The ampoule bottle with lyophilised powder contains:
Somatropin .........1.33 mg
equivalent to ......... 4 IU
Excipient ......... s.q.
The small ampoule of diluting agent contains: 0.9% sodium chloride solution .........1 ml

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

Store in the refrigerator at 2ºC to 8ºC. Do not freeze.
Do not use if the seal has been broken.
Do not use after the expiry date.
Once the mixture has been made, the product can be stored in the refrigerator at 2ºC - 8ºC.

Presentation:

Box with 1 ampoule bottle with lyophilised powder, 1.33 mg equivalent to 4 IU, and 1 small ampoule with 1 ml of diluting agent.

Keep out of children's reach.

Do not use if you are pregnant or breast-feeding.

Sold by medical prescription only.