Bexsero

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254), recombinant Neisseria meningitidis group B fHbp fusion protein, recombinant Neisseria meningitidis group B NadA protein, recombinant Neisseria meningitidis group B NHBA fusion protein

Available from:

GSK Vaccines S.r.l.

ATC code:

J07AH09

INN (International Name):

meningococcal group B Vaccine (rDNA, component, adsorbed)

Therapeutic group:

Meningococcal vaccines

Therapeutic area:

Meningitis, Meningococcal

Therapeutic indications:

Active immunisation against invasive disease caused by Neisseria meningitidis serogroup-B strains.,

Product summary:

Revision: 33

Authorization status:

Authorised

Authorization date:

2013-01-13

Patient Information leaflet

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
BEXSERO SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Meningococcal group B Vaccine (rDNA, component, adsorbed)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD RECEIVE
THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU OR YOUR CHILD.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
This vaccine has been prescribed for you or your child only.
-
If you get any side effects talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Bexsero is and what it is used for
2.
What you need to know before you or your child receive Bexsero
3.
How to use Bexsero
4.
Possible side effects
5.
How to store Bexsero
6.
Contents of the pack and other information
1.
WHAT BEXSERO IS AND WHAT IT IS USED FOR
Bexsero is a Meningococcal group B Vaccine.
Bexsero contains four different components from the surface of the
bacteria
_ Neisseria meningitidis_
group B.
Bexsero is given to individuals from 2 months of age and older to help
protect against disease caused
by the
_Neisseria meningitidis_
group B bacteria. These bacteria can cause serious, and sometimes
life-threatening, infections such as meningitis (inflammation of the
covering of the brain and spinal
cord) and sepsis (blood poisoning).
The vaccine works by specifically stimulating the body’s natural
defense system of the vaccinated
person. This results in protection against the disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD RECEIVE BEXSERO
DO NOT USE BEXSERO
-
if you or your child are allergic to the active substances or any of
the other ingredients of this
vaccine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before you or your child receive Bexsero:
-
if you or your child have a severe infection with a high temperature.
If this is the case, then
vaccination will be postponed. The presence of

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Bexsero suspension for injection in pre-filled syringe
_ _
Meningococcal group B Vaccine (rDNA, component, adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 ml) contains:
Recombinant
_Neisseria meningitidis_
group B NHBA fusion protein
1, 2, 3
50 micrograms
Recombinant
_Neisseria meningitidis _
group B NadA protein
1, 2, 3
50 micrograms
Recombinant
_Neisseria meningitidis_
group B fHbp fusion protein
1, 2, 3
50 micrograms
Outer membrane vesicles (OMV) from
_Neisseria meningitidis _
group B
strain NZ98/254 measured as amount of total protein containing the
PorA P1.4
2
25 micrograms
1
produced in
_E. coli_
cells by recombinant DNA technology
2
adsorbed on aluminium hydroxide (0.5 mg Al
3+
)
3
NHBA (Neisserial Heparin Binding Antigen), NadA (
_Neisseria_
adhesin A), fHbp
(factor H binding protein)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
White opalescent liquid suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bexsero is indicated for active immunisation of individuals from 2
months of age and older against
invasive meningococcal disease caused by
_Neisseria meningitidis_
group B. The impact of invasive
disease in different age groups as well as the variability of antigen
epidemiology for group B strains in
different geographical areas should be considered when vaccinating.
See section 5.1 for information
on protection against specific group B strains. The use of this
vaccine should be in accordance with
official recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
3
TABLE 1.
SUMMARY OF POSOLOGY
AGE AT FIRST DOSE
PRIMARY IMMUNISATION
INTERVALS
BETWEEN
PRIMARY DOSES
BOOSTER
INFANTS, 2 MONTHS
TO 5 MONTHS
A
Three doses each
of 0.5 ml
Not less
than 1 month
Yes, one dose
between 12 and 15 months of
age with an interval of at
least 6 months between the
primary series and booster
dose
b, c
Two doses
each of 0.5 ml
Not less
than 2 months
INFA