Engerix B 10mcg/0.5ml Susp for Inj in pre-filled syringe/ Hepatitis B (rDNA) vaccine adsorbed (HBV)

Land: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

HEPATITIS B, SURFACE ANTIGEN, RECOMBINANT

Fáanlegur frá:

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

ATC númer:

J07BC01

INN (Alþjóðlegt nafn):

HEPATITIS B SURFACE ANTIGEN, RECOMBINANT 10 µg

Lyfjaform:

SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Samsetning:

HEPATITIS B SURFACE ANTIGEN, RECOMBINANT 10 µg

Gerð lyfseðils:

POM

Lækningarsvæði:

VACCINES

Leyfisstaða:

Authorised

Leyfisdagur:

2006-10-31

Upplýsingar fylgiseðill

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2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENGERIX B 10 MICROGRAMS/0.5 ML, SUSPENSION FOR INJECTION
Hepatitis B (rDNA) vaccine (adsorbed) (HBV)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU/YOUR CHILD 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/your child only. Do not pass
it on to others.
•
If you/your child get any side effects, talk to your doctor or
pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
In this leaflet, any reference to ‘you’ can also mean ‘your
child’.
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 new born babies, children and adolescents
up to and including 15 years
of age.
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.

Vara einkenni

1
SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
ENGERIX B 10 micrograms/0.5 ml
Suspension for injection in pre-filled syringe
Hepatitis B (rDNA) vaccine (adsorbed) (HBV)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
Hepatitis B surface antigen
1, 2
10 micrograms
1
Adsorbed on aluminium hydroxide, hydrated
Total: 0.25 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 in neonates, infants, children and adolescents
up to and including 15 years of
age for active immunisation against hepatitis B virus infection (HBV)
caused by all known subtypes in
non-immune subjects. 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 (10 µg/0.5 ml) is intended for use in subjects up to and
including 15 years of age,
including neonates. ENGERIX B (20 µg/1 ml) is intended for use in
subjects 16 years of age and
above.
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
section 5.1 and SmPC for ENGERIX B (20
µ
g/1 ml)).
_Primary Immunisation schedules _
-
Subjects up to and including 15 years of age:
Two primary immunisation schedules can be recommended:
3
A 0, 1, 6 months schedule which gives optimal protection at month 7
and produces high anti