MenQuadfi

国家: 欧盟

语言: 英文

来源: EMA (European Medicines Agency)

有效成分:

Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid

可用日期:

Sanofi Pasteur

ATC代码:

J07AH08

INN（国际名称）:

meningococcal group A, C, W-135 and Y conjugate vaccine

治疗组:

Vaccines

治疗领域:

Meningitis, Meningococcal

疗效迹象:

MenQuadfi is indicated for active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y.The use of this vaccine should be in accordance with available official recommendations.

產品總結:

Revision: 8

授权状态:

Authorised

授权日期:

2020-11-18

资料单张

33
B. PACKAGE LEAFLET
34
Package leaflet: Information for the user
MenQuadfi, solution for injection
Meningococcal group A, C, W and Y conjugate vaccine
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 are given
this vaccine 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, pharmacist or
nurse.

This vaccine has been prescribed for you or your child only. Do not
pass it on to others

If you or your child 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 MenQuadfi is and what it is used for
2.
What you need to know before you or your child are given MenQuadfi
3.
How MenQuadfi is given
4.
Possible side effects
5.
How to store MenQuadfi
6.
Contents of the pack and other information
1.
What MenQuadfi is and what it is used for
MenQuadfi (MenACWY) is a vaccine that can be given to children from 1
year of age, adolescents and
adults.
MenQuadfi helps to protect against infections caused by a type of
bacteria (germs) called “Neisseria
meningitidis”, specifically against types A, C, W and Y.
Neisseria meningitidis bacteria (also called meningococci) can be
passed from person to person and can
cause serious and sometimes life-threatening infections, such as:

Meningitis – an inflammation of the tissues that surround the brain
and spinal cord;

Septicaemia – an infection of the blood.
Both infections can result in serious disease with long lasting
effects or possibly death.
MenQuadfi should be used in accordance with official national
guidelines.
How the vaccine works
MenQuadfi works by stimulating the vaccinated person

产品特点

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
MenQuadfi solution for injection
Meningococcal Group A, C, W and Y conjugate vaccine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 mL) contains:
Neisseria meningitidis group A polysaccharide
1
10 micrograms
Neisseria meningitidis group C polysaccharide
1
10 micrograms
Neisseria meningitidis group Y polysaccharide
1
10 micrograms
Neisseria meningitidis group W polysaccharide
1
10 micrograms
1
Conjugated to tetanus toxoid carrier protein
55 micrograms
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
MenQuadfi is indicated for active immunisation of individuals from the
age of 12 months and older
against invasive meningococcal disease caused by Neisseria
meningitidis serogroups A, C, W, and Y.
The use of this vaccine should be in accordance with available
official recommendations.
4.2
Posology and method of administration
Posology
Primary vaccination:
•
Individuals 12 months of age and older: One single dose (0.5 mL).
Booster vaccination:
•
A single 0.5 mL dose of MenQuadfi may be used to boost subjects who
have previously received a
meningococcal vaccine containing the same serogroups (see section
5.1).
•
Long-term antibody persistence data following vaccination with
MenQuadfi are available up to 7
years after vaccination (see sections 4.4 and 5.1).
3
•
There are no data available to indicate the need for or timing of a
booster dose of MenQuadfi (see
section 5.1).
Other paediatric population
The safety and immunogenicity of MenQuadfi in individuals under 12
months of age have not yet been
established.
Method of administration
For intramuscula