Product Information
Registration Status: ActiveTRASYLOL INJECTION 500,000 KIU/50ml is approved to be sold in Singapore with effective from 1994-07-26. It is marketed by LINK HEALTHCARE SINGAPORE PTE LTD, with the registration number of SIN07805P.
This product contains Aprotinin 500000 kiu/50ml in the form of INJECTION. It is approved for INTRAVENOUS use.
This product is manufactured by BAYER PHARMA AG in GERMANY.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Aprotinin, also known as bovine pancreatic trypsin inhibitor, BPTI (Trasylol, Bayer) is a protein, that is used as medication administered by injection to reduce bleeding during complex surgery, such as heart and liver surgery. Its main effect is the slowing down of fibrinolysis, the process that leads to the breakdown of blood clots. The aim in its use is to decrease the need for blood transfusions during surgery, as well as end-organ damage due to hypotension (low blood pressure) as a result of marked blood loss. The drug was temporarily withdrawn worldwide in 2007 after studies suggested that its use increased the risk of complications or death; after this was confirmed by follow-up studies, Trasylol was entirely and permanently withdrawn in May 2008, except - at least for the time being - for very restricted research use.
Indication
For prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion.
Mechanism of Action
Aprotinin inhibits several serine proteases, specifically trypsin, chymotrypsin and plasmin at a concentration of about 125,000 IU/ml, and kallikrein at 300,000 IU/ml. Its action on kallikrein leads to the inhibition of the formation of factor XIIa. As a result, both the intrinsic pathway of coagulation and fibrinolysis are inhibited. Its action on plasmin independently slows fibrinolysis.
Pharmacokinetics
- Absorption
- 100% (IV)
- Distribution
- Metabolism
- Aprotinin is slowly degraded by lysosomal enzymes.
- Elimination
Active Ingredient/Synonyms
Aprotinin (bovine) | Aprotinin Biosynthetic | Aprotinin Bovine | Aprotinin Concentrated Solution | Bovine Aprotinin | Bovine Pancreatic Trypsin Inhibitor | BPTI | Fibrinolysis Inhibitor | Trypsin Inhibitor, Pancreatic Basic | Aprotinin |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.