德国拜耳利伐沙班说明书

German Bayer Instructions

[drug name]

Generic name: Rivaroxaban tablets

Product name: Xarelto®

English name: RivaroxabanTablets

Chinese Pinyin: LifashabanPian

【Ingredients】

Main ingredient: Rivaroxaban.

【Specifications】

(1)10mg; (2)15mg; (3)20mg

[Manufacturer] Bayer, Germany

【Indications】

1. For use in adult patients undergoing elective hip or knee replacement surgery to prevent venous thrombosis (VTE).

2. For the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults, and to reduce the risk of recurrence of DVT and/or PE in patients whose risk of recurrence of DVT and/or PE persists after completion of at least 6 months of initial treatment.

3. For use in adult patients with nonvalvular atrial fibrillation who have one or more risk factors (e.g., congestive heart failure, hypertension, age ≥75 years, diabetes, history of stroke or transient ischemic attack) to reduce the risk of stroke and systemic embolism. There are limited data on the relative effectiveness of rivaroxaban compared with warfarin in reducing the risk of stroke and systemic embolism in conditions well controlled with warfarin therapy.

【Usage and Dosage】

Rivaroxaban is administered orally. Rivaroxaban 10mg can be taken with food or alone. Rivaroxaban 15 mg or 20 mg tablets should be taken with food.

For the prevention of venous thrombosis in adult patients undergoing elective hip or knee replacement surgery: The recommended dose is rivaroxaban 10 mg orally once daily. If the wound has stopped bleeding, the first dose of medication should be between 6-10 hours after surgery. For patients undergoing major hip surgery, the recommended course of treatment is 35 days. For patients undergoing major knee surgery, the recommended course of treatment is 12 days. If a missed dose occurs, the patient should take rivaroxaban immediately and continue taking the dose once daily the next day.

Treat DVT and PE and reduce the risk of recurrence of DVT and PE. The recommended dose for initial treatment of acute DVT or PE is 15 mg twice daily for the first three weeks. After the initial treatment period, the recommended dose for subsequent treatment is 20 mg orally once daily, administered at approximately the same time each day. Patients with DVT or PE caused by major transient risk factors (such as recent major surgery or trauma), or patients with a history of recurrent DVT or PE, should be considered for longer-term treatment.

After carefully evaluating the benefits and bleeding risks of rivaroxaban, the duration of treatment and the appropriate dosage should be determined based on individual circumstances.

【Side effects】

In terms of safety, domestic research statistics on bleeding complications after the use of rivaroxaban have found no increase in fatal bleeding and intracranial bleeding. Bleeding complications such as urinary tract bleeding and hemorrhoidal bleeding all have possible causes and the bleeding stops after treatment. Therefore, oral rivaroxaban is safer as an anticoagulant. Oral administration does not require routine monitoring, and the anti-factor Xa chromogenic test can be used to quantitatively determine plasma concentrations of factor Xa inhibitors when bleeding is suspected.

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