| Composition: |
|
Each vial
contains:
Recombinant human growth
hormone..................... 4 I.U
|
 |
| Properties: |
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. |
| Indications: |
Conventional
indications:
►Long term
treatment of children who have growth
failure due to lack of endogenous growth
hormone.
►Treatment of
children who have growth failure associated
with chronic renal insufficiency up to the
time of renal transplantation.
►Patients
suffering from Turners syndrome (Gonadal
digenesis). |
| Clinical
pharmacology: |
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
testing.
|
| Contraindications: |
►Pregnancy
►Cancer
►After renal
transplantation
►Children wit
closed epiphyses.
|
| Unconventional indications: |
►Aging
supplement and in the management of cachexia
secondary to some chronic diseases.
►Also in
restoration of positive nitrogen-balance due
to burns, surgery, etc.
|
| Precautions: |
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. Patients 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 (rhGH).- Dose
selection for elderly patients, impaired
hepatic and renal function patients.
Patients with premature epiphyseal closure.
(Epiphysis disorders). Patients with history
of scoliosis and malignant diseases.-
Patients with growth failure secondary to
chronic renal insufficiency 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.- Adjustment of
glucocorticoid 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.- For subcutaneous
injections: 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.- For other
applications please consult your medical
expert.
|
| 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.
|
| Adverse
reactions: |
Discomfort at
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.-
Gynecomastia.
|
| Drug
interaction: |
Patients with
coexisting ACTH deficiency should have their
glucocorticoid replacement dose carefully
adjusted to avoid an inhibitory effect on
growth.
|
| Side
effects: |
| 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
completely dissolves.
Don't shake! The prepared solution should be
clear, without sediments. If the solution is turbid, the content should
not be injected.
|
| Storage Conditions: |
Before
reconstitution:
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).
After reconstitution:
Reconstituted Somatropin 4.0 I.U Sedico
injection in vials or ampoules should be
used at once, the solution is stable for 24
hrs if kept at temperatures of 2-8°C, also
avoid freezing, and protect from direct
sunlight.
|
| Package: |
Box of one vial containing lyophilized
powder plus one vial of solvent (WFI).
|
|
Disease diagnosis and treatment (Text,
PowerPoint) |
