Azithromycin ABR capsules hard

País: Armenia

Idioma: inglés

Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes activos:

azithromycin (azithromycin dihydrate)

Disponible desde:

Balkanpharma-Razgrad AD

Código ATC:

J01FA10

Designación común internacional (DCI):

azithromycin (azithromycin dihydrate)

Dosis:

500mg

formulario farmacéutico:

capsules hard

Unidades en paquete:

(3/1x3/) in blister

tipo de receta:

Prescription

Estado de Autorización:

Registered

Fecha de autorización:

2017-12-08

Información para el usuario

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Ficha técnica

I.
NAME
OF
TIIE
IVIEDICINAL
]PRODUCT
Azithrontyciu
ABR
500
mg capsules,
harcl
2.
QUALITATI\/BAND
(,UAN.|"I.TATIVECONIPOSTTION
Each
capsule
cotltairis
the
activc
substan,:e
azitlrrorrrycirr
dihyclrate.
ecirriiralerrt
to
500
mg
azithro
nr.v"c
in.
Excipients
u,ith
knoln
eff-ect:
lactose
rnonoh)rdrate/nraize
stat.ch
(g5:
l5).
For
tlre
lirll
ll>-t
of
excipients_
see
sectiotr
6,
I
3.
PHAITIVIACEUTICAL['OItM
Capsules,
hard.
4.
CLINICAL
PARTICULARS
4.1
Therapeuticindications
A
PPfit!![il
$Y
5i]fit.
E
X
P
rR
Ilt
i1
I
a
-
t$/axtt.t
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L
I
f
A
fl
T/0{
I
i
-
t;
E'
/'/'
ta
r4/'':M-\
tment
of
infections
krror.vn
or
suspectecl
to
have
e
lnicrtlorganisnrs:
itis/tonsillitis,
sinusitis
and
otitis
media:
al
broncl
is
and
cornnrunitv
acquired
pneLuronia:
'
skin
and
sttbcutaneous
tissttes
-
tnoclera(e
acne
vul
ris,
erysipelas,
irnpetigt-l
and
secorrclar;,
pl,oderrla:
snritted
diseases
-
uncomplicated
ufethritis
arrd
cervicitis
caused
by
Chlant.vctia
Tlte
use
of
the
product
shorrld
be
in
line
rvith
national
and
local
gLridelines
and
reconrrienclations
for
conducting
anti
bacteria
I
ther.apy.
4,2
Posology
and
methorl
of
atlministrertiorr
r
LJpper
and
lower
respiratory
tract
infections
Total
course
dose
of
1500
org.
rvtiich
shoulcl
be
taken
for
3
40
ml/rrr
in).
Caution
shorrld
be
exercised
in
patients
wilfi
severe
reual
irnpairnreut
(creatiline
clsarance
<40
nrllnrin)
(see
section
4.4).
H.gpatic
impairnrerrt
sirrce
azithrornycin
is
n'retabolised
in
the
lilver
and
e.xcretecl
in
the
bile,
the
product
irr
contraindicirted
in-patients
srrffering
from
severe
livel
disezrses.
No
stu