INFANRIX IPV & HIB %v/v

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DIPHTHERIA TOXOID TETANUS TOXOID PERTUSSIS TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) PERTACTIN POLIO VIRUS TYPE 1 INACTIVATED POLIO VIRUS TYPE 2 INACTIVATED POLIO VIRUS TYPE 3 INACTIVATED HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE (PRP) AND TETANUS TOXOID TETANUS VACCINE ADSORBED

Available from:

GlaxoSmithKline (Ireland) Limited

INN (International Name):

DIPHTHERIA TOXOID TETANUS TOXOID PERTUSSIS TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) PERTACTIN POLIO VIRUS TYPE 1 INACTIVATED

Dosage:

%v/v

Prescription type:

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

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

 PACKAGE LEAFLET: INFORMATION FOR THE USER 

INFANRIX-IPV+HIB VACCINE 
POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION 
Diphtheria, tetanus, pertussis (acellular component), poliomyelitis
(inactivated) and 
_Haemophilus influenzae _
type b conjugate 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 your doctor or
pharmacist. This includes any 
possible side effects not listed in this leaflet. 

WHAT IS IN THIS LEAFLET

1.  What Infanrix-IPV+Hib is and what it is used for 
2.  What you need to know before your child receives
Infanrix-IPV+Hib 
3.  How Infanrix-IPV+Hib is given 
4.  Possible side effects 
5.  How to store Infanrix-IPV+Hib 
6.  Contents of the pack and other information 

1. 
WHAT INFANRIX-IPV+HIB IS AND WHAT IT IS USED FOR 
Infanrix-IPV+Hib is a vaccine used to protect your child against 5
diseases: 
•  DIPHTHERIA - a serious bacterial infection that mainly affects
the airways and sometimes 
the skin. The airways become swollen causing serious breathing
problems. 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 
t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Infanrix-IPV+Hib – powder and suspension for suspension for injection
Diphtheria, tetanus, pertussis (acellular component), poliomyelitis (inactivated) and _Haemophilus influenzae _type b
conjugate vaccine (adsorbed)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
A 0.5 ml dose of vaccine contains:
Diphtheria toxoid
1
not less than 30 International Units (IU) (25 Lf)
Tetanus toxoid
1
not less than 40 International Units (IU) (10 Lf)
_Bordetella pertussis _antigens
Pertussis toxoid
1
25 µg 
Filamentous haemagglutinin
1
25 µg 
Pertactin
1
8 µg 
Poliovirus (inactivated)
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
_Haemophilus influenzae_
type b polysaccharide
(polyribosylribitol phosphate)
10 µg 

conjugated to tetanus toxoid as carrier protein
approximately 30 µg 

1
Adsorbed on aluminium hydroxide, hydrated
0.5 milligrams
Al
3+
2
Propagated in VERO cells
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and suspension for suspension for injection.
The diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis (DTPa-IPV) component is a turbid white
suspension.
The lyophilised _Haemophilus influenzae _type b (Hib) component is a white powder.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 02/07/2014_
_CRN 2144401_
_page number: 1_
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INFANRIX-IPV+Hib is indicated for active immunisation against diphtheria, tetanus, pertussis, poliomyelitis and
_Haemophilus influenzae _type b disease from the age of 2 months.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Primary vaccinatio