البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
ezetimibe, Quantity: 10 mg
Lupin Australia Pty Limited
Ezetimibe
Tablet, uncoated
Excipient Ingredients: crospovidone; lactose monohydrate; sodium lauryl sulfate; stearic acid; povidone; colloidal anhydrous silica
Oral
Cold form Alu-Alu blister pack of 10,14,15 and 30
(S4) Prescription Only Medicine
Adults (greater than or equal to 18 Years),Primary Hypercholesterolaemia,Ezetimibe GH 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 GH, administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis).,Homozygous Sitosterolaemia (Phytosterolaemia) Ezetimibe GH is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia. Prevention of Cardiovascular Disease,Ezetimibe GH 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 GH 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 GH 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 (eg. LDL apheresis).
Visual Identification: White to off white, capsule shaped, flat faced, beveled edge tablet, debossed with E on one side and 10 on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-07-04
AUSTRALIAN PRODUCT INFORMATION – EZETIMIBE GH (EZETIMIBE) UNCOATED TABLET 1 NAME OF THE MEDICINE Ezetimibe. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Ezetimibe GH 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 GH 10 mg: White to off-white, capsule shaped, flat faced, bevelled edge tablet, debossed with “ E ” on one side and “ 10 ” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS ( ≥ 18 YEARS) Primary Hypercholesterolaemia Ezetimibe GH 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 GH, administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis). Homozygous Sitosterolaemia (Phytosterolaemia) Ezetimibe GH is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia. Prevention of Cardiovascular Disease Ezetimibe GH 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 Ezetimibe GH v4.0 Page 2 of 28 (ezetimibe) uncoated tablet 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 GH co-administered with simvastatin (doses up to 40 mg) is indicated اقرأ الوثيقة كاملة