Negara: Selandia Baru
Bahasa: Inggris
Sumber: Medsafe (Medicines Safety Authority)
Simvastatin 80mg
Merck Sharp & Dohme (New Zealand) Limited
Simvastatin 80 mg
80 mg
Film coated tablet
Active: Simvastatin 80mg Excipient: Ascorbic acid Butylated hydroxyanisole Citric acid monohydrate Hyprolose Hypromellose Iron oxide red Lactose monohydrate Magnesium stearate Methylated spirits Microcrystalline cellulose Purified talc Purified water Starch Titanium dioxide
Blister pack, PVC/PE/PVDC, 30 tablets
Prescription
Prescription
MSD International GmbH (Ireland)
Patients at High Risk of Coronary Heart Disease (CHD) or With Existing CHD In patients at high risk of CHD (with or without hyperlipidaemia but with a total cholesterol of >3.5 mmol/L), ie., patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing CHD, LIPEX is indicated to: · Reduce the risk of total mortality by reducing CHD deaths; · Reduce the risk of major vascular events (a composite of non-fatal myocardial infarction, CHD death, stroke, or revascularisation procedures; · Reduce the risk of major coronary events (a composite of non-fatal myocardial infarction or CHD deaths); · Reduce the risk of stroke; · Reduce the need for coronary revascularisation procedures (including coronary artery bypass grafting and percutaneous transluminal coronary angioplasty); · Reduce the need for peripheral and other non-coronary revascularisation procedures; · Reduce the risk of hospitalisation for angina pectoris. In patients with diabetes, LIPEX reduces the risk of developing peripheral macrovascular complications (a composite of peripheral revascularisation procedures, lower limb amputations, or leg ulcers). In hypercholesterolaemic patients with coronary heart disease, LIPEX slows the progression of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions.
Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC - 30 tablets - 24 months from date of manufacture stored at or below 30°C
1997-09-09
LIPEX ® 1 LIPEX ® _Simvastatin _ NEW ZEALAND CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about LIPEX. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking LIPEX 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 LIPEX IS USED FOR LIPEX helps to lower cholesterol and triglyceride levels. LIPEX is used in people who have coronary heart disease (CHD) or who are at high risk of CHD (for example, if they have diabetes, a history of stroke, or other blood vessel disease). LIPEX may be used in these people, regardless of their cholesterol level to: • help prolong life by reducing the risk of a heart attack • reduce the risk of stroke • reduce the need for surgery to increase blood flow to the heart • reduce the need for hospitalisation due to angina. _CHOLESTEROL _ Everyone has cholesterol and triglycerides in their blood. They are types of blood fat needed by the body for many things, including building cell walls, making bile acids (which help to digest food) and certain hormones. However, too much cholesterol can be a problem. Your body makes cholesterol, but it also comes from food. Normally the body balances the cholesterol it makes with the cholesterol it gets from food. This means if more cholesterol comes from food, less is made by the body. However, if you eat a diet high in fat, your body may not keep this balance and your cholesterol levels rise. High cholesterol is more likely to occur with certain diseases or if you have a family history of high cholesterol. When you have high levels of cholesterol, it may 'stick' to the inside of your blood vessels instead of being carried to the parts of the body where it is needed. Over time, this can Baca dokumen lengkapnya
NEW ZEALAND DATA SHEET Page 1 of 21 1 LIPEX (SIMVASTATIN) TABLETS LIPEX (simvastatin) 10 mg tablet LIPEX (simvastatin) 20 mg tablet LIPEX (simvastatin) 40 mg tablet LIPEX (simvastatin) 80 mg tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mg tablet contains simvastatin 10 mg Each 20 mg tablet contains simvastatin 20 mg Each 40 mg tablet contains simvastatin 40 mg Each 80 mg tablet contains simvastatin 80 mg Excipients with known effect Each 10 mg tablet contains 70.7 mg lactose monohydrate. Each 20 mg tablet contains 141.5 mg lactose monohydrate. Each 40 mg tablet contains 283 mg lactose monohydrate. Each 80 mg tablet contains 565.5 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM LIPEX 10 mg is a peach coloured oval shaped biconvex film coated tablet imprinted MSD735 on one side and unmarked on the other. Dimensions 8.51 mm x 5.05 mm. LIPEX 20 mg is a tan coloured oval shaped biconvex film coated tablet imprinted MSD740 on one side and unmarked on the other. Dimensions 11.10 mm x 6.35 mm. LIPEX 40 mg is a brick red oval shaped biconvex film coated tablet imprinted MSD749 on one side and unmarked on the other. Dimensions 8 mm x 14 mm. LIPEX 80 mg is a brick red capsule shaped tablet imprinted 543 on one side and 80 on the other. Dimensions 17.46 mm x 7.5 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Patients at High Risk of Coronary Heart Disease (CHD) or With Existing CHD In patients at high risk of CHD (with or without hyperlipidaemia but with a total cholesterol of >3.5 mmol/L), ie., patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing CHD, LIPEX is indicated to: • Reduce the risk of total mortality by reducing CHD deaths; • Reduce the risk of major vascular events (a composite of non-fatal myocardial infarction, CHD death, stroke, or revascularisation procedures; NEW ZEALAND DATA SHEET Page 2 of 21 • Reduce the risk of major coronary events (a composite of non-fatal myocar Baca dokumen lengkapnya