Label: 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,

Readthe entire labelcarefully before starting to use this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts,consult your doctor or pharmacist.
• If you experience adverse effects,consult your doctor or pharmacist,evenif theydo not appear in this label. See section4.

Pharmacotherapeutic group: solvents and diluents, including washing solutions.

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

Do not use Celsior:

Celsior should not be used if the donor or recipient is allergic (hypersensitive) to the active principles or to any of the other components of this medication(including those listed insection 6).

Warnings and precautions

Celsior is not suitable for direct injection or intravenous use in the organ recipient and should be used only for washing and cold preservation of solid organs.

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

Use ofCelsior withother medications

No interactions are known when used as instructed.

Inform your doctor or pharmacist if you are taking, have taken recentlyor may need to takeany othermedication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consultyour doctor or pharmacist before using this medication.

No data are available. Since Celsior is not administered systemically to organ recipients, no specific side effects of the solution are expected.

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

Once the organ is removed from the donor, before transplanting it into the recipient, it does not receive blood or oxygen and needs to be preserved at a temperature of between 2 and 8° C to function properly in the recipient. Normally, organs are washed to remove blood and to cool them, which slows down their metabolism. The organ is placed immediately in a sterile container filled with Celsior solution and kept cold, but not frozen.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Since Celsior is not administered to the organ receptors, no specific secondary effects are expected from the solution. However, you must immediately report any secondary effect, including those related to other medications you take during the transplant, to evaluate the necessary adaptive measures.

You may experience an abnormal heart rate or low blood pressure. Patients who receive a heart transplant may have abnormal cardiac function. An excessive increase in the solution may lead to an increase in body fluids and abnormal amounts of salt in the body.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is about possible adverse effects that do not appear 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 about the safety of this medication.

• Keepthis medicationout of the sight and reachof children.
• Do notuse this medicationafter the expiration date that appears on the outer packaging after CAD. The expiration dateis thelast day of the monththat is indicated.
• Keep in the original packaging to protect it from light. Store and transport refrigerated (between 2°C and 8°C). Do not freeze.
• After opening Celsior, it must be used within 24 hours.
• Do notuse this medication if you observeparticles,the solutionis not transparent or if it is not colorless or yellowish.

• Medicines should notbe disposed of through drains. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help to protect the environment.

Composition ofCelsior

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

Each 1-liter bag of solution contains

Glutathione0.921 g(3 mmol)

Mannitol10.930 g(60 mmol)

Lactobionic acid28.664 g(80 mmol)

Glutamic acid2.942 g(20 mmol)

Sodium hydroxide4.000 g(100 mmol)

Calcium chloride dihydrate0.037 g(0.25 mmol)

Potassium chloride1.118 g(15 mmol)

Magnesium chloride hexahydrate2.642 g(13 mmol)

Histidine4.650 g(30 mmol)

The other components (excipients) are:

Injection water

Sodium hydroxide 1N, 4% (for pH adjustment)

Appearance of the productand contents of the package

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

Solution for organ preservation.

Celsior is a transparent and colorless or slightly yellowish solution in a bag composed of a copolymer of ethylene and vinyl acetate, inside an external aluminum packaging containing an oxygen-absorbing absorbent.

pH = 7.3

Osmolality: 320mosmol/kg

Multi-pack with 4 1-liter solution bags

Holder of the marketing authorization andresponsible for manufacturing

Holder of the marketing authorization

Institut Georges Lopez - IGL

1 allee des Chevreuils - Route Nationale 6 Parc Tertiaire du Bois Dieu,

F-69380- Lissieu

France

Tel.: 00.800.1212.5656

Responsible for manufacturing

6 route de Saint Bonnet

69930 Saint-Laurent-de-Chamousset

France

This medicinal product is authorized in the member states of the European Economic Area with the following names:

AustriaCelsior Organkonservierungslösung

GermanyCelsior Organkonservierungslösung

FranceCelsior solution pour conservation d’organes

IrelandCelsior Solution for organ preservation

ItalyCelsiorsoluzione per conservazione di organi

PortugalCelsiorsolução para conservação de órgãos

SpainCelsior solución para la conservación de órganos

Revision date of this leaflet: 05/2017.

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Thisinformation is intendedonlyfor healthcare professionals:

Warnings and special precautions for use

Celsior is not suitable for direct injection or intravenous use in the recipient and should only be used for washing and cold preservation of solid organs.

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

It cannot be ruled out that residual amounts of the solution may cause arrhythmia when the tourniquet is removed, or that in the case of non-optimal preservation of the heart in the immediate post-transplant phase, heart failure may be observed.

Handling

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

The solution may turn yellow during storage. This does not affect the quality and efficacy of Celsior.

Although the packaging materials have been manufactured in sterile conditions, the exterior of the Celsior bag is not sterile. The exterior of the bag must be decontaminated if Celsior has to be poured.

No filtration of the solution is necessary before use.

The outer aluminum-protected container contains oxygen-absorbing substances in a separate bag that ensures better stability of the reduced glutathione active principle. The contents of this bag must not be mixed with the solution.

The outer aluminum container and the oxygen-absorbing substance bag must be removed before use.

As soon as the outer container has been removed, check for leaks in the inner container by pressing the bag. If leaks are found, the solution must not be used.

The Celsior bag has 3 openings. The needle of the tube used to wash the organ must be inserted into the left side opening of the bag (threaded). Until the infusion begins, the tube must be pinched.

The solution bag must be placed inside a suitable blood pressure cuff. The cuff must be inflated to apply sufficient pressure to allow the liquid to flow out. In addition, before the infusion, the solution container must be suspended from a sufficient height to ensure a continuous flow of the solution.

Administration / Posology

The organ is washed through a cannula inserted into an artery, while maintaining sufficient pressure to obtain a constant flow of the solution to achieve adequate washing. In the case of liver transplantation, the biliary tree is usually washed after removal, before placing it in the preservation and transport container.

The volume of the washing solution depends on the organ.

Minimum suggested volumes:

Heart: adult: 1-2 liters; children: 30 ml/kg

Lung: 4-6 liters

Liver: adult: 6-8 liters;

Kidney: 4-5 liters;

Pancreas: 4 liters.

Multi-organ: according to the appropriate organs.

The washing must continue until the organ is uniformly pale and the solution that comes out is relatively transparent.

After removing it from cold preservation (2-8° C), the cold solution must be used immediately.

Pediatric patients

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

Cold preservation conditions

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

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

Additional containers must be securely sealed.

The organ preservation containers must be kept, then, in a well-insulated transport container. The organ preservation containers must be surrounded by ice.

The transport times must be as short as possible.