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Selenase® In Organ Transplantation

Scientific information On

Organ Transplantation

Causes Of Ischaemia:

  • Organ isolated from blood circulation

Risks After Reperfusion:

Damage to transplanted organ due to formation of ROS e.g. in liver: damage to sinus endothelial cells, activated Kupffer cells further produce ROS and induce inflammatory mediators → vicious circle that can lead to loss of the transplant

Conventional Measures To Reduce Tissue Damage:

  • Cooling of the organ
  • Rapid transplantation (duration of ischaemia correlates with the extent of damage)

Data On Antioxidants:

  • Vitamin E (clinical study, liver resection) [Yagi et al. Transplant Proc. 1997; 29(1-2):1390-1393]
    → Reduction:
    • ROS (reduced protein and lipid peroxidation)
    • Activity of liver enzymes (ALT, AST, GLDH)
  • Selenite (pig kidney):
    → Significant reduction:
    • Lipid peroxidation in venous blood in the kidney [Treska Transplantation Proceedings 2003; 35: 1584-1586]

Possible Actions of Selenium Supplementation:

  • Reduction of organ damage
  • Prevention of loss of transplant

Suggested Timing and Dosage for Selenium Supplementation:

Time point Dosage
Immediately after donation of the organ into the perfusion solution 200 g Se/200 ml perfusion solution as selenase® solution for injection
Bolus dose before defined ischaemia or reperfusion into priming volume of heart-lung machine 1000 g Se/d as selenase® solution for injection

Abbreviated Prescribing Information

selenase® 100 micrograms, solution for injection (50 micrograms/ml)

selenase® 500 micrograms, solution for injection (50 micrograms/ml)

  • Active ingredient:sodium selenite pentahydrate.
  • Composition:Each 2 ml ampoule/10 ml injection vial contains 100 micrograms/500 micrograms selenium as 333 micrograms/ 1.66mg sodium selenite pentahydrate (Na2SeO3 x 5H2O), corresponding to 50 micrograms/ml.
  • Excipients:Sodium chloride, hydrochloric acid, Water for Injections.
  • Indication:Proven selenium deficiency that cannot be offset from food sources.
  • Posology and Administration:selenase® solution for injection is administered as an intramuscular or intravenous injection at a daily dose of 100 ­ 200 g (1.27 ­ 2.53 mol) selenium. If necessary, this dose can be increased to 500 g (6.33 mol) for a typical adult. No dosage adjustment is required for paediatric, renal or hepatic impairment patients.
  • Contraindications:Selenosis.
  • Interactions:Ensure that the pH value does not fall below 7.0 and that the solution is not mixed with reducing substances (e.g. vitamin C).
  • Pregnancy and Lactation:There are no data from the use of selenase® in pregnant or lactating women.
  • Undesirable Effects:None known to date when used as directed.
  • Overdose:Counter measures include gastric lavage, forced diuresis, dialysis or administration of high doses of vitamin C.
  • Pharmaceutical Precautions:Store below 25ºC.
  • Legal Category:POM.
  • Presentation:Cartons containing 10 x 2ml ampoules / 10 x10ml glass vials for single use.
  • MA Numbers:PL 20437/0003, PL 20437/0004.
  • MA Holder:biosyn Arzneimittel GmbH, Schorndorfer Str 32, D-70734 Fellbach, Germany.
  • Date of Preparation:November 2004