TRANSPLANT

Solution

SCOT 15Multiple Abdominal

Organs

SCOT 15 SOLUTION FOR ORGAN PRESERVATION• 4th Generation Organ Preservation Solution(1).

Extracellular-type composition containing 15 g/L of PEG 20 kDa. as colloid.• Multiple Abdominal Organs Preservation(2).

SCOT 15 Multiple Abdominal Organs - BT0200081Solution for Organ Preservation (kidney, liver, pancreas)

SOLUTION COMPOSITION

SCOT 15 Multiple Abdominal Organs (PEG 20 kDa.; 15g/L)

Description Packaging

Bag 1500mLProtected by an overwrap

1X6

Concentration

Sodium chloride 6.94 g/L

Potassium chloride 0.45 g/L

Dihydrate calcium chloride 0.17 g/L

Hexahydrate magnesium chloride 0.24 g/L

Monohydrate D-Glucose 2.20 g/L

Sodium bicarbonate 2.10 g/L

Polyethylene glycol 20 000 15 g/L

Hydrochloric acid ad pH = 7.50

Water for Injection ad 1500 mL

This material is for exclusive use of health care professionals.This product is a class III medical device that has a CE mark according to the regulations.

This medical device is not eligible for reimbursement. SCOT 15 Multiple Abdominal Organs - Ref. BT0200081Not all the products are available in every country, please contact your sales representative or Macopharma.

SCOT 15Multiple Abdominal

Organs

Kidney Liver Pancreas

COMPOSITION

INDICATIONS

• Perfusion and preservation of abdominal grafts (Kidney, Liver, Pancreas) from retrieval to reimplantation(3, 4).

Particular precautionsThis is not a cardioplegic solution.In any case, do not administer SCOT 15 to the patient for therapeutic use.For any additional information, please read the product’s instructions for use.

CHARACTERISTICS

• Extracellular-type solution with a low potassium concentration (6 mmol/L)(5).

• Stable solution with a high molecular weight polyethylene glycol (PEG 20 kDa.)(5).• Easy to store at room temperature (between +2°C and +25°C)*(6).

*The solution must be stored for at least 24 hours at a temperature ranging from +3°C and +5°C prior to use.The solution should be removed from the refrigerator just before use(7).

EFFECTS

• The low potassium concentration and the polyethylene glycol (PEG 20 kDa.)(8, 9): - Avoid acute vasoconstriction. - Decrease cellular depolarisation. - Slow ATP loss and pH reduction. - Exert oncotic pressure, limiting tissue edema during preservation and reperfusion(10). - Decrease the inflammatory response resulting from graft ischemia-reperfusion injury(11). - Reduce immunogenicity of the graft by non-pharmacological masking of antigenic sites on the cell membrane (immunomasking effect)(11, 12). - Reduces the phenomenon of post-transplant rejection(11, 12). - Protects the grafts from ischemia-reperfusion injuries(11, 12, 13).

TRANSPLANT

See references on back page

This material is for exclusive use of health care professionals.This product is a class III medical device that has a CE mark according to the regulations.

This medical device is not eligible for reimbursement. SCOT 15 Multiple Abdominal Organs - Ref. BT0200081Not all the products are available in every country, please contact your sales representative or Macopharma.

XB5A

A03A

- 0

4/ 2

016

REFERENCES : 1. Use of the SCOT Solution in Kidney Transplantation: Preliminary Report. C. Billault, 6. Vaessen, E. Van Glabeke, E. Rolland, S. Ourahma, L. Dimitru, F. Richard, M. Eugene, and B. Barrou. Transplantation Proceedings, 2006, 38, 2281 -2282. 2. Polyethylene glycols and organ protection against I/R injury. S. Giraud, R. Codas, T. Hauet, M. Eugene, L. Badet, Progrès en urologie, 2014, 24, S37-S433. 3. Influence of preservation solution on human islet isolation outcome. T. Hubert, V. Gmyr, L. Arnalsteen, Transplantation, 2007, Vol 83, 270-6. 4. Liver Preservation with SCOT 15 Solution Decreases Posttransplantation Cholestasis Compared with University of Wisconsin Solution: A Retrospective Study. E. Savier, B. Granger, F. Charlotte, N. Cormillot, J.M. Siksik, J.C. Vaillant, and L. Hannoun, Transplantation Proceedings, 2011, 43, 3402-3407. 5. New strategies to optimize kidney recovery and preservation in transplantation. D. Bon, N. Chatauret, S. Giraud, R. Thuillier, F. Favreau, T. Hauet, Nature Reviews, Nephrology, 2012, 8, 339–347. 6. Etude de stabilité aux conditions ICH : Stabilité de la solution SCOT 15 Multi-Organes Abdominaux en flacon et en poche selon la température de stockage et au cours du temps – rapport final. C. Geeraert, Macobiotech, Transplant, 2013. 7. Compte-rendu d’essai : Etude de la descente en température des solutions de la gamme. V. Duverger, Macobiotech, Transplant, 2006. 8. Beneficial effects of a Low-Potassium+ and Polyethylene Glycol Solution on Renal Function and Structure During 48-hour Cold Storage Preservation. Eugene M., Hauet T., Mothes D., Goujon J.M., Le Moyec L., Carretier M., Caritez J.C., Transplantation Proceedings, 1997,29, 2360-2362. 9. Beneficial effects of a Low-Potassium+ and Polyethylene Glycol Solution on Renal Lipid Peroxydation during 48-hour Cold Storage and normothermic reperfusion. Hauet T., Baumert H., Faure J.P., Bardou A., Beguinot S., Gibelin H., Ben Amor I., Germonville T., Caritez J.C., Carretier M. Eugène M., Transplantation Proceedings, 1998, 30, 2798-2799. 10. Protective effect of polyethylene glycol against prolonged cold ischemia and reperfusion injury: study in the isolated perfused rat kidney. Hauet T., Mothes D., Goujon J.M., Carretier M., Eugène M., The journal of Pharmacology and Experimental Therapeutics, 2001, 297, 946-952. 11. Polyethylene Glycol reduces the inflammatory injury due to cold ischemia-reperfusion in auto-transplanted pig kidneys. Hauet T., Goujoun J.M., Baumert H., Petit I., Carretier M., Eugène M., Wanderwalle A., Transplantation Proceedings, 1998, 30, 2798-2799. 12. Polyethylene Glycol reduces early and long-term cold ischemia-reperfusion and renal medulla injury. Faure J.P., Hauet T., Zeqiu Han, Goujoun J.M., Petit I., Mauco G., Eugène M., Carretier M., Vassilios P., Transplantation Proceedings, 1998, 30, 2798-2799. 13. Protection of autotransplanted pig kidneys from ischemia-reperfusion injury by polyethylene glycol. Hauet T., Baumert H., Ben Amor I., Goujoun J.M., Gibelin H., Godart C., Wanderwalle A., Carretier M. Eugène M., Transplantation, 2000, vol.70 1569-1575.

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