Active Ingredient: Somatropin
Growth disturbance [current height standard deviation score (SDS) < -2.5 and parental adjusted height SDS < -1] in short children born small for gestational age (SGA), with a birth weight and/or length below -2 SD, who failed to show catch-up growth [height velocity (HV) SDS < 0 during the last year] by 4 years of age or later.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous
1 - 1 mg per m² of body surface area (BSA)
From 1 To 1 mg per m² of body surface area (BSA) once every day
A dose of 1 mg/m² body surface area per day is usually recommended until final height is reached. Treatment should be discontinued after the first year of treatment if the height velocity SDS is below +1. Treatment should be discontinued if height velocity is <2 cm/year and, if confirmation is required, bone age is >14 years (girls) or >16 years (boys), corresponding to closure of the epiphyseal growth plates.
The injection should be given subcutaneously and the site varied to prevent lipoatrophy.
For:
Subcutaneous
35 ug per kg of body weight
35 ug per kg of body weight once every day
A dose of 0.035 mg/kg body weight per day is usually recommended until final height is reached. Treatment should be discontinued after the first year of treatment if the height velocity SDS is below +1. Treatment should be discontinued if height velocity is <2 cm/year and, if confirmation is required, bone age is >14 years (girls) or >16 years (boys), corresponding to closure of the epiphyseal growth plates.
The injection should be given subcutaneously and the site varied to prevent lipoatrophy.
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