CORHUM SOLUTION FOR CARDIOPLEGIA

Introduction

Package Leaflet: Information for the Patient

Corhum Solution for Cardioplegia

Read this entire leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience side effects, consult your doctor or nurse. Even if it is possible side effects not listed in this leaflet. See section 4.

Contents of the Leaflet:

1. What Corhum Solution for Cardioplegia is and what it is used for
2. What you need to know before starting to use Corhum Solution for Cardioplegia
3. How to use Corhum Solution for Cardioplegia
4. Possible side effects
5. Storage of Corhum Solution for Cardioplegia
6. Package Contents and Additional Information

1. What Corhum Solution for Cardioplegia is and what it is used for

Corhum Solution for Cardioplegia is a mixture of electrolytes and amino acids.

Corhum Solution for Cardioplegia is used:

• in cases of artificially induced and reversible cardiac arrest in open-heart surgery (cardioplegia in cardiac surgery) by causing a change in the electrolyte balance

2. What you need to know before starting to use Corhum Solution for Cardioplegia

Corhum Solution for Cardioplegia should only be used intraoperatively.

Do not use Corhum Solution for Cardioplegia

• if you are allergic to the active substances or to any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor before starting to use this medication.

Inform your doctor if you are pregnant, as this will affect the use of the solution. For safety reasons, in the event of emergency cardiac surgery during pregnancy, your doctor will aspirate the perfusion solution from the right atrium and ventricle of your heart after the operation.

This medication is not intended for direct administration into a blood vessel, but only for perfusion of the stopped heart. Therefore, this medication should not be used for systemic perfusion.

Depending on the type of surgery, the method used, the duration of the intervention, and the patient's size, up to 3 liters of perfusion solution may enter the entire circulatory system. This can cause a decrease in blood calcium and sodium levels. Therefore, your doctor will perform relevant laboratory tests.

Children and Adolescents

No clinical studies have been conducted in children and adolescents, but it can be used if the doctor considers it necessary.

Other Medications and Corhum Solution for Cardioplegia

Inform your doctor if you are using, have recently used, or may need to use any other medication.

No interactions are known with the following medications, which are used, in particular, during and often before and after surgery:

• certain medications used to treat heart failure (cardiac glycosides)
• diuretic medications
• medications used to treat symptoms of angina pectoris (e.g., chest pain or pressure)
• medications used in case of insufficient oxygenation of the heart muscle (such as nitro derivatives, beta-blockers, and calcium antagonists)
• antihypertensive medications (such as beta-blockers and calcium antagonists)

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

This medication should only be used during pregnancy and breastfeeding after carefully evaluating the benefit-risk ratio (see also Warnings and Precautions).

Driving and Using Machines

This medication does not affect your ability to drive and use machines.

Corhum Solution for Cardioplegia contains Sodium and Potassium

Corhum Solution for Cardioplegia contains 345 mg of sodium (main component of kitchen/table salt) per 1000 ml.

This is equivalent to 17% of the maximum recommended daily intake of sodium for an adult.

Corhum Solution for Cardioplegia contains 352 mg of potassium per 1000 ml. This should be taken into account for patients with reduced renal function or patients on a controlled potassium diet.

3. How to use Corhum Solution for Cardioplegia

The treatment plan and dose must be determined by a specialist doctor. This medication should only be used by healthcare professionals, i.e., a doctor or nurse.

If more Corhum Solution for Cardioplegia was used than prescribed:

Ingestion of large amounts of this medication in the bloodstream can cause volume overload and electrolyte imbalances (low blood calcium or sodium levels and high magnesium or potassium levels). In such cases, your doctor will perform periodic laboratory tests.

Information for the doctor:At the end of this leaflet, you will find information on overdose.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Side effects with unknown frequency (cannot be estimated from available data):

The therapeutic use of this medication may result in a decrease in blood pressure during surgery.

Reporting Side Effects

If you experience side effects, consult your doctor or nurse. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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5. Storage of Corhum Solution for Cardioplegia

Store in a refrigerator (between 2°C and 8°C) and keep the bags in the outer packaging to protect them from light.

Do not freeze. Use immediately after opening.

Keep this medication out of the sight and reach of children.

This medication should not be used after the expiration date shown on the packaging after "EXP". The expiration date is the last day of the month indicated.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Corhum Solution for Cardioplegia

The active substances are:

1000 ml of solution contain:

0.8766 g Sodium Chloride 15.0 mmol

0.6710 g Potassium Chloride 9.0 mmol

0.8132 g Magnesium Chloride Hexahydrate 4.0 mmol

3.7733 g Histidine Hydrochloride Monohydrate 18.0 mmol

27.9289 g Histidine 180.0 mmol

0.4085 g Tryptophan 2.0 mmol

5.4651 g Mannitol 30.0 mmol

0.0022 g Calcium Chloride Dihydrate 0.015 mmol

0.1461 g 2-Oxoglutaric Acid 1.0 mmol

The excipients are Water for Injection, Potassium Hydroxide (for pH adjustment), and Nitrogen.

Appearance of the Product and Package Contents

Use only clear and colorless or slightly yellowish solutions in intact packaging.

For single use only. Unused residues should be discarded.

Corhum Solution for Cardioplegia is available in 1000 ml and 2000 ml bags (block copolymer of polyolefin/styrene) with two tubes (block copolymer of polyolefin/styrene) closed with a perforable polyisoprene plug with silicate and polycarbonate filling and an injection plug made of chlorobutyl. The bags are packaged in outer polypropylene bags to ensure the exterior sterility of the primary bag.

Package sizes:

Carton box with 10 bags of 1000 ml

Carton box with 5 bags of 2000 ml

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

S.A.L.F. SpA Laboratorio Farmacologico

Via G. Marconi, 2

24069 Cenate Sotto (Bergamo) – Italy

Local Representative:

BIOJAM ESPAÑA, S.L.

Av/ de las Aguilas 2 Bq B Piso5 Pta 6

28044 Madrid – Spain

This medication is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria Corhum Kardioplege Lösung

Denmark Corhum

Spain Corhum Solution for Cardioplegia

Finland Corhum liuos sydämenpysäytystä varten

Italy Corhum soluzione per cardioplegia

Norway Corhum oppløsning til kardioplegi

United Kingdom (Northern Ireland) Corhum solution for cardioplegia

Sweden Corhum Lösning för kardioplegi

Date of the Last Revision of this Leaflet

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended only for healthcare professionals:

Special Warnings and Precautions for Use

Complete inactivation of the myocardium makes it susceptible to excessive stretching. Therefore, adequate ventricular drainage is required. The recommended perfusion volumes and pressures should not be exceeded.

Special precautions should be taken when dealing with the hearts of infants and children.

Inadequate perfusion with cardioplegic solution that is not sufficiently cooled (>20°C and >15 minutes) can cause the so-called "calcium paradox" and lead to the destruction of myocardial cells once the organ is implanted.

This risk does not apply to solutions with a sodium content <20 mmol/l, if the calcium content is >10 μmol/l and the solution is cold, i.e., <15°C and limited in time, i.e., perfused continuously for no more than 20 minutes. In contrast, the immersion of a whole heart in Corhum Solution for Cardioplegia that is cold does not pose any risk of calcium paradox, even if it lasts for hours, for example, during the time interval between organ extraction from a donor and transplantation to a recipient. Therefore, when used correctly, the calcium paradox is virtually impossible, even under extreme experimental conditions.

Overdose

Ingestion of large volumes of Corhum Solution for Cardioplegia in the systemic circulation can cause excessive circulating volume with consequent electrolyte imbalance (hypocalcemia, hyponatremia, hypermagnesemia, hyperkalemia). Therefore, adequate control of serum electrolytes is recommended.

Incompatibilities

In the absence of further information, Corhum Solution for Cardioplegia should not be mixed with other medications.