Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

american health packaging - ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24) - ezetimibe 10 mg - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. monotherapy ezetimibe, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-c), low-density lipoprotein cholesterol (ldl-c), apolipoprotein b (apo b), and non-high-density lipoprotein cholesterol (non-hdl-c) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. combination therapy with hmg-coa reductase inhibitors (statins) ezetimibe, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme a (hmg-coa) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated total

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; carmellose sodium; povidone; sodium lauryl sulfate; polysorbate 80; magnesium stearate - 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)

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; carmellose sodium; povidone; sodium lauryl sulfate; polysorbate 80; magnesium stearate - adults (greater than or equal to18 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)

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 80 mg - tablet - excipient ingredients: lactose monohydrate; citric acid; magnesium stearate; iron oxide yellow; propyl gallate; hypromellose; iron oxide red; butylated hydroxyanisole; microcrystalline cellulose; croscarmellose sodium; iron oxide black; ascorbic acid - adults (?18 years),prevention of cardiovascular disease apo-ezetimibe/simvastatin 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 (see clinical trials).,primary hypercholesterolaemia apo-ezetimibe/simvastatin 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) apo-ezetimibe/simvastatin 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) apo-ezetimibe/simvastatin 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) apo-ezetimibe/simvastatin is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 20 mg - tablet - excipient ingredients: lactose monohydrate; citric acid; propyl gallate; hypromellose; butylated hydroxyanisole; magnesium stearate; iron oxide black; croscarmellose sodium; iron oxide yellow; microcrystalline cellulose; ascorbic acid; iron oxide red - adults (?18 years),prevention of cardiovascular disease apo-ezetimibe/simvastatin 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 (see clinical trials).,primary hypercholesterolaemia apo-ezetimibe/simvastatin 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) apo-ezetimibe/simvastatin 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) apo-ezetimibe/simvastatin 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) apo-ezetimibe/simvastatin is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - simvastatin, quantity: 40 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: lactose monohydrate; butylated hydroxyanisole; hypromellose; iron oxide black; microcrystalline cellulose; propyl gallate; ascorbic acid; iron oxide yellow; croscarmellose sodium; citric acid; magnesium stearate; iron oxide red - adults (?18 years),prevention of cardiovascular disease apo-ezetimibe/simvastatin 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 (see clinical trials).,primary hypercholesterolaemia apo-ezetimibe/simvastatin 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) apo-ezetimibe/simvastatin 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) apo-ezetimibe/simvastatin 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) apo-ezetimibe/simvastatin is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - simvastatin, quantity: 10 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: croscarmellose sodium; magnesium stearate; citric acid; hypromellose; lactose monohydrate; butylated hydroxyanisole; iron oxide yellow; microcrystalline cellulose; propyl gallate; ascorbic acid; iron oxide red; iron oxide black - adults (?18 years),prevention of cardiovascular disease apo-ezetimibe/simvastatin 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 (see clinical trials).,primary hypercholesterolaemia apo-ezetimibe/simvastatin 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) apo-ezetimibe/simvastatin 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) apo-ezetimibe/simvastatin 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) apo-ezetimibe/simvastatin is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 10 mg - tablet - excipient ingredients: ascorbic acid; iron oxide red; microcrystalline cellulose; lactose monohydrate; magnesium stearate; croscarmellose sodium; butylated hydroxyanisole; iron oxide black; propyl gallate; hypromellose; iron oxide yellow; citric acid - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-sandoz 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 (see clinical trials).,primary hypercholesterolaemia ezetimibe/simvastatin-sandoz 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/simvastatin-sandoz 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/simvastatin-sandoz 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/simvastatin-sandoz is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

direct rx - ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24) - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. 1.1 primary hyperlipidemia monotherapy ezetimibe tablets, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-c), low-density lipoprotein cholesterol (ldl-c), apolipoprotein b (apo b), and non-high-density lipoprotein cholesterol (non-hdl-c) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. combination therapy with hmg-coa reductase inhibitors (statins) ezetimibe tablets, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme a (hmg-coa) reductase inhibitor (statin), is indicated as adjunctive therapy to die

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

sandoz inc - ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24) - ezetimibe 10 mg - ezetimibe is indicated: when ezetimibe is used in combination with a statin, fenofibrate, or other ldl-c lowering therapies, refer to the prescribing information of these products for information on the safe and effective use. ezetimibe is contraindicated in patients with a known hypersensitivity to ezetimibe or any of the excipients in ezetimibe. hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported [see adverse reactions (6.2)] . when used in combination with a statin, fenofibrate, or other ldl-c lowering therapy, ezetimibe is contraindicated in patients for whom a statin, fenofibrate, or other ldl-c lowering therapy are contraindicated. refer to the prescribing information of these products for a list of their contraindications [see warnings and precautions (5.1)] . risk summary there are insufficient data on ezetimibe use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in anim