SYNFLORIX pneumococcal polysaccharide conjugate vaccine, 10-valent adsorbed suspension for injection vial

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

Pneumococcal purified capsular polysaccharides

Prieinama:

GlaxoSmithKline Australia Pty Ltd

INN (Tarptautinis Pavadinimas):

Pneumococcal purified capsular polysaccharides

Autorizacija statusas:

Registered

Prekės savybės

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