Selenase® In Organ Transplantation
Scientific information On
Organ Transplantation
Causes Of Ischaemia:
- Organ isolated from blood circulation
- No 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
- Reduced microcir culation
Conventional Measures To Reduce Tissue Damage:
- Cooling of the organ
- Rapid transplantation (duration of ischaemia correlates with the extent of damage)
- ineffective
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