FrancophonIA/ELRC3.0 huggingface dataset:
English: The medicine was intended for use in patients whose cancer was classed ‘Philadelphia chromosome negative' and had not responded to initial treatment, or had come back after treatment.
Estonian: Ravim oli ette nähtud kasutamiseks Philadelphia-kromosoom-negatiivse vähiga patsientidel, kelle haigus ei olnud allunud esialgsele ravile või kellel see oli taastunud.
English: Graspa is a cancer medicine that contains the active substance eryaspase (a version of the enzyme asparaginase enclosed in red blood cells compatible with the patient's blood group).
Estonian: Graspa on vähiravim, mis sisaldab toimeainena erüaspaasi (ensüüm asparaginaasi versioon, kapseldatud patsiendi veregrupiga sobivatesse erütrotsüütidesse).
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the application because the additional data the CHMP considered necessary to support the application could not be obtained in the time available.
Estonian: Ettevõtte kirjas, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, märgib ettevõte, et võtab taotluse tagasi, sest ta ei suutnud ettenähtud aja jooksul hankida täiendavaid andmeid, mida inimravimite komitee pidas taotluse toetuseks vajalikuks.
English: Graspa was expected to be used in combination with other cancer medicines to treat adults and children over 1 year of age who have acute lymphoblastic leukaemia (ALL), a cancer of white blood cells.
Estonian: Graspat kavatseti kasutada kombinatsioonis muude vähiravimitega, et ravida ägeda lümfoblastilise leukeemiaga (teatav leukotsüütide vähk) täiskasvanuid ja üle 1 aasta vanuseid lapsi.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Graspa.
Estonian: Seetõttu oli inimravimite komitee müügiloa taotluse tagasivõtmise ajal arvamusel, et ettevõte ei ole esitanud piisavalt andmeid ravimi Graspa taotluse toetuseks.
English: Graspa was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 26 October 2006 for ALL.
Estonian: Graspa nimetati 26. oktoobril 2006 ägeda lümfoblastilise leukeemia harvikravimiks (ravim, mida kasutatakse harvaesinevate haiguste korral).
English: The asparaginase in Graspa is enclosed in red blood cells with the intention of helping protect the enzyme from being broken down in the body.
Estonian: Graspas sisalduv asparaginaas on kapseldatud erütrotsüütidesse, et kaitsta ensüümi organismis lõhustumise eest.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Graspa.
Estonian: Taotluse tagasivõtmine ei mõjuta praegu Graspa kliinilistes uuringutes osalevaid patsiente.
English: 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 Graspa could not have been approved for the treatment of ALL.
Estonian: Tuginedes esitatud andmete analüüsile, nägi komitee taotluse tagasivõtmise ajal põhjust ettevaatlikkuseks ja oli esialgsel seisukohal, et ravimi Graspa kasutamist ägeda lümfoblastilise leukeemia raviks ei ole võimalik heaks kiita.
English: The asparaginase in Graspa works by breaking up and reducing the blood levels of the amino acid asparagine.
Estonian: Graspa toimeaine asparaginaas on ensüüm, mis lõhustab aminohapet asparagiini ja vähendab selle sisaldust veres.
English: it can cause allergic reactions, but by enclosing it in red blood cells the risk of allergy is expected to be reduced.
Estonian: Kuna asparaginaas on valk, võib see põhjustada allergilisi reaktsioone, kuid erütrotsüütidesse kapseldatuna peaks allergiarisk olema väiksem.
English: * efavirenz / emtricitabine / tenofovir disoproxil (as fumarate)
Estonian: * efavirens / emtritsitabiin / tenofoviirdisoproksiil (fumaraadina)
English: 3 x 30 film-coated tablets
Estonian: 3 x 30 õhukese polümeerikattega tabletti
English: Atripla Atripla
Estonian: Ravimvorm
English: Pharmaceutical Form Route of administration Packaging
Estonian: Manustamistee Pakendi iseloomustus Pakendi suurus
English: What measures are being taken to ensure the safe and effective use of Imraldi?
Estonian: Mis meetmed võetakse, et tagada Imraldi ohutu ja efektiivne kasutamine?
English: The full EPAR for Imraldi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Imraldi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: After the starting dose, Imraldi is most often given every two weeks, but it may be given every week in certain situations.
Estonian: Pärast algannust manustatakse Imraldit tavaliselt iga kahe nädala järel, kuid teatud olukordades tohib seda manustada iga nädal.
English: Imraldi adalimumab
Estonian: Imraldi adalimumaab
English: Other information about Imraldi
Estonian: Muu teave Imraldi kohta
English: Response was measured as a 20% or more improvement in symptom score after 24 weeks of treatment: 68% of those given Imraldi responded (183 of 269 patients), compared with 67% of those given Humira (184 of 273 patients).
Estonian: Reumatoidartriidi uuringus loeti ravivastuseks sümptomite skoori vähemalt 20% paranemist pärast 24 ravinädalat: ravivastusega patsiente oli Imraldi uuringurühmas 68% (183 patsienti 269st) ja Humira uuringurühmas 67% (184 patsienti 273st).
English: Benefit continued to be seen with longer term treatment for 1 year.
Estonian: Pikemaajalise ravi korral püsis ravivastus 1 aasta.
English: What is Imraldi and what is it used for?
Estonian: Mis on Imraldi ja milleks seda kasutatakse?
English: In addition, a main study involving 544 patients with moderate or severe rheumatoid arthritis despite treatment with methotrexate showed that Imraldi and Humira had similar effectiveness.
Estonian: Lisaks tõendati põhiuuringus, milles osales 544 patsienti, kellel oli mõõdukas või raske reumatoidartriit hoolimata metotreksaadi ravist, et Imraldi ja Humira efektiivsus oli sarnane.
English: This means that Imraldi is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Estonian: See tähendab, et Imraldi sarnaneb bioloogilise ravimiga (võrdlusravimiga), millel juba on Euroopa Liidus müügiluba.
English: After training, patients or their carers may inject Imraldi if their doctor considers it appropriate.
Estonian: Patsiendid või nende hooldajad võivad pärast asjakohase väljaõppe saamist süstida Imraldit ise, kui arst peab seda kohaseks.
English: Imraldi is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Estonian: Imraldit kasutatakse enamasti raskes, mõõdukalt raskes või halvenevas seisundis täiskasvanutel või kui patsiendid ei saa muid raviviise kasutada.
English: This is a summary of the European public assessment report (EPAR) for Imraldi.
Estonian: See on ravimi Imraldi Euroopa avaliku hindamisaruande kokkuvõte.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Imraldi has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Estonian: Euroopa Ravimiamet otsustas, et vastavalt Euroopa Liidu nõuetele bioloogiliselt sarnaste ravimite kohta on Imraldi struktuuri, puhtuse ja bioloogilise toime poolest väga sarnane Humiraga ning jaotub organismis samamoodi.
English: Patients may be given other medicines during treatment with Imraldi, such as methotrexate or corticosteroids (other anti-inflammatory medicines).
Estonian: Imraldi ravi ajal võib patsientidele manustada ka muid ravimeid, näiteks metotreksaati või kortikosteroide (samuti põletikuvastased ravimid).
English: Therefore, the Agency's view was that, as for Humira, the benefit outweighs the identified risk, and it recommended that Imraldi be given marketing authorisation.
Estonian: Seetõttu arvas Euroopa Ravimiamet, et nagu ka Humira korral, ületab Imraldi kasulikkus sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: Why is Imraldi approved?
Estonian: Miks Imraldi heaks kiideti?
English: The reference medicine for Imraldi is Humira.
Estonian: Imraldi võrdlusravim on Humira.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imraldi have also been included in the summary of product characteristics and the package leaflet.
Estonian: Imraldi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Imraldi 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).
Estonian: Imraldit ei tohi kasutada aktiivse tuberkuloosi, muu raske infektsiooni ja mõõduka kuni raske südamepuudulikkusega patsiendid (kelle süda ei suuda pumbata organismi piisaval hulgal verd).
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections in the nose and throat and sinuses, injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Estonian: Adalimumaabi kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on nina-neelu- ja nina kõrvalurgete infektsioonid, süstekoha reaktsioonid (punetus, sügelus, verejooks, valu või turse), peavalu ning lihase- ja luuvalu.
English: • hidradenitis suppurativa (acne inversa), a chronic skin disease that causes lumps, abscesses
Estonian: • hidradenitis suppurativa (acne inversa) - krooniline haigus, mis põhjustab sõlmi, abstsesse
English: Imraldi is a medicine that acts on the immune system and is used to treat the following conditions:
Estonian: Imraldi on immuunsüsteemi ravim ja seda kasutatakse järgmiste haiguste korral:
English: Because Imraldi is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Imraldi.
Estonian: Et Imraldi on bioloogiliselt sarnane ravim, ei pea Humiraga tehtud adalimumaabi efektiivsus- ja ohutusuuringuid Imraldiga kordama.
English: It is not intended to provide practical advice on how to use Imraldi.
Estonian: Hindamisaruandes ei anta Imraldi kasutamise praktilisi nõuandeid.
English: What are the risks associated with Imraldi?
Estonian: Mis riskid Imraldiga kaasnevad?
English: For information on the doses to be used for each condition and other information on the use of Imraldi, see the package leaflet.
Estonian: Iga ravitava seisundi korral kasutatavate annuste teave ja muu teave Imraldi kasutamise kohta on pakendi infolehel.
English: Imraldi can only be obtained with a prescription and treatment should be started and supervised by specialist doctors experienced in the diagnosis and treatment of the conditions for which it is authorised.
Estonian: Imraldi on retseptiravim ning ravi sellega peab alustama ja jälgima näidustatud seisundite diagnoosimises ja ravis kogenud eriarst.
English: This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Imraldi is used to treat.
Estonian: See virgatsaine osaleb põletiku tekitamisel ning selle sisaldus on suur patsientidel, kelle haigusi ravitakse Imraldiga.
English: The company that markets Imraldi must provide educational packs for doctors who prescribe the medicine.
Estonian: Imraldi turustaja annab Imraldit määravatele arstidele teabematerjali.
English: For practical information about using Imraldi, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Imraldi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Studies have also shown that giving Imraldi produces similar levels of the active substance in the body to giving Humira.
Estonian: Uuringud on samuti tõendanud, et Imraldi tekitab organismis samasuguse toimeainesisalduse kui Humira.
English: How is Imraldi used?
Estonian: Kuidas Imraldit kasutatakse?
English: How does Imraldi work?
Estonian: Kuidas Imraldi toimib?
English: For the full list of side effects and restrictions with Imraldi, see the package leaflet.
Estonian: Imraldi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: For more information about treatment with Imraldi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Imraldiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Imraldi and other medicines of its class 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.
Estonian: Imraldi ja teised sama klassi ravimid võivad vähendada immuunsüsteemi võimet võidelda infektsioonide ja vähiga (adalimumaabi kasutanud patsientide seas on esinenud raske infektsiooni või verevähi juhtumeid).
English: For detailed information on the use of Imraldi in all conditions, including when it can be used in children, see the summary of product characteristics (also part of the EPAR).
Estonian: Üksikasjalik teave Imraldi kasutamise kohta kõigi nende seisundite raviks, sealhulgas lastel, on ravimi omaduste kokkuvõttes (mis on samuti Euroopa avaliku hindamisaruande osa).
English: What benefits of Imraldi have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Imraldi kasulikkus?
English: • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when there is no damage on X-ray but clear signs of inflammation
Estonian: • aksiaalne spondüloartriit (seljavalu põhjustav lülisambapõletik), sealhulgas jäigastav spondüliit, kui röntgenuuring ei näita kahjustusi, kuid on selged põletikunähud;
English: Laboratory studies comparing Imraldi with Humira have shown that the active substance in Imraldi is highly similar to that in Humira in terms of structure, purity and biological activity.
Estonian: Imraldit võrreldi Humiraga laboriuuringutes, mis tõendasid, et Imraldi toimeaine sarnaneb struktuuri, puhtuse ja bioloogilise toime poolest Humira toimeainega.
English: The active substance in Imraldi, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a chemical messenger in the body called tumour necrosis factor (TNF).
Estonian: Imraldi toimeaine adalimumaab on monoklonaalne antikeha (teatud valk), mis tunneb ära organismis leiduva virgatsaine kasvaja nekroositeguri (TNF) ja seondub sellega.
English: All these data were considered sufficient to conclude that Imraldi will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Estonian: Nende piisavate andmete põhjal järeldati, et Imraldi efektiivsus ja ohutus heakskiidetud näidustustel on võrreldav Humira efektiivsuse ja ohutusega.
English: Eye specialists treating uveitis with Imraldi should also take advice from doctors who have experience of using the medicine.
Estonian: Uveiiti raviv silmaarst peab ühtlasi konsulteerima Imraldi kasutamise kogemusega spetsialistiga.
English: Imraldi contains the active substance adalimumab and is a ‘biosimilar medicine'.
Estonian: Imraldi sisaldab toimeainena adalimumaabi ja on bioloogiliselt sarnane ravim.
English: In addition, a study in rheumatoid arthritis has shown that the effects of the medicine are equivalent to those of Humira in this condition.
Estonian: Peale selle on reumatoidartriidi ja psoriaasi uuringutes tõendatud, et Imraldi toime on mõlema seisundi korral võrreldav Humira toimega.
English: The medicine is available as a solution for injection under the skin in a pre-filled syringe.
Estonian: Imraldit turustatakse subkutaanse (naha alla) süstitava lahusena eeltäidetud süstlas.
English: • non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).
Estonian: • mittenakkuslik uveiit (silmamuna soonkesta põletik).
English: Docetaxel Accord is given as a one-hour infusion every three weeks.
Estonian: Docetaxel Accordi manustatakse üks tund kestva infusioonina iga kolme nädala tagant.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Accord on 22 May 2012.
Estonian: Euroopa Komisjon andis Docetaxel Accordi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 22. mail 2012.
English: The full EPAR for Docetaxel Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Docetaxel Accordi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: • non-small-cell lung cancer.
Estonian: • Mitteväikeserakk-kopsuvähk.
English: 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 Docetaxel Accord.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Docetaxel Accord is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3).
Estonian: Docetaxel Accordi kasutatakse ainult juhul, kui neutrofiilide (valgeliblede liik) sisaldus veres on normaalne (vähemalt 1500 rakku/mm3).
English: Docetaxel Accord docetaxel
Estonian: Docetaxel Accord dotsetakseel
English: Because Docetaxel Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Docetaxel Accord on geneeriline ravim, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: It is available as a concentrate to be made up into a solution for infusion (drip into a vein).
Estonian: Seda turustatakse kontsentraadina, millest valmistatakse infusioonilahuse (veeni tilgutatav lahus).
English: The CHMP concluded that, in accordance with EU requirements, Docetaxel Accord has been shown to be comparable to Taxotere.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud Docetaxel Accord võrreldavus ravimiga Taxotere.
English: Docetaxel Accord is used to treat the following types of cancer:
Estonian: Docetaxel Accordi kasutatakse järgmiste vähivormide ravimiseks:
English: For more information about treatment with Docetaxel Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Docetaxel Accordiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: No additional studies were needed as Docetaxel Accord is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Estonian: Lisauuringuid ei olnud vaja, sest Docetaxel Accord on infusioonina manustatav geneeriline ravim ja sisaldab sama toimeainet kui võrdlusravim Taxotere.
English: This is a summary of the European public assessment report (EPAR) for Docetaxel Accord.
Estonian: See on Docetaxel Accordi Euroopa avaliku hindamisaruande kokkuvõte.
English: The company also showed that the Docetaxel Accord solution for infusion has comparable quality to that of Taxotere.
Estonian: Ettevõte esitas ka andmed, et Docetaxel Accordi infusioonilahuse kvaliteet on võrreldav Taxotere kvaliteediga.
English: Docetaxel Accord is used with cisplatin and 5-fluorouracil.
Estonian: Docetaxel Accordi kasutatakse koos tsisplatiini või 5-fluorouratsiiliga.
English: Docetaxel Accord is used with prednisone or prednisolone (anti-inflammatory medicines);
Estonian: Docetaxel Accordi kasutatakse koos prednisooni või prednisolooniga (põletikuravimid).
English: This means that Docetaxel Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere.
Estonian: See tähendab, et Docetaxel Accord on sarnane võrdlusravimiga Taxotere, millel juba on Euroopa Liidus müügiluba.
English: Docetaxel Accord can be used on its own after other treatments have failed.
Estonian: Docetaxel Accordi tohib kasutada ainsa ravimina pärast muude raviskeemide ebaõnnestumist.
English: Other information about Docetaxel Accord
Estonian: Muu teave Docetaxel Accordi kohta
English: Docetaxel Accord is a ‘generic medicine'.
Estonian: Docetaxel Accord on geneeriline ravim.
English: Docetaxel Accord is a medicine that contains the active substance docetaxel.
Estonian: Docetaxel Accord on ravim, mis sisaldab toimeainena dotsetakseeli.
English: The Committee recommended that Docetaxel Accord be given marketing authorisation.
Estonian: Komitee soovitas anda ravimi müügiloa.
English: Docetaxel Accord is used with cisplatin and 5-fluorouracil (other anticancer medicines);
Estonian: Docetaxel Accordi kasutatakse koos tsisplatiini või 5-fluorouratsiiliga (samuti vähiravimid).
English: Docetaxel Accord should be used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Estonian: Ravi Docetaxel Accordiga peab toimuma keemiaravile (vähi ravimravi) spetsialiseerunud osakonnas keemiaravipädevusega arsti järelevalve all.
English: What is Docetaxel Accord?
Estonian: Mis on Docetaxel Accord?
English: An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Docetaxel Accord infusion.
Estonian: Alates Docetaxel Accordi infusioonile eelnevast päevast tuleb anda patsiendile ka põletikuravimit deksametasooni.
English: The active substance in Docetaxel Accord, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Estonian: Docetaxel Accordi toimeaine dotsetakseel kuulub vähiravimite taksaanide rühma.
English: Why has Docetaxel Accord been approved?
Estonian: Miks Docetaxel Accord heaks kiideti?
English: What are the benefits and risks of Docetaxel Accord?
Estonian: Milles seisnevad Docetaxel Accordi kasulikkus ja mis riskid ravimiga kaasnevad?
English: How has Docetaxel Accord been studied?
Estonian: Kuidas Docetaxel Accordi uuriti?
English: How does Docetaxel Accord work?
Estonian: Kuidas Docetaxel Accord toimib?
English: How is Docetaxel Accord used?
Estonian: Kuidas Docetaxel Accordi kasutatakse?
English: What is Docetaxel Accord used for?
Estonian: Milleks Docetaxel Accordi kasutatakse?
English: You must contact your doctor immediately if you have any of the following early symptoms:
Estonian: Peate otsekohe oma arstiga ühendust võtma, kui teil on mõni järgmistest varajastest sümptomitest:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 November 2015
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV Müügiloa esmase väljastamise kuupäev: 11. november 2015
English: ATC code: B02BD14
Estonian: ATC-kood: B02BD14
English: 500 U
Estonian: 500 Ü
English: The educational programme is aimed to minimize the risk of dose dispensing errors.
Estonian: Koolitusprogrammi eesmärk on minimeerida annustamisvigade riski.
English: Extensive cutaneous purpura do not necessarily require treatment.
Estonian: Ulatuslik purpura nahal ei pruugi vajada tingimata ravi.
English: Annually within the annual reassessment
Estonian: Iga aasta uuestihindamise käigus
English: <There are also links to other websites about rare diseases and treatments.
Estonian: Samuti on seal viited teistele kodulehtedele harvaesinevate haiguste ja ravi kohta.