Prospecto:information for theuser

Cardi-Braun Maintenance solution for perfusion

Read this prospectus carefully before starting to usethis medication.

• Keep this prospectus, 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 is severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

2. BeforeusingCardi-Braun Maintenance

3. Howto useCardi-Braun Maintenance

4. Possible adverse effects

5. Storage ofCardi-Braun Maintenance

6. Additional information

Cardi-Braun Maintenance and Cardi-Braun Reperfusión medications are solutions for intracardiac perfusion (administered directly to the heart via an external device that assumes the heart's functions) that belong to the group of medications known as cardioplegic solutions. The two solutions are used alternately during heart operations.that assume the functionsof this) that belong to the group of medications known as cardioplegic solutions. 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 Maintenance

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

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

Be Especially Cautious with Cardi-Braun Maintenance

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 functions of the heart during the operation.

During the operation, the medical team assisting you will perform a careful control of your vital signs.

In particular, they will evaluate:

• the temperature of your heart,
• the electrocardiogram (measures the electrical activity of the heart) 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 the heart's contraction force.

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.

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

Your cardiac surgeon and medical team will decide on the most suitable dose 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 procedure and allows surgeons to operate on your heart without it moving or being filled with blood.

If you have been administered more Cardi-Braun Maintenance 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 Maintenance may cause adverse effects, although not everyone will experience them.

Your surgeon will explain the possible adverse effects derived from the use of Cardi-Braun Maintenance 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 reach and sight of children.

No special conservation conditions are required.

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

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

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

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

Medicines should not be thrown away 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 Maintenance Composition

The active principles are:

By 1 ml By 500 ml

Trometamol 8,7560 mg 4,3780g

Sodium Citrate 1,5840 mg 0,7920g

Citric Acid Monohydrate 0,1976 mg 0,0988g

Dihydrogen Phosphate of Sodium Dihydrate 0,1512 mg 0,0756g

Potassium Chloride 1,7960 mg 0,8980g

Sodium Chloride 9,8600 mg 4,9300g

Glucose Monohydrate 34,6600 mg 17,3300 g

Electrolyte Composition:

Phosphates 0,97 mmol/l

Citrate 6,32 mmol/l

Sodium 185,8 mmol/l

Potassium 24,1 mmol/l

Chlorides 192,8 mmol/l

Acetates 23 mmol/l

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

Product Appearance and Packaging Content

Cardi-Braun Maintenance is a colorless and transparent perfusion solution presented in a single-dose container containing a flexible plastic bag of 500 ml.

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 Maintenance perfusion solution for intracardiac administration 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 solutions can be administered to the coronary circulation through two routes -anterograde and retrograde- or in a mixed manner.

Cardi-Braun Maintenance requires the addition of 2M potassium chloride for the cold 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 at the lower connector of the same, using an aseptic procedure.

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

Once the container is opened, use immediately.

Dispose of the unused fraction of the solution.

B|BRAUN