FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with human leukocyte antigen genotype such as HLA-DRB1*04:06 and HLA-DRB1*04:03 alleles, are more susceptible to develop IAS when treated with thioctic acid.
Estonian: Patsientidel, kellel on inimese leukotsüüdi antigeeni genotüübi alleel HLA-DRB1*04:06 või HLA-DRB1*04:03, võib ravi ajal tiokthappega tekkida suurema tõenäosusega IAS.
English: Section 4.8 Very rare: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction).
Estonian: Lõik 4.8 - Kõrvaltoimed Väga harv: väliskuulmekanali osteonekroos (bisfosfonaatide1 klassiefet).
English: Frequency unknown: Disorder of the blood glucose regulating hormones with pronounced lowering of blood sugar levels (insulin autoimmune syndrome).
Estonian: Esinemissagedus ei ole teada: vereglükoosi reguleerivate hormoonide häire koos veresuhkru sisalduse märkimisväärse vähenemisega (insuliini autoimmuunsündroom).
English: Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy.
Estonian: Bisfosfonaatide1 kasutamise korral on teatatud väliskuulmekanali osteonekroosist, peamiselt pikaajalise ravi korral.
English: IAS should be considered in the differential diagnosis of spontaneous hypoglycaemia in patients using thioctic acid (see section 4.8).
Estonian: IASi võimalust tuleb arvesse võtta tiokthapet saavatel patsientidel spontaanse hüpoglükeemia diferentsiaaldiagnostikas (vt lõik 4.8).
English: HLA-DRB1*04:03 allele (susceptibility to IAS odds ratio: 1.6) is especially found in Caucasians, with a higher prevalence in southern than in northern Europe and HLA-DRB1*04:06 allele (susceptibility to IAS odds ratio: 56.6) is especially found in Japanese and Korean patients.
Estonian: HLA-DRB1*04:06 alleeli (IASile vastuvõtlikkuse tõenäosuse suhtarv: 56.6) leidub eelkõige jaapani ja korea patsientidel.
English: Interstitial lung disease, as well as rare cases of pulmonary hypertension has have been reported during treatment with leflunomide (see section 4.8).
Estonian: Ravi ajal leflunomiidiga on teatatud interstitsiaalsest kopsuhaigusest ja harvadel juhtudel pulmonaarsest hüpertensioonist (vt lõik 4.8).
English: Frequency ‘uncommon': Cases of suspected capillary leak syndrome have been reported with trabectedin.
Estonian: Esinemissagedus „aeg-ajalt”: trabektediini kasutamisel on teatatud võimalikest kapillaaride lekke sündroomi juhtudest.
English: Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, pulmonary hypertension, male infertility [...] may also occur with an unknown frequency.
Estonian: Teadmata esinemissagedusega võivad esineda teised kõrvaltoimed nagu neerupuudulikkus, kusihappesisalduse vähenemine veres, pulmonaarne hüpertensioon ja meeste viljatus [...].
English: The risk of its their occurrence is can be increased in patients with a history of interstitial lung disease.
Estonian: Varasema interstitsiaalse kopsuhaigusega patsientidel on selle võib nende haiguste tekkerisk suurenenud olla suurem.
English: Cases of Insulin Autoimmune Syndrome (IAS) have been reported during treatment with thioctic acid.
Estonian: Lõik 4.4 - Erihoiatused ja ettevaatusabinõud kasutamisel Tiokthappe ravi ajal on teatatud insuliini autoimmuunsündroomi (IAS) juhtudest.
English: Thioctic acid - Insulin autoimmune syndrome (EPITT no
Estonian: Tiokthape - insuliini autoimmuunsündroom (EPITT nr 18406)
English: The way it works in this disease is not completely understood.
Estonian: Toimemehhanism selle haiguse korral ei ole täielikult 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), peab ravi peatama.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Trisenox on 5 March 2002.
Estonian: Euroopa Komisjon andis Trisenoxi müügiloa, mis kehtib kogu Euroopa Liidus, 5. märtsil 2002.
English: What measures are being taken to ensure the safe and effective use of Trisenox?
Estonian: Mis meetmed võetakse, et tagada Trisenoxi ohutu ja efektiivne kasutamine?
English: The full EPAR for Trisenox can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Trisenoxi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The infusion should last one to two hours, but it may last longer if the patient has certain side effects.
Estonian: Infusioon peab kestma üks kuni kaks tundi, kuid teatud kõrvalnähtude esinemisel peab kestma kauem.
English: The CHMP decided that Trisenox's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Trisenoxi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda müügiloa.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 10 August 2010.
Estonian: Et ettevõte esitas vajaliku lisateabe, tühistati müügiloa erandkorras väljastatus 10. augustil 2010.
English: Forty-five of the patients in the studies were adults.
Estonian: Uuringutes osalenud patsientidest olid 45 täiskasvanud.
English: The main measure of effectiveness was the number of patients who had complete remission.
Estonian: Efektiivsuse põhinäitaja oli täieliku remissiooniga patsientide arv.
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: • patsiendid, kelle APL ei ole reageerinud varasemale ravile retinoidide ja vähiravimitega või kui haigus on pärast sellist ravi taastunud.
English: The most common side effects with Trisenox (seen in 1 patient in 10) are hyperglycaemia (high blood glucose levels), hypomagnesaemia (low blood magnesium levels), hypokalaemia (low blood potassium levels), paraesthesia (unusual sensations like pins and needles), dizziness, headache, tachycardia (rapid heartbeat), dyspnoea (difficulty breathing), differentiation syndrome (a potentially fatal complication of chemotherapy in patients with APL), diarrhoea, vomiting, nausea (feeling sick), pruritus (itching), rash, myalgia (muscle pain), pyrexia (fever), pain, fatigue (tiredness), oedema (swelling), prolonged QT interval on an electrocardiogram (an alteration of the electrical activity of the heart), and increased levels of alanine aminotransferase and aspartate aminotransferase (liver enzymes).
Estonian: Trisenoxi kõige sagedamad kõrvalnähud (esinenud 1 patsiendil 10st) on hüperglükeemia (vereglükoosi ehk nn veresuhkru suur sisaldus), hüpomagneseemia (vere magneesiumivaegus), hüpokaleemia (vere kaaliumivaegus), paresteesia (nahanõelatunne), peapööritus, peavalu, tahhükardia (kiirenenud südametegevus), düspnoe (raskendatud hingamine), diferentseerumise sündroom (APL-iga patsientide keemiaravi eluohtlik tüsistus), kõhulahtisus, oksendamine, iiveldus, kihelus, lööve, müalgia (lihasevalu), püreksia (palavik), valu, väsimus, turse, QT-intervalli pikenemine elektrokardiogrammil (südame elektritalitluse teatud häire) ning vere alaniinaminotransferaasi ja aspartaataminotransferaasi (maksaensüümid) sisalduse suurenemine.
English: Looking at the results of these two studies together, 87% of the patients had complete remission (45 out of 52).
Estonian: Mõlema uuringu koondtulemuste põhjal oli täieliku remissiooniga patsiente 87% (45 patsienti 52st).
English: The number of times these cycles are repeated depends on whether patients have received previous treatment or not.
Estonian: Tsüklite arv oleneb sellest, kas patsienti on varem ravitud.
English: Other information about Trisenox
Estonian: Muu teave Trisenoxi kohta
English: Trisenox was originally authorised under ‘exceptional circumstances', because, as the disease is rare, limited information was available at the time of approval.
Estonian: Trisenox kiideti esialgu heaks erandkorras, sest harvaesineva haiguse tõttu ei olnud heakskiitmise ajal võimalik saada Trisenoxi kohta täielikku teavet.
English: This is a summary of the European public assessment report (EPAR) for Trisenox.
Estonian: See on ravimi Trisenox Euroopa avaliku hindamisaruande kokkuvõte.
English: On average, it took 57 days for the patients to reach complete remission.
Estonian: Täielik remissioon saabus patsientidel keskmiselt 57 päevaga.
English: Patients with APL are normally treated with retinoids (substances derived from vitamin A).
Estonian: APL-iga patsiente ravitakse tavaliselt retinoididega (A-vitamiinist saadud ained).
English: It is not intended to provide practical advice on how to use Trisenox.
Estonian: Hindamisaruandes ei anta Trisenoxi kasutamise praktilisi nõuandeid.
English: What is Trisenox and what is it used for?
Estonian: Mis on Trisenox ja milleks seda kasutatakse?
English: The active substance in Trisenox, arsenic trioxide, is a chemical that has been used in medicines for many years, including for the treatment of leukaemia.
Estonian: Trisenoxi toimeaine arseentrioksiid on kemikaal, mida on ravimites, sealhulgas leukeemiaravimites kasutatud aastaid.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trisenox have been included in the summary of product characteristics and the package leaflet.
Estonian: Trisenoxi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: During the consolidation phase, Trisenox is given once a day for five days, followed by a two-day break, repeated for four or five weeks.
Estonian: Säilitusfaasi ajal manustatakse Trisenoxi üks kord ööpäevas viie päeva jooksul, seejärel kaks ööpäeva ravimit ei manustata; seda tsüklit korratakse neli või viis nädalat.
English: The treatment is divided into 2 phases: induction and consolidation.
Estonian: Ravi jaguneb 2 faasiks: algusfaas ja säilitusravi.
English: Trisenox has also been investigated in two studies involving a total of 52 patients with APL who had been previously treated with an anthracycline and a retinoid.
Estonian: Trisenoxi uuriti ka kahes uuringus, milles osales kokku 52 APL-iga patsienti, keda oli varem ravitud antratsükliinravimi ja retinoidravimiga.
English: Why is Trisenox approved?
Estonian: Miks Trisenox heaks kiideti?
English: Trisenox contains the active substance arsenic trioxide.
Estonian: Trisenox sisaldab toimeainena arseentrioksiidi.
English: Trisenox was not compared with any other medicine in either study.
Estonian: Kummaski uuringus ei võrreldud Trisenoxi muude ravimitega.
English: During the induction phase, Trisenox 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 mahustatakse Trisenoxi iga päev, kuni ilmneb ravi toime (luuüdi ei sisalda leukeemiarakke).
English: For the full list of all side effects and restrictions with Trisenox, see the package leaflet.
Estonian: Trisenoxi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Trisenox arsenic trioxide
Estonian: Trisenox arseentrioksiid
English: • Patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid (ATRA).
Estonian: • patsiendid, kellel on väikese või mõõduka riskiga APL-i esmadiagnoos; Trisenoxi kasutatakse koos retinoehappe vormi tretinoiiniga (ATRA);
English: It is thought to prevent the production of DNA, which is necessary for leukaemia cells to grow.
Estonian: Arvatakse, et arseentrioksiid takistab leukeemiarakkude kasvamiseks vajaliku DNA teket.
English: The translocation affects the way the white blood cells grow, and as a result they lack the ability to use retinoic acid (vitamin A).
Estonian: Translokatsioon mõjutab leukotsüütide kasvu ja selle tulemusel ei omasta need retinoehapet (A-vitamiini).
English: This is when there are no more leukaemia cells in the bone marrow and the levels of platelets and white blood cells in the blood have recovered.
Estonian: See on seisund, kui luuüdis puuduvad leukeemiarakud ning vere leukotsüüdi- ja trombotsüüdisisaldus on normaliseerunud.
English: 97% (72 out of 74) of patients treated with Trisenox did not have any event, compared with 86% (65 out of 76) of those treated with anthracyclines.
Estonian: Patsiente, kellel haigusega seotud sündmused puudusid, oli Trisenoxiga ravitute seas 97% (72 patsienti 74st) ja antratsükliinidega ravitute seas 86% (65 patsienti 76st).
English: What are the risks associated with Trisenox?
Estonian: Mis riskid Trisenoxiga kaasnevad?
English: For practical information about using Trisenox, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Trisenoxi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: The recommended dose of Trisenox depends on the body weight of the patient.
Estonian: Trisenoxi annus sõltub patsiendi kehamassist.
English: For more information about treatment with Trisenox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Trisenoxiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: How does Trisenox work?
Estonian: Kuidas Trisenox toimib?
English: Trisenox can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the management of patients with acute leukaemias.
Estonian: Trisenox on retseptiravim ja ravi sellega peab toimuma ägeda leukeemiaga patsientide ravis kogenud arsti järelevalve all.
English: How is Trisenox used?
Estonian: Kuidas Trisenoxi kasutatakse?
English: Trisenox 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: See on leukeemia (leukotsüütide ehk vere valgeliblede vähi) haruldane vorm, mille põhjustab teatud geenitranslokatsioon (geenide ümberpaiknemine ühelt kromosoomilt teisele).
English: What benefits of Trisenox have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Trisenoxi kasulikkus?
English: It is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Estonian: Trisenoxi turustatakse infusioonilahuse (veeni tilgutatava lahuse) kontsentraadina.
English: Trisenox has been investigated in 159 newly diagnosed patients who had not yet received any treatment for APL. Trisenox was compared with an anthracycline (a type of cancer medicine), both taken in combination with ATRA, and the measure of effectiveness was the number of patients who did not experience any event (such as worsening of their disease or death) 2 years after diagnosis.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kellel 2 aasta jooksul pärast diagnoosimist ei esinenud haigusega seotud sündmusi (näiteks haiguse süvenemist või surma).
English: Trisenox is used in:
Estonian: Trisenoxi kasutatakse järgmiste patsientide ravis:
English: Benefit -risk balance
Estonian: Kasu ja riski suhe
English: At the request of the CHMP, an ad-hoc expert advisory group meeting was convened in February 2013.
Estonian: Inimravimite komitee palvel toimus veebruaris 2013 ajutise eksperdirühma kohtumine.
English: The CASTLE study included patients who were treated up to 3 years.
Estonian: CASTLE uuring hõlmas patsiente, keda raviti kuni 3 aasta vältel.
English: However these imbalances involved small numbers of events.
Estonian: Siiski põhines see erinevus väga väikesel juhtude arvul.
English: Overall summary of the scientific evaluation of cilostazol containing medicinal products (see Annex I)
Estonian: Tsilostasooli sisaldavate ravimite (vt I lisa) teadusliku hindamise üldkokkuvõte
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC on cilostazolcontaining medicinal products;
Estonian: • inimravimite komitee vaatas läbi direktiivi 2001/83/EÜ artikli 31 kohase esildise tsilostasooli sisaldavate ravimite kohta;
English: Annex II Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisations
Estonian: II lisa Teaduslikud järeldused ja müügilubade tingimuste muutmise alused
English: The primary objective of the CASTLE trial was to assess the long-term effect of cilostazol on all-cause mortality.
Estonian: CASTLE uuringu põhieesmärk oli hinnata tsilostasooli pikaaegset mõju kõigil põhjustel suremusele.
English: No major safety concerns were identified from the clinical trials.
Estonian: Kliinilistes uuringutes ei täheldatud olulisi ohutusprobleeme.
English: This leads to inhibition of platelet activation and aggregation and prevents the release of prothrombotic inflammatory and vasoactive substances.
Estonian: See inhibeerib trombotsüütide aktiveerumist ja agregatsiooni ning takistab protrombootiliste põletikuliste ja vasoaktiivsete ainete vabanemist.
English: In total 3,122 patients were randomised and received at least one dose of investigational product in the 9 efficacy trials.
Estonian: Üheksasse efektiivsusuuringusse randomiseeriti kokku 3122 patsienti, kes said vähemalt ühe annuse uuringuravimit.
English: To ensure that health care professionals are informed of the correct indication for use of the product, the MAH has introduced the following measures: proactive communication to physicians on the Otsuka Europe website, re-training of the Medical Information teams and Sales Force teams in the countries where cilostazol is marketed.
Estonian: Et tagada kõikide arstide teavitamine ravimi õigest näidustusest, on müügiloa hoidja võtnud järgmised meetmed: arstide proaktiivne teavitamine ravimifirma Otsuka Europe kodulehel, ravimiteabe- ja müügimeeskondade ümberkoolitamine riikides, kus tsilostasooli turustatakse.
English: In order to measure the effectiveness of the above measures, the CHMP has agreed on two drug utilisation studies (DUS).
Estonian: Eelmainitud meetmete efektiivsuse mõõtmiseks nõustus inimravimite komitee kahe ravimikasutuse uuringu läbiviimisega.
English: It was recognised by the experts that the benefit of cilostazol products was small but was clinically significant, and enough to restore independence for some patients and to get them started with their rehabilitation program.
Estonian: Eksperdid leidsid, et tsilostasooli sisaldavate ravimite kasulikkus on küll tagasihoidlik, ent siiski kliiniliselt oluline ja piisav selleks, et taastada mõne patsiendi iseseisvus ja võimaldada neil alustada rehabilitatsiooniprogrammiga.
English: It was recognised that less adverse events than expected had been reported.
Estonian: Eksperdid märkisid, et uuringus teatati kõrvalnähtudest vähem, kui oleks võinud oodata.
English: This Article 31 referral was initiated by Spain following review of safety reports received in association with cilostazol during the first 18 months of marketing in Spain (cilostazol was licenced in Spain in 2008).
Estonian: Artikli 31 kohase esildise algatas Hispaania tsilostasooli turustamise esimese 18 kuu jooksul (tsilostasool sai Hispaanias müügiloa 2008. aastal) laekunud ohutusaruannete läbivaatamise järel.
English: Therefore the CHMP recommended the variation to the terms of the Marketing Authorisations for the cilostazol-containing medicinal products referred to in Annex I, in accordance to the amendments to the Summary of Product Characteristics, Labelling and Package Leaflet set out in Annex III and subject to the conditions set out in Annex IV.
Estonian: Seetõttu soovitab inimravimite komitee muuta I lisas loetletud tsilostasooli sisaldavate ravimite müügilubade tingimusi vastavalt III lisas esitatud ravimi omaduste kokkuvõtte, pakendi märgistuse ja pakendi infolehe muudatustele ning IV lisas esitatud tingimustel.
English: Results for secondary efficacy endpoints were consistent with the results for ACD.
Estonian: Teisesed tulemusnäitajad olid sarnased ACD osas saadud tulemustega.
English: Cilostazol is mainly metabolised by CYP3A4, and CYP2C19 and has two main active metabolites, OPC13015 (dehydrocilostazol, 3-7 times more potent than cilostazol), and OPC-13213 (trans-hydroxycilostazol, 2 - 5 times less potent than cilostazol).
Estonian: Tsilostasool metaboliseerub peamiselt CYP3A4 ja CYP2C19 vahendusel ning tal on kaks peamist aktiivset metaboliiti: OPC-13015 (dehüdrotsilostasool, mis on 3-7 korda tugevama toimega kui tsilostasool) ja OPC-13213 (transhüdroksütsilostasool, mis on 2-5 korda nõrgema toimega kui tsilostasool).
English: A drug utilisation study conducted in one region of Spain found that patients receiving cilostazol were older and used more concomitant medications than those in the clinical trials.
Estonian: Ühes Hispaania piirkonnas korraldatud ravimikasutuse uuring näitas, et tsilostasooliga ravitud patsiendid olid vanemad ja kasutasid samal ajal rohkem teisi ravimeid kui kliinilistes uuringutes osalendu patsiendid.
English: The need to review the patient's response to treatment at 3 months and to continue treatment only if positive was agreed by all.
Estonian: Kõik eksperdid nõustusid, et kolme kuu möödudes tuleb hinnata patsiendi ravivastust ja et ravi võib jätkata üksnes juhul, kui positiivne toime leiab kinnitust.
English: The CHMP also concluded that the risk of bleeding was higher in patients treated concomitantly with two or more additional antiplatelet or anticoagulants agents.
Estonian: Samuti järeldas inimravimite komitee, et verejooksu risk on suurem patsientidel, keda ravitakse samal ajal kahe või enama täiendava trombotsüütide agregatsiooni vastase või hüübimisvastase ravimiga.
English: Spain therefore referred cilostazol to the CHMP/EMA, requesting that it gives its opinion under Article 31 of Directive 2001/83/EC, on whether the marketing authorisations for medicinal products containing cilostazol should be maintained, varied, suspended or withdrawn.
Estonian: Seetõttu palus Hispaania Euroopa Ravimiameti inimravimite komiteel algatada direktiivi 2001/83/EÜ artikli 31 kohane esildis ja anda oma arvamus tsilostasooli sisaldavate ravimite müügilubade säilitamise, muutmise, peatamise või tühistamise kohta.
English: The experts agreed that the CASTLE study had some limitations (including early termination and high rate of dropout, study restrictive in certain patient groups, exclusion of high risk patients, and review of the patients by their doctors in a 6-month period) but that some of those were expected with such a long term Phase IV study.
Estonian: Eksperdid olid ühisel arvamusel, et CASTLE uuringul oli teatud puudusi (sh ennetähtaegne lõpetamine ja suur katkestamise määr, uuringu piiramine teatud patsiendirühmadega, suure riskiga patsientide väljajätmine ja patsientide arstlik hindamine 6-kuuliste perioodide järel), aga mõned loetletud puudustest on pikaaegses IV faasi uuringus paratamatud.
English: The efficacy of cilostazol has been evaluated in 14 clinical trials which enrolled more than 4000 intermittent claudication (IC) patients.
Estonian: Tsilostasooli efektiivsust on hinnatud 14 kliinilises uuringus, milles osales üle 4000 vahelduva lonkamisega patsiendi.
English: Suitability of treatment with cilostazol should be carefully considered, alongside other treatment options such revascularisation.
Estonian: Tsilostasooliga ravimise sobivust tuleb hoolikalt hinnata, kaaludes ka kõiki teisi ravivõimalusi, sh revaskulariseerimist.
English: • The Committee reviewed all the data provided by the MAHs in writing and in the oral explanation and the outcome of the ad-hoc expert advisory group meeting;
Estonian: • inimravimite komitee vaatas läbi müügiloa hoidjate kirjalikult ja suuliselt esitatud andmed ning ajutise eksperdirühma kohtumise tulemused;