Boostrix – Suspension for injection. Diphtheria, tetanus and acellular pertussis (adsorbed) vaccine

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PERTACTIN, PERTUSSIS TOXOID, DIPHTHERIA TOXOID, FILAMENTOUS HAEMAGGLUTININ, FHA, TETANUS TOXOID

Available from:

GlaxoSmithKline Biologicals S.A. Rue de L'Institut 89 B-1330 Rixensart, Belgium

ATC code:

J07AJ52

INN (International Name):

DIPHTHERIA TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) 8 µg TETANUS TOXOID PERTUSSIS TOXOID 8 µg PERTACTIN 2.5 µg

Pharmaceutical form:

SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Composition:

DIPHTHERIA TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) 8 µg TETANUS TOXOID PERTUSSIS TOXOID 8 µg PERTACTIN 2.5 µg

Prescription type:

POM

Therapeutic area:

VACCINES

Authorization status:

Authorised

Authorization date:

2008-07-02

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
BOOSTRIX, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Diphtheria, tetanus, and pertussis (acellular, component) vaccine
(adsorbed, reduced antigen(s)
content)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR 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 or your child only. Do not
pass it on to others.
-
If you or 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.
WHAT IS IN THIS LEAFLET
1.
What Boostrix is and what it is used for
2.
What you need to know before you or your child receive Boostrix
3.
How Boostrix is given
4.
Possible side effects
5.
How to store Boostrix
6.
Contents of the pack and other information
1.
WHAT BOOSTRIX IS AND WHAT IT IS USED FOR
Boostrix is a vaccine used as a booster dose in children from 4 years
onwards, teenagers and
adults to prevent three diseases: diphtheria, tetanus (lockjaw) and
pertussis (whooping cough).
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 caus

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Boostrix suspension for injection in pre-filled syringe
Diphtheria, tetanus and pertussis (acellular, component) vaccine
(adsorbed, reduced antigen(s)
content)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
Diphtheria toxoid
1
not less than 2 International Units (IU) (2.5 Lf)
Tetanus toxoid
1
not less than 20 International Units (IU) (5 Lf)
_Bordetella pertussis_
antigens
Pertussis toxoid
1
8 micrograms
Filamentous Haemagglutinin
1
8 micrograms
Pertactin
1
2.5 micrograms
1
adsorbed on aluminium hydroxide, hydrated (Al(OH)
3
)
0.3 milligrams Al
3+
and aluminium phosphate (AlPO
4
)
0.2 milligrams Al
3+
The vaccine may contain traces of formaldehyde which is used during
the manufacturing process
(see section 4.3).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
Boostrix is a turbid white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Boostrix is indicated for booster vaccination against diphtheria,
tetanus and pertussis of
individuals from the age of four years onwards (see section 4.2).
Boostrix is also indicated for passive protection against pertussis in
early infancy following
maternal immunisation during pregnancy (see sections 4.2, 4.6 and
5.1).
The administration of Boostrix should be based on official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
A single 0.5 ml dose of the vaccine is recommended.
Boostrix may be administered from the age of four years onwards.
Boostrix should be administered in accordance with official
recommendations and/or local
practice regarding the use of vaccines with reduced content of
diphtheria, tetanus and pertussis
antigens.
Boostrix can be administered to pregnant women during the second or
the third trimester in
accordance with official recommendations (see sections 4.1, 4.6 and
5.1).
Boostrix may also be administered to adolescents and adults with
unknown vaccination status or