Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Rivaroxaban (micronized)
BAYER (SOUTH EAST ASIA) PTE LTD
B01AF01
20.00 mg
TABLET, FILM COATED
Rivaroxaban (micronized) 20.00 mg
ORAL
Prescription Only
Bayer AG
ACTIVE
2012-03-13
1. NAME OF THE MEDICINAL PRODUCT Xarelto 15 mg film-coated tablets Xarelto 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION XARELTO 15 MG 1 film-coated tablet contains 15 mg rivaroxaban. XARELTO 20 MG 1 film-coated tablet contains 20 mg rivaroxaban. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). XARELTO 15 MG Red, round biconvex tablets marked with the BAYER-cross on one side and “15” and a triangle on the other side. XARELTO 20 MG Brown-red, round biconvex tablets marked with the BAYER-cross on one side and “20” and a triangle on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xarelto is indicated for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. There are limited data on the relative effectiveness of Xarelto and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled (see section 5.1) . Xarelto is indicated for the treatment of Deep Vein Thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT, PE in adults. (See section 4.4 for haemodynamically unstable PE patients.) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ Prevention of stroke and systemic embolism The recommended dose is 20 mg once daily, which is also the recommended maximum dose. If a dose is missed the patient should take Xarelto immediately and continue on the following day with the once daily intake as recommended. The dose should not be doubled within the same day to make up for a missed dose. Read the complete document
Xarelto 15mg&20mg_CCDS 17_Dec 2022 1. NAME OF THE MEDICINAL PRODUCT Xarelto 15 mg film-coated tablets Xarelto 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION XARELTO 15 MG 1 film-coated tablet contains 15 mg rivaroxaban. XARELTO 20 MG 1 film-coated tablet contains 20 mg rivaroxaban. For a full list of excipients, see section ‘List of excipients’. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). XARELTO 15 MG Red, round biconvex tablets marked with the BAYER-cross on one side and “15” and a triangle on the other side. XARELTO 20 MG Brown-red, round biconvex tablets marked with the BAYER-cross on one side and “20” and a triangle on the other side. 4. CLINICAL PARTICULARS 4.1 INDICATIONS _Adults _ Xarelto is indicated for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. There are limited data on the relative effectiveness of Xarelto and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled (see section ‘Pharmacodynamic properties’) . Xarelto is indicated for the treatment of Deep Vein Thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT, PE in adults. (See section ‘Special warnings and precautions for use’ for haemodynamically unstable PE patients.) _Paediatric population _ Xarelto 15 mg Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Xarelto 15mg&20mg_CCDS 17_Dec 2022 Xarelto 20 mg Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment. 4.2 DOSAGE AND METHOD OF ADMINISTRATION _POSOLOGY _ _ _ Prevention of stroke and systemic embolism in adults The recommended dose is 20 mg once daily, which is also t Read the complete document