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

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

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

Dostopno od:

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

Koda artikla:

J07AJ52

INN (mednarodno ime):

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

Farmacevtska oblika:

SUSPENSION FOR INJECTION

Sestava:

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

Tip zastaranja:

POM

Terapevtsko območje:

VACCINES

Status dovoljenje:

Withdrawn

Datum dovoljenje:

2008-07-02

Navodilo za uporabo

PAGE 1 OF 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
BOOSTRIX, SUSPENSION FOR INJECTION
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 cause bone
fractures of the sp

Lastnosti izdelka

PAGE 1 OF 13
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE 2 OF 13
1.
NAME OF THE MEDICINAL PRODUCT
Boostrix suspension for injection
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+
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
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 not intended for primary immunisation.
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.
PAGE 3 OF 13
Boostrix should be administered in accordance with official
recommendations and/or local practice
regarding the use of vaccines that provide low (adult) dose
diphtheria, tetanus and pertussis
antigens.
In subjects

40 years of age that had not received any diphtheria or tetanus
containing vaccine in
the past 20 years, one dose of Boostrix induces an antibody response
against pertussis and protects
against tetanus and diphtheria in the majority of cases. Two
additional doses of a diphtheria and
tetanus containing vaccine will maximize the vaccine response against
diphtheria and tetanus when
administered one and six months after the first dose (see section
5.1).
Boostrix can be used in the management of tetanus prone injuries in
persons who have previousl