IGL-1. Each bag with 1 litre solution contains:

Transcription

1 Cold storage solution for abdominal organs: liver, kidney, pancreas. 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Each bag with 1 litre solution contains: Lactobionic acid 1 mmol/l 35,8 g/l Adenosine 5 mmol/l 1,336 g/l Allopurinol 1 mmol/l,136 g/l Total Glutathione 3 mmol/l,922 g/l Polythylen glycol (PEG 35),3 mmol/l 1 g/l Potassium dihydrogen phosphate 25 mmol/l 3,42 g/l Raffinose, 5H2 3 mmol/l 17,84 g/l Magnesium Sulphate, 7H2 5 mmol/l 1,232 g/l Sodium Hydroxide qs ph: 7.4 Water for injection qs 1 litre

2 PUBLICATIONS -HES I.Ben Mosbah et al.effects of Polyethylene Glycol and Hydroxyethyl Starch in University of Wisconsin Preservation Solution on Human Red Blood Cell Aggregation and Viscosity. Transplant Proc. 26 Jun;38(5): I.Ben Mosbah et al. Effects of Polyethylene Glycol and Hydroxyethyl Starch in University of Wisconsin PreservationSolution on Human Red Blood Cell Aggregation and Viscosity. Transplant Proc. 26 Jun;38(5): Blood viscosity (cl) Vascular resistance (mmhg.min.g/ml) Non-steatotic liver Steatotic liver I.Ben Mosbah et al. Preservation of Steatonic Livers in Solution. Liver Transplantation. 26 Aug; 12(8): Without colloid Oedema With colloid No cellular oedema F.O. Belzer et al. Principles of Solid-Organ Preservation of Cold-Storage Transplantation 1988 April;45(4):673-6 production of nitric oxide (pm-ol/mg) Steatotic liver production of nitric oxide (pm-ol/mg) Non-steatotic liver increases the synthesis of nitric oxide, responsible for the vasodilatation and the decrease of the inflammatory mediators levels I.Ben Mosbah et al. Preservation of Steatonic Livers in Solution. Liver Transplantation. 26 Aug; 12(8): Preservation solution WITH protective agents against ischemia-reperfusion injuries ATP ISCHEMIA ADP AMP ADENOSINE Inosina ALOPURINOL - ADE / ALO / GSH GLUTATHIONE Xanthine oxidase SOD catalase Xanthine + O2 H2O2 H2O Hipoxantina O2 REPERFUSION OH + OH- + O2 F.O. Belser et al. Principles of Solid-Organ Preservation of Cold-Storage. Transplantation April;45(4):673-6.

3 ORGAN FUNCTION Kidney Serum creatinine (µm/l) day 3 days 6 days 14 days R.Codas et al. solution in kidney transplantation: first multi-center study. Clin. Transplant. 29 Jun-Jul, 23(3); Pancreas Graft survival 1 1 year survival (%) Patient survival 1 P.Petruzzo et al. solution in pancreas transplantation. 28 Congress of TTS. Sydney, Australia, Poster Session Liver AST (IU/L) Post-operative days day 1 day 5 days 1 days 15 days 3 days F.Dondero et al. A randomized study comparing to the University of Wisconsin preservation solution in liver transplantation. Ann. Transplant. 21 Dec, 15(4);7+14. Survival (%) and 3 years graft survival All grafts CI>12h Partial grafts R.Adam et al. Compared Efficacy og and Solution in Liver Transplantation (LT), Liver Transplantation. 211 Jun; 17(6) suppl.1:s225, Abstact #P-321.

4 2. PHARMACEUTICAL FORM is a clear to light yellow, sterile, non-pyrogenic solution intending for hypothermic flushing and storage of organs (kidney, liver, pancreas). has an osmolality of 29 mosm/kg. 3. CLINICAL PARTICULARS 3.1. Intended use is intended for the flushing and the hypothermic storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transplantation and eventual transplantation into a recipient Preparation Cool the solution to +2 to +6 C. Remove overwrap prior to use. Check each bag for leaks by squeezing the container firmly. If a leak is found, discard solution bag. With the overwrap removed, perform a visual inspection of the solution for particulate matter. Do not use the solution if obvious particulate matter, precipitates, or contamination are evident in the solution. Use an administration set to flush the organ with solution. Prior to connection to the organ, the solution container should be suspended from a sufficient height to allow for a steady stream of solution and to produce flow rates of at least 3 m/lmin furing flushing. Flushing should be continued until the organ is uniformly pale and the effluent is clear. Suggested minimum volumes: In situ aortic flush: Adults, 2-4 ml Infants, 5 ml/kg Ex vivo infusion: - Liver (via portal vein and biliary tree) Adults, 12 ml Infants, 5 ml/kg - Pancreas or Kidney: Adults, 3-5 ml Infants, ml 3.3. Packaging and storage 1 ml Solution in one litre bags shelf carton of 1, or 2 ml Solution in two litre bags shelf carton of 6. Store at a temperature between +2 C and +8 C away from direct sunlight. Do not freeze the solution, and do not use if frozen. Additional solution should be dispensed into the container holding the organ. Seal the container aseptically. The organ storage container should be maintained within a well-insulated transport container. Ice should be used to surround the organ storage container, but should not be used within the container, where the ice could come into direct contact with the organ. Donor organs must be flushed free of prior to transplantation according to transplantation centers protocols. Those operations must be done by qualified operators.

5 3.4. Contraindications There are no known contraindications when used as directed Special warnings and precautions for use NOT INTENDED FOR DIRECT INJECTION OR INTRAVENOUS INFUSION. includes components (allopurinol) which individually have caused hypersensitivity reaction in patients. Physicians should be alert to treat possible reactions Adverse reactions Vascular complications (thrombosis, fistulas, primary non-functions, graft rejections, dialysis needs, biliary complications after transplantation) have been reported while testing clinically. However, thos post-transplantation reactions could not be attributed solely to Caution Federal and international laws restrict the sale of this device to or on the order of a physician or licensed practitioner. 4. ACTIONS Solution, cooled at +2 C and +6 C is used for flushing the isolated organ immediately before removal from the donor and/or immediately after removal from the donor. The solution is then left in the organ vasculature during hypothermic storage and transportation. is not intended to be used for cold storage of the organ and is not acceptable for continuous machine perfusion. Administration of, at the recommended temperature, will effectively cool the organ and lower its metabolic requirements. 5. SPECIAL PRECAUTIONS FOR STORAGE Do not freeze the solution, and do not use if frozen. Store away from direct sunlight Store solution between +2 C and +8 C 6. MARKETING AUTHORISATION HOLDER Manufactured by: Institut Georges Lopez Parc Tertiaire du Bois Dieu I RN6 I 1, allée des Chevreuils 6938 Lissieu I France Tel. +33 () I Fax +33 () I welcome@groupe-igl.com Class III Medical Device Read attentively the instruction for use.

6 Coming from the research IGL develops specific programs that have led to the development of products designed specifically to improve organ recovery, preservation, transport and evaluation systems before transplant. Flushing Transport Perfusion IGL develops, manufactures and markets three lines of products with only one goal: improve the quality of the transplanted grafts, offering to the transplantation teams a line of efficient and adapted preservation products, as well as a scientific & technological support. IGL: a key player in the world of organ transplantation. GROUPE IGL Institut Georges Lopez Parc Tertiaire du Bois Dieu RN6 I 1, allée des Chevreuils F-6938 Lissieu I France Tel. +33 () Fax +33 () IGL América Latina Rua Comendador Tavares, 118 Bairro Navegantes CEP Porto Alegre-RS I Brasil Tel Fax Waters Medical Systems Institut Georges Lopez IGL Spain IGL Spain Vilamari I bajos 815 Barcelona España Tel Fax Waters Medical Systems th St. NW, Rochester MN 5591 I USA Tel Fax IGL América Latina welcome@groupe-igl.com Please contact us for a complete list of references and authorizations Available in 1-liter and 2-liter bags Br..EN.Rev3 216/6/29