HAVRIX 1440 ADULT

Riik: Indoneesia

keel: indoneesia

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

Toimeaine:

INACTIVATED HEPATITIS A VIRUS

Saadav alates:

GLAXO WELLCOME INDONESIA - Indonesia

INN (Rahvusvaheline Nimetus):

INACTIVATED HEPATITIS A VIRUS

Annus:

1440 ELISA UNIT

Ravimvorm:

SUSPENSI INJEKSI

Ühikuid pakis:

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

Valmistatud:

GlaxoSmithKline Biologicals SA - Belgium

Loa andmise kuupäev:

2021-12-23

Toote omadused

FAW_ leaHAVpfs_OnePFS+newGSK logo_circ1_21Nov22 – for submission
_Page 1 of 6 _
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.
Pada proses pembuatannya bersinggungan dengan bahan bersumber babi
CLINICAL INFORMATION
INDICATIONS
_HAVRIX_ is indicated for active immunization 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,
immunization 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
immunization 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,