ABD - İngilizce - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz), lixisenatide (unii: 74o62bb01u) (lixisenatide - unii:74o62bb01u) - insulin glargine 100 u in 1 ml - soliqua 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use : - soliqua 100/33 has not been studied in patients with a history of pancreatitis [see warnings and precautions (5.2)] . consider other antidiabetic therapies in patients with a history of pancreatitis. - soliqua 100/33 is not recommended for use in combination with any other product containing a glp-1 receptor agonist [see warnings and precautions (5.5)] . - soliqua 100/33 is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. - soliqua 100/33 has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis. - soliqua 100/33 has not been studied in combination with prandial insulin. soliqua 100/33 is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.6)] . - in patients w

ABD - İngilizce - NLM (National Library of Medicine)

novo nordisk - insulin degludec (unii: 54q18076qb) (insulin degludec - unii:54q18076qb), liraglutide (unii: 839i73s42a) (liraglutide - unii:839i73s42a) - insulin degludec 100 [iu] in 1 ml - xultophy 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use: xultophy 100/3.6 is contraindicated: risk summary based on animal reproduction studies, there may be risks to the fetus from exposure to liraglutide during pregnancy. xultophy 100/3.6 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. there are no available data with xultophy 100/3.6, insulin degludec or liraglutide in pregnant women to inform a drug associated risk for major birth defects and miscarriage. there are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy [see clinical considerations]. for insulin degludec, rats and rabbits were exposed in animal reproduction studies at 5 times (rat) and 10 times (rabbit) the human exposure at a dose of 0.75 u/kg/day. no adverse outcomes were observed for pregnant ani

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - insulin glargine, quantity: 3.6378 mg/ml - injection, solution - excipient ingredients: water for injections; metacresol; glycerol; zinc chloride; sodium hydroxide; hydrochloric acid - insulin glargine is an insulin analogue indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for control of hyperglycaemia.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - insulin glargine, quantity: 3.6378 mg/ml - injection, solution - excipient ingredients: metacresol; sodium hydroxide; zinc chloride; glycerol; hydrochloric acid; water for injections - insulin glargine is an insulin analogue indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for control of hyperglycaemia.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - insulin glargine, quantity: 3.6378 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections; metacresol; zinc chloride; glycerol - insulin glargine is an insulin analogue indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for control of hyperglycaemia.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - insulin glargine, quantity: 3.6378 mg/ml - injection, solution - excipient ingredients: zinc chloride; polysorbate 20; metacresol; glycerol; hydrochloric acid; water for injections; sodium hydroxide - insulin glargine is an insulin analogue indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for control of hyperglycaemia.

ABD - İngilizce - NLM (National Library of Medicine)

imclone llc - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro injection is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. insulin lispro injection is contraindicated: - during episodes of hypoglycemia - in patients who are hypersensitive to insulin lispro injection or to any of its excipients. risk summary the limited available data with insulin lispro injection in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis. no adverse effects on embryo/fetal viability or morphology were obser

ABD - İngilizce - NLM (National Library of Medicine)

novo nordisk pharma, inc. - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - insulin aspart is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. insulin aspart is contraindicated: risk summary available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects or adverse maternal or fetal outcomes [see data] . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations] . in animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day, respectively. pre- and post-implantation losses and visceral/skeletal abnormalities were seen at higher exposures, which are considered secondary to maternal hypoglycemia. these effects were similar to those o

ABD - İngilizce - NLM (National Library of Medicine)

remedyrepack inc. - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro injection is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. insulin lispro injection is contraindicated: - during episodes of hypoglycemia - in patients who are hypersensitive to insulin lispro injection or to any of its excipients. risk summary the limited available data with insulin lispro injection in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis. no adverse effects on embryo/fetal

ABD - İngilizce - NLM (National Library of Medicine)

eli lilly and company - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. insulin lispro is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] . - in patients who are hypersensitive to insulin lispro or to any of the excipients in insulin lispro [see warnings and precautions (5.5)] . risk summary published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis. no adverse effects on embryo/fetal viability or morphology were observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1 unit i