أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - insulin degludec, quantity: 420 nmol/ml; insulin aspart, quantity: 180 nmol/ml - injection, solution - excipient ingredients: water for injections; metacresol; phenol; zinc acetate; sodium hydroxide; glycerol; hydrochloric acid; sodium chloride - for use in diabetes mellitus in patients aged 6 years and older.

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - insulin aspart, quantity: 180 nmol/ml; insulin degludec, quantity: 420 nmol/ml - injection, solution - excipient ingredients: zinc acetate; phenol; hydrochloric acid; sodium chloride; metacresol; water for injections; sodium hydroxide; glycerol - for use in diabetes mellitus in patients aged 6 years and older.

الولايات المتحدة - الإنجليزية - 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

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

novo nordisk a/s - insulin aspart, insulin degludec - diabetes mellitus - drugs used in diabetes - treatment of diabetes mellitus in adults, adolescents and children from the age of 2 years.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

novo nordisk pharma, inc. - insulin degludec (unii: 54q18076qb) (insulin degludec - unii:54q18076qb) - insulin degludec is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. limitations of use insulin degludec is contraindicated: risk summary available data from one unpublished trial and the published literature with insulin degludec use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. in a randomized, parallel-group, open-label actively controlled clinical trial that included 91 pregnant women with type 1 diabetes who were administered insulin degludec once daily and insulin aspart, beginning in gestational weeks 8 to 13 or prior to conception, no clear evidence of maternal or fetal risk associated with insulin degludec use was observed (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 degludec in animal reproduction studies during organogene

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

novo nordisk - insulin degludec (unii: 54q18076qb) (insulin degludec - unii:54q18076qb) - insulin degludec 100 u in 1 ml - tresiba is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. limitations of use tresiba is contraindicated: risk summary available data from one unpublished trial and the published literature with tresiba use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. in a randomized, parallel-group, open-label actively controlled clinical trial that included 91 pregnant women with type 1 diabetes who were administered tresiba once daily and insulin aspart, beginning in gestational weeks 8 to 13 or prior to conception, no clear evidence of maternal or fetal risk associated with tresiba use was observed (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 degludec in animal reproduction studies during organogenesis. pre-and post-implantation losses and vi

الولايات المتحدة - الإنجليزية - 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

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

sanofi winthrop industrie - insulin aspart - diabetes mellitus - drugs used in diabetes - insulin aspart sanofi is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

ماليزيا - الإنجليزية - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novo nordisk pharma (malaysia) sdn. bhd. - insulin aspart; insulin degludec -

الفلبين - الإنجليزية - 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)