United States - English - 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

United States - English - 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

United States - English - 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

Canada - English - Health Canada

eli lilly canada inc - insulin; insulin isophane (nph) - suspension - 30unit; 70unit - insulin 30unit; insulin isophane (nph) 70unit - insulins

Israel - English - Ministry of Health

eli lilly israel ltd - insulin lispro; insulin lispro protamine - suspension for injection - insulin lispro 50 %; insulin lispro protamine 50 % - insulin lispro - insulin lispro - for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.

Australia - English - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - insulin aspart, quantity: 100 u/ml - injection, suspension - excipient ingredients: glycerol; metacresol; sodium chloride; dibasic sodium phosphate dihydrate; hydrochloric acid; phenol; zinc; water for injections; sodium hydroxide; protamine sulfate - treatment of diabetes mellitus.

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

a-s medication solutions - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. limitations of use insulin glargine is not recommended for the treatment of diabetic ketoacidosis. insulin glargine is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] - in patients with hypersensitivity to insulin glargine or one of its excipients [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 units/kg/day. overall, the effects of insulin g

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: novo nordisk pharmaceuticals (philippines), inc.; distributor: novo nordisk pharmaceuticals (philippines), inc. - insulin degludec , insulin aspart - solution for injection (sc) - 100 units/ml (70% insulin degludec/30% insulin aspart)

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: novo nordisk pharmaceuticals (philippines), inc.; distributor: novo nordisk pharmaceuticals (philippines), inc. - insulin degludec , insulin aspart - solution for injection (sc) - 100 units/ml (70% insulin degludec/30% insulin aspart)

Australia - English - 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.