If reappearance of clinically relevant bleeding together with elevated coagulation parameters is observed after administration of 5 g Praxbind, administration of an additional 5 g dose of Praxbind may be considered. In a limited number of patients in the clinical program, between 12 and 24 hours after administration of 5 g idarucizumab, elevated coagulation parameters (e.g., activated partial thromboplastin time (aPTT) or ecarin clotting time (ECT)) have been observed. To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate. Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease. Patients being treated with dabigatran therapy have underlying disease states that predispose them to thromboembolic events. 5 WARNINGS AND PRECAUTIONS Thromboembolic Risk Injection: 2.5 g/50 mL solution in a single-dose vial.
Praxbind is a sterile, preservative-free, colorless to slightly yellow, clear to slightly opalescent solution available as: Related/similar drugs idarucizumab 3 DOSAGE FORMS AND STRENGTHS
Praxbind treatment can be used in conjunction with standard supportive measures, which should be considered as medically appropriate. No other infusion should be administered in parallel via the same intravenous access. The line must be flushed with sterile 0.9% Sodium Chloride Injection, USP solution prior to infusion. A pre-existing intravenous line may be used for administration of Praxbind. Bolus injection by injecting both vials consecutively one after another via syringe (see Figure 3). Two consecutive infusions (see Figure 2) or. Intravenously administer the dose of 5 g (2 vials, each contains 2.5 g) as. Use aseptic technique when administering Praxbind. 
Do not mix with other medicinal products. The solution in vials may be stored at room temperature, 25☌ (77☏), but must be used within 6 hours. Once solution has been removed from the vial, administration should begin promptly. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Ensure aseptic handling when preparing the infusion. Remove both vials (each containing 2.5 g/50 mL idarucizumab) from carton. There is limited data to support administration of an additional 5 g of Praxbind. Both vials are packaged together in one carton. The recommended dose of Praxbind is 5 g, provided as two separate vials each containing 2.5 g/50 mL idarucizumab (see Figure 1). In life-threatening or uncontrolled bleedingĢ DOSAGE AND ADMINISTRATION Recommended Dose. 
For emergency surgery/urgent procedures.Praxbind is indicated in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed:
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