Country: Singapor
Lingwa: Ingliż
Sors: HSA (Health Sciences Authority)
HEPATITIS B SURFACE ANTIGEN PROTEIN (YEAST)
GLAXOSMITHKLINE PTE LTD
J07BC01
10 mcg/0.5 ml
INJECTION
HEPATITIS B SURFACE ANTIGEN PROTEIN (YEAST) 10 mcg/0.5 ml
INTRAMUSCULAR
Prescription Only
GlaxoSmithKline Biologicals S.A.
ACTIVE
1988-07-04
_1 _ _ _ _ENGERIX™-B _ HEPATITIS B (RDNA) VACCINE (ADSORBED) 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. PHARMACEUTICAL FORM Suspension for injection. Turbid white suspension. Upon storage, a fine white deposit with a clear colourless supernatant may be observed. CLINICAL PARTICULARS INDICATIONS ENGERIX™-B is indicated for active immunisation against 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 immunisation with ENGERIX™-B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. Immunisation 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, immunisation is particularly recommended for those belonging to groups identified at increased risk of infection (see below), however, universal immunisation of all infants and adolescents will contribute to the control of hepatitis B on a population basis. _2 _ _ _ In areas of Aqra d-dokument sħiħ
_1 _ _ _ 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 immunisation 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 immunisation with Engerix-B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. Immunisation 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, immunisation is particularly recommended for those belonging to groups identified at increased risk of infection (see below), however, universal immunisation 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 provide universal immunisation of neonates, _2 _ _ _ infants, children and adolesce Aqra d-dokument sħiħ