FrancophonIA/ELRC3.0 huggingface dataset:
French: Des données épidémiologiques et les résultats d'essais cliniques concernant les risques cardiovasculaires des AINS, notamment du diclofénac, ont été passés en revue antérieurement par le comité des médicaments à usage humain (CHMP).
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) prethodno je pregledalo podatke epidemiološkog i kliničkog istraživanja o kardiovaskularnim rizicima NSAR lijekova, uključujući i diklofenak.
French: • le PRAC a conclu qu'au vu des données de sécurité actuellement disponibles, pour maintenir un rapport bénéfice/risque favorable, les médicaments contenant du diclofénac doivent être contreindiqués chez les patients souffrant d'insuffisance cardiaque congestive établie (NYHA II-IV), de cardiopathie ischémique, de maladie artérielle périphérique et/ou de maladie cérébrovasculaire.
Croatian: • PRAC je zaključio da lijekovi koji sadrže diklofenak moraju biti kontraindicirani za uporabu u bolesnika s utvrđenom zastojnom srčanom insufijencijom (NYHA II-IV), ishemijskom srčanom bolešću, perifernom arterijskom bolešću i/ili cerebrovaskularnom bolešću kako bi zadržali povoljnu ravnotežu koristi i rizika s obzirom na trenutno dostupne sigurnosne podatke.
French: Str. Aleea Eroilor nr. 28 Vişeu de Sus
Croatian: Aleea Eroilor nr. 28 Vişeu de Sus
French: Diclofénac potassique CATAFLAM ORAL DROPS 1.5%
Croatian: CATAFLAM ORAL DROPS 1.5%
French: VOLTARENE ENFANT, suppositoire
Croatian: VOLTARENE ENFANT, suppositoire čepić rektalno
French: Rua Prof. Sousa da Câmara,
Croatian: Sousa da Câmara,
French: Luxembourg Socobom S.A Avenue Louise 149 b24
Croatian: Luksemburg Socobom S.A Avenue Louise 149 b24
French: Autriche ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse 3 1140 Vienna
Croatian: Austrija ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse 3 1140 Vienna
French: Capsule
Croatian: kapsula
French: Orifarm Generics A/S PO 69, Energivej 15 DK-5260 Odense S Denmark
Croatian: Orifarm Generics A/S PO 69, Energivej 15 DK-5260 Odense
French: 2909 LD Capelle aan den IJssel The Netherlands
Croatian: 2909 LD Capelle aan den IJssel The Netherlands diklofenaknatrij mizoprostol
French: Finlande ratiopharm Oy P.O.Box 67
Croatian: Finska ratiopharm Oy P.O.Box 67
French: Pfizer AS Lilleakerveien 2B 1324 Lysaker Norway
Croatian: Pfizer AS Lilleakerveien 2B 1324 Lysaker Norway diklofenaknatrij mizoprostol
French: Luxembourg Hexal AG Industriestraße 25
Croatian: Luksemburg Hexal AG Industriestraße 25
French: Luxembourg Daiichi Sankyo Belgium SA Rue Fond Jean Pâques 5
Croatian: Luksemburg Daiichi Sankyo Belgium SA Rue Fond Jean Pâques 5
French: 97-107 Uxbridge Road London W5 5TL United Kingdom
Croatian: 97-107 Uxbridge Road London W5 5TL United Kingdom diklofenakkalij
French: N. Psychiko, 15451 Greece
Croatian: Psychiko, 15451 Greece
French: Scandinavian Regulatory Services, AB Svardvagen 3B Stockholm SE-182 33 Sweden
Croatian: Scandinavian Regulatory Services, AB Svardvagen 3B Stockholm SE-182 33 Sweden diklofenakkalij
French: Luxembourg Continental Pharma Rijksweg, 12
Croatian: Luksemburg Continental Pharma Rijksweg, 12
French: Pinewood Laboratories Ltd (T/A Pinewood Heathcare) Ballymacarbry Clonmel, Co. Tipperary Ireland
Croatian: Pinewood Laboratories Ltd (T/A Pinewood Heathcare) Ballymacarbry Clonmel, Co.
French: pot k sejmišču 35 1231 Ljubljana Črnuče Slovenia
Croatian: Pliva Ljubljana d.o.o. pot k sejmišču 35 1231 Ljubljana Črnuče Slovenia
French: Cheadle Royal Business Park Highfield, Cheadle Cheshire SK8 3GY United Kingdom
Croatian: Cheadle Royal Business Park Highfield, Cheadle Cheshire SK8 3GY
French: A/S "Olainfarm" Rupnicu iela 5 Olaine, LV - 2114 Latvia
Croatian: A/S "Olainfarm" Rupnicu iela 5 Olaine, LV - 2114 Latvia diklofenakkalij
French: Non applicable pour l'injection intraveineuse en bolus
Croatian: Nije primjenjivo za bolusnu injekciju u venu
French: Allemagne sigapharm GmbH Temmlerstr.
Croatian: Njemačka sigapharm GmbH Temmlerstr.
French: Allemagne hameln pharma plus gmbh Langes Feld 13
Croatian: Njemačka hameln pharma plus gmbh Langes Feld 13
French: Diclo-B „Lannacher"Kapseln
Croatian: Diclo-B „Lannacher"Kapseln kapsula, tvrda
French: Pfizer Enterprises SARL Round-Point du Kirchberg 51, Avenue J.F.Kennedy L-1855 Luxembourg Luxembourg
Croatian: Pfizer Enterprises SARL Round-Point du Kirchberg 51, Avenue J.F.Kennedy L-1855 Luxembourg Luxembourg diklofenak mizoprostol
French: Focus Pharmaceuticals Limited Unit 5, Faraday court First Avenue,Centrum 100 Burton upon trent Staffordshire, DE14 2WX United Kingdom
Croatian: Focus Pharmaceuticals Limited Unit 5, Faraday court First Avenue,Centrum 100 Burton upon trent Staffordshire, DE14 2WX United Kingdom diklofenakkalij
French: de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spain
Croatian: Avda. de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spain diklofenaknatrij mizoprostol
French: Annexe I Liste reprenant les noms, les formes pharmaceutiques, les dosages des médicaments, les voies d'administration, les titulaires de l'autorisation de mise sur le marché dans les états membres
Croatian: Dodatak I Popis imena, farmaceutskih oblika, jačina lijekova, puteva primjene,
French: Diclofénac potassique VOLTATABS 12,5 MG(EX:ZYMAMED)
Croatian: VOLTATABS 12,5 MG(EX:ZYMAMED)
French: Archimedesweg 2 2333 CN Leiden The Netherlands
Croatian: Archimedesweg 2 2333 CN Leiden The Netherlands diklofenakkalij
French: 182 12 Danderyd Sweden
Croatian: 182 12 Danderyd Sweden diklofenakkalij
French: Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium
Croatian: N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium
French: Novartis Finland OY Metsänneidonkuja 10 FIN-02130 Espoo Finland
Croatian: Metsänneidonkuja 10 FIN-02130 Espoo Finland
French: SC ANTIBIOTICE SA Str. Valea Lupului nr. 1 6600-Iaşi
Croatian: Valea Lupului nr. 1 6600-Iaşi
French: Vetenskapsvägen 10 191 90 Sollentuna Sweden
Croatian: Vetenskapsvägen 10 191 90 Sollentuna Sweden diklofenaknatrij mizoprostol
French: Actavis A/S Ornegardsvej 16 2820 Gentofte Denmark
Croatian: Actavis A/S Ornegardsvej 16 2820 Gentofte Denmark diklofenakkalij
French: BIOTECH Pharmaceutical Ltd Larissis 10
Croatian: D.A.S.T. BIOTECH Pharmaceutical Ltd Larissis 10
French: Park View, Riverside Way Watchmoor Park, Camberley Surrey GU15 3YL United Kingdom
Croatian: Park View, Riverside Way Watchmoor Park, Camberley Surrey GU15 3YL United Kingdom diklofenakkalij
French: Diclofénac potassique VOLTAREN ACTIGO EXTRA
Croatian: VOLTAREN ACTIGO EXTRA
French: Actavis EAD 29 Atanas Dukov Str. Sofia 1407
Croatian: Actavis EAD 29 Atanas Dukov Str.
French: 110 B 20097 Hamburg Germany
Croatian: Spaldingstr. 110 B 20097 Hamburg Germany
French: Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal
Croatian: Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal diklofenak mizoprostol
French: Morningside Healthcare Limited 115 Narborough Road Leicester, LE3 0PA United Kingdom
Croatian: Morningside Healthcare Limited 115 Narborough Road Leicester, LE3 0PA United Kingdom diklofenaknatrij mizoprostol
French: Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark
Croatian: Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark diklofenaknatrij mizoprostol
French: Chile, 8-2ª planta.
Croatian: GERMED FARMACEUTICA, S.L. Chile, 8-2ª planta.
French: Granulés pour suspension buvable
Croatian: granule za oralnu suspenziju
French: Largo Donegani 4/a Novara - 28100 Italy
Croatian: Proge Farm S.r.l. Largo Donegani 4/a Novara - 28100 Italy
French: Diclofénac potassique Doble action pain relief
Croatian: Doble action pain relief
French: Via Cassia Nord 351 Darvia - 53014 Siena Italy
Croatian: Industria Farmaceutica Galenica Senese S.r.l. Via Cassia Nord 351 Darvia - 53014 Siena Italy
French: Antigen Diclofenac Sodium Injection 2.5% w/v
Croatian: Antigen Diclofenac Sodium Injection 2.5% w/v otopina za injekciju u mišić
French: G. KORONIS Dilou 9, Peristeri Attikis, 12134
Croatian: PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS Dilou 9, Peristeri Attikis, 12134
French: TRATUL 120 mg 120mg
Croatian: TRATUL 120 mg 120 mg čepić rektalno
French: Via Sette Santi 3, Firenze 50131- Italy
Croatian: Menarini Industrie Farmaceutiche Riunite S.r.l. Via Sette Santi 3, Firenze 50131- Italy
French: Luxembourg Mylan bvba Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium
Croatian: Luksemburg Mylan bvba Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium
French: Capsule à libération contrôlée
Croatian: kapsula s kontroliranim oslobađanjem
French: Luxembourg Novartis Consumer Health S.A. Medialaan, 40
Croatian: Luksemburg Novartis Consumer Health S.A. Medialaan, 40
French: FLECTOR RAPID 50 mg granulátum
Croatian: FLECTOR RAPID 50 mg granulátum granule
French: Kent CT13 9NJ United Kingdom
Croatian: Kent CT13 9NJ United Kingdom diklofenaknatrij mizoprostol
French: Leskoškova cesta 9D 1000 Ljubljana Slovenia
Croatian: Medias International d.o.o. Leskoškova cesta 9D 1000 Ljubljana Slovenia
French: NOVARTIS SANTE FAMILIALE 14, boulevard Richelieu 92500 Rueil-Malmaison France
Croatian: NOVARTIS SANTE FAMILIALE 14, boulevard Richelieu 92500 Rueil-Malmaison France diklofenakkalij
French: Rowex Ltd Bantry, Co. Cork Ireland
Croatian: Rowex Ltd Bantry, Co.
French: S.C. AC HELCOR PHARMA SRL Str. Victor Babeş nr. 50 Baia-Mare
Croatian: S.C. AC HELCOR PHARMA SRL Str.
French: Flector EP Rapid 50 mg
Croatian: Flector EP Rapid 50 mg granule
French: Via Ragazzi del 99 5, Bologna - 40133 Italy
Croatian: Alpha Biotech S.r.l. Via Ragazzi del 99 5, Bologna - 40133 Italy
French: TABLETY
Croatian: tableta
French: Pfizer Hellas A.E. Messoghion Ave. 243 Neo Psychiko 15451 Greece
Croatian: Messoghion Ave. 243 Neo Psychiko 15451 Greece diklofenaknatrij mizoprostol
French: Sopharma Pharmaceuticals 5 Lachezar Stanchev Str. Sofia 1220
Croatian: Sopharma Pharmaceuticals 5 Lachezar Stanchev Str.
French: Via Enrico Fermi 1 Alanno (PE) 65020 Italy
Croatian: Alfa Wassermann S.p.A. Via Enrico Fermi 1 Alanno (PE) 65020 Italy
French: Voltaren 50 mgZäpfchen für Erwachsene
Croatian: Voltaren 50 mgZäpfchen für Erwachsene čepić rektalno
French: PANNONPHARMA Gyógyszergyártó Kft. PannonPharma út 1.
Croatian: PannonPharma út 1.
French: Diclofénac potassique VOLTARENDOLO 12,5 mg, comprimé enrobé
Croatian: VOLTARENDOLO 12,5 mg, comprimé enrobé
French: 89340 Leipheim Germany
Croatian: 89340 Leipheim Germany diklofenakkalij
French: Laboratoires Genevrier 280, rue de Goa Les Trois Moulins - Parc de Sophia Antipolis 06600 Antibes France
Croatian: Laboratoires Genevrier 280, rue de Goa Les Trois Moulins - Parc de Sophia Antipolis 06600 Antibes France diklofenakepolamin FLECTOR 50 mg, granulés pour solution buvable en sachet-dose granule za oralnu otopinu
French: Diclofénac potassique Voltarol Pain-Eze Tablets
Croatian: Voltarol Pain-Eze Tablets
French: Medialaan, 40, box 1 1800 Vilvoorde Belgium
Croatian: NOVARTIS PHARMA N.V. Medialaan, 40, box 1 1800 Vilvoorde Belgium
French: Luxembourg Novartis Pharma GmbH Roonstrasse 25
Croatian: Luksemburg Novartis Pharma GmbH Roonstrasse 25
French: Astellas Pharma Co. Ltd 5 Waterside
Croatian: Ltd 5 Waterside
French: Via Isonzo 71 Latina 04100 Italy
Croatian: Pfizer Italia S.r.l. Via Isonzo 71 Latina 04100 Italy diklofenaknatrij mizoprostol
French: Pharmacia GmbH Linkstrasse 10 10785 Berlin Germany
Croatian: Pharmacia GmbH Linkstrasse 10 10785 Berlin Germany diklofenaknatrij mizoprostol
French: Pfizer Europe MA EEIG Ramsgate Road Kent, Sandwich CT13 9NJ United Kingdom
Croatian: Pfizer Europe MA EEIG Ramsgate Road Kent, Sandwich CT13 9NJ United Kingdom diklofenak mizoprostol
French: Sweden
Croatian: Švedska
French: de Burgos, 16 D 5ª planta
Croatian: RATIOPHARM ESPAÑA, S.A. Avda. de Burgos, 16 D 5ª planta
French: Diclorapid 75 mg gastro-resistant capsules, hard
Croatian: Diclorapid 75 mg gastro-resistant capsules, hard želučanootporna kapsula, tvrda
French: Mercury Pharma Group Limited No. 1 Croydon
Croatian: Mercury Pharma Group Limited No.
French: 12th Km National Highway No 1, Metamorfosi Attikis 144 51 Greece
Croatian: NOVARTIS (HELLAS) A.E.B.E. 12th Km National Highway No 1, Metamorfosi Attikis 144 51 Greece
French: Teva UK Limited Brampton Road Hampden Park Eastbourne E Sussex BN22 9AG United Kingdom
Croatian: Teva UK Limited Brampton Road Hampden Park Eastbourne
French: DICLOFENAC DUO PHARMAVIT 75 mg kemény kapszula
Croatian: DICLOFENAC DUO PHARMAVIT 75 mg kemény kapszula kapsula, tvrda
French: Capsule rectale Voie rectale
Croatian: kapsula za rektum rektalno
French: DICLOFENAC "S.Med" retard 75 mg - Tabletten
Croatian: DICLOFENAC "S.Med" retard 75 mg - Tabletten tableta
French: Viale Certosa, 130 Milano - 20156 Italy
Croatian: Viale Certosa, 130 Milano - 20156 Italy diklofenak hidroksietilpirolidin
French: FI-02200 Espoo Finland
Croatian: FI-02200 Espoo Finland diklofenakkalij
French: Diclofenac akut 1A Pharma 50 mglösbare Tabletten
Croatian: Diclofenac akut 1A Pharma 50 mglösbare Tabletten tableta za oralnu otopinu
French: 1 G. M. Dimitrov Blvd. Sofia 1172
Croatian: 1 G. M. Dimitrov Blvd.
French: Difene 25mg Capsules
Croatian: Difene 25mg Capsules kapsula
French: Modified-Release tablets
Croatian: Modified-Release tablets tableta s prilagođenim oslobađanjem
French: Difene 50mg Capsules
Croatian: Difene 50mg Capsules kapsula
French: CATAFLAM-V 50 mg tabletta
Croatian: CATAFLAM-V 50 mg tabletta tableta
French: Herbacos Recordati s.r.o.
Croatian: Herbacos Recordati s.r.o. Štrossova 239
French: Arthrotec 75 modified-release tablets
Croatian: Arthrotec 75 modified-release tablets tableta s prilagođenim oslobađanjem
French: Novartis Hellas S.A.C.I.
Croatian: Novartis Hellas S.A.C.I. 12th km
French: Diclofénac potassique Diclo AL akut 12,5 mg
Croatian: Diclo AL akut 12,5 mg
French: NeurofenacKapseln
Croatian: NeurofenacKapseln kapsula, tvrda
French: Diclofénac potassique Diclo-CT akut 12,5 mg Filmtabletten
Croatian: Diclo-CT akut 12,5 mg Filmtabletten
French: Diclofénac potassique Voltaren Dolo Liquid 12,5 mg
Croatian: Voltaren Dolo Liquid 12,5 mg
French: Olfen-100 Rectocaps 100mg
Croatian: Olfen-100 Rectocaps 100 mg čepić rektalno
French: Deflamat DRS 75 mg - Kapseln
Croatian: Deflamat DRS 75 mg - Kapseln kapsula, tvrda
French: Diclofenac- 1 A Pharma 50 mg Zäpfchen
Croatian: Diclofenac- 1 A Pharma 50 mg Zäpfchen čepić rektalno
French: Rewodina dual 75 Kaps
Croatian: Rewodina dual 75 Kaps kapsula
French: Diclofénac potassique DICLOFENAC-KTEVA 50 MG COMPR
Croatian: DICLOFENAC-KTEVA 50 MG COMPR
French: Diclofénac potassique Diclofenac potassium 12.5mg Tablets
Croatian: Diclofenac potassium 12.5mg Tablets
French: DiclacHexal rapid 50 mg - lösbare Tabletten
Croatian: DiclacHexal rapid 50 mg - lösbare Tabletten tableta za oralnu otopinu
French: KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany
Croatian: 1 53757 Sankt Augustin Germany
French: Naklofen duo 75 mg trde kapsule
Croatian: Naklofen duo 75 mg trde kapsule kapsula, tvrda
French: Rewodina uno 100 100mg
Croatian: Rewodina uno 100 100 mg kapsula
French: Voltarol Retard 75 mg Film-coated Prolonged-release Tablets
Croatian: Voltarol Retard 75 mg Film-coated Prolonged-release Tablets filmom obložena tableta s produljenim oslobađanjem
French: VOLTARENE LP 75 mg, comprimé enrobé à libération prolongée
Croatian: VOLTARENE LP 75 mg, comprimé enrobé à libération prolongée obložena tableta s produljenim oslobađanjem
French: DICLOFENACO RATIOPHARM 50 mg comprimidos
Croatian: DICLOFENACO RATIOPHARM 50 mg comprimidos obložena tableta
French: Diclofenacratiopharm 75 mg SL Retardkapseln
Croatian: Diclofenacratiopharm 75 mg SL Retardkapseln kapsula s produljenim oslobađanjem
French: Sandoz Ltd Diclovol SR Modified Release Tablet 75 mg
Croatian: Sandoz Ltd Diclovol SR Modified Release Tablet 75 mg tableta s prilagođenim oslobađanjem
French: Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No. 7, Hardicker Street M19 2RB Manchester United Kingdom
Croatian: 7, Hardicker Street M19 2RB Manchester United Kingdom
French: Difene 75 mg Dual Release Capsules
Croatian: Difene 75 mg Dual Release Capsules kapsula s dvostrukim oslobađanjem
French: PHARMASWISS HELLAS A.E. Pentelis Avenue 53
Croatian: Pentelis Avenue 53
French: TRATUL 60 mg
Croatian: TRATUL 60 mg čepić rektalno
French: Capsule à libération modifiée
Croatian: kapsula s prilagođenim oslobađanjem
French: Diclac 75 mg Prolonged -Release Tablets
Croatian: Diclac 75 mg Prolonged -Release Tablets tableta s produljenim oslobađanjem
French: Diclofénac potassique Voltfast Sachets 50 mg Powder for Oral
Croatian: Voltfast Sachets 50 mg Powder for Oral Solution prašak za oralnu otopinu
French: 12,5mg Capsule molle
Croatian: 12,5 mg kapsula, meka
French: 02631 Espoo Finland
Croatian: 02631 Espoo Finland diklofenakkalij
French: Olfen Depotabs 75 mg prolonged release tablets
Croatian: OLFEN DEPOCAPS 75 mg tableta s produljenim oslobađanjem
French: Comprimé pelliculé à libération prolongée
Croatian: filmom obložena tableta s produljenim oslobađanjem
French: PharmaSwiss d.o.o.
Croatian: PharmaSwiss d.o.o. Wolfova 1
French: Diclac 25 mg/ml Solution for Injection 3 ml Ampoule
Croatian: Diclac 25 mg/ml Solution for Injection 3 ml Ampoule otopina za injekciju u mišić
French: Flamatak MR Tablets 75mg
Croatian: Flamatak MR Tablets 75mg tableta s prilagođenim oslobađanjem
French: Econac SR Prolonged Release Tablet 75mg
Croatian: Econac SR Prolonged Release Tablet 75mg tableta s produljenim oslobađanjem
French: VOLTAREN 50 mg végbélkúp
Croatian: VOLTAREN 50 mg végbélkúp čepić rektalno
French: Diclofénac potassique Voltarol Pain-Eze Extra Strength
Croatian: Voltarol Pain-Eze Extra Strength Tablets obložena tableta
French: Naklofen 50 mg svečke
Croatian: Naklofen 50 mg svečke čepić rektalno
French: Teva Pharma Belgium N.V.
Croatian: Teva Pharma Belgium N.V. Laarstraat 16
French: Arthrotec 50 modified release tablets
Croatian: Arthrotec 50 modified release tablets tableta s prilagođenim oslobađanjem
French: HongrieHongrie Novartis Hungária Kft. Pharma részlege
Croatian: Novartis Hungária Kft.
French: Il est actuellement disponible dans l'Union européenne (UE) dans plusieurs formulations différentes.
Croatian: Trenutno je dostupan u Europskoj uniji (EU) u nizu različitih formulacija.
French: Pour contacter nos attachés de presse Monika Benstetter ou Martin Harvey
Croatian: Kontaktirajte naše djelatnike za tisak Monika Benstetter ili Martin Harvey
French: • Si vous avez des questions, parlez-en à votre médecin ou pharmacien.
Croatian: • Ako imate bilo kakvih pitanja, razgovarajte sa svojim liječnikom ili ljekarnikom.
French: 25 septembre 2013 EMA/592685/2013
Croatian: 25. rujna 2013. EMA/592685/2013
French: Coxib et traditional NSAIDs Trialists Collaboration.
Croatian: Coxib and traditional NSAIDs Trialists Collaboration.
French: Tél. +44 (0)20 7418 8427 e-mail: press@ema.europa.eu
Croatian: +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
French: De nouvelles mesures visent à minimiser les risques cardiovasculaires
Croatian: Nove mjere za smanjivanje kardiovaskularnih rizika
French: Plus d'informations relatives à la procédure
Croatian: Više o postupku
French: Un examen de ces données a d'abord été réalisé par le comité pour l'évaluation des risques en matière de pharmacovigilance (PRAC).
Croatian: Pregled ovih podataka prvo je provelo Povjerenstvo za procjenu rizika na području farmakovigilancije (PRAC-a).
French: Vascular et upper gastrointestinal effects of nonsteroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials.
Croatian: Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials.
French: L'examen du diclofénac systémique a débuté le 31 octobre 2012, à la demande de l'agence des médicaments du Royaume-Uni, au titre de l'article 31 de la directive 2001/83/CE.
Croatian: Pregled sistemskog diklofenaka pokrenut je dana 31. listopada 2012. na zahtjev agencije za lijekove Ujedinjene Kraljevine, sukladno članku 31. Direktive 2001/83/EC.
French: • L'efficacité du diclofénac est bien établie.
Croatian: • Djelotvornost diklofenaka dobro je utvrđena.
French: Nouveaux conseils pour la sécurité du diclofénac
Croatian: Novi sigurnosni savjeti za diklofenak
French: Informations destinées aux professionnels de la santé
Croatian: Informacije za zdravstvene djelatnike
French: Autres informations relatives à l'examen de la sécurité dans l'ensemble de l'UE
Croatian: Daljnje informacije o sigurnosnom pregledu na razini EU-a:
French: Les limitations des données ont rendu difficile la quantification initiale du risque, mais l'examen de 2012 a fait ressortir un tableau constant.
Croatian: Ograničenja u podacima otežala su kvantifikaciju početnog rizika, no konzistentna slika stvorena je do pregleda provedenog 2012. godine.
French: • Vous ne devez pas arrêter de prendre votre traitement sans en parler à votre médecin.
Croatian: • Liječenje se ne smije prekinuti bez prethodnog savjetovanja s liječnikom.
French: Les nouveaux conseils visent à minimiser les risques des effets de ces médicaments sur le cœur et la circulation.
Croatian: Nove mjere usmjerene su na smanjivanje rizika učinka ovih lijekova na srce i cirkulaciju.
French: Cette dernière analyse a mis en évidence que, par comparaison avec un placebo, le risque d'événements vasculaires majeurs était augmenté d'environ un tiers pour un inhibiteur de la COX-2 (rapport de risque [RR] 1,37, intervalle de confiance à 95 % [IC] de 1,14 - 1,66; p = 0,0009) ou le diclofénac (1,41, 1,12 - 1,78; p = 0,0036), principalement en raison d'une augmentation des événements coronariens majeurs (coxibs: 1,76, 1,31 - 2,37; p = 0,0001; diclofénac: 1,70, 1,19 - 2,41; p = 0,0032).
Croatian: Potonjim je utvrđeno da je u usporedbi s placebom rizik od većih vaskularnih poremećaja povećan za otprilike jednu trećinu s inhibitorom COX-2 (omjer stope [RR] 1.37, 95% interval pouzdanosti [CI] 1.14-1.66; p=0.0009) ili diklofenakom (1.41, 1.12-1.78; p=0.0036), uglavnom uslijed povećanja ozbiljnijih koronarnih poremećaja (koksibi: 1.76, 1.31-2.37; p=0.0001; diklofenak: 1.70, 1.19-2.41; p=0.0032).
French: Le besoin du patient de soulager les symptômes et sa réponse au traitement doivent être réévalués périodiquement.
Croatian: Potreba za simptomatskim ublažavanjem i odgovor na terapiju bolesnika trebaju se periodički ponovno ocjenjivati.
French: Le [CMD(h)], un organisme représentant les États membres de l'UE, est chargé d'assurer l'harmonisation des normes de sécurité pour les médicaments autorisés à travers des procédures nationales dans l'ensemble de l'UE.
Croatian: CMDh, tijelo koje predstavlja države članice EU-a, odgovorno je za osiguravanje usklađenih sigurnosnih standarda za lijekove odobrene u nacionalnim postupcima na razini EU-a.
French: Une mise en garde de classe pour ce risque est en place et les informations sur le produit pour tous les AINS recommandent que ces médicaments soient utilisés à la dose efficace minimale et pendant la durée la plus courte possible nécessaire pour le contrôle des symptômes.
Croatian: Upozorenje za klasu ovog rizika je na snazi i informacije o proizvodu za sve NSAID-ove preporučaju da se ti lijekovi koriste u najmanjim učinkovitim dozama tijekom najkraćeg vremenskog razdoblja potrebnog za kontrolu simptoma.
French: Les médicaments contenant du diclofénac ont été autorisés à travers des procédures d'approbation nationales dans les États membres de l'UE et sont disponibles depuis de nombreuses années sous une grande variété de noms de spécialités.
Croatian: Lijekovi koji sadrže diklofenak odobreni su nacionalnim postupcima za odobravanje u državama članicama EU-a i dostupni su već dugi niz godina pod nizom različitih trgovačkih naziva.
French: Les informations sur le produit seront modifiées et les professionnels de la santé prescrivant ou dispensant du diclofénac systémique recevront une nouvelle communication appropriée diffusée au niveau national.
Croatian: Informacije o proizvodu bit će dopunjene, a zdravstveni djelatnici koji propisuju ili izdaju sistemski diklofenak zaprimit će daljnju odgovarajuću komunikaciju na nacionalnoj razini.
French: Références bibliographiques
Croatian: Reference