HAVRIX 720 JUNIOR

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

HEPATITIS A IMMUNOGLOBULIN HUMAN

Tersedia dari:

SMITH KLINE BEECHAM PHARMACEUTICAL IND. - Indonesia

INN (Nama Internasional):

HEPATITIS A IMMUNOGLOBULIN HUMAN

Dosis:

720 ELISA UNITS

Bentuk farmasi:

CAIRAN INJEKSI

Unit dalam paket:

DUS, 1 PRE-FILLED SYRINGE @ 0,5 ML (1 DOSIS)

Diproduksi oleh:

GLAXO SMITHKLINE BIOLOGICALS-Belgium

Tanggal Otorisasi:

2017-11-07

Karakteristik produk

_Page 1 of 6 _
HAVRIX 1440 ADULT / 720 JUNIOR
INACTIVATED HEPATITIS A VACCINE
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
PHARMACEUTICAL FORM
Suspension for injection.
CLINICAL PARTICULARS
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, among others.
Persons at increased risk du