Saizen Liquid 12 mg (8 mg/ml), injection solution

( ARTG ) I. Growth failure in children due to human growth hormone deficiency,II. Growth failure in girls with gonadal dysgenesis (Turner Syndrome), confirmed by chromosomal analysis,III. Growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (CRI),IV. Growth disturbance (current height standard deviation score (H SDS) <-2.5 and parental adjusted H SDS <-1) in short children born small for gestational age (SGA) with a birth weight and/or length below -2 standard deviations (SD), who failed to show catch-up growth (height velocity standard deviation score (HV SDS) <0 during the last year) by four years of age or later,V. 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.