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Selenase® In Vascular Surgery

Scientific information On

Vascular Surgery

Causes Of Ischaemia:

  • Arteriosclerosis (acute and chronic occlusions)
  • Vascular injury
  • Compartment syndrome after accidents

Risks After Reperfusion:

  • Increased formation of ROS:
    • Inactivation of NO (NO + O2 → Peroxynitrite)
    • Worsening of arteriosclerosis (ox. LDL, leukocyte and monocyte sticking [formation of foam cells])
    • Compartment syndrome: rhabdomyolysis, muscle necrosis, amputation

Conventional Measures to Prevent Reperfusion Injury:

  • Increasing NO concentration with L-arginine supplementation [Wilson et al. Circulation 2007; 116: 188-195]
  • Reduction of ROS production: Allopurinol, SOD, DHEA

Data on Selenium (Selenite):

Patients with aortic aneurysm and PAOD [Albrecht et al. Biomed. Chromatogr.1999; 13: 131-134]

  • Reduction of ROS Production
  • Increase in NO concentration

Possible Actions of Selenite Supplementation:

  • Direct inhibition of ROS and peroxynitrite formation
  • Shifting the balance of ROS/NO in favour of NO
  • Preventing the formation of atherogenic substances (ox. LDL, leukocyte and monocyte sticking [formation of foam cells])

Suggested Timing And Dosage For Selenium Supplementation:

Important: reperfusion is a two-phase process!
Early phase: immediately after declamping; Late phase: post-operative days 1 to 7

Time point Dosage
Pre-operative bolus (Boosting of selenium stores) 500 g – 1000 g Se∗ as selenase® solution for injection
Continuous infusion intra-operatively (immediately after declamping) 500 g – 1000 g Se∗/24h as selenase® solution for injection
Continuous infusion post-operatively (at least until post-op day 7) 500 g – 1000 g Se∗/d as selenase® solution for injection
Daily maintenance dose (for at least 3 months, followed by test of selenium levels) dosage adjustment according to reference value (test of selenium levels)

∗ ideally dosage adjustment is carried out after bedside tests of ROS and NO

Information sheet on VASCULAR SURGERY, biosyn Arzneimittel GmbH, RSi 2008. According to a lecture given by Dr med habil Thomas Zimmermann, 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)

  • 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