Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
vorapaxar sulfate
Merck Sharp Dohme Limited
B01
vorapaxar
Antithrombotic agents
Myocardial Infarction
Zontivityis indicated for the reduction of atherothrombotic events in adult patients with- a history of myocardial infarction (MI)co-administered with acetylsalicylic acid (ASA) and, where appropriate, clopidogrel; or- symptomatic peripheral arterial disease(PAD), co-administered with acetylsalicylic acid (ASA) or, where appropriate, clopidogrel.
Revision: 2
Withdrawn
2015-01-19
26 B. PACKAGE LEAFLET Medicinal product no longer authorised 27 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZONTIVITY 2 MG FILM-COATED TABLETS vorapaxar This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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, pharmacist, or nurse. • 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Zontivity is and what it is used for 2. What you need to know before you take Zontivity 3. How to take Zontivity 4. Possible side effects 5. How to store Zontivity 6. Contents of the pack and other information 1. WHAT ZONTIVITY IS AND WHAT IT IS USED FOR WHAT ZONTIVITY IS Zontivity contains an active substance called vorapaxar, and it belongs to a group of medicines called ‘anti-platelet medicines.’ Platelets are blood cells that help with normal blood clotting. Zontivity prevents platelets from sticking together. This reduces the chance of a blood clot forming and blocking the arteries, such as the arteries in the heart. WHAT ZONTIVITY IS USED FOR Zontivity is used in adults who have had a heart attack or have a condition known as "peripheral arterial disease" (also known as poor circulation in the legs). Zontivity is used to lower your chance of: • having another heart attack or stroke • dying from a heart attack • needing an urgent operation to open blocked arteries in the heart. Your doctor will also give you instructions about acetylsa Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 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 Zontivity 2 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.08 mg of vorapaxar (as vorapaxar sulfate). Excipient(s) with known effect: Each film-coated tablet contains 66.12 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. The film-coated tablets are yellow, oval-shaped, size 8.48 mm x 4.76 mm, with “351” on one side and the MSD logo on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zontivity is indicated for the reduction of atherothrombotic events in adult patients with - a history of myocardial infarction (MI), co-administered with acetylsalicylic acid (ASA) and, where appropriate, clopidogrel; or - symptomatic peripheral arterial disease (PAD), co-administered with acetylsalicylic acid (ASA) or, where appropriate, clopidogrel. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology MI The recommended dose of Zontivity is 2.08 mg to be taken once daily. Zontivity should be initiated at least 2 weeks after a MI and preferably within the first 12 months from the acute event (see section 5.1). A delayed onset of action (at least 7 days) should be expected when starting therapy with Zontivity. There are limited data on the efficacy and safety of Zontivity beyond 24 months. Continued therapy after this time must be based on a re-evaluation of the benefits and risks for the individual of further therapy. Medicinal product no longer authorised 3 PAD The recommended dose of Zontivity is 2.08 mg to be taken once daily. For patients being started on Zontivity due to symptomatic PAD, therapy may be initiate Прочетете целия документ