3. How to use Levosimendan Kabi

This medicine must be administered by intravenous infusion. For this reason, it should only be administered in a hospital where your doctor can monitor you.

Your doctor will decide the dose of levosimendan to be administered. Your doctor will follow your response to treatment (e.g., measuring your heart rate, blood pressure, electrocardiogram, and subjective sensations) and modify the dose if necessary.

Your doctor may want to monitor you for 4-5 days after the end of the administration of this medicine.

Treatment can be started with a rapid infusion for 10 minutes followed by a slow infusion for 24 hours.

Your doctor will assess your response to this medicine at different times. In this way, the infusion can be reduced if your blood pressure drops or your heart rate becomes too fast or you do not feel well.

If you feel that your heart is racing, you feel dizzy, or you have the impression that the effect of levosimendan is too strong or too weak, you should inform your doctor or nurse.

If your doctor considers that you need a higher dose of levosimendan and you are not experiencing side effects, the infusion can be increased.

Your doctor will continue the infusion of this medicine for as long as necessary to help your heart. It is usually recommended to infuse this medicine for 24 hours.

The effect on your heart function will continue for 24 hours after the infusion of the product has ended. The effect may continue for 9 days after the end of the infusion.

Renal Insufficiency

This medicine should be used with caution in patients with mild or moderate renal insufficiency.

This medicine should not be used in patients with severe renal insufficiency (see section 2).

Hepatic Insufficiency

This medicine should be used with caution in patients with mild or moderate hepatic insufficiency, although no dose adjustment is necessary. This medicine should not be used in patients with severe hepatic insufficiency (see section 2).

If you use more Levosimendan Kabi than you should

An overdose of this medicine will cause a drop in blood pressure and an increase in heart rate. Your doctor will know how to treat you according to your medical history.

4. Possible Side Effects

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

Very Common(may affect more than 1 in 10 people):

Abnormally high heart rate.

Headache.

Hypotension.

Common(may affect up to 1 in 10 people):

Potassium decrease in blood

Insomnia

Dizziness

Atrial fibrillation (a consequence of heart palpitations instead of a proper heartbeat)

Extra heartbeats

Heart failure

Decreased oxygen supply to the heart through the blood

Nausea

Constipation

Diarrhea

Vomiting

Decrease in hemoglobin

There have been reports of a heart rhythm disorder called ventricular fibrillation (as a consequence of heart palpitations instead of a proper heartbeat) in patients who received this medicine.

Please inform your doctor immediately if you experience side effects. Your doctor may reduce or stop the infusion of this medicine.

Reporting of Side Effects

If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levosimendan Kabi

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

Store in a refrigerator (between 2°C and 8°C).

Do not freeze.

Do not use this medicine after the expiry date stated on the carton.

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

The storage time and use after dilution should never exceed 24 hours.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Levosimendan Kabi

• The active substance is levosimendan 2.5 mg/ml.
• The other ingredients are povidone, citric acid, and anhydrous ethanol.

Appearance and Package Contents

The concentrate is a clear orange-yellow solution for dilution before use.

Package sizes:

• 1, 4, 10 vials (type I glass) of 5 ml

Not all package sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Fresenius Kabi España, S.A.U

Torre Mapfre-Vila Olímpica

C/Marina 16-18

08005 – Barcelona

Spain

Manufacturer

Wessling GmbH

Johann-Krane-Weg 42

48149 Münster

Germany

Or

BAG Health Care GmbH

Amtsgerichtsstrasse 1-5

D-35423 Lich

Germany

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of Last Revision of this Leaflet:December 2021

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

------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

Instructions for Use and Handling

For single use.

Levosimendan Kabi 2.5 mg/ml concentrate for solution for infusion should not be diluted to concentrations higher than 0.05 mg/ml, as this may cause opalescence and precipitation.

As with other parenteral products, the diluted solution should be visually inspected for particles and discoloration before administration.

To prepare the infusion of 0.025 mg/ml, mix 5 ml of this medicine with 500 ml of 5% glucose solution.

To prepare the infusion of 0.05 mg/ml, mix 10 ml of this medicine with 500 ml of 5% glucose solution.

Posology and Method of Administration

This medicine is for hospital use only. It should be administered in a hospital unit where there are monitoring facilities and experience with the use of inotropic agents.

This medicine should be diluted before administration.

The infusion should be performed exclusively by intravenous route, either by peripheral or central route.

Consult the summary of product characteristics for information on posology.