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

teva pharma australia pty ltd - filgrastim, quantity: 600 microgram/ml - injection, solution - excipient ingredients: glacial acetic acid; polysorbate 80; sodium hydroxide; sorbitol; water for injections - to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs in doses not usually requiring bone marrow transplantation. to reduce the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia. for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy, in order to accelerate neutrophil and platelet recovery by infusion of such cells after myeloablative or myelosuppressive therapy in patients with nonmyeloid malignancies. for the mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation. in patients receiving myeloablative chemotherapy, to reduce the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation. for chronic administration to

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

teva pharma australia pty ltd - filgrastim, quantity: 600 microgram/ml - injection, solution - excipient ingredients: glacial acetic acid; polysorbate 80; sodium hydroxide; sorbitol; water for injections - to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs in doses not usually requiring bone marrow transplantation. to reduce the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia. for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy, in order to accelerate neutrophil and platelet recovery by infusion of such cells after myeloablative or myelosuppressive therapy in patients with nonmyeloid malignancies. for the mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation. in patients receiving myeloablative chemotherapy, to reduce the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation. for chronic administration to

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

teva pharma australia pty ltd - dasatinib, quantity: 100 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; hyprolose; titanium dioxide; hypromellose; triacetin - dasatinib is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib is indicated for the treatment of paediatric patients with: ? ph+ cml in the chronic phase. ? newly diagnosed ph+ all in combination with chemotherapy.

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

teva pharma australia pty ltd - dasatinib, quantity: 20 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; hyprolose; croscarmellose sodium; lactose monohydrate; titanium dioxide; hypromellose; triacetin - dasatinib is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib is indicated for the treatment of paediatric patients with: ? ph+ cml in the chronic phase. ? newly diagnosed ph+ all in combination with chemotherapy.

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

teva pharma australia pty ltd - dasatinib, quantity: 70 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; hyprolose; lactose monohydrate; magnesium stearate; titanium dioxide; hypromellose; triacetin - dasatinib is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib is indicated for the treatment of paediatric patients with: ? ph+ cml in the chronic phase. ? newly diagnosed ph+ all in combination with chemotherapy.

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

teva pharma australia pty ltd - dasatinib, quantity: 50 mg - tablet, film coated - excipient ingredients: lactose monohydrate; hyprolose; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin - dasatinib is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib is indicated for the treatment of paediatric patients with: ? ph+ cml in the chronic phase. ? newly diagnosed ph+ all in combination with chemotherapy.

Israel - inglés - Ministry of Health

teva israel ltd - simvastatin - tablets - simvastatin 20 mg - simvastatin - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvastatin-teva is indicated to: - reduce the risk of total mortality by reducing coronary death - reduce the risk of non-fatal myocardial infarction - reduce the risk for undergoing myocardial revascularization procedures. - reduce the risk of stroke and transient ischemic attacks (tia). hyperlipidemia: simvastatin-teva is indicated as an adjunct to diet to reduce elevated total-c ldl-c apo b and tg and to increase hdl-c in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (frederickson types iia and iib) simvastatin-teva therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios. homozygous familial hypercholesterolemia: simvastatin-teva is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol ldl-cholesterol and apolipoprotein b in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. hypertriglyceridemia (fredrickson type iv hyperlipidemia). simvastatin-teva is indicated for the treatment of patients with primary dysbetalipoproteinemia (fredrickson type iii hyperlipidemia).

Israel - inglés - Ministry of Health

teva israel ltd - simvastatin - tablets - simvastatin 10 mg - simvastatin - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvastatin-teva is indicated to: - reduce the risk of total mortality by reducing coronary death - reduce the risk of non-fatal myocardial infarction - reduce the risk for undergoing myocardial revascularization procedures.- reduce the risk of stroke and transient ischemic attacks (tia). hyperlipidemia: simvastatin-teva is indicated as an adjunct to diet to reduce elevated total-c ldl-c apo b and tg and to increase hdl-c in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (frederickson types iia and iib) simvastatin-teva therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios.homozygous familial hypercholesterolemia: simvastatin-teva is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol ldl-cholesterol and apolipoprotein b in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. hypertriglyceridemia (fredrickson type iv hyperlipidemia). simvastatin-teva is indicated for the treatment of patients with primary dysbetalipoproteinemia (fredrickson type iii hyperlipidemia).

Israel - inglés - Ministry of Health

teva israel ltd - simvastatin - tablets - simvastatin 80 mg - simvastatin - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvastatin-teva is indicated to: reduce the risk of total mortality by reducing coronary death reduce the risk of non-fatal myocardial infarction reduce the risk for undergoing myocardial revascularization procedures.reduce the risk of stroke and transient ischemic attacks (tia). hyperlipidemia: simvastatin-teva is indicated as an adjunct to diet to reduce elevated total-c ldl-c apo b and tg and to increase hdl-c in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (frederickson types iia and iib) simvastatin-teva therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios. homozygous familial hypercholesterolemia: simvastatin-teva is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol ldl-cholesterol and apolipoprotein b in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. hypertriglyceridemia (fredrickson type iv hyperlipidemia). simvastatin-teva is indicated for the treatment of patients with hypertriglyceridemia (fredrickson type iv hyperlipidemia). dysbetalipoproteinemia (fredrickson type iii hyperlipidemia): simvastatin-teva is also indicated for the treatment of patients with primary dysbetalipoproteinemia (fredrickson type iii hyperlipidemia).

Israel - inglés - Ministry of Health

teva israel ltd - simvastatin - tablets - simvastatin 40 mg - simvastatin - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvastatin-teva is indicated to: reduce the risk of total mortality by reducing coronary death ;reduce the risk of non-fatal myocardial infarction ;reduce the risk for undergoing myocardial revascularization procedures. reduce the risk of stroke and transient ischemic attacks (tia). hyperlipidemia: simvastatin-teva is indicated as an adjunct to diet to reduce elevated total-c ldl-c apo b and tg and to increase hdl-c in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (frederickson types iia and iib) simvastatin-teva therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios. homozygous familial hypercholesterolemia: simvastatin-teva is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol ldl-cholesterol and apolipoprotein b in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. hypertriglyceridemia (fredrickson type iv hyperlipidemia). simvastatin-teva is indicated for the treatment of patients with hypertriglyceridemia ( fredrickson type iv hyperlipidemia). dysbetalipoproteinemia (fredrickson type iii hyperlipidemia): simvastatin-teva is also indicated for the treatment of patients with primary dysbetalipoproteinemia (fredrickson type iii hyperlipidemia).