FrancophonIA/ELRC3.0 huggingface dataset:
Spanish: PENSA PHARMA, S.A.U.
Croatian: Španjolska PENSA PHARMA, S.A.U.
Spanish: Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa Portugal domperidona Domperidona Actavis
Croatian: Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa Portugal domperidon Domperidona Actavis 10 mg tableta
Spanish: H-2045 Törökbálint Hungría domperidona Motilium 10 mg filmtabletta
Croatian: H-2045 Törökbálint Hungary domperidon Motilium 10 mg filmtabletta
Spanish: Domperidona RAXAR
Croatian: Domperidon RAXAR
Spanish: Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4
Croatian: João II, Lote 1.06.2.2 C7.3 e 7.4
Spanish: Rumanía
Croatian: Rumunija
Spanish: GIULIANI S.P.A Via Palagi 2 20129 Milano Italia
Croatian: GIULIANI S.P.A Via Palagi 2 20129 Milano Italy
Spanish: Pº de Las Doce Estrellas, 5-7 28042 Madrid
Croatian: Španjolska Janssen-Cilag, S.A. Pº de Las Doce Estrellas, 5-7 28042 Madrid
Spanish: 10 mg cápsula dura
Croatian: 10 mg kapsula, tvrda
Spanish: Domperidona Domperidona Gamir 10 mg cápsulas duras
Croatian: Domperidon Domperidona Gamir 10 mg cápsulas duras
Spanish: DR. REDDY'S S.R.L.
Croatian: REDDY'S S.R.L.
Spanish: Actavis Group Hf Reykjavikurvegi 76-78 220 Hafnarfjördur Islandia
Croatian: Actavis Group Hf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland
Spanish: Accord Healthcare Limited Sage House, 319, Pinner Road HA1 4HF North Harrow, Middlesex Reino Unido
Croatian: Accord Healthcare Limited Sage House, 319, Pinner Road HA1 4HF North Harrow, Middlesex United Kingdom
Spanish: Reino Unido Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD, Reino Unido
Croatian: Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD, United Kingdom domperidon maleat
Spanish: Domperidona DOMPERIDONE MYLAN GENERICS
Croatian: Domperidon DOMPERIDONE MYLAN GENERICS
Spanish: Reino Unido Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stoke-on-Trent, Staffordshire ST3
Croatian: Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stokeon-Trent, Staffordshire ST3 7UN United Kingdom domperidon maleat
Spanish: Reino Unido Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, Reino Unido domperidona Domperidone 1mg/ml Oral
Croatian: Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom domperidon Domperidone 1mg/ml Oral Suspension
Spanish: Países Bajos Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4 HF North Harrow, Middlesex Reino Unido
Croatian: Nizozemska Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4 HF North Harrow, Middlesex United Kingdom
Spanish: Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa Portugal domperidona Domperidona Baldacci
Croatian: Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa Portugal domperidon Domperidona Baldacci 10 mg filmom obložena tableta
Spanish: Domperidona PYNINAT
Croatian: Domperidon PYNINAT
Spanish: 2794-093 Carnaxide Portugal domperidona Domperidona ToLife 10 mg comprimido
Croatian: 2794-093 Carnaxide Portugal domperidon Domperidona ToLife 10 mg tableta
Spanish: Domperidona DOMPERIDONE SANDOZ
Croatian: Domperidon DOMPERIDONE SANDOZ
Spanish: 2730-055 Barcarena Portugal domperidona Motilium
Croatian: 2730-055 Barcarena Portugal domperidon Motilium
Spanish: Domperidona Domstal
Croatian: Domperidon Domstal
Spanish: Roscommon, Irlanda
Croatian: Roscommon,
Spanish: LABORATORIOS DR. ESTEVE, S.A. Avda. Mare de Déu de Montserrat,
Croatian: Španjolska LABORATORIOS DR. ESTEVE, S.A. Avda.
Spanish: Reino Unido Manx Healthcare Limited Taylor Group House
Croatian: Manx Healthcare Limited Taylor Group House Wedgnock Lane Warwick
Spanish: 5 mg/5 ml solución oral
Croatian: 5 mg/5 ml oralna otopina
Spanish: Domperidona Motilium suspensie voor oraal gebruik 1 mg/ml
Croatian: Domperidon Motilium suspensie voor oraal gebruik 1 mg/ml
Spanish: Domperidona GERDI
Croatian: Domperidon GERDI
Spanish: 20144 Milano Italia
Croatian: 20144 Milano Italy
Spanish: 20 mg/ 19 mg comprimido
Croatian: 20 mg/ 19 mg tableta
Spanish: ACTAVIS France La Boursidière Centre d'Affaires 92357 Le Plessis Robinson Francia domperidona DOMPERIDONE ACTAVIS 10 mg, comprimé pelliculé
Croatian: ACTAVIS FRANCE La Boursidière Centre d'Affaires 92357 Le Plessis Robinson France domperidon DOMPERIDONE ACTAVIS 10 mg, comprimé pelliculé
Spanish: Austria domperidona Motilium 1 mg/mlSuspension zum
Croatian: Austria domperidon Motilium 1 mg/mlSuspension zum
Spanish: Países Bajos Samenwerkende Apothekers Nederland B.V.
Croatian: Nizozemska Samenwerkende Apothekers Nederland B.V.
Spanish: 1 mg/ml suspensión
Croatian: 1 mg/ml suspenzija
Spanish: Domperidona Motilium instant
Croatian: Domperidon Motilium instant
Spanish: Reino Unido Medreich plc, Warwick House, Plane Tree Crescent, Feltham TW13 7HF Reino Unido
Croatian: Warwick House, Plane Tree Crescent, Feltham TW13 7HF United Kingdom domperidon maleat
Spanish: 20 mg / 15 mg comprimido
Croatian: 20 mg / 15 mg tableta
Spanish: Domperidona Oroperidys
Croatian: Domperidon Oroperidys
Spanish: Domperidona DOMPERIDONE GERMED
Croatian: Domperidon DOMPERIDONE GERMED
Spanish: Dinamarca
Croatian: Denmark
Spanish: Domperidona DOMPERIDONE DOC GENERICI
Croatian: Domperidon DOMPERIDONE DOC GENERICI
Spanish: 20124 Milano Italia
Croatian: 20124 Milano Italy
Spanish: Domperidona PERIDON
Croatian: Domperidon PERIDON
Spanish: SUBSTIPHARM 8, rue Bellini 75116 Paris Francia domperidona DOMPERIDONE GERDA 10 mg, comprimé pelliculé
Croatian: SUBSTIPHARM 8, rue Bellini 75116 Paris France domperidon DOMPERIDONE GERDA 10 mg, comprimé pelliculé
Spanish: Rua Alto do Montijo, 13 - 1º DtoEdifício Monsanto 2790-012 Portela de Carnaxide Portugal domperidona Domperidona Germed
Croatian: Rua Alto do Montijo, 13 - 1º DtoEdifício Monsanto 2790-012 Portela de Carnaxide Portugal domperidon Domperidona Germed 10 mg filmom obložena tableta
Spanish: Cinarizina/ Domperidona (maleato)
Croatian: Cinarizin / Domperidon (maleat)
Spanish: CRISTERS 22 quai Gallieni 92150 Suresnes Francia domperidona DOMPERIDONE CRISTERS 10 mg, comprimé orodispersible
Croatian: CRISTERS 22 quai Gallieni 92150 Suresnes France domperidon DOMPERIDONE CRISTERS 10 mg, comprimé orodispersible
Spanish: Karla Engliše 3201/6
Croatian: Češka Republika Janssen-Cilag s.r.o. Karla Engliše 3201/6
Spanish: Países Bajos Marel B.V.
Croatian: Nizozemska Marel B.V.
Spanish: 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre Francia domperidona DOMPERIDONE ZYDUS 10 mg, comprimé pelliculé
Croatian: ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre France domperidon DOMPERIDONE ZYDUS 10 mg, comprimé pelliculé
Spanish: Países Bajos Sofar S.p.A.
Croatian: Nizozemska Sofar S.p.A.
Spanish: Domperidona Motilium Tropfen 10 mg suspensión, gotas orales
Croatian: Domperidon Motilium Tropfen 10 mg oralne kapi, suspenzija
Spanish: Domperidona Tabletten bij maagklachten en misselijkheid domperidon 10 mg, tabletten
Croatian: Domperidon Tabletten bij maagklachten en misselijkheid domperidon 10 mg, tabletten
Spanish: AUROBINDO PHARMA France 22-26 rue des Gaudines 78100 Saint-Germain-en-Laye Francia domperidona DOMPERIDONE AUROBINDO 10 mg, comprimé pelliculé
Croatian: AUROBINDO PHARMA FRANCE 22-26 rue des Gaudines 78100 Saint-Germain-en-Laye France domperidone DOMPERIDONE AUROBINDO 10 mg, comprimé pelliculé
Spanish: Países Bajos Mediq Farma B.V.
Croatian: Nizozemska Mediq Farma B.V.
Spanish: B-2340, Beerse Bélgica domperidona motilium 10mg film coated tablets
Croatian: B-2340, Beerse Belgium domperidon motilium 10mg film coated tablets
Spanish: Domperidona Domerid Relief 10mg Tablets.
Croatian: Domperidone Domerid Relief 10mg Tablets.
Spanish: Países Bajos Actavis B.V.
Croatian: Nizozemska Actavis B.V.
Spanish: Reino Unido Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, Reino Unido
Croatian: Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom domperidon maleat
Spanish: Domperidona Motilium Rx 10 mg Film-coated Tablets.
Croatian: Domperidon Motilium Rx 10 mg Film-coated Tablets.
Spanish: Austria domperidona Motilium 10 mgFilmtabletten
Croatian: Austria domperidon Motilium 10 mgFilmtabletten
Spanish: Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal domperidona Domperidona Generis
Croatian: Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal domperidon Domperidona Generis 10 mg filmom obložena tableta
Spanish: República Eslovaca
Croatian: Slovačka
Spanish: Ranbaxy Pharmacie Génériques 11-15 Quai Dion Bouton 92800 Puteaux domperidona DOMPERIDONE RPG 10 mg, comprimé pelliculé
Croatian: Ranbaxy Pharmacie Génériques 11-15 Quai Dion Bouton 92800 Puteaux
Spanish: Motilium 10mg Film-coated Tablets
Croatian: Motilium 10mg Filmcoated Tablets
Spanish: domperidona DOMPERIDONE ALTER 10 mg, comprimé pelliculé
Croatian: domperidon DOMPERIDONE ALTER 10 mg, comprimé pelliculé
Spanish: Países Bajos Healthypharm B.V.
Croatian: Nizozemska Healthypharm B.V.
Spanish: B-2340, Beerse Bélgica domperidona motilium 1mg/ml oral suspension
Croatian: B-2340, Beerse Belgium domperidon motilium 1mg/ml oral suspension
Spanish: 92787 Issy-les-Moulineaux Cedex domperidona MOTILIUM 10 mg, granulés effervescents en sachet-dose
Croatian: 92787 Issy-les-Moulineaux Cedex 9 France domperidon MOTILIUM 10 mg, granulés effervescents en sachet-dose
Spanish: Wrexham Industrial Estate Wrexham LL13 9UF
Croatian: Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom domperidon maleat
Spanish: Domperidona Motilium Fastmelts 10mg Tablets
Croatian: Domperidon Motilium Fastmelts 10mg Tablets
Spanish: Luxemburgo Pierre Fabre Médicament 45 place Abel Gance
Croatian: Luksemburg Pierre Fabre Médicament 45 place Abel Gance
Spanish: Países Bajos Leidapharm B.V.
Croatian: Nizozemska Leidapharm B.V.
Spanish: Reino Unido Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar,
Croatian: Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar, Hertfordshire EN6 1AG, United Kingdom domperidon maleat
Spanish: Northbridge Road, Berkhamsted Hertfordshire
Croatian: Bristol Laboratories Limited Unit 3, Canalside Northbridge Road, Berkhamsted Hertfordshire
Spanish: Domperidona Motilium 30 mg supositorios niños
Croatian: Domperidon Motilium 30 mg supositorios niños
Spanish: 2700-451 Amadora Portugal domperidona Domperidona GP 10 mg comprimido
Croatian: 2700-451 Amadora Portugal domperidon Domperidona GP
Spanish: Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal domperidona Remotil
Croatian: Edifícios Azevedos - Estrada Nacional 117-2, Alfragide
Spanish: Domperidona Orosperidys 10 mg comprimidos bucodispersables
Croatian: Domperidon Orosperidys 10 mg comprimidos bucodispersables
Spanish: Alemania domperidona DOMPERIDONE RATIOPHARM 10 mg, comprimé pelliculé
Croatian: Germany domperidon DOMPERIDONE RATIOPHARM 10 mg, comprimé pelliculé
Spanish: Domperidona Motilium zetpillen voor zuigelingen 10 mg
Croatian: Domperidon Motilium zetpillen voor zuigelingen 10 mg
Spanish: ROTTAPHARM, S.L.
Croatian: Španjolska ROTTAPHARM, S.L. Avda.
Spanish: Domperidona Motilium
Croatian: Domperidon Motilium
Spanish: Domperidona MOTILIUM
Croatian: Domperidon MOTILIUM
Spanish: Domperidona Motilium zetpillen voor kinderen 30 mg
Croatian: Domperidon Motilium zetpillen voor kinderen 30 mg
Spanish: Domperidona Motilium zetpillen voor volwassenen 60 mg
Croatian: Domperidon Motilium zetpillen voor volwassenen 60 mg
Spanish: 92787 Issy-les-Moulineaux Cedex domperidona MOTILIUM 1 mg/ml, suspension buvable
Croatian: 92787 Issy-les-Moulineaux Cedex 9 France domperidon MOTILIUM 1 mg/ml, suspension buvable
Spanish: Domperidona Domperidon 30 PCH voor kinderen, zetpillen 30 mg
Croatian: Domperidon Domperidon 30 PCH voor kinderen, zetpillen 30 mg
Spanish: Domperidona Domperidon 60 PCH voor volwassenen, zetpillen 60 mg
Croatian: Domperidon Domperidon 60 PCH voor volwassenen, zetpillen 60 mg
Spanish: Domperidona Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg
Croatian: Domperidon Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg
Spanish: Domperidona Domperidona Gamir 1 mg/ml suspensión oral
Croatian: Domperidon Domperidona Gamir 1 mg/ml suspensión oral
Spanish: Reino Unido Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire
Croatian: Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire WD18 9SS United Kingdom domperidon maleat
Spanish: Actavis Group Hf Reykjavikurvegi 76-78 220 Hafnarfjördur Islandia domperidona Domperidon Actavis 10 mg tablets
Croatian: Actavis Group Hf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland domperidon Domperidon Actavis 10 mg tablets
Spanish: 5 mg granulado efervescente
Croatian: 5 mg šumeće granule
Spanish: B-2340, Beerse Bélgica domperidona motilium 30 mg Suppositories
Croatian: B-2340, Beerse Belgium domperidon motilium 30 mg Suppositories
Spanish: Domperidona Motilium 10 mg Suppositories
Croatian: Domperidon Motilium 10 mg Suppositories
Spanish: Via Ippolito Rossellini 12 20124 Milano Italia
Croatian: PENSA PHARMA S.P.A. Via Ippolito Rossellini 12 20124 Milano Italy
Spanish: Domperidona Motilium 60mg Suppositories
Croatian: Domperidon Motilium 60mg Suppositories
Spanish: 2340 Beerse domperidona Motilium-1mg/ml
Croatian: Belgium domperidon Motilium-1mg/ml
Spanish: REMEDICA LTD, Aharnon str. P.O.box 51706, Lemesos, Chipre domperidona PEPTOMET FILM COATED TABLETS 10MG
Croatian: REMEDICA LTD, Aharnon str. P.O.box 51706, Lemesos,
Spanish: Hungría domperidona Domperidon-EP 10 mg tabletta
Croatian: Hungary domperidon Domperidon-EP 10 mg tabletta
Spanish: Domperidona Nauzelin 10 mg comprimidos recubiertos con película
Croatian: Domperidon Nauzelin 10 mg comprimidos recubiertos con película
Spanish: 20 mg granulado efervescente
Croatian: 20 mg šumeće granule
Spanish: Austria domperidona Motilium 60 mgZäpfchen
Croatian: Austria domperidon Motilium 60 mgZäpfchen
Spanish: 2340 Beerse domperidona Motilium-10 supp.
Croatian: Belgium domperidon Motilium-10 supp.
Spanish: Domperidone EG-10 10 mg comprimido
Croatian: Domperidone EG-10 10 mg tableta
Spanish: Domperidona DOMERID 10mg Tablets.
Croatian: Domperidone DOMERID 10mg Tablets.
Spanish: Austria domperidona Motilium 30 mgZäpfchen
Croatian: Austria domperidon Motilium 30 mgZäpfchen
Spanish: Domperidona Nauzelin 1 mg/ml suspensión oral
Croatian: Domperidon Nauzelin 1 mg/ml suspensión oral
Spanish: 92100 Boulogne domperidona Oroperidys
Croatian: 92100 Boulogne
Spanish: Domperidona Motilium filmomhulde tabletten 10 mg
Croatian: Domperidon Motilium filmomhulde tabletten 10 mg
Spanish: QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest Francia domperidona DOMPERIDONE QUALIMED 10 mg, comprimé pelliculé
Croatian: QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest France domperidon DOMPERIDONE QUALIMED 10 mg, comprimé pelliculé
Spanish: Grecia domperidona OROPERIDYS
Croatian: Athens, Greece domperidon OROPERIDYS
Spanish: Domperidona Domperidon JJC filmomhulde tabletten 10 mg
Croatian: Domperidon Domperidon JJC filmomhulde tabletten 10 mg
Spanish: 2340 Beerse domperidona Motilium-60 supp 60 mg supositorio vía rectal
Croatian: Belgium domperidon Motilium-60 supp 60 mg čepić rektalno
Spanish: Teva Pharma Belgium N.V.
Croatian: Teva Pharma Belgium N.V. Laarstraat 16
Spanish: 5 mg comprimido masticable
Croatian: 5 mg šumeća tableta
Spanish: 92787 Issy-les-Moulineaux Cedex domperidona MOTILIUM 10 mg, comprimé pelliculé
Croatian: 92787 Issy-les-Moulineaux Cedex 9 France domperidon MOTILIUM 10 mg, comprimé pelliculé
Spanish: 2340 Beerse domperidona Motilium Domperidone Base
Croatian: Belgium domperidon Motilium Domperidone Base
Spanish: 10 mg granulado efervescente
Croatian: 10 mg šumeće granule
Spanish: Domperidona Domperidon JJC zetpillen voor zuigelingen 10 mg
Croatian: Domperidon Domperidon JJC zetpillen voor zuigelingen 10 mg
Spanish: Contacto con nuestros responsables de la Oficina de Prensa Monika Benstetter o Martin Harvey
Croatian: Kontaktirajte s našim službenicima za medije Monika Benstetter ili Martin Harvey
Spanish: 30 Churchill Place ● Canary Wharf ● Londres E14 5EU ● Reino Unido
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Spanish: 1 de septiembre de 2014 EMA/465179/2014
Croatian: 1. rujna 2014. EMA/465179/2014
Spanish: • Los datos para respaldar otras indicaciones fueron muy limitados.
Croatian: • Podaci koji podržavaju druge indikacije bili su iznimno ograničeni.
Spanish: Tel.: +44 (0)20 7418 8427 Correo electrónico: press@ema.europa.eu
Croatian: +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Spanish: • La domperidona debe usarse a la dosis eficaz más baja durante la duración más corta posible.
Croatian: • Domperidon treba uvijek koristiti u najmanjoj djelotvornoj dozi tijekom najkraćeg mogućeg trajanja.
Spanish: Están disponibles como comprimidos, suspensión oral y supositorios bajo diversos nombres comerciales (como Motilium).
Croatian: Dostupni su kao tablete, peroralna suspenzija i supozitoriji pod različitim trgovačkim nazivima (poput Motilium).
Spanish: Por tanto, se han incluido medidas adecuadas de minimización del riesgo en la información del producto para abordar este problema.
Croatian: Odgovarajuće mjere minimiziranja rizika stoga su uključene u informacije o proizvodu kako bi se riješio ovaj problem.
Spanish: La revisión de la domperidona se inició el 1 de marzo de 2013 a solicitud de la agencia de medicamentos belga, la Agencia Federal de Medicamentos y Productos Médicos (FAGG-AFMPS), según el artículo 31 de la Directiva 2001/83/EC.
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.
Spanish: En general, las revisiones de seguridad indican que alrededor del 40% de dichos informes corresponden a pacientes mayores de 60 años.
Croatian: Načelno, pregledi sigurnosti primjene lijeka ukazuju na to da je otprilike 40% takvih događaja prijavljeno u bolesnika starijih od 60 godina.
Spanish: Las pruebas disponibles de eficacia no fueron suficientes para respaldar su uso para otras indicaciones.
Croatian: Dostupni dokazi djelotvornosti nisu bili dostatni kako bi podržali primjenu u drugim indikacijama.
Spanish: La forma inyectable de la domperidona se retiró en 1985 debido a dichos efectos secundarios.
Croatian: Injektibilan oblik domperidona povučen je 1985. zbog navedenih nuspojava.
Spanish: Por tanto, no se consideró que los efectos beneficiosos en estas indicaciones superaran el riesgo.
Croatian: Stoga se ne smatra da koristi u ovim indikacijama nadmašuju rizik.
Spanish: Algunos productos se retirarán del mercado porque su concentración no corresponde con las nuevas dosis.
Croatian: Određeni proizvodi bit će povučeni iz prometa budući da njihova jačina ne odgovara novoj dozi.
Spanish: Las recomendaciones fueron realizadas originalmente por el Comité para la Determinación del Riesgo en Farmacovigilancia de la EMA (PRAC) en su reunión de los días 3-6 de marzo, después de una cuidadosa evaluación de las pruebas disponibles sobre los beneficios y riesgos de dichos medicamentos.
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.
Spanish: La información sobre el producto se ha modificado debidamente.
Croatian: Informacije o proizvodu dopunjene su na odgovarajući način.
Spanish: La revisión de la domperidona fue realizada a solicitud de la agencia de medicamentos belga por preocupaciones acerca de los efectos del medicamento sobre el corazón.
Croatian: Pregled domperidona proveden je na zahtjev belgijske agencije za lijekove zbog zabrinutosti o djelovanju lijekova na srce.
Spanish: Hubo datos limitados para respaldar el uso pediátrico en esta indicación y, aunque no se espera que el mecanismo de acción difiera entre adultos y niños, se han solicitado estudios para aportar más datos que respalden la eficacia en la población pediátrica.
Croatian: Dostupni su ograničeni podaci koji podržavaju pedijatrijsku primjenu u ovoj indikaciji, a iako se ne očekuje različit mehanizam djelovanja u odraslih osoba i djece, zatražena su ispitivanja s ciljem prikupljanja dodatnih podataka koji podržavaju djelotvornost u pedijatrijskoj populaciji.
Spanish: • Las formulaciones que no sean compatibles con las nuevas recomendaciones posológicas serán retiradas del mercado, al igual que las combinaciones de domperidona con cinarizina.
Croatian: • Formulacije koje nisu u skladu s novim preporukama za doziranje bit će povučene s tržišta, kao i kombinacije domperidona i cinarizina.
Spanish: Estas recomendaciones se basan en la valoración cuidadosa de los datos sobre la seguridad y la eficacia de la domperidona obtenidos de diversas fuentes.
Croatian: Ove se preporuke temelje na pažljivom pregledu podataka o sigurnoj primjeni i djelotvornosti domperidona dostupnih iz različitih izvora.
Spanish: De 57 muertes por causa cardiovascular notificadas, 27 presentaban otros factores de riesgo, mientras que 13 tenían bien una relación poco plausible con la administración de domperidona o bien una etiología alternativa.
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.
Spanish: El CMDh, un organismo que representa a los Estados miembros de la UE, es responsable de garantizar unas normas de seguridad armonizadas para los medicamentos autorizados mediante procedimientos nacionales en la UE.
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.
Spanish: Además, no debe usarse con otros medicamentos que tengan efectos similares sobre el corazón o reduzcan la eliminación de la domperidona en el organismo (aumentando así el riesgo de efectos secundarios).
Croatian: Nadalje, ne smije se koristiti zajedno s drugim lijekovima koji imaju slično djelovanje na srce ili smanjuju razgradnju domperidona u tijelu (te tako ujedno povećavaju rizik od nuspojava).
Spanish: Algunos de estos estudios también respaldaron un mayor riesgo en pacientes mayores de 60 años o que están tomando dosis altas (más de 30 mg/día).
Croatian: Neka od ovih ispitivanja podržavaju veći rizik u bolesnika starijih od 60 godina ili onih koji uzimaju velike doze (više od 30 mg/dan).
Spanish: Normalmente, el medicamento no debe usarse durante más de una semana.
Croatian: U normalnim okolnostima, lijek se ne smije koristiti dulje od tjedan dana.
Spanish: • La domperidona es un medicamento que se ha usado para diversos problemas gástricos y digestivos.
Croatian: • Domperidon je lijek koji se koristio za različite želučane i probavne probleme.
Spanish: Sin embargo, siguieron comunicándose casos de problemas cardíacos al usar el medicamento y, por tanto, se solicitó al PRAC que examinara si los beneficios seguían superando a los riesgos de estos medicamentos en sus usos y formas aprobados, y si sus autorizaciones de comercialización deberían mantenerse o cambiarse en la UE.
Croatian: No, i dalje se prijavljuju slučajevi srčanih problema u bolesnika koji koriste lijek, te je stoga od PRAC-a zatraženo da provjeri nadmašuju li koristi od ovih lijekova još uvijek rizike povezane s ovim lijekovima u njihovim odobrenim primjenama i oblicima, te trebaju li odobrenja za stavljanje tih lijekova u promet ostati na snazi ili se promijeniti diljem EU-a.