European Union - English - 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.

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)

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.

Australia - English - 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.

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

a-s medication solutions - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - insulin aspart 100 [iu] in 1 ml - novolog is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. novolog 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 observed in rats administered regular human insulin [see data] . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a periconceptional hba1c >7% and has been reported to be as high as 20 to 25% in women with a periconceptional hba1c >10%. the estimated background risk of miscarriage for the indicated population is unknown. clinical considerations disease-associated maternal and/or embryo-fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. data human data published data from 5 randomized controlled trials of 441 pregnant women with diabetes mellitus treated with insulin aspart during the late 2nd trimester of pregnancy did not identify an association of insulin aspart with major birth defects or adverse maternal or fetal outcomes. however, these studies cannot definitely establish the absence of any risk because of methodological limitations, including a variable duration of treatment and small size of the majority of the trials. animal data fertility, embryo-fetal and pre- and postnatal development studies have been performed with insulin aspart and regular human insulin in rats and rabbits. in a combined fertility and embryo-fetal development study in rats, insulin aspart was administered before mating, during mating, and throughout pregnancy. further, in a pre- and postnatal development study insulin aspart was given throughout pregnancy and during lactation to rats. in an embryo-fetal development study insulin aspart was given to female rabbits during organogenesis. the effects of insulin aspart did not differ from those observed with subcutaneous regular human insulin. insulin aspart, like human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 units/kg/day (approximately 32 times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents) and in rabbits at a dose of 10 units/kg/day (approximately three times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents). no significant effects were observed in rats at a dose of 50 units/kg/day and in rabbits at a dose of 3 units/kg/day. these doses are approximately 8 times the human subcutaneous dose of 1 unit/kg/day for rats and equal to the human subcutaneous dose of 1 unit/kg/day for rabbits, based on human exposure equivalents. the effects are considered secondary to maternal hypoglycemia. risk summary there are no data on the presence of novolog in human milk, the effects on the breastfed infant, or the effect on milk production. one small published study reported that exogenous insulin, including insulin aspart, was present in human milk. however, there is insufficient information to determine the effects of insulin aspart on the breastfed infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for novolog, and any potential adverse effects on the breastfed infant from novolog, or from the underlying maternal condition. the safety and effectiveness of novolog to improve glycemic control have been established in pediatric patients with diabetes mellitus. use of novolog for this indication is supported by evidence from an adequate and well-controlled study in 283 pediatric patients with type 1 diabetes mellitus aged 6 to 18 years and from studies in adults with diabetes mellitus [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . of the total number of patients (n=1,375) treated with novolog in 3 controlled clinical studies, 2.6% (n=36) were 65 years of age or over. one-half of these patients had type 1 diabetes (18/1285) and the other half had type 2 diabetes (18/90). the hba1c response to novolog, as compared to regular human insulin, did not differ by age. patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent novolog dose adjustment and more frequent blood glucose monitoring [see warnings and precautions (5.3) and clinical pharmacology (12.3)]. patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent novolog dose adjustment and more frequent blood glucose monitoring [see warnings and precautions (5.3) and clinical pharmacology (12.3)].

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

sanofi k.k. - insulin aspart(genetical recombination)[insulin aspart biosimilar 1] - clear and colorless injection

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

sanofi k.k. - insulin aspart(genetical recombination)[insulin aspart biosimilar 1] - clear and colorless injection

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

sanofi k.k. - insulin aspart(genetical recombination)[insulin aspart biosimilar 1] - clear and colorless injection, (body) dark gray, (injection button) pale orange

Canada - English - Health Canada

novo nordisk canada inc - insulin aspart; insulin aspart protamine - suspension - 30%; 70% - insulin aspart 30%; insulin aspart protamine 70% - insulins