LEVOSIMENDAN 2.5 mg/ml Концентрат для инфузионного раствора

Содержание инструкции

1. Levosimendan Reig Jofre 2.5 mg/mL concentrate for solution for infusion
   1. What is Levosimendan Reig Jofre and what is it used for
   2. What you need to know before using Levosimendan Reig Jofre
   3. How to use Levosimendan Reig Jofre
   4. Possible side effects
   5. How to store Levosimendan Reig Jofre
   6. Package contents and other information

Levosimendan Reig Jofre 2.5 mg/mL concentrate for solution for infusion

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effect occurs, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

• 1. What Levosimendan Reig Jofre is and what it is used for
• 2. What you need to know before you use Levosimendan Reig Jofre
• 3. How to use Levosimendan Reig Jofre
• 4. Possible side effects
• 5. How to store Levosimendan Reig Jofre
• 6. Contents of the pack and other information

1. What is Levosimendan Reig Jofre and what is it used for

Levosimendan Reig Jofre is a medicine in concentrated form and must be diluted before being
administered as an intravenous infusion.
Levosimendan Reig Jofre works by increasing the force of cardiac contraction and allows the relaxation of the
walls of blood vessels. Levosimendan Reig Jofre will reduce congestion in your lungs and facilitate
the supply of blood and oxygen to the organs. Levosimendan Reig Jofre will help you relieve shortness of breath
caused by severe heart failure.
Levosimendan Reig Jofre is indicated in the treatment of heart failure in people who still have
difficulty breathing, despite taking medicines that eliminate excess body fluids.
Levosimendan Reig Jofre is indicated in adults.

2. What you need to know before using Levosimendan Reig Jofre

Do not use LevosimendanReig Jofre

• if you are allergic to levosimendan or any of the other ingredients of this medicine (listed in section 6).
• if you have very low blood pressure or an abnormally fast heartbeat
• if you have a severe liver or kidney disease
• if you have a heart condition that prevents the heart from filling and emptying properly
• if your doctor has told you that you have had an abnormal heart rhythm called Torsade de Pointes

Warnings and precautions
Talk to your doctor or nurse before using Levosimendan Reig Jofre:

• if you have low blood pressure,
• if you are in a state of decreased blood volume (hypovolemia),
• if you have liver or kidney disease
• if you also have a low red blood cell count and if you have chest pain
• if you have a fast heartbeat, if you have an abnormal heart rhythm or if your doctor has told you that you have atrial fibrillation or a low blood potassium level, your doctor must administer Levosimendan Reig Jofre with great care.

Children and adolescents
Levosimendan Reig Jofre should not be given to children and adolescents under the age of 18
years.

Other medicines and LevosimendanReig Jofre
Tell your doctor if you are taking, have recently taken or might take any other medicines,
including those available without a prescription
If you have been given other heart medicines intravenously, your blood pressure
may drop if you are given Levosimendan Reig Jofre.
Tell your doctor if you are taking isosorbide mononitrate, as the use of Levosimendan Reig Jofre may
cause a greater drop in blood pressure when you stand up.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before using this medicine. It is not known whether Levosimendan Reig
Jofre may have an effect on your baby. The doctor must assess whether the benefit to you outweighs the potential
risks to your baby.
There is data indicating the passage of Levosimendan Reig Jofre into breast milk. You should not breastfeed
during treatment with Levosimendan Reig Jofre to avoid potential cardiovascular risks in the newborn.

Levosimendan Reig Jofre contains alcohol
This medicine contains 3925 mg of alcohol (anhydrous ethanol) in each 5 mL vial, which is equivalent to
approximately 98% vol%. The amount of alcohol in a 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 can affect your ability to drive vehicles or operate machinery.
This is because it can affect your judgment and reaction time.
If you suffer from epilepsy or liver problems, talk to your doctor or pharmacist before taking this
medicine.
The amount of alcohol in this medicine can alter the effects of other medicines. Talk to your doctor or
pharmacist if you are taking other medicines.
If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this
medicine.
If you are dependent on alcohol, talk to your doctor or pharmacist before taking this medicine.
Because this medicine is usually administered slowly over 24 hours, the effects of alcohol
may be reduced.

3. How to use Levosimendan Reig Jofre

Levosimendan Reig Jofre will be administered to you by infusion (intravenous drip). Here’s why
Levosimendan Reig Jofre must be administered only in hospital where the doctor can monitor you. The
doctor will decide how much Levosimendan Reig Jofre you should be given. Your doctor will measure your
response to Levosimendan Reig Jofre (for example by measuring your heart rate, blood pressure, ECG, and
assessing how you are feeling). If necessary, your doctor may then adjust the dosage. The
doctor may want to monitor you for up to 4-5 days after stopping Levosimendan Reig Jofre.
It may be given as a fast infusion over ten minutes, followed by a slower infusion for up to
24 hours.
Your doctor must check how you are responding to Levosimendan Reig Jofre each time. They may reduce
your infusion if your blood pressure drops suddenly or if your heart starts to beat
too fast, or if you do not feel well. Tell your doctor or nurse if you feel your
heart beating too fast, if you feel dizzy, or if you feel that the effect of Levosimendan Reig Jofre is too
strong or too weak.
If your doctor believes that you need a higher dose of Levosimendan Reig Jofre and you are not
experiencing side effects, they may increase your infusion.
Your doctor will continue the infusion of Levosimendan Reig Jofre as long as necessary to support your
heart. Usually the infusion lasts 24 hours.
The effect on your heart function will continue for at least 24 hours after the infusion of
Levosimendan Reig Jofre has been stopped. The effect may continue for 7-10 days after the infusion has ended.
Renal impairment
Levosimendan Reig Jofre must be used with caution in patients with mild to
moderate renal impairment. Levosimendan Reig Jofre should not be used in patients with severe
renal impairment (see section 2).
Hepatic impairment
Levosimendan Reig Jofre must be used with caution in patients with mild to
moderate hepatic impairment, although no dose adjustment appears to be necessary for these patients. Levosimendan
Reig Jofre should not be used in patients with severe hepatic impairment (see section 2).

If you have been given too much Levosimendan Reig Jofre
If you have been given too much Levosimendan Reig Jofre, your blood pressure may drop
suddenly and your heartbeat may accelerate. Your doctor will know how to treat you based on your
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
Abnormally fast heartbeat
Headache
Low blood pressure.

Common:may affect up to 1 in 10 people
Low potassium levels in the blood
Insomnia
Dizziness
An irregular heartbeat called atrial fibrillation (a part of the heart moves quickly and
irregularly instead of beating properly)
Extrasystoles
Heart failure
The heart does not receive enough oxygen
Nausea
Constipation
Diarrhea
Vomiting
Low blood count
In patients who have taken Levosimendan Reig Jofre, abnormal heartbeat called
ventricular fibrillation (a part of the heart moves quickly and irregularly instead of beating
properly) has been reported.
Inform your doctor immediately if you experience any side effects. Your doctor may reduce the rate of
infusion of Levosimendan Reig Jofre or stop it completely.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. You can also report side effects directly through the Italian
Medicines Agency, website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse Reporting side
effects can help provide more information on the safety of this medicine.

5. How to store Levosimendan Reig Jofre

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 which is stated on the pack. The expiry date refers to the last day of that month.
The colour of the concentrate may become more orange during storage, but this does not imply a loss of efficacy and the medicine can therefore be used until the expiry date indicated if the storage instructions are followed.

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 must be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and should generally not exceed 24 hours at a temperature between 2°C and 8°C, unless the dilution has been carried out under well controlled and validated aseptic conditions. Storage and the period for use after dilution must never exceed 24 hours.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LevosimendanReig Jofrecontains

• The active ingredient is levosimendan. Each mL of concentrate contains 2.5 mg of levosimendan. A 5 mL vial contains 12.5 mg of levosimendan.
• The other ingredients are: povidone, citric acid (for pH adjustment) and anhydrous ethanol.

Description of the appearance of Levosimendan Reig Jofre and package contents
The concentrate is a transparent solution of yellow or orange color to be diluted before administration.

Packages

• 1, 4, 10 vials (glass vials with chlorobutyl rubber closure, crimp cap and aluminum seal) of 5 mL. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Laboratorio Reig Jofre S.A.
Gran Capitán, 10
08970 Sant Joan Despí – Barcelona
Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom
(Northern Ireland) with the following denominations:
Denmark Levosimendan "Bioglan"
Germany Levosimendan Reig Jofre 2.5 mg/mL, Concentrate for the preparation of an infusion solution
Finland Levosimendan Bioglan 2.5 mg/mL infusion concentrate, for solution
France Levosimendan Reig Jofre 2.5 mg/mL, solution for dilution for perfusion
Italy Levosimendan Reig Jofre 2.5 mg/mL concentrate for solution for infusion
Norway Levosimendan Bioglan
Poland Levosimendan Reig Jofre
Portugal Levossimendano Reig Jofre 2.5 mg/mL concentrated for solution for perfusion
Sweden Levosimendan Bioglan 2.5 mg/mL concentrate for infusion fluid, solution
Spain Levosimendan Sala 2.5 mg/mL of concentrate for solution for perfusion EFG
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The following information is intended for healthcare professionals only:

Levosimendan Reig Jofre 2.5 mg/mL concentrate for solution for infusion
Instructions for use and handling
Levosimendan Reig Jofre 2.5 mg/mL concentrate for solution for infusion is intended for single use only.
Levosimendan Reig Jofre 2.5 mg/mL concentrate for solution for infusion should not be diluted to a
concentration greater than 0.05mg/mL as indicated below, otherwise opalescence and precipitation may occur.
As with all parenteral medicines, visually inspect the diluted solution for the presence of particles and discoloration before administration.

• To prepare the 0.025 mg/mL infusion, mix 5 mL of Levosimendan Reig Jofre 2.5 mg/mL concentrate for solution for infusion with 500 mL of 5% glucose solution.
• To prepare the 0.05 mg/mL infusion, mix 10 mL of Levosimendan Reig Jofre 2.5 mg/mL concentrate for solution for infusion with 500 mL of 5% glucose solution.

Dosage and method of administration
Levosimendan Reig Jofre is for hospital use only. It must be administered in a hospital setting
where adequate monitoring equipment and experience in the use of inotropic agents are available.
Levosimendan Reig Jofre must be diluted before administration.
The infusion is for intravenous use only and can be administered both peripherally and centrally.
Refer to the Summary of Product Characteristics for dosage.