Havrix 1440 suspension for injection

Krajina: Arménsko

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktívna zložka:

hepatitis A vaccine inactivated

Dostupné z:

GlaxoSmithKline Biologicals s.a.

ATC kód:

J07BC02

INN (Medzinárodný Name):

hepatitis A vaccine inactivated

Dávkovanie:

1440 ELISA U/ml

Forma lieku:

suspension for injection

Počet v balení:

1ml glass vial

Typ predpisu:

Prescription

Stav Autorizácia:

Registered

Dátum Autorizácia:

2016-12-30

Príbalový leták

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.
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, 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 partne