OUR PRODUCTS
Each film coated tablet contains 2.5 mg rivaroxaban.
Each film coated tablet contains 10 mg of rivaroxaban.
Each film coated tablet contains 15 mg of rivaroxaban.
Each film coated tablet contains 20 mg rivaroxaban.
- Hypersensitivity to the active substance or to any of the excipients
- Clinically effective bleeding.
- The lesion or condition, if considered to be a high risk of major bleeding. This may include current or recent GI ulcers, malignancy at high risk of bleeding, recent injury to the brain or spine, recent brain, spine or eye surgery, intracranial haemorrhage, known or suspected esophageal varices, or arteriovenous malformations, aneurysms or large aneurysms. Intramedullary or intracerebral vascular malformations.
- Concomitant therapy with any other anticoagulant, such as unfractionated heparin (UFH), low molecular weight heparin (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, apixaban, etc.) except under specific circumstances to switch anticoagulant therapy or when UFH is administered at the doses necessary to keep an open central venous or arterial catheter
- Liver disease associated with coagulopathy and clinically relevant bleeding risks including cirrhotic patients
- Pregnancy and breast-feeding
- CYP3A4 and P-gp Inhibitors: Rovaban is not recommended for use in patients receiving concomitant systemic therapy with azole antagonists such as ketoconazole, itraconazole, voriconazole and posaconazole or HIV protease inhibitors.
- Anticoagulants :After co-administration of enoxaparin (40 mg as a single dose) with rivaroxaban (10 mg as a single dose) an additional effect on anti-factor Xa activity was observed without any additional effects on coagulation tests (PT, aPTT). Enoxaparin did not affect the pharmacokinetics of rivaroxaban.
- NSAIDs/Inhibitors of Platelet Aggregation: Caution should be exercised if patients are concomitantly treated with NSAIDs (including acetylsalicylic acid) and inhibitors of platelet aggregation as they usually increase the risk of bleeding.
- SSRIs/SNRIs: Increase the risk of bleeding.
Adults:
- 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, and previous stroke or transient ischemic attack.
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Children:
Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents under 18 years of age who weigh more than 50 kg after at least 5 days of initial treatment with parenteral anticoagulants.
- Prevention of stroke and systemic embolism in adults: The recommended dose is 20 mg once daily, which is also the maximum recommended dose. Long-term treatment with Rovaban should be continued provided that the benefit in preventing stroke and systemic embolism outweighs the risk of bleeding.
- Treatment of DVT and treatment of PE and prevention of recurrence of DVT and PE in adults: The recommended dose for the initial treatment of DVT or acute pulmonary embolism is 15 mg twice daily for the first 3 weeks followed by 20 mg once daily for continued treatment and prevention of recurrence of DVT and PE. PE.
- Treatment of VTE and prevention of VTE recurrence in children and adolescents: In children and adolescents under 18 years of age, Rovaban should be started at least 5 days after initial parenteral anticoagulation therapy.
- The dose for children and adolescents is calculated based on body weight.
Body weight 50 kg or more: A daily dose of 20 mg of rivaroxaban is recommended. This is the maximum daily dose.
Body weight from 30 to 50 kg: A daily dose of 15 mg of rivaroxaban is recommended. This is the maximum daily dose.
The child's weight should be monitored and the dose reviewed regularly. This is to ensure that the therapeutic dose is maintained. Dosage adjustments should be made based on changes in body weight only. Treatment should continue for at least 3 months in children and adolescents. Treatment may be extended up to 12 months when clinically necessary.
Anemia, thrombocytopenia, allergic reaction, allergic angioedema, eye bleeding, tachycardia, hypotension, hematoma, nosebleed, dry mouth, bleeding gums and digestive system, hepatic impairment, increased bilirubin A, jaundice, increased blood phosphatase Alkaline, genitourinary bleeding, increased lipase, increased amylase .
Rovaban 2.5 mg film-coated tablets.......(72/2021)
Rovaban 10 mg film-coated tablets.......(73/2021)
Rovaban 15 mg film-coated tablets.......(74/2021)
Rovaban 20 mg film-coated tablets.......(75/2021)
a carton box containing 3 blisters, each one contain 10 film-coated tablets.