natgillin/translations-raw huggingface dataset:
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Docetaxel Mylan could not have been approved.
Tuginedes esitatud andmete analüüsile nägi inimravimite komitee müügiloa tagasivõtmise ajal põhjust ettevaatlikkuseks ja oli esialgsel arvamusel, et ravimile Docetaxel Mylan ei või anda müügiluba.
The active substance in Docetaxel Mylan, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Docetaxel Mylani toimeaine dotsetakseel kuulub vähiravimite taksaanide rühma.
How is Docetaxel Mylan expected to work?
Milline on Docetaxel Mylani eeldatav toime?
What was Docetaxel Mylan expected to be used for?
Milleks kavatseti Docetaxel Mylanit kasutada?
What is Javlor?
Mis on Javlor?
It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Ettevõte võib taotleda arvamuse taasläbivaatamist 15 päeva jooksul pärast negatiivse arvamuse teate saamist.
The full European Public Assessment Report for Javlor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Euroopa avaliku hindamisaruande täistekst Javlori kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 September 2014
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26.
Javlor is a cancer medicine that has been authorised in the EU since September 2009.
Javlor on vähiravim, millel on Euroopa Liidus müügiluba alates septembrist 2009.
Although there was an improvement in progression-free survival, this was considered to be small.
Kuigi progresseerumiseta elulemus suurenes, peeti seda väheseks.
In addition, there was no benefit in terms of other important measures of effectiveness, including overall survival (how long patients lived).
Kasulikkus puudus ka muude tähtsate efektiivsusnäitajate suhtes, sealhulgas üldise elulemuse suhtes (aeg, kui kaua patsiendid elasid).
The change concerned an extension of indication to add treatment of breast cancer.
Muudatus käsitles näidustuse laiendamist, et lisada rinnavähi ravi.
‘Metastatic' means that the cancer has spread to other parts of the body.
Metastaatiline (siiretega) tähendab, et vähk on levinud organismis ka mujale.
The company that applied for the change to the authorisation is Pierre Fabre Médicament.
Müügiloa muutmist taotles ettevõte Pierre Fabre Médicament.
Refusal of a change to the marketing authorisation for Javlor (vinflunine) EMA/587197/2014
Javlori (vinfluniin) müügiloa muutmisest keeldumine EMA/587197/2014
Compared with patients given capecitabine alone, more patients receiving Javlor plus capecitabine experienced side effects including neutropenia (abnormally low blood levels of white blood cells), gastrointestinal events such as constipation, nausea and vomiting and stomach ache, fatigue and nervous system disorders such as damage to the nerves in the extremities.
Võrreldes ainult kapetsitabiini kasutanud patsientidega oli Javlori ja kapetsitabiini kombinatsiooni kasutanute seas rohkem neid, kellel esines kõrvalnähte, sealhulgas neutropeeniat (neutrofiilide (teatud valgeliblede) vähesus), seedetrakti häired, näiteks kõhukinnisus, iiveldus, oksendamine ja kõhuvalu, ning väsimus ja närvisüsteemi häired, näiteks perifeerne neuropaatia (jäsemete närvikahjustus).
On 25 September 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Javlor.
25. septembril 2014 võttis inimravimite komitee vastu negatiivse arvamuse, soovitades ravimi Javlor müügiloa muutmisest keelduda.
By attaching to tubulin in cancer cells, vinflunine stops the formation of the skeleton, preventing the division and spread of the cancer cells.
Vähirakkudes sisalduva tubuliiniga seondudes takistab vinfluniin rakutoese moodustumist ning takistab vähirakkude jagunemist ja levikut.
Therefore, at that point in time, the CHMP was of the opinion that the modest effect of Javlor in the treatment of breast cancer did not outweigh the additional risks observed.
Inimravimite komitee oli sel ajal seepärast arvamusel, et Javlori tagasihoidlik toime rinnavähi ravis ei ületa täheldatud lisariske.
The main measure of effectiveness was progression-free survival (how long patients lived without their disease getting worse).
Efektiivsuse põhinäitaja oli progresseerumiseta elulemus (aeg haiguse süvenemiseni).
The company presented the results of a main study involving 770 patients with advanced breast cancer previously treated with or resistant to an anthracycline and who are taxane resistant.
Ettevõte esitas põhiuuringu tulemused, milles osales 770 varem antratsükliiniga ravitud või selle suhtes resistentse ja taksaani suhtes resistentse kaugelearenenud rinnavähiga patsienti.
Refusal of a change to the marketing authorisation for Javlor (vinflunine)
Javlori (vinfluniin) müügiloa muutmisest keeldumine
The active substance in Javlor, vinflunine, belongs to the group of cancer medicines known as ‘vinca alkaloids'.
Javlori toimeaine vinfluniin kuulub vähiravimite vinka-alkaloidide rühma.
The CHMP noted that the effectiveness of Javlor in combination with capecitabine had not been sufficiently demonstrated.
Inimravimite komitee märkis, et Javlori ja kapetsitabiini kombinatsiooni efektiivsus ei ole piisavalt tõestatud.
There are no consequences on the use of Javlor in its authorised indication.
Keeldumine ei mõjuta Javlori kasutamist heakskiidetud näidustusel.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Javlor.
Ettevõte teatas inimravimite komiteele, et praegu Javlori kliinilistes uuringutes osalevatele patsientidele keeldumine mõju ei avalda.
Hence, the CHMP recommended that the change to the marketing authorisation be refused.
Inimravimite komitee soovitas seepärast müügiloa muutmisest keelduda.
Javlor was also expected to be used in combination with the cancer medicine capecitabine for the treatment of adult patients with locally advanced or metastatic breast cancer.
Javlori kavatseti kasutada ka kombinatsioonis vähiravimi kapetsitabiiniga lokaalselt kaugelearenenud või metastaatilise rinnavähiga täiskasvanud patsientide raviks.
What were the CHMP's main concerns that led to the refusal of the change to the marketing authorisation?
Mis olid peamised probleemid, mille tõttu soovitas inimravimite komitee müügiloa muutmisest keelduda?
It was to be used in patients previously treated with, or resistant to, another type of cancer medicine called an anthracycline and who are also resistant to a third type of cancer medicines called taxanes.
Seda kavatseti kasutada patsientidel, keda oli varem ravitud teist liiki vähiravimi antratsükliiniga või kelle haigus on selle suhtes resistentne ning kelle haigus on resistentne ka kolmandat liiki vähiravimite taksaanide suhtes.
What is happening with Javlor for the treatment of transitional-cell carcinoma of the urothelial tract?
Kuidas mõjutab keeldumine Javlori kasutamist uroteeli transitoorrakulise kartsinoomi ravis?
In the study, Javlor given together with capecitabine was compared with capecitabine alone.
Uuringus võrreldi kapetsitabiini ja Javlori kombinatsiooni toimet ainult kapetsitabiini toimega.
It attaches to a cell protein called tubulin, which is important in the formation of the internal ‘skeleton' that cells need to allow them to divide.
See seondub rakkudes sisalduva valgu tubuliiniga, mis on oluline rakkude jagunemiseks vajaliku raku sisetoese
It is already used to treat adults with advanced or metastatic ‘transitional-cell carcinoma of the urothelial tract' (a cancer that affects the lining of the bladder and the rest of the urinary tract).
Praegu kasutatakse seda täiskasvanutel uroteeli (kusepõie ja kuseteede limaskesta) kaugelearenenud või metastaatilise transitoorrakulise kartsinoomi (teatud vähiliigi) raviks.
What was Javlor expected to be used for?
Milleks kavatseti Javlori kasutada?
How is Javlor expected to work?
Milline on Javlori eeldatav toime?
Javlor contains the active substance vinflunine and is available as a concentrate for solution for infusion (drip) into a vein.
Seda turustatakse infusioonilahuse (veeni tilgutatava lahuse) kontsentraadina.
1 Previously known as DuoCover.
1 anteriormente conocido como DuoCover.
EPAR summary for the public
Resumen del EPAR para el público general
The medicine can only be obtained with a prescription.
Este medicamento solo se podrá dispensar con receta médica.
The European Commission granted a marketing authorisation valid throughout the EU for DuoCover on 15 March 2010.
La Comisión Europea emitió una autorización de comercialización válida en toda la Unión Europea para el medicamento DuoCover el 15 de marzo de 2010.
Both active substances have been available in the European Union (EU) for a number of years.
Ambos principios activos se comercializan en la Unión Europea (UE) desde hace varios años.
This summary was last updated in 03-2016.
Fecha de la última actualización del presente resumen: 03-2016.
It also presented the results of 3 previous studies involving over 61,000 patients with unstable angina or who had had a heart attack.
También presentó los resultados de 3 estudios previos en los que participaron más de 61.000 pacientes con angina inestable o que habían sufrido un ataque cardíaco.
It can be used in the following groups of patients who have a condition known as ‘acute coronary syndrome':
Puede usarse en los siguientes grupos de pacientes que presenten un trastorno denominado «síndrome coronario agudo»:
The full EPAR for Clopidogrel/Acetylsalicylic acid Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
El EPAR completo de Clopidogrel/Ácido acetilsalicílico Zentiva puede consultarse en el sitio web de la Agencia: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The Committee therefore decided that Clopidogrel/Acetylsalicylic acid Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Por tanto, el Comité decidió que los beneficios de Clopidogrel/Ácido acetilsalicílico Zentiva son mayores que sus riesgos y recomendó autorizar su comercialización.
It is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid.
Se presenta en comprimidos que contienen 75 mg de clopidogrel, y 75 mg o 100 mg de ácido acetilsalicílico.
Acetylsalicylic acid has been available for over 100 years.
El ácido acetilsalicílico se comercializa desde hace más de 100 años.
• patients being treated for heart attack with ST-segment elevation, when the doctor thinks that they would benefit from treatment to dissolve blood clots.
• pacientes sometidos a tratamiento de un infarto de miocardio con elevación del segmento ST, cuando el médico considera que podrían beneficiarse de un tratamiento para disolver los coágulos.
The name of the medicine was changed to Clopidogrel/Acetylsalicylic acid Zentiva on 15 January 2016.
El nombre del medicamento se cambió por Clopidogrel/Ácido acetilsalicílico Zentiva el 15 de enero de 2016.
Clopidogrel has been authorised since 1998 for reducing platelet aggregation, and is often used in combination with acetylsalicylic acid.
El clopidogrel se autorizó en 1998 para reducir la agregación plaquetaria, y a menudo se utiliza en combinación con el ácido acetilsalicílico.
Clopidogrel stops the platelets sticking together by blocking a substance called ADP from attaching to a special receptor on their surface.
El clopidogrel impide la adhesión entre las plaquetas al bloquear la unión de una sustancia denominada ADP a un receptor especial en su superficie.
This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming.
Esto evita que las plaquetas «se peguen», lo que reduce el riesgo de que se formen coágulos de sangre.
For more information about treatment with Clopidogrel/Acetylsalicylic acid Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Para mayor información sobre el tratamiento con Clopidogrel/Ácido acetilsalicílico Zentiva, lea el prospecto (también incluido en el EPAR) o consulte a su médico o farmacéutico.
Clopidogrel/Acetylsalicylic acid Zentiva must not be used during the last three months of pregnancy.
Clopidogrel/Ácido acetilsalicílico Zentiva no debe utilizarse tampoco durante el último trimestre del embarazo.
This means that they help to prevent blood cells called platelets from sticking together and forming clots, thus helping to prevent another heart attack.
Esto significa que ayudan a impedir que las células sanguíneas denominadas plaquetas se adhieran unas a otras y formen coágulos y, por tanto, ayudan a prevenir un nuevo infarto de miocardio.
This reduces the production of a substance called thromboxane, which normally helps clots to form by attaching platelets together.
De este modo, se reduce la producción de una sustancia denominada tromboxano, que normalmente contribuye a que las plaquetas se unan, favoreciendo así la formación de coágulos.
Because the two active substances have been used together for a number of years, the company presented the results of studies showing that the active substances in Clopidogrel/Acetylsalicylic acid Zentiva are absorbed in the body in the same way when taken in a single tablet as when the two medicines are taken separately.
Dado que ambos principios activos se han venido utilizando conjuntamente desde hace años, la empresa presentó los resultados de estudios que demostraban que el organismo absorbe los principios activos de Clopidogrel/Ácido acetilsalicílico Zentiva de la misma forma cuando se toman juntos en un único comprimido que cuando se toman por separado.
The combination of the two active substances has an additive effect, reducing the risk of blood clots forming more than either medicine alone.
La combinación de los dos principios activos tiene un efecto aditivo y reduce el riesgo de formación de coágulos en mayor medida que cualquiera de los medicamentos por separado.
It must not be used in patients who have a disease that is causing bleeding, such as stomach ulcer or bleeding in the brain, or in patients with mastocytosis (high blood levels of certain white blood cells called mast cells).
No se debe usar en pacientes que tengan alguna enfermedad que esté causando una hemorragia, como una úlcera de estómago o una hemorragia cerebral, o en pacientes con mastocitosis (niveles altos en sangre de ciertos glóbulos blancos llamados mastocitos).
This document is a summary of the European Public Assessment Report (EPAR) for Clopidogrel/Acetylsalicylic acid Zentiva.
El presente documento resume el Informe Público Europeo de Evaluación (EPAR) de Clopidogrel/Ácido acetilsalicílico Zentiva.
• patients who have unstable angina (a severe type of chest pain) or who have had a heart attack with no ‘ST-segment elevation' (an abnormal reading on the ECG or electrocardiogram), including those who are having a stent (a short tube) inserted into an artery to prevent it from closing up;
• pacientes con angina de pecho inestable (un tipo intenso de dolor en el pecho) o que han sufrido un infarto de miocardio sin «elevación del segmento ST» (un signo electrocardiográfico anómalo), incluyendo aquellos a los que se ha implantado una endoprótesis (un tubo corto llamado con frecuencia stent) en una arteria para impedir que se cierre;
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel/Acetylsalicylic acid Zentiva.
En él se explica cómo el Comité de Medicamentos de Uso Humano (CHMP) ha evaluado dicho medicamento y emitido un dictamen favorable a la autorización de comercialización y unas recomendaciones sobre las condiciones de su uso.
Acetylsalicylic acid stops the platelets sticking together by blocking an enzyme called prostaglandin cyclo-oxygenase.
El ácido acetilsalicílico impide la adhesión entre las plaquetas al bloquear una enzima denominada prostaglandina-cicloxigenasa.
The most common side effects with Clopidogrel/Acetylsalicylic acid Zentiva (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising, and bleeding where the skin is punctured.
Los efectos adversos más frecuentes de Clopidogrel/Ácido acetilsalicílico Zentiva (observados en entre 1 y 10 pacientes de cada 100) son hematomas (moraduras, cardenales), epistaxis (hemorragia nasal), hemorragias gastrointestinales (sangrado del estómago o intestino), diarrea, dolor abdominal (de estómago), dispepsia (indigestión), hematomas y hemorragia en la zona de punción de la piel.
Clopidogrel/Acetylsalicylic acid Zentiva must not be used in people who are hypersensitive (allergic) to clopidogrel, non steroidal anti-inflammatory drugs (such as acetylsalicylic acid) or any of the other ingredients in Clopidogrel/Acetylsalicylic acid Zentiva.
Clopidogrel /Ácido acetilsalicílico Zentiva no se debe utilizar en personas que sean hipersensibles (alérgicas) al clopidogrel, a los antiinflamatorios no esteroideos (como el ácido acetilsalicílico) o a alguno de los componentes del medicamento.
For the full list of all side effects reported with Clopidogrel/Acetylsalicylic acid Zentiva, see the package leaflet.
Para consultar la lista completa de efectos adversos notificados sobre Clopidogrel/Ácido acetilsalicílico Zentiva, ver el prospecto.
Clopidogrel/Acetylsalicylic acid Zentiva is a medicine that contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin).
Clopidogrel/Ácido acetilsalicílico Zentiva es un medicamento que contiene dos principios activos, clopidogrel y ácido acetilsalicílico (también denominado «aspirina»).
Results from the 3 studies in patients with unstable angina or who had had a heart attack showed that the combination of clopidogrel and acetylsalicylic acid taken as separate tablets was more effective at preventing events such as heart attacks than acetylsalicylic acid alone.
También presentó los resultados de 3 estudios previos en los que participaron pacientes con angina de pecho inestable o que habían sufrido un infarto de miocardio, que demostraron que la combinación de clopidogrel y ácido acetilsalicílico tomados en comprimidos separados era más eficaz para prevenir episodios como los infartos de miocardio que el ácido acetilsalicílico en monoterapia.
The CHMP noted that Clopidogrel/Acetylsalicylic acid Zentiva is comparable to clopidogrel and acetylsalicylic acid tablets taken separately, and concluded that combining both active substances in a single Clopidogrel/Acetylsalicylic acid Zentiva tablet simplifies treatment for patients as they will need to take fewer tablets.
El Comité de Medicamentos de Uso Humano (CHMP) señaló que Clopidogrel/Ácido acetilsalicílico Zentiva es equivalente a los comprimidos de clopidogrel y ácido acetilsalicílico tomados por separado, y concluyó que la combinación de ambos principios activos en un único comprimido de Clopidogrel/Ácido acetilsalicílico Zentiva simplifica el tratamiento de los pacientes, ya que tendrán que tomar menos comprimidos.
It must not be used in patients who have severely reduced liver or kidney function, or who have a medical condition that includes a combination of asthma, rhinitis (stuffy and runny nose) and nasal polyps (growths in the lining of the nose).
Tampoco se debe administrar a pacientes con la función renal o hepática gravemente reducida, o que presenten una enfermedad que consiste en una combinación de asma, rinitis (taponamiento y moqueo nasales) y pólipos nasales (bultos en el revestimiento de las fosas nasales).
Both active substances in Clopidogrel/Acetylsalicylic acid Zentiva, clopidogrel and acetylsalicylic acid, are antiplatelet medicines.
Los dos principios activos de Clopidogrel/Ácido acetilsalicílico Zentiva, clopidogrel y ácido acetilsalicílico, son antiagregantes plaquetarios.
Clopidogrel/Acetylsalicylic acid Zentiva was shown to be comparable to clopidogrel and acetylsalicylic acid taken separately, and can therefore be used in place of the clopidogrel and acetylsalicylic acid tablets that the patients have already been taking.
Clopidogrel/Ácido acetilsalicílico Zentiva demostró ser equivalente al clopidogrel y al ácido acetilsalicílico administrados por separado y, por tanto, puede utilizarse en lugar de los comprimidos de clopidogrel y ácido acetilsalicílico que ya estaban tomando los pacientes.
What benefit has Clopidogrel/Acetylsalicylic acid Zentiva shown during the studies?
¿Qué beneficio ha demostrado tener Clopidogrel/Ácido acetilsalicílico Zentiva durante los estudios?
Clopidogrel/Acetylsalicylic acid Zentiva is taken as one tablet once a day in place of the clopidogrel and acetylsalicylic acid tablets that the patient has already been taking separately.
Clopidogrel/Ácido acetilsalicícilo Zentiva se administra en un comprimido una vez al día, en lugar de los comprimidos de clopidogrel y de ácido acetilsalicílico que el paciente esté tomando por separado.
What is the risk associated with Clopidogrel/Acetylsalicylic acid Zentiva?
¿Cuál es el riesgo asociado a Clopidogrel/Ácido acetilsalicílico Zentiva?
Other information about Clopidogrel/Acetylsalicylic acid Zentiva:
Otras informaciones sobre Clopidogrel/Ácido acetilsalicílico Zentiva
Why has Clopidogrel/Acetylsalicylic acid Zentiva been approved?
¿Por qué se ha aprobado Clopidogrel/Ácido acetilsalicílico Zentiva?
Clopidogrel/Acetylsalicylic acid Zentiva clopidogrel / acetylsalicylic acid
Clopidogrel/Ácido acetilsalicílico Zentiva1
Clopidogrel/Acetylsalicylic acid Zentiva is used to prevent problems caused by blood clots, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid as separate tablets.
Se utiliza para prevenir los problemas causados por los coágulos sanguíneos, como el infarto de miocardio, en pacientes adultos que ya estaban tomando comprimidos de clopidogrel y de ácido acetilsalicílico (normalmente conocido como «aspirina») por separado.
What is Clopidogrel/Acetylsalicylic acid Zentiva?
¿Qué es Clopidogrel/Ácido acetilsalicílico Zentiva?
How does Clopidogrel/Acetylsalicylic acid Zentiva work?
¿Cómo actúa Clopidogrel/Ácido acetilsalicílico Zentiva?
How is Clopidogrel/Acetylsalicylic acid Zentiva used?
¿Cómo se usa Clopidogrel/Ácido acetilsalicílico Zentiva?
What is Clopidogrel/Acetylsalicylic acid Zentiva used for?
¿Para qué se utiliza Clopidogrel/Ácido acetilsalicílico Zentiva?
The full EPAR for Clopidogrel Zentiva can be found on the Agency's: website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Euroopa avaliku hindamisaruande täistekst Clopidogrel Zentiva kohta on ameti veebilehel: website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This authorisation was based on the authorisation granted to Plavix in 1998 (‘informed consent').
Müügiluba põhineb 1998. aastal antud Plavixi müügiloal (teabel põhineva nõusoleku alusel).
The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel Winthrop on 16 July 2008.
Euroopa Komisjon andis Clopidogrel Zentiva müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 16. juulil 2008.
The name of the medicine was changed to Clopidogrel Zentiva on 23 August 2011.
Ravimi nimetus muudeti 23. augustil 2011 Clopidogrel Zentivaks.
Clopidogrel Zentiva clopidogrel
Clopidogrel Zentiva klopidogreel
The CHMP decided that Clopidogrel Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Clopidogrel Zentiva kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.