Posology : מינונים

4.2    Posology and method of administration

The dosage and administration schedule should be individualized.
The injection should be given subcutaneously and the site varied to prevent lipoatrophy.




•         Growth disturbance due to insufficient secretion of Growth hormone in children: Generally a dose of 0.025- 0.035 mg/kg body weight per day or 0.7-1.0 mg/m2 body surface area per day is recommended.
•         Prader Willi Syndrome, for improvement of growth and body composition in children: Generally a dose of 0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day is recommended. Daily doses of 2.7mg should not be exceeded. Treatment should not be used in children with growth velocity less than 1cm per year and near closure of epiphyses.
•         Growth disturbance due to Turner syndrome: A dose of 0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day is recommended.
Growth disturbance in chronic renal insufficiency: A dose of 1.4 mg/m2 body surface area per day (0.045-0.050 mg/kg body weight per day) is recommended. Higher doses may be needed if growth velocity is too low. A dose correction may be needed after six months of treatment. Factor (IGF-I)) in serum should be used as guidance for dose titration. The minimum effective dose should be used and dose requirements may decline with increasing age.
•         In growth disturbances in short children born SGA is usually a dose of 0.035mg/kg body weight per day (1mg/m2 body surface area per day) is recommended, until final height is reached (see Pharmacodynamic properties section). Treatment should be discontinued after 1 year if the height velocity SDS is below +1. The treatment should be discontinued if height velocity is < 2 cm/year and, if confirmation is required, bone age > 14 years (girls) or > 16 years (boys), corresponding to the closure of the epiphyseal growth plates.

Dosage Recommendations:
The dosage and administration schedule should be individualized. Somatropin should be given subcutaneously and the injection site varied to prevent lipoatrophy.



Daily Dose mg/kg       IU/kg         mg/m²              IU/m² body
Indication                        body        body          body               surface weight      weight        surface            area area
Growth hormone                  0.025 –       0.07 - 0.10   0.7 - 1.0          2.1 - 3.0 deficiency                      0.035
Turner syndrome                 0.045 –       0.14            1.4              4.3 0.050
Chronic renal                   0.045 -       0.14            1.4              4.3 insufficiency                   0.050

Prader-Willi                    0.035         0.10            1.0              3.0 syndrome
Small for gestational           0.035 –       0.10 – 0.20     1.0 – 2.0        3.0 - 6.0 age                             0.067



•        Growth hormone deficient adult patients: Therapy should start with a low dose, 0.15-0.3mg (0.45 to 0.90 IU) per day. The final dose should be gradually increased according to individual patient requirements as determined by the IGF-I concentration with respect to age and gender. Treatment goal should be insulin-like growth factor (IGF- 1) concentrations within 2 SDS from the age corrected mean. Patients with normal IGF-I concentrations at the start of the treatment should be administered growth hormone up to an IGF-I level into upper range of normal, not exceeding the 2 SDS. Clinical response and side effects may be used as guidance for dose titration.
The daily maintenance dose seldom exceeds 1.3 mg (4 IU) per day. Women may require higher doses than men, with men showing an increasing IGF-I sensitivity over time. This means that there is a risk that women, especially those on oral oestrogen replacement are under-treated while men are over-treated. The accuracy of the growth hormone dose should therefore be controlled every 6 months. As normal physiological growth hormone production decreased with age, dose requirements may be reduced. Clinical response, side effects, and determination of IGF-I in serum may be used as guidance for dose titration. The minimum effective dose should be used.