Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GLUTATHIONE MANNITOL LACTOBIONIC ACID GLUTAMIC ACID SODIUM HYDROXIDE CALCIUM CHLORIDE 2 H2O POTASSIUM CHLORIDE MAGNESIUM CHLORIDE 6 H2O HISTIDINE
Genzyme Europe B.V.
Unknown
2011-04-01
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 For a 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, 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 The exact flushing method depends on the centre and on whether or not several organs are to be removed at the same time. Flushing is often carried out in two stages: the 1 st flush while the organ is still _in situ _and the 2 nd flush once the organ has been removed. The organ is flushed via a cannula inserted into an artery, while maintaining sufficient pressure to obtain a steady stream of solution in order to produce adequate flushing. In the case of liver transplantation the biliary tree is usually flushed out after explantation, before placing in the storage and transport container. The volume of flushing solution depends on the organ(s). Suggested Minimum Volumes: 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) IRISH MEDICINES BOARD _______________________________________________________________________________________ Read the complete document