Separate vials each containing 2.5 g/50 mL idarucizumab (see Figure 1). The recommended dose of PRAXBIND is 5 g, provided as two In life-threatening or uncontrolled bleedingĭOSAGE AND ADMINISTRATION Recommended Dose.Patients treated with Pradaxa when reversal of the anticoagulant effects of PRAXBIND (idarucizumab) is supplied in 2 single-dose vials, each containing 2.5 g of idarucizumab in 50 mL formulated as a buffered, isotonic, solution containing acetic acid glacial (10.05 mg), polysorbate 20 (10 mg), sodium acetate trihydrate (147.35 mg), sorbitol (2004.20 mg), and water for injection with an osmolality of 270330 mOsm/kg and a pH of 5.3-5.7. PRAXBIND (idarucizumab) is a sterile, preservative-free, colorless to slightly yellow, clear to slightly opalescent solution for intravenous administration. Idarucizumab is composed of a light chain of 219 amino acids and a heavy chain fragment of 225 amino acids, covalently linked together by one disulfide bond between cysteine 225 of the heavy chain fragment and cysteine 219 of the light chain, and has an estimated molecular mass of approximately 47,766 Daltons. Using recombinant expression technology, idarucizumab is produced in a well characterized recombinant (mammalian) CHO cell line and is purified using standard technology. Idarucizumab is a humanized monoclonal antibody fragment (Fab) derived from an IgG1 isotype molecule, whose target is the direct thrombin inhibitor dabigatran. You may report side effects to FDA at 1-80. For more information, ask your doctor or pharmacist.Ĭall your doctor for medical advice about side effects. These are not all the possible side effects of Praxbind. Tell the doctor if you have any side effect that bothers you or that does not go away. The most common side effects of Praxbind include: Get medical help right away, if you have any of the symptoms listed above. pain, swelling, warmth, or redness in one or both legs.weakness (especially in one side of the body),.swelling of your face, lips, tongue, or throat,.Praxbind may cause serious side effects including: ![]() ![]() ![]() What are the possible side effects of Praxbind? It is not known if Praxbind is safe and effective in children. Praxbind belongs to a class of drugs called Antidotes, Other. Praxbind may be used alone or with other medications. Praxbind is a prescription medicine used to reverse the medication Dabigatran.
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