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.

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.

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.

European Union - English - EMA (European Medicines Agency)

sanofi winthrop industrie - insulin aspart - diabetes mellitus - drugs used in diabetes - insulin aspart sanofi is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

United States - English - 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 limitations of use tresiba is contraindicated: risk summary available data from one unpublished trial and the published literature with tresiba use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other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

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novo nordisk pharma (malaysia) sdn. bhd. - insulin aspart; insulin degludec -

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)

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

novo nordisk pharma, inc. - insulin degludec (unii: 54q18076qb) (insulin degludec - unii:54q18076qb) - insulin degludec is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. limitations of use insulin degludec is contraindicated: risk summary available data from one unpublished trial and the published literature with insulin degludec 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 insulin degludec 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 insulin degludec 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 organogene

Israel - English - 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.