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

sandoz pty ltd - irbesartan, quantity: 300 mg; hydrochlorothiazide, quantity: 12.5 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; lactose monohydrate; hyprolose; titanium dioxide; croscarmellose sodium; colloidal anhydrous silica; macrogol 6000; purified talc; microcrystalline cellulose; iron oxide red; iron oxide yellow - irbesartan/hct sandoz is indicated for the treatment of hypertension. treatment should not be initiated with this fixed-dose combination.

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

sandoz pty ltd - pirfenidone, quantity: 801 mg - tablet - excipient ingredients: pregelatinised starch; croscarmellose sodium; hyprolose; magnesium stearate; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - pirfenidone sandoz is indicated for the treatment of idiopathic pulmonary fibrosis (ipf).

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

sandoz pty ltd - pirfenidone, quantity: 267 mg - tablet - excipient ingredients: hyprolose; silicon dioxide; croscarmellose sodium; magnesium stearate; pregelatinised starch; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - pirfenidone sandoz is indicated for the treatment of idiopathic pulmonary fibrosis (ipf)

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - piperacillin monohydrate 4.198 g equivalent to piperacillin sodium 4.2531g and 4.0g piperacillin;  ;  ; tazobactam 0.5 g equivalent to tazobactam sodium 0.54733 g - powder for injection - 4 g/0.5 g - active: piperacillin monohydrate 4.198 g equivalent to piperacillin sodium 4.2531g and 4.0g piperacillin     tazobactam 0.5 g equivalent to tazobactam sodium 0.54733 g - indicated for the treatment of the following systemic and/or local bacterial infections in which susceptible organisms have been detected or are suspected: 1. lower respiratory tract infections 2. urinary tract infections (complicated and uncomplicated) 3. intra-abdominal infections 4. skin and skin structure infections 5. bacterial septicaemia 6. gynaecological infections 7. bacterial infections in neutropenic patients. full therapeutic doses of piptaz sandoz plus an aminoglycoside should be used. 8. bone and joint infections 9. polymicrobic infections: piptaz sandoz is indicated for polymicrobic infections including those where aerobic and anaerobic organisms are suspected (intra-abdominal, skin and skin structure, upper and lower respiratory tract, gynaecological). children under the age of 12 years in hospitalised children aged 2 to 12 years, piptaz sandoz is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in this indication for paediatric patients below the age of 2 years.

Australia - engelsk - 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 - engelsk - 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 - engelsk - 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 - engelsk - 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 - engelsk - 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 - engelsk - 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.