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City Reference / / Company Metabolized Drugs Limited / Ames / Pfizer Inc. / / Currency pence / / Event FDA Phase / Product Issues / / Facility Laboratory Tests Serum / / IndustryTerm Treatment of children with growth failure / treatment of pediatric patients who have growth failure / treatment of growth failure / subcutaneous injection site / reconstituted recombinant somatropin solution / syringe device / breakdown products / / MedicalCondition carpal tunnel syndrome / Intracranial Hypertension / Glucose intolerance / pituitary disease / Neoplasms / headaches / arthralgia / carpal tunnel syndrome / otitis / undernutrition / headache / thyroid disease / nerve compression syndromes / acromegaly / urinary tract infection / pigmented nevi / nausea / both hypoadrenalism / Pediatric Patients Otitis Media / Known hypersensitivity / Severe Non-Proliferative Diabetic Retinopathy / previously diagnosed hypoadrenalism / meningiomas / Acute Critical Illness / Prader-Willi syndrome / respiratory tract infections / hypothalamic disease / gigantism / obesity / hypoesthesia / hearing disorders / Hypersensitivity / Hypopituitarism / Type 2 diabetes mellitus / fasting hypoglycemia / sinusitis / Otitis Media / Illness / Adult Growth Hormone Deficiency / second neoplasm / hypoglycemia / influenza / Scoliosis / knee pain / brain tumors / hepatic insufficiency / gynecomastia / upper airway obstruction / precocious puberty / Turner syndrome / Leukemia / tumor / abdominal pain / papilledema / second neoplasms / diabetes mellitus requiring drug therapy / Diabetic Retinopathy / fetal deaths / Cardiovascular Disorders / hypertension / cancer / airway obstruction / nevi / tumors / disease / respiratory failure / Neoplasm / arthralgia / nasopharyngitis / gastroenteritis / Hypothyroidism / hematuria / Carcinogenesis / hyperglycemia / aortic aneurysm / stroke / hormone deficiency / pituitary tumor / childhood cancer / vomiting / hypoadrenalism / benign intracranial hypertension / sleep apnea / growth hormone deficiency / Diabetes Mellitus / Pancreatitis / allergic reactions / tonsillitis / intracranial neoplasm / respiratory infection / inflammation / persistent severe abdominal pain / rash / joint pain / paresthesia / untreated GH deficiency / disorders / fibrosis / / MedicalTreatment radiation therapy / hormone therapy / surgery / radiation / abdominal surgery / open heart surgery / thyroid hormone replacement therapy / estrogen replacement / drug therapy / hormone replacement therapies / / Organization DOSAGE AND ADMINISTRATION / FDA / / Person Pediatric Dosing / / / Position physician / General / head / Fisher / / Product SC / cyclosporine / mannitol / cortisone acetate / SC injection / glycine / Genotropin / prednisone / secretion / short stature / CYP450 / P450 / / ProvinceOrState South Dakota / South Carolina / / Technology radiation / antibodies / Pharmacokinetics / Pharmacodynamics / recombinant DNA / / URL www.fda.gov/medwatch / / SocialTag 
• Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy (4.4) • Children with closed epiphyses (4.5) • Known hypersensitivity to somatropin or m-cresol (4.6)