FLEBOGAMMA DIF (immune globulin intravenous- human injection, solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

GRIFOLS USA, LLC

INN（国際名）:

Human Immunoglobulin G

構図:

Human Immunoglobulin G 5 g in 50 mL

投与経路:

INTRAVENOUS

適応症:

Flebogamma 10% DIF is an immune globulin intravenous (human) solution indicated for the treatment of: Flebogamma 10% DIF is indicated as replacement therapy in primary immunodeficiency (PI) including the humoral immune defects in common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency, and Wiskott-Aldrich syndrome. Flebogamma 10% DIF is indicated for the treatment of patients 2 years of age and older with chronic primary immune thrombocytopenia to raise platelet count. - Flebogamma 10% DIF is contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human immune globulin. - Flebogamma 10% DIF is contraindicated in IgA deficient patients with antibodies to IgA and a history of hypersensitivity. (see Warnings and Precautions (5.1)) Risk Summary There are no studies of Flebogamma 10% DIF use in pregnant women. Animal reproduction studies have not been performed with Flebogamma 10% DIF. It is

製品概要:

Flebogamma 10% DIF is supplied in single-use, individually laser-etched vials containing the labeled amount of functionally active IgG. The following presentations of Flebogamma 10% DIF are available: Each vial has an integral suspension band and a label with two peel-off strips showing the product name and lot number. Flebogamma 10% DIF may be stored at room temperature at 2 to 25 ºC (36 to 77 ºF) for up to 24 months, as indicated by the expiration date printed on the outer carton and container label. Discard after expiration date. Do not freeze. Keep Flebogamma 10% DIF in its original carton to protect it from light. Not made with natural rubber latex.

認証ステータス:

Biologic Licensing Application

製品の特徴

FLEBOGAMMA DIF - IMMUNE GLOBULIN INTRAVENOUS (HUMAN) INJECTION,
SOLUTION
GRIFOLS USA, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLEBOGAMMA 10% DIF SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR FLEBOGAMMA 10% DIF
FLEBOGAMMA 10% DIF (IMMUNE GLOBULIN INTRAVENOUS [HUMAN]),
SOLUTION FOR INTRAVENOUS ADMINISTRATION
INITIAL U.S. APPROVAL: 2010
WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THROMBOSIS MAY OCCUR WITH IMMUNE GLOBULIN PRODUCTS, INCLUDING
FLEBOGAMMA 10%
DIF. 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 FLEBOGAMMA 10% DIF 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 OF HYPERVISCOSITY.
RENAL DYSFUNCTION, ACUTE RENAL FAILURE, OSMOTIC NEPHROSIS AND DEATH
MAY OCCUR WITH
THE ADMINISTRATION OF HUMAN IMMUNE GLOBULIN INTRAVENOUS (IGIV)
PRODUCTS,
PARTICULARLY THOSE PRODUCTS THAT CONTAIN SUCROSE. FLEBOGAMMA 10% DIF
DOES NOT
CONTAIN SUCROSE.
FOR PATIENTS AT RISK OF RENAL DYSFUNCTION OR FAILURE, ADMINISTER
FLEBOGAMMA 10% DIF
AT THE MINIMUM DOSE AND INFUSION RATE PRACTICABLE. (5.2)
RECENT MAJOR CHANGES
Dosage and Administration (2)
9/2019
INDICATIONS AND USAGE
Flebogamma 10% DIF is an immune globulin intravenous (human),
indicated for treatment of:
Primary (inherited) Immunodeficiency (PI). (1.1)
Chronic Primary Immune Thrombocytopenia (ITP) in patients 2 years of
age and older. (1.2)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY
Indication
Dose
Initial Infusion Rate
Maintenance Infusion Rate
(if tolerated)
PI
300-600 mg per kg
every 3-4 weeks
0.01 mL per kg per