PRAXBIND®
Dosing and administration
The recommended dose of PRAXBIND® is 5 g (2 x 2.5 g/50 ml).
PRAXBIND® (2 x 2.5 g/50 ml) is administered intravenously, as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
In a limited number 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.
Administration of a second 5 g dose of PRAXBIND® may be considered in the following situations:
- recurrence of clinically relevant bleeding together with prolonged clotting times, or
- patients require a second emergency surgery/urgent procedure and have prolonged clotting times.
Instructions for use/handling
Intravenous Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
PRAXBIND® must not be mixed with other medicinal products.
A pre-existing intravenous line may be used for administration of PRAXBIND®. The line must be flushed with sterile sodium chloride 9 mg/ml (0.9 %) solution prior to and at the end of infusion. No other infusion should be administered in parallel via the same intravenous access.
Prior to use, the unopened vial may be kept at room temperature (up to 30°C) for up to 48 hours, if stored in the original package in order to protect from light. Once solution has been removed from the vial, chemical and physical in-use stability of idarucizumab has been demonstrated for 6 hours at room temperature. The solution should not be exposed to light for more than 6 hours. From a microbiological point of view, the product shall be used immediately after opening.
Reference:
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PRAXBIND® approved package insert. Updated in May 2019 and approved in November 2019.