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GENOTROPIN (somatropin [rDNA origin] for injection) Contraindications

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Contraindications

GENOTROPIN (somatropin for injection) should not be used when there is any evidence of neoplastic activity.  Intracranial lesions must be inactive and antitumour therapy complete prior to the institution of therapy.  GENOTROPIN should be discontinued if there is evidence of tumour growth.

Growth hormone should not be used for growth promotion in children with fused epiphyses. 

Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.

GENOTROPIN is contraindicated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure. (see WARNINGS AND PRECAUTIONS).

GENOTROPIN is contraindicated in patients with a history of hypersensitivity to any of its components.

GENOTROPIN is contraindicated in patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. There have been reports of sudden death when somatropin was used in such patients. GENOTROPIN is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.  (see SERIOUS WARNINGS AND PRECAUTIONS).

Certain formulations of growth hormones contain metacresol as a preservative. These formulations should not be used by patients with a known sensitivity to these preservatives (see WARNINGS AND PRECAUTIONS, General).

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