| Document Date: 2011-04-15 15:56:07
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City Reference / / Company Sandoz Inc. / / Country United States / / Currency pence / PEN / / Event Product Issues / / IndustryTerm injection site / Treatment of children with growth failure / treatment of pediatric patients who have growth failure / sterile somatropin solution / treatment of growth failure / somatropin product / 4.1 Acute Critical Illness Treatment / sterile solution / somatropin products / drug products / / MedicalCondition carpal tunnel syndrome / Intracranial Hypertension / intracranial tumor / Glucose Intolerance / pituitary disease / Neoplasms / congenital/genetic growth hormone deficiency / headaches / severe obesity / acute respiratory failure / arthralgia / carpal tunnel syndrome / undernutrition / headache / seizures / intracranial hemorrhage / nerve compression syndromes / papilledema / visual changes / nausea / Known hypersensitivity / Severe Non-Proliferative Diabetic Retinopathy / previously diagnosed hypoadrenalism / meningiomas / autoimmune thyroid disease / Acute Critical Illness / Prader-Willi Syndrome / Hypothyroidism Undiagnosed/untreated hypothyroidism / hypothalamic disease / obesity / bradycardia / CNS tumor / unidentified respiratory infection / Hypersensitivity / central nervous system depression / Hypopituitarism / latent central hypothyroidism / such tumors / Adult Growth Hormone Deficiency / second neoplasm / apnea and unidentified respiratory infection / brain tumors / Scoliosis / knee pain / upper airway obstruction / hypotension / Turner Syndrome / tumor / papilledema / second neoplasms / Diabetic Retinopathy / overt diabetes mellitus / nevi / tumors / disease / Neoplasm / arthralgia / Hypothyroidism / common hypersensitivity / Carcinogenesis / metabolic acidosis / extracranial tumors / pituitary tumor / childhood cancer / vomiting / organic disease / Intracranial tumors / systemic allergic reactions / sleep apnea / growth hormone deficiency / Diabetes Mellitus / Pancreatitis / allergic reactions / PraderWilli Syndrome / onset sleep apnea / Adult Patients Adult Growth Hormone Deficiency / respiratory infection / persistent severe abdominal pain / primary hypothyroidism / syndrome / Pediatric Growth Hormone Deficiency / hepatic and renal failure / / MedicalTreatment radiation therapy / surgery / radiation / abdominal surgery / open heart surgery / thyroid hormone replacement therapy / hormone replacement therapies / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position physician / head / Pediatric Patients General / / Product Bacteriostatic Water for Injection / OMNITROPE / secretion / short stature / / Technology radiation / antibodies / Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OMNITROPE® safely and effectively. See full prescribing information for OMNITROPE®. OMNITROPE® (somatropin [rDNA