Jardiance 25 mg, film-coated tablets

( ARTG ) Type 2 diabetes mellitus Glycaemic control JARDIANCE is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults and children aged 10 years and above 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 glucoselowering medicinal products including insulin, when these, together with diet and exerc‍‍‍‍‍‍​​​‍​​​​​​ise, do not provide adequate glycaemic control (see Section 5.1 Pharmacodynamic properties - Clinical trials). Prevention of cardiovascular death JARDIANCE is indicated in adult 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 [greater than or equal to] 30 mg/g, or CKD Stages 3B, 4 and 5 irrespective of urine ACR).