국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
ezetimibe, Quantity: 10 mg
Sandoz Pty Ltd
Ezetimibe
Tablet
Excipient Ingredients: hypromellose; lactose monohydrate; sodium lauryl sulfate; magnesium stearate; croscarmellose sodium; microcrystalline cellulose
Oral
30, 5, 10
(S4) Prescription Only Medicine
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).,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 risk of cardiovascular events following at least one year 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 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),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: 10mg tablets are white to almost white, oval tablets with debossing '10' on one side and EZT on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2016-11-24
EZETIMIBE SANDOZ ® 1 EZETIMIBE SANDOZ ® _ezetimibe _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ezetimibe Sandoz. 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 Ezetimibe Sandoz 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 EZETIMIBE SANDOZ IS USED FOR Ezetimibe Sandoz 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. Ezetimibe Sandoz 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), Ezetimibe Sandoz 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 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 EZETIMIBE SANDOZ _ _WORKS _ Ezetimibe Sandoz reduces elevated total cholesterol, LDL (bad) cholesterol and triglycerides and increases HDL (good) 전체 문서 읽기
211025-Ezetimibe Sandoz-pi Page 1 of 28 AUSTRALIAN PRODUCT INFORMATION EZETIMIBE SANDOZ ® (EZETIMIBE) 1. NAME OF THE MEDICINE Ezetimibe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Ezetimibe Sandoz 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 Ezetimibe 10 mg, white to almost white oval tablets, debossed with “10” on one side and “EZT” on the other side. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC 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). _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 risk of cardiovascular events following at least one year 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) _ 211025-Ezetimibe Sandoz-pi Page 2 of 28 Ezetimibe co-administered with simvastatin (doses up to 40 mg) is i 전체 문서 읽기