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

merck healthcare pty ltd - somatropin, quantity: 8 mg/ml - injection, solution - excipient ingredients: phenol; sucrose; citric acid; poloxamer; water for injections; sodium hydroxide - saizen is indicated for:,1. treatment of growth failure in children due to human growth hormone deficiency.,2. treatment of growth failure in girls with gonadal dysgenesis (turner syndrome), confirmed by chromosomal analysis.,3. replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defind by peak gh concentrations of less than 2.5 nanogram/ml. adults must also fulfill the following criteria: childhood onset: patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with saizen is started. adult onset: patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin.,4. treatment of growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (cri).

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

merck healthcare pty ltd - somatropin, quantity: 8 mg/ml - injection, solution - excipient ingredients: sucrose; poloxamer; sodium hydroxide; water for injections; citric acid; phenol - saizen is indicated for:,1. treatment of growth failure in children due to human growth hormone deficiency.,2. treatment of growth failure in girls with gonadal dysgenesis (turner syndrome), confirmed by chromosomal analysis.,3. replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defind by peak gh concentrations of less than 2.5 nanogram/ml. adults must also fulfill the following criteria: childhood onset: patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with saizen is started. adult onset: patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin.,4. treatment of growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (cri).

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

merck healthcare pty ltd - somatropin, quantity: 5.83 mg/ml - injection, solution - excipient ingredients: poloxamer; sodium hydroxide; sucrose; citric acid; phenol; water for injections - saizen is indicated for:,1. treatment of growth failure in children due to human growth hormone deficiency.,2. treatment of growth failure in girls with gonadal dysgenesis (turner syndrome), confirmed by chromosomal analysis.,3. replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defind by peak gh concentrations of less than 2.5 nanogram/ml. adults must also fulfill the following criteria: childhood onset: patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with saizen is started. adult onset: patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin.,4. treatment of growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (cri).

European Union - English - EMA (European Medicines Agency)

biopartners gmbh - somatropin - growth - pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists - somatropin biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth-hormone deficiency (ghd).adult-onset: patients with ghd in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin. these patients should undergo a single dynamic test in order to diagnose or exclude a ghd.childhood-onset: in patients with childhood-onset isolated ghd (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like-growth-factor-i (igf-i) concentrations (< -2 standard-deviation score (sds)), who may be considered for one test. the cut-off point of the dynamic test should be strict.

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

merck healthcare pty ltd - somatropin -

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - somatropin 8.8mg ((includes 0.8 mg overfill)) - injection with diluent - 8 mg - active: somatropin 8.8mg ((includes 0.8 mg overfill)) excipient: phosphoric acid sodium hydroxide sucrose metacresol water for injection - saizen is indicated for: 1. growth failure in children due to human growth hormone deficiency. 2. growth failure in girls with gonadal dysgenesis (turner syndrome), confirmed by chromosomal analysis. 3.saizen is indicated for replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defined by peak gh concentrations of less than 2.5 nanogram/ml. adults must also fulfil the following criteria: childhood onset: patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with saizen is started. adult onset: patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin. 4. growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (cri).

Israel - English - Ministry of Health

ferring pharmaceuticals ltd - somatropin - powder and solvent for solution for injection - somatropin 10 mg - somatropin - somatropin - children :short stature due to inadequate or failed secretion of pituitary growth hormone or turner's syndrome. short stature in children with renal insufficiency.

Israel - English - Ministry of Health

ferring pharmaceuticals ltd - somatropin - powder and solvent for solution for injection - somatropin 4 mg/vial - somatropin - somatropin - children :short stature due to inadequate or failed secretion of pituitary growth hormone or turner's syndrome. short stature in children with renal insufficiency.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - somatropin - powder for solution for injection - somatropin 5.3 mg - somatropin - somatropin - children: short stature due to inadequate or failed secretion of pituitary growth hormone or turner`s syndrome. short stature in children with renal insufficiency. growth disturbance (height sds<2.5 and parenteral adjusted height sds < -1) in short children born sga (sga - small for gestational age i.e. born small in relation to the length of the fetus development) with a birth weight and/or length < 2 sd who failed to show catch up growth (hv sds < 0 during the last year) by 4 years of age or later. prader willi syndrome for improvement of growth and body composition. adults: for adults who have suffered from growth-hormone deficiency since childhood. for adults who have aquired growth hormone deficiency due to a pituitary pathology causing hypopituitarism.

Israel - English - Ministry of Health

novo nordisk ltd., israel - somatropin - solution for injection - somatropin 10 mg / 1 ml - somatropin - somatropin - children: * short stature due to inadequate or failed secretion of pituitary growth hormone or turner`s syndrome. * short stature in children with renal insufficiency. * growth disturbance (current height sds < - 2.5 and parental adjusted height sds < - 1) in short children born small for gestational age (sga) with a birth weight and/or length below - 2 sd who failed to show catch-up growth (hv sds < during the last year) by 4 years of age or later.* children with short stature associated with noonan syndrome.adults: treatment of adults with hypothalamic-pituitary disease resulting from organic disease or pituitary tumors treated medically surgically or radiotherapy or patients with childhood onset of g.h. deficiency.