HBVAXPRO INJECTION 10 MCGML

Country: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

PROTEIN (HBsAg)

Доступно од:

MSD PHARMA (SINGAPORE) PTE. LTD.

АТЦ код:

J07BC01

Дозирање:

10 MCG/ML

Фармацеутски облик:

INJECTION

Састав:

PROTEIN (HBsAg) 10 MCG/ML

Пут администрације:

INTRAMUSCULAR

Тип рецептора:

Prescription Only

Произведен од:

Merck Sharp & Dohme LLC

Статус ауторизације:

ACTIVE

Датум одобрења:

2005-04-14

Информативни летак

 
SG- HB2-I- 122011 

PHYSICIANS CIRCULAR 

Injection 

HBVAXPRO
®

(hepatitis B vaccine [recombinant] thimerosal-free, MSD) 

HBvaxPRO
®
 (hepatitis B vaccine [recombinant] thimerosal-free, MSD) is a
non-infectious 
subunit viral vaccine consisting of surface antigen (HBsAg or
Australia antigen) of hepatitis B 
virus produced in yeast cells. A portion of the hepatitis B virus
gene, coding for HBsAg, is 
cloned into yeast and the vaccine for hepatitis B is produced
from cultures of this recombinant 
yeast strain according to methods developed in the Merck Research
Laboratories. 

The antigen is harvested and purified from fermentation cultures
of a recombinant strain of 
the yeast _Saccharomyces cerevisiae_ containing the gene for
the _adw_ subtype of HBsAg.  The 
HBsAg protein is released from the yeast cells by cell disruption and
purified by a series of 
physical and chemical methods.  Each dose contains less than 1%
yeast protein. The purified 
protein is treated in phosphate buffer with formaldehyde and
then coprecipitated with alum 
(potassium aluminum sulfate) to form bulk vaccine adjuvanted with
amorphous aluminum 
hydroxyphosphate sulfate (previously referred to as aluminum
hydroxide). The vaccine 
produced by the Merck method has been shown to be comparable to
the plasma-derived 
vaccine in terms of protective efficacy (chimpanzee and human).  

The vaccine against hepatitis B, prepared from recombinant yeast
cultures, is free of 
association with human blood or blood products.  

Each lot of hepatitis B vaccine is tested for sterility. 

HBvaxPRO is a sterile suspension for intramuscular injection;
however, it may be 
administered subcutaneously to persons at risk of hemorrhage
following intramuscular 
injections (see DOSAGE AND ADMINISTRATION).  

HBvaxPRO (hepatitis B vaccine [recombinant] thimerosal-free, MSD) is
supplied in three 
formulations: 
 
Pediatric/ Adolescent Formulat

Карактеристике производа

SG-V232-I-052018
PHYSICIANS CIRCULAR
Injection
HBvaxPRO®
(hepatitis B vaccine [recombinant] thimerosal-free, MSD)
HBvaxPRO® (hepatitis B vaccine [recombinant] thimerosal-free, MSD) is
a non-infectious
subunit viral vaccine consisting of surface antigen (HBsAg or
Australia antigen) of hepatitis B
virus produced in yeast cells. A portion of the hepatitis B virus
gene, coding for HBsAg, is
cloned into yeast and the vaccine for hepatitis B is produced from
cultures of this recombinant
yeast strain according to methods developed in the Merck Research
Laboratories.
The antigen is harvested and purified from fermentation cultures of a
recombinant strain of the
yeast
Saccharomyces cerevisiae
containing the gene for the
adw
subtype of HBsAg. The
HBsAg protein is released from the yeast cells by cell disruption and
purified by a series of
physical and chemical methods. Each dose contains less than 1% yeast
protein.
The purified
protein is treated in phosphate buffer with formaldehyde and then
coprecipitated with alum
(potassium aluminum sulfate) to form bulk vaccine adjuvanted with
amorphous aluminum
hydroxyphosphate
sulfate
(previously
referred
to
as
aluminum
hydroxide).
The
vaccine
produced by the Merck method has been shown to be comparable to the
plasma-derived
vaccine in terms of protective efficacy (chimpanzee and human).
The
vaccine
against
hepatitis
B,
prepared
from
recombinant
yeast
cultures,
is
free
of
association with human blood or blood products.
Each lot of hepatitis B vaccine is tested for sterility.
HBvaxPRO is a sterile suspension for intramuscular injection; however,
it may be administered
subcutaneously
to
persons
at
risk
of
hemorrhage
following
intramuscular
injections
(see
DOSAGE AND ADMINISTRATION).
HBvaxPRO (hepatitis B vaccine [recombinant] thimerosal-free, MSD) is
supplied in three
formulations:
•
Pediatric/Adolescent Formulation, 5 mcg of hepatitis B surface antigen
in 0.5 mL dose;
•
Adult Formulation, 10 mcg of hepatitis B surface antigen in 1.0 mL
dose;
•
Dialysis Formulation, 40 mcg of