AVAXIM 160 ANTIGEN UNITS/0.5ML SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

País: Chipre

Língua: grego

Origem: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Ingredientes ativos:

HEPATITIS A VIRUS (GBM STRAIN) INACTIVATED

Disponível em:

SANOFI PASTEUR. (0000010487) 14 ESPACE HENRY VALLEE, LYON, 69007

Código ATC:

J07BC02

DCI (Denominação Comum Internacional):

HEPATITIS A, INACTIVATED, WHOLE VIRUS

Dosagem:

160 ANTIGEN UNITS/0.5ML

Forma farmacêutica:

SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Composição:

HEPATITIS A VIRUS (GBM STRAIN) INACTIVATED (8000003025) 160U

Via de administração:

INTRAMUSCULAR USE

Tipo de prescrição:

Εθνική Διαδικασία

Área terapêutica:

HEPATITIS A, INACTIVATED, WHOLE VIRUS

Resumo do produto:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 1 PRE-FILLED SYRIGNE X 0.5ML (970040701) 1 SYRINGE - Εγκεκριμένο - Με Ιατρική Συνταγή

Folheto informativo - Bula

IIIB
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
AVAXIM 160U, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE
HEPATITIS A VACCINE (INACTIVATED, ADSORBED)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE VACCINATED.
-
Keep this leaflet until you have completed the vaccination schedule.
You may need to read it
again.
-
Follow carefully the advice of your doctor or nurse. If you need more
information or advice,
please ask you doctor or nurse.
-
Make sure you complete the full vaccination schedule. Otherwise, you
may not fully
protected.
WHAT IS IN THIS LEAFLET
1. What Avaxim 160U is and what it is used for
2. What you need to know before you use Avaxim 160U
3. How to use Avaxim 160U
4. Possible side effects
5. How to store Avaxim 160U
6. Contents of the pack and other information
1.
WHAT AVAXIM 160U IS AND WHAT IT IS USED FOR
This medicinal product is a VACCINE in the form of a suspension for
injection (0.5 ml in a prefilled
syringe with or without needles in a box of 1, 5, 10 or 20)
This vaccine is indicated for the prevention of infection caused by
the hepatitis A virus in adolescents
from 16 years of age and in adults.
It does not protect against infection due to other types of hepatitis
virus or other known pathogens of
the liver.
This vaccine should be administered in accordance with official
recommendations.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AVAXIM 160U
DO NOT USE AVAXIM 160U
- in the event of fever, acute disease, progressive chronic disease
(it is preferable to postpone
vaccination).
- in the event of allergy to one of the vaccine components or
following a previous injection.
TAKE SPECIAL CARE WITH AVAXIM 160 U
-
do not inject by the intravascular route: ensure that the needle does
not penetrate a blood vessel;
-
this vaccine is not to be injected into the buttocks (due to the
presence of varying amounts of
adipose tissue), nor administered intradermally, since these methods
of administration may induce
a weaker immune response;
-
immunosuppressant treatment or a state of immune deficiency

Características técnicas

1
N
AME
OF
THE
MEDICINAL
PRODUCT
AVAXIM 160 U, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE
HEPATITIS A VACCINE (INACTIVATED, ADSORBED)
2
Q
UALITATIVE
AND
QUANTITATIVE
COMPOSITION
One dose (0.5 ml) contains:
Hepatitis A virus, GBM strain* (inactivated**)
.................................................... 160 units***
* cultured on MRC-5
human diploid cells
** adsorbed on aluminium hydroxide (quantity corresponding to 0.3 mg
of aluminium)
*** antigen units measured using an in-house manufacturer’s
reference.
For the full list of excipients, see section 6.1
3
P
HARMACEUTICAL
FORM
Suspension for injection in a prefilled syringe.
4
C
LINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This vaccine is indicated for active immunisation against infection
caused by the hepatitis A virus
in adolescents from 16 years of age and in adults.
The vaccine does not protect against infection caused by hepatitis B,
hepatitis C, or hepatitis E
viruses, or any other known liver pathogens.
Transmission of the hepatitis A virus is usually through the ingestion
of contaminated water or
food. Persons in contact with contaminated subjects are usually
infected through the oro-faecal
route.
The possibility of transmission by blood or by sexual contact
(oral-anal relations) has also been
demonstrated.
This vaccine should be administered in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage for subjects from 16 years of age is 0.5 ml.
The initial protection is obtained after one single injection.
In order to obtain a long-term protection against infections caused by
the Hepatitis A virus, in
adolescents from 16 years of age and in adults, a booster dose should
be administered, preferably
between 6 and 12 months after the first vaccination and can be
administered up to 36 months after
the first vaccination (see section 5.1). It is estimated that anti-VHA
antibodies persist several
years (at least 10 years) after the second dose (booster).
This vaccine can also be administered a