HyperHEP B Pre-filled Syringe 0.5mL

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

Hepatitis B Immune Globulin (Human)

Disponible desde:

GRIFOLS ASIA PACIFIC PTE. LTD.

Código ATC:

J06BB04

Dosis:

15-18%

formulario farmacéutico:

INJECTION

Composición:

Hepatitis B Immune Globulin (Human) 15-18%

Vía de administración:

INTRAMUSCULAR

tipo de receta:

Prescription Only

Fabricado por:

Grifols Therapeutics LLC

Estado de Autorización:

ACTIVE

Fecha de autorización:

2008-07-15

Información para el usuario

Significant inactivation of enveloped viruses is achieved at the
time of treatment of solubilized Cohn Fraction II with TNBP/sodium
cholate.
Additionally, the manufacturing process was investigated for its
capacity to decrease the infectivity of an experimental
agent of transmissible spongiform
encephalopathy (TSE), considered as a model for the vCJD and CJD
agents.
22–25
Studies of the HyperHEP B S/D manufacturing process demonstrate that
TSE clearance is achieved during the Pooled Plasma to Effluent III
Fractionation Process (6.7 log
10
). These studies provide reasonable assurance that low levels
of CJD/vCJD agent infectivity, if present in the starting
material, would be removed.
CLINICAL PHARMACOLOGY
Hepatitis B Immune Globulin (Human) provides passive immunization for
individuals exposed to the hepatitis B virus (HBV) as evidenced by a
reduction
in the attack rate of hepatitis B following its use.
1-6
The administration of the usual recommended dose of this immune
globulin generally results in a
detectable level of circulating anti-HBs which persists for
approximately 2 months or longer. The highest antibody (IgG) serum
levels were seen in the
following distribution of subjects studied:
7
DAY
% OF SUBJECTS
____
________________
3
38.9%
7
41.7%
14
11.1%
21
8.3%
Mean values for half-life were between 17.5 and 25 days, with the
shortest being 5.9 days and the longest 35 days.
7
Cases of type B hepatitis are rarely seen following exposure to HBV
in persons with preexisting anti-HBs. No confirmed
instance of transmission of
hepatitis B has been associated with this product.
In a clinical study in eight healthy human adults receiving another
hyperimmune immune globulin product treated with solvent/detergent,
Rabies
Immune Globulin (Human), HyperRAB® S/D, prepared by the same
manufacturing process, detectable passive antibody titers
were observed in the
serum of all subjects by 24 hours post injection and persisted
through the 21 day study period. These results suggest that p

Ficha técnica

colors: PMS 287
K/P Corporation
Job No. 92097 / 113099
Client: Grifols Therapeutics LLC
Cat. No. 3062848
Fonts: Stone Serif, Trade Gothic
Edits: reb
Date: 3/23/2022, 2/2/2023
ID: 1,11,15
Size: 7" x 16" (Spec 9028538)
Proof 2
DESCRIPTION
HyperHEP B
®
is a clear or slightly opalescent, and colorless or pale yellow or
light brown 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 chromato