| Document Date: 2014-10-08 15:14:50
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Company Factor IX / RCTs Subgroup / CSL Behring LLC / CSL Behring GmbH / / Country United States / / Currency CHF / INR / / Event FDA Phase / / Facility Store Kcentra / FVIIIa-Factor IXa complex / TF-FVIIa complex / FVIIa-TF complex / Prothrombin Complex / / Holiday Christmas / / IndustryTerm natural rubber latex / drug product / blood products / healthcare / aqueous solution / medicinal products / manufacturing process / plasma-derived products / replacement product / Manufacturing steps / plasma / study product / parenteral drug products / / MedicalCondition hepatitis A / arterial thrombosis / HIV / unknown infectious agents / chest pain / disseminated intravascular coagulation / headache / HBV / suspected pulmonary embolism / cardiac failure / Hypersensitivity Reactions Hypersensitivity / cerebrovascular accident / nausea/vomiting / nausea / thrombocytopenia / anaphylaxis / viral diarrhea virus / hepatitis B / hemorrhagic shock Includes anemia / Protein S. A dose-dependent acquired deficiency / transient ischemic attack / embolic cerebral infarction / lymphatic disorders / Pulmonary edema / poisoning / tachycardia / pulmonary embolism / Hypersensitivity / Diarrhea / dyspnea / pulmonary edema / HCV PRV Pseudorabies virus / infections / infectious agents / venous insufficiency / wheezing / hypotension / acute myocardial infarction / mediastinal disorders Pleural effusion / congestive heart failure / variant Creutzfeldt-Jakob disease / Creutzfeldt-Jakob disease / severe allergic reaction / bronchospasm / DNA viruses WNV West Nile virus HAV Hepatitis A / flushing / disease / respiratory failure / severe peripheral vascular disease / shortness of breath / Carcinogenesis / Venous thrombosis calf Venous thrombosis radial vein Thrombosis / venous thrombosis / stroke / acquired coagulation factor deficiency / thromboembolism / HCV / variant CreutzfeldtJakob disease / orthostatic hypotension / vomiting / pain / unstable angina pectoris / myocardial infarction / deep vein thrombosis / gastrointestinal / intracranial hemorrhage / urticaria / angioedema / Hypotension† Injury / Atrial fibrillation / Respiratory distress/dyspnea / allergic hypersensitivity / thrombosis / Hypokalemia / rash / anemia / myocardial ischemia / upper extremity venous thrombosis / / MedicalTreatment invasive procedure / invasive procedures / intravenous infusion / surgery / catheter / / MusicGroup Nausea / / Organization CSL Behring Pharmacovigilance Department / Plasma Administration / DOSAGE AND ADMINISTRATION / Kcentra administration / FDA / Endpoint Adjudication Board / / Person Bleeding Plasma / / / Position investigator / physician / Major / / Product Sodium chloride / Vitamin K / Sterile Water for Injection / Kcentra / / ProvinceOrState Illinois / / Technology antibodies / Pharmacokinetics / ion exchange / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KCENTRA safely and effectively. See full prescribing information for KCENTRA. KCENTRA® (Prothrombin Complex Concent