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City Rockville / Raleigh / London / / Company Bio Products Laboratory Limited / Serum Viscosity / EMC / BPL Inc. / IgG / / Country United Kingdom / United States / / Currency pence / / Event FDA Phase / / Facility Chapel H. Recognition / Laboratory Tests / / IndustryTerm drug product / liquid solution / buf fer solution / manufacturing process / manufacturing / immune globulin products / healthcare professional / drug products / manufacturing step / healthcare / sterile solution / manufacturing pools / concomitant nephrotoxic medicinal products / colorless solution / Monitor for signs and symptoms / / MedicalCondition photophobia / arterial thrombosis / HIV / disseminated intravascular coagulation / HBV / seizures / visceral abscess / osteomyelitis/septic arthritis / measles / Coma / dysfunction / acute / bacterial infections / anaphylaxis / viral diarrhea virus / hepatitis B / viral diseases / bacterial meningitis / Hyponatremia / pulmonary / drowsiness / embolism / severe headache / pulmonary edema / bullous dermatitis / polycythemia / Thrombotic Events Thrombosis / acute hypersensitivity / diarrhea / anaphylactic reactions / Wiskott-Aldrich syndrome / Cardiac arrest / Chronic Immune Thrombocytopenic Purpura / illness / renal dysfunction / Chronic ITP - The / abdominal pain / Fisher M. Hemolytic anemia / pneumonia / Creutzfeldt-Jakob disease / acute renal injury / true hyponatremia / arthralgia / monoclonal gammopathies / Acute chest pain / shortness of breath / chills / Aseptic Meningitis Syndrome / CJD / X-linked agammaglobulinemia / thromboembolism / HCV / fever / Allergy / vomiting / rubella / infection / Dizziness / thrombocytopenic purpura / Rash / infectious disease / ACUTE RENAL FAILURE / inflammatory / Pruritus Dehydration Hypertension Neck pain / loss of consciousness / hepatitis A / nuchal rigidity / chest pain / mumps / paraproteinemia / headache / severe combined immunodeficiencies / pleocytosis / leukopenia / dermatitis / nausea / leg pain / Infectious / hepatitis C / Stevens-Johnson syndrome / tremor / Hepatic dysfunction / Severe hypersensitivity / numbness / fatigue / Distress Syndrome / e.g. measles / tachycardia / Hypersensitivity / pruritus / infections / infectious agents / back pain / bacteremia/septicemia / osmotic nephrosis / sepsis / ACUTE RENAL DYSFUNCTION / wheezing / hypotension / purpura / Acute Lung Injury / acute serious bacterial infections / hemolytic anemia / hypertension / bronchospasm / Petechiae / disease / dyspnea / acute kidney injury / Apnea / common variable immunodeficiency / pulmonary adverse reactions / pain / renal insufficiency / congenital agammaglobulinemia / hereditary intolerance / Myocardial infarction / diabetes mellitus / rigors / serious acute bacterial infections / thrombosis / meningitis / HCV Infectious / bacteremia/ septicemia / anemia / respiratory distress / dehydration / being headache / / MedicalTreatment immunoglobulin therapy / oxygen therapy / immunization / premedication / intravenous infusions / retreatment / intravenous infusion / catheters / vaccinations / / Movie Half-Life / / MusicGroup Nausea / / Organization US PI / DOSAGE AND ADMINISTRATION / FDA / Department of Health / Stationery Office / Food and Drug Administration / Gammaplex administration / / Person M. Hemolytic / Wilson JR / Lane Elstree Hertfordshire / Because Gammaplex / / / Position immunizing physician / physician / model for HAV Canine par / General / investigator / Fisher / / Product epinephrine / glycine / Elstree Hertfordshire WD6 3BX United Kingdom / sodium chloride / sodium acetate / sorbitol / Human Par / / ProvinceOrState ARDS / North Carolina / Arkansas / / Technology Geriatrics / antibodies / Pharmacokinetics / ion exchange / / URL www.fda.gov/medwatch / /
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RECENT MAJOR CHANGES Boxed Warnings Indications and Usage (1.1, 1.2) Dosage and Administration[removed]Contraindications (4) Warnings and Precautions (5.1, 5.5, 5.8, 5.10)