United States - English - NLM (National Library of Medicine)

boehringer ingelheim pharmaceuticals, inc. - empagliflozin (unii: hdc1r2m35u) (empagliflozin - unii:hdc1r2m35u), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - empagliflozin 5 mg - synjardy synjardy is a combination of empagliflozin and metformin hydrochloride (hcl) indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. synjardy xr synjardy xr is a combination of empagliflozin and metformin hcl indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. empagliflozin empagliflozin, when used as a component of synjardy or synjardy xr, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: - cardiovascular death in adults with established cardiovascular disease. - cardiovascular death and hospitalization for heart failure in adults with heart failure. limitations of use - synjardy and synjardy xr are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. it may increase the risk of diabetic ketoacidosis in these patients [see warnings and precautions (5.2)] . - because

United States - English - NLM (National Library of Medicine)

boehringer ingelheim pharmaceuticals, inc. - empagliflozin (unii: hdc1r2m35u) (empagliflozin - unii:hdc1r2m35u), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - empagliflozin 10 mg - synjardy synjardy is a combination of empagliflozin and metformin hydrochloride (hcl) indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. synjardy xr synjardy xr is a combination of empagliflozin and metformin hcl indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. empagliflozin empagliflozin, when used as a component of synjardy or synjardy xr, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: - cardiovascular death in adults with established cardiovascular disease. - cardiovascular death and hospitalization for heart failure in adults with heart failure. limitations of use - synjardy and synjardy xr are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. it may increase the risk of diabetic ketoacidosis in these patients [see warnings and precautions (5.2)] . - because

United States - English - NLM (National Library of Medicine)

boehringer ingelheim pharmaceuticals, inc. - empagliflozin (unii: hdc1r2m35u) (empagliflozin - unii:hdc1r2m35u), linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2) - empagliflozin 10 mg - glyxambi is a combination of empagliflozin and linagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease [see clinical studies (14.2)] . limitations of use glyxambi is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. it may increase the risk of diabetic ketoacidosis in these patients [see warnings and precautions (5.1)] . glyxambi has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using glyxambi [see warnings and precautions (5.2)]. glyxambi is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an egfr less than 30 ml/min/1.73 m2 . glyxambi is likely to be ineffecti

United States - English - NLM (National Library of Medicine)

cardinal health 107, llc - empagliflozin (unii: hdc1r2m35u) (empagliflozin - unii:hdc1r2m35u) - empagliflozin 10 mg - jardiance is indicated: limitations of use risk summary based on animal data showing adverse renal effects, jardiance is not recommended during the second and third trimesters of pregnancy. the limited available data with jardiance in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations] . in animal studies, adverse renal changes were observed in rats when empagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. doses approximately 13-times the maximum clinical dose caused renal pelvic and tubule dilatations that were reversible [see data] . the estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20% to 25% in women with hba1c >10. the estimat

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: 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.