Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN (UNII: 129L90A25N) (HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN - UNII:129L90A25N)
CSL Behring AG
Human Cytomegalovirus Immune Globulin
Human Cytomegalovirus Immune Globulin 50 mg in 1 mL
INTRAVENOUS
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.
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.
Biologic Licensing Application
CYTOGAM- HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN LIQUID CSL BEHRING AG ---------- 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 Đọc toàn bộ tài liệu