Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
simvastatin, Quantity: 40 mg; ezetimibe, Quantity: 10 mg
Torrent Australasia Pty Ltd
Tablet
Excipient Ingredients: butylated hydroxyanisole; croscarmellose sodium; microcrystalline cellulose; ascorbic acid; lactose monohydrate; citric acid monohydrate; hypromellose; ferric oxide; propyl gallate; magnesium stearate
Oral
5, 10, 30
(S4) Prescription Only Medicine
Adults (greater than or equal to 18 years),Prevention of Cardiovascular Disease,EzSimva GH is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of simvastatin and in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see Section 5.1 Pharmacodynamic Properties - Clinical Trials),Primary Hypercholesterolaemia,EzSimva GH is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate:,? Patients not appropriately controlled with a statin or ezetimibe alone. ? Patients already treated with a statin and ezetimibe.,Homozygous Familial Hypercholesterolaemia (HoFH),EzSimva GH s is indicated in patients with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis).,Children and Adolescents 10-17 years (Pubertal Status: boys Tanner Stage II and above and girls who are at least one year post-menarche),Heterozygous Familial Hypercholesterolaemia (HeFH),EzSimva GH is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with HeFH where use of a combination product is appropriate:,? Patients not appropriately controlled with a statin or ezetimibe alone. ? Patients already treated with a statin and ezetimibe.,Homozygous Familial Hypercholesterolaemia (HoFH),EzSimva GH is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis).
Visual Identification: Light pink to pink colored with mosaic appearance, capsule shaped biconvex uncoated tablets 337 on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2019-10-15
CONSUMER MEDICINE INFORMATION EZSIMVA GH (EZETIMIBE AND SIMVASTATIN) UNCOATED TABLET WHAT IS IN THIS LEAFLET This leaflet answers some common questions about EzSimva GH. 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 EzSimva GH 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 EZSIMVA GH IS USED FOR EzSimva GH helps to lower cholesterol and triglyceride levels. It is used in people whose cholesterol levels are too high and when diet alone cannot lower these levels adequately. _CHOLESTEROL _ Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol. LDL cholesterol is often called 'bad' cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke. HDL cholesterol is often called 'good' cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease. _TRIGLYCERIDES _ Triglycerides are another form of fat in your blood that may increase your risk for heart disease. _HOW EZSIMVA GH WORKS _ EzSimva GH reduces elevated total cholesterol, LDL (bad) cholesterol and triglycerides and increases HDL (good) cholesterol. EzSimva GH works by decreasing the absorption of cholesterol in the small intestine and by reducing the amount of cholesterol made in the liver. EzSimva GH does not help you lose weight. If you have heart disease and a history of heart attack or hospitalisation for unstable angina (chest pain), EzSimva GH reduc Przeczytaj cały dokument
AUSTRALIAN PRODUCT INFORMATION – EZSIMVA GH 10/10, EZSIMVA GH 10/20, EZSIMVA GH 10/40, EZSIMVA GH 10/80 ( Ezetimibe and Simvastatin ) 1 NAME OF THE MEDICINE Ezetimibe Simvastatin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EzSimva GH is available for oral use as tablets containing: • 10 mg of ezetimibe and 10 mg of simvastatin (EzSimva GH 10/10); • 10 mg of ezetimibe and 20 mg of simvastatin (EzSimva GH 10/20); • 10 mg of ezetimibe and 40 mg of simvastatin (EzSimva GH 10/40); or • 10 mg of ezetimibe and 80 mg of simvastatin (EzSimva GH 10/80). List of excipients with known effect: • lactose (as monohydrate) For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Tablets EzSimva GH 10/10: [10mg Ezetimibe/ 10mg Simvastatin]: Light pink to pink colored with mosaic appearance, capsule shaped biconvex uncoated tablets ‘335’ on one side and plain on other side. EzSimva GH 10/20 [10mg Ezetimibe/ 20mg Simvastatin]: Light pink to pink colored with mosaic appearance, capsule shaped biconvex uncoated tablets ‘336’ on one side and plain on other side. EzSimva GH 10/40 [10mg Ezetimibe/ 40mg Simvastatin]: Light pink to pink colored with mosaic appearance, capsule shaped biconvex uncoated tablets ‘337’ on one side and plain on other side. EzSimva GH 10/80 [10mg Ezetimibe/ 80mg Simvastatin]: Light pink to pink colored with mosaic appearance, capsule shaped biconvex uncoated tablets ‘338’ on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS (≥18 YEARS) PREVENTION OF CARDIOVASCULAR DISEASE EzSimva GH is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of simvastatin and in need of additional lowering Page 2 of 44 of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see SECTION 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS). PRIMARY HYPERCHOLESTEROLAEMIA E Przeczytaj cały dokument