FrancophonIA/ELRC3.0 huggingface dataset:
English: a prospective observational study aimed to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination mentioned in the opinion should be performed.
Estonian: Tuleb teha arvamuses mainitud prospektiivne jälgimisuuring, mille eesmärgiks on hinnata Mifepristone Linepharma määramissoovitusi raseduse varaseks katkestamiseks.
English: The National Competent Authorities coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the MAH:
Estonian: Viiteliikmesriigi koordineeritavad riiklikud pädevad asutused tagavad, et müügiloa hoidja täidab järgmised tingimused.
English: The way it works in this disease is not completely understood.
Estonian: Toimemehhanism selle haiguse korral ei ole täiesti selge.
English: If this does not happen by day 50 (for previously treated patients) or by day 60 (for newly diagnosed patients), the treatment should be stopped.
Estonian: Kui seda ei toimu 50. päevaks (varem ravitud patsiendid) või 60. päevaks (esmadiagnoosiga patsiendid), tuleb ravi peatada.
English: Further information on Arsenic trioxide Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/arsenic-trioxide-accord.
Estonian: Lisateave ravimi Arsenic trioxide Accord kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/arsenic-trioxide-accord.
English: • Patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment.
Estonian: • kelle APL ei ole reageerinud varasemale ravile retinoidide ja vähiravimitega või kui haigus on pärast sellist ravi taastunud.
English: Treatment is divided into 2 phases: induction and consolidation.
Estonian: Ravi jaguneb 2 faasiks: algusfaas ja säilitusravi.
English: The infusion should last 1 to 2 hours, but it may need to be given for longer if the patient has certain side effects.
Estonian: Infusioon peab kestma 12 tundi, kuid teatud kõrvalnähtude esinemisel kauem.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Arsenic trioxide Accord has been shown to be comparable to Trisenox.
Estonian: Euroopa Ravimiamet järeldas, et vastavalt ELi nõuetele on tõendatud ravimi Arsenic trioxide Accord võrreldavus ravimiga Trisenox.
English: During the consolidation phase, Arsenic trioxide Accord is given on 5 days each week but the length of breaks between courses and how long it is given for depends on whether patients have received previous treatment or not.
Estonian: Säilitusravi ajal manustatakse Arsenic trioxide Accordi 5 päeval nädalas, kuid ravikuuride vaheaegade ja ravi kestus sõltub sellest, kas patsient on varem ravi saanud või mitte.
English: What measures are being taken to ensure the safe and effective use of Arsenic trioxide Accord?
Estonian: Mis meetmed võetakse, et tagada ravimi Arsenic trioxide Accord ohutu ja efektiivne kasutamine?
English: This means that Arsenic trioxide Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Trisenox.
Estonian: See tähendab, et Arsenic trioxide Accord sisaldab sama toimeainet ja toimib samamoodi nagu võrdlusravim Trisenox, millel juba on ELis müügiluba.
English: Side effects reported with Arsenic trioxide Accord are carefully evaluated and any necessary action taken to protect patients.
Estonian: Ravimi Arsenic trioxide Accord kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: During the induction phase, Arsenic trioxide Accord is given every day until there are signs that the treatment is working (when the bone marrow does not contain any leukaemia cells).
Estonian: Ravi algusfaasis manustatakse Arsenic trioxide Accordi iga päev, kuni ilmneb ravi toime (luuüdi ei sisalda leukeemiarakke).
English: Because Arsenic trioxide Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Arsenic trioxide Accord on geneeriline ravim, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: Therefore, the Agency's view was that, as for Trisenox, the benefits of Arsenic trioxide Accord outweigh the identified risks and it can be authorised for use in the EU.
Estonian: Seetõttu on amet arvamusel, et nagu ka Trisenoxi korral, ületab Arsenic trioxide Accordi kasulikkus sellega kaasnevad riskid ja seda võib kasutada ELis.
English: For more information about using Arsenic trioxide Accord, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet ravimi Arsenic trioxide Accord kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: As for every medicine, the company provided studies on the quality of Arsenic trioxide Accord.
Estonian: Nagu iga ravimi korral, esitas ettevõte Arsenic trioxide Accordi kvaliteedi uuringud.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Trisenox, and do not need to be repeated for Arsenic trioxide Accord.
Estonian: Võrdlusravimiga Trisenox on juba tehtud toimeaine heakskiidetud kasutamisviiside kasulikkuse ja riski uuringud ning neid ei ole vaja ravimiga Arsenic trioxide Accord korrata.
English: As for all medicines, data on the use of Arsenic trioxide Accord are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse Arsenic trioxide Accordi kasutamise kohta pidevat järelevalvet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arsenic trioxide Accord have been included in the summary of product characteristics and the package leaflet.
Estonian: Ravimi Arsenic trioxide Accord ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Why is Arsenic trioxide Accord authorised in the EU?
Estonian: Miks Arsenic trioxide Accord ELis heaks kiideti?
English: The recommended dose of Arsenic trioxide Accord depends on the patient's weight.
Estonian: Ravimi Arsenic trioxide Accord soovitatav annus sõltub patsiendi kehamassist.
English: The active substance in the medicine, arsenic trioxide, has been used in medicines for many years, including for the treatment of leukaemia.
Estonian: Ravimi toimeainet arseentrioksiidi on ravimites, sealhulgas leukeemiaravimites kasutatud aastaid.
English: Arsenic trioxide Accord (arsenic trioxide)
Estonian: Arsenic trioxide Accord (arseentrioksiid)
English: Other information about Arsenic trioxide Accord
Estonian: Muu teave ravimi Arsenic trioxide Accord kohta
English: Arsenic trioxide Accord contains the active substance arsenic trioxide and is a ‘generic medicine'.
Estonian: Ravim Arsenic trioxide Accord sisaldab toimeainena arseentrioksiidi ja on geneeriline ravim.
English: Arsenic trioxide Accord is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic ‘translocation' (when there is a swap of genes between two chromosomes).
Estonian: APL on leukeemia (leukotsüütide ehk vere valgeliblede vähi) haruldane vorm, mille põhjustab teatud geenitranslokatsioon (geenide ümberpaiknemine ühelt kromosoomilt teisele).
English: • Patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid.
Estonian: • kellel on väikese või mõõduka riskiga APL-i esmadiagnoos; ravimit kasutatakse koos tretinoiiniga;
English: There was no need for ‘bioequivalence' studies to investigate whether Arsenic trioxide Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Estonian: Bioekvivalentsust, st kas Arsenic trioxide Accord imendub organismis samamoodi kui võrdlusravim, et saavutada toimeaine sarnane sisaldus veres, ei olnud vaja uurida.
English: What is Arsenic trioxide Accord and what is it used for?
Estonian: Mis on Arsenic trioxide Accord ja milleks seda kasutatakse
English: Arsenic trioxide Accord can only be obtained with a prescription and its use should be supervised by a doctor who has experience in the management of patients with acute leukaemias.
Estonian: Arsenic trioxide Accord on retseptiravim ja ravi sellega peab toimuma ägeda leukeemiaga patsientide ravis kogenud arsti järelevalve all.
English: It is given as an infusion (drip) into a vein.
Estonian: Seda manustatakse veeniinfusioonina.
English: An overview of Arsenic trioxide Accord and why it is authorised in the EU
Estonian: Ülevaade ravimist Arsenic trioxide Accord ja ELis müügiloa väljastamise põhjendus
English: This is because Arsenic trioxide Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Estonian: Seda ei olnud vaja, sest ravimit Arsenic trioxide Accord manustatakse veeniinfusioonina, mille abil satub toimeaine otse vereringesse.
English: How does Arsenic trioxide Accord work?
Estonian: Kuidas Arsenic trioxide Accord toimib?
English: How is Arsenic trioxide Accord used?
Estonian: Kuidas ravimit Arsenic trioxide Accord kasutatakse?
English: How has Arsenic trioxide Accord been studied?
Estonian: Kuidas ravimit Arsenic trioxide Accord uuriti?
English: Arsenic trioxide Accord is used in:
Estonian: Ravimit Arsenic trioxide Accord kasutatakse patsientidel,
English: What are the benefits and risks of Arsenic trioxide Accord?
Estonian: Milles seisneb ravimi Arsenic trioxide Accord kasulikkus ja mis riskid ravimiga kaasnevad?
English: The full EPAR for Insulatard can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Insulatardi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Insulatard on 7 October 2002.
Estonian: Euroopa Komisjon andis Insulatardi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 7. oktoobril
English: A risk management plan has been developed to ensure that Insulatard is used as safely as possible.
Estonian: Töötati välja riskijuhtimisstrateegia, et tagada Insulatardi võimalikult ohutu kasutamine.
English: What measures are being taken to ensure the safe and effective use of Insulatard?
Estonian: Mis meetmed võetakse, et tagada Insulatardi ohutu ja efektiivne kasutamine?
English: Other information about Insulatard
Estonian: Muu teave Insulatardi kohta
English: In most patients, Insulatard was compared with other types of human insulin or insulin analogues.
Estonian: Enamikul patsientidel võrreldi Insulatardi teiste iniminsuliinide või insuliini analoogidega.
English: The CHMP decided that Insulatard's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Insulatardi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: The most common side effect with Insulatard (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Estonian: Insulatardi kõige sagedam kõrvalnäht (esinenud enam kui 1 patsiendil 10st) on hüpoglükeemia (vere vähene glükoosisisaldus).
English: Insulatard has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients).
Estonian: Insulatardi uuriti neljas kliinilises põhiuuringus, milles osales kokku 557 patsienti, sealhulgas kaks uuringut I tüüpi diabeediga patsientidel (81 patsienti), kelle kõhunäärmes ei teki insuliini, ja kaks uuringut II tüüpi diabeediga patsientidel (467 patsienti), kelle organism ei suuda insuliini tõhusalt kasutada.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Insulatard, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Strateegiast lähtudes lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Insulatardi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: For more information about treatment with Insulatard, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Insulatardiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Insulatard is used to treat diabetes.
Estonian: Insulatardi kasutatakse diabeedi raviks.
English: Further studies were also carried out in 225 patients comparing injecting Insulatard using a syringe, or using a pre-filled pen (InnoLet or FlexPen).
Estonian: 225 patsiendil tehti ka täiendavad uuringud, milles võrreldi Insulatardi süstimist süstla või eeltäidetud pensüstla abil (InnoLet või FlexPen).
English: Insulatard was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pre-filled pens.
Estonian: Insulatard oli efektiivne nii I kui ka II tüüpi diabeedi korral ning nii tavaliste süstalde kui ka eeltäidetud pensüstalde kasutamisel.
English: The studies measured the levels of fasting blood glucose or glycosylated haemoglobin (HbA1c, the haemoglobin in the blood that has glucose attached).
Estonian: Uuringutes mõõdeti vere glükoosisisaldust tühja kõhuga või vere glükohemoglobiini sisaldust (HbA1c; hemoglobiin, millele on kinnitunud glükoos).
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 Insulatard.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: This is a summary of the European public assessment report (EPAR) for Insulatard.
Estonian: See on ravimi Insulatard Euroopa avaliku hindamisaruande kokkuvõte.
English: The active substance in Insulatard, human insulin, is produced by a method known as ‘recombinant technology': the insulin is made by yeast cells into which a gene (DNA) has been introduced, which makes them able to produce insulin.
Estonian: Insulatardi toimeainet iniminsuliini valmistatakse rekombinant-DNA-tehnika abil: insuliini toodab pärm, millele on lisatud insuliini teket võimaldav geen (DNA).
English: What is the risk associated with Insulatard?
Estonian: Mis riskid Insulatardiga kaasnevad?
English: Insulatard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulins.
Estonian: Insulatard vähendas HbA1c sisaldust, mis näitas, et organism reguleeris vere glükoosisisaldust sarnasel määral kui muu iniminsuliin.
English: It can be given once or twice a day, with or without a fast-acting insulin (given at meal times), according to the doctor's recommendation.
Estonian: Insulatard on pikatoimeline insuliin, mida tohib süstida üks või kaks korda ööpäevas koos lühitoimelise insuliiniga (söögiaegadel) või ilma selleta, vastavalt arsti soovitustele.
English: Why has Insulatard been approved?
Estonian: Miks Insulatard heaks kiideti?
English: What is Insulatard?
Estonian: Mis on Insulatard?
English: Insulatard is a replacement insulin which is very similar to the insulin made by the pancreas.
Estonian: Insulatard on asendusinsuliin, mis on väga sarnane kõhunäärmes tekkiva insuliiniga.
English: For the full list of all side effects and restrictions, see the package leaflet.
Estonian: Insulatardi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Insulatard contains insulin mixed with another substance, protamine, in an ‘isophane' form which is absorbed much more slowly during the day.
Estonian: Insulatard sisaldab protamiiniga segatud insuliini isofaaninsuliinina, mis imendub ööpäeva kestel palju aeglasemalt.
English: It is available as vials, cartridges (Penfill), or pre-filled pens (InnoLet or FlexPen).
Estonian: Seda turustatakse viaalides, kolbampullides (PenFill) ja eeltäidetud pensüstaldes (InnoLet ja FlexPen).
English: Insulatard is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder).
Estonian: Insulatardi manustatakse nahaaluse süstina reiepiirkonda, kõhuseina, tuharatesse või deltalihase piirkonda (õlalihasesse).
English: This gives Insulatard a longer duration of action.
Estonian: See pikendab Insulatardi toimeaega.
English: Insulatard is a suspension for injection that contains the active substance human insulin.
Estonian: Insulatard on süstesuspensioon, mis sisaldab toimeainena iniminsuliini.
English: What benefit has Insulatard shown during the studies?
Estonian: Milles seisneb uuringute põhjal Insulatardi kasulikkus?
English: How does Insulatard work?
Estonian: Kuidas Insulatard toimib?
English: How has Insulatard been studied?
Estonian: Kuidas Insulatardi uuriti?
English: How is Insulatard used?
Estonian: Kuidas Insulatardi kasutatakse?
English: What is Insulatard used for?
Estonian: Milleks Insulatardi kasutatakse?
English: N/A = not available/not applicable (a) Lee et al 2014.
Estonian: N/A = ei ole saadaval / ei kohaldu (a) Lee et al 2014.
English: This can take 3 to 6 hours and may need to be repeated.
Estonian: Selleks kulub 3 kuni 6 tundi ja seda võib olla vaja korrata.
English: It will not be given to you again.
Estonian: Seda ei anta teile teist korda.
English: These other medicines may include:
Estonian: Need muud ravimid võivad olla järgmised:
English: Other outcomes were consistent with those of the mITT population.
Estonian: Muud tulemused olid sarnased mITT populatsioonile.
English: In particular, you must not be given certain vaccines called live vaccines:
Estonian: Eeskätt ei tohi te saada teatud vaktsiine, mida nimetatakse elusvaktsiinideks:
English: •Final report of study results: December 2038
Estonian: •Uuringutulemuste lõpparuanne: detsember 2038.
English: Your doctor or nurse will check carefully that this medicine is yours.
Estonian: Teie arst või meditsiiniõde kontrollib hoolikalt, et see ravim on teie oma.
English: An impact of these antibodies on efficacy or safety was not discernible.
Estonian: Nende antikehade mõju tõhususele või ohutusele ei olnud täheldatav.
English: • Check if you had a vaccination in the previous 6 weeks or are planning to have one in the next few months.
Estonian: • Kontrollib, kas teid on viimase 6 nädala jooksul vaktsineeritud või kas te kavatsete end lähikuudel vaktsineerida.
English: HBV reactivation
Estonian: HBV reaktivatsioon
English: A summary of the patient demographics is provided in Table 4.
Estonian: Patsientide demograafiliste andmete kokkuvõte on esitatud tabelis 4.
English: For example:
Estonian: Näiteks:
English: During the 30 to 60 minutes before you are given YESCARTA you may be given other medicines.
Estonian: 30 kuni 60 minutit enne seda, kui teile antakse YESCARTA't, võidakse teile anda muid ravimeid.
English: Nearly all patients experienced some degree of CRS.
Estonian: Peaaegu kõigil patsientidel esines teatud määral CRS.
English: - Pain in the hands or feet.
Estonian: - Käte või jalgade valu.
English: YESCARTA should only be given if the results show you are not pregnant.
Estonian: YESCARTA't võib teile anda vaid siis, kui tulemused näitavad, et te ei ole rase.
English: Key elements:
Estonian: Põhielemendid:
English: • After treatment while the immune system is recovering.
Estonian: • Pärast ravi, kui immuunsüsteem taastub.
English: As this medicine will be given by qualified healthcare professionals, they are responsible for the correct disposal of the product.
Estonian: Kuna seda ravimit annab teile kvalifitseeritud tervishoiutöötaja, vastutab tema selle toote õige hävitamise eest.
English: If not improving, manage as Grade 4 (below).
Estonian: Kui ei parane, siis ravige vastavalt 4. astmele (vt allpool).
English: Therefore, the risk/benefit of YESCARTA has not been established in this population.
Estonian: Seetõttu ei ole YESCARTA riski/kasu profiili sellele populatsioonile kindlaks määratud.
English: One out of 111 patients did not receive the product due to manufacturing failure.
Estonian: Üks patsient 111-st ei saanud toodet tootmistõrke tõttu.
English: Do not try to treat your symptoms with other medicines on your own.
Estonian: Ärge püüdke oma sümptomeid ravida teiste teil olemasolevate ravimitega.
English: YESCARTA is intended solely for autologous use and must not be administered to other patients.
Estonian: YESCARTA on mõeldud üksnes autoloogseks kasutamiseks ning seda ei tohi manustada teistele patsientidele.
English: - have had a stem cell transplant in the last 4 months.
Estonian: - On viimase 4 kuu jooksul tehtud tüvirakkude siirdamist.
English: Thawed product should not be refrozen.
Estonian: Sulatatud toodet ei tohi uuesti külmutada.
English: Age (years) Median (min, max)
Estonian: Vanus (aastates) Mediaan (min, max)
English: Talk to your doctor if you need to have any vaccinations.
Estonian: Rääkige oma arstile, kui teil on vaja teatud vaktsiine saada.
English: CRS occurred in 93% of patients.
Estonian: CRS esines 93% patsientidest.
English: You may be given medicines to help prevent the condition.
Estonian: Teile võidakse anda ravimeid selle haiguse ennetamiseks.
English: CR rates were 75% and 56%, respectively.
Estonian: CR määr oli vastavalt 75% ja 56%.
English: You should not be given YESCARTA if you are allergic to any of the ingredients of this medicine (listed in section 6).
Estonian: Teile ei tohi YESCARTA't anda, kui olete selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline.
English: - Sudden, unexpected stopping of the heart (cardiac arrest); this is serious and life-threatening.
Estonian: - Äkiline ja ootamatu südame peatumine (südame seiskumine); see on tõsine ja eluohtlik.
English: If your temperature is high, see your doctor immediately.
Estonian: Kui teie temperatuur on kõrge, pöörduge kohe arsti poole.
English: Other medicines and YESCARTA
Estonian: Muud ravimid ja YESCARTA
English: Efficacy was consistent with the overall treated patient population.
Estonian: Tõhusus oli sarnane üldise ravitud patsiendipopulatsiooniga.
English: • You will be given a pregnancy test before treatment starts.
Estonian: • Teile tehakse enne ravi algust rasedustest.
English: This is so your doctor can check if your treatment is working and help you if you have any side effects.
Estonian: Nii saab arst kontrollida, kas ravi mõjub, ja teid aidata, kui teil tekib kõrvaltoimeid.
English: Some of your white blood cells are separated from your blood and the rest of your blood is returned to your vein.
Estonian: Osa teie valgetest verelibledest eraldatakse teie verest ning ülejäänud veri suunatakse teile veeni tagasi.
English: • Check your lungs, heart and blood pressure.
Estonian: • Kontrollib teie kopse, südant ja vererõhku.
English: Ninety-eight percent (98%) of patients recovered from CRS.
Estonian: Üheksakümmend kaheksa (98%) protsenti patsientidest paranes CRS-ist.
English: Effects on male and female fertility have not been evaluated in animal studies.
Estonian: Toimet meeste ja naiste fertiilsusele ei ole loomkatsetega hinnatud.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: not yet assigned
Estonian: Farmakoterapeutiline rühm: teised kasvajavastased ained, ATC-kood: ei ole veel omistatud
English: Thawing should take approximately 3 to 5 minutes.
Estonian: Sulatamiseks kulub umbes 3 kuni 5 minutit.
English: • Your white blood cells are frozen and sent away to make YESCARTA.
Estonian: • Teie valged verelibled külmutatakse ja saadetakse ära, et YESCARTA't toota.