Ireland - English - HPRA (Health Products Regulatory Authority)

nordisk gentofte a/s -

Ireland - English - HPRA (Health Products Regulatory Authority)

nordisk gentofte a/s -

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

ge healthcare australia pty ltd - 37489 - recorder, compact disk - this device is intended to record information from any imaging modality, workstation or pacs in the medical environment and make an identical recording which is stored in a digital format. this disk is a standard compact disk and is used to make copies of previously recorded digital data.

Israel - English - Ministry of Health

novo nordisk ltd., israel - insulin aspart - suspension for injection - insulin aspart 100 u/ml - insulin aspart - insulin aspart - novomix 50 is indicated for treatment of diabetes mellitus in adults.

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 - liraglutide - solution for injection - liraglutide 6.0 mg/ml - liraglutide - liraglutide - victoza is indicated for:• treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:1. as monotherapy when metformin is considered inappropriate due to intolerance or contraindications2. in addition to other medicinal products for the treatment of diabetes.• to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease

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

Israel - English - Ministry of Health

novo nordisk ltd., israel - estradiol hemihydrate - film coated tablets - estradiol hemihydrate 10 mcg - estradiol - estradiol - treatment of atrophic vaginitis due to estrogen deficiency in postmenopausal women.the experience treating women older than 65 years is limited.שינוי משטר מינון: 1/7/2019שינויים בעלון לרופא בסעיף posology:4.2 posology and method of administrationvagifem is administered intravaginally as a local oestrogen therapy by use of an applicator. initial dose: one vaginal tablet daily for two weeks. maintenance dose: one vaginal tablet twice a week.treatment may be started on any convenient day.if a dose is forgotten, it should be taken as soon as the patient remembers. a double dose should be avoided.for initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used.for oestrogen products for vaginal application of which the systemic exposure to the oestrogen remains within the normal postmenopausal range, such as vagifem, it is not recommended to add a progestagen (but see section 4.4, ‘special warnings and precautions for use’, ‘endometrial hyperplasia and carcinoma’).