Esmya

Country: Armenia

Bahasa: Inggeris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

ulipristal (ulipristal acetate)

Boleh didapati daripada:

Gedeon Richter PLC

INN (Nama Antarabangsa):

ulipristal (ulipristal acetate)

Dos:

5mg

Borang farmaseutikal:

tablets

Jenis preskripsi:

Prescription

Ciri produk

1.
NAME
OF
TIID
MEDICINAL
PRODUCT
Esmya
5
mg
tablets
2,
QUALITATM
AND
QUANTIT.{TrVE
COMPOSTTION
Each
tablet
contains
5
mg
ofulipristal
acetate.
For
the
full
list
of
excipieLrts,
see
sec.tion
6.
I
.
3.
PHARMACEUTICAL
FORM
Tablet.
write
to
otr-white.
rouncl
biconvex
tablet
of
?
mnr
engravecl
with
,,8S5"
on
one face.
4,
CLINICAL
PARTICULARS
4,1
Therapeuticindications
Ulipristal
acetate is
indicated
for
pre-opemtive
treatment
of
moclerate
to
severe
symptoms
of
uterine
.fibroids in
adult
women
of
reproductive
age.
Uliplistal
acalate is
indicatecl
for
interrnittent
treatnlent
of
modelate
to
severe
sympl-or:rs
of
uterine
fibloicls
in adult
women
of
reprocfi.rctive
age.
4,2
Posology
and
rnethod
of
administration
Posology
The
treatment
consists
of
one
tablet
of
5 mg
to
be
taken
orally
once
claily
for
treatment
courses
of
up.
to
3 monthg
each.
Treatments
should
only
be
initiated
when
menstruation
has
occurred:
-
The
first
tleatment
course
should
start
during
the
first
week
of meustruation.
-
Re-treatment
cottrses
should
start
at
the earliest
during
the
first
weelc
of
the
secolcl
menstruation
fol
treatment
cortrse
completiou.
Th
slrotrld
explain
to the
patient
the
requiremert
for
treatment
free
interva.ls.
Re
reatment
l-ras
been
stucried
up to
4
intermittent
courses.
Ila
patient
misses
a dose,
the
patient
should
take
ulipristal
acetate
as
sooll
as
possibJe,
If
the
dose
was
missed
by
more
tl"tan
12
hout's,
the
patient
should
noi
take
the
missecl
close
and
simply
resume the
usual
dosing
schedule.
Special
pznulqtion
Renal
inzpairment
No
dose
adjustment
is
reconlmendecl
in
patients
rvith
mild
or
rnoclerate
lenal
impalr.ment.
In
the
absence
of
specitic
studies,
ulipristal
acetate
is
not
recornrrrencled
in
patients
with
severe
relal
irnpairnerrt
unless
the
patient
is
cJosely
monitorecl
(see
sectiorrs
4.4
ancl
5.2).
Hepatic
impairment
No
dose
adjustment
is
rgcotntneuded
foL
patients
with
mild
hepatic
impairment,
In
the
absence
of
specific
studies,
uliplistal
acetate
is
uot
Lecomnrended
in
patients
with
modelate
or
severe
hepatic
3