Levosimendan Vaimade

Package Leaflet: Information for the User

Levosimendan Waymade, 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, talk to your doctor or nurse. See section 4.

Table of Contents of the Package Leaflet

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

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

Levosimendan Waymade is a medicine in the form of a concentrate that must be diluted before intravenous infusion.
Levosimendan Waymade increases the strength with which the heart pumps blood and allows blood vessels to relax. Levosimendan Waymade reduces congestion in the lungs and facilitates blood and oxygen flow in the body. Levosimendan Waymade helps alleviate shortness of breath caused by severe heart failure.
Levosimendan Waymade is used to treat heart failure in people who still have difficulty breathing despite taking other medicines to remove excess fluid from the body.
Levosimendan Waymade is indicated for use in adults.

2. Important information before using Levosimendan Waymade

When not to use Levosimendan Waymade:

• if the patient is allergic (hypersensitive) 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 treatment with Levosimendan Waymade, discuss it with your 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 the doctor has informed the patient that they have atrial fibrillation or low potassium levels in the blood, Levosimendan Waymade should be used with caution.

Children and adolescents

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

Levosimendan Waymade and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
If you are taking other heart medicines given intravenously, using Levosimendan Waymade may cause a drop in blood pressure.
Tell your doctor if you are taking isosorbide mononitrate, as using Levosimendan Waymade may increase the drop in blood pressure when standing up.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine. It is not known whether Levosimendan Waymade affects the baby. The doctor will have to decide whether the benefits for you outweigh the possible risks for the baby.
There are indications that Levosimendan passes into breast milk. You should not breastfeed while using Levosimendan Waymade to avoid potential cardiovascular side effects in the baby.

Levosimendan Waymade contains alcohol

This medicine contains 3925 mg of alcohol (anhydrous ethanol) per 5 ml vial, which is 98% v/v alcohol. This amount of alcohol is equivalent to 99.2 ml of beer or 41.3 ml of wine.
The amount of alcohol in this medicine may affect your ability to drive or use machines, as it may affect your judgment and reaction time.
If you have epilepsy or liver problems, consult your doctor or pharmacist before using this medicine.
The amount of alcohol in this medicine may change the effect of other medicines. If you are taking other medicines, consult your doctor or pharmacist.
If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are addicted to alcohol, consult your doctor or pharmacist before using this medicine.
Since this medicine is usually given slowly over more than 24 hours, the effect of the alcohol may be reduced.

3. How to use Levosimendan Waymade

Levosimendan Waymade is given by intravenous infusion (drip). Levosimendan Waymade is only used in a hospital, where the doctor can monitor the patient's condition. The doctor will decide what dose of Levosimendan Waymade to give. From time to time, the doctor will assess the patient's response to Levosimendan Waymade (e.g., by measuring pulse or blood pressure, performing an ECG, and/or asking about well-being). The doctor may adjust the dose if necessary.
The doctor may monitor the patient's condition for up to 4-5 days after the infusion of Levosimendan Waymade is finished.
Usually, the medicine is given to the patient as a rapid infusion over 10 minutes, followed by a slower intravenous infusion lasting up to 24 hours.
The doctor should check the patient's response to Levosimendan Waymade from time to time. The doctor may slow down the infusion rate if the patient experiences a drop in blood pressure, rapid heart rate, or poor well-being. Tell your doctor or nurse if you experience palpitations, dizziness, or if the effect of Levosimendan Waymade seems too strong or too weak.
If the doctor decides that a higher dose of Levosimendan Waymade is needed and the patient does not experience side effects, the doctor may increase the infusion rate.
The doctor will continue the infusion of Levosimendan Waymade for as long as it is necessary to support the heart. This usually lasts 24 hours.
The effect of Levosimendan Waymade on the heart lasts for at least 24 hours after the infusion is finished. The medicine may work for 7-10 days after the infusion is finished.

Overdose of Levosimendan Waymade

If too much Levosimendan Waymade is given, it may cause a drop in blood pressure and rapid 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 (affects more than 1 in 10 people):

• abnormally fast heart rate
• headache
• low blood pressure

Common (affects up to 1 in 10 people):

• low potassium levels in the blood
• insomnia
• dizziness
• heart rhythm disorders called atrial fibrillation (part of the heart flutters instead of beating properly)
• 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 flutters instead of beating properly) have been observed.
If side effects occur, tell your doctor or nurse immediately. The doctor may slow down or stop the infusion of Levosimendan Waymade.
If any side effect gets worse or if you experience any side effects not listed in this package leaflet, tell your doctor.

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Pharmacovigilance, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levosimendan Waymade

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
After dilution
Chemical and physical stability during use has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and are normally not longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions. 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 medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Levosimendan Waymade contains

• The active substance is levosimendan 2.5 mg/ml.
• The other ingredients are povidone K12, citric acid, and anhydrous ethanol.

What Levosimendan Waymade looks like and contents of the pack

The concentrate is a clear, yellow to orange solution, to be diluted before administration.
Pack sizes

• 1, 4, or 10 vials (of type I glass) of 5 ml. Outer packaging: cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

Waymade B.V.
Herikerbergweg 88
1101CM Amsterdam
Netherlands
[email protected]

Importer:

Drehm Pharma GmbH
Grünbergstraße 15/3/3
1120 Vienna
Austria
Waymade B.V.
Herikerbergweg 88
1101CM Amsterdam
Netherlands

Date of last revision of the package leaflet: September 2024

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Information intended for healthcare professionals only:

Levosimendan Waymade 2.5 mg/ml, concentrate for solution for infusion

Instructions for use and handling

Levosimendan Waymade 2.5 mg/ml, concentrate for solution for infusion is for single use only.
Levosimendan Waymade 2.5 mg/ml, concentrate for solution for infusion should not be diluted to a concentration greater than 0.05 mg/ml according to the instructions below, otherwise opalescence and precipitation may occur.
As with all products for parenteral use, the diluted solution should be inspected visually for particulate matter and discoloration prior to administration.

• To prepare an infusion solution of 0.025 mg/ml, mix 5 ml of Levosimendan Waymade 2.5 mg/ml, concentrate for solution for infusion with 500 ml of 5% glucose solution.
• To prepare an infusion solution of 0.05 mg/ml, mix 10 ml of Levosimendan Waymade 2.5 mg/ml, concentrate for solution for infusion with 500 ml of 5% glucose solution.

Dosage and administration

Levosimendan Waymade is for hospital use only. The medicine should be administered under hospital conditions where appropriate monitoring equipment and personnel experienced in the administration of inotropic agents are available.
Levosimendan Waymade should be diluted before administration.
The solution is for intravenous infusion only and may be administered peripherally or centrally.
For information on dosing, refer to the Summary of Product Characteristics.