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

teva pharma australia pty ltd - methylphenidate hydrochloride, quantity: 54 mg - tablet, modified release - excipient ingredients: methacrylic acid copolymer; fumaric acid; purified talc; hypromellose; magnesium stearate; triethyl citrate; lactose monohydrate; colloidal anhydrous silica; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; titanium dioxide; iron oxide red; polyvinyl alcohol; macrogol 3350 - methylphenidate xr arx 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; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.,need for comprehensive treatment programme methylphenidate xr arx 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 effectiveness of methylphenidate hydrochloride extended release tablets for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use methylphenidate xr arx for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

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

teva pharma australia pty ltd - methylphenidate hydrochloride, quantity: 18 mg - tablet, modified release - excipient ingredients: fumaric acid; magnesium stearate; lactose monohydrate; triethyl citrate; purified talc; hypromellose; methacrylic acid copolymer; colloidal anhydrous silica; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; titanium dioxide; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - methylphenidate xr arx 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; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.,need for comprehensive treatment programme methylphenidate xr arx 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 effectiveness of methylphenidate hydrochloride extended release tablets for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use methylphenidate xr arx for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

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

teva pharma australia pty ltd - methylphenidate hydrochloride, quantity: 27 mg - tablet, modified release - excipient ingredients: lactose monohydrate; magnesium stearate; hypromellose; purified talc; triethyl citrate; fumaric acid; methacrylic acid copolymer; colloidal anhydrous silica; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; titanium dioxide; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - methylphenidate xr arx 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; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.,need for comprehensive treatment programme methylphenidate xr arx 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 effectiveness of methylphenidate hydrochloride extended release tablets for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use methylphenidate xr arx for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - topiramate 300mg;   - film coated tablet - 300 mg - active: topiramate 300mg   excipient: carnauba wax lactose monohydrate magnesium stearate microcrystalline cellulose opadry as opadry red ys-1-1759-g sodium starch glycolate starch

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - topiramate 400mg;   - film coated tablet - 400 mg - active: topiramate 400mg   excipient: carnauba wax lactose monohydrate magnesium stearate microcrystalline cellulose opadry white ys-1-7706-g as opadry white ys-1-7706-g sodium starch glycolate starch

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

apotex pty ltd - melatonin, quantity: 2 mg - tablet, modified release - excipient ingredients: ammonio methacrylate copolymer; calcium hydrogen phosphate dihydrate; lactose monohydrate; colloidal anhydrous silica; purified talc; magnesium stearate - monotherapy for the short term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over.

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

arrotex pharmaceuticals pty ltd - dasatinib, quantity: 70 mg - tablet, film coated - excipient ingredients: triethyl citrate; hypromellose; colloidal anhydrous silica; hyprolose; lactose monohydrate; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; ethylcellulose; titanium dioxide - dasatinib arx is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy

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

arrotex pharmaceuticals pty ltd - dasatinib, quantity: 100 mg - tablet, film coated - excipient ingredients: triethyl citrate; lactose monohydrate; hypromellose; hyprolose; colloidal anhydrous silica; titanium dioxide; croscarmellose sodium; ethylcellulose; microcrystalline cellulose; magnesium stearate - dasatinib arx is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy

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

arrotex pharmaceuticals pty ltd - dasatinib, quantity: 20 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; triethyl citrate; lactose monohydrate; hyprolose; microcrystalline cellulose; colloidal anhydrous silica; hypromellose; titanium dioxide; magnesium stearate; ethylcellulose - dasatinib arx is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy

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

arrotex pharmaceuticals pty ltd - dasatinib, quantity: 50 mg - tablet, film coated - excipient ingredients: ethylcellulose; hyprolose; microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; hypromellose; titanium dioxide; lactose monohydrate; magnesium stearate; triethyl citrate - dasatinib arx is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy