Synflorix

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Pneumococcal polysaccharide serotype 1 1ug (conjugated with NTHi protein D);  ;  ; Pneumococcal polysaccharide serotype 14 1ug (conjugated with NTHi protein D);  ;  ; Pneumococcal polysaccharide serotype 18C 3ug (conjugated with Tetanus Toxoid);  ;  ; Pneumococcal polysaccharide serotype 19F 3ug (conjugated with Diptheria Toxoid);  ;  ; Pneumococcal polysaccharide serotype 23F 1ug (conjugated with NTHi protein D);  ;  ; Pneumococcal polysaccharide serotype 4 3ug (conjugated with NTHi protein D);  ;  ; Pneumococcal polysaccharide serotype 5 1ug (conjugated with NTHi protein D);  ;  ; Pneumococcal polysaccharide serotype 6B 1ug (conjugated with NTHi protein D);  ;  ; Pneumococcal polysaccharide serotype 7F 1ug (conjugated with NTHi protein D);  ;  ; Pneumococcal polysaccharide serotype 9V 1ug (conjugated with NTHi protein D);  ;  

Διαθέσιμο από:

GlaxoSmithKline NZ Limited

INN (Διεθνής Όνομα):

Pneumococcal polysaccharide type 1 1 µg (conjugated with NTHi protein D)

Φαρμακοτεχνική μορφή:

Suspension for injection

Σύνθεση:

Active: Pneumococcal polysaccharide serotype 1 1ug (conjugated with NTHi protein D)     Pneumococcal polysaccharide serotype 14 1ug (conjugated with NTHi protein D)     Pneumococcal polysaccharide serotype 18C 3ug (conjugated with Tetanus Toxoid)     Pneumococcal polysaccharide serotype 19F 3ug (conjugated with Diptheria Toxoid)     Pneumococcal polysaccharide serotype 23F 1ug (conjugated with NTHi protein D)     Pneumococcal polysaccharide serotype 4 3ug (conjugated with NTHi protein D)     Pneumococcal polysaccharide serotype 5 1ug (conjugated with NTHi protein D)     Pneumococcal polysaccharide serotype 6B 1ug (conjugated with NTHi protein D)     Pneumococcal polysaccharide serotype 7F 1ug (conjugated with NTHi protein D)     Pneumococcal polysaccharide serotype 9V 1ug (conjugated with NTHi protein D)     Excipient: Aluminium phosphate Diphtheria toxoid, adsorbed Haemophilus influenzae protein D Sodium chloride Tetanus toxoid Water for injection

Μονάδες σε πακέτο:

Syringe, glass, Pre-filled Type 1 with rubber butyl plunger stopper, 0.5mL, 1 dose unit

Kατηγορία:

Prescription

Τρόπος διάθεσης:

Prescription

Κατασκευάζεται από:

GlaxoSmithKline Biologicals SA

Θεραπευτικές ενδείξεις:

Synflorix is indicated for the active immunisation of infants and children from the age of 6 weeks up to 5 years against disease caused by Streptococcus pneumoniae vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F and cross-reactive serotype 19A (including invasive disease, pneumonia and acute otitis media).

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Syringe, glass, Pre-filled Type 1 with rubber butyl plunger stopper, 0.5mL - 1 dose units - 4 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, Pre-filled Type 1 with rubber butyl plunger stopper, 0.5mL - 10 dose units - 4 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Type 1 with rubber butyl plunger stopper, 0.5mL - 1 dose units - 4 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Type 1 with rubber butyl plunger stopper 0.5mL - 10 dose units - 4 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Ημερομηνία της άδειας:

2009-04-15

Φύλλο οδηγιών χρήσης

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 human immunodeficiency virus
(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

Αρχείο Π.Χ.Π.

1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
SYNFLORIX pneumococcal polysaccharide conjugate vaccine, 10 valent
adsorbed.
Suspension for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 mL) contains:
Pneumococcal polysaccharide serotype 1
1,2
1 microgram
Pneumococcal polysaccharide serotype 4
1,2
3 micrograms
Pneumococcal polysaccharide serotype 5
1,2
1 microgram
Pneumococcal polysaccharide serotype 6B
1,2
1 microgram
Pneumococcal polysaccharide serotype 7F
1,2
1 microgram
Pneumococcal polysaccharide serotype 9V
1,2
1 microgram
Pneumococcal polysaccharide serotype 14
1,2
1 microgram
Pneumococcal polysaccharide serotype 18C
1,3
3 micrograms
Pneumococcal polysaccharide serotype 19F
1,4
3 micrograms
Pneumococcal polysaccharide serotype 23F
1,2
1 microgram
1
adsorbed on aluminium phosphate 0.5 milligram Al
3+
2
conjugated to protein D (derived from Non-Typeable _Haemophilus
influenza (NTHi)_) carrier protein 9-16
micrograms
3
conjugated to tetanus toxoid carrier protein 5-10 micrograms
4
conjugated to diphtheria toxoid carrier protein 3-6 micrograms
For the full list of excipients, see section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Suspension for injection.
SYNFLORIX is a turbid white suspension.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Active immunisation of infants and children from the age of 6 weeks up
to 5 years against
disease caused by _Streptococcus pneumoniae_ vaccine serotypes 1, 4,
5, 6B, 7F, 9V, 14,
18C, 19F, 23F and cross-reactive serotype 19A (including invasive
disease, pneumonia
and acute otitis media).
4.2 DOSE AND METHOD OF ADMINISTRATION
Dose
Official
recommendations
should
be
taken
into
account
when
immunising
with
SYNFLORIX.
It is recommended that subjects who receive a first dose of SYNFLORIX
complete the
full vaccination course with SYNFLORIX.
2
_VACCINATION OF INFANTS FROM 6 WEEKS TO 6 MONTHS OF AGE: _
_Three-dose primary series_
The recommended immunisation series to ensure optimal protection
consists of a total
of four doses, each of 0.5 ml. The primary infan