BEXSERO

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

NEISSERIA MENINGITIDES GROUP B STRAIN NZ98/254; NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN; NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN; NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN

متاح من:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC رمز:

J07AH06

الشكل الصيدلاني:

SUSPENSION FOR INJECTION

تركيب:

NEISSERIA MENINGITIDES GROUP B STRAIN NZ98/254 25 MCG; NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN 50 MCG; NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN 50 MCG; NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN 50 MCG

طريقة التعاطي:

I.M

نوع الوصفة الطبية :

Required

المصنعة من قبل:

GLAXO SMITHKLINE VACCINES S.R.L., ITALY

المجال العلاجي:

MENINGOCOCCUS B, OUTER MEMBRANE VESICLE VACCINE

الخصائص العلاجية:

Bexsero is indicated for active immunization of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B.

تاريخ الترخيص:

2021-02-28

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician's prescription only
Bexsero
suspension for injection in pre-filled syringe
Each dose (0.5 ml) contains:
four recombinant proteins from the
Neisseria meningitidis
group B bacteria:
For the list of the inactive and allergenic ingredients in the
medicine, see section
2 – "Important information about some of the ingredients in the
medicine" and
section 6 – "Additional information".
Read the leaflet carefully in its entirety before you or your child
are using the
medicine. This leaflet contains concise information about the
medicine. If you
have further questions, refer to the physician or pharmacist.
This medicine has been prescribed for you or for your child. Do not
pass it on
to others. It may harm them, even if it seems to you that their
medical condition
is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Active immunization of individuals from 2 months of age and older
against
invasive meningococcal disease caused by
Neisseria meningitides
group B
bacteria.
Therapeutic group:
Meningococcal group B vaccine
Recombinant
Neisseria meningitidis
group B NHBA fusion
protein
50 microgram
Recombinant
Neisseria meningitidis
group B NadA protein
50 microgram
Recombinant
Neisseria meningitidis
group B fHbp fusion
protein
50 microgram
Outer membrane vesicles (OMV) from
Neisseria
meningitidis
group B strain NZ98/254 measured as amount
of total protein containing the PorA P1.4
25 microgram
Bexsero contains four different components from the surface of the
bacteria
Neisseria meningitidis
group B.
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
immune
system of the vaccinated person. This results in protection against
the
disease.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:

خصائص المنتج

Page 1 of 23
Summary of Product characteristics
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 immunization 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.
Page 2 of 23
4.2
Posology and method of administration
Posology
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 mon