CELSIOR 1 LITRO Roztwór do konserwacji organów
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Treść ulotki
Celsior solution for organ preservation
Glutathione, Mannitol, Lactic acid, Glutamic acid, Sodium hydroxide
Calcium chloride dihydrate, Potassium chloride, Magnesium chloride hexahydrate, Histidine
Read this leaflet carefully before using this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- If any side effects occur, including those not listed in this leaflet, ask your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Celsior is and what it is used for
- 2. What you need to know before using Celsior
- 3. How to use Celsior
- 4. Possible side effects
- 5. How to store Celsior
- 6. Contents of the pack and other information
1. What is Celsior and what is it used for
Pharmacotherapeutic category: solvents and diluents, including cleansing solutions.
Solution for the preservation of thoracic organs (heart and lung) and abdominal organs
(kidney, liver and pancreas) during transplantation: from removal from the donor, as well as during
storage, transport and until transplantation into the recipient.
2. What you need to know before using Celsior
Do not use Celsior
Celsior must not be used for the preservation of organs if the donor or the recipient is
allergic (hypersensitive) to the active ingredients or to any of the other components of this
medicinal product (listed in section 6).
Warnings and precautions
Celsior is not suitable for direct injection or intravenous use in the recipient of the organ,
therefore it must be used solely for rinsing and cold storage of solid organs.
Celsior is for single use only. It is not suitable for use in machines that continuously pump
the preservation solution through the organ (imitating blood circulation).
Other medicines and Celsior
No interactions are known if used as indicated.
Inform your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
No data are available. Since Celsior is not administered to organ recipients systemically, no specific effects are expected for the solution.
3. How to use Celsior
Celsior can only be used by adequately trained medical personnel as described
in the paragraph: The following information is intended exclusively for physicians or
healthcare professionals.
Once removed from the donor and before transplantation into the recipient, the organ does not receive blood or
oxygen, therefore it must be preserved at a temperature of 2-8°C, in order to obtain proper
function in the recipient. Organs are usually rinsed to remove
blood and to cool them down, in order to slow down metabolism. The organ is immediately placed
in a sterile container filled with Celsior and kept cool, without being
frozen.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Since Celsior is not administered to organ recipients, no specific side effects are expected for the
solution. However, immediately report all side effects, including those known to be related to other
medicines taken during the transplant procedure, to assess whether precautions are necessary.
An abnormal heart rate or low blood pressure may occur. Patients receiving a heart transplant may
have abnormal heart function. An increase in solution above that recommended may lead to an
increase in body fluids and abnormal body salt levels.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or
nurse. You can also report side effects directly through http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Celsior
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bag and the carton after
EXP. The expiry date refers to the last day of that month.
To protect from light, store in the original aluminium packaging. Store and
transport in a refrigerator (2°C - 8°C). Do not freeze.
After opening, Celsior must be used within 24 hours.
Do not use this medicine if you notice any residues, if the solution is not clear, is not colourless or
does not have a yellowish colour.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help to protect the environment.
6. Contents of the pack and other information
What Celsior contains
The active ingredients are: glutathione, mannitol, lactobionic acid, glutamic acid, sodium
hydroxide, calcium chloride dihydrate, potassium chloride, magnesium chloride hexahydrate, 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 are:
Water for injections
Sodium hydroxide, 4% (for pH adjustment)
Description of the appearance of Celsior and contents of the pack
Organ preservation solution
Celsior is a clear, colorless (or slightly yellow) solution contained in a bag made of ethylene
vinyl acetate copolymer in an outer aluminum pack containing an oxygen absorber.
pH = 7.3
Osmolality: 320 mosmol/kg
Multipack of 4 bags, each containing 1 liter of solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Institut Georges Lopez – IGL
1 allée des Chevreuils – Route Nationale 6
Parc tertiaire du Bois Dieu
69380 Lissieu
France
Tel: 00.800.1212.5656
Manufacturer
6 route de Saint Bonnet
69930 Saint-Laurent-de-Chamousset
France
This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
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
<----------------------------------------------------------------------------------------------------------
The following information is intended exclusively for physicians or healthcare professionals:
Special warnings and precautions for use
Celsior is not suitable for direct injection or intravenous use in the recipient, therefore it must be
used solely for cold rinsing and storage of solid organs.
Celsior is for single use only. Do not reuse. It is not suitable for continuous mechanical perfusion.
It cannot be excluded that residual quantities of the solution may lead to arrhythmias
during declamping or that, in case of suboptimal heart preservation in the immediate post-transplant
phase, a weakening of cardiac function may be observed.
Treatment
Store in a refrigerator (2°C - 8°C). Do not freeze. Store the bag in the outer aluminum container
protected from light.
The solution may take on a yellowish color during storage. This does not affect the
quality and efficacy of Celsior.
Although the packaging materials are produced under aseptic conditions, the outside of the Celsior
bag is not sterile. Therefore, if it is intended to pour out Celsior, the outside of the bag must
be decontaminated.
The solution does not need to be filtered before use.
The outer aluminum protected bag contains substances capable of absorbing oxygen
inside a separate bag which guarantees a better stability of the active ingredient
reduced glutathione present in the active ingredient. The contents of the bag must not be
mixed with the solution.
The aluminum outer packaging and the oxygen absorber bag must be removed
before use.
Once the outer packaging has been removed, the inner container must be inspected for
any leaks by squeezing the bag. If a leak is detected, do not use the solution.
The Celsior bag has 3 openings. The tip on the cannula used to rinse the organ
must be inserted into the opening on the left side of the bag (rotating it). Until the start
of the infusion, the cannula must be held firmly.
Administration/Dosage
The organ is rinsed using a cannula inserted into an artery, while maintaining
sufficient pressure to ensure a stable flow of solution, in order to obtain an
adequate rinse. In the case of liver transplantation, the biliary tree is generally rinsed
after explantation, before placement in the storage and transport container.
The volume of the rinsing solution depends on the organ.
Suggested minimum volumes:
Heart: adults: 1-2 liters
children: 30 ml/kg;
Liver: 6-8 liters;
Lung: 4-6 liters;
Kidney: 4-5 liters;
Pancreas: 4 liters;
Multiorgan: based on the individual organs involved.
The rinsing must continue until the organ is uniformly pale and the effluent
relatively clear.
After removal from cold storage (2-8°C), the cooled 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.
Storage in cold conditions
The organ is stored at 5 ± 3°C in a sterile container of adequate size for the organ.
The organ must be completely covered with the cooled solution. The organ storage container must be sealed aseptically.
The container must then be placed in at least a second container. The latter
must be filled with ice, without the ice coming into contact with the organ storage
container, as the ice may come into direct contact with the organ. Ensure that
the organ is stored aseptically in the container, so that the inside of the organ storage container and its contents remain sterile.
Seal the additional containers carefully.
The organ storage containers must be stored inside a well-insulated transport container. The organ storage containers must be surrounded by ice.
Transport times should be minimized.
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