HAVRIX JUNIOR 720

Ország: Malajzia

Nyelv: angol

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

Aktív összetevők:

HEPATITIS A VIRAL ANTIGEN

Beszerezhető a:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (nemzetközi neve):

HEPATITIS A VIRAL ANTIGEN

db csomag:

1ml1Units mL

Gyártó:

GLAXOSMITHKLINE BIOLOGICALS S.A

Betegtájékoztató

INTERNATIONAL DATA SHEET VERSION 3.2 4 ( 16 04 / 03 07 / 2005 2007 )
HAVRIX™ 1440 ADULT / 720 JUNIOR
1 - NAME OF THE MEDICINAL PRODUCT
HAVRIX™ 1440 ADULT
HAVRIX™ 720 JUNIOR
2 - QUALITATIVE AND QUANTITATIVE COMPOSITION
HAVRIX™ hepatitis A virus vaccine is a sterile suspension containing
formaldehyde-
inactivated hepatitis A virus (HM175 hepatitis A virus strain)
adsorbed onto
aluminium hydroxide.
The virus is propagated in MRC
5
human diploid cells. Before viral extraction the cells
are extensively washed to remove culture medium constituents. A virus
suspension is
then obtained by lysis of the cells followed by purification using
ultrafiltration
techniques and gel chromatography. The virus is inactivated with
formaldehyde
HAVRIX™ meets the World Health Organisation requirements for the
Hepatitis A
vaccine (inactivated).
HAVRIX™ contains a purified sterile suspension of inactivated
hepatitis A virus; the
viral antigen content is determined by an ELISA test.
HAVRIX™ 1440 ADULT is standardised to ensure a viral antigen content
of not less than
1440 ELISA Units (El.U.) of viral antigens per 1.0 ml.
HAVRIX™ 720 JUNIOR is standardised to ensure a viral antigen content
of not less than
720 El.U. of viral antigens per 0.5 ml.
3 - PHARMACEUTICAL FORM
Suspension for injection.
4 - CLINICAL PARTICULARS
4.1 THERAPEUTIC 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 virus 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 travelling 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

Termékjellemzők

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