Celsior solution for organ preservation

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Glutathione; Mannitol ; Lactobionic acid; Glutamic acid ; Sodium hydroxide ; Calcium chloride 2 h2o; Potassium chloride; Magnesium chloride 6 h2o; Histidine

Commercializzato da:

Institut Georges Lopez - IGL

Codice ATC:

V07AB

INN (Nome Internazionale):

Glutathione; Mannitol ; Lactobionic acid; Glutamic acid ; Sodium hydroxide ; Calcium chloride 2 h2o; Potassium chloride; Magnesium chloride 6 h2o; Histidine

Dosaggio:

1L bag

Forma farmaceutica:

Solution for organ preservation

Tipo di ricetta:

Product subject to prescription which may not be renewed (A)

Area terapeutica:

Solvents and diluting agents, incl. irrigating solutions

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

2011-04-01

Foglio illustrativo

CELSIOR
®
SOLUTION FOR ORGAN PRESERVATION
PACKAGE LEAFLET: INFORMATION FOR THE USER
Glutathione, Mannitol, Lactobionic acid, Glutamic acid, Sodium
hydroxide, Calcium chloride dihydrate, Potassium chloride,
Magnesium chloride hexahydrate, Histidine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1. What Celsior is and what it is used for
2. What you need to know before you use Celsior
3. How to use Celsior
4. Possible side effects
5. How to store Celsior
6. Contents of the pack and other information
Pharmacotherapeutic group:
Solvent and diluting agents, incl. irrigating
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, transportation and
until
transplantation into the recipient.
DO NOT USE CELSIOR:
Celsior must not be used for preserving donor organs if the donor(s)
or
recipient(s) is allergic (hypersensitive) to the active substances or
any of the
other ingredients of Celsior (listed in Section 6).
WARNINGS AND PRECAUTIONS
Celsior is not suitable for direct injection or for intravenous use in
the
recipient of an organ, and must only be used for the flushing and cold
storage
of solid organs.
Celsior is for single use only. It is not suitable for use in machines
which
pump the preservation solution continuously through the organ
(mimicking
blood circulation).
OTHER MEDICINES AND CELSIOR
There are no known interactions when used as directed.
Tell your doctor or pharmacist if you are using, have recently used or
might
use any other medicines.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breas

Scheda tecnica

Health Products Regulatory Authority
28 March 2024
CRN00F2X8
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Celsior solution for organ preservation
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bag with 1 litre 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)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for organ preservation.
Clear, colourless (or slightly yellow) solution.
pH = 7.3
Osmolality: 320 mosmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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,
transportation and until transplantation into the
recipient.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Restricted to hospital use only.
Posology
The volume of flushing solution depends on the organ(s).
Suggested Minimum Volumes:

Heart: Adult: 1-2 litres

Infants: 30 ml/kg

Liver: 6-8 litres

Lung: 4-6 litres

Kidney: 4-5 litres

Pancreas: 4 litres.

Multi-organ: in accordance with the appropriate organs.
_Paediatric population_
There have been no adequate clinical studies of the use of Celsior for
organ transplantation in children.
Health Products Regulatory Authority
28 March 2024
CRN00F2X8
Page 2 of 5
Method of administration:
_Precautions to be taken before handling or administering the
medicinal product_

The bag in the aluminium-protected outer container contains
oxygen-absorber substances. The contents of this
bag should not be mixed with the solution.

Only intact containers (bag and aluminium packaging) should be used.

There is no need to filter the solution before use.
