Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - insulin detemir, quantity: 100 u/ml - injection, solution - excipient ingredients: phenol; glycerol; dibasic sodium phosphate dihydrate; metacresol; hydrochloric acid; zinc acetate; water for injections; sodium hydroxide; sodium chloride - treatment of diabetes mellitus. (see 'pharmacology' and 'clinical trials.')

Ausztrália - angol - 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.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - insulin detemir, quantity: 100 u/ml - injection, solution - excipient ingredients: glycerol; sodium hydroxide; dibasic sodium phosphate dihydrate; water for injections; hydrochloric acid; zinc acetate; metacresol; phenol; sodium chloride - treatment of diabetes mellitus. (see 'pharmacology' and 'clinical trials.')

Ausztrália - angol - 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.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 10.3 microgram (equivalent: estradiol, qty 10 microgram) - pessary, modified release - excipient ingredients: macrogol 6000; magnesium stearate; lactose monohydrate; hypromellose; maize starch - vagifem low is indicated for the treatment of atrophic vaginitis due to oestrogen deficiency. vagifem low is not intended for children or males.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 2.07 mg (equivalent: estradiol, qty 2 mg); norethisterone acetate, quantity: 1 mg - tablet, film coated - excipient ingredients: lactose monohydrate; maize starch; hyprolose; purified talc; magnesium stearate; hypromellose; triacetin - short term symptomatic treatment of postmenopausal oestrogen deficiency (see dosage and administration and clinical trials). for the prevention of postmenopausal bone mineral density loss. when prescribed solely for the prevention of postmenopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of osteoporosis and future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of osteoporosis. life style modifications and the risk benefit profile of kliogest should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing. see precautions and dosage and administration. kliogest is for use in postmenopausal women with an intact uterus. in perimenopausal women treated with kliogest the incidence of vaginal bleeding is unacceptably high and therefore therapy should not be initiated sooner than one year after the last menstrual period.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - liraglutide, quantity: 6 mg/ml - injection, solution - excipient ingredients: phenol; hydrochloric acid; water for injections; propylene glycol; dibasic sodium phosphate dihydrate; sodium hydroxide - saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial body mass index (bmi) of:,- greater than or equal to 30 kg/m2 (obese) or,- greater than or equal to 27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.,treatment with saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if a patient has not lost at least 5% of their initial body weight.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - liraglutide, quantity: 6 mg/ml - injection, solution - excipient ingredients: phenol; hydrochloric acid; water for injections; propylene glycol; dibasic sodium phosphate dihydrate; sodium hydroxide - glycaemic control,victoza is indicated as an adjunct to diet and exercise for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control:,- as monotherapy when metformin is contraindicated or is not tolerated,- in combination with other glucose lowering medicines.,prevention of cardiovascular events,in patients where victoza is indicated to improve glycaemic control, victoza is indicated to reduce the risk of cardiovascular events in those at high cardiovascular risk, as an adjunct to standard of care therapy (see clinical trials).

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - somatropin, quantity: 10 mg/ml - injection, solution - excipient ingredients: histidine; phenol; poloxamer; mannitol; water for injections - children:treatment of growth failure in children due to pituitary growth hormone deficiency. treatment of growth failure in girls due to gonadal dysgenesis (turner's syndrome). treatment of growth failure in children due to chronic renal insufficiency whose height is on or less than the twenty-fifth percentile and whose growth velocity is on or less than the twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 30 ml/min/1.73 m2. treatment of severe growth failure due to intrauterine growth retardation (i.e., children born small for gestational age (birth weight and/or length < -2 sd) without spontaneous catch up growth by 2 years of age). adults: treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/ml. in order to establish childhood onset [co] growth hormone insufficiency, reconfirmation by one provocative test is recommended. in order to establish isolated growth hormone deficiency two provocative tests are recommended. in adults, the insulin tolerance test is the provocative test of choice. when the insulin tolerance test is contraindicated, alternative provocative tests must be used. the combined arginine or the glucagon test may also be considered; however these tests have less established diagnostic value than the insulin tolerance test.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - somatropin, quantity: 6.67 mg/ml - injection, solution - excipient ingredients: poloxamer; mannitol; histidine; water for injections; phenol - children:treatment of growth failure in children due to pituitary growth hormone deficiency. treatment of growth failure in girls due to gonadal dysgenesis (turner's syndrome). treatment of growth failure in children due to chronic renal insufficiency whose height is on or less than the twenty-fifth percentile and whose growth velocity is on or less than the twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 30 ml/min/1.73 m2. treatment of severe growth failure due to intrauterine growth retardation (i.e., children born small for gestational age (birth weight and/or length < -2 sd) without spontaneous catch up growth by 2 years of age). adults: treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/ml. in order to establish childhood onset [co] growth hormone insufficiency, reconfirmation by one provocative test is recommended. in order to establish isolated growth hormone deficiency two provocative tests are recommended. in adults, the insulin tolerance test is the provocative test of choice. when the insulin tolerance test is contraindicated, alternative provocative tests must be used. the combined arginine or the glucagon test may also be considered; however these tests have less established diagnostic value than the insulin tolerance test.