Norditropin NordiFlex

Somatropin

Adult & childhood onset growth hormone deficiency (GHD). In childn, growth failure due to GHD, growth failure in girls due to gonadal dysgenesis (Turner syndrome), growth retardation in prepubertal childn due to chronic renal disease & short childn born small for gestational age (SGA) who failed to show catch-up growth by ≥4 yr.

SC Adult onset GHD Initially 0.1-0.3 mg daily, may be increased gradually at mthly intervals. Max maintenance dose: 1 mg daily. Childhood onset GHD Restart w/ 0.2-0.5 mg daily. Childn GHD 0.025-0.035 mg/kg or 0.7-1 mg/m² daily. Turner syndrome 0.045-0.067 mg/kg or 1.3-2 mg/m² daily. Chronic renal disease 0.05 mg/kg or 1.4 mg/m² daily. Born SGA 0.035 mg/kg or 1 mg/m² daily.

Hypersensitivity. Not to be used in evidence of tumour activity, for longitudinal growth promotion in childn w/ closed epiphyses, acute critical illness following open heart & abdominal surgery, multiple accidental trauma, acute resp failure or similar conditions. Childn w/ chronic renal disease at renal transplantation.

Discontinue use if papilloedema is confirmed. Not to be used if overt diabetes occurs. Patients w/ acute illness suffering complications following open heart or abdominal surgery, multiple accidental trauma or acute resp failure. Neoplasms; leukaemia; incipient hypothyroidism; Ab development; slipped capital femoral epiphysis; pancreatitis. May unmask previously undiagnosed central (secondary) hypoadrenalism. Monitor diabetes or glucose intolerance; signs of scoliosis during therapy; symptoms of intracranial HTN if treatment is restarted; thyroid & renal function. Perform otological evaluation annually in girls w/ Turner syndrome. Measure fasting insulin & blood glucose prior to & annually thereafter; IGF-I level prior to & twice yrly. Concomitant use w/ oral oestrogen therapy. Not recommended in women of childbearing potential not using contraception & during pregnancy. Lactation. Not recommended to initiate treatment near onset of puberty in short childn born SGA. Childn w/ Prader-Willi & Silver-Russell syndrome. Elderly >60 yr.

Peripheral oedema. Headache, paraesthesia; arthralgia, joint stiffness, myalgia.

Inhibited growth-promoting effect w/ glucocorticoids. Decreased cortisone to cortisol conversion. Increased clearance of CYP450 3A4-metabolised compd eg, sex steroids, corticosteroids, anticonvulsants & cyclosporine. Influenced effect by gonadotropin, anabolic steroids, oestrogens, thyroid hormone. Insulin dose adjustment after initiation of treatment. Concomitant use w/ oral oestrogen replacement.

Trophic Hormones & Related Synthetic Drugs

H01AC01 - somatropin ; Belongs to the class of somatropin and somatropin agonists. Used in anterior pituitary lobe hormone and analogue preparations.

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