FrancophonIA/ELRC3.0 huggingface dataset:
English: Neptra received a marketing authorisation valid throughout the EU on 10 December 2019.
Estonian: Neptra müügiluba, mis kehtib kogu Euroopa Liidus, anti 10/12/2019.
English: Neptra may be harmful after swallowing.
Estonian: Neptra võib olla allaneelamisel kahjulik.
English: In case of accidental eye exposure, the eyes should be flushed thoroughly with water for 10 to 15 minutes.
Estonian: Ravimi juhuslikul silma sattumisel tuleb silmi 10-15 minutit põhjalikult veega loputada.
English: What is Neptra and what is it used for?
Estonian: Mis on Neptra ja milleks seda kasutatakse?
English: Neptra can cause serious eye irritation if it accidentally gets into the eyes when the dog shakes its head during or just after application.
Estonian: Neptra võib põhjustada rasket silmaärritust, kui see satub juhuslikult silma, kui koer raputab pead manustamise ajal või vahetult pärast seda.
English: Although no potential for skin irritation was indicated by studies, skin contact should be avoided.
Estonian: Kuigi uuringud ei ole näidanud nahaärrituse võimalikkust, tuleb nahaga kokkupuudet vältida.
English: The contents of one tube are given into each infected ear.
Estonian: Kumbagi nakatunud kõrva manustatakse ühe tuubi sisu.
English: Avoid swallowing the product or accidentally transferring it from hand to mouth.
Estonian: Vältige toote allaneelamist või tahtmatut sattumist käest suhu.
English: Two of the active substances in Neptra, florfenicol and terbinafine, act against possible causes of infection.
Estonian: Kaks Neptra toimeainetest, florfenikool ja terbinafiin, toimivad infektsiooni võimalike põhjuste vastu.
English: Neptra must not be used in dogs who are allergic to the active substances, to other corticosteroids or to any of the other ingredients.
Estonian: Neptrat ei tohi kasutada koertel, kes on allergilised toimeainete, muude kortikosteroidide ja ravimi mis tahes muu koostisaine suhtes.
English: What are the risks associated with Neptra?
Estonian: Mis riskid Neptraga kaasnevad?
English: It is therefore recommended that this medicine is applied only by veterinarians or under their close supervision and that measures are taken to reduce the risk (e.g. wearing safety glasses during treatment, massaging the ear canal well after application to ensure even distribution of product, restraining the dog after application).
Estonian: Seepärast soovitatakse ravimit manustada üksnes veterinaararstidel või nende hoolika järelevalve all ning võtta riskivähendusmeetmeid (nt kanda ravi ajal kaitseprille, masseerida pärast ravimi manustamist kuulmekanalit, et ravim ühtlaselt jaotuks, või piirata koera liikumist pärast manustamist).
English: Neptra (florfenicol / terbinafine / mometasone)
Estonian: Neptra (florfenikool/terbinafiin/mometasoon)
English: The third active substance, mometasone, is a corticosteroid, a medicine that reduces inflammation and pain associated with the infection.
Estonian: Kolmas toimeaine mometasoon on kortikosteroid, mis vähendab infektsiooniga seotud põletikku ja valu.
English: In a field study in Europe involving dogs with ear infections with both Staphylococcus pseudintermedius and Malassezia pachydermatitis 43 Neptra treated dogs had their signs of infection reduced by 71% after 28 days which was as effective as the comparator group of 45 dogs, treated with another veterinary medicine authorised for ear infections, for which the reduction was 74%.
Estonian: Euroopa väliuuringus, mis tehti Staphylococcus pseudintermedius'e ja Malassezia pachydermatitis'e põhjustatud kõrvainfektsioonidega koertel, vähenesid 43 Neptraga ravitud koeral infektsiooninähud pärast 28 päeva 71%; ravimi efektiivsus oli võrreldav 74% vähenemisega 45 koerast koosnevas võrdlusrühmas, keda raviti teise kõrvainfektsioonide raviks heakskiidetud veterinaarravimiga.
English: Neptra is a veterinary medicine used to treat dogs with short lived or recurrent ear infections (otitis externa) caused by two organisms: Staphylococcus pseudintermedius (a bacterium) and Malassezia pachydermatitis (a yeast).
Estonian: Neptra on veterinaarravim, millega ravitakse koertel lühiajalisi või korduvaid kõrvainfektsioone (väliskõrvapõletikku), mida põhjustavad kaks organismi: Staphylococcus pseudintermedius (bakter) ja Malassezia pachydermatitis (seen).
English: Neptra (florfenicol / terbinafine / mometasone) EMA/560411/2019
Estonian: Neptra (florfenikool/terbinafiin/mometasoon) EMA/687939/2019
English: Side effects with Neptra occur very rarely, with the most often reported (which may affect up to 1 in 10,000 dogs) being whining, head shaking, nystagmus (uncontrolled eye movements), vomiting, inner ear disorders causing imbalance, loss of appetite, hyperactivity and application site pain and inflammation shortly after applying the medicine.
Estonian: Neptra kõige sagedamad kõrvalnähud, mida esineb väga harva (võivad esineda kuni 1 koeral 10 000st), on vingumine, pea raputamine, nüstagm (tahtmatud silmaliigutused), oksendamine, tasakaaluhäireid põhjustavad sisekõrvahaigused, isutus, hüperaktiivsus ning manustamiskoha valu ja põletik vahetult pärast ravimi manustamist.
English: An overview of Neptra and why it is authorised in the EU
Estonian: Neptra ülevaade ja Euroopa Liidus heakskiitmise põhjused
English: How does Neptra work?
Estonian: Kuidas Neptra toimib?
English: Florfenicol is an antibiotic which works by blocking the production of proteins, which are essential components of bacterial cell walls.
Estonian: Florfenikool on antibiootikum, mis blokeerib bakteri rakumembraani oluliste komponentide valkude teket.
English: The medicine is available as ear drops and can only be obtained with a prescription.
Estonian: Ravimit turustatakse kõrvatilkadena ja see on retseptiravim.
English: In a field study in the US involving dogs again with ear infections due to both organisms, 67 dogs treated with Neptra had a reduction in clinical score of 77% over 30 days.
Estonian: Mõlema organismi põhjustatud kõrvainfektsioonidega koertel USAs tehtud väliuuringus vähenes 30 päeva jooksul 67 Neptraga ravitud koera kliiniliste sümptomite punktisumma 77%.
English: For more information about using Neptra, see the package leaflet or contact your veterinarian or pharmacist.
Estonian: Kui vajate Neptraga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte või pöörduge oma veterinaararsti või apteekri poole.
English: What benefits of Neptra have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Neptra kasulikkus?
English: Neptra contains three active substances: florfenicol, terbinafine and mometasone.
Estonian: Neptra sisaldab kolme toimeainet: florfenikooli, terbinafiini ja mometasooni.
English: How is Neptra used?
Estonian: Kuidas Neptrat kasutatakse?
English: Terbinafine kills fungi by blocking the formation of ergosterol, an important part of fungal cell walls.
Estonian: Terbinafiin hävitab seened, blokeerides seene rakumembraani olulise komponendi ergosterooli teket.
English: In case of accidental skin contact, exposed skin should be thoroughly washed with water.
Estonian: Juhuslikul kokkupuutel nahaga tuleb kokkupuutunud piirkonda hoolikalt veega pesta.
English: It must also not be used if the ear drum is perforated, in dogs with generalised demodectic mange (skin infestation caused by a specific type of mite) or in pregnant or breeding animals.
Estonian: Seda ei tohi kasutada ka perforeeritud kuulmekile või generaliseerunud demodektoosiga (teatud tüüpi lesta põhjustatud nahainfektsioon) koertel, tiinetel ega aretusloomadel.
English: This was more effective than the control group of 27 dogs, which received a placebo (dummy treatment) and for which the reduction was 49%.
Estonian: See tulemus oli parem kui platseebot (näivat ravimit) saanud 27 koera kontrollrühmas, kus punktisumma vähenes
English: In case of accidental swallowing medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Estonian: Juhusliku enesesüstimise korral tuleb pöörduda kohe arsti poole ja näidata talle pakendi infolehte või etiketti.
English: If symptoms develop, medical advice should be sought and the package leaflet or the label shown to the doctor.
Estonian: Sümptomite tekke korral tuleb pöörduda kohe arsti poole ja näidata talle pakendi infolehte või etiketti.
English: Why is Neptra authorised in the EU?
Estonian: Neptra Euroopa Liidus heakskiitmise põhjused
English: What measures are being taken to ensure the safe and effective use of Polivy?
Estonian: Mis meetmed võetakse, et tagada Polivy ohutu ja efektiivne kasutamine?
English: Polivy (polatuzumab vedotin)
Estonian: Polivy (polatuzumabvedotiin)
English: Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.
Estonian: Amet vaatab igal aastal läbi kogu uue teabe ja uuendab vajaduse korral käesolevat ülevaadet.
English: The medicine must not be given to patients who have a severe infection.
Estonian: Ravimit ei tohi manustada raske infektsiooniga patsientidele.
English: Other information about Polivy
Estonian: Muu teave Polivy kohta
English: As for all medicines, data on the use of Polivy are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse Polivy kasutamise kohta pidevat järelevalvet.
English: Although the study included a limited number of patients and more data are needed to confirm the results, the European Medicines Agency considered that Polivy meets an unmet medical need.
Estonian: Kuigi uuring hõlmas piiratud arvu patsiente ja tulemuste kinnitamiseks on vaja rohkem andmeid, leidis Euroopa Ravimiamet, et Polivy täidab rahuldamata ravivajadust.
English: What is Polivy and what is it used for?
Estonian: Mis on Polivy ja milleks seda kasutatakse?
English: Why is Polivy authorised in the EU?
Estonian: Miks Polivy ELis heaks kiideti?
English: The Agency therefore decided that Polivy's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Polivy kasulikkus on suurem kui sellega kaasnevad riskid ja ravimi kasutamise võib ELis heaks kiita.
English: If the patient develops an infusion-related reaction, the infusion should be slowed down or interrupted.
Estonian: Kui patsiendil tekib infusioonireaktsioon, tuleb infusiooni aeglustada või see katkestada.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3182013.
Estonian: Lisateave harvikravimiks nimetatud ravimi kohta on leitav: ema.europa.eu/medicines/human/orphandesignations/eu3182013.
English: The main study showed that Polivy is effective at treating patients whose disease was not responding to previous treatment or had returned and who could not have a transplant.
Estonian: Põhiuuringus tõendati, et Polivy on efektiivne selliste patsientide ravimisel, kellel haigus ei allunud varasemale ravile või tekkis uuesti ja kellele ei olnud võimalik siirdamist teha.
English: What information is still awaited for Polivy?
Estonian: Mis teavet Polivy kohta veel oodatakse?
English: Side effects reported with Polivy are carefully evaluated and any necessary action taken to protect patients.
Estonian: Polivy kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: Serious side effects can occur; however, these are manageable if appropriate measures are in place.
Estonian: Ravimiga võib kaasneda raskeid kõrvalnähte, kuid need on hallatavad asjakohaste meetmetega.
English: Polivy has been given a ‘conditional authorisation'.
Estonian: Polivy on saanud müügiloa tingimusliku heakskiidu alusel.
English: What are the risks associated with Polivy?
Estonian: Mis riskid Polivyga kaasnevad?
English: It is used in combination with two other medicines, bendamustine and rituximab.
Estonian: Seda kasutatakse koos kahe teise ravimiga, bendamustiini ja rituksimaabiga.
English: For more information about using Polivy, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Polivy kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: The dose of Polivy depends on the patient's bodyweight and is given for 6 cycles.
Estonian: Polivy annus sõltub patsiendi kehamassist ja ravimit manustatakse 6 tsüklit.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Polivy have been included in the summary of product characteristics and the package leaflet.
Estonian: Polivy ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: How does Polivy work?
Estonian: Kuidas Polivy toimib?
English: Since Polivy has been given conditional authorisation, the company that markets Polivy will provide further data on its effects to confirm Polivy's safety and effectiveness when used in combination with other cancer medicines in patients with DLBCL.
Estonian: Et Polivy on saanud müügiloa tingimusliku heakskiidu alusel, esitab Polivy turustaja täiendavad andmed ravimi toime kohta, et kinnitada Polivy ohutust ja efektiivsust kasutamisel koos muude vähiravimitega difuusse B-suurrakklümfoomiga patsientidel.
English: MMAE then stops the B cells from dividing and causes them to die.
Estonian: Monometüülauristatiin E peatab B-rakkude jagunemise ja põhjustab nende surma.
English: Polivy can affect the production of blood cells.
Estonian: Polivy võib mõjutada vererakkude teket.
English: Polivy was investigated in a study involving 80 patients with DLBCL.
Estonian: Polivyt uuriti uuringus, milles osales 80 difuusse B-suurrakklümfoomiga patsienti.
English: Polivy is a cancer medicine used to treat adults with diffuse large B-cell lymphoma (DLBCL) whose cancer has returned or has stopped responding to other treatments and who cannot have a bonemarrow transplantation.
Estonian: Polivy on vähiravim, mida kasutatakse difuusse B-suurrakklümfoomiga (DLBCL) täiskasvanute raviks, kellel on vähk taastekkinud või kellel haigus ei allu muudele raviviisidele ja kellele ei ole võimalik teha luuüdi siirdamist.
English: Polivy is for infusion (drip) into a vein over 90 minutes.
Estonian: Polivyt manustatakse 90 minutit kestva veeniinfusioonina.
English: The doctor may reduce or stop the dose of Polivy if the patient develops side effects affecting blood cells.
Estonian: Arst võib Polivy annust vähendada või Polivy andmise peatada, kui patsiendil tekivad vererakke mõjutavad kõrvaltoimed.
English: After 6 to 8 weeks of treatment, there were no signs of the cancer (complete response) in 40% of patients receiving Polivy plus rituximab and bendamustine compared with 18% of patients receiving rituximab and bendamustine alone.
Estonian: Pärast 6-8 ravinädalat oli patsiente, kellele ei ilmnenud vähktõve sümptomeid (täielik ravivastus), Polivyt koos rituksimaabi ja bendamustiiniga saanud patsientide seas 40% ning 18% patsientide seas, kes said ainult rituksimaabi ja bendamustiini.
English: Serious side effects (which may affect up to 1 in 10 people) include febrile neutropenia (low white blood cell count with fever), fever, and pneumonia (infection of the lungs).
Estonian: Rasked kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on febriilne neutropeenia (palavikuga neutropeenia), palavik ja pneumoonia ehk kopsupõletik (kopsuinfektsioon).
English: Patients are given paracetamol and an antihistamine medicine before receiving Polivy to reduce the risk of reactions to the infusion.
Estonian: Enne infusiooni tegemist antakse patsientidele paratsetamooli ja antihistamiinikumi, et vähendada infusioonireaktsioonide riski.
English: How is Polivy used?
Estonian: Kuidas Polivyt kasutatakse?
English: For the full list of side effects and restrictions of Polivy, see the package leaflet.
Estonian: Polivy kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Patients with DLBCL have cancerous B cells, which are a type of white blood cell.
Estonian: Difuusse B-suurrakklümfoomiga patsientidel on kantserogeensed B-rakud, mis on teatud tüüpi valgeverelibled (leukotsüüdid).
English: The most common side effects with Polivy in combination with bendamustin and rituximab (which may affect more than 3 in 10 people) were anaemia (low red blood cell count), thrombocytopenia (low blood platelet count), neutropenia (low white blood cell count), tiredness, diarrhoea, nausea (feeling sick) and fever.
Estonian: Polivy ning bendamustiini ja rituksimaabi kombinatsiooni kõige sagedamad kõrvalnähud (võivad esineda enam kui 3 patsiendil 10st) olid aneemia (erütrotsüütide ehk punaliblede vähesus veres), trombotsütopeenia (trombotsüütide ehk vereliistakute vähesus veres), neutropeenia (neutrofiilide ehk teatud valgeliblede vähesus veres), väsimus, kõhulahtisus, iiveldus ja palavik.
English: The active substance in Polivy, polatuzumab vedotin, is made up of a monoclonal antibody (a type of protein) combined with a substance called monomethyl auristatin E (MMAE).
Estonian: Polivy toimeaine polatuzumabvedotiin koosneb monoklonaalsest antikehast (teatud tüüpi valk), mis on kombineeritud teatud ainega (monometüülauristatiin E, MMAE).
English: It is given in 21-day cycles with rituximab and bendamustine.
Estonian: Seda manustatakse 21-päevaste tsüklitena koos rituksimaabi ja bendamustiiniga.
English: Polivy received a conditional marketing authorisation valid throughout the EU on 16 January 2020 Further information on Polivy can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/polivy.
Estonian: Lisateave Polivy kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/polivy.
English: DLBCL is rare, and Polivy was designated an ‘orphan medicine' (a medicine used in rare diseases) on 16 April 2018.
Estonian: Difuusset B-suurrakklümfoomi esineb harva ja Polivy nimetati 16. aprillil 2018 harvikravimiks.
English: What benefits of Polivy have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Polivy kasulikkus?
English: Half of the patients received Polivy added to the standard regimen of bendamustine plus rituximab whereas the other half received bendamustine plus rituximab alone.
Estonian: Pooled patsientidest said Polivyt lisaks tavapärasele ravile bendamustiini ja rituksimaabiga, teised said ainult bendamustiini ja rituksimaabi.
English: An overview of Polivy and why it is authorised in the EU
Estonian: Ülevaade ravimist Polivy ja ELis müügiloa väljastamise põhjendus
English: Polivy can only be obtained with a prescription, and treatment must be given under the supervision of a healthcare professional experienced in the diagnosis and treatment of cancer.
Estonian: Ravi peab toimuma vähi diagnoosimises ja ravis kogenud arsti järelevalve all.
English: The monoclonal antibody attaches to a protein called CD79b on B cells, including cancerous B cells, and in doing so causes MMAE to be released inside them.
Estonian: (CD79b) ja see põhjustab monometüülauristatiini E vabanemise nende sees.
English: Polivy contains the active substance polatuzumab vedotin.
Estonian: Polivy sisaldab toimeainena polatuzumabvedotiini.
English: This was confirmed in the fourth study.
Estonian: Seda kinnitas ka neljas uuring.
English: The marketing authorisation was renewed on 14 February 2001 and on 14 February 2006.
Estonian: Müügiluba pikendati 14. veebruaril 2001 ja 14. veebruaril 2006.
English: The marketing authorisation holder is Orion Corporation.
Estonian: Müügiloa hoidja on Orion Corporation.
English: This summary was last updated in 03-2009.
Estonian: Kokkuvõtte viimane uuendus: 03-2009.
English: It is available as white, round tablets (60 mg).
Estonian: Seda turustatakse valgete ümmarguste tablettidena (60 mg).
English: A list of these medicines is given in the Package Leaflet.
Estonian: Selliste ravimite täielik loetelu on pakendi infolehel.
English: The recommended dose of Fareston is one tablet once a day.
Estonian: Farestoni soovitatav annus on üks tablett üks kord päevas.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fareston on 14 February 1996.
Estonian: Euroopa Komisjon andis Farestoni müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 14. veebruaril 1996.
English: As a result, the tumour cells are not stimulated to grow by oestrogen and the growth of the tumour is reduced.
Estonian: Selle tulemusena ei stimuleeri östrogeen kasvajarakkude kasvu ja kasvaja kasv väheneb.
English: The Committee recommended that Fareston be given marketing authorisation.
Estonian: Komitee soovitas anda Farestonile müügiloa.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FARESTON EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE FARESTON Kokkuvõte üldsusele
English: The effectiveness of Fareston and tamoxifen were equivalent.
Estonian: Farestoni ja tamoksifeeni efektiivsus oli samasugune.
English: The most common side effects with Fareston (seen in more than 1 patient in 10) are hot flushes and sweating.
Estonian: Farestoni kõige sagedamad kõrvalnähud (esinenud enam kui ühel patsiendil kümnest) on kuumahood ja higistamine.
English: Fareston is a medicine that contains the active substance toremifene.
Estonian: Fareston on ravim, mis sisaldab toimeainena toremifeeni.
English: It attaches to the receptors for oestrogen on the surface of cells, where its main effect is to block the effects of the hormone.
Estonian: See kinnitub rakkude pinnal olevatele östrogeeniretseptoritele, kus selle põhiline toime seisneb hormooni toime blokeerimises.
English: Fareston must not be used in patients with ‘QT prolongation' (a disruption of the electrical activity of the heart), electrolyte disturbances (altered levels of salts in the blood) especially hypokalaemia (low potassium levels), bradycardia (a very slow heart rate), heart failure (an inability of the heart to pump enough blood to the rest of the body) or a history of symptomatic arrhythmias (abnormal heart rhythms), or in patients also taking other medicines that can cause QT prolongation.
Estonian: Farestoni ei tohi kasutada patsiendid, kellel on pikenenud QT-intervall (südame elektrilise talitluse teatud häire), elektrolüütide tasakaalu häired (soolade ebatavaline sisaldus veres), eelkõige hüpokaleemia (kaaliumi väike sisaldus veres), bradükardia (südameaeglus), südamepuudulikkus (süda ei suuda pumbata organismi piisaval hulgal verd) või kellel on olnud sümptomaatilist arütmiat (südame rütmihäireid), samuti patsiendid, kes võtavad muid ravimeid, mis võivad pikendada QTintervalli.
English: Other information about Fareston:
Estonian: Muu teave Farestoni kohta
English: It should be used with caution in patients who have problems with their liver.
Estonian: Ravimi kasutamisel maksaprobleemidega patsientidel peab olema ettevaatlik.
English: The main measures of effectiveness were response rate (the number of patients whose tumours responded to treatment), time to progression (the length of time until the disease got worse) and survival.
Estonian: Efektiivsust mõõdeti põhiliselt ravivastusega patsientide osakaalu (patsientide arv, kelle kasvaja allus ravile), progresseerumiseni (haiguse süvenemiseni) kulunud aja ja elulemuse järgi.
English: Looking at the results of the three largest main studies taken together, patients taking Fareston had similar response rates, times to progression and survival rates as the patients taking tamoxifen.
Estonian: Kolme suurima põhiuuringu tulemuste kokkuvõttes olid Farestoni kasutanud patsientidel ravivastuse määrad, progresseerumiseni kulunud aeg ja elulemus sarnased kui tamoksifeeni kasutanud patsientidel.
English: The active substance in Fareston, toremifene, is an anti-oestrogen.
Estonian: Farestoni toimeaine toremifeen on antiöstrogeen.
English: Most types of breast cancer grow in response to the hormone oestrogen.
Estonian: Enamik rinnavähi vorme kasvab hormoon östrogeeni toimel.
English: Why has Fareston been approved?
Estonian: Miks Fareston heaks kiideti?
English: Fareston should not be used in people who may be hypersensitive (allergic) to toremifene or any of the other ingredients.
Estonian: Farestoni ei tohi kasutada patsiendid, kes võivad olla toremifeeni või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: What is Fareston?
Estonian: Mis on Fareston?