CYTOGAM- human cytomegalovirus immune globulin liquid

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

CSL Behring AG

INN (שם בינלאומי):

Human Cytomegalovirus Immune Globulin

הרכב:

Human Cytomegalovirus Immune Globulin 50 mg in 1 mL

מסלול נתינה (של תרופות):

INTRAVENOUS

סממני תרפויטית:

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.

leaflet_short:

CYTOGAM is supplied in a 50 mL single-dose vial (50 mg/mL). The product presentation includes a package insert and the following component: CYTOGAM should be stored between 2-8°C (36-46°F), and used within 6 hours after entering the vial.

מצב אישור:

Biologic Licensing Application

מאפייני מוצר

CYTOGAM- HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN LIQUID
CSL BEHRING AG
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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).
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.
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,
pancreas and hea