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: The recommended dose is 5 g idarucizumab (2 vials of 2.5 g/50 mL).

Pradaxa praxbind