Land: Südafrika
Sprache: Englisch
Quelle: South African Health Products Regulatory Authority (SAHPRA)
Bayer
TRASYLOL® SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): TRASYLOL ® Sterile solution for IV injection and infusion COMPOSITION: TRASYLOL ( aprotinin ) is a highly purified and concentrated form of a naturally occurring enzyme inhibitor prepared from bovine lung tissue. Each vial of 50 mL contains 70 mg aprotinin (= 500 000 Kallikrein Inactivator Units, KIU = 277,8 European Pharmacopoeia Units, E.P. units) with the vial of 100 mL containing 140 mg aprotinin (= 1 000 000 Kallikrein Inactivator Units, KIU = 555,6 European Pharmacopoeia Units, E.P. units) in sterile 0,9% sodium chloride solution. PHARMACOLOGICAL CLASSIFICATION: A.32 Enzyme Inhibitors PHARMACOLOGICAL ACTION: TRASYLOL is a proteinase inhibitor. By forming reversible stoichiometric enzyme inhibitor-complexes, aprotinin acts as an inhibitor of human trypsin, plasmin, plasma kallikrein and tissue kallikrein. Aprotinin binds not only to free enzyme molecules but also to enzyme already bound to a third partner when the active centre of the enzyme is still accessible. In this way aprotinin inhibits both free plasmin and the plasmin-streptokinase complex formed as an intermediate under thrombolytic therapy with streptokinase. INDICATIONS: TRASYLOL is indicated for the treatment of adult patients at high risk of major blood loss during and following open heart surgery with extracorporeal circulation. These include: Patients requiring re-operation through a previous median sternotomy. Patients with infective endocarditis. CONTRA-INDICATIONS: Known hypersensitivity to TRASYLOL. Experience in children, pregnancy and lactation is limited and inadequate to assess safety and efficacy. Pancreatitis. WARNING: The addition of TRASYLOL to heparinised blood will prolong the activated clotting time (ACT). Thus, the ACT should not be Lesen Sie das vollständige Dokument