Engerix B (vials) Suspension for Injection 20mcg/ml

מדינה: מלטה

שפה: אנגלית

מקור: Malta Medicines Authority

מרכיב פעיל:

HEPATITIS B SURFACE ANTIGEN, RECOMBINANT

זמין מ:

Smithkline Beecham Limited

קוד ATC:

J07BC01

INN (שם בינלאומי):

HEPATITIS B SURFACE ANTIGEN, RECOMBINANT

טופס פרצבטיות:

SUSPENSION FOR INJECTION

הרכב:

HEPATITIS B SURFACE ANTIGEN, RECOMBINANT 20 µg/l

סוג מרשם:

POM

איזור תרפויטי:

VACCINES

מצב אישור:

Authorised

עלון מידע

Adult Vials
Reason for update: Vial Carton tray registration
Agency Approval Date: 04/10/2017
Text Date: 17/06/2016
Text Issue 4 Draft No.:1
- 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, sic

מאפייני מוצר

Page 1 of 14
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 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
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 _
Page 2 of 14
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