Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Celsior solution for organ preservation

Glutathione, Mannitol, Lactobionic acid, Glutamic acid, Sodium hydroxide,
Calcium chloride 2 H2O, Potassium chloride, Magnesium chloride 6 H2O, Histidine,

Read the entire leaflet carefully before starting to use this medicine, because 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 pharmacist.
If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

What Celsior is and what it is used for
What you need to know before using Celsior
How to use Celsior
Possible adverse effects
How to store Celsior
Contents of the pack and other information

1. What Celsior is and what it is used for

Pharmacotherapeutic group: solvent and diluent agents, including washing solutions.

Solution for the preservation of thoracic organs (heart and lung) and abdominal organs (kidney, liver and pancreas) during transplantation: from the moment of organ removal from the donor, as well as during preservation, transport, and up to transplantation into the recipient.

2. What you need to know before starting to use Celsior

Do not use Celsior:

Celsior must not be used if the donor or recipient is allergic (hypersensitive) to the active substances or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Celsior is not suitable for direct injection or for intravenous use in the organ recipient and must be used only for flushing and cold storage of solid organs.

Celsior is for single use only. It is not suitable for use in devices that continuously pump the preservation solution through the organ (simulating blood circulation).

Use of Celsior with other medicines

No interactions are known when used according to instructions.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

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

Data are not available. Since Celsior is not administered systemically to organ recipients, specific adverse effects of the solution are not expected.

3. How to use Celsior

Celsior should only be used by qualified healthcare professionals, as described in the section entitled: The following information is intended exclusively for medical or healthcare professionals.

Once the organ has been removed from the donor, before transplanting it into the recipient, it has no blood or oxygen supply and must be preserved at a temperature between 2 and 8°C to ensure proper function in the recipient. Organs are usually flushed to remove blood and to cool them, thereby slowing down their metabolism. The organ is immediately placed into a sterile container filled with Celsior solution and kept cold, but not frozen.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Since Celsior is not administered to organ recipients, specific side effects related to the solution are not expected. However, you should immediately report any adverse effects, including those related to other medications taken during transplantation, so that appropriate corrective measures can be assessed.

You may experience an abnormal heart rhythm or low blood pressure. Patients receiving a heart transplant may have abnormal cardiac function. An amount of solution exceeding the recommended dose may lead to increased body fluids and abnormal levels of salts in the body.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Celsior

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging after EXP. The expiry date refers to the last day of the month indicated.
Keep in the original packaging to protect from light. Store and transport refrigerated (between 2°C and 8°C). Do not freeze.
After opening, Celsior must be used within 24 hours.
Do not use this medicine if particles are visible, if the solution is not clear, or if it is not colourless or slightly yellowish.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Celsior

The active substances are glutathione, mannitol, lactobionic acid, glutamic acid, sodium hydroxide, calcium chloride, potassium chloride, magnesium chloride, and histidine.

Each 1-liter bag of solution contains:

Glutathione 0.921 g (3 mmol)
Mannitol 10.930 g (60 mmol)
Lactobionic acid 28.664 g (80 mmol)
Glutamic acid 2.942 g (20 mmol)
Sodium hydroxide 4.000 g (100 mmol)
Calcium chloride dihydrate 0.037 g (0.25 mmol)
Potassium chloride 1.118 g (15 mmol)
Magnesium chloride hexahydrate 2.642 g (13 mmol)
Histidine 4.650 g (30 mmol)

The other components (excipients) are:
Water for injection
Sodium hydroxide 1N, 4% (to adjust pH)

Appearance of the product and contents of the container

Celsior is a ready-to-use solution (for single use) in a sterile 1-liter plastic bag with an oxygen-absorbing sachet. These bags are then stored in an outer aluminum-protected carton.

Organ preservation solution.

Celsior is a transparent, colourless or slightly yellowish solution in a bag made of ethylene-vinyl acetate copolymer, contained within an outer aluminum packaging that includes an oxygen-absorbing sachet.

pH = 7.3
Osmolality: 320 mosmol/kg

Multicartons containing 4 bags of 1 liter of solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Institut Georges Lopez - IGL
1 allee des Chevreuils - Route Nationale 6 Parc Tertiaire du Bois Dieu,
F-69380 Lissieu
France
Tel.: +34 9 36 29 27 02

Manufacturer
6 route de Saint Bonnet
69930 Saint-Laurent-de-Chamousset
France

This medicinal product is authorised in the European Economic Area member states under the following names:
Austria: Celsior Organkonservierungslösung
Germany: Celsior Organkonservierungslösung
France: Celsior solution pour conservation d’organes
Ireland: Celsior Solution for organ preservation
Italy: Celsior soluzione per conservazione di organi
Portugal: Celsior solução para conservação de órgãos
Spain: Celsior solución para la conservación de órganos

Date of most recent review of this leaflet: 04/2026

This information is intended for healthcare professionals only:

Warnings and special precautions for use

Celsior is not suitable for direct injection or intravenous use in the recipient and must be used solely for flushing and cold storage of solid organs.

Celsior is for single use only. Do not reuse. It is not suitable for continuous perfusion machines.

It cannot be excluded that residual amounts of the solution may cause arrhythmia upon unclamping, or that suboptimal heart preservation may result in cardiac failure in the immediate post-transplant phase.

Handling

Store in a refrigerator (2°C to 8°C). Do not freeze. Keep the bag in its outer aluminum-protected container to protect from light.

The solution may become slightly yellowish during storage. This does not affect the quality or efficacy of Celsior.

Although the packaging materials have been manufactured under sterile conditions, the outer surface of the Celsior bag is not sterile. The outer surface of the bag must be decontaminated if Celsior is to be poured.

Filtration of the solution before use is not required.

The outer aluminum-protected container contains an oxygen-absorbing sachet, which ensures improved stability of the active substance reduced glutathione. The contents of this sachet must not be mixed with the solution.

The outer aluminum packaging and the oxygen-absorbing sachet must be removed before use.

Immediately after removal of the outer packaging, check for leaks in the inner container by pressing the bag. If leaks are detected, the solution must not be used.

The Celsior bag has three openings. The needle of the tubing used to flush the organ must be inserted into the left-side opening of the bag (screw-type). The tubing must remain clamped until infusion begins.

The solution bag must be placed inside a sphygmomanometer cuff of appropriate size. Inflate the cuff to apply sufficient pressure to expel the liquid. Additionally, before infusion, the solution container must be suspended at a sufficient height to ensure continuous flow.

Administration / Dosage

The organ is flushed through a cannula inserted into an artery, maintaining sufficient pressure to achieve a constant flow of solution to ensure adequate washing. In liver transplantation, the biliary tree is typically flushed after removal, before placing the organ into the preservation and transport container.

The volume of flush solution depends on the organ.

Suggested minimum volumes:

Heart: adult: 1–2 litres; children: 30 ml/kg
Lung: 4–6 litres
Liver: adult: 6–8 litres
Kidney: 4–5 litres
Pancreas: 4 litres
Multi-organ: according to appropriate organs

Flushing should continue until the organ appears uniformly pale and the effluent solution is relatively clear.

After removal from cold storage (2–8°C), the cold solution must be used immediately.

Paediatric patients

Although experience in children and adolescents is limited, there are no objections to the use of Celsior in this patient group.

Cold storage

The organ is stored at 5 ± 3°C in a sterile container of appropriate size. The organ must be completely covered by cold solution. The organ preservation container must be sealed aseptically.

It should then be placed in at least a second container filled with ice, but the ice must not enter the organ preservation container, as it could come into direct contact with the organ. Care must be taken to ensure that the organ is preserved aseptically, meaning the interior of the organ preservation container and its contents remain sterile.

Additional containers must be securely sealed.

The organ preservation containers should then be placed within a well-insulated transport container. The organ preservation containers should be surrounded by ice.

Transport times should be as short as possible.