HYPERHEP B (hepatitis b immune globulin- human injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Human Hepatitis B Virus Immune Globulin (UNII: XII270YC6M) (Human Hepatitis B Virus Immune Globulin - UNII:XII270YC6M)

Available from:

GRIFOLS USA, LLC

INN (International Name):

Human Hepatitis B Virus Immune Globulin

Composition:

Human Hepatitis B Virus Immune Globulin 220 [iU] in 1 mL

Administration route:

INTRAMUSCULAR

Therapeutic indications:

Recommendations on post-exposure prophylaxis are based on available efficacy data and on the likelihood of future HBV exposure for the person requiring treatment. In all exposures, a regimen combining Hepatitis B Immune Globulin (Human) with hepatitis B vaccine will provide both short- and long-term protection, will be less costly than the two-dose Hepatitis B Immune Globulin (Human) treatment alone, and is the treatment of choice.(9) HyperHEP B  is indicated for post-exposure prophylaxis in the following situations: After either parenteral exposure, e.g., by accidental “needlestick” or direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident) involving HBsAg-positive materials such as blood, plasma or serum. For inadvertent percutaneous exposure, a regimen of two doses of Hepatitis B Immune Globulin (Human), one given after exposure and one a month later, is about 75% effective in preventing hepatitis B in this setting. Infants born to HBsAg-positive mothers are at risk of be

Product summary:

HyperHEP B is supplied in a 0.5 mL neonatal single dose syringe with attached needle, a 1 mL single dose syringe with attached needle and a 1 mL and a 5 mL single dose vial. HyperHEP B contains no preservative and is not made with natural rubber latex.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

HYPERHEP B- HEPATITIS B IMMUNE GLOBULIN (HUMAN) INJECTION
GRIFOLS USA, LLC
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HEPATITIS B IMMUNE GLOBULIN
(HUMAN)
HYPERHEP B
DESCRIPTION
Hepatitis B Immune Globulin (Human) — HyperHEP B is a clear or
slightly opalescent,
and colorless or pale yellow sterile solution of human hepatitis B
immune globulin for
intramuscular administration. HyperHEP B contains no preservative.
HyperHEP B is
prepared from pools of human plasma collected from healthy donors by a
combination
of cold ethanol fractionation, caprylate precipitation and filtration,
caprylate incubation,
anion exchange chromatography, nanofiltration and low pH incubation.
HyperHEP B
consists of a 15% to 18% protein solution at a pH of 4.1 to 4.8 in
0.16 M to 0.26 M
glycine. The product contains anti-HBs antibody equivalent to or
exceeding the potency
of anti-HBs in a U.S. reference hepatitis B immune globulin (Center
for Biologics
Evaluation and Research, FDA). The U.S. reference has been tested
against the World
Health Organization standard Hepatitis B Immune Globulin and found to
be equal to 220
international units (IU) per mL.
When medicinal biological products are administered, the risk of
infectious diseases due
to transmission of pathogens cannot be totally excluded. However, in
the case of
products prepared from human plasma, the risk of transmission of
pathogens is
reduced by epidemiological surveillance of the donor population and
selection of
individual donors by medical interview; testing of individual
donations and plasma pools;
and the presence in the manufacturing processes of steps with
demonstrated capacity
to inactivate/remove pathogen.
In the manufacturing process of HyperHEP B, there are several steps
with the capacity
for viral inactivation or removal.(1) The main steps of the
manufacturing process that
contribute to the virus clearance capacity are as follows:
Caprylate precipitation/depth filtration
Caprylate incubation
Depth filtration
Column chromatography
Nanofiltration
Low pH final container incubation
To provide additional