FrancophonIA/ELRC3.0 huggingface dataset:
English: Adempas has been shown to be effective at improving the distance patients with CTEPH or PAH could walk in 6 minutes (a way of measuring exercise capacity):
Estonian: Adempas on olnud tõendatult efektiivne kõndimiskauguse pikendamisel, mida kroonilise trombemboolilise pulmonaalhüpertensiooni või pulmonaalse arteriaalse hüpertensiooniga patsiendid suudavad läbida 6 minutiga (koormustaluvuse näitaja).
English: CTEPH and PAH are debilitating diseases where there is severe narrowing of the blood vessels of the lungs.
Estonian: Krooniline trombembooliline pulmonaalhüpertensioon ja pulmonaalne arteriaalne hüpertensioon on invaliidistavad haigused, mille korral on kopsuveresooned ahenenud tugevasti.
English: Route of Administration Immediate Packaging Pack size
Estonian: Pakendi suurus õhukese polümeerikattega
English: Strength Pharmaceutical Form
Estonian: Tugevus
English: What measures are being taken to ensure the safe and effective use of Wakix?
Estonian: Mis meetmed võetakse, et tagada Wakixi ohutu ja efektiivne kasutamine?
English: This leads to symptoms such as an irresistible urge to sleep, even at inappropriate times and places, and disturbed night-time sleep.
Estonian: See põhjustab selliseid sümptomeid nagu vastupandamatu tung magada, ka sobimatutes kohtades, ja öise une häirumine.
English: Wakix is available as tablets (4.5 and 18 mg).
Estonian: Wakixit turustatakse tablettidena (4,5 mg ja 18 mg).
English: Serious but rare side effects are abnormal loss of weight and spontaneous abortion.
Estonian: Rasked, kuid harva esinevad kõrvalnähud on ebanormaalne kehakaalu langus ja spontaanne abort.
English: A risk management plan has been developed to ensure that Wakix is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Wakixi võimalikult ohutu kasutamine.
English: The safety profile of Wakix is considered acceptable, with no major safety concerns identified.
Estonian: Wakixi ohutusprofiili peetakse vastuvõetavaks ja suuri ohutusprobleeme ei ole tuvastatud.
English: The most common side effects with Wakix (which may affect up to 1 in 10 people) are insomnia (difficulty sleeping), headache, nausea (feeling sick), anxiety, irritability, dizziness, depression, tremor, sleep disorders, tiredness, vomiting, vertigo (a spinning sensation) and dyspepsia (heartburn).
Estonian: Wakixi kõige sagedamad kõrvalnähud (võivad esineda kuni 1 patsiendil 10st) on unetus, peavalu, iiveldus, ärevus, ärrituvus, peapööritus, depressioon, treemor, unehäired, väsimus, oksendamine, vertiigo (peapööritus) ja düspepsia (kõrvetised).
English: Some patients also have episodes of severe muscle weakness (cataplexy) that can cause collapse.
Estonian: Mõnel patsiendil esineb ka raskeid lihasnõrkuse episoode (katapleksia), mis võivad põhjustada kollapsit.
English: In addition, Wakix works differently from currently available treatments and therefore offers an alternative treatment option.
Estonian: Lisaks toimib Wakixi praegu turustatavatest ravimitest erinevalt ja on seega alternatiivne ravivõimalus.
English: Results from this study also showed a decrease in the number of cataplexy attacks.
Estonian: Uuringu tulemused näitasid ka katapleksiahoogude vähenemist.
English: Wakix has been investigated in 2 main studies involving a total of 261 adults with narcolepsy, the majority of whom also had cataplexy.
Estonian: Wakixit uuriti 2 põhiuuringus, kus osales 261 narkolepsiaga täiskasvanut, kellest enamikul oli ka katapleksia.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Wakix's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Wakixi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: During the first week of treatment, the recommended dose is 9 mg per day, taken in the morning during breakfast.
Estonian: Esimese ravinädala jooksul on soovitatav annus 9 mg ööpäevas hommikusöögi ajal.
English: What is Wakix and what is it used for?
Estonian: Mis on Wakix ja milleks seda kasutatakse?
English: Wakix is a medicine used to treat adults with narcolepsy.
Estonian: Wakix on ravim, mida kasutatakse narkolepsia raviks täiskasvanutel.
English: In patients with moderately reduced liver function or with kidney problems, the maximum dose should be 18 mg per day.
Estonian: Patsientidel, kelle maksafunktsioon on mõõdukalt halvenenud või kellel on neeruprobleemid, on maksimaalne annus 18 mg ööpäevas.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Wakix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Wakixi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Other information about Wakix
Estonian: Muu teave Wakixi kohta
English: In addition, the company that markets Wakix will carry out an observational study to collect information on the safety of the medicine when used in medical practice.
Estonian: Peale selle viib Wakixit turustav ettevõte läbi vaatlusuuringu, et koguda ravimiohutuse teavet Wakixi kasutamisest kliinilises praktikas.
English: The full EPAR and risk management plan summary for Wakix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Wakixi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: the dose may be further increased to the maximum dose of 36 mg per day.
Estonian: Kolmanda ravinädala jooksul võib annust veelgi suurendada maksimaalse annuseni 36 mg ööpäevas.
English: This increases the activity of certain brain cells called ‘histamine neurons', which are important for keeping the body awake.
Estonian: See suurendab organismi ärkvel hoidvate teatud ajurakkude, histaminergiliste neuronite aktiivsust.
English: Narcolepsy is a long-term sleep disorder which affects the brain's ability to regulate the normal sleep-wake cycle.
Estonian: Narkolepsia on krooniline unehäire, mistõttu aju ei suuda tavapärast ärkveloleku-une tsüklit reguleerida.
English: Because the number of patients with narcolepsy is low, the disease is considered ‘rare', and Wakix was designated an ‘orphan medicine' (a medicine used in rare diseases) on 10 July 2007.
Estonian: Et narkolepsiaga patsientide arv on väike ja see haigus esineb harva, nimetati Wakix 10. juulil 2007 harvikravimiks.
English: This is a summary of the European public assessment report (EPAR) for Wakix.
Estonian: See on ravimi Wakix Euroopa avaliku hindamisaruande kokkuvõte.
English: During the second week of treatment, the dose can be increased to 18 mg per day or decreased to 4.5 mg per day.
Estonian: Teise ravinädala jooksul võib annust suurendada 18 mg-ni või vähendada 4,5 mg-ni ööpäevas.
English: Why is Wakix approved?
Estonian: Miks Wakix heaks kiideti?
English: This is a standard scale used in patients with narcolepsy which ranges from 0 to 24.
Estonian: See on narkolepsiaga patsientide hindamise standardskaala väärtustega vahemikus 0-24.
English: In a further study in 105 patients with narcolepsy and cataplexy, Wakix was also more effective than placebo at reducing the number of cataplexy attacks per week: the number of cataplexy attacks decreased from around 9 to around 3 per week in patients taking Wakix, while it remained at around 7 per week in patients taking placebo.
Estonian: Järgmises uuringus, kus osales 105 narkolepsia ja katapleksiaga patsienti, oli Wakix nädala jooksul esinenud katapleksiahoogude vähendamisel samuti efektiivsem kui platseebo: Wakixiga vähenes katapleksiahoogude arv nädalas ligikaudu 9-lt 3-le, kuid platseeboga esines ligikaudu 7 hoogu nädalas.
English: When looking at sleepiness with an objective test called Maintenance of Wakefulness Test or MWT, the results of the two studies together showed that Wakix significantly improved wakefulness compared with placebo.
Estonian: Uurides unisust ärkvelpüsimise testiga (Maintenance of Wakefulness Test, MWT), näitasid kahe uuringu tulemused, et võrreldes platseeboga parandas Wakix ärkvelolekut oluliselt.
English: The second study, however, did not show a difference between Wakix and placebo at reducing sleepiness or cataplexy.
Estonian: Teises uuringus aga ei olnud Wakixi ja platseebo toimes päevase liigunisuse või katapleksia vähendamisele erinevusi.
English: What are the risks associated with Wakix?
Estonian: Mis riskid Wakixiga kaasnevad?
English: The studies compared Wakix with placebo (a dummy treatment).
Estonian: Uuringutes võrreldi Wakixit platseeboga (näiv ravim).
English: The first study showed that Wakix was more effective than placebo at reducing daytime sleepiness: patients taking Wakix had an average reduction of 3 points more in the ESS scale than those taking placebo after 8 weeks of treatment.
Estonian: Esimeses uuringus oli Wakix päevase liigunisuse vähendamisel efektiivsem kui platseebo: Wakixit võtvatel patsientidel vähenes pärast 8 ravinädalat ESS keskmiselt 3 punkti rohkem kui platseebot saanud patsientidel.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Wakix, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Wakixi omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: The overall data available demonstrate that Wakix has a positive effect on the two major symptoms of narcolepsy, excessive daytime sleepiness and cataplexy.
Estonian: Üldised olemasolevad andmed näitavad Wakixi positiivset toimet narkoplepsia kahele põhisümptomile, päevasele liigunisusele ja katapleksiale.
English: The main measure of effectiveness was based on how sleepy patients felt during daytime, assessed using the Epworth Sleepiness Scale or ESS.
Estonian: Efektiivsuse põhinäitaja oli patsientide päevane liigunisus, mida hinnati Epworthi unisuse skaalal (ESS).
English: It is not intended to provide practical advice on how to use Wakix.
Estonian: Hindamisaruandes ei anta Wakixi kasutamise praktilisi nõuandeid.
English: For more information about treatment with Wakix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Wakixiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: For practical information about using Wakix, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Wakixi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: For the full list of all side effects reported with Wakix, see the package leaflet.
Estonian: Wakixi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Wakix must not be used in patients with severely reduced liver function and in women who are breastfeeding.
Estonian: Wakixit ei tohi kasutada maksa raske talitlushäirega patsiendid ega imetavad naised.
English: How does Wakix work?
Estonian: Kuidas Wakix toimib?
English: The active substance in Wakix, pitolisant, works by attaching to receptors in the brain called ‘histamine H3 receptors'.
Estonian: Wakixi toimeaine pitolisant seondub peaajus histamiin H3 retseptoritega.
English: How is Wakix used?
Estonian: Kuidas Wakixit kasutatakse?
English: Wakix should always be used at the lowest effective dose.
Estonian: Wakixit tuleb võtta väikseimas toimivas annuses.
English: What benefits of Wakix have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Wakixi kasulikkus?
English: Wakix is used in patients with or without cataplexy.
Estonian: Wakixit kasutatakse nii katapleksiaga kui ka katapleksiata patsientidel.
English: Wakix contains the active substance pitolisant.
Estonian: Ravim sisaldab toimeainena pitolisanti.
English: Wakix can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of sleep disorders.
Estonian: Ravi peab toimuma unehäirete ravis kogenud arsti järelevalve all.
English: 0.6 ml (10 mg/ml) 1 pre-filled syringe
Estonian: 0.6 ml (10 mg/ml) 1 süstel
English: Subcutaneous use pre-filled syringe (glass)
Estonian: Subkutaanne süstel (klaas)
English: 31 July 2014
Estonian: 31. juuli 2014
English: The final opinion was converted into a Decision by the European Commission on 31 July 2014.
Estonian: Lõplik arvamus vormistati Euroopa Komisjoni otsusena 31. juulil 2014.
English: The referral started on 6 November 2013.
Estonian: Esildismenetlus algas 6. novembril 2013.
English: Article 35 of Directive 2001/82/EC, as amended
Estonian: Muudetud direktiivi 2001/82/EÜ artikkel 35
English: The Committee appointed E. Persson as rapporteur and A. Wachnik-Święcicka as co-rapporteur.
Estonian: Komitee määras hindajaks E. Perssoni ja kaashindajaks A. Wachnik-Święcicka.
English: The CVMP was requested to consider whether tylosin is still effective against swine dysentery (caused by Brachyspira hyodysenteriae) and whether the treatment durations beyond three weeks are justified.
Estonian: Veterinaarravimite komiteel paluti kaaluda, kas tülosiin on endiselt efektiivne sigade düsenteeria (haigustekitaja Brachyspira hyodysenteriae) vastu ja kas kolmest nädalast pikem ravi on põhjendatud.
English: International non-proprietary name (INN): tylosin
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): tülosiin
English: Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for these products remains positive subject to amendments in the product information.
Estonian: Olemasolevate andmete hindamise alusel järeldas veterinaarravimite komitee, et nende ravimite üldine kasulikkuse ja riski profiil jääb positiivseks, kuid ravimiteavet tuleb muuta.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.
Estonian: Teaduslikud järeldused on välja toodud II lisas ning ravimi omaduste kokkuvõtete, märgistuste ja pakendi infolehtede muudatused III lisas.
English: On 30 October 2013, Sweden presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs.
Estonian: Rootsi tegi 30. oktoobril 2013 EMA-le direktiivi 2001/82/EÜ artikli 35 kohase esildise seoses tülosiini sisaldavate sigadele sööda või joogiveega manustatavate suukaudsete veterinaarravimitega.
English: Written comments on the recommendations and proposed changes in the product information were provided by the applicants and marketing authorisation holders on 7 March 2014.
Estonian: 7. märtsil 2014 esitasid taotlejad ja müügiloa hoidjad soovituste ja ravimiteabe soovitatud muudatuste kohta kirjalikud märkused.
English: Therefore, on 8 May 2014 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs.
Estonian: Seega võttis veterinaarravimite komitee 8. mail 2014 konsensuse alusel vastu positiivse arvamuse, soovitades muuta tülosiini sisaldavate sigadele sööda või joogiveega manustatavate suukaudsete veterinaarravimite müügilubade tingimusi.
English: referral for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs
Estonian: kohast esildist tülosiini sisaldavate sigadele sööda või joogiveega manustatavate suukaudsete veterinaarravimite kohta
English: Package size βlister (PVC/PE/PVDC/alu)
Estonian: Pakendi suurus blister (PVC/PE/PVDC/alu) nädalapä
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Estonian: Manustamisviis Pakendi iseloomustus
English: • Information about any registry or other monitoring system set up in the Member State and how to enter patients
Estonian: • Teave liikmesriigis loodud võimaliku registri või muu järelevalvesüsteemi kohta ning patsientide registreerimise korra kohta
English: The National Competent Authorities in each Member State shall discuss and agree with the Marketing Authorisation Holder (MAH ) measures to enhance further the monitoring of patients treated with Tysabri (e.g. registries, post-marketing surveillance studies) as appropriate and must ensure that the MAH implements the agreed measures within an agreed time frame.
Estonian: Iga liikmesriigi pädevad ametiasutused arutavad müügiloa hoidjaga läbi ja lepivad kokku sobivad meetmed Tysabri-ravi saavate patsientide järelevalve edasiseks tugevdamiseks (nt registrid, turustamisjärgse järelevalve uuringud) ning tagavad, et müügiloa hoidja rakendab kokkulepitud järelevalvemeetmed kokkulepitud tähtajaks.
English: • Prescriber name, signature and date
Estonian: • ravi määraja nimi, allkiri ja kuupäev
English: • Information about the following adverse reactions: o Infusion reactions o Hypersensitivity reactions o Antibody formation
Estonian: • Teave järgmiste kõrvaltoimete kohta: o infusioonireaktsioonid o ülitundlikkusreaktsioonid o antikehade tekkimine
English: The treatment continuation form should contain the elements of the treatment initiation form and, in addition, a statement that the risks of PML increase with duration of treatment and that treatment beyond 24 months carries additional risk.
Estonian: Ravi jätkamise vorm peab sisaldama ravi alustamise vormil sisalduvaid andmeid ning lisaks märkuse, et PMLi tekkimise risk suureneb ravi kestuse pikenedes ning et ravi kestusega kauem kui 24 kuud kaasneb täiendav risk.
English: • Physician information about TYSABRI
Estonian: • TYSABRIt tutvustav teave arstidele
English: • Confirmation of patient understanding of the risks of PML and that they have received a copy of the form and a patient alert card
Estonian: • kinnitus, et patsient saab aru PMLi tekkimisega kaasnevatest riskidest ning et talle on antud koopia sellest vormist ja patsiendi hoiatuskaart
English: • That the aim of the treatment initiation form is to provide patients with information on PML and IRIS
Estonian: • teave, et ravi alustamise vormi eesmärk on teavitada patsiente PMList ja IRISest
English: • Patient details, signature and date
Estonian: • patsiendi andmed, allkiri ja kuupäev
English: • Information on PML and IRIS including the risk of developing PML during Tysabri treatment stratified by prior treatment with immunosuppressants and JC virus infection.
Estonian: • teave PMLi ja IRISe kohta, sealhulgas PMLi tekkeriski kohta TYSABRI-ravi ajal, stratifitseeritult olenevalt eelnevast ravist immunosupressantidega ja JC-viiruse infektsioonist
English: The Member States shall discuss and agree the physician pack with the MAH and ensure that:
Estonian: Liikmesriigid arutavad müügiloa hoidjaga läbi ja lepivad kokku arsti teabematerjalie osas ja tagavad, et:
English: • Date treatment started
Estonian: • ravi alustamise kuupäev
English: • That TYSABRI therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI.
Estonian: • Teave, et ravi TYSABRIga peab alustama ja pidevalt jälgima neuroloogiliste seisundite diagnoosimises ja ravis kogenud eriarst ravikeskuses, kus on võimalik õigeaegselt teha MRTuuringut.
English: The physician information about TYSABRI shall contain the following key elements:
Estonian: TYSABRIt tutvustav teave arstile peab käsitlema järgnevat:
English: The Marketing Authorisation provides all physicians who intend to prescribe TYSABRI with a physician pack containing the following elements:
Estonian: Kõik TYSABRIt määravad arstid oleksid varustatud arstidele jagatava paketiga, mis sisaldab järgmisi komponente:
English: • Information that atypical/opportunistic infections, and in particular PML, may occur with TYSABRI and include: o That the risk of PML increases with increasing duration of treatment and that treatment beyond 24 months carries additional risk o Other factors associated with an increased risk for the development of PML Immunosuppressant treatment prior to the use of Tysabri Presence of anti-JC virus antibodies o A stratification of the risk of developing PML based on the three identified risk factors o Diagnosis of PML including differentiation between PML and MS relapse o PML management algorithm o Possibility of other opportunistic infections o The recommendation that patients should have MRI scans at the following times Within 3 months prior to starting TYSABRI Annually during treatment with TYSABRIi At the first sign of any symptoms indicative of the possibility of PML.
Estonian: • JC-viiruse antikehade olemasolu o stratifitseerimine PMLi tekkeriski suhtes kolme väljaselgitatud riskiteguri põhjal o PMLi diagnoosimise kohta, sealhulgas PMLi eristamise kohta SMi ägenemisest o PML ravi algoritm o muude oportunistlike infektsioonide tekkimise võimalikkus o soovitus, et patsiendil tuleb teha MRT-uuring järgnevatel aegadel: 3 kuu jooksul enne ravi alustamist TYSABRIga ravi ajal TYSABRIga üks kord aastas PMLi võimalikule tekkimisele viitavate esimeste sümptomite ilmumisel o vajaduse kohta teavitada patsiente TYSABRI kasutamisest saadavast kasust ja sellega seotud riskidest ning anda patsiendile: ravi alustamise vormi koopia patsiendi hoiatuskaart, mille põhitekst on inimravimite komiteega kooskõlastatud o kui ravi jätkatakse kauem kui 24 kuud, vajaduse kohta teavitada patsiente PMLi tekkimise riski suurenemisest ning anda neile ravi jätkamise vormi koopia o vajaduse kohta teavitada riigi pädevat ametiasutust PMLi tekkimise juhtumitest
English: • Confirmation that the doctor has discussed the risks of PML and the risk of IRIS if treatment is discontinued following suspicion of PML
Estonian: • kinnitus, et arst on arutanud patsiendiga PMLiga seotud riske ning IRISe tekkimise riski, kui ravi
English: The Reference Member State was Finland and the Concerned Member States were Belgium, Germany, Luxembourg and the Netherlands.
Estonian: Võrdlusliikmesriigiks olid Soome ja asjassepuutuvateks liikmesriikideks Belgia, Saksamaa, Luksemburg ja Holland.
English: Lansopon.
Estonian: TAUSTATEAVE
English: The application was withdrawn in the Netherlands and Germany referred the reasons for disagreement to the EMEA on 15 December 2004.
Estonian: Saksamaa esitas lahkarvamuse põhjused EMEAle 15. detsembril 2004.
English: During its June 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for
Estonian: Tuginedes kõigile esitatud andmetele ja komitee sisesele arutelule, jõudis inimtervishoius kasutatavate ravimite komitee oma 2005. aasta juuni koosolekul seisukohale, et Lansoponi riski ja kasu vahekord on soodne.
English: Lansopon (lansoprazole) is a proton pump inhibitor that inhibits gastric acid secretion and is used for treatment of duodenal and gastric ulcer, reflux oesophagitis, Zollinger-Ellison syndrome, and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.
Estonian: Lansoprasooli kasutatakse kaksiksõrmiksoole ja maohaavandite, refluksösofagiidi, Zollinger-Ellisoni sündroomi raviks, samuti kombinatsioonis sobivate antibakteriaalsete terapeutiliste raviskeemidega Helicobacter pylori eradikatsiooniks ja maohaavandite taastekke ennetamiseks patsientidel H.pylori'ga seonduvate haavanditega.
English: OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Lansopon 15 mg and 30 mg
Estonian: Lansopon 15 mg ja 30 mg