FrancophonIA/ELRC3.0 huggingface dataset:
Croatian: Rua Alto do Montijo, 13 - 1º DtoEdifício Monsanto 2790-012 Portela de Carnaxide Portugal domperidon Domperidona Germed 10 mg filmom obložena tableta
Maltese: Rua Alto do Montijo, 13 - 1º DtoEdifício Monsanto 2790-012 Portela de Carnaxide Il-Portugall domperidone Domperidona Germed
Croatian: Domperidon Oroperidys
Maltese: Domperidone Oroperidys
Croatian: RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3
Maltese: GmbH Graf Arco Strasse 3
Croatian: CRISTERS 22 quai Gallieni 92150 Suresnes France domperidon DOMPERIDONE CRISTERS 10 mg, comprimé orodispersible
Maltese: CRISTERS 22 quai Gallieni 92150 Suresnes Franza domperidone DOMPERIDONE CRISTERS 10 mg, comprimé orodispersible
Croatian: Rua Manuel Ribeiro de Pavia, 1 - 1ºVenda Nova
Maltese: Rua Manuel Ribeiro de Pavia, 11º - Venda Nova 2700-547 Amadora
Croatian: Domperidon Motilium Tropfen 10 mg oralne kapi, suspenzija
Maltese: Domperidone Motilium Tropfen 10 mg qtar orali, suspensjoni
Croatian: Nizozemska KELA Pharma nv Industriepark West 68
Maltese: KELA Pharma nv Industriepark West 68 9100
Croatian: B-2340, Beerse Belgium domperidon motilium 10mg film coated tablets
Maltese: B-2340, Beerse Il-Belġju domperidone motilium 10mg film coated tablets
Croatian: 2730-055 Barcarena Portugal domperidon Motilium Rapid
Maltese: 2730-055 Barcarena Il-Portugall domperidone Motilium Rapid
Croatian: Domperidon RIGES
Maltese: Domperidone RIGES
Croatian: Accord Healthcare Limited Sage House, 319, Pinner Road HA1 4HF North Harrow, Middlesex United Kingdom
Maltese: Il-Ġermanja Accord Healthcare Limited Sage House, 319, Pinner Road HA1 4HF North Harrow, Middlesex Ir-Renju Unit
Croatian: Domperidon Tabletten bij maagklachten en misselijkheid domperidon 10 mg, tabletten
Maltese: Domperidone Tabletten bij maagklachten en misselijkheid domperidon 10 mg, tabletten
Croatian: GIULIANI S.P.A Via Palagi 2 20129 Milano Italy
Maltese: S.P.A Via Palagi 2 20129 Milano L-Italja
Croatian: Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom domperidon Domperidone 1mg/ml Oral Suspension
Maltese: Ir-Renju Unit Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, Ir-Renju Unit domperidone Domperidone 1mg/ml Oral
Croatian: Patricks Road Dalkey, Co.
Maltese: Patricks Road Dalkey, Co. Dublin L-Irlanda
Croatian: Nizozemska Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4 HF North Harrow, Middlesex United Kingdom
Maltese: Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4 HF North Harrow, Middlesex Ir-Renju Unit
Croatian: Domperidon Motilium Rx 10 mg Film-coated Tablets.
Maltese: Domperidone Motilium Rx 10 mg Film-coated Tablets.
Croatian: Nizozemska Marel B.V.
Maltese: Marel B.V.
Croatian: AUROBINDO PHARMA FRANCE 22-26 rue des Gaudines 78100 Saint-Germain-en-Laye France domperidone DOMPERIDONE AUROBINDO 10 mg, comprimé pelliculé
Maltese: AUROBINDO PHARMA FRANZA 22-26 rue des Gaudines 78100 Saint-Germain-en-Laye Franza domperidone DOMPERIDONE AUROBINDO 10 mg, comprimé pelliculé
Croatian: PENSA PHARMA S.P.A. Via Ippolito Rossellini 12 20124 Milano Italy
Maltese: Via Ippolito Rossellini 12 20124
Croatian: 2730-055 Barcarena Portugal domperidon Motilium
Maltese: 2730-055 Barcarena Il-Portugall domperidone Motilium
Croatian: HEXAL AG Industriestr.
Maltese: Il-Ġermanja HEXAL AG
Croatian: Warwick House, Plane Tree Crescent, Feltham TW13 7HF United Kingdom domperidon maleat
Maltese: Ir-Renju Unit Medreich plc, Warwick House, Plane Tree Crescent, Feltham TW13 7HF Ir-Renju Unit domperidone maleate
Croatian: Labesfal Genéricos, S.A Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal domperidon Domperidona Labesfal 10 mg tableta
Maltese: Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Il-Portugall domperidone Domperidona Labesfal
Croatian: Manx Healthcare Limited Taylor Group House Wedgnock Lane Warwick
Maltese: Ir-Renju Unit Manx Healthcare Limited Taylor Group House
Croatian: Cyprus domperidon Costi
Maltese: Ċipru domperidone Costi
Croatian: Ranbaxy Pharmacie Génériques 11-15 Quai Dion Bouton 92800 Puteaux
Maltese: Ranbaxy Pharmacie Génériques 11-15 Quai Dion Bouton 92800 Puteaux domperidone DOMPERIDONE RPG 10 mg, comprimé pelliculé
Croatian: Domperidon Orosperidys 10 mg comprimidos bucodispersables
Maltese: Domperidone Orosperidys 10 mg comprimidos bucodispersables
Croatian: Domperidon maleate
Maltese: Domperidone maleate
Croatian: Domperidon Nauzelin 10 mg comprimidos recubiertos con película
Maltese: Domperidone Nauzelin 10 mg comprimidos recubiertos con película
Croatian: S.C. TERAPIA S.A.
Maltese: TERAPIA S.A. Str.
Croatian: 92787 Issy-les-Moulineaux Cedex 9 France domperidon MOTILIUM 10 mg, granulés effervescents en sachet-dose
Maltese: 92787 Issy-les-Moulineaux Cedex domperidone MOTILIUM 10 mg, granulés effervescents en sachet-dose
Croatian: Domperidon Motilium Fastmelts 10mg Tablets
Maltese: Domperidone Motilium Fastmelts 10mg Tablets
Croatian: 20124 Milano Italy
Maltese: 20124 Milano L-Italja
Croatian: Bristol Laboratories Limited Unit 3, Canalside Northbridge Road, Berkhamsted Hertfordshire
Maltese: Northbridge Road, Berkhamsted Hertfordshire
Croatian: B-2340, Beerse Belgium domperidon motilium 1mg/ml oral suspension
Maltese: B-2340, Beerse Il-Belġju domperidone motilium 1mg/ml oral suspension
Croatian: Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom domperidon maleat
Maltese: Ir-Renju Unit Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS Ir-Renju Unit domperidone maleate
Croatian: 1-10 Constantinoupoleos St. P.O. Box: 51409
Maltese: P.O. Box: 51409
Croatian: B-2340, Beerse Belgium domperidon motilium 30 mg Suppositories
Maltese: B-2340, Beerse Il-Belġju domperidone motilium 30 mg Suppositories
Croatian: 61118 Bad Vilbel Germany
Maltese: 61118 Bad Vilbel Il-Ġermanja
Croatian: Nizozemska Pharmacin B.V.
Maltese: Pharmacin B.V.
Croatian: H-2045 Törökbálint Hungary domperidon Motilium 10 mg filmtabletta
Maltese: Törökbálint L-Ungerija domperidone Motilium 10 mg filmtabletta
Croatian: Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal domperidon Domperidona Ratiopharm
Maltese: Lagoas Park, Edifício 5 A, Piso 2 2740-245
Croatian: Nizozemska Actavis B.V.
Maltese: Actavis B.V.
Croatian: Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom domperidon maleat
Maltese: Wrexham Industrial Estate Wrexham LL13 9UF
Croatian: Domperidon Domperidon 60 mg zetpillen
Maltese: Domperidone Domperidon 60 mg zetpillen
Croatian: Belgium domperidon Motilium-10 supp.
Maltese: 2340 Beerse domperidone Motilium-10 supp.
Croatian: Domperidon Motilium zetpillen voor volwassenen 60 mg
Maltese: Domperidone Motilium zetpillen voor volwassenen 60 mg
Croatian: Domperidon Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg
Maltese: Domperidone Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg
Croatian: Domperidon Motilium 30 mg supositorios niños
Maltese: Domperidone Motilium 30 mg supositorios niños
Croatian: Domperidon Motilium zetpillen voor zuigelingen 10 mg
Maltese: Domperidone Motilium zetpillen voor zuigelingen 10 mg
Croatian: 92787 Issy-les-Moulineaux Cedex 9 France domperidon MOTILIUM 1 mg/ml, suspension buvable
Maltese: 92787 Issy-les-Moulineaux Cedex domperidone MOTILIUM 1 mg/ml, suspension buvable
Croatian: Domperidon Domperidon 30 PCH voor kinderen, zetpillen 30 mg
Maltese: Domperidone Domperidon 30 PCH voor kinderen, zetpillen 30 mg
Croatian: Domperidon Domperidona Gamir 1 mg/ml suspensión oral
Maltese: Domperidone Domperidona Gamir 1 mg/ml suspensión oral
Croatian: 5 mg oralna suspenzija kroz usta
Maltese: 5 mg suspensjoni orali
Croatian: Domperidon MOTILIUM
Maltese: Domperidone Motilium
Croatian: Domperidon Motilium 10 mg Suppositories
Maltese: Domperidone Motilium 10 mg Suppositories
Croatian: Italy
Maltese: TEVA ITALIA
Croatian: Domperidon Motilium zetpillen voor kinderen 30 mg
Maltese: Domperidone Motilium zetpillen voor kinderen 30 mg
Croatian: 3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette FRANCE
Maltese: 3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette Franza domperidone DOMPERIDONE ALTER 10 mg, comprimé pelliculé
Croatian: Domperidon Domperidon 30 mg zetpillen
Maltese: Domperidone Domperidon 30 mg zetpillen
Croatian: Domperidon Motilium 10 mg comprimidos recubiertos con película
Maltese: Domperidone Motilium 10 mg comprimidos recubiertos con película
Croatian: Domperidon Motilium 60mg Suppositories
Maltese: Domperidone Motilium 60mg Suppositories
Croatian: B-2340, Beerse Belgium domperidon MOTILIUM
Maltese: B-2340, Beerse Il-Belġju domperidone MOTILIUM
Croatian: Belgium domperidon Motilium-1mg/ml
Maltese: 2340 Beerse domperidone Motilium-1mg/ml
Croatian: Domperidone EG-10 10 mg tableta
Maltese: Domperidone EG-10 10 mg pillola
Croatian: Domperidon Motilium filmomhulde tabletten 10 mg
Maltese: Domperidone Motilium filmomhulde tabletten 10 mg
Croatian: 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany
Maltese: Il-Ġermanja 1 A Pharma GmbH Keltenring 1 + 3
Croatian: Domperidon Nauzelin 1 mg/ml suspensión oral
Maltese: Domperidone Nauzelin 1 mg/ml suspensión oral
Croatian: Denmark
Maltese: Gentofte Denmark
Croatian: Domperidon Domperidon JJC filmomhulde tabletten 10 mg
Maltese: Domperidone Domperidon JJC filmomhulde tabletten 10 mg
Croatian: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France
Maltese: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne Franza
Croatian: France domperidon DOMPERIDONE ZENTIVA 20 mg, comprimé pelliculé sécable.
Maltese: Paris domperidone DOMPERIDONE ZENTIVA 20 mg, comprimé pelliculé sécable.
Croatian: Stadapharm GmbH Stadastr.
Maltese: Il-Ġermanja Stadapharm GmbH Stadastr. 2-18
Croatian: 92787 Issy-les-Moulineaux Cedex 9 France domperidon MOTILIUM 10 mg, comprimé pelliculé
Maltese: 92787 Issy-les-Moulineaux Cedex domperidone MOTILIUM 10 mg, comprimé pelliculé
Croatian: Domperidon Domperidon JJC zetpillen voor volwassenen 60 mg
Maltese: Domperidone Domperidon JJC zetpillen voor volwassenen 60 mg
Croatian: Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal domperidon Domperidona Generis 10 mg filmom obložena tableta
Maltese: Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora
Croatian: 15, boulevard Charles de Gaulle 92700 Colombes France domperidon DOMPERIDONE BIOGARAN 20 mg, comprimé pelliculé sécable.
Maltese: 15, boulevard Charles de Gaulle 92700 Colombes Franza domperidone DOMPERIDONE BIOGARAN 20 mg, comprimé pelliculé sécable.
Croatian: Domperidon Motilium 30 mg Suppositories
Maltese: Domperidone Motilium 30 mg Suppositories
Croatian: Domperidon Motilium 10mg FilmCoated Tablets
Maltese: Domperidone Motilium 10mg FilmCoated Tablets
Croatian: Belgium domperidon Motilium-60 supp 60 mg čepić rektalno
Maltese: 2340 Beerse domperidone Motilium-60 supp 60 mg suppositorju użu għal ġor-rektum
Croatian: France domperidon DOMPERIDONE ZENTIVA 10 mg, comprimé orodispersible
Maltese: Paris domperidone DOMPERIDONE ZENTIVA 10 mg, comprimé orodispersible
Croatian: Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar, Hertfordshire EN6 1AG, United Kingdom domperidon maleat
Maltese: Ir-Renju Unit Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar,
Croatian: Domperidon Motilium 1mg/ml Oral Suspension
Maltese: Domperidone Motilium 1mg/ml Oral Suspension
Croatian: Domperidon Domperidon JJC zetpillen voor kinderen 30 mg
Maltese: Domperidone Domperidon JJC zetpillen voor kinderen 30 mg
Croatian: Domperidon Domperidon JJC zetpillen voor zuigelingen 10 mg
Maltese: Domperidone Domperidon JJC zetpillen voor zuigelingen 10 mg
Croatian: 1 mg/ml oralna suspenzija kroz usta
Maltese: 1 mg/ml suspensjoni orali
Croatian: 9100 Sint-Niklaas Belgium
Maltese: Sint-Niklaas Il-Belġju
Croatian: 1. rujna 2014. EMA/465179/2014
Maltese: EMA/465179/2014
Croatian: Dana 23. travnja 2014.
Maltese: 1 ta' Settembru 2014
Croatian: Kontaktirajte s našim službenicima za medije Monika Benstetter ili Martin Harvey
Maltese: Ikkuntattja lill-uffiċjali tagħna tal-istampa Monika Benstetter jew Martin Harvey
Croatian: Pregled domperidona pokrenut je 1. ožujka 2013. na zahtjev belgijske agencije za lijekove, Savezne agencije za lijekove i zdravstvene proizvode (FAGG-AFMPS), sukladno članku 31. Direktive 2001/83/EZ.
Maltese: Ir-reviżjoni ta' domperidone nbdiet fl-1 ta' Marzu 2013 fuq it-talba tal-awtorità tal-mediċini Belġjana, lAġenzija Federali għal Mediċini u Prodotti tas-Saħħa (FAGG-AFMPS), skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
Croatian: Injektibilan oblik domperidona povučen je 1985. zbog navedenih nuspojava.
Maltese: Il-forma injettabli ta' domperidone ġiet irtirata fl-1985 minħabba tali effetti sekondarji.
Croatian: • Nova preporučena doza u odraslih osoba (i adolescenata ≥ 35 kg u slučajevima kada je primjena dopuštena) iznosi 10 mg peroralno maksimalno do tri puta dnevno (maksimalna dnevna doza je 30 mg).
Maltese: • Id-doża ġdida rrakkomandata fl-adulti (u adolexxenti ≥ 35 kg fejn liċenzjati) hija 10 mg mill-ħalq sa tliet darbiet kuljum (doża massima ta' 30 mg kuljum).
Croatian: CMDh, tijelo koje predstavlja države članice EU-a, odgovorno je za osiguravanje usklađenog standarda sigurne primjene za lijekove odobrene putem nacionalnih postupaka diljem EU-a.
Maltese: Is-CMDh, korp li jirrappreżenta lill-Istati Membri tal-UE, huwa responsabbli biex jiżgura standards ta' sigurtà armonizzati għal mediċini awtorizzati permezz ta' proċeduri nazzjonali fl-UE kollha.
Croatian: • Pregled baze podataka o sigurnosti originalnog lijeka obuhvatio je 342 ozbiljna izvještaja o srčanim događajima ili vaskularnim istraživanjima pokazao je veliku učestalost povezanosti kardiovaskularnih faktora rizika, kardiovaskularne povijesti i istodobne primjene drugih lijekova sa srčanim aritmijama u oboljelih bolesnika.
Maltese: • Reviżjoni tad-database ta' sigurtà tal-prodott oriġinatur li involviet 342 rapport serju ta' avvenimenti kardijaċi jew investigazzjonijiet vaskulari, enfasizzat il-frekwenza għolja ta' fatturi ta' riskju kardjovaskulari assoċjati, storja kardjovaskulari, u mediċini konkomittanti assoċjati ma' arritmiji kardjaċi fil-pazjenti kkonċernati.
Croatian: • Domperidon je lijek koji se koristio za različite želučane i probavne probleme.
Maltese: • Domperidone huwa mediċna li ntużat għal diversi problemi diġestivi u tal-istonku.
Croatian: Sadrže sažete nekliničke i kliničke podatke, objavljene i neobjavljene, uključujući opsežno ispitivanje QT-a, kumulativan pregled izvještaja o slučajevima srčanih poremećaja i vaskularna istraživanja iz baza podataka o sigurnoj primjeni za lijekove koji sadrže domperidon, farmakoepidemiologička ispitivanja, kao i objavljena i neobjavljena ispitivanja o djelotvornosti.
Maltese: Dan ikkonsista minn dejta klinika u mhux klinika, kemm ippubblikata kif ukoll le, inkluż studju intensiv tal-QT, reviżjoni kumulativa ta' rapporti ta' każijiet ta' disturbi kardijaċi u investigazzjonijiet vaskulari minn databases ta' sigurtà għal prodotti b'domperidone, studji farmakoepidemjoloġiċi, u studji ta' effikaċja ppubblikati u mhux ippubblikati.
Croatian: • Pregledom dokaza potvrđeno je malo povećanje rizika od ozbiljnih srčanih nuspojava povezanih s primjenom domperidona, uključujući produljenje QTc-a, torsade de pointes, ozbiljnu ventrikularnu aritmiju i iznenadnu srčanu smrt.
Maltese: • Reviżjoni tal-evidenza ikkonfermat riskju żgħir miżjud ta' reazzjonijiet avversi ta' mediċini b'effetti kardijaċi serji relatati mal-użu ta' domperidone, inklużi prolongazzjoni tal-QTc, torsade de pointes, arritmija ventrikulari serja u mewt kardijaka f'daqqa.
Croatian: Dostupni su kao tablete, peroralna suspenzija i supozitoriji pod različitim trgovačkim nazivima (poput Motilium).
Maltese: Huma disponibbli bħala pilloli, sospensjoni orali u suppożitorji b'diversi ismijiet kummerċjali (bħal Motilium).
Croatian: Od 57 prijavljenih kardiovaskularnih žrtava, 27 je imalo i druge rizične faktore, dok je kod 13 uočen nevjerodostojan odnos s primjenom domperidona ili alternativnu etiologiju.
Maltese: Mis-57 fatalità kardjovaskulari rrappurtati, 27 kellhom fatturi ta' riskju oħrajn, filwaqt li 13 kellhom jew relazzjoni implawżibbli mal-amministrazzjoni ta'
Croatian: Načelno, pregledi sigurnosti primjene lijeka ukazuju na to da je otprilike 40% takvih događaja prijavljeno u bolesnika starijih od 60 godina.
Maltese: B'mod ġenerali, reviżonijiet ta' sigurtà jindikaw li madwar 40% ta' tali rapporti huma f'pazjenti ta' ‘il fuq minn 60 sena.
Croatian: Bilo je malo dokaza u prilog dugoročne djelotvornosti domperidona u dispepsiji i poremećaju gastrooezofagealnog refluksa.
Maltese: B'mod partikolari, kien hemm evidenza limitata li tappoġġja l-effikaċja fit-tul ta' domperidone f'dispepsja u disturb ta' rifluss gastroesofagali.
Croatian: Preporuke je izvorno izdalo Povjerenstvo za ocjenu rizika na području farmakovingilacije (PRAC) pri EMA-i na svojem sastanku održanom od 3. do 6. ožujka, nakon detaljne ocjene dostupnih dokaza vezanih uz prednosti i rizike takvih lijekova.
Maltese: Ir-rakkomandazzjonijiet oriġinarjament saru mill-Kumitat għall-Valutazzjoni tar-Riskju ta' Farmakoviġilanza (PRAC) tal-EMA fil-laqgħa tiegħu tat-3-6 ta' Marzu, wara evalwazzjoni bir-reqqa talevidenza disponibbli dwar il-benefiċċiji u riskji ta' dawn il-mediċni.
Croatian: • Preporučena doza u odraslih osoba iznosi 10 mg peroralno do tri puta na dan ili 30 mg kao supozitorij dva puta na dan.
Maltese: • Id-doża rakkomandata fl-adulti hija 10 mg mill-ħalq sa tliet darbiet kuljum, jew 30 mg bħala suppożitorji darbtejn kuljum.
Croatian: Ovo je u skladu s podacima koji potječu iz ispitivanja o interakciji među lijekovima i iz spontanih prijava.
Maltese: Dan huwa f'konformità mad-dejta li ġejja minn studji ta' interazzjoni bejn il-mediċini, u minn rappurtar spontanju.
Croatian: Povišen rizik uočen je u bolesnika starijih od 60 godina, odraslih osoba koje su uzimale dnevne peroralne doze veće od 30 mg i osoba koje su istovremeno uzimale lijekove za produljenje QT-a ili inhibitore CYP3A4.
Maltese: Riskju ogħla ġie osservat f'pazjenti ikbar minn 60 sena, adulti li jieħdu dożi orali ta' kuljum ta' aktar minn 30 mg, u dawk li qegħdin jieħdu mediċini li ttawwlu l-QT jew inibituri CYP3A4 b'mod konkomittanti.
Croatian: Preporuke PRAC-a dostavljene su Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh), koja je usvojila konačno mišljenje.
Maltese: Ir-rakkomandazzjonijiet tal-PRAC intbagħtu lill-Grupp ta' Koordinazzjoni għall-Għarfien Reċiproku u Proċeduri Deċentralizzati - Uman (CMDh), li adotta pożizzjoni finali.
Croatian: Farmaceutski oblik
Maltese: 15-il pillola
Croatian: Dostupan je u obliku tableta od 20 mg.
Maltese: Jiġi bħala pilloli ta' 20-mg.
Croatian: Više informacija o lijeku Doptelet dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/doptelet.
Maltese: ema.europa.eu/medicines/human/EPAR/doptelet.
Croatian: Ostale informacije o lijeku Doptelet
Maltese: Informazzjoni oħra dwar Doptelet
Croatian: Doptelet sadržava djelatnu tvar avatrombopag.
Maltese: Doptelet fih is-sustanza attiva avatrombopag.
Croatian: Doptelet (avatrombopag) EMA/243810/2019
Maltese: EMA/243810/2019
Croatian: U tim ispitivanjima 88 % bolesnika koji su primali lijek Doptelet u dozi od 40 mg dnevno nije trebalo transfuziju ni terapiju spasa, u odnosu na 36 % bolesnika koji su primali placebo (prividno liječenje).
Maltese: F'dawn l-istudji, 88% tal-pazjenti li ngħataw 40 mg ta' Doptelet kuljum ma kinux jirrikjedu trasfużjoni jew proċedura ta' salvataġġ meta mqabbla ma' 36% tal-pazjenti li ngħataw il-plaċebo (kura finta).
Croatian: Koji su rizici povezani s lijekom Doptelet?
Maltese: X'inhuma r-riskji assoċjati ma' Doptelet?
Croatian: Među bolesnicima s težim oblikom trombocitopenije, 67 % onih koji su primali lijek Doptelet u dozi od 60 mg dnevno nije trebalo transfuziju ni terapiju spasa, u odnosu na 29 % onih koji su primali placebo.
Maltese: Fost pazjenti bi tromboċitopenija aktar severa, 67% ta' dawk li ngħataw 60 mg ta' Doptelet kuljum ma kinux jirrikjedu trasfużjoni jew proċedura ta' salvataġġ meta mqabbla ma' 29% ta' dawk li rċevew ilplaċebo.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Doptelet kontinuirano se prate.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Doptelet hija ssorveljata kontinwament.
Croatian: U dvama glavnim ispitivanjima na 435 bolesnika s niskom razinom trombocita uslijed kronične bolesti jetre utvrđena je učinkovitost lijeka Doptelet s obzirom na povećanje broja trombocita prije invazivnog postupka.
Maltese: Żewġ studji ewlenin f'435 pazjent b'livelli baxxi ta' pjastrini minħabba l-mard tal-fwied li ilu jeżisti sabu li Doptelet kien effettiv biex iżid il-livelli ta' pjastrini qabel proċedura invażiva.
Croatian: Doza je 2 ili 3 tablete (ovisno o broju trombocita na početku liječenja) dnevno tijekom razdoblja od 5 dana.
Maltese: Id-doża hija ta' 2 jew 3 pilloli (skont l-għadd ta' pjastrini fil-bidu tal-kura), kuljum għal 5 ijiem.
Croatian: Kako se Doptelet primjenjuje?
Maltese: Kif jintuża Doptelet?
Croatian: Doptelet je lijek za sprječavanje prekomjernog krvarenja u odraslih osoba s trombocitopenijom uzrokovanom kroničnom bolešću jetre.
Maltese: Doptelet huwa mediċina li tintuża biex tipprevjeni fsada eċċessiva fl-adulti bi tromboċitopenija minħabba mard tal-fwied fit-tul.
Croatian: ≥ 40 do < 50
Maltese: ≥ 40 sa < 50
Croatian: EU/1/19/1373/002
Maltese: EU/1/19/1373/001 EU/1/19/1373/002
Croatian: CockcroftGault).
Maltese: Cockcroft-Gault).
Croatian: Trombotski/tromboembolijski događaji
Maltese: Avvenimenti trombotiċi/tromboemboliċi
Croatian: 10 ili 15 tableta.
Maltese: 10 jew 15-il pillola.
Croatian: b Cochran-Mantel-Haenszelov test.
Maltese: b Test Cochran-Mantel-Haenszel.
Croatian: * Medicinski rječnik za regulatorne poslove (MedDRA) verzija 19.1.
Maltese: * Dizzjunarju Mediku għall-Attivitajiet Regolatorji (MedDRA) verżjoni 19.1.
Croatian: Poli(vinilni alkohol) (E1203) Talk (E553b)
Maltese: Poly(vinyl alcohol) (E1203) Talc (E553b)
Croatian: 5 dana
Maltese: 5 ijiem
Croatian: IRSKA
Maltese: IRELAND
Croatian: MELD rezultati u bolesnika su se kretali od < 10 (37,5%), od 10 do 14 (46,3%) i od > 14 do < 24 (16,2%) te uključivali bolesnike s CTP (Child-Turcotte-Pugh) A (56,4%), B (38,1%), i C (5,6%).
Maltese: Il-punteġġi MELD tal-pazjenti varjaw minn < 10 (37.5%), 10 sa 14 (46.3%) u minn > 14 sa < 24 (16.2%), u inkludew pazjenti b'CTP Klassi A (56.4%), Klassi B (38.1%), u Klassi C (5.6%).
Croatian: Datum prvog odobrenja: 20. lipnja 2019
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta 'Ġunju 2019
Croatian: Farmakoterapijska skupina: Antihemoragici, ostali sistemski hemostatici, ATK oznaka: B02BX08 Mehanizam djelovanja
Maltese: Antiemorraġiċi, emostatiċi sistemiċi oħra, Kodiċi ATC: B02BX08 Mekkaniżmu ta' azzjoni
Croatian: Makrogol 3350 (E1521) Titanijev dioksid (E171) Željezov oksid, žuti (E172)
Maltese: Macrogol 3350 (E1521) Titanium dioxide (E171)
Croatian: Avatrombopag nije supstrat za OATP1B1, OATP1B3, OCT2, OAT1 i OAT3.
Maltese: Avatrombopag mhuwiex substrat għal OATP1B1, OATP1B3, OCT2, OAT1, u OAT3.
Croatian: Inhibitori CYP3A4/5 i CYP2C9
Maltese: Inibituri ta' CYP3A4/5 u CYP2C9
Croatian: c Wilcoxonov test sume rangova (engl.
Maltese: c Test Rank Sum ta' Wilcoxon.
Croatian: Klasifikacija organskih sustava (MedDRA terminologija*)
Maltese: (Terminoloġija ta' MedDRA*)
Croatian: Srednja vrijednost (SD) x 109/L Medijan x 109/L P vrijednostc a Dvostrani interval pouzdanosti od 95% utemeljen na normalnoj aproksimaciji.
Maltese: Medja (SD) x 109/L Medjan x 109/L Valur-pc a 95% intervall ta' kunfidenza minn żewġ naħat ibbażat fuq approssimazzjoni normali.
Croatian: Srednja vrijednost (SD) x 109/L Medijan x 109/L P vrijednostc
Maltese: Medja (SD) x 109/L Medjan x 109/L Valur-pc
Croatian: Jedna filmom obložena tableta sadrži 120,8 mg laktoza hidrata.
Maltese: Kull pillola miksija b'rita fiha 120.8 mg ta' lactose monohydrate.
Croatian: • Doptelet je dostupan u tabletama od 20 mg.
Maltese: • Doptelet huwa disponibbli f'pilloli ta' 20 mg.
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Dova Pharmaceuticals Ireland, Limited
Maltese: Dova Pharmaceuticals Ireland, Limited
Croatian: 40 mg (dvije tablete od 20 mg)
Maltese: 40 mg (Żewġ pilloli ta' 20 mg)