德国拜耳利伐沙班的中文说明书

Bayer, headquartered in Leverkusen, Germany, has 750 production plants in 200 locations on six continents; it has 120,000 employees and 350 branches in almost every country in the world. Polymers, medicine and health care, chemical industry and agriculture are the company's four pillar industries. Produced by Bayer in Germany, it is used to prevent venous thrombosis in adult patients undergoing elective hip or knee replacement surgery.

[drug name]

Generic name: Rivaroxaban tablets

Product name: Rivaroxaban tablets (Xarelto)

English name: Rivaroxaban tablets

Full pinyin code: LiFaShaBanPian(BaiRuiTuo)

[Main Ingredients] The main ingredient of this product is rivaroxaban.

[Properties] This product is a red film-coated tablet.

[Indications/Function and Indications] 1. For adult patients undergoing elective hip or knee replacement surgery to prevent venous thrombosis (VTE). 2. Used to treat venous thrombosis (DVT) in adults and reduce the risk of DVT recurrence and pulmonary embolism (PE) after acute DVT. 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.

[Specification model] 10mg*5s*1 board

[Usage and Dosage] The recommended dose is 10 mg of oral rivaroxaban, once daily.

[Adverse Reactions] The safety of rivaroxaban 10 mg was evaluated in three phase III studies. In these three studies, a total of 4571 patients who underwent major lower limb orthopedic surgery (total hip replacement or total knee replacement) received rivaroxaban for up to 39 days. A total of approximately 14% of treated patients experienced adverse reactions. Bleeding and anemia occurred in approximately 3.3% and 1% of patients, respectively. Other common adverse reactions include nausea, increased GGT, and increased transaminases. Adverse effects should be explained in the context of surgery. Due to its pharmacological mode of action, rivaroxaban may cause an increased risk of latent or overt bleeding in some tissues or organs, possibly resulting in posthemorrhagic anemia. The signs, symptoms, and severity of bleeding (including possible fatal consequences) will vary depending on the location, extent, or extent of the bleeding. The risk of bleeding may be increased in certain patient groups, such as patients with uncontrolled severe arterial hypertension and/or patients receiving concomitant medications that affect hemostasis. Hemorrhagic complications may manifest as weakness, weakness, pallor, dizziness, headache, or unexplained swelling. Therefore, the possibility of bleeding should be considered when evaluating patients taking anticoagulants.

[Contraindications] Patients who are allergic to rivaroxaban or any excipients in the tablets; patients with clinically significant active bleeding; patients with liver disease who have coagulation abnormalities and clinically relevant bleeding risks; pregnant and lactating women are contraindicated.

[Notes] 1. Bleeding risk: As detailed below, some subgroups of patients have a higher risk of bleeding. After initiation of treatment, these patients should be monitored closely for signs of bleeding complications. This can be accomplished by regular physical examination of the patient, close observation of surgical wound drainage, and regular determination of hemoglobin. Any unexplained decrease in hemoglobin or blood pressure should prompt a search for the site of bleeding. 2. Kidney damage: In severe kidney damage (creatinine clearance<30mL/min), the plasma concentration of rivaroxaban may be significantly increased, resulting in an increased risk of bleeding. Rivaroxaban is not recommended for patients with creatinine clearance <15 mL/min. Rivaroxaban should be used with caution in patients with creatinine clearance 15-29 mL/min. Rivaroxaban should be used with caution in patients with moderate renal impairment (creatinine clearance 30-49 mL/min) when used concomitantly with other drugs that may increase rivaroxaban plasma concentrations. 3. Liver damage: In cirrhotic patients with moderate liver damage (Child Pugh category B), the plasma concentration of rivaroxaban may be significantly increased, leading to an increased risk of bleeding. Rivaroxaban is contraindicated in patients with liver disease associated with coagulation abnormalities and clinically relevant risk of bleeding. Rivaroxaban can be used with caution in patients with cirrhosis who have moderate hepatic impairment (Child Pugh category B) and are not accompanied by coagulation abnormalities. 4. Interactions with other drugs: in azole-antifungal agents (such as ketoconazole, itraconazole, voriconazole and posaconazole). Please read the instructions carefully and use it as directed by your doctor.

[Pediatric Use] Due to the lack of safety and efficacy data, rivaroxaban is not recommended for use in adolescents or children under 18 years of age.

[Dose for Elderly Patients] No dose adjustment is required for elderly patients (>65 years old).

[Storage] It needs to be sealed and stored at room temperature.

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