Presentation and Status in Health Basket
Presentation | Basket | Yarpa | Pharmasoft |
---|---|---|---|
Film Coated Tablets 56 x 2.5 mg |
16653 | 18707 | |
Film Coated Tablets 30 x 10 mg |
16667 | 18708 | |
Film Coated Tablets 28 x 15 mg |
16668 | 18709 | |
Film Coated Tablets 28 x 20 mg |
16671 | 18710 |
Related information
Dosage
Dosage must be adjusted individually according to the patient’s medical condition.
Please refer to the license holder for further details.
Indications
Rivaroxaban 2.5 mg: Co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.
Rivaroxaban 2.5 mg, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.
Rivaroxaban 10 mg: Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.
Prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE), adults (following completion of at least 6 months therapy for DVT or PE).
Rivaroxaban 15, 20 mg: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Paediatric population: Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.
Contra-Indications
Rivaroxaban 2.5, 10, 15, 20 mg:
* Hypersensitivity to the active substance or to any of the excipients.
* Active clinically significant bleeding.
* Lesion or condition, if considered to be a significant risk 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, dabigatran etexilate, 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 disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C.
* Pregnancy and breastfeeding.
Rivaroxaban 2.5mg:
* Concomitant treatment of ACS with antiplatelet therapy in patients with a prior stroke or a transient ischaemic attack (TIA).
* Concomitant treatment of CAD/PAD with ASA in patients with previous haemorrhagic or lacunar stroke, or any stroke within a month.
Special Precautions
Please refer to the license holder for further details
Side Effects
Please refer to the license holder for further details
Drug interactions
Please refer to the license holder for further details
Pregnancy and Lactation
Please refer to the license holder for further details
Overdose
Please refer to the license holder for further details