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

arrotex pharmaceuticals pty ltd - olmesartan medoxomil, quantity: 40 mg; amlodipine besilate, quantity: 6.95 mg; hydrochlorothiazide, quantity: 12.5 mg - tablet, film coated - excipient ingredients: isopropyl alcohol; pregelatinised maize starch; magnesium stearate; povidone; lactose monohydrate; silicified microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - apo-olmesartan/amlodipine/hctz 40/5/12.5 mg is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination. this fixed dose combination is not indicated for initial therapy.

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

arrotex pharmaceuticals pty ltd - hydrochlorothiazide, quantity: 25 mg; amlodipine besilate, quantity: 6.95 mg; olmesartan medoxomil, quantity: 40 mg - tablet, film coated - excipient ingredients: povidone; pregelatinised maize starch; silicified microcrystalline cellulose; lactose monohydrate; magnesium stearate; isopropyl alcohol; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - apo-olmesartan/amlodipine/hctz 40/5/25 mg is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination. this fixed dose combination is not indicated for initial therapy.

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

arrotex pharmaceuticals pty ltd - amlodipine besilate, quantity: 13.9 mg; hydrochlorothiazide, quantity: 12.5 mg; olmesartan medoxomil, quantity: 40 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; povidone; pregelatinised maize starch; silicified microcrystalline cellulose; isopropyl alcohol; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - apo-olmesartan/amlodipine/hctz 40/10/12.5 mg is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination. this fixed dose combination is not indicated for initial therapy.

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

arrotex pharmaceuticals pty ltd - hydrochlorothiazide, quantity: 12.5 mg; amlodipine besilate, quantity: 6.95 mg; olmesartan medoxomil, quantity: 20 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; silicified microcrystalline cellulose; isopropyl alcohol; magnesium stearate; lactose monohydrate; povidone; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - apo-olmesartan/amlodipine/hctz 20/5/12.5 mg is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination. this fixed dose combination is not indicated for initial therapy.

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

arrotex pharmaceuticals pty ltd - amlodipine besilate, quantity: 13.9 mg; hydrochlorothiazide, quantity: 25 mg; olmesartan medoxomil, quantity: 40 mg - tablet, film coated - excipient ingredients: isopropyl alcohol; silicified microcrystalline cellulose; povidone; lactose monohydrate; pregelatinised maize starch; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - apo-olmesartan/amlodipine/hctz 40/10/25 mg is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination. this fixed dose combination is not indicated for initial therapy.

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

boehringer ingelheim pty ltd - linagliptin, quantity: 5 mg; empagliflozin, quantity: 25 mg - tablet, film coated - excipient ingredients: purified talc; hypromellose; mannitol; crospovidone; titanium dioxide; magnesium stearate; copovidone; pregelatinised maize starch; macrogol 6000; iron oxide red; maize starch - glyxambi tablets are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties ? clinical trials).

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

boehringer ingelheim pty ltd - empagliflozin, quantity: 10 mg; linagliptin, quantity: 5 mg - tablet, film coated - excipient ingredients: iron oxide yellow; macrogol 6000; hypromellose; crospovidone; maize starch; titanium dioxide; mannitol; purified talc; pregelatinised maize starch; copovidone; magnesium stearate - glyxambi tablets are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties ? clinical trials).

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

sandoz pty ltd - voriconazole, quantity: 50 mg - tablet, film coated - excipient ingredients: povidone; croscarmellose sodium; lactose monohydrate; magnesium stearate; pregelatinised maize starch; titanium dioxide; hypromellose; triacetin - voriconazole sandoz is indicated for treatment of the following fungal infections:,- invasive aspergillosis.,- serious candida infections (including c. krusei), including oesophageal and systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,- serious fungal infections caused by scedosporium spp and fusarium spp.,- other serious fungal infections, in patients intolerant of, or refractory to, other therapy,- prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.,- this brand is only available as tablets and therefore only indicated for adults and children 12 years or older who can tolerate tablets. for dosing requirements for populations who require intravenous or oral suspension treatment see dosage and administration.

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

sandoz pty ltd - voriconazole, quantity: 200 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; lactose monohydrate; povidone; croscarmellose sodium; magnesium stearate; titanium dioxide; hypromellose; triacetin - voriconazole sandoz is indicated for treatment of the following fungal infections:,- invasive aspergillosis.,- serious candida infections (including c. krusei), including oesophageal and systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,- serious fungal infections caused by scedosporium spp and fusarium spp.,- other serious fungal infections, in patients intolerant of, or refractory to, other therapy,- prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.,- this brand is only available as tablets and therefore only indicated for adults and children 12 years or older who can tolerate tablets. for dosing requirements for populations who require intravenous or oral suspension treatment see dosage and administration.

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

arrotex pharmaceuticals pty ltd - omeprazole, quantity: 20 mg - tablet, enteric coated - excipient ingredients: iron oxide black; microcrystalline cellulose; povidone; iron oxide red; crospovidone; purified talc; lactose monohydrate; hypromellose phthalate; magnesium stearate; triacetin; ascorbyl palmitate - omeprazole tablets are indicated for: a. gastro-oesophageal reflux disease (gord): 1. symptomatic gord: the relief of heartburn and other symptoms associated with gord. 2. erosive oesophagitis: the treatment and prevention of relapse. b. peptic ulcers: 1. the treatment of duodenal and gastric ulcer. 2. combination therapy for the treatment of peptic ulcer disease associated with heliobacter pylori infection. 3. the treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs. 4. the prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. 5. long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be heliobacter pylori negative, or in whom eradication is inappropriate, e.g. the elderly, or ineffective. c. zollinger-ellison syndrome: the treatment of zollinger-ellison syndrome.