HAVRIX 1440 VACCINE (1ML/VIAL)

Država: Malezija

Jezik: angleščina

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivna sestavina:

HEPATITIS A VIRAL ANTIGEN

Dostopno od:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (mednarodno ime):

HEPATITIS A VIRAL ANTIGEN

Enote v paketu:

3ml25Units mL; 3ml1Units mL

Izdeluje:

GLAXOSMITHKLINE BIOLOGICALS S.A

Lastnosti izdelka

Havrix ® 1440 Adult / 720 Junior
Inactivated hepatitis A vaccine
QUALITATIVE AND QUAN TITATIVE COMPOSITION
One dose (1.0 ml) of Havrix 1440 Adult contains :
Hepatitis A virus (inactivated) 1,2 1440 ELISA Units
(HM175 hepatitis A virus strain) 1Produced on human diploid (MRC -5) cells 2Adsorbed on aluminium hydroxide, hydrated 0.50 milligrams Al 3+
One dose (0.5 ml) of Havrix 720 Junior contains
Hepatitis A virus (inactivated) 1,2 720 ELISA Units 1Produced on human diploid (MRC -5) cells 2Adsorbe d on aluminium hydroxide, hydrated 0.25 milligrams Al 3+
Turbid liquid suspension. Upon storage, a fine white deposit with a clear colourless
supernatant can be observed.
PHARMACEUTICAL FORM
Suspension for injection.
CLINICAL PARTICULARS
Indications
Havrix is indicated for active immunisation against hepatitis A virus (HAV) infection
in subjects at risk of exposure to HAV.
Havrix will not prevent hepatitis infection caused by other agents such as hepatitis B
virus, hepatitis C virus, hepatitis E viru s or other pathogens known to infect the liver.
In areas of low to intermediate prevalence of hepatitis A, immunisation with Havrix
is particularly recommended in subjects who are, or will be, at increased risk of
infection such as:
Travellers . Persons tr avelling to areas where the prevalence of hepatitis A is high.
These areas include Africa, Asia, the Mediterranean basin, the Middle East,
Central and South America.
Armed Forces . Armed Forces personnel who travel to higher endemicity areas or
to areas w here hygiene is poor have an increased risk of HAV infection. Active
immunisation is indicated for these individuals.
Persons for whom hepatitis A is an occupational hazard or for whom there is an
increased risk of transmission . These include employees in day -care centres,
nursing, medical and paramedical personnel in hospitals and institutions, especially