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Norditropin NordiLet

Norditropin NordiLet

somatropin

Manufacturer:

Novo Nordisk

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Biosynthetic human somatropin
Indications/Uses
Adult & childhood onset growth hormone deficiency (GHD). In childn, growth retardation due to GHD, growth retardation 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 2 yr.
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Dosage/Direction for Use
Adult onset GHD Initially 0.1-0.3 mg daily. 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 0.033-0.067 mg/kg or 1-2 mg/m2 daily.
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Overdosage
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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.
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Special Precautions
Previous malignant disease; benign intracranial HTN, growth hormone deficiency secondary to intracranial lesion; incipient hypothyroidism; scoliosis, endocrine disorders & short stature; impaired glucose tolerance, overt DM, obesity, history of DM, preexisting type 1 or 2 DM; history of upper airway obstruction, sleep apnoea, unidentified resp infection. Monitor growth of hands & feet in Turner syndrome patients. Measure IGF-1 levels prior to & regularly thereafter. Perform careful otological evaluation in girls w/ Turner syndrome. Regularly test thyroid function & receive replacement therapy when indicated. Long-term treatment (>10 yr). Monitor renal function during treatment especially in patients w/ chronic renal disease. Pregnancy & lactation. Childn w/ Prader-Willi syndrome. Elderly >60 yr.
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Adverse Reactions
Fluid retention, peripheral oedema. Headache; paraesthesia; arthralgia, joint stiffness, myalgia.
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Drug Interactions
Inhibited growth promoting effect by glucocorticoids. Increased clearance of sex steroids, corticosteroids, anticonvulsants, cyclosporine. Influenced growth hormone effect by gonadotropin, anabolic steroids, estrogens, thyroid hormone.
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Storage
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Description
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Action
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ATC Classification
H01AC01 - somatropin ; Belongs to the class of somatropin and somatropin agonists. Used in anterior pituitary lobe hormone and analogue preparations.
Patient Counseling Information
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Presentation/Packing
Form
Norditropin NordiLet soln for inj 10 mg/1.5 mL
Packing/Price
1's
Form
Norditropin NordiLet soln for inj 5 mg/1.5 mL
Packing/Price
1's
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