Iżrael - Ingliż - Ministry of Health

eli lilly israel ltd, israel - insulin glargine - solution for injection - insulin glargine 100 u/ml - insulin glargine - treatment of adult and pediatric patients, 6 years and over, with type 1 diabetes mellitus or adults patients with type 2 diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia.

Stati Uniti - Ingliż - NLM (National Library of Medicine)

dispensing solutions, inc. - insulin detemir (unii: 4ft78t86xv) (insulin detemir - unii:4ft78t86xv) - insulin detemir 14.2 mg in 1 ml - levemir is indicated for once- or twice-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia. levemir is contraindicated in patients hypersensitive to insulin detemir or one of its excipients.

Stati Uniti - Ingliż - NLM (National Library of Medicine)

physicians total care, inc. - insulin detemir (unii: 4ft78t86xv) (insulin detemir - unii:4ft78t86xv) - insulin detemir 14.2 mg in 1 ml - levemir is indicated to improve glycemic control in adults and children with diabetes mellitus. important limitations of use: - levemir is not recommended for the treatment of diabetic ketoacidosis. intravenous rapid-acting or short-acting insulin is the preferred treatment for this condition. levemir is contraindicated in patients with hypersensitivity to levemir or any of its excipients. reactions have included anaphylaxis [see warnings and precautions (5.4) and adverse reactions (6.1) ] pregnancy category c: in a fertility and embryonic development study, insulin detemir was administered to female rats before mating, during mating, and throughout pregnancy at doses up to 300 nmol/kg/day (3 times a human dose of 0.5 units/kg/day, based on plasma area under the curve (auc) ratio). doses of 150 and 300 nmol/kg/day produced numbers of litters with visceral anomalies. doses up to 900 nmol/kg/day (approximately 135 times a human dose of 0.5 units/kg/day based on auc ratio) were given to rabbits during organoge

Stati Uniti - Ingliż - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - insulin glulisine (unii: 7xiy785azd) (insulin glulisine - unii:7xiy785azd) - insulin glulisine 100 [iu] in 1 ml - apidra is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. apidra is contraindicated: - during episodes of hypoglycemia - in patients with known hypersensitivity to insulin glulisine or to any of the excipients in apidra; systemic allergic reactions have occurred with apidra [see adverse reactions (6.1)] . risk summary available pharmacovigilance data have not established an association with insulin glulisine use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . animal reproduction studies have been conducted with insulin glulisine in rats and rabbits using regular human insulin as a comparator. insulin glulisine was given to female rats throughout pregnancy at subcutaneous doses up to 10 units/kg/day (2 times the average human dose, based on body surface area comparison) and to rabbits during org

Iżrael - Ingliż - Ministry of Health

novo nordisk ltd., israel - insulin degludec - solution for injection - insulin degludec 100 u/ml - insulin degludec - treatment of diabetes mellitus in adults, adolescents and children from the age of 1 year.

Stati Uniti - Ingliż - NLM (National Library of Medicine)

novo nordisk - insulin detemir (unii: 4ft78t86xv) (insulin detemir - unii:4ft78t86xv) - insulin detemir 100 [iu] in 1 ml - levemir is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. limitations of use levemir is not recommended for the treatment of diabetic ketoacidosis. levemir is contraindicated: risk summary available data from published studies and postmarketing case reports with levemir use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in a randomized, parallel-group, open-label clinical trial that included 152 pregnant women with type 1 diabetes who were administered levemir once or twice daily, beginning in gestational weeks 8 to 12 or prior to conception, no clear evidence of maternal or fetal risk associated with levemir was observed (see data). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). animal reproduction studies were conducted in non-diabetic pregnant rats and rabbits with insulin detemir administrat

Stati Uniti - Ingliż - NLM (National Library of Medicine)

novo nordisk - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - insulin aspart 100 [iu] in 1 ml - fiasp is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. fiasp is contraindicated: risk summary there are no available data with fiasp in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. 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 1.0 unit/kg/day, respectively. pre- and post-implantation losses and visceral/skeletal abnormalities were seen a

Stati Uniti - Ingliż - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro 100 u in 1 ml - admelog is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. admelog 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 admelog [see warnings and precautions (5.5)]. risk summary published studies with another insulin lispro product 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 another insulin lispro product in animal reproduction studies during organogenesis. fetal growth retardation was observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1.0 unit/kg/day. no adverse effe

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

eli lilly australia pty ltd - insulin glargine, quantity: 100 iu/mg - injection, solution - excipient ingredients: dilute hydrochloric acid; glycerol; sodium hydroxide; water for injections; metacresol; zinc oxide - 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 the control of hypeglycaemia.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

eli lilly australia pty ltd - insulin glargine, quantity: 100 iu/mg - injection, solution - excipient ingredients: sodium hydroxide; dilute hydrochloric acid; zinc oxide; water for injections; metacresol; 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 the control of hyperglycaemia.