FrancophonIA/ELRC3.0 huggingface dataset:
English: 92.9 g/m for the ERT arm and the mean change from baseline in LVMi at Month 18 was -6.6 (95% CI: -11.0, -2.1; n=31) for Galafold and -2.0 (95% CI: -11.0, 7.0; n=13) for ERT.
Spanish: Los valores iniciales fueron de 95,3 g/m en el grupo de Galafold y 92,9 g/m en el grupo de TSE y el cambio medio respecto al periodo basal en el IMVI en el mes 18 fue de -6,6 (IC del 95 %: -11,0, -2.1; n=31) para Galafold y -2,0 (IC del 95 %: -11,0, 7,0; n=13) para TSE.
English: c.T552A or c.T552G
Spanish: c.T552A o c.T552G
English: c.982G>A or c.982G>C
Spanish: c.982G>A o c.982G>C
English: c.131G>A or c.132G>A
Spanish: c.131G>A o c.132G>A
English: c.G1074T or c.G1074C
Spanish: c.G1074T o c.G1074C
English: c.C897G or c.C897A
Spanish: c.C897G o c.C897A
English: c.G288A or c.G288T or c.G288C M96I
Spanish: c.G288A o c.G288T o c.G288C M96I
English: c.T960G or c.T960A
Spanish: c.T960G o c.T960A
English: c.G609C or c.G609T
Spanish: c.G609C o c.G609T
English: c.816C>A or c.816C>G
Spanish: c.816C>A o c.816C>G
English: c.A840T or c.A840C
Spanish: c.A840T o c.A840C
English: UNKNOWN (del Exon3?)
Spanish: DESCONOCIDO (del Exon3?)
English: c.243G>T or c.243G>C
Spanish: c.243G>T o c.243G>C
English: c.G567C or c.G567T
Spanish: c.G567C o c.G567T
English: c.1074G>T or c.1074G>C
Spanish: c.1074G>T o c.1074G>C
English: c.279C>G or c.279C>A
Spanish: c.279C>G o c.279C>A
English: c.T154A or c.G155C
Spanish: c.T154A o c.G155C
English: c.C453G or c.C453A
Spanish: c.C453G o c.C453A
English: c.G144T or c.G144C
Spanish: c.G144T o c.G144C
English: c.T610C or c.T610A
Spanish: c.T610C o c.T610A
English: c.1081G>A or c.1081G>C
Spanish: c.1081G>A o c.1081G>C
English: c.G243T or c.G243C
Spanish: c.G243T o c.G243C
English: c.525C>G or c.525C>A
Spanish: c.525C>G o c.525C>A
English: c.T514A or c.G515C
Spanish: c.T514A o c.G515C
English: UNKNOWN (del Exon1_2?)
Spanish: DESCONOCIDO (del Exon1_2?)
English: UNKNOWN (del Exon5_7?)
Spanish: DESCONOCIDO (del Exon5_7?)
English: c.540G>C or c.540G>T
Spanish: c.540G>C o c.540G>T
English: c.T280A or c.G281C
Spanish: c.T280A o c.G281C
English: c.G141C or c.G141T
Spanish: c.G141C o c.G141T
English: c.144G>T or c.144G>C
Spanish: c.144G>T o c.144G>C
English: c.T859C or c.T859A
Spanish: c.T859C o c.T859A
English: c.258T>G or c.258T>A
Spanish: c.258T>G o c.258T>A
English: c.A588T or c.A588C
Spanish: c.A588T o c.A588C
English: c.881T>G or c.881T>A
Spanish: c.881T>G o c.881T>A
English: c.707G>A or c.708G>A
Spanish: c.707G>A o c.708G>A
English: c.610T>C or c.610T>A
Spanish: c.610T>C o c.610T>A
English: c.166T>A or c.167G>C
Spanish: c.166T>A o c.167G>C
English: c.108G>C or c.108G>T
Spanish: c.108G>C o c.108G>T
English: c.141G>C or c.141G>T
Spanish: c.141G>C o c.141G>T
English: c.T369G or c.T369A
Spanish: c.T369G o c.T369A
English: c.609G>C or c.609G>T
Spanish: c.609G>C o c.609G>T
English: c.305C>G or c.305C>A
Spanish: c.305C>G o c.305C>A
English: c.830G>A or c.831G>A
Spanish: c.830G>A o c.831G>A
English: c.G831T or c.G831C
Spanish: c.G831T o c.G831C
English: c.567G>C or c.567G>T
Spanish: c.567G>C o c.567G>T
English: c.T465A or c.T465G
Spanish: c.T465A o c.T465G
English: c.G830A or c.G831A
Spanish: c.G830A o c.G831A
English: c.T408A or c.T408G
Spanish: c.T408A o c.T408G
English: c.960T>G or c.960T>A
Spanish: c.960T>G o c.960T>A
English: c.453C>G or c.453C>A
Spanish: c.453C>G o c.453C>A
English: c.G485A or c.G486A
Spanish: c.G485A o c.G486A
English: Protein Sequence change c.290delC
Spanish: Secuencia proteica modificada c.614delC
English: c.103G>C or c.103G>A
Spanish: c.103G>C o c.103G>A
English: c.G108C or c.G108T
Spanish: c.G108C o c.G108T
English: c.G860A or c.G861A
Spanish: c.G860A o c.G861A
English: Muscle spasms Myalgia
Spanish: Espasmos musculares Mialgia
English: c.870G>A or c.870G>C or c.870G>T
Spanish: c.870G>A o c.870G>C o c.870G>T
English: c.831G>T or c.831G>C
Spanish: c.831G>T o c.831G>C
English: c.G71A or c.G72A
Spanish: c.G71A o c.G72A
English: c.G861C or c.G861T
Spanish: c.G861C o c.G861T
English: c.860G>A or c.861G>A
Spanish: c.860G>A o c.861G>A
English: c.C966A or c.C966G
Spanish: c.C966A o c.C966G
English: c.859T>C or c.859T>A
Spanish: c.859T>C o c.859T>A
English: c.G394A or c.G394C
Spanish: c.G394A o c.G394C
English: c.T676C or c.T676A
Spanish: c.T676C o c.T676A
English: c.439G>A or c.439G>C
Spanish: c.439G>A o c.439G>C
English: c.G439A or c.G439C
Spanish: c.G439A o c.G439C
English: c.888G>A or c.888G>T or c.888G>C
Spanish: c.888G>A o c.888G>T o c.888G>C
English: • Reduced sense of touch or sensation
Spanish: • Reducción del sentido del tacto (hipoestesia)
English: c.897C>G or c.897C>A
Spanish: c.897C>G o c.897C>A
English: c.G837C or c.G837T
Spanish: c.G837C o c.G837T
English: c.485G>A or c.486G>A
Spanish: c.485G>A o c.486G>A
English: c.G486C or c.G486T
Spanish: c.G486C o c.G486T
English: c.71G>A or c.72G>A
Spanish: c.71G>A o c.72G>A
English: c.514T>A or c.515G>C
Spanish: c.514T>A o c.515G>C
English: Defaecation urgency Dyspepsia
Spanish: Sequedad de boca Necesidad urgente de defecar Dispepsia
English: c.T834G or c.T834A
Spanish: c.T834G o c.T834A
English: c.840A>T or c.840A>C
Spanish: c.840A>T o c.840A>C
English: c.T70C or c.T70A
Spanish: c.T70C o c.T70A
English: c.154T>A or c.155G>C
Spanish: c.154T>A o c.155G>C
English: The mean annualised rate of change from baseline in eGFRCKD-EPI in patients treated for 30 months with Galafold was -1.72 mL/min/1.73 m
Spanish: En los pacientes tratados con Galafold durante 30 meses, la tasa de cambio medio anualizada de la TFG estimada CKD-EPI desde el periodo basal fue de -1,72 ml/min/1,73 m
English: c.A868C or c.A868T
Spanish: c.A868C o c.A868T
English: c.C456A or c.C456G
Spanish: c.C456A o c.C456G
English: c.465T>A or c.465T>G
Spanish: c.465T>A o c.465T>G
English: c.708G>C or c.708G>T
Spanish: c.708G>C o c.708G>T
English: c.T648A or c.T648G
Spanish: c.T648A o c.T648G
English: c.588A>T or c.588A>C
Spanish: c.588A>T o c.588A>C
English: c.T102G or c.T102A
Spanish: c.T102G o c.T102A
English: c.T667A or c.G668C
Spanish: c.T667A o c.G668C
English: c.966C>A or c.966C>G
Spanish: c.966C>A o c.966C>G
English: c.394G>A or c.394G>C
Spanish: c.394G>A o c.394G>C
English: c.408T>A or c.408T>G
Spanish: c.408T>A o c.408T>G
English: UNKNOWN (del Exon3_7?)
Spanish: DESCONOCIDO (del Exon3_7?)
English: c.676T>C or c.676T>A
Spanish: c.676T>C o c.676T>A
English: After follow up in the OLE, the mean change from baseline in LVMi in patients with left ventricular hypertrophy at baseline at Month 36 was -30.0 (95%) CI: -57.9, -2.2; n=4) and at Month 48
Spanish: Tras seguimiento en el ensayo de extensión abierto, el cambio promedio desde el periodo basal hasta el mes 36 en el IMVI en pacientes con hipertrofia ventricular izquierda en el periodo basal fue de -30,0 (IC del 95 %: -57,9, -2,2; n=4) y en el mes 48 fue de -33,1 (IC: -60,9, -5,4; n=4).
English: c.102T>G or c.102T>A
Spanish: c.102T>G o c.102T>A
English: c.T687A or c.T687G
Spanish: c.T687A o c.T687G
English: c.837G>C or c.837G>T
Spanish: c.837G>C o c.837G>T
English: c.G936T or c.G936C
Spanish: c.G936T o c.G936C
English: c.T894G or c.T894A
Spanish: c.T894G o c.T894A
English: Galafold is not recommended for use in patients with Fabry disease who have estimated GFR less than 30 mL/min/1.73 m
Spanish: Galafold no está recomendado en pacientes con la enfermedad de Fabry portadores de una tasa de filtración glomerular (TFG) estimada inferior a 30 ml/min/1,73 m
English: c.861G>C or c.861G>T
Spanish: c.861G>C o c.861G>T
English: c.70T>C or c.70T>A
Spanish: c.70T>C o c.70T>A
English: c.C666A or c.C666G
Spanish: c.C666A o c.C666G
English: c.1018T>C or c.1018T>A c.T1018C or c.T1018A
Spanish: c.1018T>C o c.1018T>A
English: c.G707A or c.G708A
Spanish: c.G707A o c.G708A
English: c.T484C or c.T484A
Spanish: c.T484C o c.T484A
English: c.288G>A or c.288G>T or c.288G>C
Spanish: c.288G>A o c.288G>T o c.288G>C
English: c.T402G or c.T402A
Spanish: c.T402G o c.T402A
English: c.747C>G or c.747C>A
Spanish: c.747C>G o c.747C>A
English: c.G963C or c.G963T
Spanish: c.G963C o c.G963T
English: c.784T>A or c.784T>C
Spanish: c.784T>A o c.784T>C
English: c.G978C or c.G978T
Spanish: c.G978C o c.G978T
English: c.486G>C or c.486G>T
Spanish: c.486G>C o c.486G>T
English: c.720G>C or c.720G>T
Spanish: c.720G>C o c.720G>T
English: Protein sequence change c.126G>A or c.126G>C or c.126G>T
Spanish: Secuencia proteica modificada c.612G>T o c.612G>C
English: c.456C>A or c.456C>G
Spanish: c.456C>A o c.456C>G
English: c.G720C or c.G720T
Spanish: c.G720C o c.G720T
English: c.978G>C or c.978G>T
Spanish: c.978G>C o c.978G>T
English: c.G772C or c.G772A
Spanish: c.G772C o c.G772A
English: c.729G>C or c.729G>T
Spanish: c.729G>C o c.729G>T
English: c.369T>G or c.369T>A
Spanish: c.369T>G o c.369T>A
English: Composite Clinical Outcomes
Spanish: Criterios de valoración clínicos combinados
English: c.G729C or c.G729T
Spanish: c.G729C o c.G729T
English: c.G708C or c.G708T
Spanish: c.G708C o c.G708T
English: c.677G>A or c.678G>A
Spanish: c.677G>A o c.678G>A
English: c.G778C or c.G778A
Spanish: c.G778C o c.G778A
English: c.T706C or c.T706A
Spanish: c.T706C o c.T706A
English: c.834T>G or c.834T>A
Spanish: c.834T>G o c.834T>A
English: c.T784A or c.T784C
Spanish: c.T784A o c.T784C
English: c.72G>C or c.72G>T
Spanish: c.72G>C o c.72G>T
English: c.894T>G or c.894T>A
Spanish: c.894T>G o c.894T>A
English: c.648T>A or c.648T>G
Spanish: c.648T>A o c.648T>G
English: c.A886T or c.A886C
Spanish: c.A886T o c.A886C
English: c.402T>G or c.402T>A
Spanish: c.402T>G o c.402T>A
English: UNKNOWN (del Exon2_3?)
Spanish: DESCONOCIDO (del Exon2_3?)
English: c.772G>C or c.772G>A
Spanish: c.772G>C o c.772G>A
English: c.868A>C or c.868A>T
Spanish: c.868A>C o c.868A>T
English: c.T702G or c.T702A
Spanish: c.T702G o c.T702A
English: c.484T>C or c.484T>A
Spanish: c.484T>C o c.484T>A
English: c.936G>T or c.936G>C
Spanish: c.936G>T o c.936G>C
English: c.702T>G or c.702T>A
Spanish: c.702T>G o c.702T>A
English: c.G785A or c.G786A
Spanish: c.G785A o c.G786A
English: c.666C>A or c.666C>G
Spanish: c.666C>A o c.666C>G
English: c.778G>C or c.778G>A
Spanish: c.778G>C o c.778G>A
English: c.785G>A or c.786G>A
Spanish: c.785G>A o c.786G>A
English: c.678G>T or c.678G>C
Spanish: c.678G>T o c.678G>C
English: The change from baseline to Month 18 in LVMi (g/m 2) in patients with left ventricular hypertrophy (females with baseline LVMi > 95 g/m and males with baseline LVMi > 115 g/m2) was -8.4 (95% CI: -15.7, 2.6; n=13) for migalastat and 4.5 (95% CI: -10.7, 18.4; n=5) for ERT. After 30 months treatment with Galafold, the mean change from baseline in LVMi was -3.8 (95% CI: -8.9, 1.3; n=28) and the mean change from baseline in LVMi in patients with left ventricular hypertrophy at baseline was -10.0 (95% CI: -16.6, -3.3; n=10).
Spanish: El cambio desde el periodo basal hasta el mes 18 en el IMVI en pacientes con hipertrofia ventricular izquierda (mujeres con IMVI basal > 95 g/m y hombres con IMVI basal > 115 g/m2) fue de -8,4 (IC del 95 %: -15,7, 2,6; n=13) para migalastat y de 4,5 (IC del 95 %: -10,7, 18,4; n=5) para TSE.
English: c.706T>C or c.706T>A
Spanish: c.706T>C o c.706T>A
English: If more than 12 hours has passed you should resume taking Galafold at the next planned dosing day and time according to your every other day dosing schedule.. Do not take two capsules to make up for your missed dose.
Spanish: Si han transcurrido más de 12 horas, deberá volver a tomar Galafold el día correspondiente a la siguiente dosis y a la hora habitual, de acuerdo con la pauta posológica de días alternos.
English: c.G678T or c.G678C
Spanish: c.G678T o c.G678C
English: c.G677A or c.G678A
Spanish: c.G677A o c.G678A
English: c.963G>C or c.963G>T
Spanish: c.963G>C o c.963G>T
English: c.687T>A or c.687T>G
Spanish: c.687T>A o c.687T>G
English: c.667T>A or c.668G>C
Spanish: c.667T>A o c.668G>C
English: c.G786C or c.G786T
Spanish: c.G786C o c.G786T
English: c.1095T>A or c.1095T>G c.T1095A or c.T1095G
Spanish: c.1095T>A o c.1095T>G
English: c.G72C or c.G72T
Spanish: c.G72C o c.G72T
English: • Sudden need to defecate
Spanish: • Necesidad repentina de defecar (de ir al baño)
English: c.886A>T or c.886A>C
Spanish: c.886A>T o c.886A>C
English: c.786G>C or c.786G>T
Spanish: c.786G>C o c.786G>T
English: How to store Galafold
Spanish: Conservación de Galafold
English: c.T798A or c.T798G
Spanish: c.T798A o c.T798G
English: c.798T>A or c.798T>G
Spanish: c.798T>A o c.798T>G
English: c.T789A or c.T789G
Spanish: c.T789A o c.T789G
English: c.789T>A or c.789T>G
Spanish: c.789T>A o c.789T>G
English: • Persistent itch (pruritus)
Spanish: • Sensación anormal de movimiento (vértigo)
English: If you are planning to have a baby, ask your doctor, pharmacist, or nurse for advice.
Spanish: Si tiene previsto quedarse embarazada, consulte con su médico, farmacéutico o enfermero.
English: p.205_207del c.614delC
Spanish: p.205_207del
English: Protein Sequence change p.T412Sfs*37
Spanish: p.T412Sfs*37
English: c.1045T>C or c.1045T>A c.T1045C or c.T1045A
Spanish: c.1045T>C o c.1045T>A
English: BLISTER FOIL
Spanish: FUNDA DE BLÍSTER
English: Always take this medicine exactly as your doctor, pharmacist, or nurse has told you.
Spanish: Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico o farmacéutico.
English: The mean change from baseline in LVMi at Month 18 to 24 in patients with left ventricular hypertrophy at baseline (females with baseline LVMi > 95 g/m or males with baseline LVMi > 115 g/m 2) was -18.6 (95% CI: -38.2, 1.0; n=8).
Spanish: El cambio promedio desde el periodo basal del IMVI en los meses de 18 a 24 en pacientes con hipertrofia ventricular izquierda en el periodo basal (mujeres con IMVI basal > 95 g/m o varones con IMVI basal
English: c.233C>G or c.233C>A
Spanish: Secuencia proteica modificada c.233C>G o c.233C>A
English: (torticollis)
Spanish: (prurito)
English: • Dizziness
Spanish: • Exantema
English: L177X c.547G>A (putative splicing site) c.G547A (putative splicing site) UNKNOWN (G183S) c.548G>T
Spanish: c.547G>A (Sitio probable de splicing)
English: Protein Sequence change c.1202C>G or c.1202C>A c.C1202G or c.C1202A
Spanish: c.C1202G o c.C1202A
English: Diarrhoea Nausea
Spanish: Dolor abdominal Estreñimiento
English: Abdominal pain Constipation Dry mouth
Spanish: Tinta de impresión Goma laca
English: c.612G>T or c.612G>C
Spanish: c.126G>A o c.126G>C o c.126G>T
English: Galafold 123 mg hard capsules migalastat
Spanish: Galafold 123 mg cápsulas duras migalastat
English: • Tingling in extremities
Spanish: • Hormigueo en las extremidades (parestesia)
English: c.1065C>A or c.1065C>G c.C1065A or c.C1065G
Spanish: c.1065C>A o c.1065C>G
English: M267R c.801G>A (putative splicing site) c.G801A (putative splicing site) UNKNOWN (M267I) c.803T>C
Spanish: c.801G>A (Sitio probable de splicing)
English: c.1034C>G or c.1034C>A c.C1034G or c.C1034A
Spanish: c.C1034G o c.C1034A
English: Galafold 123 mg hard capsules Migalastat
Spanish: Galafold 123 mg, cápsulas duras migalastat
English: If you get any side effects, talk to your doctor, pharmacist, or nurse.
Spanish: En caso de duda, consulte a su médico, farmacéutico o enfermero.
English: Rash Pruritus
Spanish: Exantema Prurito
English: Galafold 123 mg hard capsules
Spanish: Galafold 123 mg cápsulas duras
English: c.132G>T or c.132G>C
Spanish: Secuencia proteica modificada c.132G>T o c.132G>C
English: • Shortness of breath
Spanish: • Falta de aliento (disnea)
English: • Painful stiff neck
Spanish: • Rigidez de cuello dolorosa (tortícolis)
English: The proportion of patients who had at least a 75% reduction in symptoms after 16 weeks of treatment was 68% with Halimatoz and 63% with Humira.
Spanish: La proporción de pacientes que presentaron una reducción de los síntomas de al menos el 75 % al cabo de 16 semanas de tratamiento fue del 68 % con Halimatoz y del 63 % con Humira.
English: Further information on Halimatoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Spanish: Puede encontrar información adicional sobre Halimatoz en la página web de la Agencia: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Halimatoz?
Spanish: ¿Qué medidas se han adoptado para garantizar un uso seguro y eficaz de Halimatoz?
English: The dose and frequency of injection depends on the condition to be treated and the dose for a child is usually calculated according to the child's weight; because Halimatoz is only available in doses of 40 mg, it is not suitable for children who need less than a 40-mg dose.
Spanish: La dosis y la frecuencia de inyección dependen de la enfermedad que se vaya a tratar, y la dosis para un niño se calcula habitualmente en función del peso del niño; dado que Halimatoz solo está disponible en dosis de 40 mg, no es adecuado para niños que necesiten una dosis inferior a 40 mg.
English: Other information about Halimatoz
Spanish: Otra información sobre Halimatoz
English: In addition, Halimatoz was as effective as Humira in a study involving 465 patients with moderate or severe plaque psoriasis.
Spanish: Además, Halimatoz fue tan eficaz como Humira en un estudio en el que participaron 465 pacientes con psoriasis en placas moderada o grave.
English: The reference medicine for Halimatoz is Humira.
Spanish: El medicamento de referencia de Halimatoz es Humira.
English: As for all medicines, data on the use of Halimatoz are continuously monitored.
Spanish: Como para todos los medicamentos, los datos sobre el uso de Halimatoz se controlan permanentemente.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Halimatoz have also been included in the summary of product characteristics and the package leaflet.
Spanish: Las recomendaciones y precauciones que deben seguir los profesionales sanitarios y los pacientes para un uso seguro y eficaz de Halimatoz se han incluido también en la ficha técnica o resumen de las características del producto y el prospecto.
English: All these data were considered sufficient to conclude that Halimatoz will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Spanish: Todos estos datos se consideraron suficientes para concluir que Halimatoz se comportará de la misma forma que Humira, desde el punto de vista de la eficacia y la seguridad, en las indicaciones aprobadas.
English: Halimatoz is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Spanish: En la mayoría de los casos, Halimatoz se administra a adultos cuando sus afecciones son graves, moderadamente graves o empeoran, o cuando los pacientes no pueden someterse a otros tratamientos.
English: Halimatoz is a medicine that acts on the immune system and is used to treat the following conditions:
Spanish: Halimatoz es un medicamento que actúa sobre el sistema inmunitario y se utiliza para tratar las siguientes afecciones:
English: In addition, a study in psoriasis has shown that the effects of the medicine are equivalent to those of Humira in this condition.
Spanish: Además, en un estudio realizado en la psoriasis se ha demostrado que los efectos del medicamento son equivalentes a los de Humira en esta enfermedad.
English: Why is Halimatoz authorised in the EU?
Spanish: ¿Por qué se ha autorizado Halimatoz en la UE?
English: After training, patients or their carers may inject Halimatoz if their doctor considers it appropriate.
Spanish: Tras un adecuado aprendizaje, los propios pacientes o sus cuidadores pueden administrar las inyecciones de Halimatoz si su médico lo considera apropiado.
English: The active substance in Halimatoz, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Spanish: El principio activo de Halimatoz, el adalimumab, es un anticuerpo monoclonal (un tipo de proteína) diseñado para reconocer y adherirse a una sustancia del organismo denominada factor de necrosis tumoral (TNF).
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Halimatoz has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Spanish: La Agencia Europea de Medicamentos decidió que, de acuerdo con los requisitos de la Unión Europea para los medicamentos biosimilares, Halimatoz ha demostrado tener una estructura, una pureza y una actividad biológica muy similares a las de Humira y se distribuye en el organismo de la misma forma.
English: Side effects reported with Halimatoz are carefully evaluated and any necessary action taken to protect patients.
Spanish: Los efectos adversos notificados con Halimatoz son evaluados cuidadosamente, adoptándose las medidas que pudieran resultar necesarias para proteger a los pacientes.
English: Like other medicines of its class, Halimatoz may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Spanish: Halimatoz y otros medicamentos de su clase también pueden afectar a la capacidad del sistema inmunitario para combatir las infecciones y el cáncer, y se han registrado algunos casos de infecciones graves y de cánceres de la sangre en pacientes que utilizaban adalimumab.
English: Halimatoz can only be obtained by prescription and treatment must be started and supervised by a doctor who has experience in the treatment of the diseases for which Halimatoz is used.
Spanish: Halimatoz solo se podrá dispensar con receta médica y el tratamiento debe ser iniciado y supervisado por un médico con experiencia en el tratamiento de las enfermedades para las que se utiliza Halimatoz.
English: Because Halimatoz is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Halimatoz.
Spanish: Dado que Halimatoz es un medicamento biosimilar, no es necesario repetir con Halimatoz todos los estudios sobre la eficacia y la seguridad del adalimumab realizados con Humira.
English: What is Halimatoz and what is it used for?
Spanish: ¿Qué es Halimatoz y para qué se utiliza?
English: Halimatoz is available as a solution for injection under the skin in a pre-filled syringe or pen and is usually given every 2 weeks.
Spanish: Halimatoz se presenta en una solución inyectable por vía subcutánea en jeringa o pluma precargada y se administra normalmente cada 2 semanas.
English: Halimatoz must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Spanish: Halimatoz no se debe administrar a pacientes con tuberculosis activa u otras infecciones graves, ni a pacientes con insuficiencia cardíaca (incapacidad del corazón para bombear suficiente sangre a todo el organismo) de moderada a grave.
English: Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition).
Spanish: Otros efectos adversos graves raros (que pueden afectar hasta 1 de cada 1 000 pacientes) son incapacidad de la médula ósea para producir células sanguíneas, trastornos de los nervios, lupus y trastornos similares al lupus (cuando el sistema inmunitario ataca a los propios tejidos del paciente causando inflamación y daños en los órganos) y síndrome de Stevens-Johnson (una afección cutánea grave).
English: The company that markets Halimatoz must provide educational packs for doctors who prescribe the medicine.
Spanish: La compañía que comercializa Halimatoz elaborará material educativo para los médicos que lo recetan.
English: TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Halimatoz is used to treat.
Spanish: El TNF está implicado en el origen de la inflamación y se encuentra en concentraciones elevadas en los pacientes aquejados de las enfermedades tratadas con Halimatoz.