GAMUNEX-C (immune globulin- human injection

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

GRIFOLS USA, LLC

ІПН (Міжнародна Ім'я):

Human Immunoglobulin G

Склад:

Human Immunoglobulin G 10 g in 100 mL

Адміністрація маршрут:

INTRAVENOUS

Терапевтичні свідчення:

GAMUNEX-C is an immune globulin injection (human) 10% liquid that is indicated for the treatment of: GAMUNEX-C is indicated for treatment of primary humoral immunodeficiency in patients 2 years of age and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.(1-4) GAMUNEX-C is indicated for the treatment of adults and children with Idiopathic Thrombocytopenic Purpura to raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery.(5,6) GAMUNEX-C is indicated for the treatment of CIDP in adults to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse. GAMUNEX-C is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. GAMUNEX-C is contraindicated in IgA deficient patients with antibodies against IgA and history of h

Огляд продуктів:

GAMUNEX-C is supplied in single-use, tamper evident vials (shrink band) containing the labeled amount of functionally active IgG. The four larger vial size labels incorporate integrated hangers. GAMUNEX-C is not made with natural rubber latex. GAMUNEX-C is supplied in the following sizes:

Статус Авторизація:

Biologic Licensing Application

Характеристики продукта

GAMUNEX-C - IMMUNE GLOBULIN (HUMAN) INJECTION
GRIFOLS USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GAMUNEX -C SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GAMUNEX-C.
GAMUNEX -C, [IMMUNE GLOBULIN INJECTION (HUMAN), 10%
CAPRYLATE/CHROMATOGRAPHY
PURIFIED]
INITIAL U.S. APPROVAL: 2003
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THROMBOSIS MAY OCCUR WITH IMMUNE GLOBULIN PRODUCTS, INCLUDING
GAMUNEX-C. 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.
FOR PATIENTS AT RISK OF THROMBOSIS, ADMINISTER GAMUNEX-C 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.
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. GAMUNEX-C DOES NOT CONTAIN SUCROSE.
FOR PATIENTS AT RISK OF RENAL DYSFUNCTION OR FAILURE, ADMINISTER
GAMUNEX-C AT THE
MINIMUM CONCENTRATION AVAILABLE AND THE MINIMUM INFUSION RATE
PRACTICABLE. (5.2)
INDICATIONS AND USAGE
GAMUNEX-C is an immune globulin injection (human), 10% liquid
indicated for treatment of:
Primary Humoral Immunodeficiency (PI) in patients 2 years of age and
older (1.1)
Idiopathic Thrombocytopenic Purpura (ITP) in adults and children (1.2)
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in adults
(1.3)
DOSAGE AND ADMINISTRATION
INTRAVENOUS ADMINISTRATION ONLY: ITP AND CIDP
Indication
Dose
Initial
Infusion Rate
Maintenance Infusion Rate
(if tolerated)