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dispensing solutions, inc. - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - insulin aspart 100 [iu] in 1 ml - novolog is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. novolog is contraindicated pregnancy category b. all pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. this background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. it is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. careful monitoring of glucose control is essential in these patients. therefore, female patients should be advised to tell their physician if they intend to become, or if they become pregnant while taking novolog. an open-label, randomized study compared the safety and efficacy of novolog (n=157) vers

Verenigde Staten - Engels - NLM (National Library of Medicine)

dispensing solutions, inc. - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro 100 [iu] in 1 ml - humalog is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. humalog is contraindicated: - during episodes of hypoglycemia - in patients who are hypersensitive to humalog or to any of its excipients. pregnancy category b. all pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. this background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. it is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. in patients with diabetes or gestational diabetes insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. careful monitoring of glucose control is essential in these patients. therefore, female patients should be advised to tell their physicians

Verenigde Staten - Engels - NLM (National Library of Medicine)

eli lilly and company - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 100 [iu] in 1 ml - humulin n is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. humulin n is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] , and - in patients who have had hypersensitivity reactions to humulin n or any of its excipients [see warnings and precautions (5.5)] . risk summary available data from published studies over decades have not established an association with human insulin use during pregnancy and 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). animal reproduction studies were not performed. the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7% and has been reported to be as high as 20-25% in women with a hba1c >10%. the estimated background risk of miscarriage for the indicated population is unkn

Verenigde Staten - Engels - 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

Verenigde Staten - Engels - 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 mix 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in adult patients with diabetes mellitus. limitations of use: novolog mix 70/30 is contraindicated: risk summary there are no available data with novolog mix 70/30 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 unit/kg/day,

Verenigde Staten - Engels - 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)].

Verenigde Staten - Engels - 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

Verenigde Staten - Engels - 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

Verenigde Staten - Engels - NLM (National Library of Medicine)

boehringer ingelheim animal health usa inc. - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 40 [iu] in 1 ml - prozinc is contraindicated in cats sensitive to protamine zinc recombinant human insulin or any other ingredients in prozinc. prozinc is contraindicated during episodes of hypoglycemia. prozinc is contraindicated in dogs sensitive to protamine zinc recombinant human insulin or any other ingredients in prozinc. prozinc is contraindicated during episodes of hypoglycemia.

Verenigde Staten - Engels - NLM (National Library of Medicine)

tya pharmaceuticals - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 100 [iu] in 1 ml - important: . do not change the type of insulin you use unless told to do so by your healthcare provider. the amount of insulin you take as well as the best time for you to take your insulin may need to change if you take a different type of insulin. know your insulin make sure that you know the type and strength of insulin that is prescribed for you. read the patient information leaflet that comes with novolin n before you start taking it and each time you get a refill. there may be new information. this leaflet does not take the place of talking with your healthcare provider about your diabetes or your treatment. make sure you know how to manage your diabetes. ask your healthcare provider if you have any questions about managing your diabetes. ® what is novolin n? ® novolin n is a man-made insulin (recombinant dna origin) nph, human insulin isophane suspension that is structurally identical to the insulin produced by the