Wilate 1000 powder for solution for i/v injection

Land: Armenia

Språk: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv ingrediens:

human blood coagulation factor VIII, human von Willebrand factor

Tilgjengelig fra:

Octapharma Pharmazeutika Produktionsges. m.b.H.

ATC-kode:

B02BD06

INN (International Name):

human blood coagulation factor VIII, human von Willebrand factor

Dosering :

1000IU/10ml+ 1000IU/10ml

Legemiddelform:

powder for solution for i/v injection

Enheter i pakken:

(1) glass vial, (1) solvent in glass vial 10ml, (1) equipment pack with disposable syringe, transfer set (double ended needle an

Resept typen:

Prescription

Autorisasjon status:

Registered

Autorisasjon dato:

2018-11-07

Informasjon til brukeren

ocfophormo
llilate
-
Soltttìon
for
Infusìon
-
Srtnnnry
of
Producl
Characterìstícs
&
package
Leøflet
PACKAGE
LEAFLET:
INFORMATION
FoR
THE
USER
Wilate
500'
500
IU
VWF
/500 IU
FVIII,
powder
and
solvent
for
solution
for
injection
Wilate
1000'
1000
tU VWF
/1000
ru
FVIII,
powderand
solvent
for
solution
for
injection
Human
von
Willebrand
factor
ftuman
coagulation
factor
VIll
What
is
in
this leallet:
l.
What
Wilate
is
and
what
it
is used
for
2.
What
you
need
to
know
before
you
use
Wi
3,
How to
use
rvVilate
4.
Possible
side
effects
5.
How
to
store
Wilate
6,
Contents of the
pack
and
other
information
Von
Willebrand
disease
Wilate
is used
to
treat
and
prevent
bleeding
in
patients
with
von
'rVillebrand
disease
(VWD),
which
in
fact
is
a
family
of
related
diseases.
VWD
is
a
disturbance
of
blood coagulation
where
bleeding
can
go
on
for
longer
than
expected.
This
is
either
due
to
a
lack
of
VWF
in
the
blood
or
due
to
VWF
that
does
not
work
the
way
it should.
Haemophilia
A
Wilate
is
used
to
treat
and
prevent
bleeding in
patients
with
haemophilia
A.
This
is
a
condition
in
which
bleeding
can
go
on
for
longer
than expected.
It
is
due
to
an
inborn
lack
of
FVIII
in
the
blood.
2.
lltlhat
vou'need,io
knoú
bôfoiE
vôu usäWität¿
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0l(T.
20t0
l.
What
Wilateie
and what
lt ls
used
foi
Wilate
belongs
to the
pharnacotherapeutic
group
of medicines
called
clotting
factors
and
contains
human
von
Willebrand
factor
(VWF)
and
human
blood
coagulation
factor
VIII
(FVIIÐ.
Together
these
two
proteins
are
involved
in
blood clotting.
Read
all of this
leaflet
carefully
before
important
information
for
you.
you
start
using
this
medicine
because
it
contains
o
Please
keep
this
leaflet.
You
may
need
to
read
it
again.
.
lfyou
have
further
questions,
ask
your
doctor
or
your
pharmacist.
¡
This
medicine
has been
prescribed
for
you
only.
Do not
pass
it
on
to
others.
It
may
harm
them,
even
if
their
signs
of
illness
are
the
same
as
yours,
.
lfyou
get
any
side
effects,
talk to
your
doctor
or
pharmacist.
This
includes

Preparatomtale

ocfophormo
Wilote
-
Solutìon
fot'
Ittfusìon
-
Sununary
ofProduct
Chøracteùstics
&
Pachage
Leaflet
SUMMARY
OF
PRODUCT
CHARACTERJSTICS
1
NAME
OF
THE
MEDICINAL
PRODUCT
rwilate
500,
500
IU
vwF/500
tu
FVIll,
powder
and
solvent
for
solution
for
injection
Wilate
1000'
1000
IU VWF/I000
tU
Fvtll,
powder
and
solvent
for
solution for injection
2
QUALITATIVE
AND
QUA¡ITITATIVE
COMPOSITION
v/ilate,
produced
from
the
plasma
of
human
donors, is
presented
as a
powder
and
sotvent
for solution for injection
containing
nominally
500
lU/1000
IU
human
von
Willebrand
factor
(VWF)
and
human coagulation
factor
Vlll
(FVIll)
per
vial.
The
product
contains
approximately
100
IU/ml
human
von
Willebrand
factor
when
reconstituted
with
5
ml/10
ml
Water
for
Injections
with
0.1
%
Polysorbat
80.
The
specific
activity
of Wilate
is
à
67
IU VWF:RCo/mg
protein.
The
VWF
potency
(IU)
is
measured
according
to
ristocetin
cofactor
activity
(VWF:RCo)
compared to
the International
standard for
von
tüillebrand
Factor
concenhate
(wHo).
The
product
contains
approximately 100
IU/ml
human coagulation
factor
VIII
when
reconstituted
with
5
ml/I0
ml
water for
Injections
with
0.1% Polysorbate
g0.
The
FVIII
potency
(IU)
is
determined
using
the
European
Pharmacopoeia
chromogenic
assay.
The specific
activity of Wilate
is
>
67
IU FVIII:C/mg
protein.
For
the
full
list
of
excipients,
see
section 6.1.
3
PHARMACIUTICAL
FORM
Powder
and
solvent
for
solution for
injecfion.
Freeze-dried
powder:
white
or
pale
yellow
SCDMTE
JSC
4
CLINICAL
PARTICULARS
Expert
/
Date
Øll
/o,
/,!
4.1
Therapeutic indications
Von Willebrand
disease
IVWD)
Applicant
/
Date
YULIA
S
?
5.
0r(T,
20t8
Prevention and
treatment
of
haemonhage
or
surgical
bleeding
in
von
Willebrand
disease
(VV/D),
when
desmopressin
(DDAVP)
treatment alone
is
ineffective
or contra-indicated.
HaemophiliaA
Treatnent
and
prophylaxis
of
bleeding
in
patients
with
haemophilia
A
(congenital
FVIII
deficiency).
2 0 I
8
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