Avelox solution for infusion

Riik: Armeenia

keel: inglise

Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Toimeaine:

moxifloxacin (moxifloxacin hydrochloride)

Saadav alates:

Bayer Pharma AG

ATC kood:

J01MA14

INN (Rahvusvaheline Nimetus):

moxifloxacin (moxifloxacin hydrochloride)

Annus:

1.6mg/ml

Ravimvorm:

solution for infusion

Ühikuid pakis:

glass vial 250ml

Retsepti tüüp:

Prescription

Volitamisolek:

Registered

Loa andmise kuupäev:

2015-10-20

Infovoldik

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Toote omadused

, 1 r
section
5.2 far
more
details).
There
is insufficient
data
in
patients
with impaired
liver
firnction
(see
seotion
'4r3)r
Other
special
populations
i.{$
No adjustment
of
dosage is required in the
elderly
and in
patients
with
low
l
l
r
Paediatric population
Moxifloxacin
is
contraindicated
in
chitdren
and
growing
adolescents.
Efficacy
and
safety
of
moxifloxacin
in
chilclren
and
adolescents
have
not
been
establishecl
(see
section
4.3).
Method
of adrn
in
istration
For
inffavenous
use;
constant
inf,usion
over
60 minutes
(sce
also
scction
4.4).
'
:
:
:
l
.
lf
medically
indicated
the
solution for
infusion
can be administered
via
a T-tube,
together
with
compatible
infusion
solutions
(see
section
6.6).
4.3
C o n t r a i n d i c a t i o n s '
6 . 1 .
'
Hypersensitivity
to moxifloxacin,
other
quinolones
or
to
any
of
the
excipients
listed
in section
Pregnancy
and
lactation
(see
section
4,6).
Patients
below
l8
years
of
age.
Patients
with a history
of
tendon
disease/disorder
related
to
quinolone
treatment.
Both
in
preclinical
investigations
and
in huntans,
changes
in cardiac
electrophysiology
have
been
observed
following
exposure
to
moxifloxacin,
in
the
form
of
QT
prolongation.
For
reasons
of drug
safety,
rnoxifloxacin
is therefore
contraindicated
in
patients
with:
-
Congenital
or
documented
acquired
QT
prolongation
-
Electrolyte
disturbances,padicularly
in uncorrected
hypokalaenria
-
Clinicallyrelevarrtbradycardia
-
Clinically
relevant
heart
failure
with reduced
left-ventricular
ejection
fraction
-
Previous
history
of symptomatic
arrlrythmias
Moxifloxacin
should
not bg used
concurently
lvith
other
drugs
that
prolong
the
QT
interval
(see
also
section
4.5),
Due
to lirnited
clinical
data,
moxifloxacin
is
also
contraindicated
in
patients
with
impairecl
liver
function
(Child
Pugh
C) and
in
patients
with transaminases
increase
>
5fold ULN.
4.4
Special
warnings
and
precautions
for
use
The
beriefit
of
moxifloxacin
treatment
especially
in infections
with
a low degree
of severity
should
be
balanced
with
the
information
conlained
in