PRIVIGEN- human immunoglobulin g liquid

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

Human Immunoglobulin G (UNII: 66Y330CJHS) (Human Immunoglobulin G - UNII:66Y330CJHS)

थमां उपलब्ध:

CSL Behring AG

INN (इंटरनेशनल नाम):

Human Immunoglobulin G

रचना:

Human Immunoglobulin G 5 g in 50 mL

प्रशासन का मार्ग:

INTRAVENOUS

चिकित्सीय संकेत:

PRIVIGEN is an Immune Globulin Intravenous (Human), 10% Liquid indicated for the treatment of the following conditions. PRIVIGEN is indicated as replacement therapy for primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. PRIVIGEN is indicated for the treatment of patients age 15 years and older with chronic immune thrombocytopenic purpura (ITP) to raise platelet counts. PRIVIGEN is indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment. Limitation of Use: PRIVIGEN maintenance therapy in CIDP has not been studied for periods longer than 6 months. After responding during an initial treatment period, not all patients require indefinite maintenance therapy with PRIVIGEN in order to remain free of CIDP

उत्पाद समीक्षा:

PRIVIGEN is supplied in a single-use, tamper-evident vial containing the labeled amount of functionally active IgG. The PRIVIGEN packaging components are not made with natural rubber latex. Each product presentation includes a package insert and the following components: Storage and Handling

प्राधिकरण का दर्जा:

Biologic Licensing Application

उत्पाद विशेषताएं

PRIVIGEN- HUMAN IMMUNOGLOBULIN G LIQUID
CSL BEHRING AG
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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 INTRAVENOUS (HUMAN), 10% LIQUID
INITIAL U.S. APPROVAL: 2007
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THROMBOSIS MAY OCCUR WITH IMMUNE GLOBULIN PRODUCTS, INCLUDING
PRIVIGEN. RISK
FACTORS MAY INCLUDE: ADVANCED AGE, PROLONGED IMMOBILIZATION,
HYPERCOAGULABLE
CONDITIONS, HISTORY OF VENOUS OR ARTERIAL THROMBOSIS, USE OF
ESTROGENS, INDWELLING
VASCULAR CATHETERS, HYPERVISCOSITY, AND CARDIOVASCULAR RISK FACTORS.
RENAL DYSFUNCTION, ACUTE RENAL FAILURE, OSMOTIC NEPHROSIS, AND DEATH
MAY OCCUR WITH
IMMUNE GLOBULIN INTRAVENOUS (IGIV) PRODUCTS IN PREDISPOSED PATIENTS.
RENAL
DYSFUNCTION AND ACUTE RENAL FAILURE OCCUR MORE COMMONLY IN PATIENTS
RECEIVING IGIV
PRODUCTS CONTAINING SUCROSE. PRIVIGEN DOES NOT CONTAIN SUCROSE.
FOR PATIENTS AT RISK OF THROMBOSIS, RENAL DYSFUNCTION OR FAILURE,
ADMINISTER PRIVIGEN
AT THE MINIMUM DOSE AND INFUSION RATE PRACTICABLE. ENSURE ADEQUATE
HYDRATION IN
PATIENTS BEFORE ADMINISTRATION. MONITOR FOR SIGNS AND SYMPTOMS OF
THROMBOSIS AND
ASSESS BLOOD VISCOSITY IN PATIENTS AT RISK FOR HYPERVISCOSITY.
INDICATIONS AND USAGE
PRIVIGEN is an Immune Globulin Intravenous (Human), 10% Liquid
indicated for the treatment of:
Primary humoral immunodeficiency (PI) (1.1)
Chronic immune thrombocytopenic purpura (ITP) in patients age 15 years
and older (1.2)
Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults
(1.3)
Limitations of Use:
PRIVIGEN maintenance therapy in CIDP has not been studied beyond 6
months. (1.3)
DOSAGE AND ADMINISTRATION
INTRAVENOUS USE ONLY
INDICATION
DOSE
INITIAL INFUSION
RATE
MAINTENANCE INFUSION
RATE
(AS TOLERATED)
PI
200-800 mg/kg
(2-8 mL/kg)
every 3-4 weeks
0.5 mg/kg/min
(0.005 mL/kg/min)
Increase to 8 mg/kg/min
(0.08 mL/kg/min