Country: Armenia
Bahasa: Inggeris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
rivaroxaban
Bayer Pharma AG
B01AF01
rivaroxaban
15mg
tablets film-coated
(28/2x14/), in blister
Prescription
Registered
2018-06-08
36 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Xarelto 15 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 15 mg rivaroxaban. Excipient with known effect: Each film-coated tablet contains 24.13 mg lactose (as monohydrate), see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and “15” and a triangle on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. (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. Therapy with Xarelto should be continued long term provided the benefit of prevention of stroke and systemic embolism outweighs the risk of bleeding (see section 4.4). 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. _Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE _ The recommended dose for the initial treatment of acute DVT or PE is 15 mg twice daily for the first three weeks f Baca dokumen lengkap