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

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Pertussis toxoid; Filamentous haemagglutinin; Pertactin; Diphtheria toxoid; Tetanus toxoid; Polio virus type 1 inactivated; Polio virus type 2 inactivated; Polio virus type 3 inactivated

Beschikbaar vanaf:

GlaxoSmithKline (Ireland) Limited

ATC-code:

J07CA02

INN (Algemene Internationale Benaming):

Pertussis toxoid; Filamentous haemagglutinin; Pertactin; Diphtheria toxoid; Tetanus toxoid; Polio virus type 1 inactivated; Polio virus type 2 inactivated; Polio virus type 3 inactivated

Dosering:

0.5 millilitre(s)

farmaceutische vorm:

Suspension for injection in pre-filled syringe

Prescription-type:

Product subject to prescription which may not be renewed (A)

Therapeutisch gebied:

diphtheria-pertussis-poliomyelitis-tetanus

Autorisatie-status:

Not marketed

Autorisatie datum:

2005-08-05

Bijsluiter

Reason for update: Art 61(3) P001 Corrections to list of Member States
under the cover of the FMD update to the carton text
Market: Ireland
Approval date: TBC
Text Date: 21/11/2017
Text Issue and Draft No.: Text Issue 4 Draft 1

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 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 your child only. Do not pass it
on to others.

If your child gets any side effects talk to you 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 Infanrix is and what it is used for
2.
What you need to know before your child receives IPV Infanrix
3.
How IPV Infanrix is given
4.
Possible side effects
5.
How to store IPV Infanrix
6.
Contents of the pack and other 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 c

Productkenmerken

Health Products Regulatory Authority
11 May 2023
CRN00DKK3
Page 1 of 10
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
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 0.036 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 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
recieved 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.
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). _
Method of administration
The vacci