国家: 新西兰
语言: 英文
来源: Medsafe (Medicines Safety Authority)
Ticagrelor 90mg; ; ;
AstraZeneca Limited
Ticagrelor 90 mg
90 mg
Film coated tablet
Active: Ticagrelor 90mg Excipient: Calcium hydrogen phosphate Hyprolose Hypromellose Iron oxide yellow Macrogol 400 Magnesium stearate Mannitol Purified talc Purified water Sodium starch glycolate Titanium dioxide
Blister pack, PVC/PVDC/Al sample blister sheet, 14 tablets
Prescription
Prescription
Ajinomoto OmniChem SA
BRILINTA, co-administered with acetylsalicylic acid (aspirin), is indicated for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction and stroke) · in patients with Acute Coronary Syndromes (unstable angina [UA], non ST elevation Myocardial Infarction [NSTEMI] or ST elevation Myocardial Infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG). · in patients with a history of myocardial infarction (MI occurred at least one year ago) and a high risk of developing an atherothrombotic event.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al sample blister sheet - 14 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC-PVDC/AL blister sheet - 56 tablets - 36 months from date of manufacture stored at or below 30°C
2011-03-24
Brilinta ® CMI 080621 Copyright 1(6) BRILINTA ® TICAGRELOR 60 MG OR 90 MG FILM COATED TABLETS. CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about BRILINTA. It does not contain all the information that is known about BRILINTA. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking BRILINTA against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT BRILINTA IS USED FOR BRILINTA in combination with aspirin is to be used in adults only. You have been given BRILINTA because you have had: a heart attack, or unstable angina (angina or chest pain that is not well controlled) BRILINTA reduces the chances of having another heart attack or of dying from a disease related to your heart or blood vessels. HOW BRILINTA WORKS BRILINTA contains the active substance called ticagrelor. This belongs to a group of medicines called anti-platelet medicines. BRILINTA affects cells called ‘platelets’ (also called thrombocytes). These very small blood cells help stop bleeding by clumping together to plug tiny holes in blood vessels that are cut or damaged. However, platelets can also form clots inside diseased blood vessels in the heart and brain. This can be very dangerous because: the clot can cut off the blood supply completely - this can cause a heart attack (myocardial infarction), or the clot can partly block the blood vessels to the heart - this reduces the blood flow to the heart and can cause chest pain which comes and goes (called ‘unstable angina’) BRILINTA helps stop the clumping of platelets. This reduces the chance of a blood clot forming that can reduce blood flow. This medicine is only available with a doctor’s prescription. BEFORE YOU USE BRILINTA _WHEN YOU MUST NOT USE I 阅读完整的文件
B RILINTA Data Sheet 160622 Copyright 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME B RILINTA ® 60 mg film-coated tablets B RILINTA ® 90 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 60 mg: each tablet contains 60 mg ticagrelor. 90 mg: each tablet contains 90 mg ticagrelor. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 60 mg - Round, biconvex, pink, film coated tablets, marked with “60” above “T” on one side and plain on the other. 90 mg - Round, biconvex, yellow, film coated tablets, marked with ‘90’ above ‘T’ on one side and plain on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS B RILINTA , co-administered with acetylsalicylic acid (aspirin), is indicated for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction and stroke) in patients with Acute Coronary Syndromes (unstable angina [UA], non ST elevation Myocardial Infarction [NSTEMI] or ST elevation Myocardial Infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG). in patients with a history of myocardial infarction (MI occurred at least one year ago) and a high risk of developing an atherothrombotic event. For further information, please refer to section 5.1. 4.2 DOSE AND METHOD OF ADMINISTRATION ACUTE CORONARY SYNDROMES In patients with Acute Coronary Syndromes, B RILINTA treatment should be initiated with a single 180 mg loading dose (two tablets of 90 mg) and then continued at 90 mg twice daily. Treatment is recommended for at least 12 months unless discontinuation of B RILINTA is clinically indicated (see section 5.1). After one year, patients initiated on 90 mg twice daily may continue treatment with 60 mg twice daily without interruption. B RILINTA Data Sheet 160622 Copyright 2 Patients taking B RILINTA should also take a daily low maintenance dose of aspirin of 75 -150 mg, unless specifically contraindicated. An initial 阅读完整的文件