FrancophonIA/ELRC3.0 huggingface dataset:
English: Eosinophilic oesophagitis is inflammation of the oesophagus (the food-pipe that leads from the mouth to the stomach), which causes symptoms including dysphagia (difficulty swallowing) and obstruction of the oesophagus.
Romanian: Esofagita eozinofilică este o inflamație a esofagului (tubul digestiv care leagă gura de stomac) care provoacă simptome precum disfagia (dificultatea de a înghiți) și obstrucția esofagului.
English: How does Jorveza work?
Romanian: Cum acționează Jorveza?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jorveza have been included in the summary of product characteristics and the package leaflet.
Romanian: În Rezumatul caracteristicilor produsului și în prospect au fost incluse recomandări și măsuri de precauție pentru utilizarea sigură și eficace a Jorveza, care trebuie respectate de personalul medical și de pacienți.
English: Jorveza is a medicine used to treat adults with eosinophilic oesophagitis.
Romanian: Jorveza este un medicament utilizat pentru tratarea esofagitei eozinofilice la adulți.
English: How is Jorveza used?
Romanian: Cum se utilizează Jorveza?
English: Subcutaneous or intravenous use powder: multidose vial (glass); solvent: ampoule (glass)
Romanian: Subcutanat sau intravenos pulbere: flacon (sticlă); solvent: fiolă (sticlă)
English: 50000 IU Powder and solvent for solution for injection
Romanian: Pulbere şi solvent pentru soluţie injectabilă
English: solvent: 10 ml (reconst.
Romanian: solvent: 10 ml (Soluţia reconstituită 5000 UI/ml)
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Romanian: Lista cu denumirile comerciale, formele farmaceutice, concentraţiile, căile de administrare ale medicamentelor, Deţinătorii autorizaţiei de punere pe piaţă în Statele Membre
English: Germany Hexal Aktiengesellschaft Industriestr.
Romanian: Germania Hexal Aktiengesellschaft Industriestr.
English: Denmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark
Romanian: Danemarca Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark
English: Desitin Arzneimittel GmbH Postfach 630164
Romanian: Norvegia Desitin Arzneimittel GmbH Postfach 630164
English: ARENA GROUP S.A. Str. Ştefan Mihăileanu nr.
Romanian: România S.C. ARENA GROUP S.A. Str. Ştefan Mihăileanu nr.
English: 1099-036 Lisboa Portugal
Romanian: 1099-036 Lisboa
English: 17 Bonifraterska Str. 00-203 Warsaw Poland
Romanian: z o.o. 17 Bonifraterska Str. 00-203 Warsaw Poland
English: Luxembourg Hexal AG Industriestrasse 25 83067 Holzkirchen Germany
Romanian: Luxemburg Hexal AG Industriestrasse 25 83067 Holzkirchen Germany
English: Romania GEROT PHARMAZEUTIKA Ges.m.b.H.
Romanian: România GEROT PHARMAZEUTIKA Ges.m.b.H.
English: Generis Farmacêutica, S.A. Rua João de Deus, 19 Amadora
Romanian: Portugalia Generis Farmacêutica, S.A. Rua João de Deus, 19
English: Germany IIP - Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH
Romanian: Germania IIP - Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH
English: Luxembourg Eurogenerics SA Esplanade Heysel b22
Romanian: Luxemburg Eurogenerics SA Esplanade Heysel b22
English: Sweden Sanofi AB Box 30052
Romanian: Sanofi AB Box 30052
English: Finland Sanofi Oy Huopalahdentie 24 PL 22
Romanian: Sanofi Oy Huopalahdentie 24 PL 22
English: Latvia sanofi-aventis Latvia SIA Kr.Valdemara 33-8 Riga LV1010
Romanian: Letonia sanofi-aventis Latvia SIA Kr.Valdemara 33-8 Riga LV1010
English: Luxembourg Takeda Belgium Chaussée de Gand 615 1080 Bruxelles
Romanian: Luxemburg Takeda Belgium Chaussée de Gand 615 1080 Bruxelles
English: Tecnifar - Indústria Técnica Farmacêutica, S.A.
Romanian: Portugalia Tecnifar - Indústria Técnica Farmacêutica, S.A.
English: Denmark Sanofi-aventis Denmark A/S
Romanian: Danemarca Sanofi-aventis Denmark A/S
English: Lithuania UAB „SANOFI-AVENTIS LIETUVA“
Romanian: UAB „SANOFI-AVENTIS LIETUVA“
English: Sanofi - Produtos Farmacêuticos, Lda.
Romanian: Portugalia Sanofi - Produtos Farmacêuticos, Lda.
English: Germany Sanofi-Aventis Deutschland GmbH
Romanian: Germania Sanofi-Aventis Deutschland GmbH
English: Finland Sandoz A/S C. F. Tietgens Boulevard 40 5220 ODENSE SØ Denmark
Romanian: C. F. Tietgens Boulevard 40 5220 ODENSE SØ Denmark
English: Luxembourg Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Romanian: Luxemburg Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
English: Ireland Sanofi-aventis Ireland Ltd. T/A SANOFI
Romanian: Sanofi-aventis Ireland Ltd. T/A SANOFI
English: Germany Mylan dura GmbH Wittichstr.
Romanian: Germania Mylan dura GmbH Wittichstr.
English: Rua Tierno GalvanAmoreiras - Torre 3 - 12º Lisboa
Romanian: Amoreiras - Torre 3 - 12º Lisboa
English: Luxembourg Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
Romanian: Luxemburg Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
English: Evropská 846/176a 160 00 Prague 6
Romanian: Sanofi-Aventis, s.r.o. Evropská 846/176a 160 00 Prague 6
English: Germany 1 A Pharma GmbH Keltenring 1 + 3
Romanian: Germania 1 A Pharma GmbH Keltenring 1 + 3
English: D-22311 HAMBURG Deutschland
Romanian: D-22311 HAMBURG
English: Germany Stadapharm GmbH Stadastr 2-18
Romanian: Germania Stadapharm GmbH Stadastr 2-18
English: Sandoz Farmacêutica, Lda.
Romanian: Portugalia Sandoz Farmacêutica, Lda.
English: 02101 Espoo
Romanian: 02101 Espoo Finland
English: 500-1000 mg Modified-release granules
Romanian: 500-1000 mg Granule cu eliberare modificată
English: Sanofi Malta Ltd St. Julian's Rd., San Gwann SGN 2805 Malta
Romanian: Julian's Rd., San Gwann SGN 2805 Malta
English: Germany Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1
Romanian: Germania Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str.
English: Valproic acid Convulex gelule gastro résistante
Romanian: Acid valproic Convulex gelule gastro résistante
English: Belgium Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Romanian: Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem Belgium
English: Belgium Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
Romanian: Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart Belgium
English: Romania Sanofi-Aventis France 1-13 Boulevard Romain Rolland
Romanian: România Sanofi-Aventis France 1-13 Boulevard Romain Rolland
English: Film-coated tablet Oral Use
Romanian: Comprimat filmat Administrare orală
English: Oral drops, solution Oral Use
Romanian: Picături orale, soluţie
English: Germany Neuraxpharm Arzneimittel GmbH
Romanian: Germania Neuraxpharm Arzneimittel GmbH
English: Valproic acid Depakine Chrono 500
Romanian: Acid valproic Depakine Chrono 500
English: Modified-release granules
Romanian: Granule cu eliberare modificată
English: Valproic acid VALPROATE SODIUM SANDOZ 500MG
Romanian: Acid valproic VALPROATE SODIUM SANDOZ 500MG
English: LT-09310 Vilnius
Romanian: Juozapavičiaus g. 6/2 LT-09310 Vilnius Lithuania
English: 400, poeder voor injectievloeistof 400 mg
Romanian: Depakine i.v. 400, poeder voor injectievloeistof 400 mg
English: Valproic acid Depakine Chrono 300
Romanian: Acid valproic Depakine Chrono 300
English: Germany betapharm Arzneimittel GmbH
Romanian: Germania betapharm Arzneimittel GmbH
English: Germany Winthrop Arzneimittel GmbH
Romanian: Germania Winthrop Arzneimittel GmbH
English: Valproic acid DEPAKINE 100 mg/ml por és oldószer oldatos injekcióhoz
Romanian: Acid valproic DEPAKINE 100 mg/ml por és oldószer oldatos injekcióhoz
English: Valproate semisodium
Romanian: Valproat semisodic
English: Valproic acid Ácido Valpróico Generis
Romanian: Acid valproic Ácido Valpróico Generis
English: Valproic acid Valproat "Sandoz"
Romanian: Acid valproic Valproat "Sandoz"
English: Valproic acid Depakine Chronosphere
Romanian: Acid valproic Depakine Chronosphere
English: Valproic acid Depakine 400 mg/4 ml
Romanian: Acid valproic Depakine 400 mg/4 ml
English: Solution for injection/concentra te for solution for infusion
Romanian: Soluţie injectabilă/concentr at pentru soluţie perfuzabilă
English: Germany Orion Corporation Orionintie 1 A
Romanian: Germania Orion Corporation Orionintie 1 A
English: Valpromide Depamide
Romanian: Valpromidă Depamide
English: DEPAKINE CHRONO (SPHERE) 1000 mg/sachet Coated granules in sachet
Romanian: DEPAKINE CHRONO (SPHERE) 1000 mg/sachet Granule acoperite în plic
English: Denmark Orion Corporation Orionintie 1 A
Romanian: Danemarca Orion Corporation Orionintie 1 A
English: Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
Romanian: Germania ALIUD PHARMA GmbH Gottlieb-Daimler-Str.
English: Finland Orion Pharma Orionintie 1
Romanian: Orion Pharma Orionintie 1 PL 65
English: Valproic acid Convulex 50 mg/ml - Sirup für Kinder
Romanian: Acid valproic Convulex 50 mg/ml - Sirup für Kinder
English: Germany Ratiopharm GmbH Graf-Arco-Strasse 3
Romanian: Germania Ratiopharm GmbH Graf-Arco-Strasse 3
English: Germany TAD Pharma GmbH Heinz-Lohmann-Str. 5
Romanian: Germania TAD Pharma GmbH Heinz-Lohmann-Str.
English: Valproic acid DEPAKINE 50 mg/ml szirup 50 mg/ml
Romanian: Acid valproic DEPAKINE 50 mg/ml szirup 50 mg/ml
English: Valproic acid ORFIRIL SAFT
Romanian: Acid valproic ORFIRIL SAFT
English: Valpromide Depamide 300 mg comprimidos gastrorresistentes
Romanian: Valpromidă Depamide 300 mg comprimidos gastrorresistentes
English: Valproic acid CONVULEX 50 mg/ml szirup gyermekeknek
Romanian: Acid valproic CONVULEX 50 mg/ml szirup gyermekeknek
English: Valproic acid Convulex 100 mg/mlInjektionslösung
Romanian: Acid valproic Convulex 100 mg/mlInjektionslösung
English: Valpromide DEPAMIDE 300 mg, comprimé pelliculé gastro-résistant
Romanian: Valpromidă DEPAMIDE 300 mg, comprimé pelliculé gastro-résistant
English: Valproic acid ORFIRIL LONG 1000 MG 1000 mg
Romanian: Acid valproic ORFIRIL LONG 1000 MG 1000 mg
English: Germany AbZ-Pharma GmbH Graf-Arco-Str. 3
Romanian: Germania AbZ-Pharma GmbH Graf-Arco-Str.
English: Valproic acid DEPAKINE CHRONO 300 MG 300 mg
Romanian: Acid valproic DEPAKINE CHRONO 300 MG 300 mg
English: Valproic acid Orfiril Long
Romanian: Acid valproic Orfiril Long
English: Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda Lagos Park, Edíficio 5A, Piso 2
Romanian: Lagos Park, Edíficio 5A, Piso 2
English: Valproic acid Diplexil
Romanian: Acid valproic Diplexil
English: Convulex 300 mg/ml - Lösung zum Einnehmen
Romanian: Convulex 300 mg/mlLösung zum Einnehmen
English: Valproic acid CONVULEX 100 mg/ml oldatos injekció
Romanian: Acid valproic CONVULEX 100 mg/ml oldatos injekció
English: Valproic acid Orfiril Retard
Romanian: Acid valproic Orfiril Retard
English: Valproic acid DEPAKINE CHRONO 500 MG 500 mg
Romanian: Acid valproic DEPAKINE CHRONO 500 MG 500 mg
English: Avenida Professor Doutor Cavaco Silva, 10 E 2740-255 Porto Salvo Portugal
Romanian: Avenida Professor Doutor Cavaco Silva, 10 E
English: Calcium divalproate
Romanian: Divalproat de calciu
English: Valproic acid Diplexil 1000
Romanian: Acid valproic Diplexil 1000
English: Valproic acid Depakine chrono 500 mg tablete s podaljšanim sproščanjem
Romanian: Acid valproic Depakine chrono 500 mg tablete s podaljšanim sproščanjem
English: Valproic acid Depakine chrono 300 mg tablete s podaljšanim sproščanjem
Romanian: Acid valproic Depakine chrono 300 mg tablete s podaljšanim sproščanjem
English: Valproic acid ORFIRIL 150
Romanian: Acid valproic ORFIRIL 150
English: Coated granules in sachet
Romanian: Granule acoperite în plic
English: Valproic acid Absenor 300 mg tablety s predĺženým uvoľňovaním
Romanian: Acid valproic Absenor 300 mg tablety s predĺženým uvoľňovaním
English: Solution for injection/infusion
Romanian: Soluţie injectabilă/perfuzab ilă
English: Valproic acid Delepsine Retard
Romanian: Acid valproic Delepsine Retard
English: Valproic acid Convulex 300 mg - Kapseln 300 mg
Romanian: Acid valproic Convulex 300 mg - Kapseln 300 mg
English: Valproic acid Absenor 500 mg tablety s predĺženým uvoľňovaním
Romanian: Acid valproic Absenor 500 mg tablety s predĺženým uvoľňovaním
English: Valproic acid Diplexil 150
Romanian: Acid valproic Diplexil 150
English: Valproic acid ORFIRIL 600
Romanian: Acid valproic ORFIRIL 600
English: Valproic acid Deprakine Retard
Romanian: Acid valproic Deprakine Retard
English: Valproic acid Convulex 150
Romanian: Acid valproic Convulex 150
English: Valproic acid Convulex 150 mg - Kapseln 150 mg
Romanian: Acid valproic Convulex 150 mg - Kapseln 150 mg
English: Romania Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Romanian: România Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: Valproic acid CONVULEX 300 MG/ML
Romanian: Acid valproic CONVULEX 300 MG/ML
English: Valproic acid CONVULEX RETARD 500MG 500 mg
Romanian: Acid valproic CONVULEX RETARD 500MG 500 mg
English: Valproic acid Convulex 500 mg - Kapseln 500 mg
Romanian: Acid valproic Convulex 500 mg - Kapseln 500 mg
English: Valproic acid Delepsine
Romanian: Acid valproic Delepsine
English: Valproic acid CONVULEX RETARD 300MG 300 mg
Romanian: Acid valproic CONVULEX RETARD 300MG 300 mg
English: Valproic acid ORFIRIL 300
Romanian: Acid valproic ORFIRIL 300
English: Valproic acid Diplexil 300
Romanian: Acid valproic Diplexil 300
English: Germany Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Romanian: Germania Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: Denmark Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Romanian: Danemarca Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: Prolongedrelease granules
Romanian: Granule cu eliberare prelungită
English: Valproic acid ORFIRIL LONG 150 MG
Romanian: Acid valproic ORFIRIL LONG 150 MG
English: Valproic acid Convulex Capsules 150mg 150 mg
Romanian: Acid valproic Convulex Capsules 150mg 150 mg
English: Valproic acid Diplexil 500
Romanian: Acid valproic Diplexil 500
English: Valproic acid CONVULEX 300 mg gyomornedv-ellenálló lágy kapszula
Romanian: Acid valproic CONVULEX 300 mg gyomornedv-ellenálló lágy kapszula
English: Magnesium valproate
Romanian: Valproat de magneziu
English: Valproic acid Ácido Valpróico Sandoz 500 mg Comprimidos de libertação prolongada
Romanian: Acid valproic Ácido Valpróico Sandoz 500 mg Comprimidos de libertação prolongada
English: Valproic acid ORFIRIL LONG 300 MG
Romanian: Acid valproic ORFIRIL LONG 300 MG
English: Valproic acid Convulex 300
Romanian: Acid valproic Convulex 300
English: Valproic acid Convulex 150 mg gastroresistant capsules, soft
Romanian: Acid valproic Convulex 150 mg gastroresistant capsules, soft
English: Valproic acid Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada
Romanian: Acid valproic Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada
English: Valproic acid Convulex Capsules 500mg 300 mg
Romanian: Acid valproic Convulex Capsules 500mg 300 mg
English: Valproic acid Convulex 500
Romanian: Acid valproic Convulex 500
English: Valproic acid CONVULEX 150 mg gyomornedv-ellenálló lágy kapszula
Romanian: Acid valproic CONVULEX 150 mg gyomornedv-ellenálló lágy kapszula
English: Valproic acid ORFIRIL LONG 500 MG
Romanian: Acid valproic ORFIRIL LONG 500 MG
English: Valproic acid CONVULEX 500 mg gyomornedv-ellenálló lágy kapszula
Romanian: Acid valproic CONVULEX 500 mg gyomornedv-ellenálló lágy kapszula
English: Valproic acid, Sodium valproate
Romanian: Acid valproic, Valproat de sodiu
English: Valproic acid Convulex Capsules 300mg 500 mg
Romanian: Acid valproic Convulex Capsules 300mg 500 mg
English: Valproic acid Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada
Romanian: Acid valproic Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada
English: Valproic acid Ácido Valpróico Sandoz 300 mg Comprimidos de libertação prolongada
Romanian: Acid valproic Ácido Valpróico Sandoz 300 mg Comprimidos de libertação prolongada
English: Valproic acid CONVULEX
Romanian: Acid valproic Convulex
English: Valproic acid Convulex
Romanian: Acid valproic CONVULEX
English: Valproic acid Sodium valproate
Romanian: Acid valproic Valproat de sodiu
English: Valproic acid Convulex 300 mg gastroresistant capsules, soft
Romanian: Acid valproic Convulex 300 mg gastroresistant capsules, soft
English: Valproic acid Orfiril
Romanian: Acid valproic ORFIRIL
English: Valproic acid ORFIRIL
Romanian: Acid valproic Orfiril
English: Valproic acid CONVULEX 300 mg retard filmtabletta prolonged release film-coated tablet
Romanian: Acid valproic CONVULEX 300 mg retard filmtabletta comprimat filmat cu eliberare prelungită
English: Valproic acid Convulex 300 mg kapsuly
Romanian: Acid valproic Convulex 300 mg kapsuly
English: Valproic acid Propymal Enteric 600 mg, maagsapresistente capsules
Romanian: Acid valproic Propymal Enteric 600 mg, maagsapresistente capsules
English: Valproic acid Propymal Enteric 450 mg, maagsapresistente capsules
Romanian: Acid valproic Propymal Enteric 450 mg, maagsapresistente capsules
English: Modified-release tablet
Romanian: Capsulă cu eliberare modificată
English: Valproic acid CONVULEX 500 mg retard filmtabletta prolonged release film-coated tablet
Romanian: Acid valproic CONVULEX 500 mg retard filmtabletta comprimat filmat cu eliberare prelungită
English: Valproic acid Propymal Enteric 150 mg, maagsapresistente capsules
Romanian: Acid valproic Propymal Enteric 150 mg, maagsapresistente capsules
English: Valproic acid Convulex 500 mg gastroresistant capsules, soft
Romanian: Acid valproic Convulex 500 mg gastroresistant capsules, soft
English: Valproic acid Convulex 500 mg kapsuly
Romanian: Acid valproic Convulex 500 mg kapsuly
English: Valproic acid Deprakine
Romanian: Acid valproic Deprakine
English: Valproic acid Convulex 150 mg kapsuly
Romanian: Acid valproic Convulex 150 mg kapsuly
English: Valproic acid CONVULEX 150 MG
Romanian: Acid valproic CONVULEX 150 MG
English: Valproic acid Propymal Enteric 300 mg, maagsapresistente capsules
Romanian: Acid valproic Propymal Enteric 300 mg, maagsapresistente capsules
English: Valproic acid CONVULEX 300 MG
Romanian: Acid valproic Convulex 300 mg
English: Valproic acid Convulex 300 mg
Romanian: Acid valproic CONVULEX 300 MG
English: Valproic acid Depakine
Romanian: Acid valproic DEPAKINE
English: Valproic acid DEPAKINE
Romanian: Acid valproic Depakine
English: Powder for injection Intravenous use
Romanian: Pulbere injectabilă Administrare inravenoasă
English: Valproic acid CONVULEX 500 MG
Romanian: Acid valproic Convulex 500 mg
English: Valproic acid Convulex 500 mg
Romanian: Acid valproic CONVULEX 500 MG
English: Prolonged-release granules in a sachet
Romanian: Granule cu eliberare prelungită în plic
English: Gastroresistant tablets
Romanian: Comprimate gastrorezistente
English: Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50
Romanian: Germania Heumann Pharma GmbH & Co.
English: Germany TEVA GmbH Graf-Arco-Str. 3
Romanian: Germania TEVA GmbH Graf-Arco-Str.
English: Depakine Crono 300 mg comprimidos recubiertos
Romanian: Depakine Crono 300 mg comprimidos de liberación prolongada
English: Depakine Crono 500 mg comprimidos recubiertos
Romanian: Depakine Crono 500 mg comprimidos de liberación prolongada
English: Solution for injection
Romanian: Soluţie injectabilă Administrare intravenoasă
English: The amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are set out in Annex III.
Romanian: Modificările punctelor relevante din Rezumatul caracteristicilor produsului şi din prospect sunt stabilite în anexa III.
English: The marketing authorisations for chlormadinone containing combined hormonal contraceptives are subject to the conditions set out in Annex IV.
Romanian: Autorizaţiile de introducere pe piaţă pentru contraceptivele hormonale combinate care conţin clormadinonă fac obiectul condiţiilor stabilite în anexa IV.
English: Annex II Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation
Romanian: Concluzii ştiinţifice şi motivele modificării condiţiilor autorizaţiilor de introducere pe piaţă şi explicaţia detaliată pentru diferenţele faţă de recomandarea PRAC
English: The CHMP, having considered the PRAC recommendation dated 10 October 2013 pursuant to Article 107k(3) of Directive 2001/83/EC, is of the opinion that the marketing authorisations for combined hormonal contraceptives containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norgestimate should be varied.
Romanian: După analiza recomandărilor PRAC din data de 10 octombrie 2013, în temeiul articolului 107k alineatul (3) din Directiva 2001/83/CE, CHMP consideră că autorizaţiile de introducere pe piaţă pentru contraceptivele hormonale combinate care conţin clormadinonă, desogestrel, dienogest, drospirenonă, etonogestrel, gestoden, norgestimat trebuie modificate.
English: Having considered all the above, the PRAC concluded that the benefit-risk balance of the medicinal products identified in Annex I in the indication of contraception remains favourable, subject to the inclusion of the restrictions, warnings and other changes to the product information agreed.
Romanian: După ce a analizat toate cele de mai sus, PRAC a concluzionat că raportul beneficiu-risc pentru medicamentele identificate în anexa I pentru indicaţia contracepţie se menţine favorabil, sub rezerva includerii restricţiilor, a avertismentelor şi a celorlalte modificări ale informaţiilor referitoare la produs convenite.
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products identified in Annex I in the indication of contraception remains favourable, subject to the agreed conditions, restrictions, warnings, other changes to the product information and additional risk minimisation measures.
Romanian: În consecinţă, PRAC a concluzionat că raportul beneficiu-risc pentru medicamentele identificate în anexa I pentru indicaţia contracepţie se menţine favorabil, sub rezerva condiţiilor, restricţiilor, avertismentelor şi a celorlalte modificări la informaţiile referitoare la produs şi a măsurilor de reducere la minimum a riscurilor convenite.
English: Date of first authorisation: 21 March 2007 Date of latest renewal: 23 February 2012
Romanian: Data primei autorizări: 21 martie 2007 Data ultimei reînnoiri a autorizaţiei: 23 februarie 2012
English: Do not take Januvia - if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).
Romanian: Nu utilizaţi Januvia - dacă sunteţi alergic la sitagliptin sau la oricare dintre celelalte componente ale acestui medicament (enumerate la pct. 6).
English: What Januvia is and what it is used for
Romanian: Ce este Januvia şi pentru ce se utilizează
English: STOP taking Januvia and contact a doctor immediately if you notice any of the following serious side effects:
Romanian: OPRIŢI administrarea Januvia şi contactaţi imediat un medic dacă observaţi oricare dintre următoarele reacții adverse grave:
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP'.
Romanian: Nu utilizaţi acest medicament după data de expirare înscrisă pe blister sau pe cutie după „EXP”.
English: Your doctor may ask you to stop Januvia.
Romanian: Medicul dumneavoastră vă poate solicita să opriți administrarea Januvia.
English: Tell your doctor if you have or have had: - a disease of the pancreas (such as pancreatitis) - gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood.
Romanian: Spuneţi-i medicului dumneavoastră dacă aveţi sau aţi avut: - o boală a pancreasului (cum este pancreatita) - pietre la fiere (litiază biliară), dependență de alcool sau valori foarte mari ale trigliceridelor (o formă de grăsime) în sângele dumneavoastră.
English: Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Januvia and periodically thereafter.
Romanian: Deoarece este necesară ajustarea dozei pe baza funcţiei renale, se recomandă evaluarea funcţiei renale înainte de iniţierea tratamentului cu Januvia şi periodic după aceea.
English: Method of administration Januvia can be taken with or without food.
Romanian: Mod de administrare Januvia se poate administra cu sau fără alimente.