Engerix B 20mcg/ml Susp for Inj in pre-filled syringe/ Hepatitis B (rDNA) vaccine adsorbed (HBV)

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

HEPATITIS B, SURFACE ANTIGEN, RECOMBINANT

Tilgjengelig fra:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC-kode:

J07BC01

INN (International Name):

HEPATITIS B SURFACE ANTIGEN, RECOMBINANT 20 µg

Legemiddelform:

SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Sammensetning:

HEPATITIS B SURFACE ANTIGEN, RECOMBINANT 20 µg

Resept typen:

POM

Terapeutisk område:

VACCINES

Autorisasjon status:

Authorised

Autorisasjon dato:

2006-10-31

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENGERIX B 20 MICROGRAMS/1 ML, SUSPENSION FOR INJECTION
Hepatitis B (rDNA) vaccine (adsorbed) (HBV)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS
VACCINE
BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This vaccine has been prescribed for you only. Do not pass it on to
others.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1 What Engerix B is and what it is used for
2 What you need to know before you receive Engerix B
3 How Engerix B is given
4 Possible side effects
5 How to store Engerix B
6 Contents of the pack and other information
1
WHAT ENGERIX B IS AND WHAT IT IS USED FOR
Engerix B is a vaccine used to prevent hepatitis B infection. It can
also help to prevent
hepatitis D infection.
This vaccine can be given to both adults and adolescents 16 years of
age and over. In
exceptional circumstances it can also be given to children and
adolescents 11 to 15 years of
age (see section 3).
Hepatitis B is an infectious illness of the liver caused by a virus.
Some people have the
hepatitis B virus in their body but cannot get rid of it. They can
still infect other people and
are known as carriers. The disease is spread by the virus entering the
body following contact
with body fluids, most often blood, from an infected person.
If the mother is a carrier of the virus she can pass the virus to her
baby at birth. It is also
possible to catch the virus from a carrier through, for example,
unprotected sex, shared
injection needles or treatment with medical equipment which has not
been properly
sterilised.
The main signs of the illness include headache, fever, sickness and
jaundice (yellowing of
the skin and eyes) but in about three out of 10 patients there are no
signs of illness.
In those infected with hep

Preparatomtale

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ENGERIX B 20 micrograms/1 ml
Suspension for injection in pre-filled syringe
Hepatitis B (rDNA) vaccine (adsorbed) (HBV)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (1 ml) contains:
Hepatitis B surface antigen
1, 2
20 micrograms
1
Adsorbed on aluminium hydroxide, hydrated
Total: 0.50 milligrams Al
3+
2
Produced in yeast cells (
_Saccharomyces cerevisiae_
) by recombinant DNA technology
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
The suspension is turbid white.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ENGERIX B is indicated for active immunisation against hepatitis B
virus infection (HBV) caused by
all known subtypes in non immune subjects 16 years of age and above.
The categories within the
population to be immunised are determined on the basis of official
recommendations.
It can be expected that hepatitis D will also be prevented by
immunisation with ENGERIX B as
hepatitis D (caused by the delta agent) does not occur in the absence
of hepatitis B infection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Dosage _
_ _
ENGERIX B (20 µg/1 ml) is intended for use in subjects 16 years of
age and above. ENGERIX B (10
µg/0.5 ml) is intended for use in subjects up to and including 15
years of age.
However, ENGERIX B (20 µg/1 ml) can also be used in subjects from 11
years up to and including
15 years of age as a 2-dose schedule in situations when there is a low
risk of hepatitis B infection
during the vaccination course, and when compliance with the complete
vaccination course can be
assured (see below and section 5.1).
_Primary Immunisation schedules _
_ _
-
Subjects 16 years of age and above:
Two primary immunisation schedules can be recommended:
2
A 0, 1, 6 months schedule which gives optimal protection at month 7
and produces high antibody
concentrations.
An accelerated schedule, with immunisation at 0, 1 and 2 months, which
will confer protection m