Riik: Armeenia
keel: inglise
Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
benzocaine, cetylpyridinium chloride
KRKA d.d.
առկա չէ (R02AX)
benzocaine, cetylpyridinium chloride
5mg+ 1mg
lozenges
(18/2x9/) in blister
OTC
Registered
2017-03-17
1.3.1
Benzocaine
+
Cetylpyridinium
chloride
SPC,
Labeling
and Package
Leaflet
llHCTPYKUIDI
ITO
ITPllMEHEHmO
CEITTOJIETE@
nmoe
Mell
H JlaiiM
SEPTOLETE@
plus
honey
and
lime
ToprOBoe(naTeIITOSalllloe)
na3BaUHe:
CenTOJleTe®
nmoc
Me.D,11JlaHM
Me~yHaponHoe
(lIenaTeuToBalluoe)
Ha3BaUHe
ItJIli
rpynnnpOBOQHOe
ua3Balllle:
6eH30KaHH
+
ueTliJlnJ.1pJ.1.D,HHHll
XJlOPH.D,
JIeKapcTBeHHaR
c1J0pMa:
JIe.D,eHUbl.
.
"
I.
;,
lJ
I
COCTaB
1
Jle.D,eHeu CO.D,ep}KHT:
_AKI11U6Hble ae11Iecl116a:_
ueTIJ1mlp")UofHl111
XJlOpH.D, (B BI1.D,eMOHOfH.D,paTa)
6eH30KalofH
1
Mf
5
Mr
_BcnOM02ame!lbHble_
_6eulecl11Ga:_
JleBOMeHTOJl,
MllTbl
nepe4HoH
JlHCTbeB
MaCJlO,
apOManl3aTOp
JlaHMa,
apoMaTH3aTop
MeJJ.a,
MaJIbTHTOJl
)1apMaKoTepaneBTlf'lecKMI
rpynna
DpenapaTbI.Ll.JUl
Jle4eHJ.fll
3a6oJleBaHl1H
ropJla.
AHTI1CenTI1KI1.
Ko.ll
ATX:
R02AA06
apMaKOJlOrllQeCKHe
CsoiiCTBa
UeTHllnHpH.D,HHHSI
XJlOPH.D,
-
aHTHcenTHK
H3
fpynnbl
4eTBepTH4HbiX
aMMOHHeBblX
COe.D,HHeHHH.
OH
.D,eHCTByeT
KaK
KaTHOHHblH
.D,eTepfeHT.
4eTBepTH4Hbie
aMMOHHeBble
COe.D,I1HeHHll
CBll3blBalOTClI
C
nOBepxHocTblO
6al
Lugege kogu dokumenti
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 Lugege kogu dokumenti