IPV Infanrix, suspension for injection in pre-filled syringe. Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed)

Country: Malta

Language: English

Source: Medicines Authority

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Patient Information leaflet (PIL)

28-04-2024

Summary of Product characteristics (SPC)

28-04-2024

Active ingredient:

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

Available from:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC code:

J07CA02

INN (International Name):

PERTACTIN 8 µg PERTUSSIS TOXOID 25 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) 25 µg TETANUS TOXOID

Pharmaceutical form:

SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Composition:

Prescription type:

POM

Therapeutic area:

VACCINES

Authorization status:

Withdrawn

Authorization date:

2006-08-14

Patient Information leaflet

IPV INFANRIX, SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE
Diphtheria, tetanus, pertussis (acellular, component) and
poliomyelitis (inactivated) 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
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 IPV Infanrix is and what it is used for
2. Before your child receives IPV Infanrix
3. How IPV Infanrix is given
4. Possible side effects
5. How to store IPV Infanrix
6. Further information
1. WHAT IPV INFANRIX IS AND WHAT IT IS USED FOR
IPV Infanrix is a vaccine used as a booster dose to protect your
child against 4 diseases:
• DIPHTHERIA - a serious bacterial infection that mainly affects
the
airways and sometimes the skin. The airways become swollen
causing serious breathing problems and sometimes suffocation.
The bacteria also release a poison. This can cause nerve damage,
heart problems and even death.
• TETANUS - tetanus bacteria enter the body through cuts,
scratches or wounds in the skin. Wounds that are more likely
to get tetanus infection are burns, fractures, deep wounds or
wounds that have soil, dust, horse manure or wood splinters
in them. The bacteria release a poison. This 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.
• WHOOPING COUGH (PERTUSSIS) - a highly infectious illness that
affects the airways. It causes severe coughing that may lead to
problems with breathing. The coughing often has a ‘whooping’
sound. The cough may last for one to two months or longer.
Whooping cough can also cause ear infections, chest infections
(bronchitis) which ma

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Summary of Product characteristics

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS

1.
NAME OF THE MEDICINAL PRODUCT

IPV Infanrix, suspension for injection in pre-filled syringe
Diphtheria,  tetanus,  pertussis  (acellular,  component)  and  poliomyelitis  (inactivated)  vaccine
(adsorbed)

2.
QUALITATIVE AND QUANTITATIVE COMPOSITION

One dose (0.5 ml) contains:

Diphtheria toxoid
1

not less than 30 IU
Tetanus toxoid
1

not less than 40 IU
_Bordetella pertussis_ antigens

Pertussis toxoid
1

25 micrograms

Filamentous Haemagglutinin
1

25 micrograms

Pertactin
1

8 micrograms
Poliovirus (inactivated)
2

type 1 (Mahoney strain)
40 D-antigen unit
type 2 (MEF-1 strain)
8 D-antigen unit
type 3 (Saukett strain)
32 D-antigen unit

1
adsorbed on aluminium hydroxide,hydrated
0.5 milligrams Al
3+

2
propagated in VERO cells

For a full list of excipients, see section 6.1.

3.
PHARMACEUTICAL FORM

Suspension for injection in pre-filled syringe.
IPV Infanrix is a turbid white suspension.

4.
CLINICAL PARTICULARS

4.1  THERAPEUTIC INDICATIONS

This vaccine is indicated for booster vaccination against diphtheria, tetanus, pertussis, and
poliomyelitis diseases in individuals from 16 months to 13 years of age inclusive who have
previously received primary immunisation series against these diseases.

The administration of IPV Infanrix should be based on official recommendations.

4.2  POSOLOGY AND METHOD OF ADMINISTRATION

POSOLOGY

A single dose of 0.5 ml should be administered.
Page 2 of 9

IPV Infanrix may be administered to subjects who have previously received whole cell or acellular
pertussis-containing vaccines, and oral live attenuated or injected inactivated poliomyelitis
vaccines. (See also sections 4.8 and 5.1)

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