Flushing and cold storage solutionfor heart preservation

Celsior®

� Specially formulated with: - impermeants to reduce swelling during cold storage - efficient buffering system to protect against graft acidosis - substrates to help the production of energy in anaerobic

conditions - antioxidants, with permanently reduced glutathione,

histidine, lactobionate and mannitol

� Ready to use: no additives required, no filtering required

� Available in 1 Liter bags

� Two-year shelf life

� Manufactured to FDA cGMP, by an ISO 13485 and ISO 9001certified company.

CEL

SIOR

®- Pro

duct In

form

ation USA

- R

ev. 0

2 - 20

15/09/08

SOLUTION COMPOSITION

Administration of Celsior® cools the organ, and therefore re-duces its metabolic requirements and associated energyconsumption. Effective heart preservation allows for optimalprimary function following transplantation.

COMPOSITION LEAD TO DIFFERENTPROPERTIES

WARNINGSNOT for in vivo use

NOT for direct systemic injection

NOT for intravenous infusion

NOT for continuous perfusion

For single use only

PRECAUTIONSCelsior® includes drug components which, individually, maycause hypersensitivity reactions in patients.

CAUTIONFederal law restricts this device to sale by or on the order of aphysician.

Osmolarity 320 to 360 mOsmol

Mannitol 60.0 mmol

Lactobionic Acid 80.0 mmol

Glutamic Acid 20.0 mmol

Histidine 30 mmol

Calcium Chloride 0.25 mmol

Potassium Chloride 15.0 mmol

Magnesium Chloride 13.0 mmol

Sodium Hydroxide 100.0 mmol

Reduced Glutathione 3.0 mmol

Water for Injection Up to 1 liter

Buffering CapacityApproximately 7.0 mmol - alkaline

Approximately 11.0 mmol - acid

Viscosity 1.15 cSt

pH 7.3

Antioxidants

Glutathione (in a stable reduced form): 0.921 g/l

Histidine: 4.650 g/l

Lactobionic acid: 28.664 g/l

Mannitol: 10.930 g/l

Celsior® guarantees an excellent antioxidant action, with permanentlyreduced glutathione, histidine, lactobionate and mannitol

Ioniccomposition

Sodium Hydroxide: 4.000 g/l

Potassium chloride: 1.118 g/l

Calcium chloride: 0.037 g/l

Magnesium chloride: 2.642 g/l

With a low potassium, low calcium and high magnesium content, Celsior®

can be used for the heart organs, protecting against calcium overloadImpermeantsand membranestabilisers

Lactobionic acid: 28.664 g/l

Mannitol: 10.930 g/l

Celsior®‘s composition of impermeants helps to avoid the swellings ofcells during cold ischaemic storage

Buffer Histidine: 4.650 g/l

Celsior® contains histidine, which has an excellent capacity for hydrogenion buffering thereby protecting grafts from acidosis

High-energysubstrates

Glutathione: 0.921 g/l

Glutamic acid: 2.942 g/l

Celsior® contains substrates that help the production of energy inanaerobic conditions

Waters Medical Systems2112 15th St. NW | Rochester, MN 55901 | USA

Tel. +1 507 288 7777 | Fax +1 507 252 3700www.groupe-igl.com | welcome@groupe-igl.com

Please contact us for a complete list of references and authorizations.