Livazo tablets film-coated

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiivinen ainesosa:

pitavastatin (pitavastatin calcium)

Saatavilla:

Recordati Industria Chimica e Farmaceutica S.p.A.

ATC-koodi:

C10AA08

INN (Kansainvälinen yleisnimi):

pitavastatin (pitavastatin calcium)

Annos:

4mg

Lääkemuoto:

tablets film-coated

Kpl paketissa:

(28/2x14/) in blister

Prescription tyyppi:

Prescription

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2019-03-25

Valmisteyhteenveto

Recofdati Ireland
Ltd.
I.ivazo 4mg
filnr-coated
rablels
uK/ll/
I
55-5102./DC
SUMMARY
OF PRODUCT CHARACT
IIRISTICS
1.
NAMtr
OF
THE
MEDICINAL
PRODUCT
Livazo
4rng filrrr-coated
tablets.
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each
tilm
coated
tablet
contains
pitavastatin
calcium
eqLrivalent
to 4mg
pitavastatin.
Exc
jpient(s)
include
252.34nrg
Lactose
monohyd|ate.
For
a
full
list
ofexcipients
see
section
6.
l.
J.
PHARMACNUTICAL
FORM
Film-coated tablet.
Round
whitc
film-coated tablets
eirbossed'KC
on one
face nnd
'4'on
the
reverse.
4.
CLINICAL
PARTICI-ILAIIS
4,1
Therapeuticirdications
Livaz..o
is
indicated
tbl
tlre
reduction ol'
clcvatcd
total
cholestcrol
(TC)
and
LDL-C,
in
adu
lts,
adolescents
and children
aged
6
years
ol
older
with
prirnary
hypercho
lestero
laem
ia,
including
heterozygous
farnilial
hypercholesterolaemia,
and
conrbined
(mixed)
dyslipidaemia,
when
response to
diet
and
other
non-pharnracological
measures
is
inadequate.
4,2
Posology
and
method of
administmtion
Posolosv
Patients
sirould be
on
a
clroleste|ol
lowering
diet
befbre rreatr)ler'rl.
lt
is
irnporlaDl
{ha1
all
paticnls
continue
dietary
control during fteattnent.
'fhe
Lrsual
stalling
dose
is
lnrg
once
daily.
Ad.iustrnent
oidose
should
be
made
a1
intervals
ol
4
wecks
or more.
Doses
should be
individualized
according
to
LDL-Cl levels, the
goal r:rf'therapl and
patierrt
responsc.
Thc
maxinum
daily
dose
is
4rng.
Elderlv
No
dose
adjustment
nccessary
in
patients older
Paediatlic
population
Expert
/
Ila
Chilrlren
arzd
atlolesccnts
aged
6
years
and
,{ppiicent
i
ilat.e
f
cnf
of
Livaz-o
use
in
children should
only
be
hyperlipidaemia
and
progress
should
be
reguiarly
reviewed.
ln
chilclreu
and adolesceuts
with
heterozygous
lanrilial
hypercholesletolretrtir
lhe
usual
sLaltrrrB
d(\sc
is
lmgoncedaily.
Adjustrnent
ofdose
shoLild
he
nradeat intervals
o1',1
weeks
or
tttore.
I)oses
shoulcl
be
individualized
accordiug
to [.DL-C
lcvels, the
goal
oftlrerapy
and
patient
response.
In
children
6
to
9
years
ofage
the
maxitnutn
daily
dose
is
2mg
ln
children
l0
)'ears
ol