Livazo tablets film-coated

Land: Armenien

Sprog: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv bestanddel:

pitavastatin (pitavastatin calcium)

Tilgængelig fra:

Recordati Industria Chimica e Farmaceutica S.p.A.

ATC-kode:

C10AA08

INN (International Name):

pitavastatin (pitavastatin calcium)

Dosering:

2mg

Lægemiddelform:

tablets film-coated

Enheder i pakken:

(28/2x14/) in blister

Recept type:

Prescription

Autorisation status:

Registered

Autorisation dato:

2019-03-25

Produktets egenskaber

Recordati
Ireland
Ltd.
Livarzo
2r]rg
iiltn-coatcd
tablcls
tJ
l{,'l
l/
I
5
5
i;0
l,l)c
SLIMMARY
OF
PRODUCT
CHAI{ACTERISTICS
I.
NAME
OF
THE
MEDICINAL
PRODUCT
Livazo
2nrg
film-coated
tabl€ts.
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each
film-coatetl
tablet contai|ls
pitavastatin
calcium
eqLrivalent
to
2mg
pitavastatin.
Excipient(s)
include
126.I7mg
Lactose
rllor'rolrydrate
For
a
full
list
of
excipients
see
section
6-
L.
3,
PHARMACEUTICAL
FORM
Filur-coated
tablet.
Rorlnd
white
film-coated
tablets
enrbossed'l(C'
on
otre
face
and'2'
on
the
reverse
4.
CLINICALPAITTICULARS
4.1
Therapeuticindications
Livazo
is
inclicated
for'the
reduction
of
elevatecl
total
cholesterol
(TC)
and
I"DL-C.
in
aduits
adolescents
and
chilciren
aged
6
years
oI
older
ivith
primary
hypercholesterolaemia.
including
heterozygoLrs
familiat
hypercholesterolaernia,
and
cornbined
(mixed)
dyslipidaenria,
when
response
to
diet
and
other
ron-pharntacological
measures
is
inadequate'
4.2
Posology
ancl
methotl
of
administration
Posol_qgy
Paticnts
shouLd
be
on
a
choleslcrol
lowcring
diet
before
trcatnlent.
lt
is
important
that
all
patients
coltinue
dietary
control
dulil1g
keatment
The
usual
startiirg
dose
is
lmg
ollce
daily.
Adiustmerlt
ofdose
shoutd
be
made at
intervals
of4
weeks
or
more.
Dosesihould
be
individualized
according
to ["DL-C
levels.
the
goal
of
therapy
and
patient
response.
The
maxirlum
claily
dose
is
4mg.
Elderly
No
dose
adjustrnent
necessary
in
patients
older tlran
?0
yeals
(see
5gq[94-i!
and
Sectio[j-?l
Pacdiatric
oopu
lation
Chiltlren
and
adole.scents
aged
6
yeats .ucl ot'er:
Livazo
use
in
childr.en
should
only
be
carricd
out
by
physicians
experienced
ir
the
lreatrr]etrt
ol
hyperlipidaenr
ia
and
progress should
be
regttlatll'
reviewed
Iu
children
and
adolescents
with
heterozygous
farnilial
hypercholesterolaemia
tile
usttal
starting
dose
ic
lnrc
nnee
rtaitv
Adirrsfment
ofdose
siJuld
be
nade
at
intervals
of4
weeks
or
more
Doses
shottld
is
Inrg
oncc
daily.
Adjtrstment
of
dosc
be
inciividLralized
according
to
LDL-C
levels'
9
years
ofage
the