Bexsero

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Neisseria meningitidis group B factor H binding protein fusion protein 50ug; Neisseria meningitidis group B neisseria adhesin A protein 50ug; Neisseria meningitidis group B neisseria heparin binding antigen fusion protein 50ug; Neisseria meningitidis sergroup B outer membrane vesicles 25ug;  

Mevcut itibaren:

GlaxoSmithKline NZ Limited

Doz:

0.5 mL

Farmasötik formu:

Suspension for injection

Kompozisyon:

Active: Neisseria meningitidis group B factor H binding protein fusion protein 50ug Neisseria meningitidis group B neisseria adhesin A protein 50ug Neisseria meningitidis group B neisseria heparin binding antigen fusion protein 50ug Neisseria meningitidis sergroup B outer membrane vesicles 25ug   Excipient: Aluminium hydroxide Histidine Sodium chloride Sucrose Water for injection

Reçete türü:

Prescription

Terapötik endikasyonlar:

BEXSERO is indicated for active immunisation against invasive disease caused by N. meningitidis group B strains. See Section 5.1 of the data sheet for information on protection against specific group B strains BEXSERO is indicated for vaccination of individuals from 2 months of age and older. The use of BEXSERO should be in accordance with official recommendations.

Ürün özeti:

Package - Contents - Shelf Life: Syringe, glass, with 2 needles - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, without needle - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, without needle - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Yetkilendirme tarihi:

2017-12-06

Bilgilendirme broşürü

BEXSERO
1
BEXSERO
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor, nurse or
pharmacist.
1.
WHY AM I RECEIVING BEXSERO?
BEXSERO is a vaccine used for the immunisation of children from the
age of 2 months and older, adolescents and adults to
prevent disease caused by Neisseria meningitidis Group B. Neisseria
meningitidis can cause meningitis, a very serious infection.
For more information, see Section 1. Why am I receiving BEXSERO?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I RECEIVE BEXSERO?
Do not receive if you have ever had an allergic reaction to BEXSERO or
any of the ingredients listed at the end of the CMI.
Tell your doctor or nurse if you or your child have an allergy to
kanamycin (an antibiotic) or allergy to any other vaccine or you
have a very high fever or any other infection.
TALK TO YOUR DOCTOR OR NURSE IF YOU HAVE ANY OTHER MEDICAL CONDITIONS,
TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO
BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I
receive BEXSERO?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with BEXSERO and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I RECEIVE BEXSERO?
•
Your doctor or nurse will give you BEXSERO as an injection into your
upper arm or for children into the upper thigh muscle.
More instructions can be found in Section 4. How do I receive BEXSERO?
in the full CMI.
5.
WHAT SHOULD I KNOW AFTER RECEIVING BEXSERO?
THINGS YOU
SHOULD DO
•
Keep a record of your immunisation history
•
It is important to follow the instructions from your doctor, nurse or
pharmacist so that you or your
child completes the full course of injections
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how BEXSERO affects you
LOOKING AFTER
YOUR MEDICINE
•
BE

Ürün özellikleri

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
BEXSERO Multicomponent Meningococcal group B Vaccine (recombinant,
adsorbed)
0.5 mL suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 (0.5 mg Al
3+
).
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Suspension for Injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BEXSERO is indicated for active immunisation against invasive disease
caused by _N. _
_meningitidis _ group B strains. See section 5.1 for information on
protection against
specific group B strains.
BEXSERO is indicated for vaccination of individuals from 2 months of
age and older.
The use of BEXSERO should be in accordance with official
recommendations.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
In the absence of compatibility studies, this medicinal product must
not be mixed with
2
other medicinal products. BEXSERO can be given at the same time as
other
immunisations, provided that the vaccine is administered either at a
different site or
away from the injection site of the other vaccine, according to local
guidelines_. _
_Infants 2 months