Synflorix Suspension for Injection (Prefilled Syringe)

Ország: Szingapúr

Nyelv: angol

Forrás: HSA (Health Sciences Authority)

Aktív összetevők:

Conjugate of Streptococcus pneumoniae type 1 & Haemophilus influenzae protein D; Conjugate of Streptococcus pneumoniae type 14 and Haemophilus influenzae protein D; Conjugate of Streptococcus pneumoniae type 18C and tetanus toxoid; Conjugate of Streptococcus pneumoniae type 19F and diphtheria toxoid; Conjugate of Streptococcus pneumoniae type 23F and Haemophilus influenzae protein D; Conjugate of Streptococcus pneumoniae type 4 and Haemophilus influenzae protein D; Conjugate of Streptococcus pneumoniae type 5 and Haemophilus influenzae protein D; Conjugate of Streptococcus pneumoniae type 6B and Haemophilus influenzae protein D; Conjugate of Streptococcus pneumoniae type 7F and Haemophilus influenzae protein D; Conjugate of Streptococcus pneumoniae type 9V and Haemophilus influenzae protein D; Diphtheria Toxoid (DT) Carrier Protein; Polysaccharide (PS); Protein-D (PD) Carrier Protein (derived from non-typeable Haemophilus influenzae); Tetanus Toxoid (TT) Carrier Protein

Beszerezhető a:

GLAXOSMITHKLINE PTE LTD

ATC-kód:

J07AL52

Adagolás:

1 μg PS1; 1.11-1.67 μg PD/dose

Gyógyszerészeti forma:

INJECTION, SUSPENSION

Összetétel:

Conjugate of Streptococcus pneumoniae type 1 & Haemophilus influenzae protein D 1 μg PS1; 1.11-1.67 μg PD/dose; Conjugate of Streptococcus pneumoniae type 14 and Haemophilus influenzae protein D 1 μg PS14; 1.00-1.82 μg PD/dose; Conjugate of Streptococcus pneumoniae type 18C and tetanus toxoid 3 μg PS18C; 5.45-10.00 μg TT/dose; Conjugate of Streptococcus pneumoniae type 19F and diphtheria toxoid 3 μg PS19F; 3.33-6.00 μg DT/dose; Conjugate of Streptococcus pneumoniae type 23F and Haemophilus influenzae protein D 1 μg PS23F; 0.39-0.74 μg PD/dose; Conjugate of Streptococcus pneumoniae type 4 and Haemophilus influenzae protein D 3 μg PS4; 3.33-6.67 μg PD/dose; Conjugate of Streptococcus pneumoniae type 5 and Haemophilus influenzae protein D 1 μg PS5; 0.67-1.25 μg PD/dose; Conjugate of Streptococcus pneumoniae type 6B and Haemophilus influenzae protein D 1 μg PS6B; 0.56-0.95 μg PD/dose; Conjugate of Streptococcus pneumoniae type 7F and Haemophilus influenzae protein D 1 μg PS7F; 0.87-1.43 μg PD/dose; Conjugate of Streptococcus pneumoniae type 9V and Haemophilus influenzae protein D 1 μg PS9V; 1.00-1.82 μg PD/dose; Diphtheria Toxoid (DT) Carrier Protein 3-6 μg DT/dose (total DT content); Polysaccharide (PS) 16 μg/dose (total PS content); Protein-D (PD) Carrier Protein (derived from non-typeable Haemophilus influenzae) 9-16 μg PD/dose (total PD content); Tetanus Toxoid (TT) Carrier Protein 5-10 μg/dose (total TT content)

Az alkalmazás módja:

INTRAMUSCULAR

Recept típusa:

Prescription Only

Gyártó:

GlaxoSmithKline Biologicals SA (Filling)

Engedélyezési státusz:

ACTIVE

Engedély dátuma:

2010-03-19

Betegtájékoztató

1 

SYNFLORIX
TM

1.  
NAME OF THE MEDICINAL PRODUCT 

Synflorix suspension for injection  
Pneumococcal polysaccharide_ _conjugate vaccine (adsorbed) 

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
influenzae_) 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 a full list of excipients, see section 6.1. 

3.  
PHARMACEUTICAL FORM 

Suspension for injection (injection). 
The vaccine is a turbid white suspension. 

4.  
CLINICAL PARTICULARS 

4.1   THERAPEUTIC INDICATIONS 

Active immunisation against invasive disease and acute otitis media
caused by _Streptococcus pneumoniae_ 
in infants and children from 6 weeks up to 5 years of age (prior
to the 5
th
 birthday). See sections 4.4 and 
5.1 for information on protection against specific
pneumococcal serotypes._ _
_ _
The use of Synflorix should be determined on the basis of official
recommendations taking into 
consideration the impact of invasive disease in different age groups
as well as the variability of serotype 
epidemiology in different geo

Termékjellemzők

1
SYNFLORIX
1.
NAME OF THE MEDICINAL PRODUCT
Synflorix suspension for injection
Pneumococcal polysaccharide conjugate vaccine (adsorbed)
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 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 a full list of excipients, see section 5.1.
The vaccine is a turbid white suspension.
3.
CLINICAL INFORMATION
3.1
THERAPEUTIC INDICATIONS
Active immunisation against invasive disease, pneumonia and acute
otitis media caused by
_Streptococcus _
_pneumoniae _
in infants and children from 6 weeks up to 5 years of age (prior to
the 5
th
birthday). See
sections 3.4 and 4.1 for information on protection against specific
pneumococcal serotypes.
The use of Synflorix should be determined on the basis of official
recommendations taking into
consideration the impact on pneumococcal diseases in different age
groups as well as the variability of the
epidemiology in different geographical areas.
3.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Method of administration _
2
The vaccine should be given by intramuscular injection. The preferred
sites are anterolateral aspect of the
thigh in infants or the deltoid muscle of the upper arm in young
children.
_Posology _
_ _
The immunisation schedules for Synflorix should be b