Land: Armenía
Tungumál: enska
Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
rivaroxaban
Bayer Pharma AG
rivaroxaban
10mg
tablets film-coated
Prescription
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg rivaroxaban. Excipient with known effect: Each film-coated tablet contains 2 7 . 90 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). Light red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and "10" and a triangle on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 10 mg rivaroxaban taken orally once daily. The initial dose should be taken 6 to 10 hours after surgery, provided that haemostasis has been established. The duration of treatment depends on the individual risk of the patient for venous thromboembolism which is determined by the type of orthopaedic surgery. For patients undergoing major hip surgery, a treatment duration of 5 weeks is recommended. For patients undergoing major knee surgery, a treatment duration of 2 weeks is recommended. If a dose is missed the patient should take Xarelto immediately and then continue the following day with once daily intake as before. _Converting from Vitamin K Antagonists (VKA) to Xarelto _ When converting patients from VKAs to Xarelto, International Normalized Ratio (INR) values will be falsely elevated after the intake of Xarelto. The INR is not valid to measure the anticoagulant activity of Xarelto, and therefore should not be used (see section 4.5). _Conv Lestu allt skjalið