Label: information for theuser

Cardi-Braun Reperfusion solution for perfusion

Read this label carefully before starting tousethis medication.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult yourdoctororpharmacist.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist.

1. What isCardi-Braun Reperfusionand for what it is used

2. BeforeusingCardi-Braun Reperfusion

3. How to useCardi-Braun Reperfusion

4. Possible adverse effects

5. Storage ofCardi-Braun Reperfusion

6. Additional information

Cardi-Braun Maintenance and Cardi-Braun Reperfusión medications are intracardiac perfusion solutions (administered directly to the heart via an external device that assumes the heart's functions) belonging to the cardioplegic solution group. The two solutions are used alternately during heart operations.

B. Braun Medical cardioplegic solutions are used in open-heart surgery for:

• stopping the heart and protecting the heart muscle during the operation,
• effective resuscitation of heart function once the operation is completed.

Do Not Use Cardi-Braun Reperfusion

If you are allergic (hypersensitive) to the active ingredients or to any of the other components of Cardi-Braun Reperfusion.

If, in your clinical situation, the heart stopping technique with cardioplegic solutions poses a threat to your life.

Be Cautious with Cardi-Braun Reperfusion

Cardi-Braun cardioplegic solutions will only be used by qualified cardiac surgeons and cardiologists.

Cardi-Braun cardioplegic solutions are not administered intravenously, but are released directly into the heart through an external device that assumes the heart's functions during the operation.

During the operation, the medical team assisting you will perform a careful monitoring of your vital signs. Specifically, they will evaluate:

• your heart temperature,
• the electrocardiogram (measures the heart's electrical activity) and
• the pressure and speed at which these solutions are administered.

To recover the heart once the operation is completed, you should have access to a defibrillation device (uses electrical current to restore heartbeats) and medications that increase heart contraction strength.

Adequate vitamin supply (particularly vitamin B1) should be ensured.

Use of Other Medications

Certain medications may affect the action of Cardi-Braun solutions. In these cases, it may be necessary to adjust the dosage or discontinue treatment with one of the medications.

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

In the event of pregnancy or breastfeeding, the medical team will decide whether to use this medication.

Cardi-Braun Reperfusion Contains Sodium

This medication contains less than 23 mg of sodium (1 mmol) per 1 milliliter; that is, it is essentially "sodium-free".

This medication will always be administered by a specialized medical professional.

Your cardiac surgeon and medical team will decide what the most suitable dose is for you.

This medication is injected directly into the heart (intracardiac perfusion) through a device, called extracorporeal circulation or pulmonary derivation.

This device assumes the functions of the heart and is responsible for pumping and circulating blood. In this way, your heart remains still during the intervention and allows surgeons to operate on your heart without it moving or being filled with blood.

If you have been administered more Cardi-Braun Reperfusion than you should have:

It is unlikely that this will happen because your doctor will determine the most suitable dose for you.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone (91) 562 04 20 indicating the product and the amount administered.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, Cardi-Braun Reperfusión may cause adverse effects, although not everyone will experience them.

Your surgeon will explain which possible adverse effects are derived from the use of Cardi-Braun Reperfusión during the open-heart surgery you will undergo.

The following adverse effects of unknown frequency have been reported:

Cardiac Disorders:

Myocardial infarction, ventricular arrhythmia, ventricular fibrillation.

Complementary Diagnostic Tests:

Abnormal electrocardiogram, abnormal acid-base balance.

Metabolism and Nutrition Disorders:

Electrolyte imbalance, hyperglycemia (in patients receiving solutions with high glucose content; may require insulin administration).

Once the operation is completed and blood circulation is restored, the heart rate may slow down, requiring defibrillation (use of electrical current to restore heart rhythm) and the use of medications to restore normal heart function.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Cardi-Braun Reperfusion after the expiration date indicated on the packaging. The expiration date is the last day of the month indicated.

Do not use Cardi-Braun Reperfusion if the solution shows turbidity or sedimentation.

Do not use Cardi-Braun Reperfusion if the packaging shows visible signs of deterioration.

Any unused solution must be disposed of in accordance with local requirements.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of unused packaging and medicines. This will help protect the environment.

Cardi-Braun Reperfusion Composition

The active principles are:

Per 1 mlPer 500 ml

Trometamol8,5620mg4,2810 g

Sodium Citrate6,1963mg3,0981 g

Monohydrate Citric Acid0,7730mg0,3865 g

Dihydrated Sodium Dihydrogen Phosphate0,5913mg0,2956 g

Potassium Chloride2,3419mg1,1709 g

Monohydrate Glucose40,5530mg20,2765 g

Aspartic Acid7,8970mg3,9490 g

Glutamic Acid8,7990mg4,4000 g

Electrolyte Composition:

Phosphates3,79mmol/l

Citrate24,74mmol/l

Sodium186,2mmol/l

Potassium31,4mmol/l

Chlorides31,4mmol/l

Acetates11mmol/l

The other components are: Acetic Acid (pH adjustment), Sodium Hydroxide, and water for injectable preparations

Product Appearance and Packaging Content

Cardi-Braun Reperfusion is an incolor and transparent perfusion solution that is presented in a single unit container containing a 500 ml flexible plastic bag.

Marketing Authorization Holder and Responsible Manufacturer

B. Braun Medical SA

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

This information is intended solely for medical professionals or healthcare professionals:

Cardi-Braun Reperfusion intracardiac perfusion solution is a ready-to-use solution.

Administration is performed through commercial systems that distribute the solution through the cardiopulmonary bypass apparatus.

The volumes of solution perfused depend on the duration or type of open-heart surgical procedure.

Cardi-Braun cardioplegic solutions can be administered to the coronary circulation through two routes - anterograde and retrograde - or in a mixed manner.

Cardi-Braun Reperfusion requires the addition of 2M potassium chloride for the warm induction phase.The addition of the potassium chloride solution must be performed under strict aseptic conditions.

Instructions for the correct use of Cardi-Braun cardioplegic solutions

Deploy the bag and place it on a hard surface. Open the central joint by pressing with both hands on one of the bag's chambers.

Mix the contents by inverting the bag several times. The homogeneous mixture is ready for use.

The addition of the potassium chloride solution can be incorporated directly into the bag through a syringe in the connector located at the bottom of the bag, using an aseptic procedure.

Remove the white cap from the perfusion connector. Clean the connector and insert the intracardiac perfusion equipment. Perfuse according to protocol.

Once the container is opened, use immediately.

Dispose of the unused fraction of the solution.

B|BRAUN