Saizen

Saizen

somatropin

Manufacturer:

PT. Merck Tbk
Concise Prescribing Info
Contents
Somatropin
Indications/Uses
Growth failure in childn caused by decrease or absence of secretion of endogenous growth hormone, growth failure in girls w/ gonadal dysgenesis (Turner's syndrome) confirmed by chromosomal analysis; retarded growth in childn born small for gestational age; adults w/ pronounced growth hormone deficiency w/ onset in childhood or adulthood.
Dosage/Direction for Use
Growth failure due to inadequate endogenous growth hormone secretion 0.7-1 mg/m2/day or 0.025-0.035 mg/kg/day SC or IM. Growth failure in girls due to gonadal dysgenesis (Turner's syndrome) 1.4 mg/m2/day or 0.045-0.05 mg/kg/day SC or IM. Growth failure in childn born small for gestational age 0.035-0.067 mg/kg (or 1-2 mg/m2/day) SC. Growth hormone deficiency in adult Starting dose: 0.15-0.3 mg/day SC, dose should be increased gradually once a mth if necessary. Final dosage is rarely >1 mg/day.
Contraindications
Presence of active tumour &/or active intracranial lesions, critically ill patients, proliferative or pre-proliferative diabetic retinopathy; Down's or Bloom's syndrome, or Fanconi anemia. Pregnancy & lactation.
Special Precautions
Periodically measure bone age during treatment especially in pubertal patients &/or those receiving thyroid substitution therapy. Monitor possible sign of renewal of the malignant process. Fluid retention in substitution therapy in adults, hypothyroidism, benign intracranial HTN, insulin resistance, dislocation of femoral epiphysis.
Adverse Reactions
Formation of antibodies, presence of antibodies against human growth hormones, application site reactions eg, pain, paresthesia, redness or edema, local lipoatrophy; paresthesia, hypoesthesia, benign idiopathic intracranial HTN; hypothyroidism; arthralgia, myalgia, carpal tunnel syndrome, bone pain, rigidity, dislocation of femoral ephyphysis (very rare), edema (occasional in childn); insulin resistance.
Drug Interactions
Corticosteroids, gonadotropins, estrogens, androgens & anabolic agents, sex steroids, anticonvulsants & cyclosporins.
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
Saizen inj 3.33 mg
Packing/Price
(vial) 1's (Rp1,155,000/vial)
Form
Saizen inj (click-easy) 8 mg
Packing/Price
1's (Rp2,800,001/vial)
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