Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
rivaroxaban
Mylan Ireland Limited
B01AF01
rivaroxaban
Antithrombotic agents
Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation
Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers. Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. ------Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.-------Adults 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.Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.
Revision: 4
Authorised
2021-11-12
186 B. PACKAGE LEAFLET 187 PACKAGE LEAFLET: INFORMATION FOR THE USER RIVAROXABAN VIATRIS 2.5 MG FILM-COATED TABLETS rivaroxaban READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist . - This includes any possible side effects not listed in this leaflet. See section 4. IMPORTANT: The Rivaroxaban Viatris pack includes a Patient Alert Card which contains important safety information. Keep this card with you at all times WHAT IS IN THIS LEAFLET 1. What Rivaroxaban Viatris is and what it is used for 2. What you need to know before you take Rivaroxaban Viatris 3. How to take Rivaroxaban Viatris 4. Possible side effects 5. How to store Rivaroxaban Viatris 6. Contents of the pack and other information 1. WHAT RIVAROXABAN VIATRIS IS AND WHAT IT IS USED FOR You have been given Rivaroxaban Viatris because - you have been diagnosed with an acute coronary syndrome (a group of conditions that includes heart attack and unstable angina, a severe type of chest pain) and have been shown to have had an increase in certain cardiac blood tests. Rivaroxaban Viatris reduces the risk in adults of having another heart attack or reduces the risk of dying from a disease related to your heart or your blood vessels. Rivaroxaban Viatris will not be given to you on its own. Your doctor will also tell you to take either: • acetylsalicylic acid or • acetylsalicylic acid plus clopidogrel or ticlopidine. or - you have been diagnosed with a high risk of getting a blood clot due to a coronary artery disease or peripheral artery disease which causes symptoms. Rivaroxaban Viatris reduces the risk in adults of getting blot clots (atherothrombotic eve Đọc toàn bộ tài liệu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Rivaroxaban Viatris 2.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg rivaroxaban. Excipient with known effect Each film-coated tablet contains 19.24 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 yellow to yellow coloured, film-coated, round, biconvex, beveled edge tablet (5.4 mm diameter) marked with “RX” on one side of the tablet and “1” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rivaroxaban Viatris co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1). Rivaroxaban Viatris co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 2.5 mg twice daily. _ACS _ _ _ Patients taking Rivaroxaban Viatris 2.5 mg twice daily should also take a daily dose of 75 – 100 mg ASA or a daily dose of 75 – 100 mg ASA in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine. Treatment should be regularly evaluated in the individual patient weighing the risk for ischaemic events against the bleeding risks. Extension of treatment beyond 12 months should be done on an individual patient basis as experience up to 24 months is limited (see section 5.1). _ _ Treatment with Rivaroxaban Viatris should be started as soon as possible after stabilisation of the ACS event (including revascularisation procedures); at the earliest 24 hours after Đọc toàn bộ tài liệu