FrancophonIA/ELRC3.0 huggingface dataset:
English: How does Jorveza work?
Slovenian: Kako zdravilo Jorveza deluje?
English: Jorveza can only be obtained with a prescription and treatment should be started by a doctor experienced with diagnosing and treating eosinophilic oesophagitis.
Slovenian: Predpisovanje in izdaja zdravila Jorveza je le na recept, zdravljenje pa mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem eozinofilnega ezofagitisa.
English: After Jorveza dissolves in the mouth, the saliva carries it to the oesophagus where it reduces the inflammation and relieves the symptoms of eosinophilic oesophagitis.
Slovenian: Ko se zdravilo Jorveza raztopi v ustih, po slini potuje v požiralnik, kjer zmanjšuje vnetje in blaži simptome eozinofilnega ezofagitisa.
English: How is Jorveza used?
Slovenian: Kako se zdravilo Jorveza uporablja?
English: Jorveza is a medicine used to treat adults with eosinophilic oesophagitis.
Slovenian: Zdravilo Jorveza se uporablja za zdravljenje odraslih z eozinofilnim ezofagitisom.
English: Jorveza contains the active substance budesonide.
Slovenian: Zdravilo Jorveza vsebuje zdravilno učinkovino budezonid.
English: Subcutaneous or intravenous use powder: multidose vial (glass); solvent: ampoule (glass)
Slovenian: prašek in vehikel za raztopino za injiciranje prašek: večodmerna viala (steklo); vehikel: ampula (steklo)
English: Solution 5000 IU/ml)
Slovenian: raztopina 5000 i.e./ml)
English: solvent: 10 ml (reconst.
Slovenian: vehikel: 10 ml (rekonst.
English: 50000 IU Powder and solvent for solution for injection
Slovenian: 4 napolnjene injekcijske brizge
English: Desitin Arzneimittel GmbH Postfach 630164
Slovenian: Norveška Desitin Arzneimittel GmbH Postfach 630164
English: Germany Hexal Aktiengesellschaft Industriestr.
Slovenian: Hexal Aktiengesellschaft Industriestr.
English: 1099-036 Lisboa Portugal
Slovenian: 1099-036 Lisboa
English: Romania GEROT PHARMAZEUTIKA Ges.m.b.H.
Slovenian: Romunija GEROT PHARMAZEUTIKA Ges.m.b.H.
English: Luxembourg Eurogenerics SA Esplanade Heysel b22
Slovenian: Luksemburg Eurogenerics SA Esplanade Heysel b22
English: 2700-487 Amadora Portugal
Slovenian: 2700-487 Amadora
English: 90449 Nürnberg
Slovenian: 90449 Nürnberg Germany
English: DK-2970 Hørsholm
Slovenian: DK-2970 Hørsholm Denmark
English: Generis Farmacêutica, S.A. Rua João de Deus, 19 Amadora
Slovenian: Portugalska Generis Farmacêutica, S.A. Rua João de Deus, 19
English: Luxembourg Hexal AG Industriestrasse 25 83067 Holzkirchen Germany
Slovenian: Luksemburg Hexal AG Industriestrasse 25 83067 Holzkirchen Germany
English: Germany IIP - Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH
Slovenian: IIP - Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH
English: Latvia sanofi-aventis Latvia SIA Kr.Valdemara 33-8 Riga LV1010
Slovenian: Latvija sanofi-aventis Latvia SIA Kr.Valdemara 33-8 Riga LV1010
English: Sweden Sanofi AB Box 30052
Slovenian: Sanofi AB Box 30052
English: PSC 170 00 Holesovice Czech Republic
Slovenian: PSC 170 00 Holesovice Czech Republic magnezijev valproat
English: Finland Sanofi Oy Huopalahdentie 24 PL 22
Slovenian: Sanofi Oy Huopalahdentie 24 PL 22
English: Germany Mylan dura GmbH Wittichstr.
Slovenian: Mylan dura GmbH Wittichstr.
English: 61118 Bad Vilbel
Slovenian: 61118 Bad Vilbel Germany
English: Tecnifar - Indústria Técnica Farmacêutica, S.A.
Slovenian: Portugalska Tecnifar - Indústria Técnica Farmacêutica, S.A.
English: Austria sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
Slovenian: Avstrija sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
English: Luxembourg Takeda Belgium Chaussée de Gand 615 1080 Bruxelles
Slovenian: Luksemburg Takeda Belgium Chaussée de Gand 615 1080 Bruxelles
English: 86156 Augsburg
Slovenian: 86156 Augsburg Germany
English: 83607 Hozkirchen
Slovenian: 83607 Hozkirchen Germany
English: Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50
Slovenian: Heumann Pharma GmbH & Co. Generica KG Südwestpark 50
English: Finland Sandoz A/S C. F. Tietgens Boulevard 40 5220 ODENSE SØ Denmark
Slovenian: C. F. Tietgens Boulevard 40 5220 ODENSE SØ Denmark
English: Denmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark
Slovenian: Edvard Thomsens Vej 14 DK-2300 København S Denmark
English: Ireland Sanofi-aventis Ireland Ltd. T/A SANOFI
Slovenian: Sanofi-aventis Ireland Ltd. T/A SANOFI
English: Rua Tierno GalvanAmoreiras - Torre 3 - 12º Lisboa
Slovenian: Amoreiras - Torre 3 - 12º Lisboa
English: 85101 Bratislava Slovak Republic
Slovenian: 85101 Bratislava
English: Sandoz B.V. Veluwezoom 22 1327 AH ALMERE The Netherlands
Slovenian: Veluwezoom 22 1327 AH ALMERE The Netherlands
English: Germany Stadapharm GmbH Stadastr 2-18
Slovenian: Stadapharm GmbH Stadastr 2-18
English: Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR The Netherlands
Slovenian: Nieuwe Donk 3 4879 AC ETTEN LEUR The Netherlands
English: Gebäude K703
Slovenian: Industriepark Höchst Gebäude K703
English: Luxembourg Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
Slovenian: Luksemburg Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
English: Lithuania UAB „SANOFI-AVENTIS LIETUVA“
Slovenian: UAB „SANOFI-AVENTIS LIETUVA“
English: Valproic acid Convulex gelule gastro résistante
Slovenian: Convulex gelule gastro résistante
English: Luxembourg Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Slovenian: Luksemburg Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
English: Denmark Sanofi-aventis Denmark A/S
Slovenian: Sanofi-aventis Denmark A/S
English: D-22311 HAMBURG Deutschland
Slovenian: D-22311 HAMBURG
English: 02101 Espoo
Slovenian: 02101 Espoo Finland
English: Apotex Europe B.V. Darwinweg 20 2333 CR LEIDEN The Netherlands
Slovenian: Darwinweg 20 2333 CR LEIDEN The Netherlands
English: Sanofi-Aventis Bulgaria EOOD
Slovenian: Bolgarija Sanofi-Aventis Bulgaria EOOD
English: Romania Sanofi-Aventis France 1-13 Boulevard Romain Rolland
Slovenian: Romunija Sanofi-Aventis France 1-13 Boulevard Romain Rolland
English: Germany Sanofi-Aventis Deutschland GmbH
Slovenian: Sanofi-Aventis Deutschland GmbH
English: Belgium Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Slovenian: Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem Belgium
English: Via Scarlatti Domenico, 31 20124 Milano Italy
Slovenian: Via Scarlatti Domenico, 31 20124 Milano Italy valprojska kislina, natrijev valproat
English: Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM The Netherlands
Slovenian: Swensweg 5 2031 GA HAARLEM The Netherlands
English: Belgium Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
Slovenian: Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart Belgium
English: Valproic acid Ácido Valpróico Generis
Slovenian: Ácido Valpróico Generis
English: Sandoz Pharmaceuticals d.d
Slovenian: Slovaška Sandoz Pharmaceuticals d.d
English: ARENA GROUP S.A. Str. Ştefan Mihăileanu nr.
Slovenian: Str. Ştefan Mihăileanu nr.
English: Germany Neuraxpharm Arzneimittel GmbH
Slovenian: Neuraxpharm Arzneimittel GmbH
English: Lithuania Orion Corporation Orionintie 1 A
Slovenian: Slovaška Orion Corporation Orionintie 1 A
English: Sanofi-Aventis zrt.
Slovenian: Madžarska Sanofi-Aventis zrt.
English: Sanofi-Aventis Slovakia s r.o.
Slovenian: Slovaška Sanofi-Aventis Slovakia s r.o.
English: Finland Orion Pharma Orionintie 1
Slovenian: Orion Pharma Orionintie 1 PL 65
English: Prolonged-release capsule
Slovenian: Kapsula s podaljšanim sproščanjem
English: Gastro-resistant capsule
Slovenian: Gastrorezistentna kapsula
English: Dunajska cesta 151 1000 Ljubljana Slovenia
Slovenian: Dunajska cesta 151
English: DEPAKINE CHRONO (SPHERE) 1000 mg/sachet Coated granules in sachet
Slovenian: DEPAKINE CHRONO (SPHERE) 1000 mg/sachet Obložena zrnca v vrečici
English: Gastro-resistant capsule, soft
Slovenian: Gastrorezistentna kapsula, mehka
English: Germany Winthrop Arzneimittel GmbH
Slovenian: Winthrop Arzneimittel GmbH
English: Romania Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Slovenian: Romunija Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: Germany Ratiopharm GmbH Graf-Arco-Strasse 3
Slovenian: Slovaška Ratiopharm GmbH Graf-Arco-Strasse 3
English: SI-1000 Ljubljana Slovenia
Slovenian: 1000 Ljubljana
English: Valproic acid CONVULEX 100 mg/ml oldatos injekció
Slovenian: CONVULEX 100 mg/ml oldatos injekció
English: Germany Aristo Pharma GmbH Wallenroder Str. 8-10
Slovenian: Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Germany
English: Germany betapharm Arzneimittel GmbH
Slovenian: betapharm Arzneimittel GmbH
English: 500-1000 mg Modified-release granules
Slovenian: 500-1000 mg Zrnca z prirejenim sproščanjem
English: Intravenous Use
Slovenian: Intravenska uporaba
English: LT-09310 Vilnius
Slovenian: A. Juozapavičiaus g. 6/2 LT-09310 Vilnius Lithuania
English: Germany Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1
Slovenian: Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany
English: Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda Lagos Park, Edíficio 5A, Piso 2
Slovenian: Lagos Park, Edíficio 5A, Piso 2
English: Sanofi-Aventis SpA Viale Luigi Bodio, 37/B 20158 Milano Italy
Slovenian: Sanofi-Aventis SpA Viale Luigi Bodio, 37/B 20158 Milano Italy valpromid Depamide
English: Valproic acid CONVULEX 50 mg/ml szirup gyermekeknek
Slovenian: CONVULEX 50 mg/ml szirup gyermekeknek
English: Gastro-resistant capsule, hard
Slovenian: Gastrorezistentna kapsula, trda
English: Convulex 300 mg/ml - Lösung zum Einnehmen
Slovenian: Convulex 300 mg/mlLösung zum Einnehmen
English: Avenida Professor Doutor Cavaco Silva, 10 E 2740-255 Porto Salvo Portugal
Slovenian: Avenida Professor Doutor Cavaco Silva, 10 E
English: Valproic acid Convulex 50 mg/ml - Sirup für Kinder
Slovenian: Convulex 50 mg/ml - Sirup für Kinder
English: Valproic acid Diplexil 1000
Slovenian: Diplexil 1000
English: Lithuania G.L.
Slovenian: Madžarska G.L.
English: Valproic acid DEPAKINE 100 mg/ml por és oldószer oldatos injekcióhoz
Slovenian: DEPAKINE 100 mg/ml por és oldószer oldatos injekcióhoz
English: Valproic acid Convulex 300 mg - Kapseln 300 mg
Slovenian: Convulex 300 mg - Kapseln 300 mg
English: Germany 1 A Pharma GmbH Keltenring 1 + 3
Slovenian: 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany
English: Magnesium valproate
Slovenian: Italy magnezijev valproat
English: 13435 Berlin espa-valept 300 mg retard 199.8 mg, 87 mg
Slovenian: Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Germany espa-valept 300 mg retard 199.8 mg, 87 mg
English: Valproic acid Convulex 500 mg - Kapseln 500 mg
Slovenian: Convulex 500 mg - Kapseln 500 mg
English: Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
Slovenian: ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany
English: Belgium Takeda Belgium Gentsesteenweg 615
Slovenian: Takeda Belgium Gentsesteenweg 615 1080 Brussels Belgium
English: Valproic acid Convulex 150 mg - Kapseln 150 mg
Slovenian: Convulex 150 mg - Kapseln 150 mg
English: 104 25 Stockholm Sweden
Slovenian: 104 25 Stockholm Sweden valprojska kislina natrijev valproat
English: Sweden Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Slovenian: Slovaška Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: Coated granules in sachet
Slovenian: Obložena zrnca v vrečici
English: Solution for injection/concentra te for solution for infusion
Slovenian: Raztopina za injiciranje/koncentr at za raztopino za infundiranje
English: Valproic acid VALPROATE SODIUM SANDOZ 500MG
Slovenian: NATRIJEV VALPROAT SANDOZ 500MG
English: Valproic acid CONVULEX 300 mg gyomornedv-ellenálló lágy kapszula
Slovenian: CONVULEX 300 mg gyomornedv-ellenálló lágy kapszula
English: 40764 Langelfeld
Slovenian: Elisabeth-Selbert-Str. 23 40764 Langelfeld Germany
English: Valproic acid Convulex Capsules 150mg 150 mg
Slovenian: Convulex Capsules 150mg 150 mg
English: Valproic acid DEPAKINE 50 mg/ml szirup 50 mg/ml
Slovenian: DEPAKINE 50 mg/ml szirup 50 mg/ml
English: Valproic acid CONVULEX 150 mg gyomornedv-ellenálló lágy kapszula
Slovenian: CONVULEX 150 mg gyomornedv-ellenálló lágy kapszula
English: Valproic acid Convulex 300 mg gastroresistant capsules, soft
Slovenian: Convulex 300 mg gastroresistant capsules, soft
English: Valproic acid Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada
Slovenian: Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada
English: Valproic acid Convulex 150 mg gastroresistant capsules, soft
Slovenian: Convulex 150 mg gastroresistant capsules, soft
English: Valproic acid CONVULEX 500 mg gyomornedv-ellenálló lágy kapszula
Slovenian: CONVULEX 500 mg gyomornedv-ellenálló lágy kapszula
English: Film-coated tablet Oral Use
Slovenian: Obložena tableta Peroralna uporaba
English: Valproic acid Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada
Slovenian: Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada
English: Valproic acid Ácido Valpróico Sandoz 500 mg Comprimidos de libertação prolongada
Slovenian: Ácido Valpróico Sandoz 500 mg Comprimidos de libertação prolongada
English: Valproic acid Depakine 400 mg/4 ml
Slovenian: Depakine 400 mg/4 ml
English: Valproic acid Convulex 500 mg gastroresistant capsules, soft
Slovenian: Convulex 500 mg gastroresistant capsules, soft
English: Valproic acid CONVULEX RETARD 500MG 500 mg
Slovenian: CONVULEX RETARD 500MG 500 mg
English: Valproic acid Absenor 300 mg tablety s predĺženým uvoľňovaním
Slovenian: Absenor 300 mg tablety s predĺženým uvoľňovaním
English: Valproic acid Convulex Capsules 300mg 500 mg
Slovenian: Convulex Capsules 300mg 500 mg
English: Valproate sodium Sandoz
Slovenian: Natrijev valproat Sandoz
English: Valproic acid Ácido Valpróico Sandoz 300 mg Comprimidos de libertação prolongada
Slovenian: Ácido Valpróico Sandoz 300 mg Comprimidos de libertação prolongada
English: Modified-release capsule, hard
Slovenian: Kapsula z prirejenim sproščanjem, trda
English: Valproic acid Convulex Capsules 500mg 300 mg
Slovenian: Convulex Capsules 500mg 300 mg
English: Valproic acid Convulex 300 mg kapsuly
Slovenian: Convulex 300 mg kapsuly
English: Valproic acid Propymal Enteric 150 mg, maagsapresistente capsules
Slovenian: Propymal Enteric 150 mg, maagsapresistente capsules
English: Valproic acid Propymal Enteric 600 mg, maagsapresistente capsules
Slovenian: Propymal Enteric 600 mg, maagsapresistente capsules
English: Valproic acid CONVULEX RETARD 300MG 300 mg
Slovenian: CONVULEX RETARD 300MG 300 mg
English: Valproic acid Propymal Enteric 450 mg, maagsapresistente capsules
Slovenian: Propymal Enteric 450 mg, maagsapresistente capsules
English: Valproic acid Absenor 500 mg tablety s predĺženým uvoľňovaním
Slovenian: Absenor 500 mg tablety s predĺženým uvoľňovaním
English: Valproic acid Convulex 150 mg kapsuly
Slovenian: Convulex 150 mg kapsuly
English: Valproic acid CONVULEX 500 mg retard filmtabletta prolonged release film-coated tablet
Slovenian: CONVULEX 500 mg retard filmtabletta filmsko obložena tableta s podaljšanim sproščanjem
English: Valproic acid Convulex 500 mg kapsuly
Slovenian: Convulex 500 mg kapsuly
English: Valproid acid, Sodium valproate
Slovenian: valprojska kislina, natrijev valproat
English: Capsule, soft
Slovenian: Kapsula, mehka Peroralna uporaba
English: Powder for injection Intravenous use
Slovenian: Prašek za injiciranje
English: Valproic acid Propymal Enteric 300 mg, maagsapresistente capsules
Slovenian: Propymal Enteric 300 mg, maagsapresistente capsules
English: Sanofi-Aventis d.o.o.
Slovenian: Slovenija Sanofi-Aventis d.o.o.
English: Germany TAD Pharma GmbH Heinz-Lohmann-Str. 5
Slovenian: TAD Pharma GmbH Heinz-Lohmann-Str. 5 27472 Cuxhaven Germany
English: Valproic acid Depakine chrono 300 mg tablete s podaljšanim sproščanjem
Slovenian: Depakine chrono 300 mg tablete s podaljšanim sproščanjem
English: Valproic acid Depakine chrono 500 mg tablete s podaljšanim sproščanjem
Slovenian: Depakine chrono 500 mg tablete s podaljšanim sproščanjem
English: 13435 Berlin espa-valept 500 mg retard 333 mg, 145 mg
Slovenian: Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Germany espa-valept 500 mg retard 333 mg, 145 mg
English: 103, Alexander Stamboliiski Blvd 1303 Sofia
Slovenian: 1303 Sofia
English: MICROPAKINE L.P. 750 mg, granulés à libération prolongée en sachet-dose
Slovenian: 750 mg, granulés à libération prolongée en sachet-dose
English: Romania S.C.
Slovenian: Romunija S.C. ARENA GROUP S.A.
English: MICROPAKINE L.P. 1000 mg, granulés à libération prolongée en sachet-dose
Slovenian: 1000 mg, granulés à libération prolongée en sachet-dose
English: Depakine Crono 300 mg comprimidos recubiertos
Slovenian: Depakine Crono 300 mg comprimidos de liberación prolongada
English: Modified-release granules
Slovenian: Zrnca z prirejenim sproščanjem
English: MICROPAKINE L.P. 250 mg, granulés à libération prolongée en sachet-dose
Slovenian: 250 mg, granulés à libération prolongée en sachet-dose
English: MICROPAKINE L.P. 500 mg, granulés à libération prolongée en sachet-dose
Slovenian: 500 mg, granulés à libération prolongée en sachet-dose
English: Modified-release tablet
Slovenian: Tableta z prirejenim sproščanjem
English: Valproic acid CONVULEX 300 MG/ML
Slovenian: CONVULEX 300 MG/ML
English: Gastroresistant tablets
Slovenian: Filmsko obložena tableta
English: MICROPAKINE L.P. 100 mg, granulés à libération prolongée en sachet-dose
Slovenian: 100 mg, granulés à libération prolongée en sachet-dose
English: Solution for injection/infusion
Slovenian: Raztopina za injiciranje/infundira nje
English: Depakine Crono 500 mg comprimidos recubiertos
Slovenian: Depakine Crono 500 mg comprimidos de liberación prolongada
English: Germany G.L.
Slovenian: Bolgarija G.L.
English: Valproic acid Valproat "Sandoz"
Slovenian: Valproat "Sandoz"
English: Valproat Aristo 600 mg magensaftresistente Filmtabletten
Slovenian: Valproat Aristo 600 mg magensaftresistente Filmtabletten betapharm Arzneimittel GmbH
English: Powder and solvent for solution for injection
Slovenian: Prašek in vehikel za raztopino za injiciranje
English: Valpro beta chrono 300 mg Retardtabletten
Slovenian: Valpro beta chrono 300 mg Retardtabletten betapharm Arzneimittel GmbH
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
Slovenian: Priloga II Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravili ter podrobna obrazložitev odstopanj od priporočila odbora PRAC
English: The marketing authorisations for chlormadinone containing combined hormonal contraceptives are subject to the conditions set out in Annex IV.
Slovenian: Za dovoljenja za promet s kombiniranimi hormonskimi kontraceptivi, ki vsebujejo klormadinon, veljajo pogoji, opredeljeni v Prilogi IV.
English: The amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are set out in Annex III.
Slovenian: Spremembe zadevnih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo so opredeljene v Prilogi III.
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.
Slovenian: Potem ko je CHMP proučil priporočilo, ki ga je dne 10. oktobra 2013 v skladu s členom 107k(3) Direktive 2001/83/ES izdal PRAC, je menil, da bi bilo treba spremeniti dovoljenja za promet s kombiniranimi hormonskimi kontraceptivi, ki vsebujejo klormadinon, dezogestrel, dienogest, drospirenon, etonogestrel, gestoden ali norgestimat.
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.
Slovenian: Posledično je PRAC zaključil, da je razmerje med tveganji in koristmi zdravil, navedenih v Prilogi I, za indikacijo kontracepcije še naprej ugodno pod pogojem, da se upoštevajo dogovorjeni pogoji, omejitve, opozorila in druge spremembe informacij o zdravilu ter dodatni ukrepi za zmanjšanje tveganja.
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.
Slovenian: Potem ko je proučil vse navedeno, je PRAC zaključil, da je razmerje med tveganji in koristmi zdravil, navedenih v Prilogi I, za indikacijo kontracepcije še naprej ugodno pod pogojem, da se v informacije o zdravilu vključijo dogovorjene omejitve, opozorila in druge spremembe.
English: Date of first authorisation: 21 March 2007 Date of latest renewal: 23 February 2012
Slovenian: Datum prve odobritve: 21. marec 2007 Datum zadnjega podaljšanja: 23. februar 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).
Slovenian: Ne jemljite zdravila Januvia - če ste alergični na sitagliptin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: STOP taking Januvia and contact a doctor immediately if you notice any of the following serious side effects:
Slovenian: Zdravilo Januvia takoj PRENEHAJTE jemati in se posvetujte z zdravnikom, če opazite katerega koli od naslednjih resnih neželenih učinkov:
English: Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Slovenian: Zdravila Januvia se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 ali za zdravljenje diabetične ketoacidoze.
English: Due to lack of human data, Januvia should not be used during pregnancy.
Slovenian: Zaradi pomanjkanja podatkov pri ljudeh se zdravila Januvia med nosečnostjo ne sme jemati.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli za oznako "EXP".
English: Your doctor may ask you to stop Januvia.
Slovenian: Zdravnik vam bo morda naročil, da prenehate z jemanjem zdravila Januvia.
English: If you take more Januvia than you should If you take more than the prescribed dosage of this medicine, contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Januvia, kot bi smeli Če ste vzeli večji odmerek tega zdravila od predpisanega, se takoj posvetujte z zdravnikom.
English: What Januvia is and what it is used for
Slovenian: Kaj je zdravilo Januvia in za kaj ga uporabljamo
English: If you have kidney problems, your doctor may prescribe lower doses(such as 25mg or 50mg).
Slovenian: Če imate težave z ledvicami, vam zdravnik lahko predpiše manjše odmerke zdravila (npr. 25 mg ali 50 mg).
English: Other medicines and Januvia
Slovenian: Druga zdravila in zdravilo Januvia
English: What you need to know before you take Januvia
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Januvia
English: Incidenc e rate per 100 patientyears* N (%)
Slovenian: Pojavnost na 100 bolnik-let* N (%)
English: For adult patients with type 2 diabetes mellitus, Januvia is indicated to improve glycaemic control:
Slovenian: Pri odraslih bolnikih s sladkorno boleznijo tipa 2 je zdravilo Januvia indicirano za izboljšanje urejenosti glikemije:
English: When used in combination with metformin and/or a PPAR agonist, the dose of metformin and/or PPAR agonist should be maintained, and Januvia administered concomitantly.
Slovenian: Pri uporabi v kombinaciji z metforminom in/ali agonistom PPAR je treba odmerek metformina in/ali agonista PPAR ohraniti in zdravilo Januvia uporabljati sočasno.
English: What Januvia is and what it is used for What you need to know before you take Januvia How to take Januvia
Slovenian: Kaj je zdravilo Januvia in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Januvia Kako jemati zdravilo Januvia Možni neželeni učinki