Livazo tablets film-coated

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

pitavastatin (pitavastatin calcium)

Disponibil de la:

Recordati Industria Chimica e Farmaceutica S.p.A.

Codul ATC:

C10AA08

INN (nume internaţional):

pitavastatin (pitavastatin calcium)

Dozare:

1mg

Forma farmaceutică:

tablets film-coated

Unități în pachet:

(28/2x14/) in blister

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2019-03-25

Caracteristicilor produsului

Recordati
Leland
Ltd.
SUMMARY
OF
PIIODUCT CHAITACTERISTICS
NAME
O}-
THE
MI,DICINAL
PRODUCT
Livazo
I
mg
filnr-coated
tablets.
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each
fihr-coated
lablet
contains
pitavastatin
calcium
equivalerrt
to
I
mg
Pitavastatin.
Excipient(s)
include 63.085mg
Laclose
monohydrate
For
a
full
list
ofexcipients
see
section
6
I
3.
PHARMACEUTICAL
FORM
Film-coated
tablel.
Round
white
film-coated
tablets
embossed
'KC'
ot't
one
face
and
'1'
on
the
Ieverse.
4.
CI,INICALPARTICULARS
4.t
Therapeuticindications
Livazo
is
inclicated
tbr
the
rcductiorr
of
clevated
total
cllolesterol
(lC)
and
l-Dl.-C.
in
adults.
adolescents
ancl
childlen
aged
6
years
or
older
with
prinrary
hyperclto
Iestcro laenr
ia.
incltrding
heterozygous
fanilial
hypercho
lestero
laerr
ia, aud
coltbirted
(nrixed)
dyslipidaemia.
u'hen
respo!rsc
lo
diet
and
other
non-pharmacological
moasures
is
inadequate.
4.2
Posology
and method
of
Ad
nr
inistration
Posoloqy
patients
should
be
on
a
cholestorol
lorvering
diet
befbre
treatrnent.
It
is
inlpotlant that
a!l
patients
continue
dietary
control during
treatnlerlt.
The
usual
startirrg
dose
is
lmg
once
daily.
Adjustment
ofdose
should
be made
at
intervals
ot
4 weeks
or more.
Doses
should be individualized
according
to
LDL-C
levels,
the
goal
of
therapy and
patient
response.
The
maximttm
daily
dose
is
4mg
Ekle-rly
No
dose
adjustment
necessary
in
patients
older
than
70
years
(see
sectiorl!-!
arrd
Sef1iolllj'
Pagdi4lrs-pgpdalql
Childrett
qnd
adolescents
aged
6
years
and over"
Livazo
use
ip
childrerr
shoulcl
only
be
carried
out
by
physicians
exper-ienced
in
thc
treatnlent
of
hyperlipidaerr
ia
and
progress should
be
regulatly
reviewed.
l-ivazo
l
ng
filrn-coaled
tabiels
u
Kr-l/155iio3rDC
starting
dose
Doses should
ildrcn
6
tt:
In
chilclren
and aclolescents
with
heterorygous
farnilial
hypercholesterolaelnia
the ustlal
is
lng
once
daily.
Adjustrrent
ofdose
shrltrld
bcmadeat
inlervals
of4
rveeks
ot
more
be
individualized
aocording
to
LDL-C
levels.
the
9
years
oI
age
the
tnaxintunl
daily
dose
is
2rng
ln
is