Septolete plus honey and lime lozenges

国: アルメニア

言語: 英語

ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有効成分:

benzocaine, cetylpyridinium chloride

から入手可能:

KRKA d.d.

ATCコード:

առկա չէ (R02AX)

INN（国際名）:

benzocaine, cetylpyridinium chloride

投薬量:

5mg+ 1mg

医薬品形態:

lozenges

パッケージ内のユニット:

(18/2x9/) in blister

処方タイプ:

OTC

認証ステータス:

Registered

承認日:

2017-03-17

情報リーフレット

1.3.1
Benzocaine
+
Cetylpyridinium
chloride
SPC,
Labeling
and Package
Leaflet
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plus
honey
and
lime
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完全なドキュメントを読む

製品の特徴

1.3.1
Benzocaine + Cet
1
ridinium chloride
SPC, Labelin
1.
NAME OF THE MEDICINAL
PRODUCT
Septolete
plus
honey
and lime
5 mg/l
mg lozenges
2.
QUALITATIVE
AND QUANTITATIVE
COMPOSITION
Each lozenge
contains
5 mg benzocaine
and
1 mg cetylpyridinium
chloride.
Excipients:
maltitol:
529.03
mg/tablet
liquid
maltitol
(dry substance):
478 mg/tablet
For
a full
list
of
excipients,
see section
6.1.
_I,_ P
r
R 0 V E D
L Y S C 0
1,1
T E
Jl£
#
E X PER
T /
[)
AT
A_
~,(
6//·
_O?f1_
3.
PHARMACEUTICAL
FORM
~
!p(Llr'::TfOATL
_cRti.l)f).lrJ_
_'_
Lozenge.
The lozenges
are round,
biconvex,
smooth,
dark yellow.
4.
CLINICAL
PARTICULARS
4.1.
Therapeutic indications
Septolete
plus
honey
and lime
lozenges
are recommended
for
symptomatic
relief
of
pain in the throat:
in milder
infections
in the mouth
and throat
(pharyngitis,
laryngitis,
initial
stage
of angina),
in inflammation
of the gums
and mucous
membrane
of the mouth
(gingivitis,
stomatitis)
and
in cold and flu.
4.2.
Posology and method
of administration
The recommended
dose
for
adults
and children
over
12
years
of age is up to
8
lozenges
a day.
Dissolve
one lozenge
in the mouth
every
2
to
3
hours.
The recommended
dose
for
children
from
6
to
12
years
of
age is up to
4
lozenges
a day.
Dissolve
one
lozenge
every
4
hours.
The experience
in children
is limited.
Septolete
plus
honey
and lime
lozenges
are not
recommended
for
use in children
under
6 years
of age
due to insufficient
data on safety.
4.3.
Contraindications
Hypersensitivity
to the active
substances
or
any of
the excipients.
Children
under
6
years
of
age.
4.4.
Special
warnings
and precautions
for
use
Patients
should
not
take
the lozenges
if they have
open wounds
in the mouth
because
cetylpyridinium
chloride
slows
the healing
of
wounds.
In
more
severe
infections
accompanied
by high fever,
headache
and vomiting,
a doctor
should
be
consulted,
especially
if the condition
does
not
improve
after
three
days.
I
SmPCPIL072636
1
I
02.02.2016 -
Updated:
02.02.2016
I
Page 1
of5
SPC, Labelin
Benzocaine
+
Cet
1
ridinium chloride
1.3.1
Diabetics