Selenase® In Heart Surgery
Scientific information On
Heart Surgery
Causes Of Ischaemia:
Pre-operative
- Coronary heart disease/coronary infarction
- Increasingly advanced age of patients
Intra-operativ
- Extracorporeal circulation with a heart-lung machine (Bypasses the heart and lungs, optionally brain)
- Reduction of micro-circulation
- Increase of inflammatory parameters
- Hyperinflammation
Risks After Reperfusion:
- Damage to heart and lung tissue
- Hyperinflammation (= post reperfusion syndrome) leads to SIRS
- Necrosis
- SIRS
Conventional Measures To Prevent SIRS:
- Corticosteroids
- Heparin coated extra corporeal circulation systems
- Aprotinin (anti-coagulant, withdrawn from the market end of 2007)
- Leukocyte filters
- Intraoperative ultrafiltration
- However, up to date no clear-cut proof efficacy
Data on Selenium (Selenite, Some With Selenase®):
- Coronary heart disease patients have low selenium levels [Altekin et al. Journal of Trace Elements in Medicine and Biology 2005; 18: 235-242]
- During extracorporeal circulation selenium levels fall by half within 30 minutes [Al-Bader et al. Cardiovasc Surg. 1998; 6(4): 406-414]
- Selenium status correlates with the duration of stay in ICU [Holzer et al. Pediatr Cardiol 2004; 25: 522-528]
- Selenium supplementation reduces ischaemia/reperfusion damage (animal model) [Turan et al. Antioxidants & Redox Signaling 2005; 7: 1388-1397]
- Selenium supplementation reduces mortality in SIRS/sepsis patients (SIC) [Angstwurm et al. Crit Care Med 2007; 35: 1-9]
Possible Actions of Selenium/Selenase® Supplementation:
- Maintenance of selenium levels during extracorporeal circulation
- Reduction of tissue damage in heart, lungs and brain
- Prevention or minimisation of systemic inflammation (SIRS)
Suggested timing and dosage for selenium supplementation:
| Time point | Dosage |
|---|---|
| 1 week pre-operative | 500 μg Se/d as selenase® solution for injection |
| Bolus dose before defined ischaemia or reperfusion into priming volume of heart-lung machine | 1000 μg Se/d as selenase® solution for injection |
Information sheet on HEART SURGERY, biosyn Arzneimittel GmbH, RSi 2008. According to a lecture given by Prof Dr med P Feindt, Thieme Workshop 2008 entitled “Ischaemia and reperfusion an interdisciplinary challenge”. For personal use only.
Abbreviated Prescribing Information
selenase® 100 micrograms, solution for injection (50 micrograms/ml) selenase® 500 micrograms, solution for injection (50 micrograms/ml)
- 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 μg (1.27 – 2.53 μmol) selenium. If necessary, this dose can be increased to 500 μg (6.33 μmol) 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 25°C.
- 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