ENGERIX-B (ADULT)

Country: Ինդոնեզիա

language: ինդոնեզերեն

source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

active_ingredient:

HEPATITIS B VACCINE

MAH:

SMITHKLINE BEECHAM PHARMACEUTICALS - Indonesia

INN:

HEPATITIS B VACCINE

dosage:

20 MCG

pharmaceutical_form:

SUSPENSI INJEKSI

units_in_package:

DUS, 1 VIAL @ 1 DOSIS (1 ML)

manufactured_by:

GlaxoSmithKline Biologicals SA - Belgium

authorization_date:

2020-04-22

SPC

ERS_leaENGinj_MA Transfer SBP to GWI (Project Rinjani)_circ1_3Nov21
_Page 1 of 8 _
_ENGERIX-B _
HEPATITIS B (RDNA) VACCINE (ADSORBED)
SUSPENSION FOR INJECTION
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 ΜG DOSE VACCINE
1 dose (0.5 mL) contains:
Hepatitis B surface antigen
1, 2
10 micrograms
1
Adsorbed on aluminium hydroxide, hydrated
Total: 0.25 milligrams Al
3+
2
Produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant
DNA technology
20 ΜG DOSE VACCINE
1 dose (1 mL) contains:
Hepatitis B surface antigen
1, 2
20 micrograms
1
Adsorbed on aluminium hydroxide, hydrated
Total: 0.50 milligrams Al
3+
2
Produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant
DNA technology
The vaccine is highly purified, and exceeds the WHO requirements for
recombinant hepatitis B
vaccines. No substances of human origin are used in its manufacture.
Turbid white suspension.
Upon storage, a fine white deposit with a clear colourless supernatant
may be observed.
CLINICAL INFORMATION
INDICATIONS
_ENGERIX-B_ is indicated for active immunization against hepatitis B
virus (HBV) infection caused by all
known subtypes in subjects of all ages considered at risk of exposure
to HBV. It can be expected that
hepatitis D will also be prevented by immunization with _ENGERIX-B _as
hepatitis D (caused by the delta
agent) does not occur in the absence of hepatitis B infection.
Immunization against hepatitis B is expected in the long term to
reduce not only the incidence of this
disease, but also its chronic complications such as chronic active
hepatitis B and hepatitis B
associated cirrhosis.
In areas of LOW PREVALENCE of hepatitis B, immunization is
particularly recommended for those
belonging to groups identified at increased risk of infection (see
below), however, universal
immunization of all infants and adolescents will contribute to the
control of hepatitis B on a population
basis.
In areas of INTERMEDIATE AND HIGH PREVALENCE of hepatitis B, with most
of the population at risk of
acquiring the HBV, the best strategy is to pr