Menveo
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
05-04-2018
Produktets egenskaber
(SPC)
05-04-2018
Offentlige vurderingsrapport
(PAR)
07-10-2015
Aktiv bestanddel:
meningococcal group A, C, W-135 and Y conjugate vaccine
Tilgængelig fra:
GSK Vaccines S.r.l.
ATC-kode:
J07AH08
INN (International Name):
meningococcal group A, C, W-135 and Y conjugate vaccine
Terapeutisk gruppe:
BACTERIAL VACCINES
Terapeutisk område:
Immunization, Meningitis, Meningococcal
Terapeutiske indikationer:
Prefilled syringe Menveo is indicated for active immunisation of adolescents (from 11 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. Vials Menveo is indicated for active immunisation of children (from two years of age), adolescents 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.,
Produkt oversigt:
Revision: 23
Autorisation status:
Authorised
Autorisation dato:
2010-03-14
Indlægsseddel
29
B. PACKAGE LEAFLET
30
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 BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This vaccine has been prescribed for you or your child only.
-
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Menveo is and what it is used for
2.
What you need to know before you or your child are given Menveo
3.
How to use Menveo
4.
Possible side effects
5.
How to store Menveo
6.
Contents of the pack and other information
1.
WHAT MENVEO IS AND WHAT IT IS USED FOR
Menveo is a vaccine that is used for active immunization of children
(from 2 years of age),
adolescents and adults at risk of exposure to a bacterium named
_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_ serogroup 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. This vaccine contains a
protein (called CRM
197
) from
the bacteria that cause diphtheria. Menveo does not protect against
diphtheria. This means that
you (or your child) should receive other vaccines to protect against
diphtheria when these are due
or when advised by your doctor.
2.
WHAT YOU NEED TO KNOW 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 this
vaccine (listed in section 6)
-
ever had an allergic re
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 the 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), adolescents 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
_Children (from 2 years of age), adolescents and adults _
Menveo should be administered as a single dose (0.5 ml).
To ensure optimal antibody levels against all vaccine serogroups, the
primary vaccination schedule
with Menveo should be completed one month prior to risk of exposure to
_Neisseria meningitidis_
groups A, C, W135 and Y. Bactericidal antibodies (hSBA≥1:8) were
observed in at least 64% of
subjects at 1 week post vaccination (see section 5.1 for
immunogenicity data
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