COMPOSITION:
GENOTROPIN 16 IU
Each multidose cartridge with two compartments:
Part I: Hormone
Recombinant human somatotropin 5.3 mg (16 IU)
Glycine 2 mg
Mannitol 41 mg
Monosodium phosphate anhydrous 0.290 mg
Disodium phosphate anhydrous 0.280 mg
Part II: Solvent
m-Cresol 3.0 mg
Water for injection 1.0 mL
GENOTROPIN 36 IU
Each multidose cartridge with two compartments:
Part I: Hormone
Recombinant human somatotropin 12 mg (36 IU)
Glycine 2 mg
Mannitol 40 mg
Monosodium phosphate anhydrous 0.410 mg
Disodium phosphate anhydrous 0.400 mg
Part II: Solvent
m-Cresol 3.0 mg
Water for injection 1.0 mL
THERAPEUTIC ACTION:
ATC code: H01AC01.
Somatotropin is secreted by the pituitary gland. It acts by promoting human growth.
INDICATIONS:
In children:
GENOTROPIN is indicated for the treatment of pediatric patients who have insufficiency.
growth due to inadequate secretion of endogenous growth hormone.
GENOTROPIN is indicated for the treatment of pediatric patients with insufficiency.
growth due to Prader-Willi syndrome (PWS).
GENOTROPIN is indicated for the treatment of growth failure in young children.
born for gestational age (SGA) who have not shown recovery of growth at
age 2 years.
GENOTROPIN is indicated for the treatment of growth failure associated with
Turner syndrome.

PHARMACOLOGICAL PROPERTIES:
Pharmacological Action
In vitro, preclinical and clinical trials have shown that GENOTROPIN lyophilized powder is a
therapeutic equivalent to growth hormone of human pituitary origin and achieves profiles
similar pharmacokinetics in normal adults. In pediatric patients with deficiency of
growth hormone (DHC) or with Prader Willi Syndrome (PWS), treatment with GENOTROPIN
stimulates growth and can normalize plasma concentrations of IGF-I (Factor
Insulin/Somatomedin type growth C). In adults with GHD, treatment with GENOTROPIN
increases the proportion of lean body mass and reduces the proportion of fat mass, modifies the
metabolism with beneficial changes in lipid metabolism and normalizes
IGF-I concentrations. In addition, the following actions of GENOTROPIN have been demonstrated:
1- Tissue growth
A. Growth of the bone skeleton: GENOTROPIN stimulates bone growth in patients
pediatric patients with DHC or PWS. The growth measurable by the increase in height after
administering GENOTROPIN is the result of the effect on the epiphyses of the long bones. The
Serum concentrations of IGF-I, which have an action on bone growth, are generally
low in patients with GHD or PWS, but tend to increase during treatment with
GENOTROPIN. Increases in the mean concentration of alkaline phosphatase are also observed
serum.
B. Cell growth: It has been shown that, compared to the normal pediatric population,
There is a lower number of skeletal muscle cells in pediatric patients with low
height due to deficiency in the secretion of endogenous growth hormone. The treatment with
Somatotropin produces an increase in both the number and size of muscle cells.

STABILITY AND STORAGE:
Except as indicated below, it will be stored refrigerated, at a temperature of 2º to 8º C. No
freeze. Avoid direct light.
After reconstitution, cartridges can be stored, refrigerated at a temperature of
2º to 8º C, up to 28 days.