Hexyon

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

filamentous haemagglutinin, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), hepatitis B surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells, poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells, poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, Diphtheria toxoid

Available from:

Sanofi Pasteur Europe

ATC code:

J07CA09

INN (International Name):

diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)

Therapeutic group:

Vaccines

Therapeutic area:

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

Therapeutic indications:

Hexyon (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).The use of this vaccine should be in accordance with official recommendations.

Product summary:

Revision: 30

Authorization status:

Authorised

Authorization date:

2013-04-17

Patient Information leaflet

37
B. PACKAGE LEAFLET
38
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
HEXYON SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B
(rDNA), poliomyelitis (inactivated)
and
_Haemophilus influenzae_
type b conjugate vaccine (adsorbed)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD IS VACCINATED
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR HIM/HER.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
If your child gets any side effects, talk to your doctor, pharmacist
or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Hexyon is and what it is used for
2.
What you need to know before Hexyon is given to your child
3.
How Hexyon is given
4.
Possible side effects
5.
How to store Hexyon
6.
Contents of the pack and other information
1.
WHAT HEXYON IS AND WHAT IT IS USED FOR
Hexyon (DTaP-IPV-HB-Hib) is a vaccine used to protect against
infectious diseases.
Hexyon helps to protect against diphtheria, tetanus, pertussis,
hepatitis B, poliomyelitis and serious
diseases caused by
_Haemophilus influenzae_
type b. Hexyon is given to children from six weeks of age.
The vaccine works by causing the body to produce its own protection
(antibodies) against the bacteria
and viruses that cause these different infections:
•
Diphtheria is an infectious disease that usually first affects the
throat. In the throat, the infection
causes pain and swelling that can lead to suffocation. The bacterium
that causes the disease also
makes a toxin (poison) that can damage the heart, kidneys, and nerves.
•
Tetanus (often called lock jaw) is usually caused by the tetanus
bacterium entering a deep
wound. The bacterium makes a toxin (poison) that causes spasms of the
muscles leading to
inability to breathe and the possibility of suffocation.
•
Pertussis (often called whooping cough) is a highly infectious illness
that affects t

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Hexyon suspension for injection in pre-filled syringe
Hexyon suspension for injection
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B
(rDNA), poliomyelitis (inactivated)
and
_Haemophilus influenzae_
type b conjugate vaccine (adsorbed).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose
1
(0.5 mL) contains:
Diphtheria Toxoid
not less than 20 IU
2,4
(30 Lf)
Tetanus Toxoid not less than 40 IU
3,4
(10 Lf)
_Bordetella_
_pertussis_
antigens
Pertussis Toxoid
25 micrograms
Filamentous Haemagglutinin
25 micrograms
Poliovirus (Inactivated)
5
Type 1 (Mahoney)
29 D-antigen units
6
Type 2 (MEF-1)
7 D-antigen units
6
Type 3 (Saukett)
26 D-antigen units
6
Hepatitis B surface antigen
7
10 micrograms
_Haemophilus influenzae_
type b polysaccharide
12 micrograms
(Polyribosylribitol Phosphate)
conjugated to Tetanus protein
22-36 micrograms
1
Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al
3+
)
2
As lower confidence limit (p= 0.95) and not less than 30 IU as mean
value
3
As lower confidence limit (p= 0.95)
4
Or equivalent activity determined by an immunogenicity evaluation
5
Cultivated on Vero cells
6
These antigen quantities are strictly the same as those previously
expressed as 40-8-32 D-antigen
units, for virus type 1, 2 and 3 respectively, when measured by
another suitable immunochemical
method
7
Produced in yeast
_ Hansenula polymorpha _
cells by recombinant DNA technology
The vaccine may contain traces of glutaraldehyde, formaldehyde,
neomycin, streptomycin and
polymyxin B which are used during the manufacturing process (see
section 4.3).
Excipient with known effect
Phenylalanine……………85 micrograms
(See section 4.4)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Hexyon is a whitish, cloudy suspension.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hexyon (DTaP-IPV-HB-Hib) is indicated for primary and booster
vaccination of infants and toddlers
from six week