biosyn Corporation

We Do Research!

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)

Risks After Reperfusion:

  • Damage to heart and lung tissue
  • Hyperinflammation (= post reperfusion syndrome) leads to 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  • Aprotinin (anti-coagulant, withdrawn from the market end of 2007)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

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