Levosimendan Kalceks

Package Leaflet: Information for the User

Levosimendan Kalceks, 2.5 mg/mL, Concentrate for Solution for Infusion

Levosimendan

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 nurse.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or nurse. See section 4.

Table of Contents of the Package Leaflet

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

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

Levosimendan Kalceks is a concentrated solution that must be diluted before intravenous infusion.
Levosimendan Kalceks works by increasing the force with which the heart pumps blood and allows blood vessels to relax. Levosimendan Kalceks reduces congestion in the lungs and facilitates blood and oxygen flow in the body. This medicine helps alleviate shortness of breath caused by severe heart failure.
Levosimendan Kalceks is used to treat heart failure in patients who still experience breathing difficulties despite taking other medications that remove excess fluid from the body.
Levosimendan Kalceks is used in adults.

2. Important information before using Levosimendan Kalceks

When not to use Levosimendan Kalceks:

• if the patient is allergic to levosimendan or any of the other ingredients of this medicine (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 to use this medicine, discuss it with your doctor or nurse if:

• the patient has any kidney or liver disease;
• the patient has a low red blood cell count (anemia) and chest pain;
• the patient has an abnormally rapid heart rate, an abnormal heart rhythm, or has been informed by a doctor that they have a heart condition called "atrial fibrillation" or have a very low potassium level in the blood;
• the patient has low blood pressure;
• the patient has a significant decrease in blood volume (hypovolemia). The doctor should use this medicine with caution. If in doubt whether any of the above points apply to the patient, consult a doctor or nurse.

Children and adolescents

This medicine should not be given to children and adolescents under 18 years of age.

Levosimendan Kalceks and other medicines

Tell your doctor or nurse about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
If the patient is taking other intravenous medicines used for heart conditions, the use of levosimendan may cause a decrease in blood pressure.
Tell your doctor or nurse if the patient is taking isosorbide mononitrate (used to treat angina pectoris, or chest pain), as levosimendan 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 a doctor before using this medicine.
It is not known whether the use of this medicine affects the unborn child. The doctor will have to decide whether the benefits for the mother outweigh the possible risks for the child.
It has been shown that levosimendan passes into human milk. Breastfeeding should be avoided during treatment with this medicine to prevent any potential adverse effect on the baby's cardiovascular system.

Levosimendan Kalceks contains alcohol

This medicine contains 3925 mg of alcohol (anhydrous ethanol) in each 5 mL vial, which is equivalent to 785 mg/mL (approximately 98% v/v). The amount of alcohol in one 5 mL vial of this medicine is equivalent to 99.2 mL of beer or 41.3 mL of wine.
The amount of alcohol in this medicine may affect the ability to drive or use machines, as it may affect judgment and reaction speed.
Pregnant women, patients with epilepsy, or those with liver problems should talk to their doctor or nurse before using this medicine.
The amount of alcohol in this medicine may alter the effects of other medicines. If the patient is taking other medicines, they should consult their doctor or nurse.
If the patient is addicted to alcohol, they should consult their doctor or nurse before using this medicine.
Since this medicine is usually administered slowly over more than 24 hours, the effect of the alcohol may be reduced.

3. How to use Levosimendan Kalceks

The medicine will be given as an intravenous infusion (drip). Therefore, this medicine should only be administered in a hospital where the doctor can monitor the patient.
The doctor will decide what dose of the medicine to give to the patient. They will assess the patient's response to the medicine (e.g., by measuring heart rate or blood pressure, performing an ECG, and/or asking about their well-being) and adjust the dose if necessary. The doctor may want to monitor the patient for up to 4-5 days after stopping this medicine.
Usually, the medicine is given to the patient as a rapid infusion over 10 minutes, followed by a slower infusion over a period of up to 24 hours.
From time to time, the doctor should assess the patient's response to levosimendan. They may reduce the infusion rate if the patient experiences a decrease in blood pressure, an increase in heart rate, or feels unwell. Tell your doctor or nurse if you experience palpitations, dizziness, or if the effect of this medicine seems too strong or too weak.
If the doctor decides that a higher dose of levosimendan is necessary and the patient is not experiencing any side effects, they may increase the infusion rate.
The doctor will continue the levosimendan infusion for as long as it is necessary to support the heart. This usually lasts for 24 hours.
The effect of the medicine on the heart lasts for at least 24 hours after the end of the levosimendan infusion. This effect may last for 7-10 days after the end of the infusion.
Kidney problems
Caution should be exercised when using this medicine in patients with mild or moderate kidney problems. Levosimendan should not be used in patients with severe kidney problems (see section 2, When not to use Levosimendan Kalceks).
Liver problems
Caution should be exercised when using this medicine in patients with mild or moderate liver problems, although dose adjustment is not necessary in these patients.
Levosimendan should not be used in patients with severe liver problems (see section 2, When not to use Levosimendan Kalceks).

Using a higher dose of Levosimendan Kalceks than recommended

If the patient receives too much of the medicine, 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 medicines, this medicine can cause side effects, although not everybody gets them.
Very common(may affect more than 1 in 10 people)

• headache
• abnormally rapid heart rate
• decrease in blood pressure

Common(may affect up to 1 in 10 people)

• low potassium levels in the blood
• insomnia
• dizziness
• heart rhythm disorders, called atrial fibrillation (part of the heart quivers instead of beating properly)
• increased heart rate
• extra heartbeats
• heart failure
• myocardial ischemia
• nausea
• constipation
• diarrhea
• vomiting
• low red blood cell count

In patients receiving levosimendan, heart rhythm disorders, called ventricular fibrillation (part of the heart quivers instead of beating properly), have been reported.
If side effects occur, tell your doctor immediately. The doctor may reduce the infusion rate or stop the levosimendan infusion.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levosimendan Kalceks

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2 °C – 8 °C).
During storage, the concentrate may change color to orange, but it does not lose its potency and can still be used until the expiry date, provided that the storage conditions have been observed.
Shelf-life after dilution
Chemical and physical stability has been demonstrated for 24 hours at 2-8 °C and 25 °C.
From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and are normally not longer than 24 hours at 2 to 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.
EXP – expiry date
Lot – batch number
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Levosimendan Kalceks contains

• The active substance is levosimendan. Each mL of concentrate contains 2.5 mg of levosimendan. Each 5 mL vial contains 12.5 mg of levosimendan.
• The other ingredients are: povidone K12, citric acid, and anhydrous ethanol.

What Levosimendan Kalceks looks like and contents of the pack

Clear solution, yellow or orange, practically free from visible particles.
Colourless glass (type I) vial with a bromobutyl rubber stopper and an aluminium seal and flip-off cap, in a cardboard box.
Pack sizes: 1 vial of 5 mL or 4 vials of 5 mL.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AS KALCEKS
Krustpils iela 71E
LV-1057 Rīga
Latvia
Phone: +371 67083320
Email: [email protected]

Date of last revision of the package leaflet:

---------------------------------------------------------------------------------------------------------------------------
Information intended for healthcare professionals only:

Special precautions for disposal of a used medicinal product or waste materials

For single use only.
Inspect the medicinal product before use. Only clear solutions free from particles should be used.
The medicinal product should be used immediately after opening. Any remaining contents should be discarded.
Levosimendan Kalceks 2.5 mg/mL, concentrate for solution for infusion, should not be diluted to a concentration greater than 0.05 mg/mL, as specified below, otherwise opalescence and precipitation may occur.

• To prepare an infusion solution with a concentration of 0.025 mg/mL, mix 5 mL of Levosimendan Kalceks 2.5 mg/mL concentrate for solution for infusion with 500 mL of 5% glucose solution or 0.9% sodium chloride infusion solution.
• To prepare an infusion solution with a concentration of 0.05 mg/mL, mix 10 mL of Levosimendan Kalceks 2.5 mg/mL concentrate for solution for infusion with 500 mL of 5% glucose solution or 0.9% sodium chloride infusion solution.

As with all products for parenteral use, inspect the diluted solution for visible particles and discoloration prior to administration.
The following medicinal products can be administered simultaneously with levosimendan through the same intravenous access:

• Furosemide 10 mg/mL
• Digoxin 0.25 mg/mL
• Glyceryl trinitrate 0.1 mg/mL

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Dosage and administration

Levosimendan Kalceks is intended for use in hospitals only. The medicine should be administered under hospital conditions where monitoring equipment and specialist care for the use of inotropic agents are available.
Levosimendan Kalceks must be diluted before administration.
The solution is for intravenous infusion only and can be administered peripherally or centrally.
For information on dosing, refer to the Summary of Product Characteristics.