MENVEO POWDER & SOLUTION FOR SOLUTION FOR INJECTION

البلد: ماليزيا

اللغة: الإنجليزية

المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

العنصر النشط:

MENINGOCOCCAL GROUP C OLIGOSACCHARIDE; MENINGOCOCCAL GROUP W OLIGOSACCHARIDE; MENINGOCOCCAL GROUP Y OLIGOSACCHARIDE; MENINGOCOCCAL GROUP A OLIGOSACCHARIDE

متاح من:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (الاسم الدولي):

MENINGOCOCCAL GROUP C OLIGOSACCHARIDE; MENINGOCOCCAL GROUP W OLIGOSACCHARIDE; MENINGOCOCCAL GROUP Y OLIGOSACCHARIDE; MENINGOCOCCAL GROUP A OLIGOSACCHARIDE

الوحدات في الحزمة:

2Units Units; 10Units Units

المصنعة من قبل:

GlaxoSmithKline Vaccines S.r.l

نشرة المعلومات

1
MENVEO
®
PACKAGE LEAFLET: INFORMATION FOR THE USER
MENVEO POWDER AND SOLUTION FOR SOLUTION FOR INJECTION
Meningococcal Group A, C, W135 and Y conjugate vaccine
Read all of this leaflet carefully before you or your child are given
this medicine
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Menveo is and what it is used for
2.
Before you or your child are given Menveo
3.
How to use Menveo
4.
Possible side effects
5.
How to store Menveo
6.
Further information
1. WHAT MENVEO IS AND WHAT IT IS USED FOR
Menveo is a vaccine that is used for active immunization of
adolescents (from 11 years of age) and
adults at risk of exposure to
_Neisseria meningitidis _
serogroups A, C, W135 and Y, to prevent
invasive disease
_. _
The vaccine works by causing your body to make its own protection
(antibodies)
against these bacteria.
_Neisseria meningitidis _
group A, C, W135 and Y bacteria can cause serious and sometimes life-
threatening infections such as meningitis and sepsis (blood
poisoning).
Menveo cannot cause bacterial meningitis or diphtheria.
2. BEFORE YOU OR YOUR CHILD ARE GIVEN MENVEO
DO NOT USE MENVEO IF YOU OR YOUR CHILD HAS
:
•
ever had an allergic reaction to the active substances or any of the
other ingredients of
Menveo (see Section 6 Further Information)
•
ever had an allergic reaction to diphtheria toxoid (a substance used
in a number of other
vaccines)
•
an illness with high fever. However, a mild fever or upper respiratory
infection (for example
cold) itself is not a reason to delay vaccination.
TAKE SPECIAL CARE WITH MENVEO IF YOU (OR YOUR CHILD) HAVE:
•
Haemophilia or any other problem that may stop your blood from
clotting properly, such as
persons receiving blood thinners (anticoagulants).
This vaccine can only protect against meningococcal group A, C, W135,
a

خصائص المنتج

[GSK Logo]
MENVEO
®
MENINGOCOCCAL GROUP A, C W135 AND Y CONJUGATE VACCINE
1.
NAME OF THE MEDICINAL PRODUCT
Menveo powder and solution for solution for injection
Meningococcal Group A, C, W135 and Y conjugate vaccine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 ml of the reconstituted vaccine) contains:
(Originally contained in the powder)
•
Meningococcal group A oligosaccharide
10 micrograms
Conjugated to
_Corynebacterium diphtheriae _
CRM
197
protein
16.7 to 33.3 micrograms
(Originally contained in the solution)
•
Meningococcal group C oligosaccharide
5 micrograms
Conjugated to
_Corynebacterium diphtheriae _
CRM
197
protein
7.1 to 12.5 micrograms
•
Meningococcal group W135 oligosaccharide
5 micrograms
Conjugated to
_Corynebacterium diphtheriae _
CRM
197
protein
3.3 to 8.3 micrograms
•
Meningococcal group Y oligosaccharide
5 micrograms
Conjugated to
_Corynebacterium diphtheriae _
CRM
197
protein
5.6 to 10.0 micrograms
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solution for solution for injection (powder and solution
for injection).
The powder is a white to off- white cake.
The solution is a colourless clear solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Menveo is indicated for active immunization of children (from 2 years
of age) and adults
at risk
of exposure to
_Neisseria meningitidis _
groups A, C, W135 and Y, to prevent
invasive disease.
The use of this vaccine should be in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children (above 5 years of age)
Menveo should be administered as a single 0.5 ml injection.
[GSK Logo]
Children (2-5 years of age)
Menveo should be administered as a single 0.5 ml injection. A second
dose may be
administered 2 months after the first dose.
Elderly
There are limited data in individuals aged 56-65 and there are no data
in individuals aged
>65 years.
_Booster vaccination _
Long-term antibody persistence data following vaccination with Menveo
are avai