Australia - English - 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 - English - 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.

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

novo nordisk pharmaceuticals pty ltd - catridecacog, quantity: 5.25 mg/ml - drug delivery system - excipient ingredients: - novothirteen is indicated for routine prophylaxis of bleeding in patients with congenital factor xiii a-subunit deficiency.

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.

Israel - English - Ministry of Health

novo nordisk ltd., israel - eptacog alfa (activated) - powder for solution for injection - eptacog alfa (activated) 1 mg/vial - eptacog alfa (activated) - eptacog alfa (activated) - novoseven ® rt is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: •in patients with congenital haemophilia with inhibitors to coagulation factors viii or ix > 5 bethesda units (bu) •in patients with congenital haemophilia who are expected to have a high anamnestic response to factor viii or factor ix administration •in patients with acquired haemophilia •in patients with congenital fvii deficiency •in patients with glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.severe postpartum haemorrhagenovoseven rt is indicated for the treatment of severe postpartum haemorrhage when uterotonics are insufficient to achieve haemostasis

Israel - English - Ministry of Health

novo nordisk ltd., israel - eptacog alfa (activated) - powder for solution for injection - eptacog alfa (activated) 2 mg/vial - eptacog alfa (activated) - eptacog alfa (activated) - novoseven ® rt is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: •in patients with congenital haemophilia with inhibitors to coagulation factors viii or ix > 5 bethesda units (bu) •in patients with congenital haemophilia who are expected to have a high anamnestic response to factor viii or factor ix administration •in patients with acquired haemophilia •in patients with congenital fvii deficiency •in patients with glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.severe postpartum haemorrhagenovoseven rt is indicated for the treatment of severe postpartum haemorrhage when uterotonics are insufficient to achieve haemostasis

Israel - English - Ministry of Health

novo nordisk ltd., israel - eptacog alfa (activated) - powder for solution for injection - eptacog alfa (activated) 5 mg/vial - eptacog alfa (activated) - eptacog alfa (activated) - novoseven ® rt is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: •in patients with congenital haemophilia with inhibitors to coagulation factors viii or ix > 5 bethesda units (bu) •in patients with congenital haemophilia who are expected to have a high anamnestic response to factor viii or factor ix administration •in patients with acquired haemophilia •in patients with congenital fvii deficiency •in patients with glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.severe postpartum haemorrhagenovoseven rt is indicated for the treatment of severe postpartum haemorrhage when uterotonics are insufficient to achieve haemostasis

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

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

New Zealand - English - Medsafe (Medicines Safety Authority)

novo nordisk pharmaceuticals ltd - insulin aspart 100 iu/ml;   - suspension for injection - 100 iu/ml - active: insulin aspart 100 iu/ml   excipient: dibasic sodium phosphate dihydrate glycerol hydrochloric acid metacresol phenol protamine sulfate sodium chloride sodium hydroxide water for injection zinc as chloride - the treatment of diabetes mellitus

New Zealand - English - Medsafe (Medicines Safety Authority)

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