מדינה: ארמניה
שפה: אנגלית
מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
lansoprazole
KRKA d.d.
A02BC03
lansoprazole
30mg
capsules
(14/2x7/) in blister
Prescription
Registered
2018-02-07
Lansoptol capsules 30 mg VOL: 1; P: 94 _f_ _1277_ SPC, Labelin 1.3.1 HHCTPYKQHH NO METJ,HUHHCKOMYNPHMEHEHHIO ~eKapcTBeHHorocpetJ,cTBa JIAH30NTOJL TOPROBOE HA3BAHHE JIaH30rrTOJl MELK,LLYHAPOTJ,HOE HENATEHTOBAHHOE HA3BAHHE JIaHcOrrpa30Jl JIEKAPCTBEHHAH 4LOPMA KarrcYJIhI 30 Mr COCTAB O.n:HaKarrCYJIaco.n:ep:>KHT _QKmlUfHOeeeU/ecmeo -_ JIaHCOrrpa30JI30 Mr, _6cnOM02amellbHbie_ _eeulecmea:_ caxapmle ccjJepbI, rH,LlpOKCHrrpOrrHJIueJIJIlOJI03a, MarHlliI Kap60HaT nDKeJIbIM., caxapo3a, KpaXMaJI KYKYPY3HbIH, HaTpIDl JIaYPHJIcYJIbcjJaT, nmpOMeJIJI03a, KHCJIOTbI MeTaKp~OBOH - 3THJIaKpHJIaTa KOnOJIHMepa (1:1) 30 % .n:HcrrepclliI, TaJIbK, MaKpOrOJI 6000, THTaHa .n:HOKCH.n: (E171), _cocmae KanCYllbl:_ THTaHa .n:HOKCH.IJ: (E171), :>KeJIaTHH OMLCAHHE KarrcYJIhI 6eJIoro UBeTa. Co.n:ep:>KHMOeKanCYJI - rreJIJIeTbI OT 6eJIoro .n:o CJIerKa KopmHeBoro HJIH CJIerKa p030Boro UBeTa.areaJIbHOrO pecjJmoKca. flaHCOrrpa30JI. Ko.n: A TX A02BC03 H npenapaTbI .n:JI5I MHfH6HTOPhl npoToHoBoro JIeqeHlliI Hacoca. קרא את המסמך השלםapMaKO~OrH'IeCKHe CBOHCTBA _(/)ap~zaKo() UUAMLLKA_ JIaHcOrrpa30JI 51BJIReTC.SI HHrH6HTopOM npoToHHoro Hacoca (l1I1H), 6JIOKHpyeT 3aKJIIO'IHTeJIbHYIO CTa.n:HIO cjJOpMHpOBaHHR :>KeJIy.n:O'IHOrO COKa, 3aMe.n:J1R51 aKTlIBHOCTb _H+/K_ + AT<1>a3bI napHeTaJIbHbIX KJIeTOK:>Keny,nKa.MHrH611pOBaHHe .SIBJIJleTC5I ,n0303aBHCHMbIM H o6paTHMbIM, OKa3bIBaeT BJIlliIHHe KaK Ha 6a3aJIbHYIO, TaK H Ha CTHMYJIHpOBaHHYIOceKpeuHIO :>Keny,nO'IHOrO COKa. JIaHcOrrpa30JI KOHUeHTpHpyeTC.SI B napHeTaJIbH.bIX KJIeTKaX H CTaHOBHTC.SI SmPCPIL095894 3 28.07.2017 - U dated: 28.07.2017 CONFIDENTIAL En:RT/2:TL , " I " , I' - 'n \ T A _dl_ _,~_ I . ,L • ;, II J. _-.,01'.1'/17"_ /.£ &/ /11 Lansoptol capsules 30 mg VOL: 1; P: 95 _11277_ SPC, Labelin 1.3.1 aKTHBHIlIM B HX KHCJIOH: cpe,[(e, rrpH 3TOM rrperrapaT BcryrraeT B peaKQHIO C CYJIbtPHW:PHJIOBOH: rpyrrrrOH: _H+/K_ + A T a3bl, BbI3bIBaJI 3aMe,[(JIeHHe ,[(eHcTBIDI epMeHToB. _BllUflHue_ _HG JlCellyoollHYIO_ _ceKpeljUlO_ O'[(HoKpaTHaH rrepOPaJI
Lansoptol capsules 30 mg VOL: 1; P: 82/1277 1.3.1 e Leaflet 1. NAME OF THE MEDICINAL PRODUCT Lansoptol30 mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg lansoprazole. 30 mg capsules 149.11 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule White capsules containing white to slightly brown or slightly pink pellets. 4. CLlNlCAL PARTICULARS 4.1 Therapeutic indications Treatment of duodenal and gastric ulcer. Treatment and prophylaxis of reflux oesophagitis. Eradication of _Helicobacter pylori_ _(H pylori)_ concurrently given with appropriate antibiotic therapy for treatment of _Hpylori-associated_ ulcers. Treatment and prophylaxis ofNSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment. Symptomatic gastroesophageal reflux disease. Zollinger-Ellison syndrome. 4.2 Posology and method of administration Posology For optimal effect. Lansoptol should be taken once daily in the morning. except when used for _H_ _pylori_ eradication when treatment should be twice a day, once in the morning and once in the evening. Treatment of duodenal ulcer: The recommended dose is 30 mg once daily for 2 weeks. In patients not fully healed within this time, the medication is continued at the same dose for another two weeks. Treatment of gastric ulcer: The recommended dose is 30 mg once daily for 4 weeks. The ulcer usually heals within 4 weeks, but in patients not fully healed within this time, the medication may be continued at the same dose for another 4 weeks. Reflux oesophagitis: The recommended dose is 30 mg once daily for 4 weeks. In patients not fully healed within this time, the treatment may be continued at the same dose for another 4 weeks. CONFIDENTIAL Lansoptol capsules 30 mg VOL: I; P: 83 / 1277 SPC, Labelin 1.3.1 Prophylaxis of reflux oesoDhagitis: _30_ mg once daily. Eradication of _Helicobacter_ _pylori:_ When selecting appropriate combination therapy, consideration should be given to official local guidance regar קרא את המסמך השלם