Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
clopidogrel besilate, Quantity: 112.1 mg (Equivalent: clopidogrel, Qty 75 mg)
Arrotex Pharmaceuticals Pty Ltd
clopidogrel besilate
Tablet, film coated
Excipient Ingredients: mannitol; polyethylene glycol monomethyl ether; iron oxide red; stearic acid; hyprolose; purified talc; citric acid monohydrate; hypromellose; lactose monohydrate; microcrystalline cellulose; triacetin; crospovidone; titanium dioxide
Oral
30, 28, 4, 84, 50, 7, 112, 14, 56, 280
(S4) Prescription Only Medicine
Prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. Acute Coronary Syndrome: Plidogrel is indicated in combination with aspirin for patients with: Unstable angina or non-ST-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). Plidogrel is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularisation (surgical or PCI, with or without stent); ST-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. In this population, Plidogrel has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.
Visual Identification: Pink, round, biconvex tablet; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2014-10-16
PLIDOGREL- Consumer Medicine Information Page 1 of 4 PLIDOGREL TABLETS _Clopidogrel besilate_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Plidogrel tablets. It does not contain all the available information. Some of the information it contains may not apply to you. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. In deciding to give you Plidogrel, your doctor has weighed the risks of you taking Plidogrel against the expected benefits it will have for you. ALWAYS FOLLOW THE INSTRUCTIONS THAT YOUR DOCTOR AND PHARMACIST GIVE YOU ABOUT PLIDOGREL TABLETS . IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING PLIDOGREL. YOU MAY WISH TO KEEP IT TO READ AGAIN. WHAT IS PLIDOGREL USED FOR PLIDOGREL CONTAINS THE MEDICINE CLOPIDOGREL BESILATE. PLIDOGREL BELONGS TO A GROUP OF MEDICINES CALLED ANTI- PLATELET MEDICINES. Platelets are very small blood cells which clump together during blood clotting. By preventing this clumping, anti-platelet medicines reduce the chances of blood clots forming (a process called thrombosis). Plidogrel is used to prevent blood clots forming in hardened blood vessels (a process known as atherothrombosis) which can lead to events such as stroke, heart attack or death. You may have been prescribed Plidogrel to help prevent blood clots forming and to reduce the risk of stroke, heart attack and death because: • YOU HAVE PREVIOUSLY SUFFERED A HEART ATTACK, STROKE OR HAVE A CONDITION KNOWN AS PERIPHERAL ARTERIAL DISEASE (LEG PAIN ON WALKING OR AT REST). • YOU HAVE SUFFERED ACUTE CORONARY SYNDROME (EITHER A SEVERE TYPE OF CHEST PAIN CALLED UNSTABLE ANGINA, OR A HEART ATTACK). IN THIS CASE YOU MAY ALSO BE PRESCRIBED ASPIRIN. Your doctor may have prescribed this medicine for another use. IF YOU WANT MORE INFORMATION, ASK YOUR DOCTOR. Plidogrel is only available on a doctor's prescription. BEFOR Baca dokumen lengkap
AUSTRALIAN PRODUCT INFORMATION – PLIDOGREL (CLOPIDOGREL BESILATE ) TABLETS 1 NAME OF THE MEDICINE Clopidogrel besilate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PLIDOGREL tablets contain 75mg of clopidogrel besilate EXCIPIENTS WITH KNOWN EFFECT : PLIDOGREL tablets contain lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM PLIDOGREL film coated tablets are pink, round, biconvex tablets. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. ACUTE CORONARY SYNDROME PLIDOGREL is indicated in combination with aspirin for patients with: • Unstable angina or non-ST-elevation myocardial infarction in order to prevent early and long- term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). PLIDOGREL is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularisation (surgical or PCI, with or without stent). • ST-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. In this population, PLIDOGREL has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy. 4.2 D OSE AND METHOD OF ADMINISTRATION Clopidogrel should be taken once a day with or without food. ADULTS Generally, clopidogrel should be given as a single daily dose of 75 mg. In patients with acute coronary syndrome: • unstable angina or non-ST-elevation myocardial infarction- clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued long-term at 75 mg once a day (with aspirin 75 mg-325 mg daily). • ST segment elevation acute myocardial infarction – clopidogrel treatment should be given as a single daily dose of 75 m Baca dokumen lengkap