Atortonus tablets film-coated

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

atorvastatin (atorvastatin calcium trihydrate)

متاح من:

Arpimed LLC

ATC رمز:

C10AA05

INN (الاسم الدولي):

atorvastatin (atorvastatin calcium trihydrate)

جرعة:

20mg

الشكل الصيدلاني:

tablets film-coated

الوحدات في الحزمة:

(30/3x10/) in blister

نوع الوصفة الطبية :

Prescription

الوضع إذن:

Registered

تاريخ الترخيص:

2016-06-22

خصائص المنتج

suMMARy
PRODUCT
CHARACTERTSTIC
(SpC)
ATORTONUS@
20
mg
film-eoated
tablets
I.I.TRADE
NAME
-
Atortonus@
1.2.
T|{TERNATI{)NAL
NoN-PRopERTy
NAME
-
Atorvasrarin
2.
CUALITATM
AND
QUANTTTATTYE
COMPOSTTTON
Each
film-coated
tablet
contains:
Aetive
ingredients.'
Atorvastatin
(as
atorvastatin
calcium
trihydrate)
*
20mg;
For
a
full
list
af
excipients,
see
seetion
6.
I
.
3.
PHARMACEUTICAL
FORI{
Fil.n-coated
tablets.
Oval
biconvex
coated
one-sided
scored
whitE
tablets,
odorless.
4.
CLINICAL
PARTICULARS
4.1.
Therapeutic
indications
Hy
p
er
ch o
I
e
s
t
e
r
o
I
ee
mi a
Atarvastatin
is
indicated
as an
adjunct
to
diet
for
reduction
of
elevated
total
cholesterol
(total-C),
LDL-
cholesterol
(LDL-C),
apolipoprotein
B,
and
triglycerides
in
adults,
adolescents
and
children
aged
ib
years
or
older
with
primary
hypercholesterolaemia
including
familial
hypercholesterolaemia
6i*trrorygou,
vdriant)
or
combined
(mixed)
hyperlipidaemia
(Conesponding
to
Tyies IIa
and
IIb
of
the
Fredrickson
classification)
when
response
to
diet
and other
nonpharmacological
**arure,
is
inadequate.
Atorvastatin
is
also
indicated
to
reduce
total-C
and
LDL-C
in
adults
with
iromozygous
familial
hy;ercholesterolaemia
as
an
adjunct
to
ofher
lipid-lowering
trearmenrs
(e.g.
LDL
apheresis;
or
if
such
treatrnents
are
unavai
labl
e.
Prcvenlion
of cardiovasculsr
disease
Prevention
of
cardiovascular
events
in
adult
patients
estimated
to
have
a
high
risk.for
a
firsJcardio;ascular
event
(see
section
5.l),
as an
adjunct
to
correction
of
other
risk
factqr$*,"
1..,".
'
..r*
.ro".a{ErL
'
,,{t
4.2.
Posology
and
method
of
administration
Posologt
The
patient
should
be
placed
on
a
standard
cholesteror-rowering
should
continue
on
this
diet
during
treatment
with
Atorvastatin.
The
dose
should
be individualised
according
to
baseline
LDL-C
response.
**na
rerlffita6-par
t*
rl
patient
Th:
usual
sta*ing
dose
is
l0
mg
once
a
day.
Adjustment
of
dose
should
be
made
at intervals
of
4 weeks
cr
more.
The
rnaximum
dose
is
80 mg
once
a
day.
Primary
hypercho
Ie
stero
laemia
and
co
mbin ett
(mixed)
hype