Selenase® In Vascular Surgery
Scientific information On
Vascular Surgery
Causes Of Ischaemia:
- Arteriosclerosis (acute and chronic occlusions)
- Vascular injury
- Compartment syndrome after accidents
- Reduction of micro circulation
- Increase of inflamma tory parameters
- Release of NO
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
- ineffective
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