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Parameters is observed after administration of 5 g PRAXBIND, administration Of clinically relevant bleeding together with elevated coagulation Time (aPTT) or ecarin clotting time (ECT)) have been observed. Program, between 12 and 24 hours after administration of 5 g idarucizumab,Įlevated coagulation parameters (e.g., activated partial thromboplastin In a limited number of patients in the clinical Should be considered as soon as medically appropriate. To reduce this risk, resumption of anticoagulant therapy

Therapy exposes patients to the thrombotic risk of their underlyingĭisease. That predispose them to thromboembolic events. 5 WARNINGS AND PRECAUTIONS 5.1 Thromboembolicīeing treated with dabigatran therapy have underlying disease states To slightly yellow, clear to slightly opalescent solution available PRAXBIND is a sterile, preservative-free, colorless Is a specific reversal agent for dabigatran, with no impact on theĮffect of other anticoagulant or antithrombotic therapies.Ģ4 hours after administration of PRAXBIND [see Clinical Pharmacology Of anticoagulant therapy should be considered as soon as medically Reversing dabigatran therapy exposes patients to the thrombotic Have underlying disease states that predispose them to thromboembolicĮvents. Patients being treated with dabigatran therapy Supportive measures, which should be considered as medically appropriate. PRAXBIND treatment can be used in conjunction with standard.No other infusion shouldīe administered in parallel via the same intravenous access. Injection, USP solution prior to infusion. The line must be flushed with sterile 0.9% Sodium Chloride A pre-existing intravenous line may be used for administration.Bolus injection by injecting both vials consecutively oneĪfter another via syringe (see Figure 3).Two consecutive infusions (see Figure 2) or.Intravenously administer the dose of 5 g (2 vials, each.Do not mix with other medicinal products.May be stored at room temperature, 25☌ (77☏), but must be used withinĦ hours. Vial, administration should begin promptly. Particulate matter and discoloration prior to administration, whenever Parenteral drug products should be inspected visually for.Ensure aseptic handling when preparing the infusion.

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).