Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
ezetimibe, Quantity: 10 mg
Arrotex Pharmaceuticals Pty Ltd
Ezetimibe
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; carmellose sodium; povidone; sodium lauryl sulfate; polysorbate 80; magnesium stearate
Oral
30 tablets in blister pack, 10 tablets in blister pack, 7 tablets in blister pack
(S4) Prescription Only Medicine
Adults (greater than or equal to 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 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 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: White to off white, capsule shaped, flat faced with beveled edge, uncoated tablets, debossed with 10 on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-10-05
-2018- Page 1 of 5 EZEMICHOL _Ezetimibe _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about EZEMICHOL. 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 EZEMICHOL 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 EZEMICHOL IS USED FOR EZEMICHOL 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. _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 EZEMICHOL _ _WORKS _ EZEMICHOL reduces elevated total-cholesterol, LDL (bad) cholesterol and triglycerides and increases HDL (good) cholesterol. EZEMICHOL works by decreasing the absorption of cholesterol in the small intestine. Statins lower cholesterol in a different way, by reducing the amount of cholesterol made in the liver. EZEMICHOL adds to the cholesterol-lowering effect of statins. Your doctor may have prescribed EZEMICHOL for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY Прочитайте повний документ
1 AUSTRALIAN PI – EZEMICHOL (EZETIMIBE) TABLETS 1 NAME OF THE MEDICINE Ezetimibe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of EZEMICHOL for oral administration contains 10mg ezetimibe. EXCIPIENTS: EZEMICHOL tablets contain lactose monohydrate. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM EZEMICHOL tablets are white to off white, capsule shaped, flat faced with beveled edge, uncoated tablets, debossed with “10” on one side and plain on 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). _CHILDREN AND ADOLESCENTS 10-17 YEARS_ _(PUBERTAL STATUS: BOYS TANNER STAGE II AND ABOVE AND GIRLS WHO ARE AT LEAST ONE YEAR POST-_ _MENARCHE) _ _ _ 2 _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) 4.2 D OSE AND METHOD OF ADMINISTRATION The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with ezetimibe. The recommended Прочитайте повний документ