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Norditropin(R) Approved for Treatment of Children with Short Stature Associated with Turner Syndrome
Date:9/21/2007

lowing two criteria:

1) Adult Onset: Patients who have GHD, either alone or associated with

multiple 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 as a result of congenital, genetic, acquired, or idiopathic

causes.

In general, confirmation of the diagnosis of adult GHD in both groups usually requires an appropriate growth hormone stimulation test.

Important Safety Information

Somatropin should not be used for growth promotion in pediatric patients with closed epiphyses or in patients with active proliferative or severe non- proliferative diabetic retinopathy. Norditropin should not be used in patients with known hypersensitivity to somatropin or any of its excipients.

Somatropin should not be used or should be discontinued with any evidence of active malignancy. Patients with preexisting malignancy should be monitored carefully for any progression or reoccurrence.

Somatropin should not be used to treat patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure as increased mortality may occur.

Deaths have been reported in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment and are treated with somatropin. Unless patients with Prader-Willi syndrome also have a diagnosis of GHD, Norditropin is not indicated for the treatment of patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

Blood glucose levels should be monitored periodically as treatment with somatropin may decrease insulin sensitivity. Patients with preexisting diabetes or glucose intolerance should be monitored closely during somatropin therapy. Doses of insulin or oral
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SOURCE Novo Nordisk
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