Synflorix suspension for injection

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F

Dostopno od:

GlaxoSmithKline Biologicals s.a.

Koda artikla:

J07AL52

INN (mednarodno ime):

Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F

Odmerek:

1mcg/dose+ 3mcg/dose+ 1mcg/dose+ 1mcg/dose+ 1mcg/dose+ 1mcg/dose+ 1mcg/dose+ 3mcg/dose+ 3mcg/dose+ 1mcg/dose

Farmacevtska oblika:

suspension for injection

Enote v paketu:

(100) glass vials 1ml (2 dose)

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2016-07-20

Lastnosti izdelka

"
.
SUMMARY
OF PRODUCT
CHARACTERISTICS
I
,
I
I.
NAME OFTHE
MEDICINAL
PRODUCT
Syntlorix
suspension for
injection
in multidose container
Pneumococca I polysaccharide
conjugate vaccine (adsorbed)
2.
QUALITATIVE
ANO QUANTITATIVE
COMPOSITION
I
dose (0.5 ml)
contains:
,
Pneumococcal
polysaccharide
serotype
11.1
Pneumococcal
polysaccharide
serotype
4'·2
Pneumococcal
polysaccharide
serotype
5'·2
Pneumococcal
polysaccharide
serotype
613,·2
Pneumococcal
polysaccharide
serotype
7P1.2
Pneumococcal
polysaccharide
serotype 9V
u
Pneumococcal
polysaccharide
serotype
14 '.'
Pneumococcal
polysaccharide
serotype
18C"]
Pneumococcal
polysaccharide
serotype
19FI.··
Pneumococcal
polysaccharide
serotype
23F
u
microgram
3
micrograms
I
microgram
I microgram
I
microgram
I
III
icrograrn
I
microgram
3
micrograms
3
micrograms
I microgram
•adsorbed on aluminium phosphate
0.5 milligram All'
~conjugated
to
protein [)
(derived
Irom non-typeable
_l loetnophilus_
_il!/lllr.!lI:::ae)_
carrier
protein
9-
16
III
icrogra
rns
5-10 micrograms
3-6
micrograms
> conj
ugated
to tetanus toxoid carrier
protein
"conjugated
to diphtheria
toxoid carrier
protein
This is
a
III
lilt idose container.
See section
6.5
tor
the number
of
doses per
vial.
For
the full
list
of
excipients.
see section 6.1.
3.
PHARMACEUTICAL
FORM
Suspension
tor
injection
(injection).
The vaccine is
a turbid
white
suspension.
4.
CLINICAL
PARTICULARS
4.1
Therapeutic
indications
Active
inununisation
ugains:
invasive disease.
pneumonia
and acute otitis
media caused by
_Streptococcus_
_P'H'II/1wl1i(le_
ill
infants and children
from
6 weeks up to S years or age. See sections 4.4
and 5.1
for
information
on protection against
specific
pneumococcal
serotypes,
The LiseofSynflorix
should be determined
on the basi,
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.
4.2
Posology
and method
of
administration
I'osolog,y
The immunisation
schedules
1'01'
Synllor