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

micro labs pty ltd - nitrofurantoin, quantity: 50 mg - capsule, hard - excipient ingredients: lactose monohydrate; pregelatinised maize starch; magnesium stearate; purified talc; titanium dioxide; sunset yellow fcf; purified water; quinoline yellow; gelatin - treatment of urinary tract infections such as cystitis and pyelitis when due to susceptible pathogens. nitrofurantoin does not reach effective levels in plasma and consequently is not indicated for cortical or perinephric abscesses and in cases of prostatitis.

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

takeda pharmaceuticals australia pty ltd - lisdexamfetamine dimesilate, quantity: 20 mg - capsule, hard - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; magnesium stearate; iron oxide yellow; titanium dioxide; 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)

arrotex pharmaceuticals pty ltd - sunitinib malate, quantity: 66.825 mg (equivalent: sunitinib, qty mg) - capsule, hard - excipient ingredients: gelatin; mannitol; magnesium stearate; titanium dioxide; purified water; croscarmellose sodium; povidone; iron oxide black; iron oxide yellow; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia; potassium hydroxide - arx-sunitinib is indicated for:,? treatment of advanced renal cell carcinoma (rcc),? treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,? treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net).

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

arrotex pharmaceuticals pty ltd - sunitinib malate, quantity: 50.119 mg (equivalent: sunitinib, qty mg) - capsule, hard - excipient ingredients: gelatin; mannitol; magnesium stearate; titanium dioxide; purified water; croscarmellose sodium; povidone; iron oxide yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - arx-sunitinib is indicated for:,? treatment of advanced renal cell carcinoma (rcc),? treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,? treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net).

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

arrotex pharmaceuticals pty ltd - sunitinib malate, quantity: 33.413 mg (equivalent: sunitinib, qty 25 mg) - capsule, hard - excipient ingredients: gelatin; mannitol; magnesium stearate; iron oxide red; titanium dioxide; purified water; croscarmellose sodium; povidone; iron oxide yellow; iron oxide black; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia; potassium hydroxide - arx-sunitinib is indicated for:,? treatment of advanced renal cell carcinoma (rcc),? treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,? treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net).

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

sandoz pty ltd - lenalidomide, quantity: 15 mg - capsule - excipient ingredients: gelatin; lactose; shellac; croscarmellose sodium; microcrystalline cellulose; indigo carmine; magnesium stearate; propylene glycol; potassium hydroxide; titanium dioxide; iron oxide black - multiple myeloma (mm),lenalidomide sandoz is indicated for the treatment of multiple myeloma.,myelodysplastic syndromes (mds),lenalidomide sandoz is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.,mantle cell lymphoma (mcl),lenalidomide sandoz is indicated for the treatment of patients with relapsed and/or refractory mantle cell lymphoma.

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

sandoz pty ltd - lenalidomide, quantity: 10 mg - capsule - excipient ingredients: lactose; titanium dioxide; iron oxide yellow; gelatin; microcrystalline cellulose; croscarmellose sodium; propylene glycol; shellac; potassium hydroxide; magnesium stearate; indigo carmine; iron oxide black - multiple myeloma (mm),lenalidomide sandoz is indicated for the treatment of multiple myeloma.,myelodysplastic syndromes (mds),lenalidomide sandoz is indicated for treatment of patients with transfusion-dependent anaemia,due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic,abnormality with or without additional cytogenetic abnormalities.,mantle cell lymphoma (mcl),lenalidomide sandoz is indicated for the treatment of patients with relapsed and/or refractory mantle,cell lymphoma.

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

sandoz pty ltd - lenalidomide, quantity: 5 mg - capsule - excipient ingredients: magnesium stearate; lactose; potassium hydroxide; propylene glycol; gelatin; titanium dioxide; microcrystalline cellulose; croscarmellose sodium; iron oxide black; shellac - multiple myeloma (mm),lenalidomide sandoz is indicated for the treatment of multiple myeloma.,myelodysplastic syndromes (mds),lenalidomide sandoz is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.,mantle cell lymphoma (mcl),lenalidomide sandoz is indicated for the treatment of patients with relapsed and/or refractory mantle cell lymphoma.

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

sandoz pty ltd - lenalidomide, quantity: 25 mg - capsule - excipient ingredients: propylene glycol; croscarmellose sodium; titanium dioxide; lactose; gelatin; microcrystalline cellulose; iron oxide black; shellac; potassium hydroxide; magnesium stearate - multiple myeloma (mm),lenalidomide sandoz is indicated for the treatment of multiple myeloma.,myelodysplastic syndromes (mds),lenalidomide sandoz is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.,mantle cell lymphoma (mcl),lenalidomide sandoz is indicated for the treatment of patients with relapsed and/or refractory mantle cell lymphoma.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - lipegfilgrastim - solution for injection - 10mg/1ml