Nimenrix

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

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

Saatavilla:

Pfizer Europe MA EEIG

ATC-koodi:

J07AH08

INN (Kansainvälinen yleisnimi):

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

Terapeuttinen ryhmä:

Vaccines

Terapeuttinen alue:

Meningitis, Meningococcal

Käyttöaiheet:

Nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135, and Y.

Tuoteyhteenveto:

Revision: 36

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2012-04-20

Pakkausseloste

67
B. PACKAGE LEAFLET
68
Package leaflet: Information for the user
Nimenrix powder and solvent for solution for injection in pre-filled
syringe
Meningococcal groups A, C, W-135
and Y conjugate vaccine
Read all of this leaflet carefully before you receive this vaccine
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 or pharmacist.

This vaccine has been prescribed for you or your child. Do not pass it
on to others.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
This leaflet has been written assuming the person receiving the
vaccine is reading it, but it can be
given to adults and children so you may be reading it for your child.
What is in this leaflet
1.
What Nimenrix is and what it is used for
2.
What you need to know before you receive Nimenrix
3.
How Nimenrix is given
4.
Possible side effects
5.
How to store Nimenrix
6.
Contents of the pack and other information
1.
What Nimenrix is and what it is used for
What Nimenrix is and what it is used for
Nimenrix is a vaccine which helps protect against infections caused by
bacteria (germs) called
“Neisseria meningitidis" types A, C, W-135 and Y.
“Neisseria meningitidis" types A, C, W-135 and Y bacteria can cause
serious illnesses such as:
 meningitis - an infection of the tissue that lines the brain and
spinal cord.
 septicaemia - an infection of the blood.
These infections are passed easily from person to person and can cause
death if not treated.
Nimenrix may be given to adults, adolescents, children and infants
over the age of 6 weeks.
How Nimenrix works
Nimenrix helps your body to produce its own protection (antibodies)
against the bacteria. These
antibodies help protect you against the diseases.
Nimenrix will only protect against infections caused by the bacteria
“Neisseria meningitidis” types A,
C, W-135 and Y.
2.
What you need to kno

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Nimenrix powder and solvent for solution for injection in pre-filled
syringe
Meningococcal groups A, C, W-135
and Y conjugate vaccine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 ml) contains:
Neisseria meningitidis group A polysaccharide
1
5 micrograms
Neisseria meningitidis group C polysaccharide
1
5 micrograms
Neisseria meningitidis group W-135
polysaccharide
1
5 micrograms
Neisseria meningitidis group Y polysaccharide
1
5 micrograms
1
conjugated to tetanus toxoid carrier protein
44 micrograms
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder or cake is white.
The solvent is clear and colourless.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Nimenrix is indicated for active immunisation of individuals from the
age of 6 weeks against invasive
meningococcal disease caused by Neisseria meningitidis groups A, C,
W-135, and Y.
4.2
Posology and method of administration
Posology
Nimenrix should be used in accordance with available official
recommendations.
Primary immunisation
Infants from 6 weeks to less than 6 months of age: two doses, each of
0.5 ml, should be administered
with an interval of 2 months between doses.
Infants from 6 months of age, children, adolescents and adults: a
single 0.5 mL dose should be
administered.
An additional primary dose of Nimenrix may be considered appropriate
for some individuals (see
section 4.4).
Booster doses
Long-term antibody persistence data following vaccination with
Nimenrix are available up to 10 years
after vaccination (see sections 4.4 and 5.1).
After completion of the primary immunisation course in infants 6 weeks
to less than 12 months of age,
a booster dose should be given at 12 months of age with an interval of
at least 2 months after the last
Nimenrix vaccination (see section 5.1).
3
In previously vaccinated individuals 12 months of age and older,
Nimenrix may be given a