甲磺酸达比加群酯 英文说明书.pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION DOSAGE FORMS AND STRENGTHS­ These highlights do not include all the information needed to use Capsules: 75 mg and 150 mg (3) PRADAXA safely and effectively. See full prescribing information for PRADAXA. CONTRAINDICATIONS­  Active pathological bleeding (4) PRADAXA® (dabigatran etexilate mesylate) capsules for oral use  History of serious hypersensitivity reaction to PRADAXA (4) Initial U.S. Approval: 2010  Mechanical prosthetic heart valve (4) WARNING: DISCONTINUING PRADAXA IN PATIENTS WARNINGS AND PRECAUTIONS­ WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION  Risk of bleeding: PRADAXA can cause serious and, sometimes, fatal INCREASES RISK OF STROKE bleeding. Promptly evaluate signs and symptoms of blood loss. (5.2) See full prescribing information for complete boxed warning.  Bioprosthetic heart valves: PRADAXA use not recommended (5.3)  P-gp inducers and inhibitors: Effects on dabigatran exposure (5.4) Discontinuing PRADAXA places patients at an increased risk of thrombotic events. If anticoagulation with PRADAXA must be ADVERSE REACTIONS­ discontinued for a reason other than pathological bleeding, consider