Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
clopidogrel hydrogen sulfate, Quantity: 97.875 mg (Equivalent: clopidogrel, Qty 75 mg)
Pharmacor Pty Ltd
clopidogrel hydrogen sulfate
Tablet, film coated
Excipient Ingredients: hyprolose; colloidal anhydrous silica; hydrogenated castor oil; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red; microcrystalline cellulose
Oral
30 Tablets in blister pack, 7 Tablets in blister pack, 280 Tablets in blister pack, 4 Tablets in blister pack, 84 Tablets in blister pack, 28 Tablets in blister pack, 56 Tablets in blister pack, 50 Tablets in blister pack, 14 Tablets in blister pack, 112 Tablets in blister pack
(S4) Prescription Only Medicine
For 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: Clopidogrel Tablets 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). Clopidogrel Tablets is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularization (surgical or PCI, with or without stent); ,- ST-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. In this population, Clopidogrel 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 coloured, round, biconvex, film coated tablets, debossed with 'Cl' on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2012-05-17
PLAVICOR 75 (V 02) 1 PLAVICOR 75 _clopidogrel_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Plavicor 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 Plavicor, your doctor has weighed the risks of you taking Plavicor against the expected benefits it will have for you. Always follow the instructions that your doctor and pharmacist give you about Plavicor tablets IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING PLAVICOR. YOU MAY WISH TO KEEP IT TO READ AGAIN. WHAT PLAVICOR IS USED FOR PLAVICOR CONTAINS THE MEDICINE CLOPIDOGREL. PLAVICOR BELONGS TO A GROUP OF MEDICINES CALLED ANTIPLATELET 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). Plavicor 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 Plavicor 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. Plavicor is only available on a doctor's prescription. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT _ YOU SHOULD NOT TAKE PLAVICOR Læs hele dokumentet
Plavicor 75 (V 02) Page 1 of 28 AUSTRALIAN PRODUCT INFORMATION PLAVICOR 75 (CLOPIDOGREL HYDROGEN SULFATE) FILM COATED TABLET 1 NAME OF THE MEDICINE Clopidogrel hydrogen sulfate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains clopidogrel hydrogen sulfate equivalent to clopidogrel 75 mg. Excipient with known effect: lactose monohydrate. For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Plavicor 75 - Pink coloured, round, biconvex, film coated tablets, debossed with “Cl” on one side and plain on other side. 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 Plavicor Tablets are 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). Plavicor Tablets are 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, Plavicor Tablets have 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. Plavicor 75 (V 02) Page 2 of 28 In patients with acute coronary syndrome: • unstable angina or non-ST-elevation myocardial infarction - clopidogrel treatment should be initiated with a 300 mg loading dose and then continued long-term at 75 mg onc Læs hele dokumentet