Cardi-Braun reperfusion solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cardi-Braun Reperfusion solution for infusion

Read the entire 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 effects not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents

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

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

Cardi-Braun Maintenance and Cardi-Braun Reperfusion are cardioplegic perfusion solutions (administered directly to the heart via an external device that takes over its functions) belonging to a group of medicines called 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,
• effectively resuscitate heart function after completion of the surgery.

2. Before using Cardi-Braun Reperfusion

2.1. When not to use Cardi-Braun Reperfusión

Do not use Cardi-Braun Reperfusion:

• if you are allergic to ascorbic acid (Acidum ascorbicum), sodium chloride (Natrium chloratum), or any of the other ingredients of this medicine (listed in section 6);
• if you have glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency);
• if you have a high level of iron in the blood (hemochromatosis);
• if you have a high level of oxalic acid in the urine (hyperoxaluria);
• if you have a history of kidney stones caused by oxalate.

2.2. Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Cardi-Braun Reperfusion:

• if you have kidney problems;
• if you have heart problems;
• if you have a history of kidney stones;
• if you have a genetic disorder affecting iron metabolism;
• if you are undergoing dialysis;
• if you are receiving other intravenous solutions or medications.

Vitamin C (ascorbic acid) may interfere with certain laboratory tests, including blood and urine glucose tests. Inform your healthcare provider if you are using this medicine.

2.3. Interactions with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, especially:

• anticoagulants (e.g., warfarin);
• chemotherapy agents;
• aspirin or other salicylates;
• oral contraceptives;
• deferoxamine (used in iron overload);
• drugs metabolized by CYP3A4 enzymes;
• other intravenous vitamin C or electrolyte solutions.

High doses of ascorbic acid may affect the effectiveness of certain medicines.

2.4. Use during pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, talk to your doctor before using this medicine.

Ascorbic acid crosses the placenta. While vitamin C is essential during pregnancy, high doses may pose risks to the fetus. Use only under medical supervision.

Vitamin C is excreted in breast milk. Normal dietary intake is generally safe during breastfeeding, but high intravenous doses should be used with caution.

2.5. Effects on ability to drive and use machines

Cardi-Braun Reperfusion has no or negligible influence on the ability to drive and use machines.

2.6. Important information about ingredients

This medicine contains sodium. Each liter contains 52 mmol (1200 mg) of sodium. Consider this if you are on a low-sodium diet.

The solution contains no antimicrobial preservatives. It is intended for single use only. Discard any unused portion.

The pH of the solution is adjusted with hydrochloric acid or sodium hydroxide to approximately 6.0 (5.0–7.0).

Do not use Cardi-Braun Reperfusion

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

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

Take special care with Cardi-Braun Reperfusion

Cardi-Braun cardioplegic solutions will 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 heart's functions during surgery.

During the operation, the medical team assisting you will carefully monitor your vital signs. Specifically, they will assess:

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

For recovery of the heart after completion of the surgery, a defibrillation team (using electrical current to restore heart rhythm) and medications to increase the force of cardiac contraction must be readily 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 taking or have recently taken 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 medication.

Cardi-Braun Reperfusion contains sodium

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

3. How Cardi-Braun Reperfusion is Administered

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 ensures blood pumping and circulation. This allows your heart to remain still during the procedure, enabling surgeons to operate on your heart without movement or blood filling the surgical field.

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

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 at telephone number (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 Reperfusion may cause adverse effects, although not everyone experiences them.

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

The following adverse effects of unknown frequency have been reported:

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 insulin administration).

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects 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 through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cardi-Braun Reperfusion

Keep out of the reach and sight of children.

No special storage conditions are required.

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

Do not use Cardi-Braun Reperfusion if the solution is cloudy or contains sediment.

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

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

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

6. Additional Information

Composition of Cardi-Braun Reperfusion

The active substances are:

Per 1 ml Per 500 ml

Tromethamine 8.5620 mg 4.2810 g
Sodium citrate 6.1963 mg 3.0981 g
Citric acid monohydrate 0.7730 mg 0.3865 g
Disodium dihydrogen phosphate dihydrate 0.5913 mg 0.2956 g
Potassium chloride 2.3419 mg 1.1709 g
Glucose monohydrate 40.5530 mg 20.2765 g
Aspartic acid 7.8970 mg 3.9490 g
Glutamic acid 8.7990 mg 4.4000 g

Electrolyte composition:

Phosphates 3.79 mmol/l
Citrate 24.74 mmol/l
Sodium 186.2 mmol/l
Potassium 31.4 mmol/l
Chloride 31.4 mmol/l
Acetate 11 mmol/l

Other components: Acetic acid (pH adjustment), sodium hydroxide, and water for injections.

Presentation of the product and contents of the pack

Cardi-Braun Reperfusion is a colorless and transparent solution for perfusion, supplied in a single-unit pack containing a flexible plastic bag of 500 ml.

Marketing Authorization Holder and Manufacturer

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

This leaflet was last approved in: December 2024

This information is intended for healthcare professionals only:

Cardi-Braun Reperfusion solution for intracardiac perfusion is a ready-to-use solution.
It is administered via commercial systems that deliver the solution through a 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 administered to the coronary circulation via two routes—antegrade and retrograde—or by a mixed approach.

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

Instructions for the correct use of Cardi-Braun cardioplegic solutions

Unfold the bag and place it on a firm 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 perfusion connector. Clean the connector and attach the intracardiac perfusion set. Administer according to protocol.

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

B|BRAUN