| Document Date: 2013-07-02 17:20:53
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Company IgG / Caprylate / IGIV / AE (percentage of all subjects) AE / Talecris Biotherapeutics Inc. / / Event FDA Phase / / Facility Laboratory Tests / Laboratory Tests If / Laboratory Abnormalities / Laboratory Abnormalities During / / IndustryTerm amino acid solutions / physical and chemical inactivation / parallel / healthcare / ready-to-use sterile solution / manufacturing process / test product / / MedicalCondition photophobia / loss of consciousness / hepatitis A / anaphylactic reaction / nuchal rigidity / pseudorabies / HIV / infection at least one infection Validated Infections / mumps / paraproteinemia / headache / liver dysfunction / seizures / e.g. herpes viruses / leukopenia / visceral abscess / hives / osteomyelitis/septic arthritis / measles / dermatitis / coma / dysfunction / bacteremia/sepsis / nausea / anaphylaxis / serious infections / Rhinitis / immediate hypersensitivity / infectious / hepatitis C / tremor / pulmonary / drowsiness / non-validated Infections / viral meningitis / pulmonary edema / erythema multiforme / Diarrhea / anaphylactic reactions / severe infections / Wiskott-Aldrich syndrome / cardiac arrest / chronic sinusitis / infections / back pain / annual infection / IgA deficiency / sepsis / nephrosis / Asthma / hypotension / Aseptic meningitis / acute lung injury / abdominal pain / pneumonia / Hemolytic anemia / convulsions / bronchospasm / disease / atherosclerosis / monoclonal gammopathies / dyspnea / validated infections / shortness of breath / chills / Confidence Interval Serious Infections / CJD / hypochromic anemia / oliguria / thromboembolism / severe / selective IgA deficiencies / apnea / itching / fever / common variable immunodeficiency / clinically defined pneumonia / vomiting / renal insufficiency / congenital agammaglobulinemia / rubella / diabetes mellitus / Urticaria / lethal infections / transmissible spongiform encephalopathy / allergic reactions / rigors / Any Infection / bovine viral diarrhea virus / infection / Cough / anuria / thrombosis / Idiopathic Thrombocytopenic Purpura / meningitis / Pharyngitis / acute sinusitis / acute renal failure / syndrome / pure red cell aplasia / serious infection / disorders / respiratory distress / pancytopenia / / MedicalTreatment red blood cell transfusions / antibiotics / oxygen therapy / alternative therapies / dialysis / / / Position investigator / physician / General / model for human parvovirus B19 / / Product acetaminophen / aminoacetic acid / Epinephrine / glycine / prednisone / GAMUNEX® GAMIMUNE / GAMUNEX / GAMUNEX® / / ProgrammingLanguage Hoc / / ProvinceOrState ARDS / / Technology antibodies / pharmacokinetics / dialysis / /
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[removed]Rev. November[removed]Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified GAMUNEX® DESCRIPTION