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Levosimendan Mercapharm

Levosimendan Mercapharm

About the medicine

How to use Levosimendan Mercapharm

Package Leaflet: Information for the User

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

Levosimendan

Read All of This Leaflet Carefully Before Using This Medicine.

  • Keep This Leaflet. You May Need to Read It Again.
  • If You Have Any Further Questions, Ask Your Doctor or Nurse.
  • If You Get Any Side Effects, Talk to Your Doctor or Nurse. This Includes Any Possible Side Effects Not Listed in This Leaflet. See Section 4.

Contents of the Pack

  • 1. What is Levosimendan Mercapharm and What It Is Used For
  • 2. Before You Use Levosimendan Mercapharm
  • 3. How to Use Levosimendan Mercapharm
  • 4. Possible Side Effects
  • 5. How to Store Levosimendan Mercapharm
  • 6. Contents of the Pack and Other Information

1. What is Levosimendan Mercapharm and What It Is Used For

Levosimendan Mercapharm is a medicine that is given as an infusion into a vein. It is used to treat adults with severe heart failure who are having trouble breathing despite receiving other treatments.

2. Before You Use Levosimendan Mercapharm

Do Not Use Levosimendan Mercapharm:

  • If You Are Allergic to Levosimendan or Any of the Other Ingredients of This Medicine;
  • If You Have Very Low Blood Pressure and a Fast Heart Rate;
  • If You Have a Heart Condition That Makes It Difficult for Your Heart to Fill or Empty Properly;
  • If You Have Severe Kidney Disease;
  • If You Have Severe Liver Disease;
  • If You Have Ever Been Told by a Doctor That You Have an Abnormal Heart Rhythm Called Torsades de Pointes.

Warnings and Precautions

You Should Discuss This with Your Doctor or Nurse Before Starting Treatment with This Medicine:

  • If You Have Low Blood Pressure;
  • If You Have a Low Blood Volume (Hypovolemia);
  • If You Have Any Kidney or Liver Disease;
  • If You Have Ever Been Told by a Doctor That You Have a Low Potassium Level in Your Blood;
  • If You Have a Low Red Blood Cell Count and Chest Pain;
  • If You Have a Fast Heart Rate, Abnormal Heart Rhythm, or Have Ever Been Told by a Doctor That You Have Atrial Fibrillation.

If You Have Any of These Conditions or Symptoms, You Should Discuss Them with Your Doctor or Nurse.

Children and Adolescents

The Safety and Efficacy of Levosimendan Mercapharm in Children and Adolescents Below 18 Years of Age Have Not Been Established.

Levosimendan Mercapharm and Other Medicines

Tell Your Doctor About All Medicines You Are Taking or Have Recently Taken, Including Those You Can Buy Without a Prescription.

Pregnancy and Breast-Feeding

If You Are Pregnant or Breast-Feeding, Think You May Be Pregnant or Are Planning to Have a Baby, Ask Your Doctor for Advice Before Taking This Medicine.

Levosimendan Mercapharm Contains Alcohol

This Medicine Contains 3925 mg of Alcohol (Anhydrous Ethanol) in Each 5 mL Vial, Which Is Equivalent to 98% V/V Alcohol.

3. How to Use Levosimendan Mercapharm

Levosimendan Mercapharm Is for Hospital Use Only. It Will Be Given to You by a Doctor or Nurse in a Hospital.

Overdose

If You Receive Too Much Levosimendan Mercapharm, You May Experience a Decrease in Blood Pressure and a Faster Heart Rate.

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):
  • Fast Heart Rate
  • Headache
  • Low Blood Pressure

If You Experience Any Side Effects, Tell Your Doctor or Nurse Immediately.

Reporting of Side Effects

If You Get Any Side Effects, Talk to Your Doctor or Nurse. This Includes Any Possible Side Effects Not Listed in This Leaflet.

5. How to Store Levosimendan Mercapharm

Keep This Medicine Out of the Sight and Reach of Children.

Do Not Use This Medicine After the Expiry Date Which Is Stated on the Vial or Carton.

6. Contents of the Pack and Other Information

What Levosimendan Mercapharm Contains

  • The Active Substance Is Levosimendan 2.5 mg/mL.
  • The Other Ingredients Are Povidone, Citric Acid, and Anhydrous Ethanol.

What Levosimendan Mercapharm Looks Like and Contents of the Pack

Levosimendan Mercapharm Is a Clear, Yellow or Orange Solution.

  • 1 Vial (Type I Glass) of 5 mL, in a Cardboard Box.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Mercapharm Sp. z o.o.

Manufacturer

Pharmidea SIA, Rupnicu Iela 4, Olaine, Olaines Novads, 2114, Latvia

This Medicinal Product Is Authorised in the Member States of the European Economic Area Under the Following Names:

Estonia: Levosimendan Auxilia

France: Levosimendan Pharmidea 2.5 mg/ml, solution à diluer pour perfusion

Spain: Levosimendan ever pharma 2.5 mg/ml concentrado para solucion para perfusion efg

Poland: Levosimendan Mercapharm

Portugal: Levosimendano ever pharma 2.5 MG/ML Concentrado para solução para perfusão

Date of Last Revision of the Leaflet:

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Information Intended for Healthcare Professionals Only:

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

Instructions for Use and Handling

Levosimendan Mercapharm 2.5 mg/mL, Concentrate for Solution for Infusion Is for Single Use Only.

  • In Order to Prepare an Infusion Solution of 0.025 mg/mL, 5 mL of Levosimendan Mercapharm 2.5 mg/mL Concentrate for Solution for Infusion Should Be Mixed with 500 mL of 5% Glucose Solution.
  • In Order to Prepare an Infusion Solution of 0.05 mg/mL, 10 mL of Levosimendan Mercapharm 2.5 mg/mL Concentrate for Solution for Infusion Should Be Mixed with 500 mL of 5% Glucose Solution.

Levosimendan Mercapharm May Be Used in Combination with the Following Medicines at the Specified Concentrations, Administered Through the Same Intravenous Line:

  • Furosemide 10 mg/mL
  • Digoxin 0.25 mg/mL
  • Glyceryl Trinitrate 0.1 mg/mL
  • Country of registration
  • Active substance
  • Prescription required
    No
  • Manufacturer
  • Importer
    PHARMIDEA SIA

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