Fendrix

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

hepatitis B surface antigen

MAH:

GlaxoSmithKline Biologicals S.A.

ATC_code:

J07BC01

INN:

hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)

therapeutic_group:

Vaccines

therapeutic_area:

Hepatitis B; Immunization

therapeutic_indication:

Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients).

leaflet_short:

Revision: 12

authorization_status:

Authorised

authorization_date:

2005-02-02

PIL

18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET: INFORMATION FOR THE USER
FENDRIX SUSPENSION FOR INJECTION
Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE 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 Fendrix is and what it is used for
2.
What you need to know before you receive Fendrix
3.
How Fendrix is given
4.
Possible side effects
5.
How to store Fendrix
6.
Contents of the pack and other information
1.
WHAT FENDRIX IS AND WHAT IT IS USED FOR
Fendrix is a vaccine which prevents hepatitis B.
It is used for patients with kidney problems:
•
patients having “haemo-dialysis”- where a “dialysis” machine
removes waste products from the
blood
•
patients who are going to have “haemo-dialysis” in the future.
Fendrix is for adults and young people aged 15 years and above.
WHAT IS HEPATITIS B?
Hepatitis B is caused by a virus which makes the liver swollen.
•
Signs may not be seen for 6 weeks to 6 months after infection.
•
The main signs of the illness include mild signs of flu such as
headache or fever, feeling very
tired, dark urine, pale stools (faeces), yellow skin or eyes
(jaundice). These or other signs may
mean the person might need treatment in hospital. Most people fully
recover from the illness.
•
Some people with hepatitis B do not look or feel ill - they do not
have any signs of illness.
•
The virus is found in body fluids such as in the vagina, blood, semen,
or saliva (spit).
CARRIERS OF HEPATITIS B
•
The hepatitis B virus stays in the body of some people all through
their lives.
•
This means they can still infect other people and are k

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Fendrix suspension for injection
Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
Hepatitis B surface antigen
1, 2, 3
20 micrograms
1
adjuvanted by AS04C containing:
- 3-
_O_
-desacyl-4’- monophosphoryl lipid A (MPL)
2
50 micrograms
2
adsorbed on aluminium phosphate (0.5 milligrams Al
3+
in total)
3
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.
Turbid white suspension. Upon storage, a fine white deposit with a
clear colourless supernatant can be
observed.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fendrix is indicated in adolescents and adults from the age of 15
years onwards for active
immunisation against hepatitis B virus infection (HBV) caused by all
known subtypes for patients with
renal insufficiency (including pre-haemodialysis and haemodialysis
patients).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
PRIMARY IMMUNISATION:
The primary immunisation consists of 4 separate 0.5 ml doses
administered at the following schedule:
1 month, 2 months and 6 months from the date of the first dose.
Once initiated, the primary course of vaccination at 0, 1, 2 and 6
months should be completed with
Fendrix, and not with other commercially available HBV vaccine.
BOOSTER DOSE:
As pre-haemodialysis and haemodialysis patients are particularly
exposed to HBV and have a higher
risk to become chronically infected, a precautionary attitude should
be considered i.e. giving a booster
dose in order to ensure a protective antibody level as defined by
national recommendations and
guidelines.
3
Fendrix can be used as a booster dose after a primary vaccination
course with either Fendrix or any
other commercial recombinant hepatitis B vaccine.
SPECIAL POSOLOGY RECOMMENDATION FOR KNOWN OR PRESUMED EXPOSURE TO HBV:
Data on concomitant a