Summary of Product Characteristics: Information for the User

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

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

• Keep this summary, as you may need to read it again.
• 1. If you have any questions, consult your doctor or nurse.

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

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

2.What you need to know before starting to use Levosimendan Kabi

3.How to use Levosimendan Kabi

4.Possible side effects

5Storage of Levosimendan Kabi

6.Contents of the pack and additional information

Levosimendan Kabi is presented in a concentrated form that must be diluted before administration via intravenous infusion.

This medication acts by increasing the heart's pumping force and allowing blood vessel relaxation. Levosimendan will reduce pulmonary congestion and facilitate blood and oxygen circulation throughout the body. Levosimendan helps to alleviate severe heart failure respiratory difficulty.

This medication is indicated for the treatment of heart failure in individuals who continue to experience breathing difficulties despite taking other medications to remove fluids from the body.

This medication is indicated for adults.

Do not use Levosimendán Kabi

• If you are allergic to levosimendán or any of the other components of this medication (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 disease that makes it difficult for the heart to fill and empty.
• If your doctor has told you that you have had a type of arrhythmia called Torsades de Pointes.

Warnings and precautions

Consult your doctor or nurse before starting to use this medication

• If you have liver or kidney disease.
• If you have anemia and chest pain at the same time.
• If you have tachycardia, your doctor has told you that you have atrial fibrillation or have abnormally low levels of potassium in your blood, your doctor must use this medication with great caution.

Children and adolescents

Levosimendán should not be administered to children and adolescents under 18 years old.

Other medications and Levosimendán Kabi

Inform your doctor if you are using, have used recently, or may have to use any other medication

If you have been given other intravenous cardiac medications, the administration of this medication may cause a drop in blood pressure

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

Pregnancy and breastfeeding

If you have been given other intravenous cardiac medications, the administration of levosimendán may cause a drop in blood pressure.It is unknown if this medication affects your baby.It is not known if affects your baby.

No se sabe si afecta a su bebé.

It is not known if affects your baby.

You cannot load all the results

Try again

Trying again...

Trying again...

Your doctor will have to decide whether 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.

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

Your doctor will need to decide if the benefit to you is worth the possible risk to your baby.

You cannot load all the results

Try again

Trying again...

Trying again...

There are indications that this medication passes into breast milk. Do not breastfeed while being treated with levosimendán, to avoid possible cardiovascular adverse effects in the child.

Levosimendán Kabicontains alcohol

This medication contains 98% ethanol (alcohol), which corresponds to a quantity of 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 medication is harmful to people with alcoholism.

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

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

This medicine must be administered through intravenous infusion (drip). Therefore, it should only be administered in a hospital where your doctor can monitor you. Your doctor will decide the dose of levosimendan to administer. Your doctor will follow your response to treatment (for example, by measuring your heart rate, blood pressure, electrocardiogram, and subjective sensations), and adjust the dose if necessary. Your doctor may want to monitor you for 4-5 days after the completion of this medication administration.

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

Your doctor will evaluate your response to this medication at different times. In this way, they can decrease the infusion if your blood pressure drops or your heart rate begins to be too fast or you do not feel well. If you feel that your heart is racing, you feel dizzy or have the impression that the effect of levosimendan is too strong or too light, you must inform your doctor or nurse.

If your doctor considers that you need a higher dose of levosimendan and you are not experiencing side effects, they may increase the infusion.

Your doctor will continue the infusion of this medication as long as they deem necessary to help your heart. Generally, it is recommended to infuse this medication for 24 hours.

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

Renal Insufficiency

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

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

Liver Insufficiency

This medication should be used with caution in patients with mild or moderate liver insufficiency, despite not requiring a dose adjustment. This medication should not be used in patients with severe liver insufficiency (see section 2).

If you use more Levosimendan Kabi than you should

A overdose of this medication will produce a drop in blood pressure and an increase in heart rate. Your doctor will know how to treat it according to your medical history.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Abnormally high heart rate.

Headache.

Hypotension.

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

Decrease in potassium levels in the blood.

Insomnia.

Dizziness.

Abnormal heart rhythm called atrial fibrillation (a consequence of heart palpitations instead of a normal heartbeat)

Additional heartbeats.

Heart failure.

Decrease in oxygen supply to the heart through the blood.

Nausea.

Constipation.

Diarrhea.

Vomiting.

Decrease in hemoglobin.

Cases of a heart rhythm alteration called ventricular fibrillation (a consequence of heart palpitations instead of a normal heartbeat) have been reported in patients who receivedthis medication.

Please inform your doctor immediately if you experience any side effects. Your doctor may reduce or stop the infusion ofthis medication.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

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

Do not freeze.

Do not use this medication after the expiration date that appears on the box.

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

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

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 Levosimendan Kabi

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

Appearance of the product and contents of the package

The concentrate is a clear yellow-orange solution to be diluted before use.

Package sizes:

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

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Fresenius Kabi España, S.A.U

Torre Mapfre-Vila Olímpica

C/Marina 16-18

08005 – Barcelona

Spain

Manufacturer responsible

Wessling GmbH

Johann-Krane-Weg 42

48149 Münster

Germany

O

BAG Health Care GmbH

Amtsgerichtsstrasse 1-5

D-35423 Lich

Germany

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

Last review date of this leaflet:December 2021

For detailed information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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

This information is intended solely for healthcare professionals:

Instructions for use and handling

For single use only.

Levosimendan Kabi 2.5 mg/ml concentrate for solution for infusion should not be diluted to concentrations above 0.05 mg/ml as indicated below, as otherwise opalescence and precipitation may occur.

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

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

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

Posology and method of administration

This medicinal product is only for hospital use. It should be administered in a hospital unit with monitoring facilities and experience with the use of inotropic agents.

This medicinal product should be diluted before administration.

The infusion should be administered exclusively by intravenous route, both by peripheral and central routes.

See the technical data sheet for information on posology.