| Document Date: 2013-03-19 16:14:25
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City Boca Raton / Smith / Kennedy / Siber / London / / Company Biotest Pharmaceuticals Corporation / Misbah SA / IgG / Academic Press / BIVIGAM / Ford / / Country United States / / Event Product Issues / / Facility Chapel HM / Laboratory Tests / / IndustryTerm manufacturing pool / liquid solution / 50mL solution / manufacturing process / manufacturing / yellow solution / healthcare / 100mL solution / concomitant nephrotoxic medicinal products / / MedicalCondition photophobia / Transfusion Associated Lung Injury / acute severe hypersensitivity / HIV / hypoxemia / pulmonary edema / HBV / seizures / measles / Coma / osteomyelitis / Transfusion-Related Acute Lung Injury / viral diarrhea virus / hepatitis B / HIV RNA / viral diseases / bacterial meningitis / hyponatremia / septic arthritis / drowsiness / severe headache / severe respiratory distress / pulmonary edema / bullous dermatitis / acute hypersensitivity / anaphylactic reactions / diarrhea / Wiskott-Aldrich syndrome / Cardiac arrest / Renal dysfunction / upper respiratory tract infection / abdominal pain / Creutzfeldt-Jakob disease / true hyponatremia / bacterial infections / bacterial pneumonia / monoclonal gammopathies / coagulation disorders / shortness of breath / Carcinogenesis / Aseptic meningitis syndrome / CJD / X-linked agammaglobulinemia / thromboembolism / autoimmune thrombocytopenia / HCV / fever / lethargy / Pseudorabies virus / septicemia / vomiting / rubella / recurrent serious opportunistic infections / infection / dizziness / serious bacterial infections / varicella / infectious disease / acute renal failure / Pancytopenia / HCV RNA / loss of consciousness / herpes viruses / hepatitis A / nuchal rigidity / chest pain / mumps / paraproteinemia / headache / symptomatic Fifth's disease / severe combined immunodeficiencies / pleocytosis / leukopenia / bronchitis / nausea / Infectious / hepatitis C / Stevens-Johnson syndrome / tremor / Hepatic dysfunction / severe hypersensitivity / fatigue / Murine encephalomyelitis virus / erythema multiforme / tachycardia / hypersensitivity / sinusitis / MS / pruritus / infections / infectious agents / Back Pain / IgA deficiency / osmotic nephrosis / sepsis / Acute Renal Dysfunction / hypotension / aseptic meningitis / acute lung injury / hemolytic anemia / bacteremia / bronchospasm / disease / atherosclerosis / dyspnea / Migraine / Apnea / common variable immunodeficiency / pulmonary adverse reactions / renal insufficiency / congenital agammaglobulinemia / diabetes mellitus / rigors / clinically compromising anemia / SCID / cough / thrombosis / meningitis / anemia / abscess / dehydration / / MedicalTreatment immunoglobulin therapy / Immunotherapy / oxygen therapy / immunization / premedication / antibiotics / intravenous infusion / vaccinations / / MusicGroup Nausea / / Organization FDA / Department of Health / Live Virus Vaccines Immunoglobulin administration / / Person M. Hemolytic / Wilson JR / Ann Intern Med / Davis J. Hemolysis / Van Daele / / / Position immunizing physician / physician / Fisher / / Product Virus Removal/Inactivation (log10) Virus Type / epinephrine / glycine / sodium chloride / patients / coagulation disorders / cardiac output / / ProvinceOrState ARDS / Mississippi / Georgia / Illinois / Florida / / Region West Nile / USA U.S. / / Technology antibodies / Pharmacokinetics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BIVIGAMTM safely and effectively. See full prescribing information for BIVIGAM. Immune Globulin Intravenous (Human),