Levosimendan kalceks

Package leaflet: Information for the user

Levosimendan Kalceks, 2.5 mg/mL, concentrate for solution for infusion
Levosimendanum
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or nurse. See section 4.

Contents of the leaflet

1. What Levosimendan Kalceks is and what it is used for
2. What you need to know before receiving 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 Levosimendan Kalceks is and what it is used for

Levosimendan Kalceks is a concentrated formulation of the medicine, which must be diluted before intravenous infusion.
Levosimendan Kalceks works by increasing the force with which the heart pumps blood and by causing blood vessels to dilate. Levosimendan Kalceks reduces pulmonary congestion and improves blood and oxygen flow throughout the body. This medicine helps to relieve breathlessness caused by severe heart failure.
Levosimendan Kalceks is used in the treatment of heart failure in patients who still experience breathing difficulties despite treatment with other medicines that remove excess fluid from the body.
Levosimendan Kalceks is intended for use in adults.

2. Important information before using Levosimendan Kalceks

When not to use Levosimendan Kalceks:

• if the patient is allergic to levosimendan or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has very low blood pressure or a rapid heartbeat;
• if the patient has severe kidney or liver disease;
• if the patient has a heart condition that impairs filling or emptying of the heart;
• if the patient has ever been informed by a doctor of having an abnormal heart rhythm called Torsades de Pointes.

Warnings and precautions
Before starting treatment with this medicine, discuss with the doctor or nurse if:

• the patient has any kidney or liver disease;
• the patient has a low number of blood cells (anaemia) and chest pain;
• the patient has abnormally rapid heartbeat, an irregular heart rhythm, or has ever been told by a doctor of having a heart condition called "atrial fibrillation", or extremely low blood potassium levels;
• the patient has low blood pressure;
• the patient has a significant reduction in blood volume in the body (hypovolemia). The doctor should use this medicine with great caution. If in doubt whether any of the above points apply to the patient, consult the 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 the doctor or nurse about all medicines the patient is currently taking, has recently taken, or plans to take.
If the patient is taking other intravenous medicines used for heart conditions, the use of levosimendan may cause a drop in blood pressure.
Tell the doctor or nurse if the patient is taking isosorbide mononitrate (used to treat angina (chest pain)), as levosimendan may increase the drop in blood pressure upon standing.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
It is not known whether use of this medicine affects the unborn child. The doctor will have to decide whether the benefits to the mother outweigh the potential risks to the child.
It has been shown that levosimendan passes into human milk. Breastfeeding should not be undertaken during treatment with this medicine to avoid potential adverse effects on the infant's cardiovascular system.

Levosimendan Kalceks contains alcohol
This medicine contains 3925 mg of alcohol (anhydrous ethanol) in each 5 mL vial, equivalent to 785 mg/mL (approximately 98% w/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 operate machinery, as it may impair judgment and reaction speed.
Pregnant women, patients with epilepsy, or those with liver problems should speak 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 alcohol-dependent, they should consult their doctor or nurse before using this medicine.
Since this medicine is usually administered slowly over more than 24 hours, the effects of alcohol may be reduced.

3. How to use Levosimendan Kalceks

The medicine will be given as an intravenous infusion (by infusion drip). Therefore, this medicine should only be administered in a hospital where a doctor can monitor the patient.
The doctor will decide what dose of the medicine should be given to the patient. The doctor will assess the patient's response to the medicine (e.g. by measuring pulse or blood pressure, performing an ECG and (or) asking about well-being) and, if necessary, adjust the dose. The doctor may wish to monitor the patient for up to 4–5 days after discontinuation of this medicine.
Usually, the medicine 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 periodically assess the patient's response to levosimendan. The doctor may reduce the infusion rate if the patient develops low blood pressure, increased heart rate, or feels unwell. You should tell the doctor or nurse if you experience palpitations, dizziness, or if you feel that the effect of this medicine is too strong or too weak.
If the doctor considers a higher dose of levosimendan necessary and the patient does not experience adverse effects, the doctor may increase the infusion rate.
The doctor will continue the levosimendan infusion for as long as cardiac support is required. This usually lasts 24 hours.
The effect of the medicine on the heart persists 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.

Renal impairment
Caution should be exercised when administering this medicine to patients with mild or moderate renal impairment. Levosimendan should not be used in patients with severe renal impairment (see section 2., When not to use Levosimendan Kalceks).

Hepatic impairment
Caution should be exercised when administering this medicine to patients with mild or moderate hepatic impairment, although dose adjustment is not necessary in these patients. Levosimendan should not be used in patients with severe hepatic impairment (see section 2., When not to use Levosimendan Kalceks).

Administration of a higher than recommended dose of Levosimendan Kalceks
If the patient receives too high a dose of the medicine, a decrease in blood pressure and an increased heart rate may occur. The doctor will provide appropriate treatment based on the patient's condition.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Very common (may affect more than 1 in 10 patients):

• headache
• abnormally rapid heartbeat
• decreased blood pressure

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

• low blood potassium levels
• insomnia
• dizziness
• heart rhythm disorders called atrial fibrillation (a part of the heart flutters instead of beating properly)
• increased heart rate
• extra heartbeats
• heart failure
• myocardial ischaemia
• nausea
• constipation
• diarrhoea
• vomiting
• low number of blood cells

Frequency not known (cannot be estimated from the available data):

• hypersensitivity (symptoms may include rash and itching)

In patients receiving levosimendan, heart rhythm disorders called ventricular fibrillation (a part of the heart flutters instead of beating properly) have been reported.

If adverse reactions occur, inform your doctor immediately. The doctor may reduce the infusion rate or discontinue the levosimendan infusion.

Reporting of adverse reactions

If any adverse symptoms occur, including any adverse effects not listed in this leaflet, tell your doctor or nurse.

Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions allows further collection of information on the safety of the medicine.

5. How to store Levosimendan Kalceks

Keep this medicine out of sight and reach of children.
Store in a refrigerator (2 °C – 8 °C).
During storage, the concentrate may turn orange in colour, but this does not affect its potency and it may still be used until the expiry date, provided storage instructions have been followed.
Period of stability after dilution
Chemical and physical stability has been demonstrated for 24 hours at temperatures of 2–8 °C and 25 °C.
From a microbiological standpoint, the product should be used immediately. If it is not used immediately, the responsibility for storage conditions and duration prior to use lies with the user and should normally not exceed 24 hours at a temperature of 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 stated 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. Such 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 components are: povidone K12, citric acid, and absolute ethanol.

What Levosimendan Kalceks looks like and contents of the pack
A clear, yellow or orange solution, practically free from visible particles.
Vial made of colourless glass (type I) with a bromobutyl rubber stopper, aluminium seal, and flip-off cap, packed 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 Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E
LV-1057 Rīga
Latvia
Tel.: +371 67083320
E-mail: [email protected]

Information intended exclusively for medical professionals:

Special precautions for preparing the medicinal product for use
For single use only.
The medicinal product should be inspected visually before use. Only clear solutions free from
particulate matter should be used.
The medicinal product should be used immediately after opening. Any remaining contents must be
discarded.
Levosimendan Kalceks 2.5 mg/mL concentrate for solution for infusion must not be diluted to a
concentration greater than 0.05 mg/mL, as directed 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 solution for infusion.
• 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 solution for infusion.

As with all parenteral products, the diluted solution should be inspected visually for particulate matter and discoloration before administration.
The following medicinal products may be administered simultaneously with levosimendan through the same intravenous access:

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

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Dosage and method of administration
Levosimendan Kalceks is intended for use only in hospital settings. The medicine must be administered in a hospital environment where appropriate monitoring equipment and specialist support for inotropic drugs are available.
Levosimendan Kalceks must be diluted before administration.
The solution is intended for intravenous infusion only and may be administered peripherally or centrally.
For dosage information, refer to the Product Characteristics.