אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - lixisenatide -

ארצות הברית - אנגלית - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - lixisenatide (unii: 74o62bb01u) (lixisenatide - unii:74o62bb01u) - lixisenatide 50 ug in 1 ml - adlyxin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use : - adlyxin has not been studied in patients with chronic pancreatitis or a history of unexplained pancreatitis. consider other antidiabetic therapies in patients with a history of pancreatitis [see warnings and precautions (5.2)] . - adlyxin should not be used in patients with type 1 diabetes mellitus. - adlyxin has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis. adlyxin is contraindicated in patients with known severe hypersensitivity to lixisenatide or to any component of adlyxin. hypersensitivity reactions including anaphylaxis have occurred with adlyxin [see warnings and precautions (5.1)and adverse reactions (6.1)] . risk summary the limited available data with lixisenatide in pregnant women are not sufficient to inform a drug-associated risk of major birth defects a

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - insulin glargine,lixisenatide -

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - insulin glargine,lixisenatide -

ארצות הברית - אנגלית - NLM (National Library of Medicine)

a-s medication solutions - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine 100 [iu] in 1 ml - lantus is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. limitations of use lantus is not recommended for the treatment of diabetic ketoacidosis. lantus is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] - in patients with hypersensitivity to insulin glargine or any of the excipients in lantus [see warnings and precautions (5.5)] risk summary published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes (see data) . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dosage of 0.2 units/kg/day. overall, the effects of insulin glargine did not generally differ from those observed with regular huma

ארצות הברית - אנגלית - NLM (National Library of Medicine)

a-s medication solutions - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine 100 [iu] in 1 ml - lantus is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. limitations of use lantus is not recommended for the treatment of diabetic ketoacidosis. lantus is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] - in patients with hypersensitivity to insulin glargine or any of the excipients in lantus [see warnings and precautions (5.5)] risk summary published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes (see data) . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dosage of 0.2 units/kg/day. overall, the effects of insulin glargine did not generally differ from those observed with regular huma

ארצות הברית - אנגלית - NLM (National Library of Medicine)

a-s medication solutions - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine 300 u in 1 ml - toujeo is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus. limitations of use: toujeo is not recommended for the treatment of diabetic ketoacidosis. toujeo is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] . - in patients with hypersensitivity to insulin glargine or any excipients in toujeo [see warnings and precautions (5.5)] . risk summary published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes (see data) . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dose of 0.2 unit/kg/day. overall, the effects of insulin glargine did not generally differ from those obser

האיחוד האירופי - אנגלית - EMA (European Medicines Agency)

sanofi-aventis deutschland gmbh - insulin human - diabetes mellitus - drugs used in diabetes - diabetes mellitus where treatment with insulin is required. insulin human winthrop rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and postoperative stabilisation in patients with diabetes mellitus.

האיחוד האירופי - אנגלית - EMA (European Medicines Agency)

sanofi winthrop industrie - insulin lispro - diabetes mellitus - drugs used in diabetes - for the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. insulin lispro sanofi is also indicated for the initial stabilisation of diabetes mellitus.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

biocon biologics inc. - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. limitations of use insulin glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis. insulin glargine-yfgn is contraindicated: risk summary published studies with use of insulin glargine products during pregnancy have not reported a clear association with insulin glargine products and adverse developmental outcomes (see data). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dosage of 0.2 units/kg/day. overall, the effects of insulin glargine did not generally differ from those observed with regular human insulin (see data). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically r