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Hormone Replacement Therapy

SAIZEN

Saizen® [somatropin (rDNA origin) for injection] is therapeutically equivalent to the natural GH produced by the body, made by recombinant DNA technology. Saizen® is indicated for the treatment of Growth Hormone deficiency in children and adults, Turner’s syndrome, chronic renal failure.

Growth Hormone treatment of GH deficient (GHD) children with Saizen® leads to accelerated growth. The overall effect of GH therapy in GHD children who respond well is that, as adults, they will be taller than they would have been if left untreated.

The role of Growth Hormone in the human body: Growth Hormone (GH) is a protein produced by the pituitary gland, which is situated under the hypothalamus of the brain. This hormone controls children’s growth and regulates a number of metabolic and physiologic processes during the whole life. Saizen® works by replacing the Growth Hormone the body normally produces.

Adult Growth Hormone Deficiency at a glance
Growth deficiencies do not just affect children, they can be a significant problem for adults too. Until recently the effects of Growth Hormone Deficiency in adults were unknown. It is now recognized as a specific clinical syndrome with numerous physiological consequences, with effects on:

* Changes in body composition, including central obesity;
* Lipids in the blood;
* Muscle strength;
* Bone composition;
* Exercise capacity an energy;
* Cardiovascular risk; and
* Psychological well-being (social isolation and depression).

In addition, there are also studies indicating that patients with hypo-pituitarism have an increased risk of mortality from cardiovascular disease, possibly attributable to their GH deficiency.

GH deficiency in adults can result from a pituitary or peri-pituitary tumor or as a direct result of the surgery/radiation used to manage these conditions. Less commonly GH deficiency in adults arises from a deficiency acquired in childhood.

Adult Growth Hormone Deficiency (AGHD) can be effectively treated recombinant human Growth Hormone. In August 2001, Serono received approval for the use of Saizen® in the treatment of this condition in most European countries.

The Saizen® Device Family: Serono is committed to simplifying treatment with Growth Hormone. We have therefore developed a "family" of devices. This opportunity to choose the best solution for individual patients' needs aims to increase convenience and improve compliance with Growth Hormone treatment.

The Saizen® Device Family is composed of two injection devices: cool.click™ the advanced needle-free option and one.click™, the next generation auto injector for GH delivery. Both one.click™ and cool.click™ are for use with Saizen® 8 mg click.easy™. .

For additional product Information. or visit: www.serono.com

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