Infanrix suspenion for injection

País: Armênia

Língua: inglês

Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes ativos:

diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous haemagglutinin, pertactin

Disponível em:

GlaxoSmithKline Biologicals s.a.

Código ATC:

J07AJ52

DCI (Denominação Comum Internacional):

diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous haemagglutinin, pertactin

Dosagem:

not less than 30IU/dose+ not less than 40IU/dose+ 25mcg/dose+ 25mcg/dose+ 8mcg/dose

Forma farmacêutica:

suspenion for injection

Unidades em pacote:

0.5ml/dose pre-filled glass syringe and needle

Tipo de prescrição:

Prescription

Status de autorização:

Registered

Data de autorização:

2016-06-08

Folheto informativo - Bula

Infanrix
™
Diphtheria
(D), tetanus
(T),
pertussis
(acellular,
component)
(Pa) vaccine
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Illfllllrix™_
contains
diphtheria
toxoid,
tetanus
toxoid and three
purified
pertussis
antigens
(pertussis
toxoid
(PT),
filamentous
hacmagglutinin (FHA)
and
69
kiloDalton
outer
membrane
protein
(pertactin)]
adsorbed
onto aluminium
salts.
The diphtheria
and tetanus
toxins
obtained
from cultures
of
_Corynebacterium_
_diphtheriae_
and
_Clostridium_
_tetani_
are detoxified
and purified.
The acellular
pertussis
vaccine
components
(PT,
FHA and pertactin)
are prepared
by growing
phaseI
_Bordetel!a_
_pertussis_
from which the
PT and
FHA
and pertactin
are extracted,
purified
and treated
with formaldehyde;
PT
is
irreversibly
detoxified.
The diphtheria
toxoid,
tetanus
toxoid
and acellular
pertussis
vaccine
components
are adsorbed
on aluminium
salts.
The
final
vaccine
is formulated
ill
saline.
_[1lj"tlllri.\;?·lf_
meets
the World
Health
Organisation
requirements
for
manufacture
of
biological
substances
and for
diphtheria
and tetanus
vaccines.
No substances
of
human
origin
are used in
its
manufacture.
A 0.5
ml
dose
of the vaccine
contains
not
less than 30
International
Units
(IU)
of diphtheria
toxoid.
40 IU of tetanus
toxoid
25 mcg of
PT,
25 I11cgof
FilA and 8 mcg of
periactin.
PHARMACEUTICAL
FORM
Suspension
for
injection.
CLINICAL PARTICULARS
Indications
_Infanrix':_
is indicated
for
active
primary
immunisation
against
diphtheria,
tetanus
and
pertussis
from the age of2
months
onwards.
_In/tfllri.'.?1If_
is indicated
as a booster
dose
for children
who have
previously
been
imrnunised
with three
or
four
doses
of
either
DTPu vaccine
or diphtheria,
tetanus
and
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be administered.
As vaccination
schemes
vary from country
to country,
the sch

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Infanrix'
D1
Diphtheria
(D).
tetanus
(T),
pertussis
(acellular,
component)
CPa) vaccine
2. QUALITATIVE
AND QUANTITATIVE
COMPOSITION
_Illjanrix™colltains_
diphtheria
toxoid,
tetanus
toxoid
and three purified
pertussis
antigens
[pertussis
toxoid
CPT),
filamentous
haemagglutinin
(FHA)
and
69
kiloDalton
outer
membrane
protein
(pertactin)J
adsorbed
onto aluminium
salts.
The diphtheria
and tetanus
toxins
obtained
from cultures
of
_Corynebacterium diphtheriae_
and
_Clostridium tetani_
are detoxified
and purified.
The acellular
pertussis
vaccine
components
(PT,
FHA
and pertactin)
are prepared
by growing
phase
1
_Bordetella pertussis_
from which
the
PT and
FHA
and pertactin
are extracted,
purified
and treated
with formaldehyde;
PT is
irreversibly
detoxified.
The diphtheria
toxoid,
tetanus
toxoid
and acellular
pertussis
vaccine
components
are adsorbed
on aluminium
salts.
The
final
vaccine
is formulated
in saline.
_Injanrixi"_
meets
the World
Health Organisation
requirements
for
manufacture
of
biological
substances
and for
diphtheria
and tetanus
vaccines.
No substances
of
human
origin
are used in
its manufacture.
A 0.5 ml
dose
of the vaccine
contains
not
less
than 30 International
Units
(lU)
of diphtheria
toxoid,
40 LU
of
tetanus
toxoid,
25
mcg
ofPT,
25 I11cgof
FHA and 8 I11cgof
per lac tin.
3.
PHARMACEUTICAL
FORM
Suspension
for
injection.
4.
CLINICAL PARTICULARS
4.1 Therapeutic
Indications
_fI~ra1l1L'CTj\/_
is indicated
for active
primary
imrnunisation
against
diphtheria,
tetanus
and
pertussis
from the age of2
months
onwards.
_Infanrixi"_
is indicated
as
a
booster
dose
for
children
who have previously
been
imrnunised
with three or
four
doses
of
either
DTPa
vaccine
or diphtheria,
tetanus
and whole-cell
pertussis
(DTP)
.
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