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

fujifilm toyama chemical co., ltd. - insulin glargine (genetical recombination) [insulin glargine biosimilar 2] - limpid and colorless injection

New Zealand - engelsk - Ministry for Primary Industries

schering-plough animal health limited - insulin - insulin 0.04 thou iu/ml - endocrine agent (hormone)

Belgien - engelsk - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

intervet international b.v. - insulin porcine 40 iu/ml - suspension for injection - 40 iu/ml - insulin zinc suspension, crystalline 28 iu/ml; insulin zinc suspension, amorphous 12 iu/ml - insulin (pork) - dog; cat

Belgien - engelsk - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

intervet international b.v. - insulin porcine 40 iu/ml - suspension for injection - 40 iu/ml - insulin zinc suspension, amorphous 12 iu/ml; insulin zinc suspension, crystalline 28 iu/ml - insulin (pork) - dog; cat

USA - engelsk - NLM (National Library of Medicine)

mannkind corporation - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 4 - afrezza® is a rapid acting inhaled human insulin indicated to improve glycemic control in adult patients with diabetes mellitus. limitations of use: - afrezza is not recommended for the treatment of diabetic ketoacidosis [see warning and precautions (5.6)] . - the safety and effectiveness of afrezza in patients who smoke have not been established. the use of afrezza is not recommended in patients who smoke or who have recently stopped smoking. afrezza is contraindicated: - during episodes of hypoglycemia [see warning and precautions (5.3)]. - chronic lung disease, such as asthma or chronic obstructive pulmonary disease (copd), because of the risk of acute bronchospasm [see warnings and precautions (5.1)] - hypersensitivity to regular human insulin or any of the excipients in afrezza [see warnings and precautions (5.7)] risk summary limited available data with afrezza use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes. available information from published studies with human insulin use during pregnancy has not reported a clear association with human insulin and adverse developmental 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, there were no adverse developmental outcomes with subcutaneous administration of carrier particles (vehicle without insulin) to pregnant rats during organogenesis at doses 21 times the human daily dose of 99 mg afrezza, based on auc (see data) . the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with hba1c >7 and has been reported to be as high as 20-25% in women with hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia- related morbidity. data human data there are limited data with afrezza use in pregnant women. published data do not report a clear association with human insulin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when human insulin is used during pregnancy. however, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and lack of blinding. animal data in pregnant rats given subcutaneous doses of 10, 30, and 100 mg/kg/day of carrier particles (vehicle without insulin) from gestation day 6 through 17 (organogenesis), no major malformations were observed at doses up to 100 mg/kg/day (21 times the human systemic exposure at a daily dose of 99 mg afrezza, based on auc). in pregnant rabbits given subcutaneous doses of 2, 10, and 100 mg/kg/day of carrier particles (vehicle without insulin) from gestation day 7 through 19 (organogenesis), adverse maternal effects were observed in all dose groups (at human systemic exposure following a daily dose of 99 mg afrezza, based on auc). in pregnant rats given subcutaneous doses of 10, 30, and 100 mg/kg/day of carrier particles (vehicle without insulin) from gestation day 7 through lactation day 20 (weaning), decreased epididymis and testes weights were observed in f1 male offspring, however, no decrease in fertility was noted, and impaired learning were observed in f1 pups at ³ 30 mg/kg/day (6 times the human systemic exposure at a daily dose of 99 mg afrezza, based on auc). risk summary there are no data on the presence of afrezza in human milk, the effects on the breastfed infant, or the effects on milk production. one small published study reported that exogenous subcutaneous insulin was present in human milk. no adverse effects in infants were noted. the carrier particles are present in rat milk (see data ). potential adverse reactions that are related to inhalational administration of afrezza are unlikely to be associated with potential exposure of afrezza through breast milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for afrezza and any potential adverse effects on the breastfed infant from afrezza or from the underlying maternal condition. data subcutaneous administration of the carrier particle in lactating rats resulted in excretion of the carrier particle in rat milk at levels that were approximately 10% of the maternal exposure. given the results of the rat study, it is highly likely that the insulin and carrier in afrezza are excreted in human milk. the safety and effectiveness of afrezza to improve glycemic control in pediatric patients with diabetes mellitus has not been established. afrezza has not been studied in pediatric patients. in the afrezza clinical studies, 671 (12%) patients were 65 years of age or older, of which 42 (0.8%) were 75 years of age or older. in these studies, 381 (13%) of afrezza-treated patients were 65 years of age or older, of which 20 (0.7%) were 75 years of age or older. no overall differences in effectiveness of afrezza have been observed between patients 65 years of age and older and younger adult patients [see clinical studies (14)] . clinical studies of afrezza did not include sufficient numbers of patients 65 years of age and older to determine whether there were differences in safety between these patients and younger adult patients. pharmacokinetic and pharmacodynamic studies to assess the effect of age on pharmacokinetics or pharmacodynamics on insulin human, respectively, have not been conducted. the effect of hepatic impairment on the pharmacokinetics of afrezza has not been studied. frequent glucose monitoring and a lower dosage may be necessary in afrezza-treated patients with hepatic impairment [see warnings and precautions (5.3)] . the effect of renal impairment on the pharmacokinetics of afrezza has not been studied. some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. frequent glucose monitoring and a lower dosage may be necessary in afrezza-treated patients with renal impairment [see warnings and precautions (5.3)] . instructions for use afrezza® (uh-frezz-uh) (insulin human) inhalation powder, for oral inhalation use this “instructions for use” contains information on how to use afrezza® (insulin human) inhalation powder. read this instructions for use before you start using afrezza and each time you get a new afrezza inhaler. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. your healthcare provider should show you how to use your afrezza inhaler the right way before you use it for the first time. important information about afrezza: - afrezza comes in 3 strengths (see figure a): 4 units (blue cartridge) 8 units (green cartridge) 12 units (yellow cartridge) - 4 units (blue cartridge) - 8 units (green cartridge) - 12 units (yellow cartridge) - if your prescribed afrezza dose is higher than 12 units, you will need to use more than 1 cartridge. - if you need to use more than 1 cartridge for your dose, throw away the used cartridge before getting a new one. you can tell when a cartridge has been used, because the cup has moved to the center. - do not try to open the afrezza cartridges. the afrezza inhaler opens the cartridge automatically during use. - afrezza cartridges should only be used with the afrezza inhaler. do not try to breathe in the afrezza insulin powder in any other way. do not put cartridges in your mouth and do not swallow cartridges. - use only 1 afrezza inhaler at a time. the same inhaler should be used for the 4 unit, 8 unit or 12 unit cartridges. - store the inhaler in a clean, dry place with the mouthpiece cover on until your next dose. - throw away your afrezza inhaler after 15 days and get a new one. if you are having problems with your afrezza inhaler or if it breaks and you need a new one, call 1-877-323-8505. know your afrezza inhaler: know your afrezza cartridges: manufactured by: mannkind corporation danbury, ct 06810 us license no. #2190 © 2016 – 2023 mannkind corporation this instructions for use has been approved by the u.s. food and drug administration. revised: 02/2023 afrezza is a registered trademark of mannkind corporation patent: www.mannkindcorp.com/patent-notices

USA - engelsk - 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

USA - engelsk - NLM (National Library of Medicine)

imclone llc - 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 viability or morphology were obser

USA - engelsk - 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

USA - engelsk - 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

USA - engelsk - NLM (National Library of Medicine)

eli lilly and company - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. insulin lispro 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 insulin lispro [see warnings and precautions (5.5)] . risk summary 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 viability or morphology were observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1 unit i