BEXSERO

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

Neisseria meningitidis Group B Neisseria Heparin Binding Antigen fusion protein, Quantity: 50 microgram; Neisseria meningitidis serogroup B outer membrane vesicles, Quantity: 25 microgram; Neisseria meningitidis Group B Factor H Binding Protein fusion protein, Quantity: 50 microgram; Neisseria meningitidis Group B Neisseria Adhesin A protein, Quantity: 50 microgram

Mevcut itibaren:

GlaxoSmithKline Australia Pty Ltd

INN (International Adı):

Neisseria meningitidis Group B Factor H Binding Protein fusion protein,Neisseria meningitidis Group B Neisseria Adhesin A protei

Farmasötik formu:

Injection, suspension

Kompozisyon:

Excipient Ingredients: water for injections; aluminium hydroxide hydrate; histidine; sodium chloride; sucrose

Uygulama yolu:

Intramuscular

Paketteki üniteler:

1 x pre-filled syringe plus 2 needles

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

BEXSERO is indicated for active immunisation against invasive disease caused by N. meningitidis group B strains. For information on protection against specific group B strains see Section 5.1 PHARMACODYNAMIC PROPERTIES. BEXSERO is indicated for vaccination of individuals from 2 months of age and older.

Ürün özeti:

Visual Identification: White suspension; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Yetkilendirme durumu:

Licence status A

Yetkilendirme tarihi:

2013-08-14

Bilgilendirme broşürü

BEXSERO
_Multicomponent Meningococcal group B vaccine (recombinant, adsorbed)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Read all of this leaflet carefully
before you are vaccinated.
This leaflet answers some common
questions about BEXSERO.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP-TO-DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP-TO-
DATE LEAFLET FROM HTTP://
WWW.EBS.TGA.GOV.AU/.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines, including vaccines,
have risks and benefits. Your doctor
has weighed the risks of you or your
child having BEXSERO against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR, NURSE
OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT BEXSERO IS
USED FOR
BEXSERO is a meningococcal group
B vaccine.
BEXSERO is given to individuals
from 2 months of age and older to
help protect against disease caused
by bacteria called 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
defense system of the vaccinated
person. This results in protection
against this disease.
The use of this vaccine should be in
accordance with the official
recommendations.
PLEASE NOTE THAT BEXSERO CAN
ONLY PROTECT YOU OR YOUR CHILD FROM
MENINGITIS CAUSED BY NEISSERIA
MENINGITIDIS GROUP B.
BEXSERO IS NOT EXPECTED TO
PROVIDE PROTECTION AGAINST ALL
CIRCULATING MENINGOCOCCAL GROUP B
TYPES.
HOW BEXSERO WORKS
BEXSERO works by

Ürün özellikleri

1
AUSTRALIAN PRODUCT INFORMATION
BEXSERO (MULTICOMPONENT MENINGOCOCCAL GROUP B VACCINE)
SUSPENSION FOR INJECTION
1
NAME OF THE MEDICINE
Multicomponent Meningococcal group B Vaccine (recombinant, adsorbed)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BEXSERO is a multicomponent Meningococcal group B vaccine presented as
a suspension
for injection in a pre-filled syringe containing purified recombinant
meningococcal protein
antigens expressed in E. coli and outer membrane vesicles (OMV)
derived from N.
meningitidis group B. Bactericidal antibodies directed against
components of the bacterium
protect against Invasive Meningococcal Disease (IMD).
1 dose (0.5 mL) of BEXSERO contains:
Neisseria meningitidis Group B Neisseria Heparin Binding Antigen
fusion protein
1,2
(rbe)
- 50 micrograms
Neisseria meningitidis Group B Neisseria Adhesin A protein
1,2
(rbe)
- 50 micrograms
Neisseria meningitidis Group B Factor H Binding Protein fusion
protein
1,2
(rbe)
- 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. The NHBA
(Neisseria Heparin
Binding Antigen) is derived from strain NZ98/254 and is fused with
accessory protein 953,
derived from strain 2996; NadA (Neisseria adhesin A) is derived from
strain 2996; fHBP (factor
H Binding Protein) is derived from strain MC58 and is fused with
accessory protein 936,
derived from strain 2996.
2
Adsorbed on aluminium hydroxide hydrate (0.5 mg Al3+).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
White opalescent liquid suspension.
BEXSERO is supplied in a 1.0 mL (Type I glass) pre-filled syringe.
Syringes are sealed with a
plunger stopper (Type I bromobutyl rubber) and with a protective tip
cap (Type II rubber).
2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BEXSERO is indicated for active immunisation against invasive disease
caused by N.
meningitidis group B s