what is Dynatrope somatropina 4iu x 25 vials?
Active ingredient: Somatotropin 4 IU (1,33 mg) / 10 IU (3,33 mg) Dynatrope somatropina 4iu x 25 vials
16 IU (5,33 mg) / 20 IU (6,67 mg)
Inactive ingredients: mannitol, glycine, sodium dihydrogen phosphate, sodium chloride.
Solvent: water for injections.
Growth inhibition due to insufficient secretion of growth hormone, gonadal digenesis (Turner’s syndrome), chronic renal insufficiency in prepubertal period.
Replacement therapy in adults with confirmed inheritable or nonheritable growth hormone deficiency.
DOSAGE AND ADMINISTRATION OF Dynatrope somatropina 4iu x 25 vials
Dynatrope somatropina 4iu x 25 vials is injected subcutaneously, slowly, 1 time a day, usually before going to bed. To prevent lipoatrophy, sites of injections should be changed.
Vial content need to be dissolved in 1 ml of enclosed solvent, on the basis of calculated dose. In this purpose the solvent is taken to the syringe and brought into the vial with lyophilizate through the stopper. Carefully shake until content of vial is fully dissolved. Sharp shaking is impermissible. Ready solution can be stored during two weeks at temperature of 2-8 degrees Celsius.
The dosage is individual, based on level of growth hormone deficiency, body weight or body surface area and efficiency of treatment.
In children with growth hormone deficiency recommended dose is 25-35 µg/kg/day, which is equivalent to 0,7-1 mg/m2/day (2-3 IU/m2/day). Treatment must be initiated as early as possible in the younger age and continued until sexual maturation begins or until bones growth plates close. Treatment may be finished when desirable result obtained.
Turner’s syndrome, chronic kidney disease in children, which is accompanied with growth inhibition: recommended dose is 50µg/kg/day, which is equivalent to 1,4 mg/m2/day (4,3 IU/m2/day). Insufficient growth dynamics may require dose correction.
Growth hormone deficiency in adult: initial dose is 0,15-0,3mg/day (which is equivalent to 0,45-0,9 IU/day) with following increase, depending on result obtained. Level of insulin-like growth factor I (IGF-1) in serum may be used as control value for dose titration. Maintaining dose is individual, but it is not higher than, generally, 1 mg/day, which is equivalent to 3 IU/day. Lower dosages are recommended for use in elderly.
Lyophilizate for solution for subcutaneous injections 4 IU, 10 IU.
Lyophilizate: 4 IU and 10 IU in glass vial.
Solvent: 1 ml in ampoule of neutral glass.
25 vials with lyophilizate c/w 10 ampoules with solvent in cardboard pack with application data sheet.
Store in shadowed place at temperature from 2 to 8 degrees Celsius.
Do not freeze.
Reconstituted solution may be kept during 2 weeks at temperature from 2 to 8 degrees Celsius.
Keep out of reach of children.