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Microsoft Word - 15D030-ISA-WPI.doc
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Document Date: 2015-05-15 03:41:40


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Company

Astellas Pharma US Inc. / /

Event

FDA Phase / /

IndustryTerm

food / patient infusion solution / administration site / infusion solution / /

MedicalCondition

cholecystitis / Chest pain / neutropenia post-chemotherapy / lymphatic system disorders / headache / Invasive Mucormycosis CRESEMBA / cholelithiasis / Skin disorders / Stevens Johnson syndrome / graft-versus-host disease / Hypersensitivity Reactions Serious hypersensitivity / subcutaneous tissue disorders / dermatitis / convulsion / neck pain Nervous system disorders / severe hepatic injury / ventricular extrasystoles / nausea / Ear disorders / anaphylaxis / alopecia / peripheral neuropathy / hypersensitivity Injury / syncope / hematological malignancy / encephalopathy / Nausea Vomiting Diarrhea Abdominal pain Constipation Dyspepsia General disorders / gastritis / hypoesthesia / bradycardia / Hypersensitivity / diarrhea / End Stage Renal Disease / hepatitis / constipation / confusional state / liver disease / hypoglycemia / back pain / hypoalbuminemia / agranulocytosis / atrial flutter / hypotension / nutrition disorders / Invasive aspergillosis / hallucination / bronchospasm / Invasive mucormycosis / petechiae / gingivitis / respiratory failure / supraventricular extrasystoles / urinary disorders / dyspnea / leukopenia / pancytopenia Cardiac / chills / dysgeusia / Carcinogenesis / ESRD / migraine / Invasive Aspergillosis CRESEMBA / disorientation / labyrinth disorders / stomatitis General disorders / erythema / exfoliative dermatitis / Serious hypersensitivity / hepatic failure Immune system disorders / vomiting / pain / stupor / familial short QT syndrome / catheter thrombosis / thoracic and mediastinal disorders / hepatic failure / myositis / supraventricular tachycardia / Delirium / epilepsy / atrial fibrillation / connective tissue disorders / dizziness / cough / hematuria / proteinuria Respiratory / hypokalemia / paresthesia / cholestasis / acute renal failure / tinnitus / hematologic malignancy / /

MedicalTreatment

chemotherapy / catheter / antifungal therapy / /

Organization

Caution Concomitant administration / Intravenous Administration / DOSAGE AND ADMINISTRATION / FDA / /

Person

Ear / Stevens Johnson / /

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Position

Nausea Vomiting Diarrhea Abdominal pain Constipation Dyspepsia General / physician / General / physician in managing the risks / /

Product

DOSAGE FORMS AND STRENGTHS Each CRESEMBA capsule / sodium chloride / cyclosporine / Fatigue Chest pain Injection / carbamazepine / dextrose / rifampin / For Injection / digoxin / ketoconazole / CRESEMBA capsules / CRESEMBA / /

Technology

Pharmacokinetics / chemotherapy / Pharmacodynamics / /

URL

www.fda.gov/medwatch / /

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