Propafenon Alkaloid

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

propafenone (propafenone hydrochloride)

Доступна с:

Alkaloid AD Skopje

ИНН (Международная Имя):

propafenone (propafenone hydrochloride)

дозировка:

150mg

Фармацевтическая форма:

tablets film-coated

Тип рецепта:

Prescription

Характеристики продукта

Propafenon Alkaloid
150
mg film-coated tablets
Summary
of
Product Characteristics
SUMMAH.Y
OF
PR
ODUCT
CHARACTER
I
STICS
I.
NAME
OF
THE
IVIEDICl NAL
PROJ)lJCT
Propa l
enon
A lkaloid 150
mg
fi
lm-coated tablets
2.
QUALITATIVE
AND
QUANTITATIVE
COM
P
OSITION
Each fi lm-coated tablet contains 150 mg propafen
one
hydrochloride.
Exci
pie
nt(s) with known
ef
fect:
Lactose monohydrate
for
the fu
ll
I ist
of
excipients,
see
sect i
on
6.1.
3.
PHARMACEUTICAL
FORM
Fi
lm-coated tablets
Wh
it
e, round, biconvex, film-coared tablets with a break-
mark
on on
e side.
4.
CLINICAL
PARTICULARS
4.1
T h
er
apeuti
c Indi
cat
ions
Propafenon Alkaloid is indicated for the prophylaxis
and
t r
eatment
of vent
ri
cu
lar arrhythmias.
Propafenon Alkaloid is al
so
indicated for the prophylax is and treat
ment
of
paroxysmal
supr
ave
nt
ri
cu lar tachyarrhyt hmi
as
which include paro
xy
smal atrial flu
tt
er/fibrillation and
paroxysmal
re-entrant tachycardias involving the A V n
od
e or accessory bypass tracts, when
stan
da
rd therapy has fai led
or
is contraindicated.
4.2
l)osology
and
m
et
hod of admini
strat
ion
Po
so
logy
It is recommended that Propafenon Alkaloid therapy should
be
initiated under hospital
conditions, by a physician
expe
ri
enced in the treatment
of
arrhyth mia
s.
The
individual
ma
in
tenance close should be determined under cardiological sur
ve
illan
ce
including
ECG
moni loring and blood pressure
co
ntrol.
If
the QRS interval is p rolonged by more t
han
20%,
the
do
se shonld be re
du
ce
d or discontinued until the
ECG
returns to normal limits.
_Adults: _
Init ia
ll
y,
ISO
mg
three times daily increasing at a mi nimum
of
t
hr
ee-day intervals to 300
mg
twice daily and
if
necessary, to a m
axim
um
of300
mg three ti
me
s daily.
Propafenon Alkaloid 1
50
mg
film-coated tablets
---------
--
Sm
nmm
y
of
Prodm:t Clmracteristics
D
ose
increases sh
ou
ld not be a
tt
e
mp
ted until
the
patient has been receiving treatment
for
th
ree
to four
cl
ays.
Th
e tablets should be
swa
ll
owed whole and taken
wit
h a drink.
_1\ _
reduction in
t