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)

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).

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

boehringer ingelheim pty ltd - empagliflozin, quantity: 12.5 mg; metformin hydrochloride, quantity: 1000 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide red; iron oxide black; macrogol 400 - jardiamet is 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 metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults 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, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

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

boehringer ingelheim pty ltd - empagliflozin, quantity: 12.5 mg; metformin hydrochloride, quantity: 850 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide red; iron oxide black; macrogol 400 - jardiamet is 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 metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults 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, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

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

boehringer ingelheim pty ltd - empagliflozin, quantity: 12.5 mg; metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide red; iron oxide black; macrogol 400 - jardiamet is 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 metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults 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, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

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

boehringer ingelheim pty ltd - empagliflozin, quantity: 5 mg; metformin hydrochloride, quantity: 1000 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; hypromellose; purified talc; iron oxide yellow; macrogol 400 - jardiamet is 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 metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults 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, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

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

boehringer ingelheim pty ltd - empagliflozin, quantity: 5 mg; metformin hydrochloride, quantity: 850 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 400 - jardiamet is 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 metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults 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, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

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

boehringer ingelheim pty ltd - empagliflozin, quantity: 5 mg; metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 400 - jardiamet is 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 metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults 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, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

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

boehringer ingelheim pty ltd - empagliflozin, quantity: 10 mg - tablet, film coated - excipient ingredients: magnesium stearate; hyprolose; croscarmellose sodium; microcrystalline cellulose; colloidal anhydrous silica; 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).