| Document Date: 2013-12-11 15:13:04
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Company Misbah SA / IgG / CSL Behring LLC / Ford / CSL Behring AG / / Country United States / / Event Product Issues / FDA Phase / Product Recall / / Facility Chapel HM / Laboratory Tests Various / Laboratory Tests / / IndustryTerm liquid solution / manufacturing process / manufacturing / parenteral drug products / immune globulin products / natural rubber latex / yellow solution / concomitant nephrotoxic medicinal products / human immune globulin products / Monitor for signs and symptoms / / MedicalCondition inflammatory response / photophobia / arterial thrombosis / HIV / hypoxemia / pulmonary edema / disseminated intravascular coagulation / HBV / inflammatory state / seizures / certain current virus infections / visceral abscess / hives / osteomyelitis/septic arthritis / measles / Coma / osteomyelitis / Transfusion-Related Acute Lung Injury / anaphylaxis / mild urticaria / hepatitis B / bacterial meningitis / Hyponatremia / septic arthritis / severe hemolysis-related renal dysfunction / drowsiness / severe headache / severe respiratory distress / pulmonary edema / bullous dermatitis / acute hypersensitivity / infectious agent / anaphylactic reactions / diarrhea / Acute Renal Failure Renal dysfunction / Cardiac arrest / Chronic Immune Thrombocytopenic Purpura / illness / Renal dysfunction / Chronic Immune Thrombocytopenic Purpura A / upper respiratory tract infection / abdominal pain / Fisher M. Hemolytic anemia / pneumonia / Creutzfeldt-Jakob disease / true hyponatremia / certain virus infections / monoclonal gammopathies / nasopharyngitis / shortness of breath / chills / Aseptic meningitis syndrome / Chronic / CJD / X-linked agammaglobulinemia / thromboembolism / autoimmune thrombocytopenia / HCV / fever / vomiting / acute renal insufficiency / rubella / transmissible spongiform encephalopathy / bovine viral diarrhea virus / infection / dizziness / renal failure / thrombocytopenic purpura / varicella / DYSFUNCTION AND ACUTE RENAL FAILURE / acute renal failure / pancytopenia / loss of consciousness / hepatitis A / nuchal rigidity / pseudorabies / influenza-like illness / chest pain / mumps / paraproteinemia / headache / severe combined immunodeficiencies / pleocytosis / WiskottAldrich syndrome / leukopenia / bronchitis / infectious agent transmission / Thrombosis Thrombosis / nausea / rhinitis / hepatitis C / transient ischemic attack / Stevens-Johnson syndrome / tremor / Headache Elevated body temperature Positive DAT Anemia Nausea Epistaxis / Hepatic dysfunction / severe hypersensitivity / numbness / fatigue / hemoglobinuria/hematuria / erythema multiforme / Chronic ITP / tachycardia / Hypersensitivity / sinusitis / MS / pruritus / infections / infectious agents / back pain / bacteremia/septicemia / IgA deficiency / sepsis / osmotic nephrosis / Acute renal dysfunction / wheezing / hypotension / aseptic meningitis / acute lung injury / acute serious bacterial infections / epistaxis / hemolytic anemia / bronchospasm / flushing / disease / dyspnea / herpes virus / shock / acute kidney injury / Apnea / vCJD/CJD / common variable immunodeficiency / pulmonary adverse reactions / pain / renal insufficiency / congenital agammaglobulinemia / diabetes mellitus / urticaria / rigors / clinically compromising anemia / cough / THROMBOSIS / meningitis / anemia / lightheadedness / / MedicalTreatment immunoglobulin therapy / oxygen therapy / immunization / premedication / intravenous infusion / catheters / / MusicGroup Nausea / / Organization Privigen administration / DOSAGE AND ADMINISTRATION / FDA / / Person M. Hemolytic / Wilson JR / / / Position immunizing physician / physician / General / investigator / counsel / Fisher / / Product acetaminophen / subject / Dextrose / epinephrine / Sodium Chloride / Privigen / patients / B19 / / ProvinceOrState ARDS / Illinois / / Region West Nile / / 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 PRIVIGEN safely and effectively. See full prescribing information for PRIVIGEN . Privigen®, Immune Globulin Intrave