| Document Date: 2013-07-02 17:20:48
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City Barcelona / Washington DC / London / / Company IgG / AEs / Grifols Biologicals Inc. / Instituto Grifols S.A. / EMC / Misbah SA / / Country United States / / Event Product Issues / / Facility Chapel HM / Laboratory Test Assessment Criteria AST Above / Hospital Subjects N / Laboratory Tests / / IndustryTerm administration devices / manufacturing facilities / healthcare / manufacturing process / immunoglobulin product / polymerase chain reaction technology / manufacturing method / / MedicalCondition loss of consciousness / photophobia / Hepatitis A / anaphylactic reaction / inflammatory reactions / nuchal rigidity / acute anaphylactic reactions / HIV / hypoxemia / pulmonary edema / mumps / paraproteinemia / headache / HBV / hypotension Neurological Coma / seizures / pleocytosis / bullous dermatitis Hematologic Pancytopenia / leukopenia / certain current virus infections / osteomyelitis/septic arthritis / measles / tremor Integumentary Stevens-Johnson Syndrome / nausea / Transfusion-related acute lung injury / serious infections / Hepatitis C / Hepatitis B / Upper Respiratory tract infection Wheezing / primary humoral immunodeficiency disease / Tetanus Antitoxoid Antibody / bacterial meningitis / AE Adverse Event Bronchitis Cough / fatigue / drowsiness / severe headache / severe respiratory distress / pulmonary edema / productive cough Diarrhoea NOSa Headache NOS / selective IgA deficiency / rigors Musculoskeletal Back pain Gastrointestinal Hepatic dysfunction / infectious agent / tachycardia / anaphylactic reactions / Wiskott-Aldrich Syndrome / muscle cramps / MS / renal dysfunction / infections / infectious agents / back pain / acute tubular necrosis / osmotic nephrosis / sepsis / visceral abscesses / wheezing / asthma / Aseptic meningitis / Brophy MT. Acute renal failure / immunodeficiency diseases / bronchospasm Cardiovascular Cardiac arrest / Pseudorabies rabies / Hemolytic anemia / bacteremia / disease / atherosclerosis / arthralgia / bacterial pneumonia / acute aseptic meningitis / monoclonal gammopathies / dyspnea / shortness of breath / chills / shock / noncardiogenic pulmonary edema / Aseptic Meningitis Syndrome / CJD / thromboembolism / Infectious Bovine Rhinotracheitis / autoimmune thrombocytopenia / HCV / oliguria and anuria requiring dialysis / fever / common variable immunodeficiency / humoral immunodeficiency disorders / pulmonary adverse reactions / vomiting / renal insufficiency / rubella / diabetes mellitus / primary humoral immunodeficiency diseases / Prog Allergy / Respiratory Apnea / chest tightness / infection / erythema multiformae / abdominal cramps / Renal failure / primary humoral immune deficiency / agammaglobulinemia / severe combined immunodeficiency / meningitis / rash / acute renal failure / syndrome / serious infection / / MedicalTreatment immunoglobulin therapy / oxygen therapy / alternative therapies / Pharmacotherapy / dialysis / / Organization US Department of Health and Human Services / Instituto Grifols / PRECAUTIONS / DOSAGE AND ADMINISTRATION / FDA / IGIV administration / / Person Min - Max Mean / Arch Neurol / Van Daele / / / Position editor / Physician / General / / Product polyethylene glycol / sorbitol / cardiac output / / ProvinceOrState ARDS / / RadioStation J AM / / Technology chromotography / antibodies / pharmacokinetics / ion exchange / polymerase chain reaction technology / dialysis / /
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Immune Globulin Intravenous (Human) Flebogamma® 5% Table 4. Summary of Secondary Efficacy Variables Variable