Engerix B 20 micrograms/1 ml Suspension for injection in pre-filled syringe Hepatitis B (rDNA) vaccine (adsorbed) (HBV)

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Hepatitis b surface antigen, recominant

Disponibbli minn:

GlaxoSmithKline (Ireland) Limited

Kodiċi ATC:

J07BC; J07BC01

INN (Isem Internazzjonali):

Hepatitis b surface antigen, recominant

Dożaġġ:

20/1 microgram(s)/millilitre

Għamla farmaċewtika:

Suspension for injection in pre-filled syringe

Tip ta 'preskrizzjoni:

Product subject to prescription which may not be renewed (A)

Żona terapewtika:

Hepatitis vaccines; hepatitis B, purified antigen

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

1998-06-26

Fuljett ta 'informazzjoni

502796
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 hepatitis B one out of 10 adults and up to nine
out of 10 babies will become carriers of the virus and are likely to
go on
to develop serio

Karatteristiċi tal-prodott

Health Products Regulatory Authority
11 May 2023
CRN00DKK3
Page 1 of 9
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 A1
3+
2
Produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant
DNA technology
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
Turbid white suspension.
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 microgram/1 ml) is intended for use in subjects 16 years
of age and above. ENGERIX B (10 microgram/0.5 ml) is
intended for use in subjects up to and including 15 years of age.
However, ENGERIX B (20 micrograms1 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:
A 0, 1, 6 months schedule which gives optimal protection at month 7
and produces high antibody concentrations.
An accelerated schedule, with immun