Polio Sabin suspension oral

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

poliovirus types 1, poliovirus types 3

Доступна с:

GlaxoSmithKline Biologicals s.a.

код АТС:

J07BF04

ИНН (Международная Имя):

poliovirus types 1, poliovirus types 3

дозировка:

not less than-106CCID50/dose+ not less than-105.8CCID50/dose

Фармацевтическая форма:

suspension oral

Штук в упаковке:

(100) glass vials 1ml (10dose)

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2016-07-20

тонкая брошюра

DESCRIPTION
_Polio Sabin ™O_
_lle_
_ami_
_Three_
_(oral),_
oral
suspension
Bivalent
Oral
Poliomyelitis
vaccine
Types
1 and 3 (bOPY)
_Po/~o Sabin ™OJ/e and Three (oral)_
is a bivalent,
live attenuated
poliomyelitis
virus
vaccine
of
the Sabin
strains
Type
I
(lSc,
2ab)
and Type
3 (Leon
12a,
] b),
propagated
in MRC5
human
diploid
cells.
Each dose (0.1
1111)
contains
not
less
than
10
6
.
0
CCTDso of
Type
1 and
10
5
.
8
CCIDso
of
Type
3.
Excipients:
Magnesium
chloride,
L-arginine,
polysorbate
80 and water
for
injections.
Neomycin
sulphate.
polymyxin
B sulphate
and phenol
red are present
as
residuals
from the
manufacturing
process.
ADMINlSTRATION
_Polio Sabin_
_TMOl1e_
_and Three (oral)_
is for
oral
use only
(see
also sections
_Immunization_
_Schedule_
and
_Precautions )._
One dose of
vaccine
(0.1 ml)
is contained
in two drops
which
are delivered
from the
polyethylene
dropper
supplied
with the
multi
dose
container.
The vaccine
may
be administered
alone
or
mixed
with
beverages
or
foods
provided
that
these
do not
contain
substances
that
may
inactivate
polioviruses,
such
as preservatives.
Suitable
vehicles
are
simple
syrup,
milk,
bread and a lump
of
sugar.
Since
the vaccine
has
a bitter
salty
taste,
it
may be given
in syrup
or
on a lump of
sugar,
particularly
when
it
is to be given
to young
children.
The vaccine
should
be administered
to breast-fed
infants,
preferably
two
hours
before
or
after
breast-feeding
in order
to avoid
contact
with
the
antibodies
present
in the
breast
milk.
Care should
be taken
not
to contaminate
a multidose
dropper
with
saliva
of
the
vaccinee.
The vaccine
is presented
as a clear
liquid,
yellowish
to pink suspension.
Due to minor
variation
of
its
pH,
_Polio Sabin_
_™_
_One and Three (oral)_
may vary
in colour
from
yellow to
pink.
Changes
of
the
colour
of
the vaccine
within
this
range
do not
signify
deterioration
of
the vaccine.
Vaccines
should
be inspected
visually
for
any particulate
matter
prior
to administration.
Multidose
vials
of
_Polio Sabin_
_T1"OIlC_
_and Three (oral)_
from which
one
o

Характеристики продукта

_A2_
SUMMARY OF PRODUCT
CHARACTERISTICS
1.
NAME OF THE MEDICINAL
PRODUCT
Polio Sabin One
and Three
(oral),
drinkable
suspension,
rnultidose.
Bivalent
poliomyelitis
vaccine
Types
I
and
3
(Jive,
attenuated).
2.
QUALIT ATlVE AND QUANTITATIVE
COMPOSITION
Each dose
(0.1 ml)
contains:
Polio virus
type
1
(LSe,
2ab strain)
live attenuated"
Polio virus
type
3
(Leon,
12a,
Ib
strain)
live
attenuated"
not
less than
106.0
_CCIDso_
not
less
than
_lOs.~_
CCIDso
*produced
on a eulture
of
human
diploid
cells
The
vaccine
is presented
in
a
multidose
pack.
See section
6.5
for
the
number
of
doses
per
vial.
For
the full
list
of
excipients,
see section
6.1.
3.
PHARMACEUTICAL
.FORM
Drinkable
suspension.
Clear,
yellowish
to pink
suspension
for
oral
administration.
4.
CLINICAL PARTICULARS
4.1.
Therapeutic
indications
Polio Sabin One
and Three
(oral)
is indicated
for
active immunisation
at
any age against
poliomyelitis
infection
caused
by poliomyelitis
viruses
Types
I
and 3.
4.2.
Posology
and method
of
administration
Posology
In a
multi dose
vial,
one immunising
dose
consists
of two drops.
111e vaccination
schedule
must
be
ill
accordance
with official
recommendations.
Method
of administration
Polio Sabin
One
and Three
(oral)
is presented
ready for
use and is for
oral
administration
only.
V
15'06'2015
_FA.MHP_
[Documencs A2,
B2,
C2,
_D2,_
E2,
F2 and G2 are translations of Documents
AI,
Bl,
cr.
Dl,
E I and FI.
Translations certified by the translator,
Shirley Yvonne Barrett]
Date:
. ~.
_10._
_.(,l:t21S·_
_,'._
_'._
_._
_...._
_~.~_
_~_
_'O;J;_
Page
1
of1
82
The vaccine
can b~ administered
alone
or
together
with beverages
or foods
(syrup,
milk,
bread,
a
sugar
IUl~p),
pr~V1ded that
th~se do not
contain
substances
that
may inactivate
the virus
such as
preservatl:es.
Since
the
~a~cl~e
has
a slightly
bitter,
salty taste,
it
can be given
in syrup
or
on a sugar
lump,
particularly
when
It
IS
given
to young
children.
In
breast-fed
infants,
the vaccine
should
be administered
preferably
two hours
before
or
after
breast-
feeding ill order
to avoid
any