View Document Preview and Link Document Date: 2005-11-17 09:59:16 Open Document File Size: 165,64 KB Share Result on Facebook
City Kalamazoo / / Company IgG / Concur / Upjohn Company / Pharmacia / All / / Country United States / / IndustryTerm irinotecan products / pediatric oncology protocol / / MedicalCondition previously untreated rhabdomyosarcoma / Post-Marketing Experience Hypersensitivity / severe hypokalemia / fibrosis Paraneoplastic meningoencephalitis Hives Neutropenia / facial paresis / WARNINGS Hypersensitivity Hypersensitivity / fever N / hives / Kalifa G. Paraneoplastic encephalomyelitis / convulsion / nausea / thrombocytopenia / neuroblastoma / depressed level of consciousness / pulmonary fibrosis / hyponatremia / malignant neoplasm / fatigue / paraneoplastic encephalomyelitis / hemiparesis / lymphadenitis / venous congestion / pulmonary embolism / demyelination / Diarrhea / hypersensitivity / constipation / Wilms’ tumor / recurrent disease / sepsis / hypotension / tumor / abdominal pain / pneumonia / Cancer / Third nerve paralysis / disease / Resultant paraneoplastic encephalitis / dyspnea / relapsed undifferentiated sarcoma / shortness of breath / paraneoplastic meningoencephalitis / brain edema / neutropenic fever / Required intervention Treatment indication Wilms’ tumor Neuroblastoma Undifferentiated sarcoma Astrocytoma Adverse event Pulmonary / progressive disease / neutropenia / pulmonary injury / thromboembolism / fever / vomiting / active tumor / urticaria / focal seizures / hypotonia / infection / fungal infection / refractory solid tumors / paraneoplastic encephalitis / diplopia / refractory astrocytoma / anemia / neuroblastoma and small cell lung cancer / fibrosis / dehydration / / MedicalTreatment radiation therapy / premedications / Radiation / / Organization FOOD AND DRUG ADMINISTRATION / Team Leader Division of Counter-Terrorism and Pediatrics / DEPARTMENT OF HEALTH AND HUMAN SERVICES / Drug Risk Evaluation office of Drug Safety / / Person Mark Avigan / Solomon Iyasu / Jennie Chang / Susan Lu / Jennie T. Chang / / / Position Team Leader / Director Division / Executive / Safety Evaluator / / Product PUBLIC HEALTH SERVICE FOOD AND DRUG / ranitidine / omeprazole / fluconazole / Ceftazidime / prednisone / ciprofloxacin / / Technology radiation / antibodies / pediatric oncology protocol / / URL http / SocialTag 
MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH