Nimenrix

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

Wirkstoff:

Neisseria meningitidis Group A polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 15 mcg of tetanus toxoid);  ; Neisseria meningitidis Group C polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 15 mcg of tetanus toxoid);  ; Neisseria meningitidis Group W135 polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 7.5 mcg of tetanus toxoid);  ; Neisseria meningitidis Group Y polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 6.5 mcg of tetanus toxoid);  

Verfügbar ab:

Pfizer New Zealand Limited

INN (Internationale Bezeichnung):

Neisseria meningitidis Group A polysaccharide 5 µg (polysaccharide conjugated to approx 15 mcg of tetanus toxoid)

Darreichungsform:

Powder for injection with diluent

Zusammensetzung:

Active: Neisseria meningitidis Group A polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 15 mcg of tetanus toxoid)   Neisseria meningitidis Group C polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 15 mcg of tetanus toxoid)   Neisseria meningitidis Group W135 polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 7.5 mcg of tetanus toxoid)   Neisseria meningitidis Group Y polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 6.5 mcg of tetanus toxoid)   Excipient: Sucrose Tetanus toxoid Trometamol hydrochloride Sodium chloride Water for injection

Verschreibungstyp:

Prescription

Hergestellt von:

GlaxoSmithKline Biologicals SA

Anwendungsgebiete:

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

Produktbesonderheiten:

Package - Contents - Shelf Life: Combination pack, vial + syringe, with or without separate needles - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours reconstituted (not refrigerated) stored at or below 30°C - Combination pack, Vial + syringe, with or without separate needles - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours reconstituted (not refrigerated) stored at or below 30°C - Syringe, glass, 1.25 mL - Diluent-syringe - 1 dose units -   - Vial, glass, type 1 glass, 3 mL - Vaccine - 1 dose units -   - Vial, glass, type 1 glass, 3 mL - Vaccine - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours reconstituted (not refrigerated) stored at or below 30°C

Berechtigungsdatum:

2014-04-02

Gebrauchsinformation

NIMENRIX
®
1
NIMENRIX
®
_Meningococcal polysaccharide groups A, C, W-135 and Y conjugate
vaccine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please
read
this
leaflet
carefully
before you or your child are given
NIMENRIX.
This leaflet answers some common
questions about NIMENRIX. It does
not
contain
all
the
available
information. It does not take the place
of
talking
to
your
doctor
or
pharmacist.
All vaccines and medicines have risks
and
benefits.
Your
doctor
has
weighed the expected benefits of you
or
your
child
having
NIMENRIX
against the possible risks.
IF YOU HAVE ANY QUESTIONS ABOUT
NIMENRIX,
ASK
YOUR
DOCTOR,
NURSE OR PHARMACIST.
Keep this leaflet. You may need to
read it again.
WHAT
NIMENRIX
IS
USED FOR
NIMENRIX is a vaccine used to help
prevent
meningococcal
disease,
caused
by
four
types
of
_Neisseria _
_meningitidis _
bacteria (types A, C, W
and Y)
_. _
NIMENRIX works by causing your
body to produce its own protection (or
antibodies),
against
these
types
of
meningococcal bacteria. NIMENRIX
cannot cause meningococcal disease.
The
most
common
types
of
meningococcal disease are meningitis
(infection of a lining around the brain
and
spinal
cord)
and
septicaemia
(blood infection).
_Neisseria_
bacteria
can less commonly infect the joints,
lungs or other organs.
Meningococcal disease is spread by
small droplets from the nose, mouth
or throat. Meningococcal disease is
generally
serious
and
sometimes
causes
long-term
effects
(e.g.
deafness, memory problems, loss of
fingers or toes), or death.
AS WITH ALL VACCINES, NIMENRIX
MAY NOT PROTECT ALL PEOPLE WHO ARE
VACCINATED.
Also, NIMENRIX does not help to
protect against meningococcal disease
caused by other types of Neisseria, or
meningitis caused by other bacteria or
viruses.
NIMENRIX can be used in infants
from 6 weeks of age, children and
adults.
NIMENRIX may also be prescribed
for other people or situations.
IF YOU ARE NOT SURE WHETHER YOU OR
YOUR
CHILD
SHOULD
BE
GIVEN
THIS
VACCINE, TALK TO YOUR DOCTOR.
BEFORE
YOU
OR
YOUR
CHILD
IS
GIVEN
NIMENRIX
_WHEN

Fachinformation

Version: pfdnimev10323 Supersedes: pfdnimev10322
Page 1 of 31
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
NIMENRIX
®
injection with diluent.
Meningococcal polysaccharide groups A, C, W-135 and Y conjugate
vaccine.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 mL) contains:
Meningococcal polysaccharide - Group A
1
5 micrograms
Meningococcal polysaccharide - Group C
1
5 micrograms
Meningococcal polysaccharide - Group W-135
1
5 micrograms
Meningococcal polysaccharide - Group Y
1
5 micrograms
1
conjugated to tetanus toxoid carrier protein
44 micrograms
For the full list of excipients (see Section 6.1 List of excipients).
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 6
weeks of age against
invasive meningococcal disease caused by
_Neisseria meningitidis_
groups A, C, W-135 and
Y.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
NIMENRIX should be used in accordance with available official
recommendations.
_ _
Version: pfdnimev10323 Supersedes: pfdnimev10322
Page 2 of 31
AGE GROUP
PRIMARY IMMUNISATION
BOOSTER
Infants from 6 weeks to less
than 6 months of age*
1,2
Two doses, each of 0.5 ml,
with the first dose given from
6 weeks of age, with an
interval of 2 months between
doses
At 12 months of age
Unvaccinated infants from
6 months to less than
12 months of age**
One dose of 0.5 ml given
from 6 months of age
At 12 months of age with
a minimum interval of at
least 2 months after the
primary dose
Children from 12 months of
age, adolescents and
adults**
One dose of 0.5 ml
Not routinely
administered
* See Section 5.1 Pharmacodynamic properties for further information.
**In some situations, consideration may be given to administering an
additional primary dose or a booster
dose of NIMENRIX (see Section 4.4 Special warnings and precautions for
use and Section 5.1
Pharmacodynamic properties for fur