Infanrix-IPV vaccine suspension for injection 0.5ml pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diphtheria toxoid; Tetanus toxoid; Pertussis antigens; Human poliovirus type 1 inactivated; Human poliovirus type 2 inactivated; Human poliovirus type 3 inactivated

Available from:

GlaxoSmithKline UK Ltd

ATC code:

J07CA02

INN (International Name):

Diphtheria toxoid; Tetanus toxoid; Pertussis antigens; Human poliovirus type 1 inactivated; Human poliovirus type 2 inactivated; Human poliovirus type 3 inactivated

Pharmaceutical form:

Suspension for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 14040000; GTIN: 5000483111496

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
INFANRIX®IPV, 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 Infanrix-IPV is and what it is used for
2.
What you need to know before your child receives Infanrix-IPV
3.
How Infanrix-IPV is given
4.
Possible side effects
5.
How to store Infanrix-IPV
6.
Contents of the pack and other information
1.
WHAT INFANRIX-IPV IS AND WHAT IT IS USED FOR
Infanrix-IPV 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. Th

Summary of Product characteristics

OBJECT 1
INFANRIX IPV
Summary of Product Characteristics Updated 25-Apr-2017 |
GlaxoSmithKline UK
1. Name of the medicinal product
Infanrix®-IPV, 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
2
propagated in VERO cells
0.5 milligrams Al
3+
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Suspension for injection in pre-filled syringe.
Infanrix-IPV 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 Infanrix-IPV should be based on official
recommendations.
4.2 Posology and method of administration
POSOLOGY
A single dose of 0.5 ml should be administered.
Infanrix-IPV 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 vaccine is for intramuscular injection, usually into the deltoid
muscle. However, the anterolateral
thigh may be used in very young subjects if preferred.
Do not administer intravascularly.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1 or neo