Norditropin NordiFlex

Norditropin NordiFlex

somatropin

Manufacturer:

Novo Nordisk

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Somatropin
Indications/Uses
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.
Dosage/Direction for Use
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.
Contraindications
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.
Special Precautions
Not to be used if overt diabetes occurs. Increased risk of DM, evidence of glucose intolerance; neoplasms; leukaemia; benign intracranial HTN, GHD secondary to intracranial lesion; incipient hypothyroidism; insulin sensitivity; Ab development. Monitor growth of hands & feet in Turner syndrome patients. Perform otological evaluation annually in girls w/ Turner syndrome. Regularly monitor renal function, signs of scoliosis & thyroid function. Measure fasting insulin & blood glucose prior to & annually thereafter; IGF-I level prior to & twice yrly. Long-term treatment (>10 yr). Not recommended in women of childbearing potential & pregnancy. Lactation. Not recommended in SGA patients near onset of puberty. Childn w/ Prader-Willi & Silver-Russell syndrome. Elderly >60 yr.
Adverse Reactions
Peripheral oedema. Headache, paraesthesia; arthralgia, joint stiffness, myalgia.
Drug Interactions
Inhibited growth promoting effect by glucocorticoids. Increased clearance of sex steroids, corticosteroids, anticonvulsants, cyclosporine. Influenced effect by gonadotropin, anabolic steroids, estrogens, thyroid hormone.
ATC Classification
H01AC01 - somatropin ; Belongs to the class of somatropin and somatropin agonists. Used in anterior pituitary lobe hormone and analogue preparations.
Presentation/Packing
Form
Norditropin NordiFlex soln for inj 10 mg/1.5 mL
Packing/Price
1's
Form
Norditropin NordiFlex soln for inj 5 mg/1.5 mL
Packing/Price
1's
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