البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
ezetimibe, Quantity: 10 mg
Pharmacor Pty Ltd
Ezetimibe
Tablet
Excipient Ingredients: microcrystalline cellulose; hypromellose; crospovidone; lactose monohydrate; magnesium stearate; croscarmellose sodium; sodium lauryl sulfate
Oral
30, 10
(S4) Prescription Only Medicine
Adults (? 18 Years) Primary Hypercholesterolaemia,AKM EZETIMIBE administered alone, or with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,Homozygous Familial Hypercholesterolaemia (HoFH),AKM EZETIMIBE, administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).,Homozygous Sitosterolaemia (Phytosterolaemia),AKM EZETIMIBE is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,Prevention of Cardiovascular Disease,AKM EZETIMIBE, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) 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).,Children and Adolescents 10-17 Years (pubertal status: boys Tanner Stage II and above and girls who are at least one year postmenarche),Heterozygous Familial Hypercholesterolaemia (HeFH),AKM EZETIMIBE co-administered with simvastatin (doses up to 40 mg) is indicated as an 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),AKM EZETIMIBE co-administered with simvastatin (doses up to 40 mg) 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, flat faced, beveled edge tablets, debossed with A25 on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-06-07
AKM EZETIMIBE _Ezetimibe _ Consumer Medicine Information AKM EZETIMIBE VER: 03 1 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about AKM EZETIMIBE. 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 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 IS USED FOR AKM EZETIMIBE helps to lower cholesterol levels. It is used in people whose cholesterol levels are too high and when diet alone cannot lower these levels adequately. AKM EZETIMIBE may be taken alone or with other cholesterol- lowering medicines known as HMG- CoA reductase inhibitors (or statins), in addition to diet. In people who have high levels of plant sterols in their blood (which doctors call sitosterolaemia), AKM EZETIMIBE helps to lower these levels. _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 on 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 _ _TABLET WORKS _ AKM EZETIMIBE reduces elevated total-cholesterol, LDL (bad) cholesterol and triglycerides and increases HDL (good) cholesterol. AKM EZETIM اقرأ الوثيقة كاملة
AKM Ezetimibe Ver: 03 1 AUSTRALIAN PRODUCT INFORMATION AKM EZETIMIBE TABLETS (ezetimibe) 1. NAME OF THE MEDICINE Ezetimibe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION AKM Ezetimibe 10 mg tablets: Each tablet of AKM Ezetimibe for oral administration contains 10 mg ezetimibe.. List of excipients with known effect Lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Tablets AKM Ezetimibe 10 mg tablets: white to off white capsule shaped, flat faced, beveled edge tablets, debossed with 'A25' on one side and plain on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ADULTS (≥ 18 YEARS)_ _PRIMARY HYPERCHOLESTEROLAEMIA_ EZETIMIBE administered alone, or with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia. _HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH)_ EZETIMIBE, administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis). AKM Ezetimibe Ver: 03 2 _HOMOZYGOUS SITOSTEROLAEMIA (PHYTOSTEROLAEMIA)_ EZETIMIBE is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia. _PREVENTION OF CARDIOVASCULAR DISEASE _ Ezetimibe, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) 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). _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 co-administered with sim اقرأ الوثيقة كاملة