FrancophonIA/ELRC3.0 huggingface dataset:
English: The final study reports of the above studies should be submitted to the National Competent Authorities for assessment.
Romanian: Rapoartele finale ale studiilor menţionate anterior trebuie transmise pentru evaluare autorită ilor naţionale competente.
English: • The MAHs should conduct a pre-clinical study on identification of reactive metabolites and protein adduct information.
Romanian: • Titularii autorizaţiilor de introducere pe piaţă trebuie să efectueze un studiu preclinic pentru identificarea metaboliţilor reactivi şi a informaţiilor privind aductul de proteină.
English: Further updates of the Risk Management Plan should be submitted for assessment at national level.
Romanian: Versiunile actualizate ulterioare ale Planului de gestionare a riscurilor trebuie transmise pentru evaluare autorităţilor naţionale competente.
English: The MAHs should strengthen the medical review, refine the monitoring of reporting rates, and improve the quality of Individual Case Safety Reports of nimesulide.
Romanian: Titularii autorizaţiilor de introducere pe piaţă trebuie să amelioreze raportul medical, să perfecţioneze monitorizarea ritmului de raportare şi să îmbunătăţească calitatea rapoartelor de siguranţă pentru cazuri individuale pentru nimesulidă.
English: • The MAHs should inform healthcare professionals on the outcome of this review on nimesulide via a “Direct Healthcare Professional Communication” (DHPC) to be agreed with the CHMP.
Romanian: • Titularii autorizaţiilor de introducere pe piaţă trebuie să informeze personalul medico-sanitar cu privire la rezultatele analizei privind nimesulida printr-o comunicare directă (Direct Healthcare Professional Communication - DHPC) care va fi redactată în acord cu CHMP.
English: • The MAHs should conduct a retrospective cohort study in transplant centres.
Romanian: • Titularii autorizaţiilor de introducere pe piaţă trebuie să efectueze un studiu de cohortă retrospectiv în centre de transplant.
English: The MAHs should expedite and submit all safety reports and case series in PSURs for nimesulide, with a six monthly periodicity.
Romanian: Titularii autorizaţiilor de introducere pe piaţă trebuie să urgenteze şi să transmită toate rapoartele de siguranţă şi seriile de cazuri din PSUR pentru nimesulidă, la fiecare şase luni.
English: • The MAHs should submit a revised Risk Management Plan for nimesulide, considering the comments raised during this procedure, to the CHMP.
Romanian: • Titularii autorizaţiei de introducere pe piaţă trebuie să transmită CHMP un Plan revizuit de gestionare a riscurilor pentru nimesulidă, ţinând seama de comentariile făcute în cadrul acestei proceduri.
English: These PSURs should be submitted to the National Competent Authorities for assessment.
Romanian: PSUR trebuie transmise pentru evaluare autorităţilor naţionale competente.
English: • The MAHs should perform a monitoring activity to evaluate the effectiveness of risk communication on nimesulide.
Romanian: • Titularii autorizaţiilor de introducere pe piaţă desfăşoară o activitate de monitorizare pentru a evalua eficienţa comunicării privind nimesulida.
English: • The MAHs should conduct a review of epidemiological data to review the risk of hepatic damage from nimesulide in comparison with other NSAIDs
Romanian: • Titularii autorizaţiilor de introducere pe piaţă trebuie să efectueze o analiză a datelor epidemiologice pentru evaluarea riscului nimesulidei de afectare hepatică faţă de alte AINS.
English: The following conditions in relation to post-marketing surveillance, studies and review and communication shall be fulfilled by the Marketing Authorisation Holders of nimesulide containing medicinal products (systemic formulation).
Romanian: Titularii autorizaţiilor de introducere de piaţă pentru produsele medicamentoase care conţin nimesulidă (formulă sistemică) trebuie să îndeplinească următoarele condiţii referitoare la supravegherea ulterioară introducerii pe piaţă, studii, analize şi comunicări.
English: Medicinal product no longer authorised
Romanian: Produsul m edicinal nu ai este autorizat
English: Name Strength
Romanian: Numele Concentraţia Forma farmacêutica
English: 1 ml (120 mg/ml) 1 pre-filled pen + 2 alcohol pads
Romanian: 1 ml (120 mg/ml) 2 seringi preumplute + 2 tampoane de alcool
English: 75014 PARIS
Romanian: 75014 Paris France
English: em., H-1036 Budapest Hungary
Romanian: H-1036 Budapest Hungary
English: 13353 Berlin
Romanian: D-13353 Berlin
English: 92931 PARIS LA DEFENSE FRANCE
Romanian: 92931 Paris la Defence France
English: 28108 Alcobendas (Madrid) Spain
Romanian: 28108 Alcobendas Madrid
English: Rua Quinta Pinheiro, 5, Outurela - Carnaxide
Romanian: Rua Quinta Pinheiro, 5, Outurela
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for cyproterone acetate/ethinylestradiol containing medicinal products
Romanian: Lista cu denumirile comerciale, formele farmaceutice, concentraţiile, calea de administrare ale medicamentelor, solicitanţii, deţinătorii autorizaţiei de punere pe piaţă în statele membre
English: LADEEPHARMA PHARMACEUTICAL Limited Lajos u. 48-66, E ép.
Romanian: Ladeepharma Pharmaceutical Limited Lajos u. 48-66
English: MAROUSSI GR-15125 ATHENS
Romanian: Athens GR-15125 Greece
English: Osa Mayor, 4 28023 Aravaca (Madrid) Spain
Romanian: Osa Mayor, 4 28023 Aravaca Madrid
English: Ilford, Essex IG3 8BS
Romanian: Essex IG3 8BS
English: TEVA PHARMA, SLU Anabel Segura 11, Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain
Romanian: Teva Pharma, SLU Anabel Segura 11 Edificio Albatros B 1ª planta 28108 Alcobendas Madrid
English: Sandoz d.d Verovskova 57, 1000 Ljubljana
Romanian: Sandoz d.d Verovskova 57 1000 Ljubljana Slovenia
English: LABORATOIRES MAJORELLE 80-82 rue Gallieni 92100 BOULOGNE BILLANCOURT FRANCE
Romanian: Laboratoires Majorelle 80-82 rue Gallieni 92100 Boulogne Billancourt
English: Berlifarma - Especialidades Farmaceuticas, Lda.
Romanian: BerlifarmaEspecialidades Farmaceuticas, Lda.
English: United Kingdom Fannin (UK) Limited, 42-46 Booth Drive, Park Farm
Romanian: Marea Britanie Fannin (UK) Limited 42-46 Booth Drive
English: United Kingdom Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL
Romanian: Generics (UK) Limited Station Close Potters Bar Hertfordshire EN6 1TL United Kingdom
English: Bayer S.p.A. Viale Certosa, 130 - 20156 Milano (MI) Italy
Romanian: Viale Certosa, 130 20156 Milano (MI) Italy
English: Parc d'Activités des Peupliers - 25 rue des Peupliers 92000 NANTERRE FRANCE
Romanian: 25 rue des Peupliers 92000 Nanterre France
English: EG LABO - LABORATOIRES EUROGENERICS 12 rue Danjou le Quintet bâtiment A 92517 BOULOGNE BILLANCOURT CEDEX FRANCE
Romanian: LABORATOIRES EUROGENERICS 12 rue Danjou le Quintet bâtiment A 92517 Boulogne Billancourt Cedex France
English: Pliva Hungária Kereskedelmi és Szolgáltató Kft. Rákóczi út 70-72 Budapest 1074 Hungary
Romanian: Rákóczi út 70-72 Budapest 1074 Hungary
English: CYPROTERONE/ETHIN YLESTRADIOL BAYER 35 µg
Romanian: CYPROTERONE/ETHINYLESTRADIOL BAYER 35 µg
English: Patient Health Protection
Romanian: Concentraţia Forma farmaceutică
English: 220, avenue de la Recherche 59120 Loos
Romanian: Bayer Santé 220, avenue de la Recherche 59120 Loos France
English: United Kingdom Teva UK Limited, Brampton Road, Hampden Park,
Romanian: Marea Britanie Teva UK Limited Brampton Road
English: United Kingdom Strandhaven Limited, 600 High Road, Seven Kings,
Romanian: Marea Britanie Strandhaven Limited 600 High Road
English: Medico Uno Worldwide Ltd.,2 Grigori Afxentiou Street + Larnaca 6023
Romanian: 2 Grigori Afxentiou Street Larnaca 6023
English: EFFIK bâtiment ''le Newton'' 9-11 rue Jeanne Braconnier 92366 MEUDON LA FORET FRANCE
Romanian: EFFIK bâtiment ''le Newton'' 9-11 rue Jeanne Braconnier
English: 49 avenue Georges Pompidou 92593 LEVALLOIS PERRET CEDEX
Romanian: 92593 Levallois Perret Cedex
English: United Kingdom Stragen UK Limited, Castle Court, 41 London Road,
Romanian: Marea Britanie Stragen UK Limited Castle Court 41
English: United Kingdom Bayer plc, Bayer House, strawberry Hill, Newbury, Berkshire RG14 1JA
Romanian: Strawberry Hill Newbury, Berkshire RG14 1JA,
English: United Kingdom Farmalider SA, Calle Aragoneses 15, Alcobendas, Madrid E-28108
Romanian: Farmalider S.A. Calle Aragoneses, 15 28108 Alcobendas Madrid
English: FIDIA Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/A, 35031 Abano Terme (PD) Italy
Romanian: FIDIA Farmaceutici S.p.A. Via Ponte della Fabbrica 3/A
English: United Kingdom Chatfiled Pharmaceuticals Limited, Kramer Mews,
Romanian: Marea Britanie Chatfield Pharmaceuticals Limited
English: Marszałka J.Piłsudskiego 5 95-200 Pabianice Poland
Romanian: 95-200 Pabianice Poland
English: Poland acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grunwald Germany
Romanian: Acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grünwald Germany
English: Chloe 35 micrograms/2 mg film-coated tablets
Romanian: Chloe 35 micrograms/2 mg filmcoated tablets
English: Diane 2000 micrograms/35 micrograms filmcoated tablets
Romanian: Diane 2000 micrograms/35 micrograms film-coated tablets
English: Reigate, Surrey RH2 9RJ
Romanian: Reigate, Surrey RH2 PRJ United Kingdom
English: Mithra Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège
Romanian: Rue Saint Georges 5 4000 Liège
English: Estonia ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Romanian: Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
English: United Kingdom Sandoz Limited, Frimley Business Park, Frimley,
Romanian: Marea Britanie Sandoz Limited Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
English: South, Wellingborough, Kent NN8 6GT
Romanian: Kent NN8 6GT
English: The Netherlands ratiopharm Nederland B.V. Swensweg 5
Romanian: Olanda ratiopharm Nederland B.V.
English: Castle Court 41, London Road, Reigate, Surrey RH2 PRJ,
Romanian: London Road Reigate, Surrey RH2 PRJ United Kingdom
English: PIERRE FABRE DERMATOLOGIE 45 place Abel Gance 92100 BOULOGNE FRANCE
Romanian: Luxemburg Pierre Fabre Dermatologie 45, place Abel Gance
English: Stragen UK Ltd.
Romanian: Medico Uno Worldwide Ltd.
English: Fannin UK CoCyprindiol 2000/35 Tablets
Romanian: Fannin UK Co-Cyprindiol 2000/35 Tablets
English: BAYER ΕΛΛΑΣ ΑΒΕΕ SOROU 18-20
Romanian: Bayer Hellas ABEE Sorou 18-20
English: Bellgyn "ratiopharm" 2 mg/ 0,035 mgüberzogene Tabletten
Romanian: Bellgyn "ratiopharm" 2 mg/ 0,035 mg - überzogene Tabletten
English: 11-15 quai de Dion Bouton 92800 PUTEAUX FRANCE
Romanian: 92800 Puteaux France
English: Almirall Hermal GmbH Scholzstr.
Romanian: Taurus Pharma GmbH Benzstr.
English: ACETATO DE CIPROTERONA/ETINIL ESTRADIOL SANDOZ 2 mg/0,035 mg comprimidos recubiertos EFG
Romanian: CIPROTERONA/ETINILESTRADIOL SANDOZ 2 mg/0,035 mg comprimidos recubiertos EFG
English: 21465 Reinbek Germany
Romanian: 61352 Bad Homburg Germany
English: Cyproteronacetaat/Eth inylestradiol Sandoz 2/0,035, omhulde tabletten
Romanian: Cyproteronacetaat/Ethinylestradiol Sandoz 2/0,035, omhulde tabletten
English: BN22 9AG
Romanian: East Sussex BN22 9AG United Kingdom
English: TEVASANTE
Romanian: Comprimat
English: Cyproteronacetaat/eth inylestradiol Actavis 2/0,035 mg, filmomhulde tabletten 2 mg/0,035 mg
Romanian: Cyproteronacetaat/ethinylestradiol Actavis 2/0,035 mg, filmomhulde tabletten 2 mg/0,035 mg
English: 0,035mg/2mg überzogene Tablette
Romanian: Diane-35 0,035mg/2mg überzogene Tablette
English: Camilette CoCyprindiol 2000/35 Tablets
Romanian: Camilette Co-Cyprindiol 2000/35 Tablets
English: Alternova A/S, Lodshusvej 11, DK-4230 Skælskør Denmark
Romanian: DK-4230 Skælskør Denmark
English: Strandhaven CoCyprindiol 2000/35 Tablets
Romanian: Strandhaven Co-Cyprindiol 2000/35 Tablets
English: Sandoz A/S, Edvard Thomsens Vej 14, DK-2300 København S
Romanian: Edvard Thomsens Vej 14 DK-2300 København S Denmark
English: Acetato Ciproterona/ Etinilestradiol 2 mg/ 0,035 mg
Romanian: Acetato Ciproterona/ Etinilestradiol 2 mg/ 0,035 mg Comprimidos
English: Cyproteronacetaat/Eth inylestradiol 2/0,035 PCH, omhulde tabletten 2 mg/0,035 mg
Romanian: Cyproteronacetaat/Ethinylestradiol 2/0,035 PCH, omhulde tabletten 2 mg/0,035 mg
English: Clevia 2 mg/0,035 mg Filmtabletten
Romanian: Cyprotomin 2 mg/0,035 mg Filmtabletten
English: CYPROTERONE/ETHIN YLESTRADIOL DCI PHARMA 2 mg/0,035 mg
Romanian: CYPROTERONE/ETHINYLESTRADIOL DCI PHARMA 2 mg/0,035 mg
English: CYPROTERONE/ETHIN YLESTRADIOL RATIOPHARM 2 mg/0,035 mg
Romanian: CYPROTERONE/ETHINYLESTRADIOL RATIOPHARM 2 mg/0,035 mg
English: Orifarm Generics Energivej 15 - POB 69 DK-5260 Odense S Denmark
Romanian: DK-5260 Odense S. Denmark
English: CYPROTERONE/ETHIN YLESTRADIOL RANBAXY 2 mg/0,035 mg
Romanian: CYPROTERONE/ETHINYLESTRADIOL RANBAXY 2 mg/0,035 mg
English: Cyproteronacetaat/eth inylestradiol Apotex 2/0,035 mg, omhulde tabletten
Romanian: Cyproteronacetaat/ethinylestradiol Apotex 2/0,035 mg, omhulde tabletten
English: FARMALIDER, S.A.
Romanian: Generis Farmaceutica, S.A.
English: Cyproteronacetaat/Eth inylestradiol CF 2/0,035 mg, omhulde tablet
Romanian: Cyproteronacetaat/Ethinylestradiol CF 2/0,035 mg, omhulde tablet
English: CYPROTERONE/ETHIN YLESTRADIOL SANDOZ 2 mg/0,035 mg
Romanian: CYPROTERONE/ETHINYLESTRADIOL SANDOZ 2 mg/0,035 mg
English: Cyproteronacetaat/eth inylestradiol ratiopharm 2 mg/0,035 mg, omhulde tabletten
Romanian: Cyproteronacetaat/ethinylestradiol ratiopharm 2 mg/0,035 mg, omhulde tabletten
English: Comprimidos
Romanian: Alcobendas
English: Generics (UK) Limited trading as Mylan
Romanian: Marea Britanie Generics (UK) Limited Station Close
English: CYPROTERONE/ETHIN YLESTRADIOL ZENTIVA 2 mg/0,035 mg
Romanian: CYPROTERONE/ETHINYLESTRADIOL ZENTIVA 2 mg/0,035 mg
English: Cyproteronacetaat/Eth inylestradiol Mylan 2 mg/0,035 mg, omhulde tabletten
Romanian: Cyproteronacetaat/Ethinylestradiol Mylan 2 mg/0,035 mg, omhulde tabletten
English: CYPROTERONE/ETHIN YLESTRADIOL TEVA 2 mg/0,035 mg
Romanian: CYPROTERONE/ETHINYLESTRADIOL TEVA 2 mg/0,035 mg
English: CYPROTERONE/ETHIN YLESTRADIOL ZYDUS 2 mg/0,035 mg
Romanian: CYPROTERONE/ETHINYLESTRADIOL ZYDUS 2 mg/0,035 mg
English: CYPROTERONE/ETHIN YLESTRADIOL EG 2 mg/0,035 mg
Romanian: CYPROTERONE/ETHINYLESTRADIOL EG 2 mg/0,035 mg
English: Bayer Schering Pharma AG Müllerstr.
Romanian: Bayer N.V. Jan Emiel Mommaertslaan
English: GINESERVICE 0,035 mg/2 mg comprimidos EFG
Romanian: ETINILESTRADIOL/CIPROTERONA GINESERVICE 0,035 mg/2 mg comprimidos EFG
English: Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S., Denmark
Romanian: Orifarm Generics A/S Postbox 69
English: Aragoneses, 15
Romanian: Piłsudskiego 5
English: Cyproteronacetaat/Eth inylestradiol 2 mg/0,035 mg, omhulde tabletten
Romanian: Cyproteronacetaat/Ethinylestradiol 2 mg/0,035 mg, omhulde tabletten
English: RANBAXY PHARMACIE GENERIQUES
Romanian: Ranbaxy Pharmacie Generiques 11-15 quai de Dion Bouton
English: United Kingdom Cipla (EU) Limited, Millbrow House, Millbrow Road, Esher, Surrey KT10 9NW
Romanian: Marea Britanie Cipla (EU) Limited Hillbrow House
English: STRAGEN
Romanian: Esher
English: 130 U kabelovny+Prague
Romanian: Republica Cehă Zentiva, k.s. U kabelovny 130
English: Cyproderm
Romanian: Cyproterone
English: Generis Farmaceutica, S.A. Rua Joao de Deus, 19Amadora
Romanian: Rua Joao de Deus, 19 2700-487 Amadora Portugal
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: ANEXA I LISTA CU DENUMIRILE COMERCIALE, FORMA FARMACEUTICĂ, CONCENTRAŢIA, CALEA DE ADMINISTRARE A MEDICAMENTULUI, DEŢINĂTORII AUTORIZAŢIEI DE PUNERE PE PIAŢĂ ÎN STATELE MEMBRE
English: Etterstad 0601, OSLO
Romanian: Etterstad 0601, OSLO Norway
English: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels, Belgium
Romanian: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussel, Belgium
English: Folate supplementation was optional and only used in 10 % of patients.
Romanian: Administrarea suplimentară de folat a fost opţională şi s-a utilizat numai la 10 % dintre pacienţi.
English: • if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
Romanian: • dacă aţi avut vreodată tuberculoză sau dacă aţi venit în contact cu o persoană care are sau care a avut tuberculoză.
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the bottle after EXP.
Romanian: Nu utilizaţi acest medicament după data de expirare înscrisă pe cutie şi flacon după “EXP”.
English: • if you are pregnant, think you may be pregnant, or are breast-feeding.
Romanian: • dacă sunteţi gravidă, credeţi că sunteţi gravidă sau alăptaţi.
English: Some patients may even still feel further improvements after 4 to 6 months of therapy.
Romanian: Unii pacienţi pot să simtă şi în continuare o ameliorare, chiar după 4-6 luni de tratament.
English: • if you suffer from any problem which affects your immune system (e.g. AIDS),
Romanian: • dacă suferiţi de orice fel de problemă care vă afectează sistemul imun (de exemplu SIDA),
English: Leflunomide medac is not recommended for use in children and adolescents below 18 years of age.
Romanian: Leflunomidă medac nu este recomandată pentru utilizare la copii şi adolescenţi cu vârsta sub 18 ani.
English: Date of latest renewal: 23 March 2015
Romanian: Data ultimei reînnoiri a autorizaţiei: 23 martie 2015
English: Tell your doctor immediately if you experience:
Romanian: Adresaţi-vă imediat medicului dumneavoastră dacă aveţi:
English: You will normally take Leflunomide medac over long periods of time.
Romanian: În mod normal, veţi lua Leflunomidă medac pentru perioade lungi de timp.
English: • severe and potentially severe allergic reactions,
Romanian: • reacţii alergice severe şi posibil severe,
English: Patients should be closely monitored for signs and symptoms of excessive exposure to the medicinal products and reduction of the dose of these medicinal products should be considered.
Romanian: Pacienţii trebuie monitorizaţi cu atenţie pentru apariţia semnelor şi simptomelor expunerii în exces la medicamente şi trebuie luată în considerare scăderea dozelor acestor medicamente.
English: Leflunomide medac can make you feel dizzy which may impair your ability to concentrate and react.
Romanian: Leflunomidă medac vă poate face să vă simţiţi ameţit(ă), ceea ce poate afecta capacitatea dumneavoastră de a vă concentra şi de a reacţiona.
English: Leflunomide medac with food, drink and alcohol Leflunomide medac may be taken with or without food.
Romanian: Leflunomidă medac împreună cu alimente, băuturi şi alcool etilic Leflunomidă medac poate fi luată cu sau fără alimente.
English: Pharmacokinetic data in elderly (> 65 years) are limited but consistent with pharmacokinetics in younger adults.
Romanian: Datele farmacocinetice la vârstnici (> 65 de ani) sunt limitate, dar în concordanţă cu datele farmacocinetice observate la adulţii mai tineri.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 July 2010
Romanian: DATA PRIMEI AUTORIZĂRI SAU A REÎNNOIRII AUTORIZAŢIEI Data primei autorizări: 27 iulie 2010
English: LIST OF EXCIPIENTS This medicinal product contains lactose and soya lecithin (see leaflet for further information).
Romanian: LISTA EXCIPIENŢILOR Acest medicament conţine lactoză şi lecitină din soia (vezi prospectul pentru informaţii suplimentare).
English: The tablets are packed in bottles.
Romanian: Comprimatele sunt ambalate în flacoane.
English: • tizanidine, a muscle relaxant
Romanian: • tizanidină, un relaxant muscular,
English: • if you are suffering from a serious infection,
Romanian: • dacă aveţi o infecţie gravă,
English: • loss of appetite, weight loss (usually insignificant),
Romanian: • pierdere poftei de mâncare, scădere în greutate (de obicei nesemnificativă),
English: leucopenia (leucocytes > 2 G/l)
Romanian: leucopenie (leucocite > 2 g/l)
English: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Romanian: Clasificarea în funcţie de frecvenţă a reacţiilor adverse anticipate Foarte frecvente (≥ 1/10); frecvente (≥ 1/100 şi < 1/10); mai puţin frecvente (≥ 1/1000 şi < 1/100); rare (≥ 1/10000 şi < 1/1000); foarte rare (< 1/10000); cu frecvenţă necunoscută (care nu poate fi estimată din datele disponibile).
English: It has immunomodulating/ immunosuppressive characteristics, acts as an antiproliferative agent, and displays anti-inflammatory properties.
Romanian: Prezintă efecte imunomodulatoare/imunosupresoare, acţionează ca medicament antiproliferativ şi prezintă proprietăţi antiinflamatoare.
English: • if you have any problem with your bone marrow, or if you have low numbers of red or white cells in your blood or a reduced number of blood platelets,
Romanian: • dacă aveţi orice fel de problemă cu măduva osoasă sau dacă aveţi un număr redus de globule roşii sau albe în sângele dumneavoastră sau un număr redus de plachete sanguine,
English: • if you are due to have a specific blood test (calcium level).
Romanian: • dacă urmează să faceți o analiză de sânge specifică (nivelul de calciu).
English: SPECIAL STORAGE CONDITIONS Keep the bottle tightly closed in order to protect from moisture.
Romanian: CONDIŢII SPECIALE DE PĂSTRARE A se ţine flaconul bine închis pentru a fi protejat de umiditate.
English: • The active substance is leflunomide.
Romanian: • Substanţa activă este leflunomida.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 July 2013
Romanian: DATA PRIMEI AUTORIZĂRI SAU A REÎNNOIRII AUTORIZAŢIEI Data primei autorizări: 25 iulie 2013
English: • tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the feet or hands),
Romanian: • tendinită (manifestată prin durere determinată de inflamaţia membranei din jurul tendoanelor, de obicei la picioare şi la mâini),
English: The unbound fraction of A771726 is about 0.62 %.
Romanian: Proporţia nelegată a A771726 este de aproximativ 0,62 %.
English: If you take more Leflunomide medac than you should If you take more Leflunomide medac than you should, contact your doctor or get other medical advice.
Romanian: Dacă luaţi mai multă Leflunomidă medac decât trebuie Dacă aţi luat mai multă Leflunomidă medac decât trebuie, adresaţi-vă medicului dumneavoastră sau cereţi sfatul altui medic.
English: There have been reports of chronic overdose in patients taking Leflunomide medac at daily doses up to five times the recommended daily dose, and reports of acute overdose in adults and children.
Romanian: Au fost raportate cazuri de supradozaj cronic la pacienţii care au utilizat Leflunomidă medac în doze zilnice de până la de cinci ori doza zilnică recomandată şi cazuri de supradozaj acut la adulţi şi copii.
English: • tendon rupture,
Romanian: • ruptură de tendon,
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Romanian: Leflunomidǎ medac împreună cu alte medicamente Vă rugăm să spuneţi medicului dumneavoastră sau farmacistului dacă luaţi, aţi luat recent sau s-ar putea să luaţi orice alte medicamente.
English: The efficacy of Leflunomide medac in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III).
Romanian: Eficacitatea Leflunomidei medac în tratamentul poliartritei reumatoide a fost demonstrată în 4 studii controlate (un studiu de fază II şi 3 studii de fază III).
English: Warfarin and other coumarin anticoagulants
Romanian: Warfarină şi alte anticoagulante cumarinice
English: • problems in the nerves of the arms or legs (peripheral neuropathy).
Romanian: • probleme ale nervilor de la nivelul braţelor sau picioarelor (neuropatie periferică).