Bexsero vaccine suspension for injection 0.5ml pre-filled syringes

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Outer membrane vesicles (OMV) from Neisseria meningitidis group B containing the PorA P1.4; Neisseria meningitidis group B NHBA fusion protein; Neisseria meningitidis group B NadA protein; Neisseria meningitidis group B fHbp fusion protein

متاح من:

GlaxoSmithKline UK Ltd

ATC رمز:

J07AH09

INN (الاسم الدولي):

Outer membrane vesicles (OMV) from Neisseria meningitidis group B containing the PorA P1.4; Neisseria meningitidis group B NHBA

الشكل الصيدلاني:

Suspension for injection

طريقة التعاطي:

Intramuscular

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Never Valid To Prescribe As A VMP

ملخص المنتج:

BNF: 14040000; GTIN: 5000123114641

نشرة المعلومات

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BEXSERO SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Meningococcal group B Vaccine (rDNA, component, adsorbed)
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of
section 4 for how to report side effects.
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 y

خصائص المنتج

OBJECT 1
BEXSERO MENINGOCOCCAL GROUP B VACCINE FOR
INJECTION IN PRE-FILLED SYRINGE
Summary of Product Characteristics Updated 29-Sep-2017 |
GlaxoSmithKline UK
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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 (Neisseria Heparin Binding Antigen), NadA (Neisserial 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
TABLE 1. SUMMARY O