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

organon pharma pty ltd - mometasone furoate, quantity: 50 microgram/actuation - spray, suspension - excipient ingredients: benzalkonium chloride; citric acid monohydrate; sodium citrate dihydrate; dispersible cellulose; glycerol; citric acid; polysorbate 80; purified water - uniclar aqueous nasal spray 0.05% is indicated for the treatment of symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis and the prophylaxis of seasonal allergic rhinitis in adults, adolescents and children between the ages of 3 and 11 years. uniclar aqueous nasal spray 0.05% is also indicated for the treatment of nasal polyps in adult patients 18 years of age and older. uniclar aqueous nasal spray 0.05% is indicated for the treatment of symptoms associated with acute rhinosinusitis in patients 12 years of age and older without signs or symptoms of severe bacterial infection.

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.

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

alphapharm pty ltd - lansoprazole, quantity: 30 mg - capsule, enteric - excipient ingredients: purified talc; macrogol 6000; hyprolose; titanium dioxide; polysorbate 80; methacrylic acid copolymer; sucrose; maize starch; magnesium carbonate hydrate; colloidal anhydrous silica; brilliant blue fcf; purified water; sorbitan monolaurate; erythrosine; gelatin; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; ethanol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - adults . 1. healing and long-term management of reflux oesophagitis. . 2. healing and long-term management for patients with duodenal ulcer. . 3. healing of benign gastric ulcer. patients whose gastric or duodenal ulcer is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. . 4. lansoprazole is also effective in patients with benign peptic lesions that do not respond to h2-receptor antagonists. . 5. eradication of h. pylori from the upper gastrointestinal tract in patients with peptic ulcer or chronic gastritis when used in combination with appropriate antibiotics (see clinical trials). . 6. relief of reflux-like and/or ulcer-like symptoms associated with acid-related dyspepsia. . paediatric patients 1 to 17 years of age. 1. treatment of gastro-oesophageal reflux disease, including all grades of oesophagitis. . 2. healing of erosive oesophagitis.

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

alphapharm pty ltd - lansoprazole, quantity: 15 mg - capsule, enteric - excipient ingredients: hyprolose; polysorbate 80; magnesium carbonate hydrate; sucrose; colloidal anhydrous silica; purified talc; maize starch; macrogol 6000; titanium dioxide; methacrylic acid copolymer; purified water; sorbitan monolaurate; allura red ac; gelatin; fast green fcf; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; ethanol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - adults . 1. healing and long-term management of reflux oesophagitis. . 2. healing and long-term management for patients with duodenal ulcer. . 3. healing of benign gastric ulcer. patients whose gastric or duodenal ulcer is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. . 4. lansoprazole is also effective in patients with benign peptic lesions that do not respond to h2-receptor antagonists. . 5. eradication of h. pylori from the upper gastrointestinal tract in patients with peptic ulcer or chronic gastritis when used in combination with appropriate antibiotics (see clinical trials). . 6. relief of reflux-like and/or ulcer-like symptoms associated with acid-related dyspepsia. . paediatric patients 1 to 17 years of age. 1. treatment of gastro-oesophageal reflux disease, including all grades of oesophagitis. . 2. healing of erosive oesophagitis.

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

eli lilly australia pty ltd - duloxetine hydrochloride, quantity: 67.3 mg (equivalent: duloxetine, qty 60 mg) - capsule, enteric - excipient ingredients: hypromellose; triethyl citrate; indigo carmine; purified talc; sodium lauryl sulfate; gelatin; iron oxide yellow; sucrose; hypromellose acetate succinate; titanium dioxide; propylene glycol; isopropyl alcohol; ethanol; shellac; povidone; tert-butyl alcohol; sodium hydroxide; maize starch - cymbalta is indicated for the treatment of major depressive disorder (mdd).,treatment of diabetic peripheral neuropathic pain (dpnp). treatment of generalised anxiety disorder.

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

eli lilly australia pty ltd - duloxetine hydrochloride, quantity: 33.7 mg (equivalent: duloxetine, qty 30 mg) - capsule, enteric - excipient ingredients: sodium lauryl sulfate; sucrose; triethyl citrate; titanium dioxide; gelatin; indigo carmine; hypromellose; purified talc; hypromellose acetate succinate; maize starch; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; iron oxide yellow; shellac; ethanol absolute; iron oxide black; potassium hydroxide; ammonia - cymbalta is indicated for the treatment of major depressive disorder (mdd).,treatment of diabetic peripheral neuropathic pain (dpnp). treatment of generalised anxiety disorder.

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

arrotex pharmaceuticals pty ltd - atomoxetine hydrochloride, quantity: 114 mg (equivalent: atomoxetine, qty 100 mg) - capsule, hard - excipient ingredients: iron oxide yellow; gelatin; pregelatinised maize starch; titanium dioxide; iron oxide red; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - for the treatment of attention deficit hyperactivity disorder (adhd) as defined by dsm-iv criteria in children 6 years of age and older, adolescents and adults.

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

arrotex pharmaceuticals pty ltd - atomoxetine hydrochloride, quantity: 91.2 mg (equivalent: atomoxetine, qty 80 mg) - capsule, hard - excipient ingredients: gelatin; iron oxide yellow; iron oxide red; pregelatinised maize starch; titanium dioxide; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - for the treatment of attention deficit hyperactivity disorder (adhd) as defined by dsm-iv criteria in children 6 years of age and older, adolescents and adults.