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

novo nordisk pharmaceuticals pty ltd - insulin aspart, quantity: 100 u/ml - injection, solution - excipient ingredients: phenol; zinc; dibasic sodium phosphate dihydrate; sodium hydroxide; glycerol; metacresol; sodium chloride; water for injections; hydrochloric acid - treatment of diabetes mellitus.

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

novo nordisk pharmaceuticals pty ltd - insulin aspart, quantity: 100 u/ml - injection, solution - excipient ingredients: water for injections; metacresol; glycerol; sodium chloride; dibasic sodium phosphate dihydrate; hydrochloric acid; sodium hydroxide; zinc; phenol - treatment of diabetes mellitus.

Israel - engleză - Ministry of Health

novo nordisk ltd., israel - insulin aspart - suspension for injection - insulin aspart 100 u/ml - insulin aspart - insulin aspart - novomix® 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above. משטר מינון : 7/8/2019posology and method of administrationposologythe potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency of human insulin is expressed in international units.novomix ®30 dosing is individual and determined in accordance with the needs of the patient. blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control.in patients with type 2 diabetes, novomix® 30 can be given as monotherapy. novomix® 30 can also be given in combination with oral antidiabetic medicinal products and/or glp-1 receptor agonists . for patients with type 2 diabetes, the recommended starting dose of novomix® 30 is 6 units at breakfast and 6 units at dinner (evening meal). novomix® 30 can also be initiated once daily with 12 units at dinner (evening meal). when using novomix® 30 once daily, it is generally recommended to move to twice daily when reaching 30 units by splitting the dose into equal breakfast and dinner doses. if twice daily dosing with novomix ®30 results in recurrent daytime hypoglycaemic episodes, the morning dose can be split into morning and lunchtime doses (thrice daily dosing).the following titration guideline is recommended for dose adjustments:pre-meal blood glucose level novomix® 30 dose adjustment<4.4 mmol/l <80 mg/dl -2 units4.4–6.1 mmol/l 80–110 mg/dl 06.2–7.8 mmol/l 111–140 mg/dl +2 units7.9–10 mmol/l 141–180 mg/dl +4 units>10 mmol/l >180 mg/dl +6 unitsthe lowest of the three previous days’ pre-meal blood glucose levels should be used. the dose should not be increased if hypoglycaemia occurred within these days. dose adjustments can be made once a week until target hba1c is reached. pre-meal blood glucose levels should be used to evaluate the adequacy of the preceding dose.in patients with type 2 diabetes, a dose reduction of 20% is recommended for patients with an hba1c less than 8% when a glp-1 receptor agonist is added to novomix 30, to minimise the risk of hypoglycaemia. for patients with an hba1c higher than 8% a dose reduction should be considered. subsequently, dosage should be adjusted individually.

Statele Unite ale Americii - engleză - 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

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

a-s medication solutions - 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 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 insulin aspart 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 insulin aspart, and any potential adverse effects on the breastfed infant from insulin aspart, or from the underlying maternal condition. the safety and effectiveness of insulin aspart to improve glycemic control have been established in pediatric patients with diabetes mellitus. use of insulin aspart 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 insulin aspart 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 insulin aspart, 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 insulin aspart 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 insulin aspart 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)

a-s medication solutions - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - insulin aspart is a rapid acting human insulin analog indicated to improve glycemic control in adults and children 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 effec

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

physicians total care, inc. - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - insulin aspart 100 [iu] in 1 ml - novolog mix 70/30 is an insulin analog indicated to improve glycemic control in patients with diabetes mellitus.   important limitations of use:   in premix insulins, such as novolog mix 70/30, the proportions of rapid acting and long acting insulins are fixed and do not allow for basal versus prandial dose adjustments. novolog mix 70/30 is contraindicated - during episodes of hypoglycemia - in patients with hypersensitivity to novolog  mix 70/30 or one of its excipients. enter section text here 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

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

tya pharmaceuticals - 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

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

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

Statele Unite ale Americii - engleză - 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,