| Document Date: 2014-06-04 14:49:22 Open Document File Size: 475,87 KBShare Result on Facebook
City Reference / / Company Ipsen Biopharmaceuticals Inc. / / Event FDA Phase / / 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 / Anaphylaxis Allergic reactions / e.g. erythema / papilledema / visual changes / nausea / Anaphylaxis / alopecia / 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 / pruritus / Infections / systemic allergic reaction / ear tube insertion Hypoglycemia / Scoliosis / knee pain / skin and subcutaneous tissue disorders / hypotension / Nutrition Disorders / abnormal tympanometry Cardiac Disorders / malnutrition / local and systemic hypersensitivity / Mediastinal Disorders / osteonecrosis/avascular necrosis / 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 / fetal death / severe hypoglycemia / Connective Tissue Disorders / dizziness / deficiency / GH deficiency / rash / convulsions Gastrointestinal Disorders / syndrome / Disorders / 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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