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GENOTROPIN 12 mg powder for injection with solvent.

Two chamber cartridge, for use in a Pfizer injection device (GENOTROPIN Pen) or sealed in
a disposable pre-filled Genotropin pen Pfizer 12mg GoQuick. The cartridge contains 5 mg
somatropin, glycine, sodium dihydrogen phosphate anhydrous, disodium phosphate
anhydrous, water for injection, m-cresol, mannitol.
GENOTROPIN 5.3 mg powder for injection with solvent.
Two-chamber cartridge, for use in a Pfizer injection device (GENOTROPIN Pen) or sealed in
a disposable pre-filled Genotropin pen Pfizer 12mg GoQuick. The cartridge contains 5.3 mg
somatropin glycine, sodium dihydrogen phosphate anhydrous, disodium phosphate
anhydrous, water for injection, m-cresol, mannitol.
GENOTROPIN 12 mg powder for injection with solvent.
Two-chamber cartridge, for use in a Pfizer injection device (GENOTROPIN Pen) or sealed in
a disposable pre-filled Genotropin pen Pfizer 12mg GoQuick. The cartridge contains 12 mg
somatropin, glycine, sodium dihydrogen phosphate anhydrous, disodium phosphate
anhydrous, water for injection, m-cresol, mannitol.
USES
Actions
Genotropin pen Pfizer 12mg (36iu) – Somatropin is a potent metabolic hormone of importance for the metabolism of lipids, carbohydrates and proteins. In children with inadequate endogenous growth hormone and in
children with Prader-Willi syndrome, somatropin stimulates linear growth and increases
growth rate. In adults, as well as in children, somatropin maintains a normal body
composition by increasing nitrogen retention and stimulation of skeletal muscle growth, and
by mobilisation of body fat. Visceral adipose tissue is particularly responsive to somatropin.
In addition to enhanced lipolysis, somatropin decreases the uptake of triglycerides into body
fat stores. Serum concentrations of IGF-I (Insulin-like Growth Factor-I), and IGFBP3
(Insulin-like Growth Factor Binding Protein 3) are increased by somatropin. In addition, the
following actions have been demonstrated:

– Lipid metabolism: Somatropin induces hepatic LDL cholesterol receptors, and affects the
profile of serum lipids and lipoproteins. In general, administration of somatropin to growth
hormone deficient patients results in reductions in serum LDL and apolipoprotein B. A
reduction in serum total cholesterol may also be observed.
– Carbohydrate metabolism: Somatropin increases insulin but fasting blood glucose is
commonly unchanged. Children with hypopituitarism may experience fasting
hypoglycaemia. This condition is reversed by somatropin.
– Water and mineral metabolism: Growth hormone deficiency is associated with decreased
plasma and extracellular volumes. Both are rapidly increased after treatment with
somatropin. Somatropin induces the retention of sodium, potassium and phosphorus.
– Bone metabolism: Somatropin stimulates the turnover of skeletal bone. Long-term
administration of somatropin to growth hormone deficient patients with osteopenia results in
an increase in bone mineral content and density at weight-bearing sites.
– Physical capacity: Muscle strength and physical exercise capacity are improved after longterm
treatment with somatropin. Somatropin also increases cardiac output, but the
mechanism has yet to be clarified. A decrease in peripheral vascular resistance may
contribute to this effect.
– GENOTROPIN improves energy, vitality, memory functions and subjective well-being.
Pharmacokinetics
Absorption
The bioavailability of subcutaneously administered GENOTROPIN is approximately 80% in
both healthy subjects and growth hormone deficient patients. A subcutaneous dose of
0.035 mg/kg of GENOTROPIN results in plasma Cmax and tmax values in the range of 13-
35 ng/ml and 3-6 hours respectively.
Elimination
The mean terminal half-life of GENOTROPIN after intravenous administration in growth
hormone deficient adults is about 0.4 hours. However, after subcutaneous administration,
half-lives of 2-3 hours are achieved. The observed difference is likely due to slow absorption
from the injection site following subcutaneous administration.
Sub-populations
The absolute bioavailability of GENOTROPIN seems to be similar in males and females
following s.c. administration.
Information about the pharmacokinetics of GENOTROPIN in geriatric and paediatric
populations, in different races and in patients with renal, hepatic or cardiac insufficiency is
either lacking or incomplete.

CONTRAINDICATIONS
GENOTROPIN should not be used when there is any evidence of tumour activity and antitumour
therapy must be completed prior to starting therapy.
GENOTROPIN should not be used for growth promotion in children with closed epiphyses.
Patients with acute critical illness suffering complications following open heart surgery,
abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions
should not be treated with GENOTROPIN. (Regarding patients undergoing substitution
therapy, see Warnings and Precautions).
GENOTROPIN is contraindicated in patients with Prader-Willi syndrome who are severely
obese or have severe respiratory impairment (see Warnings and Precautions).
Hypersensitivity to the active substance or to any of the excipients.
WARNINGS AND PRECAUTIONS
Diagnosis and therapy with GENOTROPIN should be initiated and monitored by physicians
who are appropriately qualified and experienced in the diagnosis and management of patients
with growth disturbance.
There have been reports of fatalities associated with the use of growth hormone in paediatric
patients with Prader-Willi syndrome who had one or more of the following risk factors:
severe obesity, history of respiratory impairment or sleep apnoea, or unidentified respiratory
infection. Another possible risk factor may be male gender. Patients with Prader-Willi
syndrome should be evaluated for upper airway obstruction before initiation of treatment with.