NABI-HB (hepatitis b immune globulin- human liquid

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN (UNII: XII270YC6M) (HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN - UNII:XII270YC6M)

Dostępny od:

ADMA Biologics, Inc.

Droga podania:

INTRAMUSCULAR

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Nabi-HB, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infec- tion in the following settings: - Acute Exposure to Blood Containing HBsAg: Following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving HBsAg-positive materials such as blood, plasma, or serum. - Perinatal Exposure of Infants Born to HBsAg-positive Mothers: Infants born to mothers positive for HBsAg with or without HBeAg 12 . - Sexual Exposure to HBsAg-positive Persons: Sexual partners of HBsAg-positive persons. - Household Exposure to Persons with Acute HBV Infection: Household Exposure to Persons with Acute HBV Infection: Infants less than 12 months old whose mother or primary caregiver is positive for HBsAg. O

Podsumowanie produktu:

Nabi-HB, Hepatitis B Immune Globulin (Human), is supplied as:

Status autoryzacji:

Biologic Licensing Application

Charakterystyka produktu

NABI-HB- HEPATITIS B IMMUNE GLOBULIN (HUMAN) LIQUID
ADMA BIOLOGICS, INC.
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HEPATITIS B IMMUNE GLOBULIN (HUMAN)
NABI-HB
SOLVENT/DETERGENT TREATED AND FILTERED
DESCRIPTION
Hepatitis B Immune Globulin (Human), Nabi-HB, is a sterile solution of
immunoglobulin (5
± 1% protein) containing antibodies to hepatitis B surface antigen
(anti-HBs). It is
prepared from plasma donated by individuals with high titers of
anti-HBs. The plasma is
processed using a modified Cohn 6 / Oncley 9 cold-alcohol
fractionation process
with
two added viral reduction steps described below. Nabi-HB is formulated
in 0.042-0.108
M sodium chloride, 0.10-0.20 M glycine, and 0.005-0.050% polysorbate
80, at pH 5.8-
6.5. The product is supplied as a nonturbid sterile liquid in single
dose vials and appears
as clear to opalescent. It contains no preservative and is intended
for single use by the
intramuscular route only.
Each plasma donation used for the manufacture of Nabi-HB is tested for
the presence
of hepatitis B virus (HBV) surface antigen (HBsAg), human
immunodeficiency viruses
(HIV) 1/2, and hepatitis C virus (HCV) antibodies. In addition, pooled
samples of Source
Plasma used in the manufacture of this product are tested by FDA
licensed Nucleic Acid
Testing (NAT) for HIV and HCV and found to be negative.
Investigational NAT for
hepatitis A virus (HAV) and HBV is also performed on pooled samples of
all Source
Plasma used, and found to be negative; however, the significance of a
negative result
has not been established. Investigational NAT for parvovirus B19 (B19)
is also
performed on pooled samples of all Source Plasma and the limit for B19
DNA in a
manufacturing pool is set not to exceed 10
IU/mL.
The manufacturing steps for Nabi-HB are designed to reduce the risk of
transmission of
viral disease. The solvent/detergent treatment step, using tri-
_n_-butyl phosphate and
Triton
X-100, is effective in inactivating known enveloped viruses such as
hepatitis B
virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus
(HIV)
. Vi