オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - empagliflozin, quantity: 25 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; hyprolose; croscarmellose sodium; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 400 - type 2 diabetes mellitus,glycaemic control,jardiance is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults as:,monotherapy,when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance.,add-on combination therapy,in combination with other glucose?lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 5.1 pharmacodynamic properties - clinical trials).,prevention of cardiovascular death,jardiance is indicated in patients with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see section 5.1 pharmacodynamic properties - clinical trials).,to prevent cardiovascular deaths, jardiance should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.,heart failure,jardiance is indicated in adults for the treatment of symptomatic heart failure independent of left ventricular ejection fraction, as an adjunct to standard of care therapy (see section 5.1 pharmacodynamic properties - clinical trials).,chronic kidney disease,jardiance is indicated to reduce the risk of kidney disease progression in adults with chronic kidney disease (ckd stages 2 and 3a with urine acr ?30 mg/g, or ckd stages 3b, 4 and 5 irrespective of urine acr).

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg); telmisartan, quantity: 80 mg - tablet, multilayer - excipient ingredients: povidone; microcrystalline cellulose; maize starch; pregelatinised maize starch; sodium hydroxide; magnesium stearate; colloidal anhydrous silica; meglumine; sorbitol; colour - treatment of hypertension. treatment should not be initiated with this fixed-dose combination. (see dosage and administration)

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - amlodipine besilate, quantity: 6.935 mg (equivalent: amlodipine, qty 5 mg); telmisartan, quantity: 80 mg - tablet, multilayer - excipient ingredients: pregelatinised maize starch; microcrystalline cellulose; meglumine; magnesium stearate; maize starch; colloidal anhydrous silica; sodium hydroxide; povidone; sorbitol; colour - treatment of hypertension. treatment should not be initiated with this fixed-dose combination. (see dosage and administration)

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - telmisartan, quantity: 40 mg; amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg) - tablet, multilayer - excipient ingredients: colloidal anhydrous silica; sodium hydroxide; sorbitol; magnesium stearate; pregelatinised maize starch; povidone; microcrystalline cellulose; maize starch; meglumine; colour - treatment of hypertension. treatment should not be initiated with this fixed-dose combination. (see dosage and administration)

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - telmisartan, quantity: 40 mg; amlodipine besilate, quantity: 6.935 mg (equivalent: amlodipine, qty 5 mg) - tablet, multilayer - excipient ingredients: magnesium stearate; meglumine; sorbitol; sodium hydroxide; microcrystalline cellulose; povidone; colloidal anhydrous silica; maize starch; pregelatinised maize starch; colour - treatment of hypertension. treatment should not be initiated with this fixed-dose combination. (see dosage and administration)

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - afatinib dimaleate, quantity: 73.9 mg - tablet, film coated - excipient ingredients: purified talc; polysorbate 80; indigo carmine aluminium lake; colloidal anhydrous silica; magnesium stearate; lactose monohydrate; macrogol 400; hypromellose; microcrystalline cellulose; titanium dioxide; crospovidone - giotrif is indicated as monotherapy for the treatment of adult patients with:,? locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have activating epidermal growth factor receptor (egfr) mutations.,? locally advanced or metastatic squamous non-small cell carcinoma of the lung progressing on or after platinum-based chemotherapy.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - afatinib dimaleate, quantity: 44.34 mg - tablet, film coated - excipient ingredients: crospovidone; titanium dioxide; polysorbate 80; lactose monohydrate; macrogol 400; colloidal anhydrous silica; microcrystalline cellulose; hypromellose; magnesium stearate; purified talc; indigo carmine aluminium lake - giotrif is indicated as monotherapy for the treatment of adult patients with:,? locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have activating epidermal growth factor receptor (egfr) mutations.,? locally advanced or metastatic squamous non-small cell carcinoma of the lung progressing on or after platinum-based chemotherapy.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - afatinib dimaleate, quantity: 59.12 mg - tablet, film coated - excipient ingredients: titanium dioxide; macrogol 400; purified talc; crospovidone; lactose monohydrate; hypromellose; microcrystalline cellulose; indigo carmine aluminium lake; colloidal anhydrous silica; polysorbate 80; magnesium stearate - giotrif is indicated as monotherapy for the treatment of adult patients with:,? locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have activating epidermal growth factor receptor (egfr) mutations.,? locally advanced or metastatic squamous non-small cell carcinoma of the lung progressing on or after platinum-based chemotherapy.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - afatinib dimaleate, quantity: 29.56 mg - tablet, film coated - excipient ingredients: lactose monohydrate; polysorbate 80; magnesium stearate; macrogol 400; titanium dioxide; crospovidone; microcrystalline cellulose; colloidal anhydrous silica; hypromellose; purified talc - giotrif is indicated as monotherapy for the treatment of adult patients with:,? locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have activating epidermal growth factor receptor (egfr) mutations.,? locally advanced or metastatic squamous non-small cell carcinoma of the lung progressing on or after platinum-based chemotherapy.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - dabigatran etexilate mesilate, quantity: 172.95 mg (equivalent: dabigatran etexilate, qty 150 mg) - capsule, hard - excipient ingredients: dimeticone 350; purified talc; hyprolose; purified water; indigo carmine; hypromellose; carrageenan; acacia; potassium chloride; titanium dioxide; tartaric acid; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - prevention of venous thromboembolic events in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement). (see section 4.2 dose and method of administration for details of treatment duration). prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke. treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and for the prevention of recurrent dvt and pe in adults.