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

sun pharma anz pty ltd - fluconazole, quantity: 200 mg - capsule, hard - excipient ingredients: purified water; lactose monohydrate; maize starch; patent blue v; magnesium stearate; titanium dioxide; erythrosine; gelatin; colloidal anhydrous silica; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; ethanol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - ozole (fluconazole) capsules, given orally, are indicated for the following conditions: - treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note: data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin b in the acute phase of cryptococcal meningitis. - maintenance therapy to prevent relapse of cryptococcal meningitis in patients with aids. - treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. - secondary prophylaxis of oropharyngeal candidiasis in patients with hiv infection. - serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note: it remains to be shown that fluconazole is as effective as amphotericin b in the treatment of serious and life-threatening candida infecctions. until such data are available, amphotericin b remains the drug of choice. - vaginal candidiasis, when topical therapy has failed. - treatment of extensive tinea cor

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

sun pharma anz pty ltd - fluconazole, quantity: 100 mg - capsule, hard - excipient ingredients: titanium dioxide; patent blue v; sodium lauryl sulfate; maize starch; magnesium stearate; lactose monohydrate; colloidal anhydrous silica; erythrosine; purified water; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; ethanol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - ozole (fluconazole) capsules, given orally, are indicated for the following conditions: - treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note: data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin b in the acute phase of cryptococcal meningitis. - maintenance therapy to prevent relapse of cryptococcal meningitis in patients with aids. - treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. - secondary prophylaxis of oropharyngeal candidiasis in patients with hiv infection. - serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note: it remains to be shown that fluconazole is as effective as amphotericin b in the treatment of serious and life-threatening candida infecctions. until such data are available, amphotericin b remains the drug of choice. - vaginal candidiasis, when topical therapy has failed. - treatment of extensive tinea cor

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

sun pharma anz pty ltd - fluconazole, quantity: 50 mg - capsule, hard - excipient ingredients: maize starch; lactose monohydrate; colloidal anhydrous silica; sodium lauryl sulfate; magnesium stearate; patent blue v; purified water; titanium dioxide; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; ethanol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - ozole (fluconazole) capsules, given orally, are indicated for the following conditions: - treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note: data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin b in the acute phase of cryptococcal meningitis. - maintenance therapy to prevent relapse of cryptococcal meningitis in patients with aids. - treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. - secondary prophylaxis of oropharyngeal candidiasis in patients with hiv infection. - serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note: it remains to be shown that fluconazole is as effective as amphotericin b in the treatment of serious and life-threatening candida infecctions. until such data are available, amphotericin b remains the drug of choice. - vaginal candidiasis, when topical therapy has failed. - treatment of extensive tinea cor

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

sun pharma anz pty ltd - imatinib mesilate, quantity: 478 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red - imatinib rbx is indicated for the: ? treatment of patients with chronic myeloid leukaemia (cml) ? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy ? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials) ? treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

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

sun pharma anz pty ltd - imatinib mesilate, quantity: 119.5 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red - imatinib rbx is indicated for the: ? treatment of patients with chronic myeloid leukaemia (cml) ? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy ? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials) ? treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

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

sun pharma anz pty ltd - topiramate, quantity: 200 mg - tablet - excipient ingredients: pregelatinised maize starch; lactose monohydrate; sodium starch glycollate type a; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; iron oxide red; macrogol 400 - 1. epilepsy. rbx topiramate tablets are indicated in adults and children, 2 years and over:. - as monotherapy in patients with newly diagnosed epilepsy. - for conversion to monotherapy in patients with epilepsy. - as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome.. 2. migraine. rbx topiramate tablets are indicated for the prophylaxis of migraine headache in adults.

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

sun pharma anz pty ltd - topiramate, quantity: 50 mg - tablet - excipient ingredients: lactose monohydrate; magnesium stearate; pregelatinised maize starch; microcrystalline cellulose; sodium starch glycollate type a; titanium dioxide; polysorbate 80; hypromellose; iron oxide yellow; macrogol 400 - 1. epilepsy. rbx topiramate tablets are indicated in adults and children, 2 years and over:. - as monotherapy in patients with newly diagnosed epilepsy. - for conversion to monotherapy in patients with epilepsy. - as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome.. 2. migraine. rbx topiramate tablets are indicated for the prophylaxis of migraine headache in adults.

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

sun pharma anz pty ltd - topiramate, quantity: 100 mg - tablet - excipient ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; pregelatinised maize starch; magnesium stearate; titanium dioxide; polysorbate 80; hypromellose; iron oxide yellow; macrogol 400 - 1. epilepsy. rbx topiramate tablets are indicated in adults and children, 2 years and over:. - as monotherapy in patients with newly diagnosed epilepsy. - for conversion to monotherapy in patients with epilepsy. - as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome.. 2. migraine. rbx topiramate tablets are indicated for the prophylaxis of migraine headache in adults.

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

sun pharma anz pty ltd - topiramate, quantity: 25 mg - tablet - excipient ingredients: pregelatinised maize starch; sodium starch glycollate type a; magnesium stearate; microcrystalline cellulose; lactose monohydrate; titanium dioxide; hypromellose; polysorbate 80; macrogol 400 - 1. epilepsy. rbx topiramate tablets are indicated in adults and children, 2 years and over:. - as monotherapy in patients with newly diagnosed epilepsy. - for conversion to monotherapy in patients with epilepsy. - as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome.. 2. migraine. rbx topiramate tablets are indicated for the prophylaxis of migraine headache in adults.

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

sun pharma anz pty ltd - esomeprazole magnesium, quantity: 41.4 mg (equivalent: esomeprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: povidone; macrogol 400; macrogol 6000; microcrystalline cellulose; diethyl phthalate; hypromellose phthalate; crospovidone; macrogol 4000; sodium stearylfumarate; hyprolose; purified talc; titanium dioxide; hypromellose; iron oxide red; maize starch; sucrose - gastro-oesophageal reflux disease (gord),- treatment of erosive reflux oesophagitis,- long-term management of patients with healed oesophagitis to prevent relapse,- symptomatic treatment of gastro-oesophageal reflux disease (gord),patients requiring nsaid therapy,- short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy,- healing of gastric ulcers associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy,- prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy in patients at risk,prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazolesolution administered by intravenous infusion,pathological hypersecretory conditions including zollinger-ellison syndrome and idiopathic hypersecretion,in combination with appropriate antibiotics for:,- healing of duodenal ulcer associated with helicobacter pylori,- eradication of helicobacter pylori in patients with active or healed peptic ulcer