FrancophonIA/ELRC3.0 huggingface dataset:
English: em., H-1036 Budapest Hungary
Spanish: H-1036 Budapest Hungary
English: 75014 PARIS
Spanish: 75014 Paris France
English: 13353 Berlin
Spanish: D-13353 Berlin
English: Rua Quinta Pinheiro, 5, Outurela - Carnaxide
Spanish: Rua Quinta Pinheiro, 5, Outurela
English: 92931 PARIS LA DEFENSE FRANCE
Spanish: 92931 Paris la Defence France
English: LADEEPHARMA PHARMACEUTICAL Limited Lajos u. 48-66, E ép.
Spanish: Ladeepharma Pharmaceutical Limited Lajos u. 48-66
English: 28108 Alcobendas (Madrid) Spain
Spanish: 28108 Alcobendas Madrid
English: MAROUSSI GR-15125 ATHENS
Spanish: Athens GR-15125 Greece
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
Spanish: Relación de los nombres del medicamento, formas farmacéuticas, dosis, vía de administración, titulares de la autorización de comercialización en los Estados Miembros
English: Comprimidos
Spanish: Comprimido
English: Baix Llobregat 3 y 5 08970 Sant Joan Despi (Barcelona)
Spanish: Avda. Baix Llobregat 3 y 5 08970 Sant Joan Despi Barcelona
English: Sandoz d.d Verovskova 57, 1000 Ljubljana
Spanish: Sandoz d.d Verovskova 57 1000 Ljubljana Slovenia
English: TEVA PHARMA, SLU Anabel Segura 11, Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain
Spanish: Teva Pharma, SLU Anabel Segura 11 Edificio Albatros B 1ª planta 28108 Alcobendas Madrid
English: LABORATOIRES MAJORELLE 80-82 rue Gallieni 92100 BOULOGNE BILLANCOURT FRANCE
Spanish: Laboratoires Majorelle 80-82 rue Gallieni 92100 Boulogne Billancourt
English: Berlifarma - Especialidades Farmaceuticas, Lda.
Spanish: BerlifarmaEspecialidades Farmaceuticas, Lda.
English: Osa Mayor, 4 28023 Aravaca (Madrid) Spain
Spanish: Avda. Osa Mayor, 4 28023 Aravaca Madrid
English: United Kingdom Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL
Spanish: Generics (UK) Limited Station Close Potters Bar Hertfordshire EN6 1TL United Kingdom
English: Bayer S.p.A. Viale Certosa, 130 - 20156 Milano (MI) Italy
Spanish: Viale Certosa, 130 20156 Milano (MI) Italy
English: EG LABO - LABORATOIRES EUROGENERICS 12 rue Danjou le Quintet bâtiment A 92517 BOULOGNE BILLANCOURT CEDEX FRANCE
Spanish: LABORATOIRES EUROGENERICS 12 rue Danjou le Quintet bâtiment A 92517 Boulogne Billancourt Cedex France
English: Parc d'Activités des Peupliers - 25 rue des Peupliers 92000 NANTERRE FRANCE
Spanish: 25 rue des Peupliers 92000 Nanterre France
English: United Kingdom Teva UK Limited, Brampton Road, Hampden Park,
Spanish: Teva UK Limited Brampton Road Hampden Park Eastbourne
English: CYPROTERONE/ETHIN YLESTRADIOL BAYER 35 µg
Spanish: CYPROTERONE/ETHINYLESTRADIOL BAYER 35 µg
English: United Kingdom Bayer plc, Bayer House, strawberry Hill, Newbury, Berkshire RG14 1JA
Spanish: Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA, United Kingdom
English: 220, avenue de la Recherche 59120 Loos
Spanish: Bayer Santé 220, avenue de la Recherche 59120 Loos France
English: United Kingdom Stragen UK Limited, Castle Court, 41 London Road,
Spanish: Stragen UK Limited Castle Court 41
English: 3 DDD Pharma N.V. Diestersteenweg 349 3510 Hasselt Belgium
Spanish: Diestersteenweg 349 3510 Hasselt Belgium
English: United Kingdom Farmalider SA, Calle Aragoneses 15, Alcobendas, Madrid E-28108
Spanish: Farmalider SA Calle Aragoneses 15 Alcobendas Madrid E-28108 Spain
English: Medico Uno Worldwide Ltd.,2 Grigori Afxentiou Street + Larnaca 6023
Spanish: 2 Grigori Afxentiou Street Larnaca 6023
English: EFFIK bâtiment ''le Newton'' 9-11 rue Jeanne Braconnier 92366 MEUDON LA FORET FRANCE
Spanish: EFFIK bâtiment ''le Newton'' 9-11 rue Jeanne Braconnier
English: 49 avenue Georges Pompidou 92593 LEVALLOIS PERRET CEDEX
Spanish: 92593 Levallois Perret Cedex
English: London SW5 9JL
Spanish: Kramer Mews London SW5 9JL United Kingdom
English: Marszałka J.Piłsudskiego 5 95-200 Pabianice Poland
Spanish: 95-200 Pabianice Poland
English: Poland acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grunwald Germany
Spanish: Acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grünwald Germany
English: Castle Court 41, London Road, Reigate, Surrey RH2 PRJ,
Spanish: London Road Reigate, Surrey RH2 PRJ United Kingdom
English: Chloe 35 micrograms/2 mg film-coated tablets
Spanish: Chloe 35 micrograms/2 mg filmcoated tablets
English: Mithra Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège
Spanish: Rue Saint Georges 5 4000 Liège
English: Diane 2000 micrograms/35 micrograms filmcoated tablets
Spanish: Diane 2000 micrograms/35 micrograms film-coated tablets
English: United Kingdom Fannin (UK) Limited, 42-46 Booth Drive, Park Farm
Spanish: Fannin (UK) Limited 42-46 Booth Drive Park Farm South Wellingborough Kent NN8 6GT United Kingdom
English: Estonia ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Spanish: Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
English: Bayer Pharma
Spanish: Bayer plc
English: BAYER ΕΛΛΑΣ ΑΒΕΕ SOROU 18-20
Spanish: Bayer Hellas ABEE Sorou 18-20
English: Camberley, Surrey GU16 7SR UK
Spanish: Sandoz Limited Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
English: Fannin UK CoCyprindiol 2000/35 Tablets
Spanish: Fannin UK Co-Cyprindiol 2000/35 Tablets
English: Stragen UK Ltd.
Spanish: Medico Uno Worldwide Ltd.
English: Bellgyn "ratiopharm" 2 mg/ 0,035 mgüberzogene Tabletten
Spanish: Bellgyn "ratiopharm" 2 mg/ 0,035 mg - überzogene Tabletten
English: 11-15 quai de Dion Bouton 92800 PUTEAUX FRANCE
Spanish: 92800 Puteaux France
English: United Kingdom Strandhaven Limited, 600 High Road, Seven Kings,
Spanish: Strandhaven Limited 600 High Road Seven Kings, Ilford Essex IG3 8BS United Kingdom
English: Almirall Hermal GmbH Scholzstr.
Spanish: Taurus Pharma GmbH Benzstr.
English: BN22 9AG
Spanish: East Sussex BN22 9AG United Kingdom
English: ACETATO DE CIPROTERONA/ETINIL ESTRADIOL SANDOZ 2 mg/0,035 mg comprimidos recubiertos EFG
Spanish: CIPROTERONA/ETINILESTRADIOL SANDOZ 2 mg/0,035 mg comprimidos recubiertos EFG
English: United Kingdom Chatfiled Pharmaceuticals Limited, Kramer Mews,
Spanish: Chatfield Pharmaceuticals Limited
English: 21465 Reinbek Germany
Spanish: 61352 Bad Homburg Germany
English: United Kingdom Cipla (EU) Limited, Millbrow House, Millbrow Road, Esher, Surrey KT10 9NW
Spanish: Cipla (EU) Limited Hillbrow House Hillbrow Road Esher
English: Jan Emiel Mommaertslaan 14 1831 Machelen Belgium
Spanish: Mommaertslaan B-1831 Diegem Belgium
English: Cyproteronacetaat/Eth inylestradiol Sandoz 2/0,035, omhulde tabletten
Spanish: Cyproteronacetaat/Ethinylestradiol Sandoz 2/0,035, omhulde tabletten
English: Cyproteronacetaat/eth inylestradiol Actavis 2/0,035 mg, filmomhulde tabletten 2 mg/0,035 mg
Spanish: Cyproteronacetaat/ethinylestradiol Actavis 2/0,035 mg, filmomhulde tabletten 2 mg/0,035 mg
English: 0,035mg/2mg überzogene Tablette
Spanish: Diane-35 0,035mg/2mg überzogene Tablette
English: Camilette CoCyprindiol 2000/35 Tablets
Spanish: Camilette Co-Cyprindiol 2000/35 Tablets
English: Alternova A/S, Lodshusvej 11, DK-4230 Skælskør Denmark
Spanish: DK-4230 Skælskør Denmark
English: Strandhaven CoCyprindiol 2000/35 Tablets
Spanish: Strandhaven Co-Cyprindiol 2000/35 Tablets
English: FIDIA Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/A, 35031 Abano Terme (PD) Italy
Spanish: 35031 Abano Terme (PD) Italy
English: Sandoz A/S, Edvard Thomsens Vej 14, DK-2300 København S
Spanish: Edvard Thomsens Vej 14 DK-2300 København S Denmark
English: Acetato Ciproterona/ Etinilestradiol 2 mg/ 0,035 mg
Spanish: Acetato Ciproterona/ Etinilestradiol 2 mg/ 0,035 mg Comprimidos
English: Patient Health Protection
Spanish: Forma farmacéutica
English: Cyproteronacetaat/Eth inylestradiol 2/0,035 PCH, omhulde tabletten 2 mg/0,035 mg
Spanish: Cyproteronacetaat/Ethinylestradiol 2/0,035 PCH, omhulde tabletten 2 mg/0,035 mg
English: Clevia 2 mg/0,035 mg Filmtabletten
Spanish: Cyprotomin 2 mg/0,035 mg Filmtabletten
English: CYPROTERONE/ETHIN YLESTRADIOL DCI PHARMA 2 mg/0,035 mg
Spanish: CYPROTERONE/ETHINYLESTRADIOL DCI PHARMA 2 mg/0,035 mg
English: CYPROTERONE/ETHIN YLESTRADIOL RATIOPHARM 2 mg/0,035 mg
Spanish: CYPROTERONE/ETHINYLESTRADIOL RATIOPHARM 2 mg/0,035 mg
English: Orifarm Generics Energivej 15 - POB 69 DK-5260 Odense S Denmark
Spanish: DK-5260 Odense S. Denmark
English: CYPROTERONE/ETHIN YLESTRADIOL RANBAXY 2 mg/0,035 mg
Spanish: CYPROTERONE/ETHINYLESTRADIOL RANBAXY 2 mg/0,035 mg
English: Cyproteronacetaat/eth inylestradiol Apotex 2/0,035 mg, omhulde tabletten
Spanish: Cyproteronacetaat/ethinylestradiol Apotex 2/0,035 mg, omhulde tabletten
English: Cyproteronacetaat/Eth inylestradiol CF 2/0,035 mg, omhulde tablet
Spanish: Cyproteronacetaat/Ethinylestradiol CF 2/0,035 mg, omhulde tablet
English: CYPROTERONE/ETHIN YLESTRADIOL SANDOZ 2 mg/0,035 mg
Spanish: CYPROTERONE/ETHINYLESTRADIOL SANDOZ 2 mg/0,035 mg
English: Cyproteronacetaat/eth inylestradiol ratiopharm 2 mg/0,035 mg, omhulde tabletten
Spanish: Cyproteronacetaat/ethinylestradiol ratiopharm 2 mg/0,035 mg, omhulde tabletten
English: CYPROTERONE/ETHIN YLESTRADIOL ZENTIVA 2 mg/0,035 mg
Spanish: CYPROTERONE/ETHINYLESTRADIOL ZENTIVA 2 mg/0,035 mg
English: Cyproteronacetaat/Eth inylestradiol Mylan 2 mg/0,035 mg, omhulde tabletten
Spanish: Cyproteronacetaat/Ethinylestradiol Mylan 2 mg/0,035 mg, omhulde tabletten
English: CYPROTERONE/ETHIN YLESTRADIOL TEVA 2 mg/0,035 mg
Spanish: CYPROTERONE/ETHINYLESTRADIOL TEVA 2 mg/0,035 mg
English: CYPROTERONE/ETHIN YLESTRADIOL ZYDUS 2 mg/0,035 mg
Spanish: CYPROTERONE/ETHINYLESTRADIOL ZYDUS 2 mg/0,035 mg
English: Aragoneses, 15
Spanish: Piłsudskiego 5
English: CYPROTERONE/ETHIN YLESTRADIOL EG 2 mg/0,035 mg
Spanish: CYPROTERONE/ETHINYLESTRADIOL EG 2 mg/0,035 mg
English: GINESERVICE 0,035 mg/2 mg comprimidos EFG
Spanish: ETINILESTRADIOL/CIPROTERONA GINESERVICE 0,035 mg/2 mg comprimidos EFG
English: Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S., Denmark
Spanish: Orifarm Generics A/S Postbox 69
English: Cyproteronacetaat/Eth inylestradiol 2 mg/0,035 mg, omhulde tabletten
Spanish: Cyproteronacetaat/Ethinylestradiol 2 mg/0,035 mg, omhulde tabletten
English: Czech Republic
Spanish: Dolní Měcholupy Czech Republic
English: Generis Farmaceutica, S.A. Rua Joao de Deus, 19Amadora
Spanish: Rua Joao de Deus, 19 2700-487 Amadora Portugal
English: Reigate, Surrey RH2 9RJ
Spanish: Surrey KT10 9NW United Kingdom
English: Cyproderm
Spanish: Cyproterone
English: Etterstad 0601, OSLO
Spanish: Etterstad 0601, OSLO Norway
English: AstraZeneca Österreich GmbH, Schwarzenbergplatz 7, A-1037 Wien,
Spanish: AstraZeneca Österreich GmbH, Schwarzenbergplatz 7, A-1037 Wien, Austria
English: AstraZeneca Kft. 1113 Budapest, Bocskai ut 134
Spanish: 1113 Budapest, Bocskai ut 134146 Hungary
English: AstraZeneca S.A. 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens,
Spanish: 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens, Greece
English: AstraZeneca UK Limited Silk Road Business Park Macclesfield, Cheshire
Spanish: AstraZeneca UK Ltd Silk Road Business Park Macclesfield Cheshire
English: AstraZeneca UK Limited 2 Kingdom Street, London
Spanish: AstraZeneca UK Limited 2 Kingdom Street, London W2 6BD, United Kingdom
English: S-15185 Södertälje, Sweden
Spanish: AstraZeneca Pharmaceuticals AB, S-15185 Södertälje, Sweden
English: AstraZeneca A/S Roskildevej 22 2620 Albertslund, Denmark
Spanish: 2620 Albertslund, Denmark
English: W2 6BD,
Spanish: 2 Kingdom Street, London W2 6BD, United Kingdom
English: AstraZeneca UK Ltd. 2 Kingdom Street, London
Spanish: AstraZeneca UK Ltd.
English: LU1 3LU
Spanish: SK10 2NA
English: This is especially important if you are taking:
Spanish: Esto es especialmente importante si usted está tomando:
English: • if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
Spanish: • si usted ha tenido alguna vez tuberculosis o si ha estado en contacto cercano con alguien que tenga o haya tenido tuberculosis.
English: The tablets are packed in bottles.
Spanish: Los comprimidos están envasados en frascos.
English: Folate supplementation was optional and only used in 10 % of patients.
Spanish: La administración de un suplemento fólico fue opcional y sólo se utilizó en el 10 % de los pacientes.
English: C study indicated that at least about 82 to 95 % of the dose is absorbed.
Spanish: C, indican que al menos se absorbe de un 82 a un 95 % de la dosis.
English: If you are affected, do not drive or use machines.
Spanish: Si esto le sucede, no conduzca ni use máquinas.
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the bottle after EXP.
Spanish: No utilice este medicamento después de la fecha de caducidad que aparece en la caja exterior y en el frasco después de CAD.
English: • loss of appetite, weight loss (usually insignificant),
Spanish: • pérdida de apetito, pérdida de peso (normalmente insignificante),
English: Pharmacokinetic data in elderly (> 65 years) are limited but consistent with pharmacokinetics in younger adults.
Spanish: Los datos farmacocinéticos en pacientes de edad avanzada (> 65 años) son limitados pero consistentes con la farmacocinética en adultos jóvenes.
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).
Spanish: Muy frecuentes (≥ 1/10), frecuentes (≥ 1/100 a < 1/10), poco frecuentes (≥ 1/1.000 a < 1/100), raras (≥ 1/10.000 a < 1/1.000), muy raras (< 1/10.000), frecuencia no conocida (no puede estimarse a partir de los datos disponibles).
English: • increased hair loss,
Spanish: • aumento de la caída de cabello,
English: • zidovudine for HIV infection
Spanish: • zidovudina para infeccion por VIH
English: • if you are pregnant, think you may be pregnant, or are breast-feeding.
Spanish: • si está embarazada, piensa que puede estar embarazada o se encuentra en periodo de lactancia.
English: Leflunomide medac with food, drink and alcohol Leflunomide medac may be taken with or without food.
Spanish: Toma de Leflunomida medac con alimentos, bebida y alcohol Leflunomida medac puede tomarse con o sin alimentos.
English: • tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the feet or hands),
Spanish: • tendinitis (dolor causado por la inflamación de la membrana que rodea los tendones de, normalmente, los pies o de las manos),
English: Absorption Excretion data from the
Spanish: Absorción Los datos de excreción del ensayo con
English: Leflunomide medac can make you feel dizzy which may impair your ability to concentrate and react.
Spanish: Leflunomida medac puede hacer que se sienta mareado lo que puede afectar a su capacidad para concentrarse y reaccionar.
English: • tizanidine, a muscle relaxant
Spanish: • tizanidina, un relajante muscular
English: Your doctor may perform tests to see if you have tuberculosis
Spanish: Su médico puede realizarle pruebas para ver si usted tiene tuberculosis,
English: C-leflunomide in three healthy volunteers, no unchanged leflunomide was detected in plasma, urine or faeces.
Spanish: C-leflunomida) en tres voluntarios sanos, no se detectó leflunomida inalterada en plasma, orina o heces.
English: • problems in the nerves of the arms or legs (peripheral neuropathy).
Spanish: • problemas en los nervios de los brazos o las piernas (neuropatía periférica).
English: • Patients with moderate to severe renal insufficiency, because insufficient clinical experience is available in this patient group.
Spanish: • Pacientes con insuficiencia renal de moderada a grave, debido a que la experiencia clínica de la que se dispone en este grupo de pacientes es insuficiente,
English: • if you are suffering from a serious infection,
Spanish: • si padece una infección grave,
English: • Patients with serious infections (see section 4.4).
Spanish: • Pacientes con infecciones graves (ver sección 4.4),
English: LIST OF EXCIPIENTS This medicinal product contains lactose and soya lecithin (see leaflet for further information).
Spanish: LISTA DE EXCIPIENTES Este medicamento contiene lactosa y lecitina de soja (para mayor información consultar el prospecto).
English: • anxiety,
Spanish: • ansiedad,
English: • if you suffer from any problem which affects your immune system (e.g. AIDS),
Spanish: • si padece algún problema que afecte al sistema inmunitario, (por ejemplo SIDA),
English: • a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as these medicines can reduce the amount of Leflunomide medac which is absorbed by the body.
Spanish: • un medicamento denominado colestiramina (utilizado para reducir el colesterol alto) o el carbón activo ya que estos medicamentos pueden reducir la cantidad de Leflunomida medac absorbida por el cuerpo.
English: • teriflunomide for multiple sclerosis
Spanish: • teriflunomida para esclerosis múltiple
English: Warfarin and other coumarin anticoagulants
Spanish: Warfarina y otros anticoagulantes cumarínicos
English: • theophylline for asthma
Spanish: • teofilina para asma
English: • alosetron for the management of severe diarrhoea
Spanish: • alosetron para el control de la diarrea severa
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).
Spanish: Se ha demostrado la eficacia de Leflunomida medac en el tratamiento de la artritis reumatoide en 4 ensayos clínicos controlados (1 en fase II y 3 en fase III).
English: • an increase in some liver test results,
Spanish: • aumento de los resultados obtenidos en algunas pruebas de hígado,
English: Not known: marginal (reversible) decreases in sperm concentration, total sperm count and rapid progressive motility
Spanish: leve disminución (reversible) de la concentración de esperma, recuento total de esperma y de la motilidad progresiva rápida
English: Uncommon: anxiety
Spanish: Poco frecuentes: ansiedad
English: Your doctor will carry out blood tests at regular intervals, before and during treatment with Leflunomide medac, to monitor your blood cells and liver.
Spanish: Su médico le realizará análisis de sangre a intervalos regulares, antes y durante el tratamiento con Leflunomida medac, para monitorizar las células sanguíneas y el hígado.
English: Leflunomide medac is not recommended for use in children and adolescents below 18 years of age.
Spanish: Niños y adolescentes No está recomendado el uso de Leflunomida medac en niños y adolescentes menores de 18 años.
English: In a small prospective study in women (n = 64) who became inadvertently pregnant while taking leflunomide for no more than three weeks after conception and followed by a drug elimination procedure, no significant differences (p = 0.13) were observed in the overall rate of major structural defects (5.4 %) compared to either of the comparison groups (4.2 % in the disease matched group [n = 108] and 4.2 % in healthy pregnant women [n = 78]).
Spanish: En un reducido estudio prospectivo en mujeres (n = 64) que se quedaron embarazadas involuntariamente mientras estaban tomando leflunomida durante un periodo de tiempo de no más de tres semanas después de la concepción y seguido de un procedimiento de eliminación del fármaco, no se observaron diferencias significativas (p = 0,13) en la tasa total de defectos estructurales graves (5,4 %) en comparación con cualquiera de los grupos comparativos (4,2 % en el grupo en el que se presenta la enfermedad [n = 108] y 4,2 % en mujeres sanas embarazadas [n = 78]).
English: Your doctor will also check your blood pressure regularly as Leflunomide medac can cause an increase in blood pressure.
Spanish: Su médico deberá también controlar su presión sanguínea regularmente ya que Leflunomida medac puede producir un aumento de la presión sanguínea.
English: • cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
Spanish: • cefaclor, bencilpenicilina (penicilina G), ciprofloxacino para infecciones
English: • Patients with severe immunodeficiency states, e.g. AIDS.
Spanish: • Pacientes con estados de inmunodeficiencia grave, por ejemplo, SIDA,
English: Leflunomide medac is not recommended for use in patients below 18 years since efficacy and safety in juvenile rheumatoid arthritis (JRA) have not been established (see sections 5.1 and 5.2).
Spanish: No se recomienda la utilización de Leflunomida medac en pacientes menores de 18 años, ya que no se ha establecido la eficacia y la seguridad en la artritis reumatoide juvenil (ARJ) (ver secciones 5.1 y
English: Blood pressure Blood pressure must be checked before the start of leflunomide treatment and periodically thereafter.
Spanish: La presión sanguínea debe comprobarse antes de comenzar el tratamiento con leflunomida y posteriormente de forma periódica.
English: • severe infections called sepsis which may be fatal,
Spanish: • infecciones graves a las que se denomina sepsis, que pueden llegar a ser mortales,
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Leflunomide medac are provided with a physician educational pack containing the following:
Spanish: El Titular de la Autorización de Comercialización (TAC) se asegurará de que los profesionales sanitarios con intención de prescribir/usar Leflunomida medac dispongan de un material educacional sanitario que contenga la siguiente información:
English: Interstitial lung disease is a potentially fatal disorder, which may occur acutely during therapy.
Spanish: La enfermedad pulmonar intersticial es una alteración potencialmente mortal, que puede aparecer de forma aguda durante la terapia.
English: Tell your doctor immediately and stop taking Leflunomide medac:
Spanish: Informe a su médico inmediatamente y deje de tomar Leflunomida medac:
English: Women of childbearing potential must not take Leflunomide medac without using reliable contraceptive measures.
Spanish: Las mujeres en edad fértil no deben tomar Leflunomida medac sin utilizar medidas de contracepción fiables.
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,
Spanish: • si padece algún problema en la médula ósea o si tiene un número reducido de glóbulos rojos o blancos en la sangre o un número reducido de plaquetas,
English: This metabolite is responsible for essentially all the in-vivo activity of Leflunomide medac.
Spanish: Este metabolito es mayoritariamente el responsable de la actividad total in vivo de Leflunomida medac.
English: Leflunomide medac can occasionally cause some problems with your blood, liver, lungs or nerves in your arms or legs.
Spanish: Ocasionalmente, Leflunomida medac puede producir algunos problemas en la sangre, en el hígado, en los pulmones, o en los nervios de los brazos o las piernas.
English: This may be reduced to a few weeks by taking certain medicines which speed up removal of Leflunomide medac from your body.
Spanish: Este intervalo de tiempo puede reducirse a unas pocas semanas tomando ciertos medicamentos que aceleran la eliminación de Leflunomida medac del organismo.
English: What Leflunomide medac is and what it is used for What you need to know before you take Leflunomide medac How to take Leflunomide medac Possible side effects
Spanish: Qué es Leflunomida medac y para qué se utiliza Qué necesita saber antes de empezar a tomar Leflunomida medac Cómo tomar Leflunomida medac Posibles efectos adversos
English: • oral contraceptives (containing ethinylestradiol and levonorgestrel)
Spanish: • anticonceptivos orales (que contengan etinilestradiol y levonorgestrel)
English: • if you have ever suffered from interstitial lung disease,
Spanish: • si ha padecido alguna vez una enfermedad pulmonar intersticial,
English: • if you experience weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic reaction,
Spanish: • si se siente débil, aturdido o mareado, o tiene dificultad al respirar, porque estos pueden ser síntomas de una reacción alérgica grave,
English: What Leflunomide medac is and what it is used for
Spanish: Qué es Leflunomida medac y para qué se utiliza