FrancophonIA/ELRC3.0 huggingface dataset:
English: Pemetrexed Fresenius Kabi as single agent
Spanish: Pemetrexed Fresenius Kabi en monoterapia
English: Cytotoxic
Spanish: FpOXODVPP
English: Very common( may affect more than 1 in 10 people) Low white blood cells
Spanish: Muy frecuentes (pueden afectar a más de 1 de cada 10 pacientes)
English: Common SGPT (ALT) elevation
Spanish: 3HPHWUH[HG &LVSODWLQR
English: C.
Spanish: Q
English: Stomatitis/
Spanish: 'LDUUHD
English: Acute renal failure
Spanish: Pacientes con disfunción renal
English: EXP
Spanish: PP
English: Fresenius Kabi Deutschland GmbH Pfingstweide 53
Spanish: 7UDVWRUQRV JDVWURLQWHVWLQ DOHV
English: Rash Alopecia
Spanish: FRPSOHWDURQ
English: 100 mg
Spanish: 1HXURSDWtD
English: PC:
Spanish: PJ
English: Docetaxel
Spanish: ODDOWHUDFLyQGHO
English: Vomiting
Spanish: HQORV
English: 4.3 Contraindications
Spanish: 6REUHGRVLV
English: N=863 0.94
Spanish: )250$<9Ë$6'($'0,1,675$&,Ï1
English: Constipation
Spanish: SDUDSODFHER
English: All
Spanish: DO
English: Progression free survival (PFS) and overall response rate were similar between treatment arms: median PFS was 4.8 months for pemetrexed plus cisplatin versus 5.1 months for gemcitabine plus cisplatin (adjusted hazard ratio 1.04; 95% CI = 0.94-1.15), and overall response rate was 30.6% (95% CI = 27.3-33.9) for pemetrexed plus cisplatin versus 28.2% (95% CI = 25.0-31.4) for gemcitabine plus cisplatin.
Spanish: )(&+$'(/$35,0(5$$8725,=$&,Ï15(129$&,Ï1'(/$$8725,=$&,Ï1 GH-XOLRGHO )(&+$'(/$5(9,6,Ï1'(/7(;72 /DLQIRUPDFLyQGHWDOODGDGHHVWHPHGLFDPHQWRHVWiGLVSRQLEOHHQODSiJLQDZHEGHOD$JHQFLD(XURSHDGH 0HGLFDPHQWRVKWWSZZZHPDHXURSDHX
English: Grade
Spanish: SDUD
English: Breast-feeding
Spanish: SDUDFDGD
English: The recommended dose of cisplatin is 75 mg/m
Spanish: )UHFXHQWHV$XPHQWRGH$/7 $XPHQWRGH$67
English: Pemetrexed*** (N =800)
Spanish: 'RFHWD[HO
English: Patients also required lower administration of erythropoietin/darbopoietin (10.4% versus 18.1%, p<0.001), G-CSF/GM-CSF (3.1% versus 6.1%, p=0.004), and iron preparations (4.3% versus 7.0%, p=0.021).
Spanish: $)$%5,&$17(65(63216$%/(6'(/$/,%(5$&,Ï1'(/26/27(6
English: 1 vial
Spanish: 3DUDXQVRORXVR
English: An analysis of the impact of NSCLC histology on the treatment effect on overall survival was in favour of pemetrexed versus docetaxel for other than predominantly squamous histologies (n = 399, 9.3 versus 8.0 months, adjusted HR = 0.78; 95% CI = 0 .61-1.00, p = 0.047) and was in favour of docetaxel for squamous cell carcinoma histology (n = 172, 6.2 versus 7.4 months, adjusted HR = 1.56; 95% CI = 1.08-2.26, p = 0.018).
Spanish: -0(1*UiILFDVGH.DSODQ0HLHUSDUDVXSHUYLYHQFLDOLEUHGHSURJUHVLyQ6/3\VXSHUYLYHQFLD JOREDOGH3(0(75(;(')5(6(1,86.$%,IUHQWHDSODFHERHQSDFLHQWHVFRQ&310VDOYR DTXHOORVTXHSUHVHQWDEDQKLVWRORJtDSUHGRPLQDQWHPHQWHGHFpOXODHVFDPRVD
English: Sienkiewicza 25, Kutno, 99-300, Poland
Spanish: 3REODFLyQ,77
English: Dose for cisplatin (mg/m
Spanish: 3HPHWUH[HG
English: Fresenius Kabi Oncology Plc Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF
Spanish: JUDGRGHWR[LFLGDG 'HDFXHUGRFRQORV&7&GHO,QVWLWXWR1DFLRQDOGHO&iQFHUY1&,
English: Pharyngitis
Spanish: GHORV
English: Hydrochloric acid concentrated (E507) (pH adjustment) Trometamol (pH adjustment)
Spanish: &XDOTXLHUWR[LFLGDGJUDGRy H[FHSWRPXFRVLWLV
English: Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe Germany
Spanish: D&ULWHULRV&RPXQHVGH7R[LFLGDGGHO,QVWLWXWR1DFLRQDOGHO&iQFHU&7&Y1&, E6HH[FOX\HQHXURWR[LFLGDG
English: CTC
Spanish: HQ
English: Conjunctivitis (inflamed eye)
Spanish: 7LWXODUGHODDXWRUL]DFLyQGHFRPHUFLDOL]DFLyQ
English: Elderly
Spanish: YDORUGHS
English: Nadir ANC < 500 /mm and nadir platelets
Spanish: GH*&6)*0&6)IUHQWHD
English: a
Spanish: S
English: Pemetrexed + cisplatin
Spanish: 1RLQIHULRULGDGGHYDORUS+5
English: A.
Spanish: ±S
English: Mannitol (E421)
Spanish: &LWRWy[LFR
English: A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (JMEN), compared the efficacy and safety of maintenance treatment with pemetrexed plus best supportive care (BSC) (n = 441) with that of placebo plus BSC (n = 222) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) Non Small Cell Lung Cancer (NSCLC) who did not progress after 4 cycles of first line doublet therapy containing cisplatin or carboplatin in combination with gemcitabine, paclitaxel, or docetaxel.
Spanish: SDFLHQWHVLQFOXLGRVHQHVWHHQVD\RSUHVHQWDEDQXQYDORUGHyHQODHVFDOD(&2* (ODQiOLVLVSULQFLSDOGHHILFDFLDVHUHDOL]yVREUHODSREODFLyQ,77/RVDQiOLVLVGHVHQVLELOLGDGGHORV SDUiPHWURVSULQFLSDOHVGHHILFDFLDIXHURQWDPELpQDQDOL]DGRVHQODSREODFLyQSRUSURWRFROR33/RV UHVXOWDGRVGHORVDQiOLVLVGHHILFDFLDSDUDODSREODFLyQ33VRQFRQVLVWHQWHVFRQORVUHVXOWDGRVREWHQLGRV SDUDODSREODFLyQ,77\DYDODQODQRLQIHULRULGDGGH3&IUHQWH*& /DVXSHUYLYHQFLDOLEUHGHSURJUHVLyQ6/3\ODWDVDGHUHVSXHVWDJOREDOIXHURQVLPLODUHVHQWUHORVGRV EUD]RVGHWUDWDPLHQWRODPHGLDQDGH6/3IXHGHPHVHVSDUDSHPHWUH[HGPiVFLVSODWLQRIUHQWHD PHVHVSDUDJHPFLWDELQDPiVFLVSODWLQRFRFLHQWHGHULHVJRDMXVWDGR,&GHO
English: b
Spanish: R
English: Common Pain Edema Renal disorders Common Renal disorders**** Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT = serum glutamic oxaloacetic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
Spanish: 4XpHV3HPHWUH[HG)UHVHQLXV.DEL\SDUDTXpVHXWLOL]D 4XpQHFHVLWDVDEHUDQWHVGHHPSH]DUDXVDU3HPHWUH[HG)UHVHQLXV.DEL &yPRXVDU3HPHWUH[HG)UHVHQLXV.DEL 3RVLEOHVHIHFWRVDGYHUVRV &RQVHUYDFLyQGH3HPHWUH[HG)UHVHQLXV.DEL &RQWHQLGRGHOHQYDVHHLQIRUPDFLyQDGLFLRQDO
English: N=106
Spanish: '$726&/Ë1,&26
English: Fatigue (tiredness)
Spanish: 3HPHWUH[HGFLVSODWLQR
English: Log rank p-value*
Spanish: 7R[LFLGDG JUDGR
English: Nausea
Spanish: ODDORSHFLD
English: (n = 288)
Spanish: (PEDUD]R
English: Pemetrexed / Cisplatin (N = 226)
Spanish: )UHFXHQWHV(OHYDFLyQGH$/7 (OHYDFLyQGH
English: Creatinine clearance decreased**
Spanish: PJSROYRSDUDFRQFHQWUDGRSDUDVROXFLyQSDUDSHUIXVLyQ()* SHPHWUH[HG
English: A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (PARAMOUNT), compared the efficacy and safety of continuation maintenance treatment with ALIMTA plus BSC (n = 359) with that of placebo plus BSC (n = 180) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC other than predominantly squamous cell histology who did not progress after 4 cycles of first line doublet therapy of ALIMTA in combination with cisplatin.
Spanish: FRQ&310ORFDOPHQWHDYDQ]DGR(VWDGtR,,,%RPHWDVWiVLFR(VWDGtR,9VDOYRDTXHOORVTXHSUHVHQWDEDQ KLVWRORJtDSUHGRPLQDQWHPHQWHGHFpOXODHVFDPRVDTXHQRSURJUHVDURQWUDVFLFORVGHXQDSULPHUDOtQHDGH WHUDSLDGHFRPELQDFLyQGHSHPHWUH[HGFRQFLVSODWLQR'HORVSDFLHQWHVWUDWDGRVFRQSHPHWUH[HGPiV FLVSODWLQRHQLQGXFFLyQSDFLHQWHVIXHURQDOHDWRUL]DGRVDUHFLELUWUDWDPLHQWRGHPDQWHQLPLHQWRFRQ SHPHWUH[HGRSODFHER'HORVSDFLHQWHVDOHDWRUL]DGRV
English: Muscle weakness
Spanish: SDFLHQWHV
English: *P-values < 0.05 comparing pemetrexed/cisplatin to gemcitabine/cisplatin, using Fisher Exact test. **Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity.
Spanish: )8(5$'(/$9,67$<'(/$/&$1&('(/261,f26 0DQWHQHUIXHUDGHODYLVWD\GHODOFDQFHGHORVQLxRV
English: Dose of pemetrexed (mg/m
Spanish: 'RVLVGHSHPHWUH[HG PJP
English: A multi-centre, randomised, double-blind, placebo-controlled Phase 3 study (PARAMOUNT), compared the efficacy and safety of continuation maintenance treatment with pemetrexed plus BSC (N = 359) with that of placebo plus BSC (N = 180) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC other than predominantly squamous cell histology who did not progress after 4 cycles of first-line doublet therapy of pemetrexed in combination with cisplatin.
Spanish: ([FLSLHQWHV0DQLWROiFLGRFORUKtGULFRFRQFHQWUDGRWURPHWDPRO )250$)$50$&e87,&$<&217(1,'2'(/(19$6( 3ROYRSDUDFRQFHQWUDGRSDUDVROXFLyQSDUDSHUIXVLyQ YLDO
English: Malignant pleural mesothelioma
Spanish: FGHOD'LUHFWLYD
English: AST (SGOT) elevation
Spanish: SHPHWUH[HG
English: Efficacy of pemetrexed vs docetaxel in NSCLC - ITT population Pemetrexed
Spanish: &yPRXVDU3HPHWUH[HG)UHVHQLXV.DEL
English: Haemoglobin decreased
Spanish: DGPLQLVWUDFLyQ
English: 19 January 2017 EMA/747766/2016
Spanish: 19 de enero de 2017 EMA/747766/2016
English: This could lead to fluctuations in blood glucose control.
Spanish: Esto podría causar fluctuaciones en el control de la glucosa en sangre.
English: Suliqua is a medicine that is used for the treatment of type-2 diabetes.
Spanish: Suliqua es un medicamento que se usa para tratar la diabetes de tipo 2.
English: Information for patients and carers
Spanish: Información para los pacientes y los cuidadores
English: • Pharmacists should clarify with the prescriber any incomplete prescription.
Spanish: • Los farmacéuticos deben aclarar con el médico prescriptor las recetas incompletas.
English: Your healthcare professional will give you this information.
Spanish: El profesional sanitario que le atiende le dará esta información.
English: Measures intended to reduce risk of confusion between two pens of different strengths
Spanish: Medidas para reducir el riesgo de confusión entre dos plumas de dosis diferentes
English: • If you have any questions about your treatment, speak to your healthcare professional.
Spanish: • Si tiene alguna duda sobre su tratamiento, consulte al profesional sanitario que le atiende.
English: More information about Suliqua can be found on the Agency's website: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004243/human_ med_002064.jsp
Spanish: Puede obtener más información sobre Suliqua en el sitio web de la Agencia: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004243/ human_med_002064.jsp
English: • You must therefore not use the pens interchangeably as you could receive too much or too little lixisenatide and this could disrupt the control of your blood sugar levels.
Spanish: • Por tanto, no debe utilizar las plumas indistintamente, ya que podría recibir una cantidad excesiva o insuficiente de lixisenatida, lo que podría alterar el control de su nivel de azúcar en sangre.
English: • When starting Suliqua and in the weeks thereafter you should measure your blood sugar levels more frequently than usual.
Spanish: • Cuando empiece a usar Suliqua y en las semanas siguientes, deberá medirse el azúcar en sangre con más frecuencia de la habitual.
English: Patients will receive a ‘patient guide' from their healthcare professional which they should read carefully along with the package leaflet.
Spanish: Los pacientes recibirán una «guía para el paciente» de su profesional sanitario, la cual deberán leer atentamente junto con el prospecto.
English: Before you use Suliqua be clear on how many dose steps you require.
Spanish: Antes de utilizar Suliqua, debe saber con seguridad cuántas unidades de dosis necesita.
English: It is available as a solution for injection in pre-filled pens.
Spanish: Se presenta en forma solución inyectable en plumas precargadas.
English: To reduce the risk of medication errors, educational materials will be sent out to relevant healthcare professionals in the EU where the product is marketed, to raise awareness about the differences between the two pens, the way the dose is expressed and how to use the medicine correctly.
Spanish: Para reducir el riesgo de errores de medicación, se enviarán materiales educativos a los profesionales sanitarios adecuados en los países de la UE donde está comercializado el producto, con el fin de dar a conocer las diferencias entre las dos plumas, la forma en la que se expresa la dosis y el uso correcto del medicamento.
English: • Ensure that patients and their caretakers are adequately informed on how to use their medicine.
Spanish: • Asegúrese de que los pacientes y sus cuidadores disponen de suficiente información sobre cómo usar el medicamento.
English: • Explain the design and features of the pen to the patient and if the patient has been transferred from another pen device, highlight the differences in design between the two devices to avoid confusion (focus on colour differentiation, warning statements on carton/label).
Spanish: • Explique al paciente el diseño y las características de la pluma y, si el paciente ha utilizado antes otra pluma distinta, destaque las diferencias en el diseño entre ambas plumas para evitar confusiones (céntrese en diferenciar los colores y en las advertencias de precaución de la caja/etiqueta).
English: • Tell patients to closely monitor their blood sugar levels when starting Suliqua and in the weeks thereafter.
Spanish: • Pida a los pacientes que controlen estrechamente sus niveles de azúcar en sangre cuando comiencen a usar Suliqua y en las semanas posteriores.
English: Healthcare professionals should ensure that they train their patients on how to use Suliqua correctly.
Spanish: Los profesionales sanitarios deberán ocuparse de enseñar a sus pacientes a utilizar Suliqua correctamente.
English: Suliqua is available in two different pens:
Spanish: Suliqua se presenta en dos plumas diferentes:
English: • Suliqua must only be used with its pre-filled pen.
Spanish: • Suliqua solo debe utilizarse con su pluma precargada.
English: • Provide patients with the patient guide prior to prescribing or dispensing Suliqua.
Spanish: • Entregue a sus pacientes la guía para el paciente antes de prescribir o dispensar Suliqua.
English: • Suliqua is supplied in a pre-filled pen and must only be used with this device.
Spanish: • Suliqua se presenta en una pluma precargada y solo se deberá usar con este dispositivo.
English: It is used together with diabetes medicines taken by mouth in adults whose blood glucose (sugar) levels are not satisfactorily controlled by metformin alone or metformin combined with either a glucose-lowering medicine or insulin.
Spanish: Se utiliza junto con medicamentos antidiabéticos orales en adultos cuyos niveles de glucosa (azúcar) en sangre no pueden controlarse satisfactoriamente con metformina en monoterapia o con metformina combinada con un hipoglucemiante o con insulina.
English: Healthcare professionals and patients expected to use the diabetes medicine Suliqua will be given educational materials to ensure that the medicine is used correctly and prevent medication errors such as confusion between the two different strengths of the product.
Spanish: Los profesionales sanitarios y los pacientes que vayan a utilizar el medicamento antidiabético Suliqua recibirán materiales educativos para garantizar el correcto uso del medicamento y evitar errores de medicación, como la confusión entre las dos dosis del producto.
English: It is used for people needing 10-40 units of insulin daily.
Spanish: Se emplea en personas que necesitan 10-40 unidades de insulina al día.
English: • Pharmacists are encouraged to check that patients and carers are able to read the strength of Suliqua, the dose range of the pre-filled pen and the dose counter of the pen device before dispensing Suliqua.
Spanish: • Se anima a los farmacéuticos a comprobar que los pacientes y cuidadores saben leer la dosis de Suliqua, el intervalo de dosis de la pluma precargada y el contador de dosis de la pluma antes de dispensar Suliqua.
English: • Patients who are blind or with poor vision must be instructed to always get assistance from another person who has good vision and is trained in using the Suliqua pen device.
Spanish: • A los pacientes invidentes o con problemas de visión se les debe indicar que dispongan siempre de la ayuda de otra persona con buena visión y que sepa usar la pluma de Suliqua.
English: The lixisenatide strength is lower to ensure an adequate but not excessive dose in people requiring higher doses of insulin.
Spanish: La dosis de lixisenatida es más baja para garantizar una dosis suficiente, pero no excesiva, en las personas que necesitan dosis más altas de insulina.
English: • Read the instructions in your package leaflet carefully before using your medicine.
Spanish: • Lea atentamente las instrucciones del prospecto antes de utilizar el medicamento.
English: Pharmacists should also check that patients have been trained on how to use the pen.
Spanish: Los farmacéuticos también deberán verificar que los pacientes han aprendido a usar la pluma.
English: The lixisenatide strength is higher to ensure an adequate dose in people requiring lower doses of insulin.
Spanish: La dosis de lixisenatida es más alta para garantizar una dosis suficiente en las personas que necesitan dosis más bajas de insulina.
English: You must never use a syringe to remove the medicine from its pen as this may lead to dosing errors and serious harm.
Spanish: Nunca debe utilizar una jeringa para extraer el medicamento de la pluma, ya que se pueden producir errores de dosificación y daños graves.
English: A syringe must never be used to withdraw insulin glargine and lixisenatide from the pre-filled pen as this may lead to dosing errors and serious harm.
Spanish: Nunca se debe utilizar una jeringa para extraer la insulina glargina y la lixisenatida de la pluma precargada, ya que se pueden producir errores de dosificación y daños graves.
English: • Because the two pens contain different concentrations of lixisenatide, the dose step of one pen is not equivalent to the dose step of the other.
Spanish: • Las dos plumas contienen concentraciones diferentes de lixisenatida, por lo que una unidad de dosis de una pluma no es equivalente a una unidad de dosis de la otra.
English: deliver between 10 and 40 dose steps per day (and is also referred to as Suliqua 10-40).
Spanish: Esta pluma puede proporcionar entre 10 y 40 unidades de dosis al día (y se denomina también Suliqua 10-40).
English: As for similar combination medicines used for the treatment of diabetes, the dose of Suliqua is expressed in ‘dose steps', with each dose step corresponding to one unit of insulin plus a fixed amount of lixisenatide.
Spanish: Al igual que sucede con otros medicamentos combinados parecidos que se utilizan para el tratamiento de la diabetes, la dosis de Suliqua se expresa en «unidades de dosis», de manera que cada unidad de dosis se corresponde con una unidad de insulina más una cantidad fija de lixisenatida.
English: One dose step always contains one unit of insulin, regardless of the Suliqua pen being used.
Spanish: Una unidad de dosis contiene siempre una unidad de insulina, con independencia de la pluma de Suliqua que se utilice.
English: • Suliqua is a fixed combination of insulin glargine/lixisenatide available in two strengths:
Spanish: • Suliqua es una combinación de dosis fijas de insulina glargina/lixisenatida disponible en dos dosis:
English: • Suliqua is given in dose steps which correspond to a set number of units of insulin plus a fixed amount of lixisenatide.
Spanish: • Suliqua se administra en unidades de dosis que corresponden a un número determinado de unidades de insulina más una cantidad fija de lixisenatida.
English: • Suliqua is supplied in two pre-filled pens:
Spanish: • Suliqua se presenta en dos plumas precargadas:
English: The amount of lixisenatide per dose step however varies (0.50 micrograms per dose step for the 10-40 pen and 0.33 micrograms per dose step for the 30-60 pen).
Spanish: En cambio, la cantidad de lixisenatida por unidad de dosis es variable (0,50 microgramos por unidad de dosis en la pluma 10-40 y 0,33 microgramos por unidad de dosis en la pluma 30-60).
English: • Explain to your patient that the dose counter of the pen device shows the number of dose steps to be injected.
Spanish: • Explique a sus pacientes que el contador de dosis de la pluma muestra el número de unidades de dosis que se van a inyectar.
English: Your healthcare professional will train you on how to use the pen.
Spanish: El profesional sanitario que le atiende le enseñará a utilizar la pluma.
English: • As for similar medicines containing insulin with a non-insulin medicine, the dose is expressed in dose steps.
Spanish: • Al igual que sucede con otros medicamentos parecidos que contienen insulina y un medicamento no relacionado con la insulina, la dosis de Suliqua se expresa en unidades de dosis.
English: • The dose counter of the pen device shows the number of dose steps to be injected.
Spanish: • El contador de dosis de la pluma muestra el número de unidades de dosis que se van a inyectar.
English: The prescription must state the type of pen to be used (either Suliqua 10-40 or Suliqua 30-60), the strength (i.e. insulin glargine 100 units/ml + lixisenatide 50 micrograms/ml or insulin glargine 100 units/ml + lixisenatide 33 micrograms/ml) and the number of dose steps to be administered.
Spanish: En la receta se debe especificar el tipo de pluma que se ha de emplear (Suliqua 10-40 o Suliqua 30-60), la dosis (es decir, insulina glargina 100 unidades/ml + lixisenatida 50 microgramos/ml o insulina glargina 100 unidades/ml + lixisenatida 33 microgramos/ml) y el número de unidades de dosis que se tienen que administrar.
English: Suliqua contains a combination of insulin glargine and a non-insulin medicine, lixisenatide.
Spanish: Suliqua contiene una combinación de insulina glargina y un medicamento no relacionado con la insulina, la lixisenatida.
English: The doses of insulin and lixisenatide contained in increasing dose steps are given in the figure below:
Spanish: En la figura siguiente se muestran las dosis de insulina y de lixisenatida en unidades de dosis crecientes:
English: One dose step always contains one unit of insulin plus a fixed amount of lixisenatide.
Spanish: Una unidad de dosis contiene siempre una unidad de insulina y una cantidad fija de lixisenatida.
English: • Suliqua contains insulin glargine and a non-insulin medicine, lixisenatide.
Spanish: • Suliqua contiene insulina glargina y un medicamento no relacionado con la insulina, la lixisenatida.
English: deliver between 30 and 60 dose steps per day (and is also referred to as Suliqua 30-60) Since the two pens contain different amounts of lixisenatide for each dose step, it is important that they are not used interchangeably as this would result in patients receiving too much or too little lixisenatide.
Spanish: Dado que las dos plumas contienen cantidades diferentes de lixisenatida para cada unidad de dosis, es importante que no se utilicen indistintamente, ya que los pacientes podrían recibir una cantidad excesiva o insuficiente de lixisenatida.
English: − Suliqua 30-60 (containing insulin glargine 100 units/ml with lixisenatide 33 micrograms/ml)this pen can deliver between 30 and 60 dose steps per day.
Spanish: − Suliqua 30-60 (que contiene 100 unidades/ml de insulina glargina y 33 microgramos/ml de lixisenatida); esta pluma puede proporcionar entre 30 y 60 unidades de dosis al día.
English: Suliqua 10-40 (containing insulin glargine 100 units/ml with lixisenatide 50 micrograms/ml) - this pen can deliver between 10 and 40 dose steps per day.
Spanish: Suliqua 10-40 (que contiene 100 unidades/ml de insulina glargina y 50 microgramos/ml de lixisenatida); esta pluma puede proporcionar entre 10 y 40 unidades de dosis al día.
English: − Suliqua 10-40 (containing insulin glargine 100 units/ml with lixisenatide 50 micrograms/ml)this pen can deliver between 10 and 40 dose steps per day.
Spanish: − Suliqua 10-40 (que contiene 100 unidades/ml de insulina glargina y 50 microgramos/ml de lixisenatida); esta pluma puede proporcionar entre 10 y 40 unidades de dosis al día.
English: It has been available in the EU since the 1950s.
Spanish: Está disponible en la UE desde la década de 1950.
English: The majority of these data had already been used in the authorisation of Forxiga.
Spanish: La mayor parte de estos datos ya se había utilizado en la autorización de Forxiga.
English: Xigduo received a marketing authorisation valid throughout the EU on 16 January 2014.
Spanish: Xigduo recibió una autorización de comercialización válida en toda la UE el 16 de enero de 2014.
English: Further information on Xigduo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/xigduo.
Spanish: Puede encontrar información adicional sobre Xigduo en la página web de la Agencia: ema.europa.eu/medicines/human/EPAR/xigduo.
English: Dapagliflozin has been authorised in the European Union (EU) as Forxiga since 2012;
Spanish: La dapagliflozina está autorizada en la Unión Europea (UE) con el nombre de Forxiga desde 2012;