Infanrix Hexa

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), hepatitis B surface antigen, poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain)), Haemophilus influenzae type b polysaccharide

Available from:

GlaxoSmithKline Biologicals S.A.

ATC code:

J07CA09

INN (International Name):

diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed)

Therapeutic group:

Vaccines

Therapeutic area:

Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria

Therapeutic indications:

Infanrix Hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type-b.

Product summary:

Revision: 47

Authorization status:

Authorised

Authorization date:

2000-10-23

Patient Information leaflet

35
B. PACKAGE LEAFLET
36 PACKAGE LEAFLET: INFORMATION FOR THE USER
INFANRIX HEXA, POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION IN A
PRE-FILLED SYRINGE
Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa),
hepatitis B (rDNA) (HBV),
poliomyelitis (inactivated) (IPV) and
_Haemophilus influenzae _
type b (Hib) conjugate vaccine
(adsorbed).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD RECEIVES 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Infanrix hexa is and what it is used for
2.
What you need to know before your child receives Infanrix hexa
3.
How Infanrix hexa is given
4.
Possible side effects
5.
How to store Infanrix hexa
6.
Contents of the pack and other information
1.
WHAT INFANRIX HEXA IS AND WHAT IT IS USED FOR
Infanrix hexa is a vaccine used to protect your child against six
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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Infanrix hexa, Powder and suspension for suspension for injection.
Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa),
hepatitis B (rDNA) (HBV),
poliomyelitis (inactivated) (IPV) and
_Haemophilus influenzae _
type b (Hib) conjugate vaccine
(adsorbed).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 ml) contains:
Diphtheria toxoid
1
not less than 30 International Units (IU)
Tetanus toxoid
1
not less than 40 International Units (IU)
_Bordetella pertussis_
antigens
Pertussis toxoid (PT)
1
25 micrograms
Filamentous Haemagglutinin (FHA)
1
25 micrograms
Pertactin (PRN)
1
8 micrograms
Hepatitis B surface antigen (HBs)
2,3
10 micrograms
Poliovirus (inactivated) (IPV)
type 1 (Mahoney strain)
4
40 D-antigen unit
type 2 (MEF-1 strain)
4
8 D-antigen unit
type 3 (Saukett strain)
4
32 D-antigen unit
_Haemophilus_
_influenzae_
type b polysaccharide
10 micrograms
(polyribosylribitol phosphate, PRP)
3
conjugated to tetanus toxoid as carrier protein
approximately 25 micrograms
1
adsorbed on aluminium hydroxide, hydrated (Al(OH)
3
)
0.5 milligrams Al
3+
2
produced in yeast cells (
_Saccharomyces cerevisiae_
) by recombinant DNA technology
3
adsorbed on aluminium phosphate (AlPO
4
)
0.32 milligrams Al
3+
4
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 0.057 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
Powder and suspension for suspension for injection.
The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated
poliomyelitis (DTPa-HBV-IPV)
component is a turbid white suspension.
The lyophilised
_Haemophilus influenzae_
type b (Hib) component is a white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC IND