FrancophonIA/ELRC3.0 huggingface dataset:
English: Attacks of gout can still occur during the first few months of treatment, so it is recommended that patients take other medicines to prevent attacks of gout for at least the first six months of treatment with Febuxostat Mylan.
Estonian: Ravi esimestel kuudel võib veel tekkida podagrahooge, seega on patsientidel soovitatav kasutada vähemalt ravi esimese kuue kuu jooksul podagrahoogude ennetamiseks lisaks ravimile Febuxostat Mylan ka teisi ravimeid.
English: As for every medicine, the company provided studies on the quality of Febuxostat Mylan.
Estonian: Nagu iga ravimi korral, esitas ettevõte uuringud ravimi Febuxostat Mylan kvaliteedi kohta.
English: This can reduce the symptoms of gout.
Estonian: See võib leevendada podagrasümptomeid.
English: What is Febuxostat Mylan and what is it used for?
Estonian: Mis on Febuxostat Mylan ja milleks seda kasutatakse?
English: Febuxostat Mylan febuxostat
Estonian: Febuxostat Mylan febuksostaat
English: This usually reduces blood uric acid levels within two weeks, but the dose can be increased to 120 mg once a day if blood uric acid levels remain high (above 6 mg per decilitre) after two to four weeks.
Estonian: Tavaliselt vähendab Febuxostat Mylan vere kusihappesisaldust kahe nädalaga, ent kui vere kusihappesisaldus on kahe kuni nelja nädala pärast endiselt suur (üle 6 mg/dl), võib annust suurendada 120 mg-ni üks kord ööpäevas.
English: This is a summary of the European public assessment report (EPAR) for Febuxostat Mylan.
Estonian: See on ravimi Febuxostat Mylan Euroopa avaliku hindamisaruande kokkuvõte.
English: This means that Febuxostat Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Adenuric.
Estonian: See tähendab, et Febuxostat Mylan sisaldab sama toimeainet ja toimib samal viisil kui võrdlusravim Adenuric, millel juba on Euroopa Liidus müügiluba.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Febuxostat Mylan has been shown to have comparable quality and to be bioequivalent to Adenuric.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Febuxostat Mylan võrreldav kvaliteet ja bioekvivalentsus ravimiga Adenuric.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Adenuric, and do not need to be repeated for Febuxostat Mylan.
Estonian: Võrdlusravimiga Adenuric on juba tehtud toimeaine heakskiidetud kasutusviiside kasulikkuse ja riski uuringud ning neid ei ole vaja ravimiga Febuxostat Mylan korrata.
English: Because Febuxostat Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Febuxostat Mylan on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: The Committee recommended that Febuxostat Mylan be approved for use in the EU.
Estonian: Komitee soovitas ravimi Febuxostat Mylan kasutamise Euroopa Liidus heaks kiita.
English: In patients who are on chemotherapy a reduction in uric acid levels is expected to reduce the risk of tumour lysis syndrome.
Estonian: Keemiaravi saavatel patsientidel vähendab kusihappesisalduse vähenemine eeldatavalt tuumori lüüsi sündroomi riski.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Febuxostat Mylan have been included in the summary of product characteristics and the package leaflet.
Estonian: Ravimi Febuxostat Mylan ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Febuxostat Mylan is available as tablets (80 and 120 mg) and can only be obtained with a prescription.
Estonian: Febuxostat Mylani turustatakse tablettidena (80 ja 120 mg).
English: For the treatment of long-term hyperuricaemia, the recommended dose of Febuxostat Mylan is 80 mg once a day.
Estonian: Pikaajalise hüperurikeemia ravis on Febuxostat Mylani soovitatav annus 80 mg üks kord ööpäevas.
English: Febuxostat Mylan is also used to treat and prevent high levels of uric acid in the blood in adults with blood cancers who are receiving chemotherapy (medicines to treat cancer) and at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells causing a sudden rise of uric acid in the blood which can cause damage to the kidneys).
Estonian: Ravimit Febuxostat Mylan kasutatakse ka vere suure kusihappesisalduse ravimiseks ja ennetamiseks verevähiga täiskasvanutel, kes saavad keemiaravi (vähiravi) ja kellel on tuumori lüüsi sündroomi risk (vähirakkude lagunemisest tingitud tüsistus, mis põhjustab veres äkki suure kusihappesisalduse, mis võib kahjustada neerusid).
English: For the prevention and treatment of hyperuricaemia in patients undergoing chemotherapy, the recommended dose is 120 mg once a day.
Estonian: Keemiaravi saavate patsientide hüperurikeemia ennetuses ja ravis on soovitatav annus 120 mg üks kord ööpäevas.
English: By reducing the production of uric acid, Febuxostat Mylan can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up.
Estonian: Kusihappe tekke vähendamisega vähendab Febuxostat Mylan vere kusihappesisaldust ja hoiab selle väiksena, peatades kristallide kogunemise.
English: Febuxostat Mylan is used in patients who have signs of a build-up of crystals, including gouty arthritis (pain and inflammation in the joints) or tophi (‘stones', larger deposits of urate crystals that can cause joint and bone damage).
Estonian: Ravimit Febuxostat Mylan kasutatakse patsientidel, kellel on juba tekkinud kristallide kogunemise nähud, sealhulgas podagraartriit (liigesevalu ja -põletik) või podagrasõlmed (nn kivid ehk suuremad uraadikristallide ladestused, mis võivad kahjustada liigeseid ja luid).
English: Hyperuricaemia can lead to urate crystals forming and building up in the joints and the kidneys.
Estonian: Hüperurikeemia korral võivad moodustuda ja koguneda liigestesse ja neerudesse uraadikristallid.
English: Febuxostat Mylan contains the active substance febuxostat and is a ‘generic medicine'.
Estonian: Febuxostat Mylan sisaldab toimeainena febuksostaati ja on geneeriline ravim.
English: For practical information about using Febuxostat Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Febuxostat Mylani kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: For more information about treatment with Febuxostat Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate ravimiga Febuxostat Mylan toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Keeping uric acid levels low for long enough can also shrink tophi.
Estonian: Kusihappesisalduse väiksena hoidmine piisavalt pika aja jooksul aitab ka podagrasõlmi vähendada.
English: When this happens in the joints and causes pain, it is known as ‘gout'.
Estonian: Kui see tekitab liigestes valu, on tegu podagraga.
English: Why is Febuxostat Mylan approved?
Estonian: Miks Febuxostat Mylan heaks kiideti?
English: It is not intended to provide practical advice on how to use Febuxostat Mylan.
Estonian: Hindamisaruandes ei anta ravimi Febuxostat Mylan kasutamise praktilisi nõuandeid.
English: Febuxostat Mylan treatment should not be stopped if an attack of gout occurs.
Estonian: Ravi Febuxostat Mylaniga ei tohi podagrahoo tekkimisel katkestada.
English: Therefore, the CHMP's view was that, as for Adenuric, the benefit outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu ka Adenurici korral, ületab ravimi Febuxostat Mylan kasulikkus sellega kaasnevad riskid.
English: It works by blocking an enzyme called xanthine oxidase, which is needed to make uric acid in the body.
Estonian: Selle toime seisneb kusihappe tekkeks vajaliku ensüümi ksantiinoksüdaasi blokeerimises.
English: Febuxostat Mylan is a medicine used to treat adults with long-term hyperuricaemia (high levels of uric acid or ‘urate' in the blood).
Estonian: Ravimit Febuxostat Mylan kasutatakse kroonilise (pikaajalise) hüperurikeemia (suur kusihappesisaldus veres) raviks täiskasvanutel.
English: Other information about Febuxostat Mylan
Estonian: Muu teave ravimi Febuxostat Mylan kohta
English: How does Febuxostat Mylan work?
Estonian: Kuidas Febuxostat Mylan toimib?
English: How is Febuxostat Mylan used?
Estonian: Kuidas ravimit Febuxostat Mylan kasutatakse?
English: How has Febuxostat Mylan been studied?
Estonian: Kuidas ravimit Febuxostat Mylan uuriti?
English: What are the benefits and risks of Febuxostat Mylan?
Estonian: Milles seisneb ravimi Febuxostat Mylan kasulikkus ja mis riskid ravimiga kaasnevad?
English: The active substance in Febuxostat Mylan, febuxostat, reduces the formation of uric acid.
Estonian: Ravimi Febuxostat Mylan toimeaine febuksostaat vähendab kusihappe teket.
English: MA (EU) number (Invented) name
Estonian: (Väljamõeldud ) nimetus
English: Jetrea ocriplasmin
Estonian: Jetrea okriplasmiin
English: What measures are being taken to ensure the safe and effective use of Jetrea?
Estonian: Mis meetmeid võetakse, et tagada Jetrea ohutu ja efektiivne kasutamine?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Jetrea on 13 March 2013.
Estonian: Euroopa Komisjon andis Jetrea müügiloa, mis kehtib kogu Euroopa Liidus, 13. märtsil 2013.
English: Other information about Jetrea
Estonian: Muu teave Jetrea kohta
English: The full EPAR for Jetrea can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Jetrea kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: After 28 days, the results were that adhesions had cleared in 25% and 28% of patients who were given Jetrea injection (61 out of 219 and 62 out of 245), compared with 13% and 6% of those who received placebo (14 out of 107 and 5 out of 81).
Estonian: Pärast 28 päeva olid liited kadunud vastavalt 25%-l ja 28%-l patsientidest, kellele süstiti Jetreat (61 patsienti 219-st ja 62 patsienti 245-st), võrreldes 13% ja 6%-ga patsientidest, kellele süstiti platseebot (14 patsienti 107-st ja 5 patsienti 81-st).
English: The procedure should be carried out under sterile conditions.
Estonian: Süstima peab steriilsetes tingimustes.
English: What is Jetrea and what is it used for?
Estonian: Mis on Jetrea ja milleks seda kasutatakse?
English: Why is Jetrea approved?
Estonian: Miks Jetrea heaks kiideti?
English: Although the effects shown were modest (resolution of vitreomacular adhesion in a quarter of patients), they were considered to be significant as treatment may improve vision and prevent the need for surgery.
Estonian: Kuigi ravimi efektiivsus oli mõõdukas (vitreomakulaarne adhesioon kadus ligikaudu veerandil patsientidest), peeti seda siiski oluliseks, sest see raviviis võib aidata parandada nägemist ja ära hoida operatsiooni vajaduse.
English: It is not intended to provide practical advice on how to use Jetrea.
Estonian: Hindamisaruandes ei anta Jetrea kasutamise praktilisi nõuandeid.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Jetrea outweigh its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Jetrea kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: In two main studies involving 652 adults with vitreomacular adhesion and decreased vision, patients were given a single intravitreal injection of 0.125 mg Jetrea or a placebo injection (a dummy treatment).
Estonian: Kahes põhiuuringus, milles osales 652 vitreomakulaarse adhesiooni ja nägemise halvenemisega täiskasvanut, tehti patsientidele üks 0,125 mg Jetreat või platseebot (näiv ravim) sisaldav intravitreaalne süst.
English: What are the risks associated with Jetrea?
Estonian: Mis riskid Jetreaga kaasnevad?
English: This is a summary of the European public assessment report (EPAR) for Jetrea.
Estonian: See on ravimi Jetrea Euroopa avaliku hindamisaruande kokkuvõte.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jetrea have also been included in the summary of product characteristics and the package leaflet.
Estonian: Jetrea ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: The most common side effects are vitreous floaters (small, often irregular, dark shapes in the field of vision), eye pain, photopsia (flashes of light in the field of vision) and chromatopsia (changes in colour perception), as well as conjunctival haemorrhage (bleeding of the membrane that lies over the white part of the eye).
Estonian: Kõige sagedamad kõrvalnähud on klaaskeha hõljumid (väikesed, enamasti ebaregulaarse kujuga tumedad kujundid nägemisväljas), silmavalu, fotopsia (valgussähvatused nägemisväljas), kromatopsia (muutused värvide tajumises) ning sidekesta (silma eesosa) verejooks.
English: The company that markets Jetrea must ensure that all healthcare professionals who are expected to use Jetrea receive the summary of product characteristics for the medicine as well as an information pack to be given to patients.
Estonian: Jetrea tootja tagab kõigile tervishoiutöötajatele, kes Jetreat eeldatavalt kasutavad, ravimi omaduste kokkuvõtte ja teabepakme patsientidele.
English: It contains the active substance ocriplasmin.
Estonian: Ravim sisaldab toimeainena okriplasmiini.
English: The risk of more serious side effects such as decreased vision that is non-reversible, other changes to the retinal function or supporting structures of the lens appear to be small.
Estonian: Raskemate kõrvalnähtude, nagu nägemise pöördumatu halvenemise, võrkkesta funktsiooni või läätse tugistruktuuride muutuste tekkerisk on väike.
English: Regarding its safety, the most common side effects were short-lived and considered manageable, and often occurred as a response to the injection procedure or were linked to the resolution of the disease itself.
Estonian: Ravimi ohutuse osas olid sagedamad kõrvalnähud lühiaegsed ja kontrollitavad ning tekkisid pigem süstimisprotseduuri või haiguse taandumise tõttu.
English: The side effects seen with Jetrea affect the eye.
Estonian: Jetrea kõrvalnähud on seotud silmaga.
English: Studies have shown that Jetrea was effective in treating vitreomacular adhesion and it is therefore expected to be effective in preventing worsening of vision which may occur with untreated and progressive vitreomacular traction.
Estonian: Uuringud näitasid, et Jetrea on vitreomakulaarse adhesiooni ravis efektiivne, ja seetõttu eeldatakse, et Jetrea aitab edukalt ennetada nägemise halvenemist, mis võib esineda ravimata ja progresseeruva vitreomakulaarse traktsiooni korral.
English: The other eye should not be treated with Jetrea for at least 7 days.
Estonian: Teise silma võib ravimit süstida mitte varem kui 7 päeva pärast.
English: For more information about treatment with Jetrea, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Jetreaga 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 Jetrea, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Jetrea kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Jetrea must not be used in patients who have or are thought to have infections in or around the eyes.
Estonian: Jetreat ei tohi kasutada patsiendid, kellel on silma- või silmakudede infektsioonid või selliste infektsioonide kahtlus.
English: The recommended dose is 0.125 mg given as a single injection into the affected eye which should not be repeated.
Estonian: Jetrea soovitatav annus on 0,125 mg, mis manustatakse ühekordse süstina haigesse silma.
English: How is Jetrea used?
Estonian: Kuidas Jetreat kasutatakse?
English: Successful treatment of vitreomacular adhesion can help reverse disturbances of the vision caused by vitreomacular traction, and prevent further loss of vision from untreated and progressive traction at the retina.
Estonian: Vitreomakulaarse adhesiooni edukas ravi võib aidata kõrvaldada vitreomakulaarse traktsiooni põhjustatud nägemishäireid ning peatada ravimata ja progresseeruvast võrkkesta traktsioonist tingitud nägemise edasise halvenemise.
English: The ophthalmologist may prescribe antibiotic eye drops before and after treatment with Jetrea to prevent eye infections.
Estonian: Enne ja pärast Jetrea süstimist võib oftalmoloog määrata antibiootilisi silmatilku, et ära hoida silmainfektsioonide teket.
English: Vitreomacular traction is caused by vitreomacular adhesion in which the vitreous humour has an abnormally strong attachment to the central part of the retina (the light sensitive membrane at the back of the eye).
Estonian: Vitreomakulaarse traktsiooni põhjuseks on vitreomakulaarne adhesioon, mille korral on klaaskeha ebanormaalselt tugevasti kinnitunud silma võrkkesta (valgustundlik membraan silma tagaosas) tsentraalse osa külge.
English: For the full list of all side effects reported with Jetrea, see the package leaflet.
Estonian: Jetrea kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: What benefits of Jetrea have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Jetrea kasulikkus?
English: The active substance in Jetrea, ocriplasmin, is similar to human plasmin, a naturally occurring enzyme in the eye which is capable of breaking down proteins between the vitreous humour and the retina which are responsible for the adhesion, thereby reducing retinal swelling and improving vision.
Estonian: Jetrea toimeaine okriplasmiin on sarnane inimese silmas esineva loodusliku ensüümi plasmiiniga, mis lagundab klaaskeha ja võrkkesta ühendavaid valke, vähendades seeläbi võrkkesta turset ja parandades nägemist.
English: It can only be obtained with a prescription and must be given by a qualified ophthalmologist (eye specialist) experienced in intravitreal injections (injections into the vitreous humour, the jelly-like material at the back of the eye).
Estonian: Lahust tohib süstida üksnes kvalifitseeritud oftalmoloog (silmaarst), kellel on intravitreaalsete süstide (silmasisesed süstid ehk süstid silma klaaskehasse) tegemise kogemus.
English: How does Jetrea work?
Estonian: Kuidas Jetrea toimib?
English: Jetrea has been shown in studies to be effective in resolving the adhesion between the vitreous humour and the retina, reducing the need for surgery.
Estonian: Uuringud näitasid, et Jetrea oli efektiivne klaaskeha ja võrkkesta vaheliste liidete lõhustamisel, vähendades sel teel silmaoperatsioonide vajadust.
English: When the vitreous humour shrinks with aging, this strong attachment results in a pulling force on the retina, which causes retinal swelling and leads to blurred or distorted vision.
Estonian: Kui klaaskehavedelik hakkab inimese vananedes vähenema, avaldavad liited võrkkestale tõmmet, mis põhjustab võrkkesta turse koos sellest tingitud ähmase või moonutatud nägemisega.
English: Jetrea is a solution for injection into the eye.
Estonian: Jetrea on retseptiravim.
English: Jetrea is a medicine used to treat adults with vitreomacular traction, an eye disease that can cause severe visual disturbance.
Estonian: Jetrea on ravim, mida kasutatakse täiskasvanutel vitreomakulaarse traktsiooni raviks.
English: 0.10 g/1 g per 100 ml oral solution
Estonian: 0.10 g/1 g/100 ml
English: Member State (in EEA)
Estonian: Liikmesriik (EMP)
English: 4 mg/40 mg tablet
Estonian: 4 mg/40 mg tablett suukaudne
English: Marketing Authorisaton Holder
Estonian: Müügiloa hoidja
English: Pharmaceutical form
Estonian: Ravimvormi
English: (Invented) Name Strength
Estonian: Ravimi (väljamõeldud) nimetus
English: There is no evidence that either short or long term protection has been impacted.
Estonian: Mõju kohta lühi- või pikaajalisele kaitsele tõendid puuduvad.
English: The Committee also noted that the last study performed in infants below one year was completed in 2001.
Estonian: Komitee märkis ka, et viimane uuring alla üheaastaste lastega viidi läbi 2001. aastal.
English: It was considered that a decision will be taken according to the responses given on quality and clinical concerns.
Estonian: Leiti, et otsus võetakse vastu kvaliteedi- ja kliiniliste probleemide kohta saadavate vastuste põhjal.
English: In the past experience, there has never been an instance when high performance in adolescents and young adults did not correspond with high performance in infants.
Estonian: Varasemate kogemuste kohaselt ei ole kunagi juhtunud, et kõrged tulemused noorukitel ja noortel täiskasvanutel poleks olnud vastavuses kõrgete tulemustega väikelastel.
English: Pending the outcome of the studies, the MAH committed to amend the SPC sections 4.2, 4.4, 4.5 (where relevant) and 5.1 as follows:
Estonian: Kuni uuringute tulemuste saamiseni kohustus müügiloa hoidja muutma ravimi omaduste kokkuvõtte lõike 4.2, 4.4, 4.5 (kus see on asjakohane) ja 5.1 järgmiselt:
English: CONCLUSION
Estonian: KOKKUVÕTE
English: Information will be provided to health care professionals and will ensure that the vaccine will be correctly used in the different age and risk categories.
Estonian: Tervishoiutöötajatele esitatakse teavet, mis tagab vaktsiini õige kasutamise erinevates vanuse- ja riskikategooriates.
English: These changes, in principle, address the concerns raised by the CHMP and its Working Parties.
Estonian: Nende muudatustega lahendatakse põhimõtteliselt inimtervishoius kasutatavate ravimite komitee ja selle töörühmade poolt tõstatatud mured.
English: • The need of the 4th dose at 12 months has been reinforced, when the compressed administration schedule 0, 1, 2 and 12 months is used
Estonian: • kinnitati 4. annuse vajalikkust 12. kuul, kui kasutatakse kiirendatud vaktsineerimiskuuri - 0, 1, 2 ja 12 kuud;
English: The reason for decreasing immunogenicity over several years remains still unidentified.
Estonian: Immunogeensuse aastate jooksul vähenemise põhjus ei ole veel teada.
English: Although the root cause for reduced immunogenicity during the past 5 years is still not ascertained, evidence was provided that the manufacturing process seems now to be better controlled.
Estonian: Kuigi immunogeensuse vähenemisele viimase 5 aasta jooksul ei ole algpõhjust leitud, esitati tõendeid selle kohta, et tootmisprotsess näib nüüd olevat paremini kontrolli all.
English: • The use of this vaccine will not pose an immediate risk to any of the target groups the vaccine is indicated for.
Estonian: • Selle vaktsiini kasutamine ei tekita vahetut riski ühelegi sihtrühmale, kellele see vaktsiin on näidustatud.
English: These trials were carried out in different risk groups and age categories, i.e. children born to Hepatitis B positive mothers, infants, healthy young adults and healthy subjects between 16-35 years of age.
Estonian: Need uuringud viidi läbi erinevate riskirühmade ja vanusekategooriatega, s.t B-hepatiidi positiivsetel emadel sündinud laste, väikelaste, tervete noorte täiskasvanute ja 16-35-aastaste tervete uuringus osalejatega.