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 - 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 - 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 - 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.