Cardi-Braun maintenance solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cardi-Braun Maintenance infusion solution

Read the entire package leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Cardi-Braun Maintenance is and what it is used for
2. Before using Cardi-Braun Maintenance
3. How to use Cardi-Braun Maintenance
4. Possible adverse effects
5. Storage of Cardi-Braun Maintenance
6. Additional information

1. What Cardi-Braun Maintenance is and what it is used for

Cardi-Braun Maintenance and Cardi-Braun Reperfusion are cardioplegic solutions for intracardiac perfusion (administered directly into the heart via an external device that takes over its functions) belonging to the group of medicines known as cardioplegic solutions. The two solutions are used alternately during heart surgery.

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

• stop the heart and protect the heart muscle during surgery,
• achieve effective resuscitation of heart function after completion of the procedure.

2. Before using Cardi-Braun Maintenance

Do not use Cardi-Braun Maintenance

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

If, due to your clinical condition, the technique of cardiac arrest using cardioplegic solutions may pose a threat to your life.

Take special care with Cardi-Braun Maintenance

Cardi-Braun cardioplegic solutions shall only be used by qualified cardiac surgeons and specialists.

Cardi-Braun cardioplegic solutions are not administered intravenously; they are delivered directly to the heart through an external device that assumes the functions of the heart during surgery.

During the operation, the medical team attending you will carefully monitor your vital signs.

Specifically, they will assess:

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

For the heart's recovery after completion of the operation, a defibrillation team (using electrical current to restore heart rhythm) and medications to enhance the heart's contractile force must be available.

An adequate supply of vitamins (particularly vitamin B1) must be ensured.

Use of other medicines

Certain medicines may influence the action of Cardi-Braun solutions. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

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

Pregnancy and Lactation

Consult your doctor or pharmacist before using any medication.

If you are pregnant or breastfeeding, your healthcare provider will decide whether it is appropriate to use this medicine.

3. How to use Cardi-Braun Maintenance

This medicine will always be administered by specialized medical personnel.

Your cardiac surgeon and medical team will decide the most appropriate dose for you.

This medicine is injected directly into the heart (intracardiac perfusion) through a device called a cardiopulmonary bypass machine or extracorporeal circulation device.

This device takes over the function of the heart and manages blood pumping and circulation. This allows your heart to remain still during the procedure and enables surgeons to operate on your heart without movement or blood filling it.

If you have been given more Cardi-Braun Maintenance than you should have received:

This is unlikely to occur, as your doctor will determine the most appropriate dose for you.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone (91) 562 04 20, indicating the product and the amount administered.

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

4. Possible adverse effects

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

Your surgeon will explain the possible adverse effects associated with the use of Cardi-Braun Maintenance during the open-heart surgery you are about to undergo.

The following adverse effects have been reported with unknown frequency:

Cardiac disorders:

Myocardial infarction, ventricular arrhythmia, ventricular fibrillation.

Investigations:

Abnormal electrocardiogram, abnormal acid-base balance.

Metabolism and nutrition disorders:

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

After completion of the operation and restoration of blood circulation, heartbeats may be delayed; therefore, defibrillation of the heart (use of electric current to restore heart rhythm) and administration of medications to restore normal cardiac function may be necessary.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not mentioned in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cardi-Braun Maintenance

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Cardi-Braun Maintenance after the expiry date stated on the container. The expiry date is the last day of the month indicated.

Do not use Cardi-Braun Maintenance if the solution is cloudy or shows signs of sedimentation.

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

Any unused solution must be disposed of according to local requirements.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Additional Information

Composition of Cardi-Braun Maintenance

The active substances are:

Per 1 ml Per 500 ml

Tromethamine 8.7560 mg 4.3780 g
Sodium citrate 1.5840 mg 0.7920 g
Citric acid monohydrate 0.1976 mg 0.0988 g
Disodium dihydrogen phosphate dihydrate 0.1512 mg 0.0756 g
Potassium chloride 1.7960 mg 0.8980 g
Sodium chloride 9.8600 mg 4.9300 g
Glucose monohydrate 34.6600 mg 17.3300 g

Electrolytic composition:
Phosphates 0.97 mmol/l
Citrate 6.32 mmol/l
Sodium 185.8 mmol/l
Potassium 24.1 mmol/l
Chloride 192.8 mmol/l
Acetate 23 mmol/l

The other components are: Acetic acid (pH adjustment) and water for injections.

Appearance of the product and contents of the container

Cardi-Braun Maintenance is a colourless and transparent infusion solution supplied in a single-unit container consisting of a flexible plastic bag containing 500 ml.

Marketing Authorization Holder and Manufacturer

• Braun Medical, S.A.
  Ctra. de Terrassa, 121
  08191-Rubí (Barcelona)

This summary of product characteristics was approved in: December 2024

This information is intended exclusively for physicians or healthcare professionals:

Cardi-Braun Maintenance infusion solution for intracardiac administration is a ready-to-use solution.
It is administered via commercial systems that deliver the solution through the cardiopulmonary bypass apparatus.
The volumes of solution infused depend on the duration or type of open-heart surgical procedure.

Cardioplegic solutions Cardi-Braun may be delivered to the coronary circulation via two routes—antegrade and retrograde—or by a mixed approach.

Cardi-Braun Maintenance requires the addition of 2M potassium chloride solution for the cold induction phase. The addition of potassium chloride solution must be performed under strictly aseptic conditions.

Instructions for the correct use of Cardi-Braun cardioplegic solutions

Unfold the bag and place it on a hard surface. Open the central seal by pressing with both hands on one of the chambers of the bag.

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

The potassium chloride solution may be added directly into the bag using a syringe through the connector located at the bottom of the bag, using an aseptic technique.

Remove the white cap from the infusion connector. Clean the connector and attach the intracardiac infusion set. Administer according to protocol.

Once the container has been opened, use immediately.
Discard any unused portion of the solution.

B|BRAUN