kiger.blogg.se - Idarucizumab reversal

It is licensed for use in adults treated with dabigatran etexilate ( Pradaxa, Boehringer Ingelheim Limited) when rapid reversal of its anticoagulant effects is required for emergency surgery or urgent procedures, or in life‑threatening or uncontrolled bleeding.

Regulatory status: Idarucizumab ( Praxbind, Boehringer Ingelheim Limited) was launched in the UK in December 2015. People may still need other supportive measures, for example blood products, to manage their bleeding and these should be considered as medically appropriate. In the interim analysis of an ongoing, phase III, uncontrolled, cohort study (RE‑VERSE AD n=90), treatment with a 5 g dose of idarucizumab completely reversed the anticoagulant effect of dabigatran etexilate in adults who had either serious bleeding or required urgent surgery. Its action is specific against the NOAC dabigatran etexilate. National Library of Medicine.Idarucizumab is the first agent to be licensed in the UK that reverses the anticoagulant effect of a non‑vitamin K antagonist oral anticoagulant (NOAC). ^ Statement On A Nonproprietary Name Adopted By The USAN Council - Idarucizumab Archived at the Wayback Machine, American Medical Association."International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 76". "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 71".

Food and Drug Administration (FDA) (Press release).

^ "FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa".

^ Pollack CV, Reilly PA, Eikelboom J, Glund S, Verhamme P, Bernstein RA, et al.

^ a b c "Praxbind- idarucizumab injection".

^ "Praxbind 2.5 g/50 mL solution for injection/infusion - Summary of Product Characteristics (SmPC)".

^ "Prescription medicines: registration of new chemical entities in Australia, 2016".