Аустралија - Енглески - 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.

Аустралија - Енглески - 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.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - methylphenidate hydrochloride, quantity: 10 mg - capsule, modified release - excipient ingredients: iron oxide yellow; iron oxide red; methacrylic acid copolymer; triethyl citrate; macrogol 6000; iron oxide black; purified talc; gelatin; ammonio methacrylate copolymer; titanium dioxide; maize starch; purified water; sucrose; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; ethanol absolute; potassium hydroxide - ritalin 10 tablets and ritalin la capsules are indicated for the treatment of adhd. ritalin 10 tablets are also indicated for the treatment of narcolepsy. attention-deficit hyperactivity disorder (adhd) adhd was previously known as attention-deficit disorder. other terms used to describe this behavioural syndrome include: minimal brain dysfunction in children, hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction and psycho-organic syndrome of children. ritalin 10 / ritalin la are indicatedas 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. special diagnostic considerations for adhd in children: the aetiology of this syndrome is unknown and there is no single diagnostic test. adequate diagnosis requires the use, not only of medical, but also of psychological, educational and social resources. characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and an abnormal eeg. learning may or may not be impaired. the diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. drug treatment is not indicated for all children with this syndrome. stimulants are not intended for use in children who exhibit symptoms secondary to environmental factors (e.g. child abuse in particular) or primary psychiatric disorders. appropriate educational placement is essential and psychosocial intervention is generally necessary. when remedial measures alone are insufficient, the decision to prescribe stimulant medicine will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. continuation of treatment in adolescent and special diagnostic considerations for adhd in adults: there is limited information to guide clinicians about how long older adolescents should continue to receive treatment with drugs for attention deficit hyperactivity disorder (adhd). the decision should be based on the extent to which symptoms of adhd and social functioning have improved to a point that medication is no longer needed. if older adolescents have been largely symptom-free for a year and are functioning well, a trial without medication is warranted. this should be undertaken at times of low stress such as during holidays or in a period when a school routine is well established. adhd needs to be considered in adults who present with longstanding symptoms suggestive of adhd (inattention, impulsivity, disorganisation) that appear to have started in childhood and are persisting into adult life. further, people with personality disorder and/or problems with drug use accompanied by a significant level of impulsivity and inattention should be referred for evaluation by a psychiatrist with the training and skills required to assess and treat adhd. this expertise is necessary due to the overlap of adhd symptoms with anxiety, mood and personality disorders. narcolepsy the symptoms include daytime sleepiness, inappropriate sleep episodes and rapidly occurring loss of voluntary muscle tone. ritalin 10 is effective for symptoms of sleepiness but not for loss of voluntary muscle tone.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - ramipril, quantity: 5 mg - capsule, hard - excipient ingredients: meglumine; pregelatinised maize starch; titanium dioxide; brilliant blue fcf; sorbitan monolaurate; allura red ac; potable water; gelatin; sodium lauryl sulfate - treatment of hypertension. data are currently not available to support the use of ramipril ch capsules in renovascular hypertension. post mi heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. for reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke, or peripheral vascular disease. for reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure >160mmhg or diastolic blood pressure >90mmhg (or on antihypertensive treatment); total cholesterol >5.2mmol/l; hdl cholesterol <0.9mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - ramipril, quantity: 2.5 mg - capsule, hard - excipient ingredients: pregelatinised maize starch; meglumine; titanium dioxide; quinoline yellow; sorbitan monolaurate; allura red ac; potable water; gelatin; sodium lauryl sulfate - treatment of hypertension. data are currently not available to support the use of ramipril ch capsules in renovascular hypertension. post mi heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. for reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke, or peripheral vascular disease. for reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure >160mmhg or diastolic blood pressure >90mmhg (or on antihypertensive treatment); total cholesterol >5.2mmol/l; hdl cholesterol <0.9mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - ramipril, quantity: 1.25 mg - capsule, hard - excipient ingredients: meglumine; pregelatinised maize starch; titanium dioxide; iron oxide yellow; sorbitan monolaurate; potable water; gelatin; sodium lauryl sulfate - treatment of hypertension. data are currently not available to support the use of ramipril ch capsules in renovascular hypertension. post mi heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. for reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke, or peripheral vascular disease. for reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure >160mmhg or diastolic blood pressure >90mmhg (or on antihypertensive treatment); total cholesterol >5.2mmol/l; hdl cholesterol <0.9mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - ramipril, quantity: 10 mg - capsule, hard - excipient ingredients: pregelatinised maize starch; titanium dioxide; indigo carmine; purified water; sorbitan monolaurate; erythrosine; gelatin; iron oxide black; sodium lauryl sulfate; propylene glycol; brilliant blue fcf; butan-1-ol; quinoline yellow; allura red ac; sd alcohol 45; sd alcohol 3-a - treatment of hypertension. data are currently not available to support the use of tryzan caps in renovascular hypertension. post myocardial infarction heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. for reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke, or peripheral vascular disease. for reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure >160 mmhg or diastolic blood pressure >90 mmhg (or on antihypertensive treatment); total cholesterol >5.2 mmol/l; hdl cholesterol <0.9 mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - ramipril, quantity: 5 mg - capsule, hard - excipient ingredients: pregelatinised maize starch; propylene glycol; brilliant blue fcf; indigo carmine; butan-1-ol; quinoline yellow; allura red ac; iron oxide black; sd alcohol 45; sd alcohol 3-a; titanium dioxide; purified water; sorbitan monolaurate; erythrosine; gelatin; sodium lauryl sulfate - treatment of hypertension. data are currently not available to support the use of tryzan caps in renovascular hypertension. post myocardial infarction heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. for reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke, or peripheral vascular disease. for reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure >160 mmhg or diastolic blood pressure >90 mmhg (or on antihypertensive treatment); total cholesterol >5.2 mmol/l; hdl cholesterol <0.9 mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - ramipril, quantity: 2.5 mg - capsule, hard - excipient ingredients: pregelatinised maize starch; propylene glycol; brilliant blue fcf; indigo carmine; butan-1-ol; quinoline yellow; allura red ac; iron oxide black; sd alcohol 45; sd alcohol 3-a; titanium dioxide; purified water; iron oxide yellow; sorbitan monolaurate; erythrosine; gelatin; sodium lauryl sulfate - treatment of hypertension. data are currently not available to support the use of tryzan caps in renovascular hypertension. post myocardial infarction heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. for reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke, or peripheral vascular disease. for reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure >160 mmhg or diastolic blood pressure >90 mmhg (or on antihypertensive treatment); total cholesterol >5.2 mmol/l; hdl cholesterol <0.9 mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - ramipril, quantity: 1.25 mg - capsule, hard - excipient ingredients: pregelatinised maize starch; titanium dioxide; purified water; iron oxide yellow; sorbitan monolaurate; gelatin; sodium lauryl sulfate; propylene glycol; brilliant blue fcf; indigo carmine; butan-1-ol; quinoline yellow; allura red ac; iron oxide black; sd alcohol 45; sd alcohol 3-a - treatment of hypertension. data are currently not available to support the use of tryzan caps in renovascular hypertension. post myocardial infarction heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. for reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke, or peripheral vascular disease. for reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure >160 mmhg or diastolic blood pressure >90 mmhg (or on antihypertensive treatment); total cholesterol >5.2 mmol/l; hdl cholesterol <0.9 mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease