No dose adjustment is required in elderly patients aged 65 years and above (see section 5.2). low-molecular weight heparin) can be started at any time, if the patient is clinically stable and adequate haemostasis has been achieved.Ībsence of antithrombotic therapy exposes patients to the thrombotic risk of their underlying disease or condition. Pradaxa (dabigatran etexilate) treatment can be re-initiated 24 hours after administration of idarucizumab, if the patient is clinically stable and adequate haemostasis has been achieved.Īfter administration of idarucizumab, other antithrombotic therapy (e.g. Relevant coagulation parameters are activated partial thromboplastin time (aPTT), diluted thrombin time (dTT) or ecarin clotting time (ECT) (see section 5.1).Ī maximum daily dose has not been investigated. patients require a second emergency surgery/urgent procedure and have prolonged clotting times.if potential re-bleeding would be life-threatening and prolonged clotting times are observed, or.recurrence of clinically relevant bleeding together with prolonged clotting times, or.In a subset of patients, recurrence of plasma concentrations of unbound dabigatran and concomitant prolongation of clotting tests have occurred up to 24 hours after administration of idarucizumab (see section 5.1).Īdministration of a second 5 g dose of idarucizumab may be considered in the following situations: National Library of Medicine.The recommended dose is 5 g idarucizumab (2 vials of 2.5 g/50 mL). ^ 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".
0 kommentar(er)
