Each vial contains:
Recombinant human growth
hormone ..................... 4 I.U
Recombinant human growth hormone (rhGH), is a
polypeptide with a sequence of 191 Amino
Acid residues and a molecular weight of
about 22, 125D.
The amino acid sequence of (rhGH) is
identical to that of the naturally occurring
pituitary gland hormone.
► Long term
treatment of children who have growth
failure due to lack of endogenous growth
► Treatment of
children who have growth failure associated
with chronic renal insufficiency up to the
time of renal transplantation.
suffering from Turners syndrome (Gonadal
Recombinant human growth hormone (rhGH), is a protein
synthesized by specific laboratory strain of
E.Coli bacteria as a precursor, consisting
of the (rhGH) molecule preceded by the
secretion signal an E.Coli protein. (rhGH),
is therapeutically equivalent to pituitary
derived human growth hormone in clinical
► After renal transplantation
► Children with closed epiphysis.
supplement and in the management of cachexia
secondary to some chronic diseases.
► Also in
restoration of positive nitrogen-balance due
to burns, surgery, etc.
Prior to administration, a competent medical expert
is needed for intensive guidance:-
► For diabetic patients:
The dose of
anti-hyperglycemic medications may need to
be adjusted regularly.
with growth hormone deficiency secondary to
an intracranial neoplasia or lesion:
should be examined frequently for
progression or recurrence of the underlying
lesion, so as to ensure inactive lesions
before the initiation of therapy with
selection for elderly patients, impaired
hepatic and renal function patients.
► Patients with premature epiphyseal closure.
► Patients with history
of scoliosis and malignant diseases.
with growth failure secondary to chronic
► Patients with Turners syndrome:
should be evaluated for
Otitis media and other Relative deficiencies
of other pituitary hormones.
► Untreated hypothyroidism:
Hypothyroidism may interfere
with the response to Somatropin 4.0 I.U
injection a state of hypothyroidism may
develop during treatment with Somatropin 4.0
I.U, so patients should have periodic
thyroid gland tests and treated with thyroid
hormone when indicated.
► Patients with
co-existing ACTH deficiency:
gluco-corticoid therapy to avoid the
inhibitory effect on growth.
Dosage and administration:
The dose should be
individualized, expressed in units 1 mg
Somatropin= 3.0 I.U.
- 0.1- 0.2 I.U/kg body weight, 6-7
times a week, or 2-3 I.U/m2 body surface
area 3 times a week.
- 0.2- 0.24 I.U/kg body weight, 3
times a week
- or 4-6 I.U/m2 body
surface area 3 times a week.
applications please consult your medical
Duration of administration:
Therapy should be initiated before the onset of puberty &
children should be treated before epiphyseal
closure or the patient has not reached the
satisfactory adult height.
the site of injection &/ or mild transient
edema have been sometimes reported in early
stages following administration, but
occurrence rates decreases as the therapy
continues. Musculoskeletal arthralgia.
Patients with co-existing ACTH deficiency should have their
glucocorticoid replacement dose carefully
adjusted to avoid an inhibitory effect on
Side effects during therapy with Somatropin 4.0 I.U
SEDICO injection were not observed.
Instructions for use/ Handling:
Somatropin 4.0 I.U injection should be
reconstituted prior to use with 1 ml of
sterile water for injection. The water
should be injected into the vial by aiming
the stream of liquid against the glass wall.
The vial should be swirled with a gentle
rotatory movement until the content
Don't shake! The prepared solution
should be clear, without sediments. If the
solution is turbid, the content should not
Somatropin 4.0 I.U SEDICO injection in vials
or ampoules is stable for 2 years when
stored at temperatures of 2-8°C
(refrigerated in a dark place).
Reconstituted Somatropin 4.0 I.U SEDICO
injection in vials or ampoules should be
used at once, the solution is stable for 14
days if kept at temperatures of 2-8°C, also
avoid freezing, and protect from direct
Disease diagnosis and treatment (Text, PowerPoint)
Box of one vial containing lyophilized
powder plus one vial of solvent (WFI).