Tritanrix HepB

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

Diphtheria toxoid, hepatitis B surface antigen, Bordetella pertussis (inactivated), tetanus toxoid

Beschikbaar vanaf:

GlaxoSmithKline Biologicals S.A.

ATC-code:

J07CA05

INN (Algemene Internationale Benaming):

diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)

Therapeutische categorie:

Vaccines

Therapeutisch gebied:

Hepatitis B; Tetanus; Immunization; Whooping Cough; Diphtheria

therapeutische indicaties:

Tritanrix HepB is indicated for active immunisation against diphtheria, tetanus, pertussis and hepatitis B (HBV) in infants from six weeks onwards (see section 4.2).

Product samenvatting:

Revision: 15

Autorisatie-status:

Withdrawn

Autorisatie datum:

1996-07-19

Bijsluiter

Medicinal product no longer authorised
31
B. PACKAGE LEAFLET
Medicinal product no longer authorised
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRITANRIX HEPB SUSPENSION FOR INJECTION
Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis
B (rDNA) (HBV) vaccine (adsorbed)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS RECEIVING
THIS VACCINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or your pharmacist.
-
This vaccine has been prescribed for your child. Do not pass it on to
others.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Tritanrix HepB is and what it is used for
2.
Before your child receives Tritanrix HepB
3.
How Tritanrix HepB is given
4.
Possible side effects
5.
How to store Tritanrix HepB
6.
Further information
1.
WHAT TRITANRIX HEPB IS AND WHAT IT IS USED FOR
Tritanrix HepB is a vaccine used in children to prevent four diseases:
diphtheria, tetanus (lockjaw), pertussis
(whooping cough) and hepatitis B. The vaccine works by causing the
body to produce its own protection
(antibodies) against these diseases.
•
DIPHTHERIA
: Diphtheria mainly affects the airways and sometimes the skin.
Generally the airways
become inflamed (swollen) causing severe breathing difficulties and
sometimes suffocation. The bacteria
also release a toxin (poison), which can cause nerve damage, heart
problems, and even death.
•
TETANUS
(Lockjaw): Tetanus bacteria enter the body through cuts, scratches or
wounds in the skin.
Wounds that are especially prone to infection are burns, fractures,
deep wounds or wounds contaminated
with soil, dust, horse manure/dung or wood splinters. The bacteria
release a toxin (poison), which can
cause muscle stiffness, painful muscle spasms, fits and even death.
The muscle spasms can be strong
enough to cause bone fractures of the spine.
•
PERTUSSIS
(Whooping cough): Pertussis is a hig

Productkenmerken

Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Tritanrix HepB, suspension for injection
Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis
B (rDNA) (HBV) vaccine (adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
Diphtheria toxoid
1
not less than 30 IU
Tetanus toxoid
1
not less than 60 IU
_Bordetella pertussis _
(inactivated)
2
not less than 4 IU
Hepatitis B surface antigen
2,3
10 micrograms
1
Adsorbed on aluminium hydroxide, hydrated
0.26 milligrams Al
3+
2
Adsorbed on aluminium phosphate
0.37 milligrams Al
3+
3
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.
Turbid white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tritanrix HepB is indicated for active immunisation against
diphtheria, tetanus, pertussis and hepatitis B
(HBV) in infants from 6 weeks onwards (see
section 4.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
The recommended dose is 0.5 ml.
Primary vaccination:
The primary vaccination schedule consists of three doses within the
first six months of life. Where HBV
vaccine is not given at birth, the combined vaccine can be
administered beginning as early as 8 weeks of age.
Where there is
a high endemicity of HBV, the practice to administer HBV vaccine at
birth should be
continued. In these circumstances, vaccination with the combined
vaccine should start at 6 weeks of age.
Three vaccine doses must be administered at intervals of at least 4
weeks.
When Tritanrix HepB is given according to the 6-10-14 weeks schedule,
it is recommended to
administer a dose of HBV vaccine at birth to improve protection.
In the case of children born of known HBV carrier mothers the
immunoprophylactic measures for hepatitis B
should not be modified. This may require separate vaccination with HBV
and DTPw