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 with closed epiphysis.

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 co-existing 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).