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Thread: Pradaxa 110 mg capsules

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    Default Pradaxa 110 mg capsules

    Composition: Each hard capsule contains: 126,83 mg dabigatran etexilate mesilate equivalent to 110 mg dabigatran etexilate.

    Therapeutic indications
    • Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
    • Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension.
    • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults

    Pradaxa capsules attachment.php?attachmentid=442&stc=1&d=1436861768
    Contraindications
    • Hypersensitivity to the active substance or to any of the excipients.
    • Patients with severe renal impairment (CrCL < 30 mL/min)
    • Active clinically significant bleeding
    • Lesion or condition, if considered a significant risk factor for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
    • Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc), oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under specific circumstances of switching anticoagulant therapy or when UFH is given at doses necessary to maintain an open central venous or arterial catheter
    • Hepatic impairment or liver disease expected to have any impact on survival
    • Concomitant treatment with systemic ketoconazole, cyclosporine, itraconazole and dronedarone
    • Prosthetic heart valves requiring anticoagulant treatment











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