Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - capecitabine, quantity: 150 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; hypromellose; croscarmellose sodium; titanium dioxide; purified talc; magnesium stearate; iron oxide red - colon cancer,capecitabine sandoz is indicated for the adjuvant treatment of patients with dukes' stage c and high-risk stage b, colon cancer, either as monotherapy or in combination with oxaliplatin.,colorectal cancer,capecitabine sandoz is indicated for the treatment of patients with advanced or metastatic colorectal cancer.,oesophagogastric cancer,capecitabine sandoz is indicated for the first-line treatment of patients with advanced oesophagogastric cancer in combination with a platinum-based regimen.,breast cancer,capecitabine sandoz is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen unless therapy with these and other standard agents are clinically contraindicated.,capecitabine sandoz in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - quetiapine fumarate, quantity: 115.13 mg (equivalent: quetiapine, qty 100 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; calcium hydrogen phosphate dihydrate; iron oxide yellow; sodium starch glycollate type a; silicon dioxide; povidone; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 4000 - quetiapine sandoz is indicated for:,bipolar disorder adults ? maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes ? treatment of depressive episodes associated with bipolar disorder (see dose and method of administration) ? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years ? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years) ? treatment of schizophrenia

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - quetiapine fumarate, quantity: 345.39 mg (equivalent: quetiapine, qty 300 mg) - tablet, film coated - excipient ingredients: povidone; calcium hydrogen phosphate dihydrate; silicon dioxide; lactose monohydrate; microcrystalline cellulose; magnesium stearate; sodium starch glycollate type a; titanium dioxide; hypromellose; macrogol 4000 - quetiapine sandoz is indicated for:,bipolar disorder adults ? maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes ? treatment of depressive episodes associated with bipolar disorder (see dose and method of administration) ? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years ? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years) ? treatment of schizophrenia

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - quetiapine fumarate, quantity: 28.78 mg (equivalent: quetiapine, qty 25 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; silicon dioxide; iron oxide yellow; sodium starch glycollate type a; povidone; magnesium stearate; iron oxide red; calcium hydrogen phosphate dihydrate; titanium dioxide; hypromellose; macrogol 4000 - quetiapine sandoz is indicated for:,bipolar disorder adults ? maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes ? treatment of depressive episodes associated with bipolar disorder (see dose and method of administration) ? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years ? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years) ? treatment of schizophrenia

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - quetiapine fumarate, quantity: 230.26 mg (equivalent: quetiapine, qty 200 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate type a; microcrystalline cellulose; lactose monohydrate; magnesium stearate; silicon dioxide; povidone; calcium hydrogen phosphate dihydrate; titanium dioxide; hypromellose; macrogol 4000 - quetiapine sandoz is indicated for:,bipolar disorder adults ? maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes ? treatment of depressive episodes associated with bipolar disorder (see dose and method of administration) ? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years ? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years) ? treatment of schizophrenia

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - simvastatin, quantity: 80 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: propyl gallate; iron oxide black; croscarmellose sodium; citric acid; butylated hydroxyanisole; microcrystalline cellulose; lactose monohydrate; ascorbic acid; iron oxide yellow; iron oxide red; magnesium stearate; hypromellose - 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).

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - simvastatin, quantity: 20 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: magnesium stearate; butylated hydroxyanisole; iron oxide black; iron oxide yellow; ascorbic acid; lactose monohydrate; microcrystalline cellulose; hypromellose; citric acid; iron oxide red; propyl gallate; croscarmellose sodium - 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).

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - simvastatin, quantity: 40 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; butylated hydroxyanisole; iron oxide yellow; citric acid; iron oxide red; magnesium stearate; propyl gallate; lactose monohydrate; hypromellose; ascorbic acid; iron oxide black - 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).

Australia - English - 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).

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - rosuvastatin calcium, quantity: 41.583 mg - tablet, film coated - excipient ingredients: macrogol 6000; mannitol; purified talc; colloidal anhydrous silica; sodium stearylfumarate; microcrystalline cellulose; silicon dioxide; lactose; hypromellose; maize starch; titanium dioxide; iron oxide yellow; iron oxide red - rosuvastatin sandoz should be used as an adjunct to diet when the response to diet and exercise is inadequate.,prevention of cardiovascular events,rosuvastatin sandoz is indicated for prevention of major cardiovascular events in men greater than equal to 50 years old and women greater than equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease).,rosuvastatin sandoz is indicated to: ? reduce the risk of nonfatal myocardial infarction ? reduce the risk of nonfatal stroke ? reduce the risk of coronary artery revascularisation procedures.,in patients with hypercholesterolaemia,rosuvastatin sandoz is indicated for the treatment of hypercholesterolaemia (excluding heterozygous familial hypercholesterolaemia).,prior to initiating therapy with rosuvastatin sandoz, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.