SYNFLORIX pneumococcal polysaccharide conjugate vaccine, 10-valent adsorbed suspension for injection pre-filled syringe

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

Pneumococcal purified capsular polysaccharides

Tillgänglig från:

GlaxoSmithKline Australia Pty Ltd

INN (International namn):

Pneumococcal purified capsular polysaccharides

Bemyndigande status:

Registered

Bipacksedel

1
SYNFLORIX
®
_Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you use SYNFLORIX.
This leaflet answers some
common questions about
SYNFLORIX. It does not contain
all of the available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Sometimes new risks
are found even when a medicine
has been used for many years.
Your doctor has weighed the
expected benefits of your child
having SYNFLORIX against the
possible risks.
IF YOU HAVE ANY CONCERNS ABOUT
YOUR CHILD RECEIVING
SYNFLORIX, TALK TO YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
VACCINE.
You may need to read it again.
WHAT IS SYNFLORIX
USED FOR?
SYNFLORIX is a pneumococcal
vaccine. SYNFLORIX helps
protect your child against
diseases such as: meningitis,
blood infection, pneumonia and
ear infection caused by ten types
of the bacteria _Streptococcus _
_pneumoniae_.
The vaccine works by helping the
body to make its own antibodies,
which protect your child against
these diseases.
As with all vaccines, SYNFLORIX
may not fully protect all children
who are vaccinated.
SYNFLORIX will only protect
against infections caused by the
groups of _Streptococcus _
_pneumoniae_ for which the vaccine
has been developed.
Children with a weakened
immune system, for example due
to HIV infection, may not get the
full benefit from SYNFLORIX.
BEFORE YOUR CHILD
RECEIVES SYNFLORIX
_ _
_SYNFLORIX SHOULD NOT BE _
_GIVEN IF YOUR CHILD: _

has previously had any allergic
reaction to SYNFLORIX, or any
ingredient contained in
SYNFLORIX. The active
substances and other
ingredients in SYNFLORIX are
listed at the end of the leaflet.
Signs of an allergic reaction
may include itchy skin rash,
shortness of breath and
swelling of the face or tongue.
BEFORE YOUR CHILD IS VACCINATED,
MAKE SURE YOUR DOCTOR KNOWS IF
ANY OF THE FOLLOWING APPLY TO
YOUR CHILD

has a severe infection with a
high temperature. It

Produktens egenskaper

1
SYNFLORIX
®
PRODUCT INFORMATION
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed
_ _
NAME OF THE MEDICINE
Synflorix
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed
_ _
DESCRIPTION
Synflorix is a pneumococcal polysaccharide conjugate vaccine using
Protein D as the
main carrier protein. Protein D is a highly conserved surface protein
from Non-Typeable
_Haemophilus influenzae_ (NTHi). Each 0.5ml dose of Synflorix contains
1 microgram of
Pneumococcal polysaccharide serotypes 1*, 5*, 6B*, 7F*, 9V*, 14* and
23F* and 3
micrograms of Pneumococcal polysaccharide serotypes 4*, 18C
†
and 19F
#
adsorbed onto
Aluminium
phosphate
(0.5
mg
Al
3+
).
Synflorix
also
contains
approximately
9
to
16
micrograms of Protein D carrier protein, 5 to10 micrograms of tetanus
toxoid carrier protein
and 3 to 6 micrograms of diphtheria toxoid carrier protein_. _
Synflorix also contains 4.3
milligrams of sodium chloride (NaCl) and water for injection as
excipients. Synflorix does
not contain a preservative.
* conjugated to Protein D
# conjugated to diphtheria toxoid carrier protein
† conjugated to tetanus toxoid carrier protein.
PHARMACOLOGY
Synflorix is a pneumococcal polysaccharide conjugate vaccine using
Protein D as the
main carrier protein. Protein D is a highly conserved surface protein
from Non-Typeable
_Haemophilus influenzae_ (NTHi). The vaccine contains 10 _
Streptococcus pneumoniae_
serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F).
Protection against the _ Streptococcus pneumoniae_ bacterium is
triggered by antibodies,
directed against its polysaccharide capsule, which can mediate
bacterial killing.
_ _
CLINICAL TRIALS
_ _
1.
EPIDEMIOLOGICAL DATA
_ _
The 10 serotypes included in this vaccine represent the major
disease-causing serotypes
worldwide covering approximately 50% to 96% of IPD in children <5
years of age.
Pneumonia of different aetiologies is a leading cause of childhood
morbidity and mortality
globally. In studies in developing and developed countries, _
Streptococcus pneumonia