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Norditropin ®

Norditropin ® Somatropin (rDNA origin) for subcutaneous injection

Norditropin ® is the Novo Nordisk A/S registered trademark for somatropin, a polypeptide hormone of recombinant DNA origin. The hormone is synthesized by a special strain of E.coli bacteria that has been modified by the addition of a plasmid which carries the gene for human growth hormone. Norditropin ® contains the identical sequence of 191 amino acids constituting the naturally occurring pituitary human growth hormone with a molecular weight of about 22,000 Daltons.

Norditropin ® is a sterile, almost white, lyophilized powder. It is a highly purified preparation intended for subcutaneous injection in the thighs after reconstitution with 2 mL diluent.

Indications and Usage
Norditropin ® is indicated for:

• Pediatric Patients (Children):
  • Long-term treatment of children who have growth failure due to inadequate secretion of endogenous growth hormone (GH).
• Adults Patients:
  • Replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:
    • 1. Adult Onset: Patients who have growth hormone deficiency, either alone or associated withmultiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma

    OR

    • 2. Childhood Onset: Patients who were growth hormone deficient during childhood should havegrowth hormone deficiency confirmed as an adult before replacement therapy with Norditropinis started.

In both of these patient populations, growth hormone deficiency should be confirmed by anappropriate growth hormone stimulation test.

Norditropin ® - somatropin (rDNA origin) for subcutaneous injection - made by Novo Nordisk A/S. For more information visit www.norditropin-us.com/

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