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City BLA / / Facility Laboratory Eficucy / / IndustryTerm protein product / injection site / active product / intravenous protein product / treatment of Hemophilia / clear colorless solution / / MedicalCondition abdominal pain / classical hemophilia / hemophilia A / acne / flushing / headache / gastroenteritis / dyspnea / chills / hives / nausea / anaphylaxis / VIII deficiency / muscle weakness / coughing / Known hypersensitivity / fever / lethargy / hernia / allergic type hypersensitivity / vomiting / von Willebrand’s disease / Fatigue / angina pectoris / urticaria / Gastritis / allergic reactions / abdominal pain Moniliasis / tachycardia / hypersensitivity / diarrhea / dizziness / asthenia Paresthesia / hemarthroses / pruritus / rash / classic hemophilia / pain in finger / wheezing / hypotension / / MedicalTreatment catheter / orthopedic procedures / surgery / / Organization World Health Organization / FDA / / Person Vol / / / Position investigator / General / / Product sodium chloride / calcium chloride / / Technology antibodies / recombinant DNA technology / /
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Part II3 IB:l Labeling Annotated