Statele Unite ale Americii - engleză - 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

Statele Unite ale Americii - engleză - 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

Statele Unite ale Americii - engleză - 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

Kenya - engleză - Pharmacy and Poisons Board

empagliflozin and linagliptin tablets - tablet - empagliflozin 10 mg and linagliptin 5 mg tablets - linagliptin and empagliflozin

Kenya - engleză - Pharmacy and Poisons Board

empagliflozin and linagliptin - film-coated tablet - empagliflozin 25mg and linagliptin 5mg - linagliptin and empagliflozin

Kenya - engleză - Pharmacy and Poisons Board

empagliflozin + linagliptin - film-coated tablet - 10mg empagliflozin + 5mg linagliptin per tablet - metformin and empagliflozin

Israel - engleză - Ministry of Health

boehringer ingelheim israel ltd. - empagliflozin; metformin hydrochloride - film coated tablets - empagliflozin 12.5 mg; metformin hydrochloride 500 mg - metformin and empagliflozin - jardiance duo is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control• in patients inadequately controlled on their maximally tolerated dose of metformin alone.• in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin.• in patients already being treated with the combination of empagliflozin and metformin as separate tablets.

Israel - engleză - Ministry of Health

boehringer ingelheim israel ltd. - empagliflozin; metformin hydrochloride - film coated tablets - empagliflozin 12.5 mg; metformin hydrochloride 500 mg - metformin and empagliflozin - jardiance duo is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control• in patients inadequately controlled on their maximally tolerated dose of metformin alone.• in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin.• in patients already being treated with the combination of empagliflozin and metformin as separate tablets.

Israel - engleză - Ministry of Health

boehringer ingelheim israel ltd. - empagliflozin; metformin hydrochloride - film coated tablets - empagliflozin 5 mg; metformin hydrochloride 500 mg - metformin and empagliflozin - jardiance duo is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control• in patients inadequately controlled on their maximally tolerated dose of metformin alone.• in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin.• in patients already being treated with the combination of empagliflozin and metformin as separate tablets.

Israel - engleză - Ministry of Health

boehringer ingelheim israel ltd. - empagliflozin; metformin hydrochloride - film coated tablets - empagliflozin 5 mg; metformin hydrochloride 500 mg - metformin and empagliflozin - jardiance duo is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control• in patients inadequately controlled on their maximally tolerated dose of metformin alone.• in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin.• in patients already being treated with the combination of empagliflozin and metformin as separate tablets.