| Document Date: 2011-03-04 08:08:08
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City Reference / / IndustryTerm injection site / treatment of growth failure / serous otitis media / sterile solution / otitis media / adequate food intake / treatment of / MedicalCondition Intracranial Hypertension Intracranial hypertension / Intracranial Hypertension / hypoglycemia General Disorders / Known Hypersensitivity INCRELEX / Lymphatic System Disorders / headache / obstructive sleep apnea / seizures / chronic middle-ear effusions / hypoglycemic seizures / Thyroid and nutritional deficiencies / ear and labyrinth disorders / intracranial hemorrhage / hives / acromegaly / Anaphylaxis Allergic reactions / papilledema / visual changes / nausea / pruritis / Anaphylaxis / cardiomegaly / Known Hypersensitivity / Local allergic reactions / severe hypersensitivity / Symptomatic hypoglycemia / bradycardia / tonsillar hypertrophy Nervous System Disorders / Hypersensitivity / central nervous system depression / Systemic hypersensitivity / hypoacusis / otitis media / hypoglycemia / Infections / systemic allergic reaction / ear tube insertion Hypoglycemia / Scoliosis / knee pain / hypotension / Nutrition Disorders / malnutrition / abnormal tympanometry Cardiac Disorders / local and systemic hypersensitivity / Mediastinal Disorders / subjects reporting hypoglycemia / disease / arthralgia / hypothyroidism / dyspnea / angioedema / dyspnea In / chronic treatment / metabolic acidosis / Carcinogenesis / ear pain / vomiting / pain / sleep apnea / urticaria / angioedema / Allergic Reactions / severe hypoglycemia / Connective Tissue Disorders / dizziness / deficiency / GH deficiency / convulsions Gastrointestinal Disorders / syndrome / hepatic and renal failure / / Organization Intravenous Administration Intravenous administration / Intravenous Administration / DOSAGE AND ADMINISTRATION / FDA / / / Position General / / Product INCRELEX / / Technology antibodies / ultrasound / 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 INCRELEX® safely and effectively. See full prescribing information for INCRELEX®. INCRELEX® (mecasermin [rDNA ori