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 - posaconazole, quantity: 100 mg - tablet, modified release - excipient ingredients: hypromellose acetate succinate; microcrystalline cellulose; hyprolose; croscarmellose sodium; silicon dioxide; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - posaconazole sandoz (posaconazole) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older:,? invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy. ? fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy.,posaconazole sandoz is also indicated for the prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

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

sandoz pty ltd - sitagliptin hydrochloride monohydrate, quantity: 56.69 mg (equivalent: sitagliptin, qty 50 mg); metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; triethyl citrate; hyprolose; povidone; hypromellose; purified talc; titanium dioxide; microcrystalline cellulose; sodium lauryl sulfate; sodium stearylfumarate; iron oxide red - sitagliptin/metformin sandoz is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.

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

sandoz pty ltd - metformin hydrochloride, quantity: 850 mg; sitagliptin hydrochloride monohydrate, quantity: 56.69 mg (equivalent: sitagliptin, qty mg) - tablet, film coated - excipient ingredients: hypromellose; sodium lauryl sulfate; croscarmellose sodium; povidone; sodium stearylfumarate; hyprolose; titanium dioxide; iron oxide red; triethyl citrate; purified talc; microcrystalline cellulose; iron oxide yellow - sitagliptin/metformin sandoz is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.

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

sandoz pty ltd - metformin hydrochloride, quantity: 1000 mg; sitagliptin hydrochloride monohydrate, quantity: 56.69 mg (equivalent: sitagliptin, qty mg) - tablet, film coated - excipient ingredients: iron oxide yellow; titanium dioxide; hyprolose; povidone; iron oxide red; sodium lauryl sulfate; triethyl citrate; purified talc; microcrystalline cellulose; sodium stearylfumarate; hypromellose; croscarmellose sodium - sitagliptin/metformin sandoz is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.

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

sandoz pty ltd - pomalidomide, quantity: 4 mg - capsule, hard - excipient ingredients: microcrystalline cellulose; maltodextrin; sodium stearylfumarate; gelatin; titanium dioxide; iron oxide yellow; iron oxide red; indigo blue; erythrosine; shellac - pomalidomide sandoz, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide. pomalidomide sandoz, in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior threatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

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

sandoz pty ltd - pomalidomide, quantity: 3 mg - capsule, hard - excipient ingredients: microcrystalline cellulose; maltodextrin; sodium stearylfumarate; gelatin; titanium dioxide; iron oxide yellow; iron oxide red; indigo blue; shellac - pomalidomide sandoz, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide. pomalidomide sandoz, in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior threatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

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

sandoz pty ltd - buprenorphine, quantity: 5 mg - drug delivery system, transdermal - excipient ingredients: levulinic acid; oleyl oleate; povidone; polyethylene; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; butyl acrylate; acrylic acid; 2,2'-azobisisobutyronitrile; aluminium acetylacetonate; heptane; acrylates copolymer; ethylene distearamide; adipic acid/1,4-butanediol/mdi copolymer; pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate - buprenorphine sandoz patches are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. buprenorphine sandoz patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. buprenorphine sandoz patches are not indicated as an as-needed (prn) analgesia.