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

novo nordisk pharmaceuticals pty ltd - insulin, quantity: 70 iu/ml; insulin, quantity: 30 iu/ml - injection, suspension - excipient ingredients: protamine sulfate; dibasic sodium phosphate dihydrate; hydrochloric acid; glycerol; zinc chloride; sodium hydroxide; metacresol; water for injections; phenol - the treatment of insulin-requiring diabetes.

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

novo nordisk pharmaceuticals pty ltd - insulin, quantity: 30 iu/ml; insulin, quantity: 70 iu/ml - injection, suspension - excipient ingredients: glycerol; protamine sulfate; phenol; metacresol; hydrochloric acid; dibasic sodium phosphate dihydrate; zinc chloride; water for injections; sodium hydroxide - the treatment of insulin-requiring diabetes.

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

sanofi-aventis australia pty ltd - insulin aspart, quantity: 3.5 mg/ml - injection, solution - excipient ingredients: phenol; sodium hydroxide; sodium chloride; water for injections; polysorbate 20; zinc chloride; hydrochloric acid; metacresol - treatment of diabetes mellitus.

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

sanofi-aventis australia pty ltd - insulin aspart, quantity: 3.5 mg/ml - injection, solution - excipient ingredients: polysorbate 20; hydrochloric acid; water for injections; metacresol; phenol; zinc chloride; sodium chloride; sodium hydroxide - treatment of diabetes mellitus.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

a-s medication solutions - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - 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)].

Statele Unite ale Americii - engleză - 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

Statele Unite ale Americii - engleză - 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

Australia - engleză - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - insulin - parenteral liquid/solution/suspension - insulin hormone active 40.0 iu/ml - endocrine system - cat | dog | bitch | castrate | cat - queen | cat - tom | kitten | puppy - insulin deficiency

Uniunea Europeană - engleză - EMA (European Medicines Agency)

novo nordisk a/s - insulin aspart - diabetes mellitus - drugs used in diabetes, insulins and analogues for injection, fast-acting - treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

tya pharmaceuticals - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 100 [iu] in 1 ml - novolin r is indicated to improve glycemic control in adults and children with diabetes mellitus. novolin r 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 glycemic control. it is essential for patients with diabetes or a history of gestational diabetes to maintain good glycemic 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 important during pregnancy in patients with diabetes. therefore, women should be advised to tell their healthcare provider if they intend to become, or if they become, pregnant while taking novolin r. no reproductive toxicity studies have been performed with novolin r. it