מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
simvastatin, Quantity: 80 mg; ezetimibe, Quantity: 10 mg
Pharmacor Pty Ltd
Tablet
Excipient Ingredients: lactose monohydrate; sodium lauryl sulfate; citric acid monohydrate; croscarmellose sodium; microcrystalline cellulose; magnesium stearate; butylated hydroxyanisole; propyl gallate; hypromellose
Oral
30 tablets
(S4) Prescription Only Medicine
Adults (?18 years),Prevention of Cardiovascular Disease,Ezetimibe and Simvastatin Tablets 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.,Primary Hypercholesterolaemia,Ezetimibe and Simvastatin Tablets 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),Ezetimibe and Simvastatin Tablets is indicated in patients with HoFH. Patients may also receive adjunctive treatments (e.g., 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),Ezetimibe and Simvastatin Tablets is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia 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),Ezetimibe and Simvastatin Tablets is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).
Visual Identification: White to off white, capsule shaped tablets debossed with "A026" on one side and plain on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2019-02-18
AKM-EZETIMIBE SIMVASTATIN Ver 02 1 AKM-EZETIMIBE SIMVASTATIN _Ezetimibe/Simvastatin _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about AKM-EZETIMIBE SIMVASTATIN. 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 AKM-EZETIMIBE SIMVASTATIN 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 AKM-EZETIMIBE SIMVASTATIN IS USED FOR AKM-EZETIMIBE SIMVASTATIN 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 _ _AKM-EZETIMIBE _ _SIMVASTATIN WORKS _ _ _ AKM-EZETIMIBE SIMVASTATIN reduces elevated total cholesterol, LDL (bad) cholesterol and triglycerides and increases HDL (good) cholesterol. AKM-EZETIMIBE SIMVASTATIN works by decreasing the absorption of cholesterol in the small intestine and by reducing the amount of cholesterol made in the liver. AKM-EZETIMIBE SIM קרא את המסמך השלם
AKM EZETIMIBE SIMVASTATIN Ver 02 1 AUSTRALIAN PRODUCT INFORMATION AKM EZETIMIBE SIMVASTATIN 10 / 10 AKM EZETIMIBE SIMVASTATIN 10 / 20 AKM EZETIMIBE SIMVASTATIN 10 / 40 AKM EZETIMIBE SIMVASTATIN 10 / 80 (ezetimibe and simvastatin) 1. NAME OF THE MEDICINE The active ingredients of AKM EZETIMIBE SIMVASTATIN are Ezetimibe and Simvastatin. _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION AKM EZETIMIBE SIMVASTATIN 10 / 10 (Ezetimibe 10 mg and Simvastatin 10 mg Tablets) Each tablet contains 10 mg ezetimibe and 10 mg of simvastatin AKM EZETIMIBE SIMVASTATIN 10 / 20 (Ezetimibe 10 mg and Simvastatin 20 mg Tablets) Each tablet contains 10 mg ezetimibe and 20 mg of simvastatin AKM EZETIMIBE SIMVASTATIN 10 / 40 (Ezetimibe 10 mg and Simvastatin 40 mg Tablets) Each tablet contains 10 mg ezetimibe and 40 mg of simvastatin AKM EZETIMIBE SIMVASTATIN 10 / 80 (Ezetimibe 10 mg and Simvastatin 80 mg Tablets) Each tablet contains 10 mg ezetimibe and 80 mg of simvastatin Excipients with known effect: contains sugars (as lactose). For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Tablets. AKM EZETIMIBE SIMVASTATIN 10 / 10 (Ezetimibe 10 mg and Simvastatin 10 mg Tablets) White to off white, capsule shaped tablets debossed with "A029" on one side and plain on other side. AKM EZETIMIBE SIMVASTATIN Ver 02 2 AKM EZETIMIBE SIMVASTATIN 10 / 20 (Ezetimibe 10 mg and Simvastatin 20 mg Tablets) White to off white, capsule shaped tablets debossed with "A028" on one side and plain on other side. AKM EZETIMIBE SIMVASTATIN 10 / 40 (Ezetimibe 10 mg and Simvastatin 40 mg Tablets) White to off white, capsule shaped tablets debossed with "A027" on one side and plain on other side. AKM EZETIMIBE SIMVASTATIN 10 / 80 (Ezetimibe 10 mg and Simvastatin 80 mg Tablets) White to off white, capsule shaped tablets debossed with "A026" on one side and plain on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ _ADULTS (≥18 YEARS)_ _PREVENTION OF CARDIOVASCULAR DISEASE_ AKM EZETIMIBE SIMVASTATIN is indicated in קרא את המסמך השלם