FrancophonIA/ELRC3.0 huggingface dataset:
Danish: Storbritannien McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,
Latvian: McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,
Danish: Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal domperidone Remotil
Latvian: Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal
Danish: Domperidone DOMPERIDONE TEVA
Latvian: DOMPERIDONE TEVA
Danish: Medochemie Ltd. 1-10 Astronafton Str.+ Limassol
Latvian: 1-10 Astronafton Str.+ Limassol
Danish: 20092 Cinisello Balsamo - MilanoItaly
Latvian: 20092 Cinisello BalsamoMilano - Italy
Danish: Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa Portugal domperidone Domperidona Actavis
Latvian: Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa Portugal
Danish: Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal domperidone Domperidona Ratiopharm
Latvian: Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal
Danish: Sanofi-Aventis France 1-13, boulevard Romain Rolland 75014 Paris
Latvian: Sanofi-Aventis France 1-13, boulevard Romain Rolland
Danish: Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4
Latvian: João II, Lote 1.06.2.2 C - 7.3 e 7.4
Danish: ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre France domperidone DOMPERIDONE ZYDUS 10 mg, comprimé pelliculé
Latvian: ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre France
Danish: Domperidone DOMPERIDONE PENSA
Latvian: DOMPERIDONE PENSA
Danish: Via Cesarea 11/10 16121 Genova Italy
Latvian: ALMUS S.R.L. Via Cesarea 11/10 16121 Genova Italy
Danish: 10 mg/10 ml suspension
Latvian: 10 mg/10 ml suspensija
Danish: France domperidone MOTILIUM 10 mg, granulés effervescents en sachet-dose
Latvian: MOTILIUM 10 mg, granulés effervescents en sachet-dose
Danish: Domperidone Domperidona Gamir 10 mg cápsulas duras
Latvian: Domperidona Gamir 10 mg cápsulas duras
Danish: Storbritannien Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD, United Kingdom domperidone maleate
Latvian: Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD, United Kingdom domperidone maleate
Danish: Storbritannien Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stokeon-Trent, Staffordshire ST3 7UN United Kingdom domperidone maleate
Latvian: Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stoke-on-Trent, Staffordshire ST3 7UN United Kingdom domperidone maleate
Danish: Rua Manuel Ribeiro de Pavia, 11º - Venda Nova 2700-547 Amadora Portugal domperidone Cinet
Latvian: Rua Manuel Ribeiro de Pavia, 1 - 1º - Venda Nova 2700-547 Amadora Portugal
Danish: Storbritannien Manx Healthcare Limited Taylor Group House
Latvian: Manx Healthcare Limited Taylor Group House Wedgnock Lane Warwick
Danish: 1314 SJ Almere
Latvian: 1314 SJ Almere The Netherlands
Danish: Rua Alto do Montijo, 13 - 1º DtoEdifício Monsanto 2790-012 Portela de Carnaxide Portugal domperidone Domperidona Germed
Latvian: Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto 2790-012 Portela de Carnaxide Portugal
Danish: Domperidone DOMPERIDONE MYLAN GENERICS
Latvian: DOMPERIDONE MYLAN GENERICS
Danish: EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou
Latvian: EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex
Danish: Grækenland PIERRE FABRE MEDICINES SA Messogeion 350, Agia Paraskevi
Latvian: PIERRE FABRE MEDICINES SA Messogeion 350, Agia Paraskevi 15341
Danish: Wise Pharmaceuticals Ltd.
Latvian: Bellwood Pharmaceuticals Ltd.
Danish: Storbritannien Medreich plc, Warwick House, Plane Tree Crescent, Feltham TW13 7HF United Kingdom domperidone maleate
Latvian: Warwick House, Plane Tree Crescent, Feltham TW13 7HF United Kingdom domperidone maleate
Danish: Faribérica, Productos Farmacêuticos, SA Estrada da Luz, 90-9° CDE 1600-160 Lissabon Portugal
Latvian: Faribérica, Productos Farmacêuticos, SA Estrada da Luz, 90-9°
Danish: Domperidone Domperidone instant EG
Latvian: Domperidone instant EG
Danish: Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4 HF North Harrow, Middlesex United Kingdom
Latvian: Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4 HF North Harrow, Middlesex
Danish: Domperidone DOMPERIDONE DOC GENERICI
Latvian: DOMPERIDONE DOC GENERICI
Danish: Belgium domperidone Motilium-10 supp.
Latvian: Motilium-10 supp.
Danish: 3460 Birkeroed Denmark domperidone Motilium
Latvian: 3460 Birkeroed Denmark
Danish: MEDOCHEMIE LTD 1-10 Constantinoupoleos Str, P.O.Box 51409, Lemesos Cyprus domperidone COSTI TABLETS 10MG
Latvian: MEDOCHEMIE LTD 1-10 Constantinoupoleos Str, P.O.Box 51409, Lemesos Cyprus
Danish: Maroussi 15125
Latvian: Epidarvou 4 & Aigialeias Maroussi 15125
Danish: Domperidone DOMPERIDONE ALTER
Latvian: DOMPERIDONE ALTER
Danish: Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal domperidone Domperidona Generis
Latvian: Rua João de Deus, 19 2700-487 Amadora Portugal
Danish: mg/100 ml sirup
Latvian: 100 mg/10 0 ml sīrups
Danish: Domperidone Motilium suspensie voor oraal gebruik 1 mg/ml
Latvian: Motilium suspensie voor oraal gebruik 1 mg/ml
Danish: 1 mg/ml suspension
Latvian: 1 mg/ml suspensija
Danish: Belgium domperidone Motilium Domperidone Base
Latvian: Motilium Domperidone Base
Danish: Domperidone Tabletten bij maagklachten en misselijkheid domperidon 10 mg, tabletten
Latvian: Tabletten bij maagklachten en misselijkheid domperidon 10 mg, tabletten
Danish: Accord Healthcare Limited Sage House, 319, Pinner Road HA1 4HF North Harrow, Middlesex United Kingdom
Latvian: Accord Healthcare Limited Sage House, 319, Pinner Road HA1 4HF North Harrow, Middlesex
Danish: B-2340, Beerse Belgium domperidone motilium 1mg/ml oral suspension
Latvian: B-2340, Beerse Belgium motilium 1mg/ml oral suspension
Danish: B-2340, Beerse Belgium domperidone motilium 10mg film coated tablets
Latvian: B-2340, Beerse Belgium motilium 10mg film coated tablets
Danish: Domperidone Motilium 30 mg supositorios niños
Latvian: Motilium 30 mg supositorios niños
Danish: 20 mg/ 19 mg tablet
Latvian: 20 mg/ 19 mg tablete
Danish: Apothekers
Latvian: Samenwerkende Apothekers
Danish: AUROBINDO PHARMA FRANCE 22-26 rue des Gaudines 78100 Saint-Germain-en-Laye France domperidone DOMPERIDONE AUROBINDO 10 mg, comprimé pelliculé
Latvian: AUROBINDO PHARMA FRANCE 22-26 rue des Gaudines 78100 Saint-Germain-en-Laye France
Danish: Luxembourg Johnson & Johnson Consumer N.V.
Latvian: Luksemburga Johnson & Johnson Consumer N.V.
Danish: Storbritannien Bristol Laboratories Limited Unit 3, Canalside
Latvian: Bristol Laboratories Limited Unit 3, Canalside Northbridge Road, Berkhamsted
Danish: 20 mg / 15 mg tablet
Latvian: 20 mg/ 15 mg tablete
Danish: REMEDICA LTD, Aharnon str. P.O.box 51706, Lemesos, Cyprus domperidone PEPTOMET FILM COATED TABLETS 10MG
Latvian: REMEDICA LTD, Aharnon str. P.O.box 51706, Lemesos, Cyprus
Danish: ACTAVIS FRANCE La Boursidière Centre d'Affaires 92357 Le Plessis Robinson France domperidone DOMPERIDONE ACTAVIS 10 mg, comprimé pelliculé
Latvian: ACTAVIS FRANCE La Boursidière Centre d'Affaires 92357 Le Plessis Robinson France
Danish: Domperidone DOMPERIDONE SANDOZ
Latvian: DOMPERIDONE SANDOZ
Danish: SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini
Latvian: SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini 75116 Paris France
Danish: Janssen-Cilag (TIBOTEC) Hammerbakken 19
Latvian: Janssen-Cilag (TIBOTEC)
Danish: Luxembourg Pierre Fabre Médicament 45 place Abel Gance
Latvian: Luksemburga Pierre Fabre Médicament 45 place Abel Gance
Danish: Domperidone DOMPERIDONE ALMUS
Latvian: DOMPERIDONE ALMUS
Danish: Storbritannien Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom domperidone maleate
Latvian: Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom domperidone maleate
Danish: B-2340, Beerse Belgium domperidone motilium 30 mg Suppositories
Latvian: B-2340, Beerse Belgium motilium 30 mg Suppositories
Danish: QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest France domperidone DOMPERIDONE QUALIMED 10 mg,
Latvian: QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest France
Danish: Domperidone Nauzelin 10 mg comprimidos recubiertos con película
Latvian: Nauzelin 10 mg comprimidos recubiertos con película
Danish: Domperidone DOMPERIDONE GERMED
Latvian: DOMPERIDONE GERMED
Danish: Domperidone Domerid Relief 10mg Tablets.
Latvian: Domerid Relief 10mg Tablets.
Danish: Rua Henrique Paiva Couceiro, 29Venda Nova
Latvian: Rua Henrique Paiva Couceiro, 29 - Venda Nova 2700-451 Amadora Portugal
Danish: Bellwood Pharmaceuticals Ltd. First Floor 69, St. Patricks Road Dalkey, Co. Dublin Ireland
Latvian: First Floor 69, St. Patricks Road
Danish: Domperidone Orosperidys 10 mg comprimidos bucodispersables
Latvian: Orosperidys 10 mg comprimidos bucodispersables
Danish: CRISTERS 22 quai Gallieni 92150 Suresnes France domperidone DOMPERIDONE CRISTERS 10 mg, comprimé orodispersible
Latvian: CRISTERS 22 quai Gallieni 92150 Suresnes France
Danish: Via Messina 38 20154 Milano Italy
Latvian: TEVA ITALIA S.R.L. Via Messina 38 20154 Milano Italy
Danish: Laboratório Medinfar - Produtos Farmacêuticos, S.A.
Latvian: Laboratório MedinfarProdutos Farmacêuticos, S.A.
Danish: France domperidone DOMPERIDONE ARROW 1 mg/ml, suspension buvable
Latvian: DOMPERIDONE ARROW 1 mg/ml, suspension buvable
Danish: Hamwells Business Park Unit No7, Hardicker Street
Latvian: Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No7, Hardicker Street M19 2RB Manchester United Kingdom
Danish: Domperidone Motilium zetpillen voor zuigelingen 10 mg
Latvian: Motilium zetpillen voor zuigelingen 10 mg
Danish: Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Latvian: Laboratórios AzevedosIndústria Farmacêutica, S.A.
Danish: 10 mg capsule, hard
Latvian: 10 mg cietā kapsula
Danish: Domperidone Motilium Tropfen 10 mg oral drabber, suspension
Latvian: Motilium Tropfen 10 mg pilieni iekšķīgai lietošanai, suspensija
Danish: Domperidone Domperidon 60 PCH voor volwassenen, zetpillen 60 mg
Latvian: Domperidon 60 PCH voor volwassenen, zetpillen 60 mg
Danish: Domperidone Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg
Latvian: Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg
Danish: Domperidone Motilium zetpillen voor volwassenen 60 mg
Latvian: Motilium zetpillen voor volwassenen 60 mg
Danish: Domperidone Domperidon 60 mg zetpillen
Latvian: Domperidon 60 mg zetpillen
Danish: domperidone DOMPERIDONE ALTER 10 mg, comprimé pelliculé
Latvian: DOMPERIDONE ALTER 10 mg, comprimé pelliculé
Danish: Domperidone Domperidon 30 PCH voor kinderen, zetpillen 30 mg
Latvian: Domperidon 30 PCH voor kinderen, zetpillen 30 mg
Danish: Šmarješka cesta 6 8501 Novo mesto Slovenia domperidone Tametil 10 mg filmsko obložene tablete
Latvian: Šmarješka cesta 6 8501 Novo mesto Slovenia
Danish: Wrexham Industrial Estate Wrexham LL13 9UF
Latvian: Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom domperidone maleate
Danish: Domperidone Domperidon 30 mg zetpillen
Latvian: Domperidon 30 mg zetpillen
Danish: Domperidone Domperidona Gamir 1 mg/ml suspensión oral
Latvian: Domperidona Gamir 1 mg/ml suspensión oral
Danish: Via Ippolito Rossellini 12 20124 Milano Italy
Latvian: PENSA PHARMA S.P.A. Via Ippolito Rossellini 12 20124 Milano Italy
Danish: H-2045 Törökbálint Hungary domperidone Motilium 10 mg filmtabletta
Latvian: H-2045 Törökbálint Hungary
Danish: Domperidone Motilium Fastmelts 10mg Tablets
Latvian: Motilium Fastmelts 10mg Tablets
Danish: Domperidone Motilium 10 mg comprimidos recubiertos con película
Latvian: Motilium 10 mg comprimidos recubiertos con película
Danish: Domperidone Motilium zetpillen voor kinderen 30 mg
Latvian: Motilium zetpillen voor kinderen 30 mg
Danish: Via Fernanda Wittgens 3 - 20123 Milano
Latvian: REDDY'S S.R.L. Via Fernanda Wittgens 320123 Milano Italy
Danish: Domperidone Domperidon JJC filmomhulde tabletten 10 mg
Latvian: Domperidon JJC filmomhulde tabletten 10 mg
Danish: 1MG/ML
Latvian: Motilium-1mg/ml
Danish: Domperidone COSTI
Latvian: Costi
Danish: 1-10 Constantinoupoleos St. P.O. Box: 51409
Latvian: 1-10 Constantinoupoleos St. P.O.
Danish: Domperidone Domperidon JJC zetpillen voor zuigelingen 10 mg
Latvian: Domperidon JJC zetpillen voor zuigelingen 10 mg
Danish: Domperidone Motilium 60mg Suppositories
Latvian: Motilium 60mg Suppositories
Danish: 5 mg oral suspension Oral anvendelse
Latvian: 5 mg suspensija iekšķīgai lietošanai
Danish: Domperidone Motilium 10 mg Suppositories
Latvian: Motilium 10 mg Suppositories
Danish: Domperidone Domperidon JJC zetpillen voor kinderen 30 mg
Latvian: Domperidon JJC zetpillen voor kinderen 30 mg
Danish: Domperidone Domperidon JJC zetpillen voor volwassenen 60 mg
Latvian: Domperidon JJC zetpillen voor volwassenen 60 mg
Danish: Storbritannien Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar,
Latvian: Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar, Hertfordshire EN6 1AG, United Kingdom domperidone maleate
Danish: Storbritannien Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire
Latvian: Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire WD18 9SS United Kingdom domperidone maleate
Danish: Domperidone EG-10 10 mg tablet
Latvian: Domperidone EG-10 10 mg tablete
Danish: 20 mg brusegranulat
Latvian: 20 mg putojošās granulas iekšķīgai lietošanai
Danish: LABORATORI ALTER S.R.L.
Latvian: LABORATORI ALTER S.R.L. Via Egadi 7
Danish: Den 1. september 2014 EMA/465179/2014
Latvian: 2014. gada 1. septembris EMA/465179/2014
Danish: Tlf. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Latvian: Tālr. +44 (0)20 7418 8427 E-pasts: press@ema.europa.eu
Danish: Kontakt vores pressesekretærer Monika Benstetter eller Martin Harvey
Latvian: Mūsu preses sekretāru kontaktinformācija Monika Benštetere (Monika Benstetter) vai Martins Hārvejs (Martin Harvey)
Danish: • Domperidon bør anvendes i den laveste effektive dosis i kortest mulig tid.
Latvian: • Domperidons jālieto mazākajā efektīvajā devā iespējami īsāko laiku.
Danish: Samlet viser gennemgangene af sikkerheden, at omkring 40 % af sådanne indberetninger omfatter patienter over 60 år.
Latvian: Kopumā drošuma pārskati liecina, ka aptuveni 40 % šādu ziņojumu ir par 60 gadiem vecākiem pacientiem.
Danish: Nogle produkter skal trækkes tilbage fra markedet, fordi deres styrke ikke svarer til de nye doser.
Latvian: Dažus preparātus atsauks no tirgus, jo to stiprums neatbilst jaunajām devām.
Danish: • Patienter eller omsorgsgivere, der har spørgsmål, bør henvende sig til en sundhedsperson.
Latvian: • Pacientiem vai aprūpētājiem, kuriem ir kādas bažas, jākonsultējas ar veselības aprūpes speciālistu.
Danish: • Data til dokumentation af andre indikationer var yderst begrænsede.
Latvian: • Citas indikācijas atbalstošo datu bija ļoti maz.
Danish: Disse oplysninger blev først gennemgået af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC).
Latvian: Šo datu pārskatīšanu vispirms veica Farmakovigilances riska vērtēšanas komiteja (PRAC).
Danish: Gennemgangen af lægemidler indeholdende domperidon blev indledt den 1. marts 2013 på anmodning af den belgiske lægemiddelstyrelse, Agence Fédérale des Médicaments et des Produits de Santé (FAGG-AFMPS), i henhold til artikel 31 i direktiv 2001/83/EF.
Latvian: Domperidona lietas pārskatīšanu sāka 2013. gada 1. martā pēc Beļģijas Zāļu aģentūras, Federālās zāļu un veselības produktu aģentūras (FAGG-AFMPS), lūguma saskaņā ar Direktīvas 2001/83/EK 31. pantu.
Danish: Disse anbefalinger er baseret på nøje vurdering af data fra forskellige kilder vedrørende sikkerheden og virkningen af domperidon.
Latvian: Šie ieteikumi ir balstīti uz rūpīgi izvērtētiem, no dažādiem avotiem iegūtiem datiem par domperidona drošumu un iedarbīgumu.
Danish: Produktinformationen for produkter indeholdende domperidon er blevet ajourført, og der udsendt et brev til sundhedspersoner med redegørelse for de nye anbefalinger.
Latvian: Domperidonu saturošo zāļu informācija ir atjaunināta un ir nosūtīta vēstule veselības aprūpes speciālistiem, kurā skaidroti jaunie ieteikumi.
Danish: Dette er på linje med data fra undersøgelser af lægemiddelinteraktioner og fra spontane indberetninger.
Latvian: Tas atbilst zāļu savstarpējas mijiedarbības pētījumos iegūtajiem un spontānajos ziņojumos iekļautajiem datiem.
Danish: Selv om gennemgangen ikke omfattede andre anvendelser end de godkendte indikationer, bør principperne i anbefalingerne altid følges, når domperidon anvendes.
Latvian: Lai gan pārskatīšanas mērķis neietvēra lietošanu nereģistrētām indikācijām, šajos ieteikumos ietvertie principi ir jāņem vērā vienmēr, kad lieto domperidonu.
Danish: De leveres som tabletter, oral suspension og suppositorier under forskellige handelsnavne (såsom Motilium).
Latvian: Tās ir pieejamas kā tabletes, suspensija iekšķīgai lietošanai un supozitoriji ar dažādiem tirdzniecības nosaukumiem (piemēram, Motilium).
Danish: Der har været betænkeligheder ved, at det kan øge risikoen for bivirkninger på hjertet, herunder farlig uregelmæssig hjerterytme hos nogle patienter.
Latvian: Bija izteiktas bažas, ka tas varētu palielināt ari sirdi saistīto blakusparādību risku, tostarp izraisīt bīstami neregulāru sirdsdarbību dažiem pacientiem.
Danish: Injektionspræparatet af domperidon blev trukket tilbage i 1985 som følge af sådanne bivirkninger.
Latvian: Domperidona injicējamo zāļu formu atsauca 1985. gadā šādu blakusparādību dēļ.
Danish: Gennemgangen af domperidon blev foretaget på anmodning af den belgiske lægemiddelstyrelse på grund af betænkeligheder vedrørende lægemidlets virkninger på hjertet.
Latvian: Domperidona lietas pārskatīšanu veica pēc Beļģijas Zāļu aģentūras lūguma, lai kliedētu bažas par zāļu ietekmi uz sirdi.
Danish: Lægemidler indeholdende domperidon har været godkendt i de fleste EU-medlemsstater via nationale procedurer siden 1970'erne og er bredt tilgængelige i håndkøb eller på recept.
Latvian: Domperidonu saturošas zāles ir reģistrētas lielākajā daļā Eiropas Savienības dalībvalstu nacionālo procedūru veidā kopš 1970. gadiem un ir plaši pieejamas kā bezrecepšu vai recepšu zāles.
Danish: Den 23. april 2014 vedtog koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - human (CMDh) anbefalinger om begrænsning af anvendelsen af lægemidler indeholdende domperidon.
Latvian: 2014. gada 23. aprīlī Cilvēkiem paredzēto zāļu savstarpējās atzīšanas un decentralizēto procedūru koordinācijas grupa (CMDh) apstiprināja ieteikumus ierobežot domperidonu saturošo zāļu lietošanu.
Danish: Anbefalingerne fra PRAC blev fremsendt til koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - human (CMDh), som vedtog et endeligt standpunkt.
Latvian: PRAC ieteikumus nosūtīja Cilvēkiem paredzēto zāļu savstarpējās atzīšanas un decentralizēto procedūru koordinācijas grupai (CMDh), kas pieņēma galīgo lēmumu.
Danish: Der blev imidlertid fortsat indberettet tilfælde med hjerteproblemer hos patienter, der anvendte lægemidlet, og PRAC blev derfor anmodet om at undersøge, om fordelene stadig opvejede risiciene for disse lægemidler med de godkendte anvendelser og former, og om markedsføringstilladelserne for dem burde opretholdes eller ændres i EU.
Latvian: Tomēr aizvien tika ziņots par sirdsdarbības traucējumu gadījumiem pacientiem, kuri lieto šīs zāles, un tādēļ PRAC tika izteikts lūgums izvērtēt, vai šo zāļu ieguvumi aizvien attaisno risku apstiprināto indikāciju un zāļu formu gadījumā un vai reģistrācijas apliecības visā Eiropas Savienībā vajadzētu saglabāt vai mainīt.
Danish: CMDh repræsenterer EU's medlemsstater og har ansvaret for harmonisering af sikkerhedsnormerne i EU for lægemidler, der godkendes ved nationale procedurer.
Latvian: CMDh, institūcija, kas pārstāv Eiropas Savienības dalībvalstis, ir atbildīga par saskaņotu drošuma standartu nodrošināšanu visā Eiropas Savienībā nacionālo procedūru veidā reģistrētām zālēm.
Danish: Der var kun begrænsede data til støtte for pædiatrisk anvendelse ved denne indikation, og skønt virkningsmekanismen ikke forventes at afvige mellem voksne og børn, er der anmodet om undersøgelser for at tilvejebringe yderligere data til støtte for virkningen hos den pædiatriske population.
Latvian: Lai atbalstītu lietošanu bērniem šīs indikācijas gadījumā, datu bija pārāk maz, un, lai gan nav paredzams, ka darbības mehānisms pieaugušajiem un bērniem varētu atšķirties, pieprasīja papildu datus, kas apliecinātu iedarbīgumu pediatriskā populācijā.
Danish: Fordelene ved disse indikationer blev derfor ikke anset for at opveje risikoen.
Latvian: Tādēļ uzskatīja, ka ieguvumi šo indikāciju gadījumā neattaisno risku.
Danish: Desuden må det ikke bruges sammen med andre lægemidler, der har tilsvarende virkninger på hjertet, eller som begrænser nedbrydningen af domperidon i kroppen (og dermed øger risikoen for bivirkninger).
Latvian: Turklāt šīs zāles nedrīkst lietot kopā ar citām zālēm, kurām ir līdzīga ietekme uz sirdi vai kuras mazina domperidona sadalīšanos organismā (tādējādi palielinot blakusparādību risku).
Danish: Eftersom CMDh vedtog dette standpunkt ved en flertalsafgørelse, blev det overgivet til EuropaKommissionen, som godkendte det og den 1. september 2014 vedtog en retligt bindende beslutning, der er gyldig i hele EU.
Latvian: Tā kā CMDh lēmumu apstiprināja ar balsu vairākumu, to nosūtīja Eiropas Komisijai, kas 2014.gada 1.Septembrī to apstiprināja un pieņēma galīgo, visā Eiropas Savienībā likumīgi saistošu lēmumu.
Danish: Navnlig var der kun ringe evidens for den langsigtede virkning af domperidon ved dyspepsi og gastroøsofageal reflukssygdom.
Latvian: Īpaši maz bija pierādījumu, kas apliecinātu domperidona ilgtermiņa iedarbīgumu dispepsijas un gastroezofageālā atviļņa slimības gadījumā.
Danish: • Selv om resultaterne af den gennemgribende QT-undersøgelse viser, at domperidon ikke forlænger QTc-intervallet væsentligt, når det gives til raske voksne i doser på 10 og 20 mg fire gange dagligt, indskrænker undersøgelsens begrænsninger de konklusioner, der kan drages af den
Latvian: • Lai gan visaptveroša, ar domperidonu veikta QT pētījuma rezultāti liecina, ka tas būtiski nepagarina QTc intervālu, lietojot veselām pētāmām personām pa 10 mg un 20 mg četras reizes dienā, pētījumam ir ierobežojumi, kas ierobežo secinājumu izdarīšanu.
Danish: Af 57 indberettede kardiovaskulære dødsfald fandtes der at foreligge andre risikofaktorer i 27 tilfælde, mens der i 13 tilfælde enten ikke var sandsynlig sammenhæng med administration af domperidon eller forelå anden ætiologi.
Latvian: No 57 ziņotiem kardiovaskulāras nāves gadījumiem 27 gadījumos bija citi riska faktori, bet 13 gadījumos bija vai nu maz ticama saistība ar domperidona lietošanu vai alternatīva etioloģija.
Danish: Disse bestod af ikke-kliniske og kliniske data, både publicerede og upublicerede, herunder en gennemgribende QT-undersøgelse, en kumulativ gennemgang af caserapporter om hjertesygdom og karundersøgelser fra sikkerhedsdatabaser for produkter indeholdende domperidon, farmakoepidemiologiske undersøgelser og publicerede og upublicerede undersøgelser af virkningen.
Latvian: Šie dati ietvēra neklīniskus un klīniskus gan publicētus, gan nepublicētus datus, to vidū visaptverošu QT pētījumu, sirdsdarbības traucējumu gadījumu ziņojumu kumulatīvu pārskatu un vaskulārus pētījumus no dažādām domperidona preparātu drošuma datu bāzēm, farmakoepidemioloģiskus pētījumus un publicētus un nepublicētus iedarbīguma pētījumus.
Danish: Den foreliggende evidens for virkningen var ikke tilstrækkelig til anvendelse til andre indikationer.
Latvian: Pieejamie pierādījumi par iedarbīgumu nebija pietiekami, lai atbalstītu šo zāļu lietošanu citām indikācijām.
Danish: Eftersom CMDh vedtog dette standpunkt ved en flertalsafgørelse, blev det overgivet til EuropaKommissionen, som godkendte det og vedtog en retligt bindende beslutning, der er gyldig i hele EU.
Latvian: Tā kā CMDh lēmumu apstiprināja ar balsu vairākumu, to nosūtīja Eiropas Komisijai, kas to apstiprināja un pieņēma galīgo, visā Eiropas Savienībā likumīgi saistošu lēmumu.