أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

organon pharma pty ltd - atorvastatin calcium trihydrate, quantity: 86.8 mg (equivalent: atorvastatin, qty 80 mg); ezetimibe, quantity: 10 mg - tablet, multilayer - excipient ingredients: lactose monohydrate; sodium lauryl sulfate; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; calcium carbonate; polysorbate 80; povidone; hyprolose; silicon dioxide; titanium dioxide; macrogol 8000; hypromellose; purified talc - prevention of cardiovascular disease atozet is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin 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 atozet is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe homozygous familial hypercholesterolaemia (hofh) atozet is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis).

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

organon pharma pty ltd - atorvastatin calcium trihydrate, quantity: 10.9 mg (equivalent: atorvastatin, qty 10 mg); ezetimibe, quantity: 10 mg - tablet, multilayer - excipient ingredients: hyprolose; povidone; microcrystalline cellulose; magnesium stearate; silicon dioxide; lactose monohydrate; croscarmellose sodium; calcium carbonate; sodium lauryl sulfate; polysorbate 80; titanium dioxide; macrogol 8000; hypromellose; purified talc - prevention of cardiovascular disease atozet is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin 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 atozet is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe,homozygous familial hypercholesterolaemia (hofh) atozet is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis).

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

organon pharma pty ltd - ezetimibe, quantity: 10 mg; atorvastatin calcium trihydrate, quantity: 43.4 mg (equivalent: atorvastatin, qty 40 mg) - tablet, multilayer - excipient ingredients: hyprolose; lactose monohydrate; croscarmellose sodium; silicon dioxide; magnesium stearate; microcrystalline cellulose; povidone; polysorbate 80; sodium lauryl sulfate; calcium carbonate; titanium dioxide; macrogol 8000; hypromellose; purified talc - prevention of cardiovascular disease atozet is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin 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 atozet is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe homozygous familial hypercholesterolaemia (hofh) atozet is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis).

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

organon pharma pty ltd - atorvastatin calcium trihydrate, quantity: 21.7 mg (equivalent: atorvastatin, qty 20 mg); ezetimibe, quantity: 10 mg - tablet, multilayer - excipient ingredients: lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; calcium carbonate; polysorbate 80; sodium lauryl sulfate; silicon dioxide; povidone; magnesium stearate; hyprolose; titanium dioxide; macrogol 8000; hypromellose; purified talc - prevention of cardiovascular disease atozet is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of atorvastatin 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 atozet is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe homozygous familial hypercholesterolaemia (hofh) atozet is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis).

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - adefovir dipivoxil, quantity: 10 mg - tablet - excipient ingredients: pregelatinised maize starch; magnesium stearate; purified talc; croscarmellose sodium; lactose monohydrate - ? adefovir dipivoxil is indicated for the treatment of chronic hepatitis b in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alt or ast) or histologically active disease. ? for adult patients, this indication is based on histological, virological, biochemical, and serological responses in adult patients with hbeag+ and hbeag-/hbvdna+ chronic hepatitis b with compensated liver function, and in adult patients with clinical evidence of lamivudine-resistant hepatitis b virus with either compensated or decompensated liver function. ? for adolescent patients (12 to <18 years of age), the indication is based on virological and biochemical responses in patients with hbeag+ chronic hepatitis b virus with compensated liver function.

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - simvastatin, quantity: 80 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; ascorbic acid; pregelatinised maize starch; citric acid monohydrate; microcrystalline cellulose; butylated hydroxyanisole; titanium dioxide; hypromellose; purified talc; iron oxide red; hyetellose - simvastatin is indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (eg poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. simvastatin is indicated in patients at high risk of chd (coronary heart disease) (with or without hypercholesterolaemia), including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - simvastatin, quantity: 40 mg - tablet, film coated - excipient ingredients: ascorbic acid; magnesium stearate; microcrystalline cellulose; citric acid monohydrate; lactose monohydrate; pregelatinised maize starch; butylated hydroxyanisole; titanium dioxide; hypromellose; purified talc; iron oxide red; hyetellose - simvastatin is indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (eg poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. simvastatin is indicated in patients at high risk of chd (coronary heart disease) (with or without hypercholesterolaemia), including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - simvastatin, quantity: 20 mg - tablet, film coated - excipient ingredients: butylated hydroxyanisole; pregelatinised maize starch; citric acid monohydrate; lactose monohydrate; ascorbic acid; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; hyprolose; purified talc; iron oxide yellow; iron oxide red - simvastatin is indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (eg poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. simvastatin is indicated in patients at high risk of chd (coronary heart disease) (with or without hypercholesterolaemia), including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - simvastatin, quantity: 10 mg - tablet, film coated - excipient ingredients: magnesium stearate; butylated hydroxyanisole; microcrystalline cellulose; lactose monohydrate; pregelatinised maize starch; ascorbic acid; citric acid monohydrate; titanium dioxide; hypromellose; hyprolose; purified talc; iron oxide yellow; iron oxide red; iron oxide black - simvastatin is indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (eg poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. simvastatin is indicated in patients at high risk of chd (coronary heart disease) (with or without hypercholesterolaemia), including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - pemetrexed disodium hemipentahydrate, quantity: 604 mg (equivalent: pemetrexed, qty 500 mg) - injection, powder for - excipient ingredients: mannitol; hydrochloric acid; sodium hydroxide - malignant pleural mesothelioma,pemetrexed, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma.,non-small cell lung cancer (nsclc),pemetrexed, in combination with cisplatin, is indicated for initial treatment of patients with locally advanced or metastatic nsclc other than predominantly squamous cell histology.,pemetrexed, as monotherapy, is indicated for the treatment of patients with locally advanced or metastatic nsclc other than predominantly squamous cell histology after prior platinum-based chemotherapy.