HAVRIX JUNIOR VACCINE 720 elisa units0.5 ml

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

HEPATITIS A VIRUS INACTIVATED

Dostupné z:

GLAXOSMITHKLINE PTE LTD

ATC kód:

J07BC02

Dávkovanie:

720 elisa units/0.5ml

Forma lieku:

INJECTION

Zloženie:

HEPATITIS A VIRUS INACTIVATED 720 elisa units/0.5ml

Spôsob podávania:

INTRAMUSCULAR

Typ predpisu:

Prescription Only

Výrobca:

GSK Biologicals, Branch of SmithKline Beecham Pharma GmbH & Co. KG (primary packager)

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

1998-05-04

Príbalový leták

1
Proposed Package Insert (updated 1Jun12)   

HAVRIX™ 1440 ADULT / 720 JUNIOR 
INACTIVATED HEPATITIS A VACCINE

QUALITATIVE AND QUANTITATIVE COMPOSITION

Suspension for injection. 
One dose (1.0 ml) of Havrix 1440 Adult contains :  
Hepatitis A virus (inactivated)
1,2

1440 ELISA Units 
1
Produced on human diploid (MRC-5) cells 
2
Adsorbed 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 
1
Produced on human diploid (MRC-5) cells 
2
Adsorbed 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 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 Forces.  Armed Forces personnel who
travel to higher endemicity areas or 
to areas where 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

Súhrn charakteristických

1
HAVRIX 1440 ADULT / 720 JUNIOR
INACTIVATED HEPATITIS A VACCINE
SUSPENSION FOR INJECTION
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (1.0 mL) of Havrix 1440 Adult contains:
Hepatitis A virus (inactivated)
1,2
1440 ELISA Units
1
Produced on human diploid (MRC-5) cells
2
Adsorbed 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
1
Produced on human diploid (MRC-5) cells
2
Adsorbed 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.
CLINICAL INFORMATION
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 Forces. Armed Forces personnel who travel to higher endemicity
areas or
to areas where 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
gastroenterology
and
paediatric
units,
sewage
workers,
food
handlers,
among
others.
Persons at increased risk due to their sexual behaviour. Homosexuals,_
_persons with
multiple sexual partners.
Haemophiliacs.
Abusers of Injecta