Somatropin treatment of children who have a growth failure due to lack of endogenous growth hormone secretion

Somatropin 41U SEDICO (B.P)
Somatropin (rDNA origin) for injection

Composition :

Each vial contains:
Recombinant human growth hormone 1.6 mg

Properties :

Recombinant human growth hormone (rhGH), a polypeptide with a sequence of 191 amino acid residues and a molecular weight of about 22,125 D. The amino acid sequence of (rhGH) is identical to that of naturally occurring pituitary gland hormone

Clinical Pharmacology :

Recombinant human growth hormone (rhGHj-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 from an E-coli protein. (rhGH) is therapeutically
equivalentto pituitary-derived human growth hormone in clinical testing.

Indications :

Conventional indications:
– Long-term treatment of children who have a growth failure due to lack of endogenous growth hormone secretion, ,
– Treatment of children who have growth failure associated with chronic renal insufficiency up to the time of renal transplantation= ”
– Patients suffering from Turner’s syndrome (Gonadal dysgenesis).
– Patients suffering from Prader – Willi syndrome (PWS).
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.

Contra – indications :

– Pregnancy.
-After renal transplantation.
– Children with closed epiphyses.

Precautions :

Prior to the administration, a competent medical expert is needed for intensive quidance:
– For diabetic patients, the dose of antihyperglycemic 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 a history of scoliosis and malignant diseases.
– Patients with growth failure secondary to chronic renal insufficiency.
– Patients with turner’s syndrome should be evaluated for otitis media and other ear disorders.
Relative deficiencies of other pituitary hormones:
– Untreated hypothyroidism: Hypothyroidism may interfere with the response to somatropin 4 IU injection a state of hypothyroidism may develop during treatment with somatropin 4 IU, so patients should have periodic thyroid gland tests & treated with thyroid hormone when indicated.
– Patients with co-existing ACTH deficiency: Adjust dose of glucocorticoid to avoid the inhibitory effect on growth.

Dosage &Administration :

– For Somatropin injection, S.C route of administration is preferable & I.M injection is acceptable but it must not be injected l.V.
– The weekly dose should be divided into 6 or 7 subcutaneous injections.
– Pediatric growth hormone deficiency Patients: Generally, a dose of 0.16 to 0.24 mg I kg body weight! week is recommended.
– Pediatric PWS Patients: Generally, a dose of 0.24 mg I kg body weight I week is recommended.
– Pediatric Turner’s syndrome: A week dosage up to 0.375 mg I kg of body weight.
– Adult growth hormone deficiency Patients: The recommended dosage at the start of therapy is not more than 0.04 mg I kg I week. The dose may be increased at 4- to 8- week intervals to a maximum of O.OS mg I kg I week.

Warning :

When administering somatropin to newborns, don’t reconstitute with accompanied diluent, reconstitute with sterile water for injection and reject remaining solution after injection.

Duration of administration :

Therapy should be initiated before the onset of puberty and 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 and or mild transient edema have been sometimes reported in early stages following administration, but occurrence rate decreases as the therapy continues.
– Musculoskeletal arthralgia.
– Gynecomastia.

Side effects :

Side effects during therapy with Somatropin 4 IU SEDICO Injection were not observed.

Drug interactions :

Patients with coexisting ACTH deficiency should have their glucocorticoid replacement dose carefully adjusted to avoid an inhibitory effect on growth.

Instructions for use I Handling :

Somatropin 41U SEDICO Injection should be reconstituted prior to use with 1 – 2 ml of accompanied diluent. The diluent 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 is completely dissolved.
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 41U SEDICO injection is stable for 2 years when stored in refrigerator (at2-S0C) .
After reconstitution:
Somatropin 4 IU SEDICO Injection reconstituted with accompanied diluent, is stable for 14 days when stored in refrigerator (at 2- S °c ) .

Package :

Box of one vial containing lyophilized powder + Diluent (2ml bacteriostatic water for injection containing benzyl Alcohol as preservative 0.9%).

Produced by :

SEDICO Pharmaceutical Co.
6 October City – Egypt