IPV-Boostrix suspension for injection in pre-filled syringe

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PERTACTIN, PERTUSSIS TOXOID, POLIOVIRUS, INACTIVATED, TYPE, MAHONEY STRAIN, MEF, SAUKETT STRAIN, DIPHTHERIA TOXOID, FILAMENTOUS HAEMAGGLUTININ, FHA, TETANUS TOXOID

Available from:

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

ATC code:

J07CA02

INN (International Name):

PERTACTIN 2.5 µg PERTUSSIS TOXOID 8 µg POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) 40 DAgU POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) 8 DAgU POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) 32 DAgU DIPHTHERIA TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) 8 µg TETANUS TOXOID

Pharmaceutical form:

SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Composition:

PERTACTIN 2.5 µg PERTUSSIS TOXOID 8 µg POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) 40 DAgU POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) 8 DAgU POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) 32 DAgU DIPHTHERIA TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) 8 µg TETANUS TOXOID

Prescription type:

POM

Therapeutic area:

VACCINES

Authorization status:

Authorised

Authorization date:

2008-07-02

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
IPV-BOOSTRIX, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Diphtheria, tetanus, pertussis (acellular component) and poliomyelitis
(inactivated) 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 IPV-Boostrix is and what it is used for
2.
What you need to know before you or your child receive IPV-Boostrix
3.
How IPV-Boostrix is given
4.
Possible side effects
5.
How to store IPV-Boostrix
6.
Contents of the pack and other information
1.
WHAT IPV-BOOSTRIX IS AND WHAT IT IS USED FOR
IPV-Boostrix is a vaccine used as a booster dose in children from 3
years onwards, teenagers and
adults to prevent four diseases: diphtheria, tetanus (lockjaw),
pertussis (whooping cough) and
poliomyelitis (polio). 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 m

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
IPV-Boostrix suspension for injection in pre-filled syringe
Diphtheria, tetanus, pertussis (acellular, component) and
poliomyelitis (inactivated) 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
Inactivated poliovirus
type 1 (Mahoney strain)²
40 D-antigen unit
type 2 (MEF-1 strain)²
8 D-antigen unit
type 3 (Saukett strain)²
32 D-antigen unit
1
adsorbed on aluminium hydroxide, hydrated (Al(OH)
3
)
0.3 milligrams Al
3+
and aluminium phosphate (AlPO
4
)
0.2 milligrams Al
3+
² propagated in VERO cells
The vaccine may contain traces of formaldehyde, neomycin and polymyxin
which
are used during the manufacturing process (see section 4.3).
Excipients with known effect
The vaccine contains para-aminobenzoic acid < 0.07 nanograms per dose
and phenylalanine 0.0298
micrograms per dose (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
IPV-Boostrix is a turbid white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IPV-Boostrix is indicated for booster vaccination against diphtheria,
tetanus, pertussis and
poliomyelitis of individuals from the age of three years onwards (see
section 4.2).
IPV-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 IPV-Boostrix should be based on official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
3
Posology
A single 0.5 ml dose of the vaccine is recommended.
IPV-Boostrix may be administered from the age of three years onwards.
IPV-Boostrix