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

roche products pty ltd - rituximab, quantity: 10 mg/ml - injection, concentrated - excipient ingredients: sodium chloride; water for injections; citric acid; polysorbate 80; hydrochloric acid; sodium citrate dihydrate; sodium hydroxide - non-hodgkin's lymphoma: mabthera is indicated for treatment of patients with: cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin's lymphoma. cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma, cd20 positive, diffuse large b-cell non-hodgkin's lymphoma, in combination with chemotherapy. chronic lymphocytic leukaemia: mabthera is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy. rheumatoid arthritis: mabthera (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with severe, active rheumatoid arthritis who have had an inadequate response or intolerance to at least one tumour necrosis factor (tnf) inhibitor therapy. mabthera has been shown to reduce the rate of progression of joint damage as measured by x-ray when given in combination with methotrexate. granulomatosis with polyangiitis (wegener's ) (gpa) and microscopic poly

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

pfizer australia pty ltd - vincristine sulfate, quantity: 1 mg/ml - injection, solution - excipient ingredients: sulfuric acid; mannitol; water for injections; sodium hydroxide - vincristine sulfate is indicated in acute leukaemia - current practices of cancer chemotherapy involve the simultaneous use of several agents. for enhanced therapeutic effect without additive toxicity, agents with different dose-limiting clinical toxicities and different mechanisms of action are generally selected. it is rarely possible to achieve equally good results with single agent treatment. thus vincristine sulfate is often chosen as part of polychemotherapy because of its unique clinical toxicity (neuropathy). see dosage and administration for possible increased toxicity when used in combination therapy. it has been shown to be useful in combination with other oncolytic agents in hodgkin's disease, non-hodgkin's malignant lymphomas (lymphocytic, mixed-cell, histiocytic, undifferentiated, nodular and diffuse types), rhabdomyosarcoma, neuroblastoma, wilm's tumour, osteogenic sarcoma, mycosis fungoides, ewing's sarcoma, carcinoma of the uterine cervix, breast cancer, malignant melanoma, oat-cell carcinoma

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

pfizer australia pty ltd - vincristine sulfate, quantity: 1 mg/ml - injection, solution - excipient ingredients: water for injections; mannitol; sulfuric acid; sodium hydroxide - vincristine sulfate is indicated in acute leukaemia - current practices of cancer chemotherapy involve the simultaneous use of several agents. for enhanced therapeutic effect without additive toxicity, agents with different dose-limiting clinical toxicities and different mechanisms of action are generally selected. it is rarely possible to achieve equally good results with single agent treatment. thus vincristine sulfate is often chosen as part of polychemotherapy because of its unique clinical toxicity (neuropathy). see dosage and administration for possible increased toxicity when used in combination therapy. it has been shown to be useful in combination with other oncolytic agents in hodgkin's disease, non-hodgkin's malignant lymphomas (lymphocytic, mixed-cell, histiocytic, undifferentiated, nodular and diffuse types), rhabdomyosarcoma, neuroblastoma, wilm's tumour, osteogenic sarcoma, mycosis fungoides, ewing's sarcoma, carcinoma of the uterine cervix, breast cancer, malignant melanoma, oat-cell carcinoma

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

organon pharma pty ltd - simvastatin, quantity: 80 mg; ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; propyl gallate; magnesium stearate; citric acid monohydrate; hypromellose; lactose monohydrate; butylated hydroxyanisole - adults (greater than or equal to 18 years) prevention of cardiovascular disease vytorin 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 vytorin 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) vytorin is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

organon pharma pty ltd - simvastatin, quantity: 40 mg; ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: citric acid monohydrate; propyl gallate; butylated hydroxyanisole; lactose monohydrate; hypromellose; microcrystalline cellulose; croscarmellose sodium; magnesium stearate - adults (greater than or equal to 18 years),prevention of cardiovascular disease vytorin 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 vytorin 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) vytorin 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) vytorin 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) vytorin 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)

organon pharma pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 20 mg - tablet, uncoated - excipient ingredients: magnesium stearate; lactose monohydrate; microcrystalline cellulose; hypromellose; propyl gallate; croscarmellose sodium; butylated hydroxyanisole; citric acid monohydrate - adults (greater than or equal to 18 years) prevention of cardiovascular disease vytorin 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 vytorin 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) vytorin 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) vytorin 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) vytorin 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)

organon pharma pty ltd - simvastatin, quantity: 10 mg; ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: butylated hydroxyanisole; magnesium stearate; citric acid monohydrate; propyl gallate; microcrystalline cellulose; hypromellose; lactose monohydrate; croscarmellose sodium - adults (greater than or equal to 18 years) prevention of cardiovascular disease vytorin 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 vytorin 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) vytorin 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) vytorin 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) vytorin 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)

amgen australia pty ltd - evolocumab, quantity: 420 mg - injection, solution - excipient ingredients: proline; glacial acetic acid; polysorbate 80; sodium hydroxide; water for injections - repatha is indicated as an adjunct to diet and exercise in:,prevention of cardiovascular events,repatha is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke and coronary revascularisation) in adults with established cardiovascular disease in combination with an optimally dosed statin and/or other lipid-lowering therapies (see clinical trials).,primary hypercholesterolaemia,repatha is indicated in adults with primary hypercholesterolaemia (including heterozygous familial hypercholesterolaemia and non-familial hypercholesterolaemia) to reduce low-density lipoprotein cholesterol (ldl-c): - in combination with a statin or statin with other lipid lowering therapies, or - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant.,homozygous familial hypercholesterolaemia,repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid lowering therapies.

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

organon pharma pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 10 mg - tablet, uncoated - excipient ingredients: hypromellose; citric acid monohydrate; lactose monohydrate; microcrystalline cellulose; propyl gallate; croscarmellose sodium; magnesium stearate; butylated hydroxyanisole - adults (greater than or equal to 18 years),prevention of cardiovascular disease,zeklen 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 section 5.1 pharmacodynamic properties, clinical trials).,primary hypercholesterolaemia,zeklen 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),zeklen 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),zeklen 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),zeklen 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)

organon pharma pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 80 mg - tablet, uncoated - excipient ingredients: magnesium stearate; butylated hydroxyanisole; lactose monohydrate; hypromellose; microcrystalline cellulose; croscarmellose sodium; propyl gallate; citric acid monohydrate - adults (greater than or equal to 18 years),prevention of cardiovascular disease,zeklen 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 section 5.1 pharmacodynamic properties, clinical trials).,primary hypercholesterolaemia,zeklen 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),zeklen 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),zeklen 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),zeklen is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).