Transcription of Product Monograph - Pradaxa® Reversal Agent
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Product Monograph - Pradaxa® Reversal Agent
Product Monograph1 Please see safety information throughout. Please see complete Important Safety Information on page 14 and full Prescribing ..3 Indications and Usage ..3 Dosage and Administration ..4 Description ..5 Clinical Pharmacology ..5 Clinical Studies ..7 Contraindications ..9 Warnings and Precautions ..10 Adverse Reactions ..10 Use in Specific Populations ..12 Nonclinical Toxicology ..12 Dosage Forms and Strengths ..13 How Supplied/Storage and Handling ..13 Patient Counseling Information ..13 Important Safety Information ..142 Please see safety information throughout. Please see complete Important Safety Information on page 14 and full Prescribing PRAXBIND is an immediate and specific Reversal Agent for PRADAXA PRAXBIND is indicated in patients treated with PRADAXA when Reversal of the anticoagulant effects of dabigatran is needed: For emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding This indication is approved under accelerated approval based on a reduction in unbound dabigatran and normalization of coagulation parameters in healthy volunteers.
Overview • PRAXBIND is an immediate and specific reversal agent for PRADAXA • PRAXBIND is indicated in patients treated with PRADAXA when reversal of the anticoagulant effects of
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