Land: Singapore
Språk: engelsk
Kilde: HSA (Health Sciences Authority)
RIVAROXABAN MICRONIZED
BAYER (SOUTH EAST ASIA) PTE LTD
B01AF01
10.00 mg
TABLET, FILM COATED
RIVAROXABAN MICRONIZED 10.00 mg
ORAL
Prescription Only
Bayer AG
ACTIVE
2008-11-05
1. NAME OF THE MEDICINAL PRODUCT Xarelto 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Xarelto 10 mg 1 film-coated tablet contains 10 mg rivaroxaban. Each 10mg film-coated tablet contains 27.90mg lactose monohydrate (= 26.51mg lactose) per tablet. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated, round, biconvex, light red immediate release tablets of 6 mm diameter and 9mm radius of curvature for oral use. BAYER-cross on the bottom side and "10" and a triangle on the top side. 4. CLINICAL PARTICULARS 4.1 INDICATIONS Prevention of venous thromboembolism (VTE) in patients undergoing total hip replacement or total knee replacement surgery. 4.2 DOSAGE AND METHOD OF ADMINISTRATION The recommended dose is 10 mg rivaroxaban taken orally once daily. The initial dose should be taken within 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 the 10mg Xarelto dose immediately and then continue on the following day with the once daily intake as before. Xarelto may be taken with or without food. For patients who are unable to swallow whole tablets, Xarelto tablet may be crushed and mixed with water or soft foods such as applesauce immediately prior to use and administered orally. The crushed Xarelto tablet Les hele dokumentet
1 Xarelto 10mg_CCDS 14+17_ June 2023 1. NAME OF THE MEDICINAL PRODUCT Xarelto 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Xarelto 10 mg 1 film-coated tablet contains 10 mg rivaroxaban. Each 10mg film-coated tablet contains 27.90mg lactose monohydrate (= 26.51mg lactose) per tablet. For a full list of excipients, see section ‘List of excipients’. 3. PHARMACEUTICAL FORM Film-coated, round, biconvex, light red immediate release tablets of 6 mm diameter and 9mm radius of curvature for oral use. BAYER-cross on the bottom side and "10" and a triangle on the top side. 4. CLINICAL PARTICULARS 4.1 INDICATIONS Prevention of venous thromboembolism (VTE) in patients undergoing total hip replacement or total knee replacement surgery. 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.) 4.2 DOSAGE AND METHOD OF ADMINISTRATION _Prevention of VTE in patients undergoing total hip replacement or total knee replacement surgery _ The recommended dose is 10 mg rivaroxaban taken orally once daily. The initial dose should be taken within 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 the 10mg Xarelto dose immediately and then continue on the following day with the once daily intake as before. _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 followed by 20 m Les hele dokumentet