ENGERIX-B (PEDIATRIC)

Krajina: Indonézia

Jazyk: indonézština

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

Aktívna zložka:

HEPATITIS B SURFACE ANTIGEN

Dostupné z:

GLAXO WELLCOME INDONESIA - Indonesia

INN (Medzinárodný Name):

HEPATITIS B SURFACE ANTIGEN

Dávkovanie:

10 MCG

Forma lieku:

SUSPENSI INJEKSI

Počet v balení:

DUS,1 PREFILLED SYRINGE @ 1 DOSIS ( 0,5 ML )

Výrobca:

GlaxoSmithKline Biologicals SA - Belgium

Dátum Autorizácia:

2021-12-31

Súhrn charakteristických

FAW_ leaENGinj_
PI udpate GDS17 IPI13 (OnePFS)
+newGSK logo_circ1_23Nov22 – for submission
_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, t