CYTOGAM- human cytomegalovirus immune globulin liquid

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN (UNII: 129L90A25N) (HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN - UNII:129L90A25N)

Disponibil de la:

Kamada Ltd.

Calea de administrare:

INTRAVENOUS

Indicații terapeutice:

Cytomegalovirus Immune Globulin Intravenous (Human) is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. In transplants of these organs other than kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir. CytoGam® should not be used in individuals with a history of a prior severe reaction associated with the administration of this or other human immunoglobulin preparations. Persons with selective immunoglobulin A deficiency have the potential for developing antibodies to immunoglobulin A and could have anaphylactic reactions to subsequent administration of blood products that contain immunoglobulin A, including CytoGam® .

Rezumat produs:

CytoGam® , Cytomegalovirus Immune Globulin Intravenous (Human), is supplied in one single-dose vial (50 mg/mL). The product presentation includes a carton with a package insert and the following component:

Statutul autorizaţiei:

Biologic Licensing Application

Caracteristicilor produsului

CYTOGAM- HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN LIQUID
KAMADA LTD.
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KAMADA LTD.
CYTOGAM
CYTOMEGALOVIRUS IMMUNE GLOBULIN INTRAVENOUS (HUMAN)
LIQUID FORMULATION
SOLVENT DETERGENT TREATED
R ONLY
DESCRIPTION
CytoGam , Cytomegalovirus Immune Globulin Intravenous (Human)
(CMV-IGIV), is an
immunoglobulin G (IgG) containing a standardized amount of antibody to
Cytomegalovirus (CMV). CMV-IGIV is formulated in final vial as a
sterile liquid. The globulin
is stabilized with 5% sucrose and 1% Albumin (Human). CytoGam contains
no
preservative. The purified immunoglobulin is derived from pooled adult
human plasma
selected for high titers of antibody for Cytomegalovirus (CMV) (1).
Source material for
fractionation may be obtained from another U.S. licensed manufacturer.
Pooled plasma
was fractionated by ethanol precipitation of the proteins according to
Cohn Methods 6
and 9, modified to yield a product suitable for intravenous
administration. A widely
utilized solvent-detergent viral inactivation process is also used
(2). Certain
manufacturing operations may be performed by other firms. Each
milliliter contains: 50
± 10 mg of immunoglobulin, primarily IgG, and trace amounts of IgA
and IgM; 50 mg of
sucrose; 10 mg of Albumin (Human). The sodium content is 20-30 mEq per
liter, i.e.,
0.4-0.6 mEq per 20 mL or 1.0-1.5 mEq per 50 mL. The solution should
appear colorless
and translucent.
CLINICAL PHARMACOLOGY
CytoGam contains IgG antibodies representative of the large number of
normal
persons who contributed to the plasma pools from which the product was
derived. The
globulin contains a relatively high concentration of antibodies
directed against
Cytomegalovirus (CMV). In the case of persons who may be exposed to
CMV,
CytoGam can raise the relevant antibodies to levels sufficient to
attenuate or reduce
the incidence of serious CMV disease.
INDICATIONS AND USAGE
Cytomegalovirus Immune Globulin Intravenous (Human) is indicated for
the prophylaxis
of cytomegalovirus disease associated with transplantation of kidney,
lung, liver