SAIZEN®
Saizen® is approved for the treatment of children with growth failure due to inadequate production
of growth hormone by the body.
Saizen is also approved for use in adults whohave growth hormone deficiency.
About growth hormone deficiency Growth hormone deficiency occurs when the pituitary gland in the brain is unable to produce enough growth hormone.
In children, growth hormone deficiency causes slow growth, and without treatment, few will
reach their full height potential.
Tissue growth
Skeletal growth
Cell growth (especially muscle growth)
Organ growth
Metabolism
Protein metabolism
Carbohydrate metabolism
Lipid metabolism
Mineral metabolism
Connective tissue and bone metabolism
Saizen usage should be performed under the regular guidance of a physician who is experienced in the diagnosis and management of growth disorders.
Properties:
The main active ingredient of Saizen ® is Somatropin, a biosynthetic human growth hormone produced from mammal cells through genetic engineering. It contains 191 amino acids, in identical sequence to that of the natural hypophysiary hormone. Saizen ® brings about an increase in the average growth rate by means of Somamedins or growth factors similar to insulin.
Contraindications:
Individual hypersensitivity to the active component in the product. Diabetes mellitus must be considered as a relative contraindication. In subjects suffering from diabetes mellitus, treatment should be carried out under strict medical and laboratory supervision. Saizen ® must not be used when there are progression data of a concomitant cerebral tumour.
Adverse side effects
Pharmacokinetic and toxicological studies carried out with Saizen ® and pit-hGH have confirmed that the safety of the recombinant product is similar to that of the natural growth hormone, with no side effects produced by the drug itself. However, treatment with human proteins can cause reactions as a result of hypersensitivity (such as redness and itchiness in the area of the injection site), the formation of antibodies with or without the attenuating effect of growth, or both.
In a small number of patients, where short stature is due to a genetic defect (depletion of the gene complex for hGH), Somatropin treatment can stimulate the production of antibodies which attenuate growth in the majority of cases.
Precautions:
Treatment must be carried out under strict periodic medical supervision. Patients with a deficiency of the growth hormone secondary to an intracraneal lesion should be examined frequently in order to follow the progression or recurrence of the underlying pathological process. Administering Saizen ® subcutaneously in the same site over a prolonged period of time may cause lipoatrophy. This can be prevented if the injection site is changed each time.
Drug interactions:
Concomitant therapy with corticoids may inhibit the growth promoting effect of Somatropin.
Directions for use:
Saizen ® can be administered intramuscularly or subcutaneously, preferably at bedtime. The contents of one ampoule bottle must be reconstituted with the diluting agent, by inserting the liquid into the ampoule bottle and gently shaking it until it is completely dissolved. Do not shake it vigorously, as this can cause a slight darkening of the solution.
Administration method:
Saizen ® can be administered intramuscularly or subcutaneously, preferably at bedtime. The dosage and method for administering Saizen ® must be adapted to the needs of each patient.
Dosage: Follow your doctor's instructions
