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(2.3) HIZENTRA •Infusion sites – Up to 8 infusion sites ...

FULL PRESCRIBING INFORMATION: CONTENTS*WARNING: THROMBOSIS1 INDICATIONS AND USAGE Primary Immunodeficiency (PI) Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)2 DOSAGE AND ADMINISTRATION Preparation and Handling Dose Administration3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS Hypersensitivity Thrombosis Aseptic Meningitis Syndrome (AMS) Renal Dysfunction/Failure Hemolysis Transfusion Related Acute Lung Injury (TRALI) Transmissible Infectious Agents Laboratory Tests6 ADVERSE REACTIONS Clinical Trials Experience Postmarketing Experience7 DRUG INTERACTIONS Live Virus Vaccines Serological Testing8 USE IN SPECIFIC POPULATIONS Pregnancy Lactation Pediatric Use Geriatric Use11 DESCRIPTION12 CLINICAL PHARMACOLOGY Mechanism of Action Pharmacokinetics13 NONCLINICAL TOXICOLOGY Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES Primary Immunodeficiency (PI) Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)15 REFERENCES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not OF PRESCRIBING INFOR

o Ensure that patients have received Immune Globulin Intravenous (Human) (IGIV) treatment at regular intervals for at least 3 months. o Obtain the patient’ s serum IgG trough level to guide subsequent dose adjustments (see below, under Dose Adjustment).

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  Human, Immune globulin intravenous, Immune, Globulin, Intravenous

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