FrancophonIA/ELRC3.0 huggingface dataset:
Greek: 4045 Kingswood Road City West Business Park Co Dublin, Ireland
Romanian: Marea Britanie Mercury Pharma International Limited 4045 Kingswood Road City West Business Park Co Dublin, Ireland
Greek: Via Enrico Fermi 1 Alanno (PE) 65020 Italy
Romanian: Alfa Wassermann S.p.A. Via Enrico Fermi 1 Alanno (PE) 65020 Italy
Greek: Mylan bvba Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium
Romanian: Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium
Greek: Etienne Demunter 5, box 8
Romanian: Etienne Demunter 5, box 8 1090 Jette
Greek: Ennogen Pharma Limited Unit G4, Riverside Way Dartford, DA1 5BS United Kingdom
Romanian: Marea Britanie Ennogen Pharma Limited Unit G4, Riverside Way Dartford, DA1 5BS
Greek: Largo Donegani 4/a Novara - 28100 Italy
Romanian: Proge Farm S.r.l. Largo Donegani 4/a Novara - 28100 Italy
Greek: 36/a Budapest, 1145
Romanian: Budapest, 1145
Greek: Suppository
Romanian: Supozitor
Greek: LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain
Romanian: Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain
Greek: Πορτογαλία Laboratórios Vitória, S.A. Rua Elias Garcia, 28 - Venda Nova 2700-327 Amadora
Romanian: Laboratórios Vitória, S.A. Rua Elias Garcia, 28 - Venda Nova
Greek: B-dul Aurel Vlaicu nr. 82A Constanţa 900055
Romanian: S.C. MAGISTRA C&C S.R.L. B-dul Aurel Vlaicu nr. 82A Constanţa 900055
Greek: Oficina 203 28290 Las Matas (Madrid) Spain
Romanian: 28290 Las Matas (Madrid) Spain
Greek: VOLTATABS 12,5 MG(EX:ZYMAMED)
Romanian: Diclofenac potasic VOLTATABS 12,5 MG(EX:ZYMAMED)
Greek: EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou
Romanian: EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex
Greek: Estrada do Rio da Mo, 8, 8 A e 8 B - Fervenca
Romanian: Estrada do Rio da Mo, 8, 8 A e 8 B - Fervenca 2705-906 Terrugem SNT Portugal
Greek: Εσθόνια
Romanian: Estonia
Greek: Ολλανδία ratiopharm Nederland B.V.
Romanian: Olanda ratiopharm Nederland B.V. Florapark 4
Greek: 21B LT-09200, Vilnius Lithuania
Romanian: UAB „PharmaSwiss" Šeimyniškių g. 21B LT-09200, Vilnius Lithuania
Greek: Via Sette Santi 3, Firenze 50131Italy
Romanian: Menarini Industrie Farmaceutiche Riunite S.r.l. Via Sette Santi 3, Firenze 50131- Italy
Greek: Hamwells Business Park Unit No. 7, Hardicker Street M19 2RB Manchester United Kingdom
Romanian: 7, Hardicker Street M19 2RB Manchester United Kingdom
Greek: Rowex Ltd Bantry, Co. Cork Ireland
Romanian: Rowex Ltd Bantry, Co.
Greek: Medialaan, 40, box 1 1800 Vilvoorde Belgium
Romanian: NOVARTIS PHARMA N.V. Medialaan, 40, box 1 1800 Vilvoorde Belgium
Greek: Wellington Street Development Pharma Limited 47 Oaklands Drive Rathgar Dublin 6
Romanian: 47 Oaklands Drive Rathgar Dublin 6
Greek: Winthrop Arzneimittel GmbH Industriestrasse 26
Romanian: Republica Cehă Winthrop Arzneimittel GmbH Industriestrasse 26
Greek: Via Ragazzi del 99 5, Bologna - 40133 Italy
Romanian: Alpha Biotech S.r.l. Via Ragazzi del 99 5, Bologna - 40133 Italy
Greek: Πορτογαλία Labesfal - Laboratórios Almiro, S.A.
Romanian: Labesfal - Laboratórios Almiro, S.A.
Greek: AC HELCOR PHARMA SRL Str. Victor Babeş nr. 50 Baia-Mare
Romanian: Str. Victor Babeş nr. 50 Baia-Mare
Greek: DOCPHARM Arzneimittelvertrieb GmbH & Co.
Romanian: Arzneimittelvertrieb GmbH & Co.
Greek: MEDUMAN S.A.
Romanian: S.C. MEDUMAN S.A.
Greek: Rua Félix Correia, 1-B
Romanian: Rua Félix Correia, 1-B 1500-271 Lisboa Portugal
Greek: Codal Synto ltd 33 Theklas Lysioti str. P.O.
Romanian: Codal Synto ltd 33 Theklas Lysioti str. P.O. Box 51785
Greek: Doble action pain relief
Romanian: Diclofenac potasic Doble action pain relief
Greek: Voltaren-100 Zäpfchen υπόθετο
Romanian: Voltaren-100 Zäpfchen
Greek: 3465-051 Santiago de Besteiros Portugal
Romanian: Campo de Besteiros 3465-051 Santiago de Besteiros
Greek: Therabel pharma UK Limited Compass House, vision Park Chivers, Histon Cambridge CB24 9AD United Kingdom
Romanian: Marea Britanie Therabel pharma UK Limited Compass House, vision Park Chivers, Histon
Greek: 81829 München
Romanian: 81829 München Germany
Greek: Via Paolo Di Dono 73 00142, Rome
Romanian: DAICHI SANKYO Italia S.p.a. Via Paolo Di Dono 73 00142, Rome
Greek: Πορτογαλία Laboratório Normal - Produtos Farmacêuticos, Lda.
Romanian: Laboratório NormalProdutos Farmacêuticos, Lda.
Greek: 12th Km National Highway No 1, Metamorfosi Attikis 144 51 Greece
Romanian: 12th Km National Highway No 1, Metamorfosi Attikis
Greek: 2909 LD Capelle aan den IJssel The Netherlands
Romanian: Rivium Westlaan 142 2909 LD Capelle aan den IJssel
Greek: Καψάκιο διπλής αποδέσμευσης
Romanian: Capsulă cu eliberare dublă
Greek: Industriestrasse, 25, D-83607 HOLZKIRCHEN
Romanian: Industriestrasse, 25, D83607 HOLZKIRCHEN Germany
Greek: Apotex Europe B.V.
Romanian: Apotex Europe B.V. Darwinweg 20
Greek: de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spain
Romanian: Avda. de Europa, 20 B Parque Empresarial La Moraleja
Greek: Mercury Pharma International Limited
Romanian: Marea Britanie Mercury Pharma Group Limited
Greek: Marathonos Avenue 106, Gerakas
Romanian: PHARMANEL COMMERCE PHARMACEUTICAL S.A. Marathonos Avenue 106, Gerakas 15344
Greek: Dr. R. Pfleger Chemische Fabrik GmbH
Romanian: Republica Cehă Dr. R. Pfleger Chemische Fabrik GmbH
Greek: IBSA Slovakia s.r.o.
Romanian: IBSA Slovakia s.r.o. Mytna 42
Greek: Λούξεμβούργο ratiopharm GmbH Graf Arco Strasse 3
Romanian: Republica Cehă ratiopharm GmbH Graf Arco Strasse 3
Greek: RI Pharma Limited First floor,6 St John's Court Upper Fforest Way Swansea Enterprise Park Swansea SA6 8QQ United Kingdom
Romanian: Marea Britanie RI Pharma Limited First floor,6 St John's Court Upper Fforest Way
Greek: Actavis Deutschland GmbH & Co. KG
Romanian: Actavis Deutschland GmbH & Co.
Greek: Astellas Pharma Co. Ltd 5 Waterside
Romanian: Ltd 5 Waterside
Greek: NOVARTIS SANTE FAMILIALE 14, boulevard Richelieu 92500 Rueil-Malmaison France
Romanian: 14, boulevard Richelieu 92500 Rueil-Malmaison France
Greek: Dexcel Pharma Limited 7 Sopwith Way Drayton Fields Industrial Estate, Daventry Northamptonshire NN11 8PB United Kingdom
Romanian: Industrial Estate, Daventry Northamptonshire NN11 8PB United Kingdom
Greek: Γερμανία betapharm Arzneimittel GmbH Kobelweg 95
Romanian: Germania betapharm Arzneimittel GmbH
Greek: Chephasaar ChemischPharmazeutische Fabrik GmbH Muehlstr.
Romanian: Chephasaar ChemischPharmazeutische Fabrik GmbH
Greek: Kommanditgesellschaft auf Aktien Greschbachstr.
Romanian: Greschbachstr.
Greek: VOLTARENDOLO 12,5 mg, comprimé enrobé
Romanian: Diclofenac potasic VOLTARENDOLO 12,5 mg, comprimé enrobé
Greek: Voltarol Pain-Eze Extra Strength Tablets
Romanian: Diclofenac potasic Voltarol Pain-Eze Extra Strength
Greek: Medochemie Ltd 1-10 Constantinoupoleos str P.O.
Romanian: Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box 51409
Greek: Πορτογαλία Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda Rua Quinta do Pinheiro
Romanian: Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda Rua Quinta do Pinheiro Edifício Tejo - 6º Piso 2790-143 Carnaxide Portugal
Greek: Herbacos Recordati s.r.o.
Romanian: Herbacos Recordati s.r.o. Štrossova 239
Greek: Voltarol Pain-Eze Tablets
Romanian: Diclofenac potasic Voltarol Pain-Eze Tablets
Greek: Diclofenacratiopharm Lösung bei Migräne
Romanian: Diclofenac potasic Diclofenacratiopharm Lösung bei Migräne
Greek: Novartis Hellas S.A.C.I.
Romanian: Novartis Hellas S.A.C.I. 12th km
Greek: Morningside Healthcare Limited 115 Narborough Road Leicester, LE3 0PA United Kingdom
Romanian: 115 Narborough Road Leicester, LE3 0PA United Kingdom
Greek: Les Trois Moulins - Parc de Sophia Antipolis
Romanian: Laboratoires Genevrier 280, rue de Goa Les Trois Moulins - Parc de Sophia Antipolis 06600 Antibes France
Greek: Kappler Pharma Consult GmbH Fonyoder Str. 18
Romanian: Kappler Pharma Consult GmbH
Greek: ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D-89150 Laichingen Germany
Romanian: Gottlieb Daimler Strasse 19 D-89150 Laichingen Germany
Greek: 81379 München
Romanian: 81379 München Germany
Greek: Waymade Plc Regency House Miles Gray Road Basildon, Essex SS14 3RF United Kingdom
Romanian: Basildon, Essex SS14 3RF United Kingdom
Greek: Γαστροανθεκτικό καψάκιο
Romanian: Capsulă gastrorezistentă
Greek: 3465-157 Santiago de Besteiros Portugal
Romanian: Zona Industrial do Lagedo 3465-157 Santiago de Besteiros
Greek: AWD.pharma GmbH & Co. KG
Romanian: AWD.pharma GmbH & Co.
Greek: Chatfield Pharmaceuticals Limited Kramer Mews
Romanian: Marea Britanie Chatfield Pharmaceuticals Limited
Greek: Walter Ritter GmbH & Co. Spaldingstr.
Romanian: Walter Ritter GmbH & Co.
Greek: N.V.
Romanian: N.
Greek: DEMO SA Pharmaceutical Industry 21st km National Road Athens-Lamia 14568
Romanian: 21st km National Road Athens-Lamia 14568 Athens
Greek: 49, avenue Georges Pompidou 92300 Levallois-Perret France
Romanian: 92300 Levallois-Perret France
Greek: Diclo-CT akut 12,5 mg Filmtabletten
Romanian: Diclofenac potasic Diclo-CT akut 12,5 mg Filmtabletten
Greek: Δικλοφενάκη νατριούχος Κωδεΐνη φωσφορική ημιυδρική
Romanian: Diclofenac sodic Codeină hemihidrat fosfat
Greek: SANDOZ FARMACEUTICA, S.A. Avda.
Romanian: SANDOZ FARMACEUTICA, S.A.
Greek: UAB „BERLIN CHEMIE MENARINI BALTIC"
Romanian: UAB „BERLIN CHEMIE MENARINI BALTIC" Jasinskio g. 16 a, 01112 Vilnius Lithuania
Greek: 351 Darvia - 53014 Siena Italy
Romanian: Industria Farmaceutica Galenica Senese S.r.l. Via Cassia Nord 351 Darvia - 53014 Siena Italy
Greek: Otriflu 12.5mg Filmcoated Tablets
Romanian: 12.5mg Film-coated tablets
Greek: Voltaren Akti 25 mg soft capsules
Romanian: Diclofenac potasic Voltaren Akti 25 mg soft capsules
Greek: Eminocs 50 mg/ml, drank
Romanian: Diclofenac potasic Eminocs 50 mg/ml, drank
Greek: Swensweg 5
Romanian: Šmarješka cesta 6
Greek: Novartis Pharma S.p.A.
Romanian: NOVARTIS FARMACEUTICA, S.A.
Greek: Diclofenac EG 100 suppositoire υπόθετο
Romanian: Diclofenac EG 100 suppositoire
Greek: Rua do Centro Empresarial, Edf 8, Quinta da Beloura
Romanian: Rua do Centro Empresarial, Edf 8, Quinta da Beloura 2710-693 Sintra Portugal
Greek: Wörwag Pharma GmbH & Co.KG Calwer Str. 7
Romanian: Wörwag Pharma GmbH & Co.KG
Greek: 4818 CP Breda
Romanian: Claudius Prinselaan 142 4818 CP Breda The Netherlands
Greek: Voltfast Sachets 50 mg Powder for Oral Solution
Romanian: Diclofenac potasic Voltfast Sachets 50 mg Powder for Oral
Greek: BIOTECH Pharmaceutical Ltd
Romanian: D.A.S.T. BIOTECH Pharmaceutical Ltd Larissis 10
Greek: Δικλοφενάκη Θειαμίνη
Romanian: Diclofenac Tiamina
Greek: Largo Umberto Boccioni, 1 Origgio - 21040 Varese Italy
Romanian: Novartis Farma S.p.A. Largo Umberto Boccioni, 1 Origgio - 21040 Varese Italy
Greek: Disphar International B.V.
Romanian: Disphar International B.V. Winkelskamp 6
Greek: ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines
Romanian: ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines Achaias & Trizinias Nea Kifissia 14564
Greek: Voltaren Dolo Liquid 12,5 mg
Romanian: Diclofenac potasic Voltaren Dolo Liquid 12,5 mg
Greek: 15, boulevard Charles de Gaulle 92700 Colombes France
Romanian: 15, boulevard Charles de Gaulle
Greek: Via Manuzio 7 Milano - 20124 Italy
Romanian: Doc Generici S.r.l. Via Manuzio 7 Milano - 20124 Italy
Greek: VOLTAREN DOLO 25 mg lágy kapszula
Romanian: Diclofenac potasic VOLTAREN DOLO 25 mg lágy kapszula
Greek: Δικλοφενάκη νατριούχος Λιδοκαΐνη υδροχλωρική
Romanian: Diclofenac sodic Clorhidrat de lidocaină
Greek: Svardvagen 3B
Romanian: Uzsoki u. 36/a
Greek: Teva Nederland B.V.
Romanian: Teva Nederland B.V. Swensweg 5
Greek: Diclo AL akut 12,5 mg
Romanian: Diclofenac potasic Diclo AL akut 12,5 mg
Greek: Voltaren rapid 50 mg - Dragees
Romanian: Diclofenac potasic Voltaren rapid 50 mg - Dragees
Greek: Via Pavia, 6 Milano - 20136 Italy
Romanian: Crinos S.p.a. Via Pavia, 6 Milano - 20136 Italy
Greek: Ενδομυϊκή χρήση
Romanian: Administrare intravenoasă
Greek: Καψάκιο παρατεταμένης αποδέσμευσης
Romanian: Comprimat cu eliberare prelungită
Greek: Πορτογαλία Labesfal - Laboratórios Almiro S.A. Zona Industrial do Lagedo
Romanian: Labesfal - Laboratórios Almiro S.A.
Greek: Περαιτέρω πληροφορίες σχετικά με την επανεξέταση ασφάλειας σε όλη την ΕΕ:
Romanian: Informaţii suplimentare privind evaluarea siguranţei la nivelul UE:
Greek: Στοιχεία επικοινωνίας εκπροσώπων Τύπου του Οργανισμού Monika Benstetter ή Martin Harvey
Romanian: Contactaţi ataşaţii noştri de presă Monika Benstetter sau Martin Harvey
Greek: • Εάν έχετε περαιτέρω απορίες, ρωτήστε τον γιατρό ή τον φαρμακοποιό σας.
Romanian: • Dacă aveţi întrebări, discutaţi cu medicul dumneavoastră sau cu farmacistul.
Greek: • Δεν πρέπει να σταματήσετε να λαμβάνετε τη θεραπεία σας χωρίς να ενημερώσετε τον γιατρό σας.
Romanian: • Nu trebuie să întrerupeţi tratamentul fără a discuta cu medicul dumneavoastră.
Greek: Η ασφάλεια των ΜΣΑΦ παρακολουθείται στενά στην ΕΕ από τις ρυθμιστικές αρχές.
Romanian: Siguranţa AINS a fost atent monitorizată de către autorităţile de reglementare din Uniunea Europeană.
Greek: Οι περιορισμοί των δεδομένων κατέστησαν δυσχερή την ποσοτικοποίηση του κινδύνου αρχικά, αλλά η επανεξέταση του 2012 συνέβαλε στη διαμόρφωση μιας συνεκτικής εικόνας.
Romanian: Iniţial, datele limitate au făcut dificilă cuantificarea riscului, însă în cursul evaluării din 2012 s-a conturat o imagine coerentă.
Greek: Νέα μέτρα για την ελαχιστοποίηση των καρδιαγγειακών κινδύνων
Romanian: Noile măsuri au ca scop reducerea la minimum a riscurilor cardiovasculare
Greek: • Η αποτελεσματικότητα της δικλοφαινάκης είναι επαρκώς τεκμηριωμένη.
Romanian: • Eficacitatea diclofenacului este bine stabilită.
Greek: Επί του παρόντος διατίθεται στην Ευρωπαϊκή Ένωση (ΕΕ) με τη μορφή διαφόρων σκευασμάτων.
Romanian: Medicamentul este disponibil în prezent în Uniunea Europeană (UE) sub mai multe forme farmaceutice diferite.
Greek: Η επανεξέταση των συναφών δεδομένων διενεργήθηκε αρχικά από την Επιτροπή Φαρμακοεπαγρύπνησης-Αξιολόγησης Κινδύνου (PRAC).
Romanian: O primă evaluare a acestor date a fost efectuată de către Comitetul pentru evaluarea riscurilor în materie de farmacovigilență (PRAC).
Greek: Οι πληροφορίες του προϊόντος θα τροποποιηθούν και οι επαγγελματίες του τομέα της υγείας που συνταγογραφούν ή διανέμουν συστημικά σκευάσματα δικλοφαινάκης θα λάβουν πρόσθετη κατάλληλη ενημέρωση σε εθνικό επίπεδο.
Romanian: Informaţiile referitoare la produs vor fi modificate, iar personalul medical care prescrie sau distribuie diclofenac cu administrare sistemică va primi o comunicare corespunzătoare suplimentară la nivel naţional.
Greek: Η CMDh, οργανισμός που εκπροσωπεί τα κράτη μέλη της ΕΕ, είναι υπεύθυνη για τη διασφάλιση εναρμονισμένων προτύπων ασφάλειας για τα φαρμακευτικά προϊόντα που λαμβάνουν άδεια κυκλοφορίας μέσω εθνικών διαδικασιών στην ΕΕ.
Romanian: CMD(h), un organism care reprezintă statele membre ale UE, este responsabil cu asigurarea standardelor de siguranţă armonizate pentru medicamentele autorizate prin intermediul procedurilor naţionale pe întreg teritoriul UE.
Greek: Νέες συμβουλές σχετικά με την ασφάλεια της δικλοφαινάκης
Romanian: Noi recomandări privind siguranţa pentru diclofenac
Greek: Σύμφωνα με την τελευταία, διαπιστώθηκε ότι σε σύγκριση με το εικονικό φάρμακο ο κίνδυνος μειζόνων αγγειακών συμβαμάτων αυξήθηκε κατά περίπου ένα τρίτο με έναν αποκλειστή COX-2 (λόγος συχνότητας εμφάνισης των συμβαμάτων ίσος με 1,37, για διάστημα εμπιστοσύνης 95% οι τιμές κυμαίνονται μεταξύ 1,14-1,66, p=0,0009) ή με τη δικλοφαινάκη (1,41, 1,12-1,78, p=0,0036), κυρίως λόγω αύξησης στα μείζονα συμβάματα στεφανιαίας νόσου (κοξίμπες: 1,76, 1,31-2,37, p=0,0001, δικλοφαινάκη: 1,70, 1,19-2,41, p=0,0032).
Romanian: Aceasta din urmă a constatat că, în comparaţie cu placebo, riscul de evenimente vasculare majore a crescut cu aproximativ o treime cu un inhibitor de COX-2 [risc relativ (RR) 1,37, interval de încredere 95 % (IÎ) 1,14-1,66; p=0,0009] sau cu diclofenac (1,41, 1,12-1,78; p=0,0036), în principal datorită unei creşteri a evenimentelor coronariene majore (coxibi: 1,76, 1,31-2,37; p=0,0001; diclofenac: 1,70, 1,19-2,41; p=0,0032).
Greek: Η επανεξέταση των συστημικών σκευασμάτων δικλοφαινάκης ξεκίνησε στις 31 Οκτωβρίου 2012 κατόπιν αιτήματος του οργανισμού φαρμάκων του Ηνωμένου Βασιλείου δυνάμει του άρθρου 31 της οδηγίας 2001/83/ΕΚ.
Romanian: Evaluarea diclofenacului cu administrare sistemică a fost iniţiată la cererea agenţiei de reglementare în domeniul medicamentelor din Regatul Unit, în temeiul articolului 31 din Directiva 2001/83/CE, la 31 octombrie 2012.
Greek: Τα φαρμακευτικά προϊόντα που περιέχουν δικλοφαινάκη έχουν λάβει άδεια κυκλοφορίας μέσω εθνικών διαδικασιών έγκρισης στα κράτη μέλη της ΕΕ και διατίθενται εδώ και αρκετά χρόνια με διάφορες εμπορικές ονομασίες.
Romanian: Medicamentele care conţin diclofenac au fost autorizate în statele membre ale UE prin proceduri de aprobare naţionale şi au fost disponibile timp de mulţi ani într-o gamă largă de denumiri comerciale.
Greek: • Καθώς οι καρδιαγγειακοί κίνδυνοι της δικλοφαινάκης ενδέχεται να αυξηθούν ανάλογα με τη δόση και τη διάρκεια της έκθεσης, πρέπει να επιλέγονται η συντομότερη δυνατή διάρκεια και η χαμηλότερη αποτελεσματική ημερήσια δόση.
Romanian: • Întrucât riscurile cardiovasculare ale diclofenacului pot creşte odată cu doza şi durata expunerii, trebuie utilizate durata cea mai scurtă posibil şi cea mai mică doză zilnică eficace.
Greek: Αυτό ισχύει ιδίως όταν η δικλοφαινάκη χρησιμοποιείται σε υψηλές δόσεις και στο πλαίσιο μακροχρόνιας θεραπείας.
Romanian: Această situaţie este valabilă în special atunci când diclofenacul se utilizează în doză mare şi ca tratament de lungă durată.
Greek: Η προειδοποίηση σχετικά με τον κίνδυνο της συγκεκριμένης κατηγορίας φαρμάκων έχει ήδη διατυπωθεί, ενώ στις πληροφορίες προϊόντος όλων των ΜΣΑΦ συνιστάται τα εν λόγω φάρμακα να λαμβάνονται στη μικρότερη αποτελεσματική δόση για το συντομότερο χρονικό διάστημα που κρίνεται απαραίτητο για τον έλεγχο των συμπτωμάτων.
Romanian: În momentul de faţă există o atenţionare privind riscul acestei clase de medicamente, iar informaţiile referitoare la produs pentru toate AINS recomandă ca aceste medicamente să fie utilizate în cea mai mică doză eficace pentru cea mai scurtă perioadă de timp necesară pentru controlul simptomelor.
Greek: Στις 28 Ιουνίου 2013, η Συντονιστική Ομάδα για τη διαδικασία αμοιβαίας αναγνώρισης και την αποκεντρωμένη διαδικασία - φάρμακα για ανθρώπινη χρήση (CMDh) υιοθέτησε κατά πλειοψηφία νέες συμβουλές σχετικά με την ασφάλεια των φαρμακευτικών προϊόντων που περιέχουν δικλοφαινάκη υπό μορφή καψακίων, δισκίων, υποθέτων ή ενέσεων και τα οποία αναμένεται να επηρεάζουν ολόκληρο τον οργανισμό (συστημική επίδραση).
Romanian: La 28 iunie 2013, Grupul de coordonare pentru procedura de recunoaștere reciprocă și procedura descentralizată - Medicamente de uz uman [CMD(h)] a aprobat, cu majoritate de voturi, noi recomandări privind siguranţa pentru medicamentele care conţin diclofenac, ce se administrează sub formă de capsule, comprimate, supozitoare sau injecţii, destinate să aibă efect asupra întregului organism (cunoscut ca efect sistemic).
Greek: Λόγω του ότι όλα τα φαρμακευτικά προϊόντα που περιέχουν δικλοφαινάκη είχαν λάβει άδεια κυκλοφορίας μέσω εθνικής διαδικασίας, οι συστάσεις της PRAC υποβλήθηκαν στη Συντονιστική Ομάδα για τη διαδικασία αμοιβαίας αναγνώρισης και την αποκεντρωμένη διαδικασία - φάρμακα για ανθρώπινη χρήση (CMDh), η οποία εξέδωσε οριστική γνωμοδότηση.
Romanian: Deoarece toate medicamentele care conţin diclofenac sunt autorizate la nivel naţional, recomandările PRAC au fost transmise Grupului de coordonare pentru procedura de recunoaștere reciprocă și procedura descentralizată - Medicamente de uz uman [CMD(h)], care a adoptat o poziţie finală.
Greek: Η θέση της CMDh υποβλήθηκε στην Ευρωπαϊκή Επιτροπή, η οποία στις 25 Σεπτεμβρίου 2013 την ενέκρινε και εξέδωσε νομικά δεσμευτική οριστική απόφαση που ισχύει σε ολόκληρη την ΕΕ.
Romanian: Poziţia CMD(h) a fost transmisă Comisiei Europene, care a confirmat-o şi a adoptat o decizie finală obligatorie din punct de vedere juridic valabilă pe întreg teritoriul Uniunii Europene, la 25 septembrie 2013.
Greek: Καθότι η θέση της CMDh εγκρίθηκε κατά πλειοψηφία, υποβλήθηκε στην Ευρωπαϊκή Επιτροπή η οποία την ενέκρινε και εξέδωσε νομικά δεσμευτική οριστική απόφαση για ολόκληρη την ΕΕ.
Romanian: Întrucât poziţia CMD(h) a fost adoptată cu majoritate de voturi, aceasta a fost transmisă Comisiei Europene, care a confirmat-o şi a adoptat o decizie finală obligatorie din punct de vedere juridic valabilă pe întreg teritoriul Uniunii Europene.
Greek: Τα περισσότερα σκευάσματα προορίζονται για συστημική χρήση (χορηγούνται ως θεραπεία σε ολόκληρο το σώμα, όπως τα πόσιμα και ενέσιμα φάρμακα) και αποτελούν αντικείμενο της παρούσας επανεξέτασης.
Romanian: Cele mai multe forme farmaceutice sunt destinate utilizării sistemice (administrate ca tratament pentru întregul organism, aşa cum sunt medicamentele orale sau injectabile) şi fac obiectul acestei evaluări.
Greek: • Η PRAC εξέτασε εις βάθος τα διαθέσιμα δεδομένα, μεταξύ των οποίων δεδομένα από αρκετές νέες μελέτες ασθενών-μαρτύρων και μελέτες κοόρτης, μια εκ των υστέρων ανάλυση των δεδομένων του προγράμματος MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-term, πρόγραμμα μακράς διάρκειας πολυεθνικής μελέτης με ετορικοξίμπη και δικλοφαινάκη για την αρθρίτιδα)1 και μια μετα-ανάλυση2 που διενεργήθηκε από τη συνεργατική ομάδα Coxib and traditional NSAID Trialists, και περιλάμβανε πάνω από 600 κλινικές δοκιμές.
Romanian: • PRAC a evaluat suplimentar datele disponibile, inclusiv mai multe studii noi de caz-control şi de cohortă, o analiză post-hoc a datelor obţinute din programul MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-term)1 şi o metaanaliză2 realizată de Coxib and traditional NSAID Trialists Collaboration care a inclus peste 600 de studii clinice.
Greek: • Εάν λαμβάνετε μακροχρόνια θεραπεία με δικλοφαινάκη, η θεραπεία σας θα πρέπει να επανεξεταστεί προκειμένου να διασφαλιστεί ότι εξακολουθεί να είναι η κατάλληλη για την περίπτωσή σας.
Romanian: • Dacă urmaţi un tratament de lungă durată cu diclofenac va trebui să vi se evalueze tratamentul pentru a se asigura că acesta este în continuare corespunzător pentru dumneavoastră.
Greek: 25 Σεπτεμβρίου 2013
Romanian: 25 septembrie 2013 EMA/592685/2013
Greek: Πέρα από τη δικλοφαινάκη, τα ευρέως χρησιμοποιούμενα ΜΣΑΦ περιλαμβάνουν επίσης ιβουπροφένη και ναπροξένη.
Romanian: Pe lângă diclofenac, medicamentele AINS utilizate pe scară largă includ, de asemenea, ibuprofenul şi naproxenul.
Greek: Οι νέες συμβουλές έχουν ως στόχο την ελαχιστοποίηση των κινδύνων για την καρδιά και το κυκλοφορικό σύστημα από τη χρήση των εν λόγω φαρμάκων.
Romanian: Noile recomandări urmăresc reducerea la minimum a riscurilor de apariţie a efectelor asupra inimii şi circulaţiei provocate de aceste medicamente.
Greek: • Εάν έχετε άλλους παράγοντες κινδύνου όπως υψηλή αρτηριακή πίεση, υψηλή χοληστερόλη αίματος, διαβήτη, ή εάν καπνίζετε, ο γιατρός σας θα αξιολογήσει το εάν πρέπει να λαμβάνετε δικλοφαινάκη, καθώς και τον βέλτιστο τρόπο λήψης της.
Romanian: • Dacă prezentaţi alţi factori de risc, cum ar fi tensiune arterială crescută, nivel ridicat al colesterolului în sânge, diabet sau dacă fumaţi, medicul dumneavoastră va trebui să evalueze dacă este necesar să utilizaţi diclofenac şi care este cel mai bun mod de administrare a acestuia.
Greek: Η επανεξέταση της δικλοφαινάκης από την PRAC κινήθηκε τον Οκτώβριο του 2012 κατόπιν αιτήματος του ρυθμιστικού οργανισμού φαρμάκων του Ηνωμένου Βασιλείου, του MHRA, σε απάντηση των ευρημάτων της επανεξέτασης των ΜΣΑΦ που διενεργήθηκε το 2012.
Romanian: Evaluarea diclofenacului realizată de PRAC a fost iniţiată la solicitarea agenţiei de reglementare în domeniul medicamentelor din Regatul Unit, MHRA, în octombrie 2012, ca urmare a rezultatelor evaluării AINS din 2012.
Greek: Καθώς ορισμένες προσταγλανδίνες συμμετέχουν στην πρόκληση πόνου και φλεγμονής σε σημεία τραυματισμού ή βλάβης στο σώμα, η μειωμένη σύνθεση προσταγλανδινών μειώνει τον πόνο και τη φλεγμονή.
Romanian: Întrucât unele prostaglandine sunt implicate în producerea durerii şi a inflamaţiei la nivelul zonelor lezate sau afectate ale organismului, scăderea producţiei de prostaglandine reduce durerea şi inflamaţia.