Levosimendan Kabi

Package Leaflet: Information for the User

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

Levosimendan

Read the Package Leaflet Carefully Before Using the Medicinal Product, 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.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Levosimendan Kabi and What is it Used For
• 2. Important Information Before Using Levosimendan Kabi
• 3. How to Use Levosimendan Kabi
• 4. Possible Side Effects
• 5. How to Store Levosimendan Kabi
• 6. Contents of the Package and Other Information

1. What is Levosimendan Kabi and What is it Used For

Levosimendan Kabi is a concentrated solution for infusion that must be diluted before intravenous administration.
Levosimendan Kabi increases the strength of the heart's contractions and allows blood vessels to relax.
This leads to a reduction in congestion in the lungs and improved blood flow and oxygen supply to the body.
Levosimendan Kabi helps alleviate shortness of breath caused by severe heart failure.
Levosimendan Kabi is used for the short-term treatment of acute, decompensated, severe, chronic heart failure in adult patients who continue to experience breathing difficulties despite the use of other medications that remove excess fluid from the body.
Levosimendan Kabi is indicated for use in adult patients.

2. Important Information Before Using Levosimendan Kabi

When Not to Use Levosimendan Kabi:

• if the patient is hypersensitive to levosimendan or any of the other ingredients of this medicinal product (listed in section 6);
• if the patient has very low blood pressure or a rapid heart rate;
• if the patient has severe kidney or liver disease;
• if the patient has heart disease that makes it difficult for the heart to fill or empty;
• if the patient has been informed by a doctor that they have an abnormal heart rhythm called Torsades de Pointes.

Warnings and Precautions

Before starting treatment with Levosimendan Kabi, the patient should discuss the following with their doctor or nurse:

• if the patient has any kidney or liver disease;
• if the patient has a low red blood cell count and chest pain;
• if the patient has a rapid heart rate, abnormal heart rhythm, or has been informed by a doctor that they have atrial fibrillation or low potassium levels in the blood, Levosimendan Kabi should be used with caution.

Children and Adolescents

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

Levosimendan Kabi and Other Medicinal Products

The patient should inform their doctor about all medicinal products they are currently taking or have recently taken, as well as any medicinal products they plan to take.
If the patient is taking other intravenous heart medications, the use of Levosimendan Kabi may cause a decrease in blood pressure.
The patient should inform their doctor about the use of isosorbide mononitrate, as the use of Levosimendan Kabi may increase the decrease in blood pressure when standing up.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicinal product.
It is not known whether the use of Levosimendan Kabi has an effect on the unborn child. The doctor will decide whether the benefits to the mother outweigh the risks to the fetus.
There are indications that Levosimendan Kabi passes into human milk, so breastfeeding should be avoided during treatment with Levosimendan Kabi to prevent potential cardiovascular side effects in infants.

Levosimendan Kabi Contains Alcohol

This medicinal product contains 3925 mg of alcohol (anhydrous ethanol) per 5 ml vial, which is equivalent to 98% v/v. The amount of alcohol in one 5 ml vial of this medicinal product is equivalent to 99.2 ml of beer or 41.3 ml of wine.
The amount of alcohol in this medicinal product may affect the ability to drive and use machines, as it may affect the assessment of the situation and reaction time.
If the patient has epilepsy or liver problems, they should consult their doctor or pharmacist before using this medicinal product.
The amount of alcohol in this medicinal product may alter the effects of other medicinal products. If the patient is taking other medicinal products, they should consult their doctor or pharmacist.
If the patient is pregnant or breastfeeding, they should consult their doctor or pharmacist before using this medicinal product.
If the patient is addicted to alcohol, they should consult their doctor or pharmacist before using this medicinal product.
Since this medicinal product is administered slowly over 24 hours, the effects of alcohol may be reduced.

3. How to Use Levosimendan Kabi

Levosimendan Kabi is administered as an intravenous infusion. Levosimendan Kabi is only used in a hospital setting, where the doctor can monitor the patient's condition. The doctor will decide what dose of Levosimendan Kabi to administer. The doctor will regularly assess the patient's response to Levosimendan Kabi (e.g., by measuring heart rate or blood pressure, performing an ECG, and/or asking about their well-being) and adjust the dose as necessary. The doctor may monitor the patient's condition for up to 4-5 days after the infusion is completed.
Usually, the medicinal product is administered to the patient as a rapid infusion over 10 minutes, followed by a slower intravenous infusion lasting up to 24 hours.
The doctor should regularly check the patient's response to Levosimendan Kabi. The doctor may reduce the infusion rate if the patient experiences a decrease in blood pressure, an increase in heart rate, or feels unwell. The patient should inform their doctor or nurse if they experience palpitations, dizziness, or if the effects of Levosimendan Kabi seem too strong or too weak.
If the doctor decides that a higher dose of Levosimendan Kabi is necessary and the patient does not experience any side effects, they may increase the infusion rate.
The doctor will continue the infusion of Levosimendan Kabi for as long as necessary to support the heart. This usually lasts for 24 hours.
The effects of Levosimendan Kabi on the heart last for at least 24 hours after the infusion is completed. The medicinal product may continue to work for up to 9 days after the infusion is completed.
Renal Impairment
Caution should be exercised when using Levosimendan Kabi in patients with mild or moderate renal impairment. The medicinal product should not be used in patients with severe renal impairment (see section 2).
Hepatic Impairment
Caution should be exercised when using Levosimendan Kabi in patients with mild or moderate hepatic impairment, although dose adjustment is not necessary in these patients. The medicinal product should not be used in patients with severe hepatic impairment (see section 2).

Overdose of Levosimendan Kabi

If the patient receives too high a dose of Levosimendan Kabi, they may experience a decrease in blood pressure and an increase in heart rate. The doctor will provide appropriate treatment based on the patient's condition.

4. Possible Side Effects

Like all medicinal products, Levosimendan Kabi can cause side effects, although not everybody gets them.

Very Common (May Affect More Than 1 in 10 Patients):

• abnormal heart rate;
• headache;
• decrease in blood pressure.

Common (May Affect Up to 1 in 10 Patients):

• low potassium levels in the blood;
• insomnia;
• dizziness;
• abnormal heart rhythm, called atrial fibrillation (a part of the heart flutters instead of beating properly);
• extra heartbeats;
• heart failure;
• myocardial ischemia;
• nausea;
• constipation;
• diarrhea;
• vomiting;
• low blood cell count.

In patients receiving Levosimendan Kabi, there have been reports of abnormal heart rhythms, called ventricular fibrillation (a part of the heart flutters instead of beating properly).
If side effects occur, the patient should immediately inform their doctor or nurse. The doctor may reduce the infusion rate or stop the infusion of Levosimendan Kabi.

Reporting Side Effects

If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicinal product.

5. How to Store Levosimendan Kabi

The medicinal product should be stored out of sight and reach of children.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Do not use this medicinal product after the expiry date stated on the vial and carton. The expiry date refers to the last day of the month.
The shelf-life of the diluted solution is not longer than 24 hours.
Medicinal products should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicinal products they no longer use. This will help protect the environment.

6. Contents of the Package and Other Information

What Levosimendan Kabi Contains

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

What Levosimendan Kabi Looks Like and Contents of the Package

The concentrate is a clear, yellow to orange solution for dilution prior to administration.
Pack sizes:
1, 4, or 10 vials (type I glass) of 5 ml, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

BAG Health Care GmbH
Amtsgerichtsstrasse 1-5
D-35423 Lich
Germany
For further information, please contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134, 02-305 Warsaw
tel.: +48 22 345 67 89

This Medicinal Product is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under the Following Names:

Date of Last Revision of the Package Leaflet:01.01.2023
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Information Intended for Healthcare Professionals Only:

Instructions for Use and Handling

Levosimendan Kabi is intended for single use only.
Levosimendan Kabi should not be diluted to a concentration higher than 0.05 mg/ml, as specified in the instructions below, otherwise opalescence and precipitation may occur.
As with all parenteral medicinal products, the diluted solution should be inspected visually for particulate matter and discoloration prior to administration.

• to prepare an infusion solution with a concentration of 0.025 mg/ml, 5 ml of Levosimendan Kabi concentrate for solution for infusion, 2.5 mg/ml should be mixed with 500 ml of 5% glucose solution;
• to prepare an infusion solution with a concentration of 0.05 mg/ml, 10 ml of Levosimendan Kabi concentrate for solution for infusion, 2.5 mg/ml should be mixed with 500 ml of 5% glucose solution.

Dosage and Administration

Levosimendan Kabi is intended for use in a hospital setting only. The medicinal product should be administered under conditions where monitoring equipment and personnel experienced in the use of inotropic agents are available.
Levosimendan Kabi should be diluted prior to administration.
The solution is intended for intravenous infusion only and may be administered peripherally or centrally.
For information on dosing, please refer to the Summary of Product Characteristics.