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

takeda pharmaceuticals australia pty ltd - metformin hydrochloride, quantity: 1000 mg; alogliptin benzoate, quantity: 17 mg (equivalent: alogliptin, qty 12.5 mg) - tablet, film coated - excipient ingredients: povidone; microcrystalline cellulose; hypromellose; crospovidone; mannitol; purified talc; titanium dioxide; iron oxide yellow; magnesium stearate - nesina met is indicated to improve glycaemic control in adult patients (> or = 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control and treatment with both alogliptin and metformin is appropriate,,- when treatment with metformin alone does not provide adequate control; or - in combination with a thiazolidinedione or with insulin, when dual therapy does not provide adequate control.,nesina met can also be used to replace separate tablets of alogliptin and metformin in patients already being treated with this combination.

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

takeda pharmaceuticals australia pty ltd - metformin hydrochloride, quantity: 500 mg; alogliptin benzoate, quantity: 17 mg (equivalent: alogliptin, qty 12.5 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; mannitol; titanium dioxide; magnesium stearate; iron oxide yellow; purified talc; crospovidone; povidone; hypromellose - nesina met is indicated to improve glycaemic control in adult patients (> or = 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control and treatment with both alogliptin and metformin is appropriate,,- when treatment with metformin alone does not provide adequate control; or - in combination with a thiazolidinedione or with insulin, when dual therapy does not provide adequate control.,nesina met can also be used to replace separate tablets of alogliptin and metformin in patients already being treated with this combination.

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

takeda pharmaceuticals australia pty ltd - metformin hydrochloride, quantity: 850 mg; alogliptin benzoate, quantity: 17 mg (equivalent: alogliptin, qty 12.5 mg) - tablet, film coated - excipient ingredients: titanium dioxide; purified talc; microcrystalline cellulose; povidone; mannitol; crospovidone; hypromellose; iron oxide yellow; magnesium stearate - nesina met is indicated to improve glycaemic control in adult patients (> or = 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control and treatment with both alogliptin and metformin is appropriate,,- when treatment with metformin alone does not provide adequate control; or - in combination with a thiazolidinedione or with insulin, when dual therapy does not provide adequate control.,nesina met can also be used to replace separate tablets of alogliptin and metformin in patients already being treated with this combination.

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

takeda pharmaceuticals australia pty ltd - alogliptin benzoate, quantity: 17 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; macrogol 8000; hypromellose; hyprolose; mannitol; titanium dioxide; iron oxide yellow; microcrystalline cellulose; magnesium stearate; shellac; ethanol absolute; iron oxide black; 1-butanol - nesina is indicated to improve glycaemic control in adult patients (>= 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control, as add on to metformin, a sulphonylurea, a thiazolidinedione, insulin (with or without metformin), or in combination with metformin and a thiazolidinedione when dual therapy does not provide adequate glycaemic control.

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

takeda pharmaceuticals australia pty ltd - alogliptin benzoate, quantity: 8.5 mg - tablet, film coated - excipient ingredients: titanium dioxide; croscarmellose sodium; magnesium stearate; mannitol; macrogol 8000; hyprolose; hypromellose; iron oxide red; microcrystalline cellulose; shellac; ethanol absolute; iron oxide black; 1-butanol - nesina is indicated to improve glycaemic control in adult patients (>= 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control, as add on to metformin, a sulphonylurea, a thiazolidinedione, insulin (with or without metformin), or in combination with metformin and a thiazolidinedione when dual therapy does not provide adequate glycaemic control.

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

takeda pharmaceuticals australia pty ltd - alogliptin benzoate, quantity: 34 mg - tablet, film coated - excipient ingredients: iron oxide red; titanium dioxide; mannitol; magnesium stearate; croscarmellose sodium; hypromellose; microcrystalline cellulose; macrogol 8000; hyprolose; shellac; ethanol absolute; iron oxide black; 1-butanol - nesina is indicated to improve glycaemic control in adult patients (>= 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control, as add on to metformin, a sulphonylurea, a thiazolidinedione, insulin (with or without metformin), or in combination with metformin and a thiazolidinedione when dual therapy does not provide adequate glycaemic control.

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

takeda pharmaceuticals australia pty ltd - lisdexamfetamine dimesilate, quantity: 70 mg - capsule, hard - excipient ingredients: titanium dioxide; croscarmellose sodium; erythrosine; microcrystalline cellulose; magnesium stearate; brilliant blue fcf; gelatin - attention deficit hyperactivity disorder (adhd): vyvanse is indicated for the treatment of attention deficit hyperactivity disorder (adhd). treatment should be commenced by a specialist. a diagnosis of attention deficit hyperactivity disorder (adhd) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before 12 years of age.,need for comprehensive treatment programme: vyvanse is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,long term use: the physician who elects to use vyvanse for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.,binge eating disorder (bed): vyvanse is indicated for the treatment of moderate to severe bed in adults when nonpharmacological treatment is unsuccessful or unavailable. treatment should be commenced and managed by a psychiatrist.,need for comprehensive treatment programme: vyvanse is indicated as part of a total treatment program for bed that optimally includes other measures (nutritional, psychological, and medical) for patients with this disorder. when remedial measures including psychotherapy are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,limitation of use: vyvanse is not indicated or recommended for weight loss. use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. the safety and effectiveness of vyvanse for the treatment of obesity have not been established. prescribers should consider that serious cardiovascular events have been reported with this class of sympathomimetic drugs. the bed clinical trials were not designed to assess cardiovascular safety. while there is an accumulation of safety data with vyvanse use in the adhd population, this is of limited relevance regarding cardiovascular risk in the bed population. given the higher cardiovascular risk associated with obesity, the bed population may be at a higher risk. see sections 4.4 special warnings and precautions for use, cardiovascular disease and 4.2 dose and method of administration.,long term use: for bed the initial treatment period is 12 weeks. patients should then be observed to assess whether further treatment with vyvanse is required. periodic re-evaluation of the usefulness of vyvanse for the individual patient should be undertaken. see section 5.1 pharmacodynamic properties, clinical trials.

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

takeda pharmaceuticals australia pty ltd - lisdexamfetamine dimesilate, quantity: 30 mg - capsule, hard - excipient ingredients: magnesium stearate; croscarmellose sodium; erythrosine; titanium dioxide; microcrystalline cellulose; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - attention deficit hyperactivity disorder (adhd): vyvanse is indicated for the treatment of attention deficit hyperactivity disorder (adhd). treatment should be commenced by a specialist. a diagnosis of attention deficit hyperactivity disorder (adhd) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before 12 years of age.,need for comprehensive treatment programme: vyvanse is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,long term use: the physician who elects to use vyvanse for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.,binge eating disorder (bed): vyvanse is indicated for the treatment of moderate to severe bed in adults when nonpharmacological treatment is unsuccessful or unavailable. treatment should be commenced and managed by a psychiatrist.,need for comprehensive treatment programme: vyvanse is indicated as part of a total treatment program for bed that optimally includes other measures (nutritional, psychological, and medical) for patients with this disorder. when remedial measures including psychotherapy are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,limitation of use: vyvanse is not indicated or recommended for weight loss. use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. the safety and effectiveness of vyvanse for the treatment of obesity have not been established. prescribers should consider that serious cardiovascular events have been reported with this class of sympathomimetic drugs. the bed clinical trials were not designed to assess cardiovascular safety. while there is an accumulation of safety data with vyvanse use in the adhd population, this is of limited relevance regarding cardiovascular risk in the bed population. given the higher cardiovascular risk associated with obesity, the bed population may be at a higher risk. see sections 4.4 special warnings and precautions for use, cardiovascular disease and 4.2 dose and method of administration.,long term use: for bed the initial treatment period is 12 weeks. patients should then be observed to assess whether further treatment with vyvanse is required. periodic re-evaluation of the usefulness of vyvanse for the individual patient should be undertaken. see section 5.1 pharmacodynamic properties, clinical trials.

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

takeda pharmaceuticals australia pty ltd - lisdexamfetamine dimesilate, quantity: 50 mg - capsule, hard - excipient ingredients: microcrystalline cellulose; titanium dioxide; magnesium stearate; croscarmellose sodium; brilliant blue fcf; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - attention deficit hyperactivity disorder (adhd): vyvanse is indicated for the treatment of attention deficit hyperactivity disorder (adhd). treatment should be commenced by a specialist. a diagnosis of attention deficit hyperactivity disorder (adhd) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before 12 years of age.,need for comprehensive treatment programme: vyvanse is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,long term use: the physician who elects to use vyvanse for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.,binge eating disorder (bed): vyvanse is indicated for the treatment of moderate to severe bed in adults when nonpharmacological treatment is unsuccessful or unavailable. treatment should be commenced and managed by a psychiatrist.,need for comprehensive treatment programme: vyvanse is indicated as part of a total treatment program for bed that optimally includes other measures (nutritional, psychological, and medical) for patients with this disorder. when remedial measures including psychotherapy are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,limitation of use: vyvanse is not indicated or recommended for weight loss. use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. the safety and effectiveness of vyvanse for the treatment of obesity have not been established. prescribers should consider that serious cardiovascular events have been reported with this class of sympathomimetic drugs. the bed clinical trials were not designed to assess cardiovascular safety. while there is an accumulation of safety data with vyvanse use in the adhd population, this is of limited relevance regarding cardiovascular risk in the bed population. given the higher cardiovascular risk associated with obesity, the bed population may be at a higher risk. see sections 4.4 special warnings and precautions for use, cardiovascular disease and 4.2 dose and method of administration.,long term use: for bed the initial treatment period is 12 weeks. patients should then be observed to assess whether further treatment with vyvanse is required. periodic re-evaluation of the usefulness of vyvanse for the individual patient should be undertaken. see section 5.1 pharmacodynamic properties, clinical trials.

United States - English - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - pioglitazone 15 mg - actoplus met xr is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and metformin is appropriate [see clinical studies (14)] . important limitations of use pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. actoplus met xr should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.5)]. - initiation in patients with established nyha class iii or iv heart failure [see boxed warning] . - severe renal impairment ( egfr below 30 ml/min/1.73 m2 ) [see warnings and precautions (5.2)]. - use in patients with known hypersensitivity to pioglitazone, metformin or any other component of actoplus met xr. - metabolic acidosis, including diabetic ketoacidosis. diabetic ketoacidosis should be treated with insulin. risk summary