Engerix B 10mcg/0.5ml (vial) Susp for Inj / Hepatitis B (rDNA) vaccine adsorbed (HBV)

Երկիր: Մալթա

Լեզու: անգլերեն

Աղբյուրը: Medicines Authority

Ակտիվ բաղադրիչ:

HEPATITIS B, SURFACE ANTIGEN, RECOMBINANT

Հասանելի է:

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

ATC կոդը:

J07BC01

INN (Միջազգային անվանումը):

HEPATITIS B SURFACE ANTIGEN, RECOMBINANT 20 µg/l

Դեղագործական ձեւ:

SUSPENSION FOR INJECTION

Կազմը:

HEPATITIS B SURFACE ANTIGEN, RECOMBINANT 20 µg/l

Ռեկվիզորի տեսակը:

POM

Թերապեւտիկ տարածք:

VACCINES

Լիազորման կարգավիճակը:

Withdrawn

Հաստատման ամսաթիվը:

2006-10-31

Տեղեկատվական թերթիկ

- 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/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.
In t

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Engerix B 20 micrograms/1 ml
Suspension for injection
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
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.
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 The 20 µg
dose
vaccine in 1.0 ml suspension is intended for use in subjects 16 years
of age and above.
The 10 µg dose vaccine in 0.5 ml suspension is intended for use in
subjects up to and
including 15 years of age, including neonates. 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 _
The 20 µg dose vaccine in 1.0 ml suspension is intended for use in
subjects 16 years
of age and above. The 10 µg dose vaccine in 0.5 ml suspension is
intended for use in
subjects up to and including 15 years of age, including neonates.
However, the 20 µg vaccine 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 vaccina