FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients who have mild to moderately reduced liver function lower starting doses are recommended.
Estonian: Maksa kerge kuni mõõduka talitlushäirega patsientidel soovitatakse kasutada väiksemat algannust.
English: The doctor may increase the dose depending on the patient's response but the daily dose should not be higher than 24 mg buprenorphine.
Estonian: Sõltuvalt patsiendi ravivastusest võib arst annust suurendada, kuid maksimumannus ei tohi ületada
English: This is because, when injected, naloxone counteracts the effects of opioids, causing the patient to experience acute withdrawal symptoms.
Estonian: Naloksooni lisamine aitab väärtarvitust ennetada, sest süstimisel on naloksoonil opioididele vastupidine toime, mis tekitab patsiendil ägedaid võõrutussümptomeid.
English: What benefit has Suboxone shown during the studies?
Estonian: Milles seisneb uuringute põhjal Suboxone kasulikkus?
English: The craving score, which was between 62.4 and 65.6 before treatment, decreased at the end of the study to 29.8 with Suboxone, compared with 55.1 with placebo.
Estonian: Suboxone-rühmas oli see uuringu lõpus 29,8 ja platseeborühmas 55,1.
English: What is Suboxone used for?
Estonian: Milleks Suboxonet kasutatakse?
English: How is Suboxone used?
Estonian: Kuidas Suboxonet kasutatakse?
English: How does Suboxone work?
Estonian: Kuidas Suboxone toimib?
English: How has Suboxone been studied?
Estonian: Kuidas Suboxonet uuriti?
English: The marketing authorisation was renewed on 22 September 2003 and on 22 September 2008.
Estonian: Müügiluba pikendati 22. septembril 2003 ja 22. septembril 2008.
English: The Committee recommended that Comtan be given marketing authorisation.
Estonian: Komitee soovitas anda Comtanile müügiloa.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Comtan to Novartis Europharm Limited on 22 September 1998.
Estonian: Euroopa Komisjon väljastas Comtani müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Novartis Europharm Limited 22. septembril 1998.
English: Comtan should not be used in patients with:
Estonian: Comtanit ei tohi kasutada ka patsientidel, kellel on:
English: Comtan was more effective than placebo in both studies.
Estonian: Comtan oli mõlemas uuringus platseebost efektiivsem.
English: Other information about Comtan:
Estonian: Muu teave Comtani kohta
English: What is Comtan?
Estonian: Mis on Comtan?
English: In the first study, adding Comtan increased the ‘on' time by 1 hour and 18 minutes more than adding placebo.
Estonian: Esimeses uuringus pikendas Comtani lisamine on-seisundi kestust 1 tund ja 18 minutit rohkem kui platseebo lisamine.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) COMTAN EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE COMTAN Kokkuvõte üldsusele
English: Comtan is a medicine that contains the active substance entacapone.
Estonian: Comtan on ravim, mis sisaldab toimeainena entakapooni.
English: What is the risk associated with Comtan?
Estonian: Mis riskid Comtaniga kaasnevad?
English: Comtan is used to treat patients with Parkinson's disease.
Estonian: Comtanit kasutatakse Parkinsoni tõvega patsientide raviks.
English: Why has Comtan been approved?
Estonian: Miks Comtan heaks kiideti?
English: Comtan is only used in combination either with levodopa and benserazide or with levodopa and carbidopa.
Estonian: Comtanit kasutatakse ainult koos kas levodopa ja benserasiidi või levodopa ja karbidopaga.
English: Comtan is used when these fluctuations cannot be treated with the standard levodopacontaining combination alone.
Estonian: Comtanit kasutatakse siis, kui neid kõikumisi ei saa ravida üksnes tavapärase levodopat sisaldava ravimikombinatsiooniga.
English: Comtan should not be used together with other medicines that belong to the group ‘monoamine oxidase inhibitors' (a type of antidepressant).
Estonian: Comtanit ei tohi kasutada koos teiste monoaminooksüdaasi inhibiitorite (antidepressantide liik) rühma kuuluvate ravimitega.
English: Comtan should not be used in people who may be hypersensitive (allergic) to entacapone or any of the other ingredients.
Estonian: Comtanit ei tohi kasutada patsiendid, kes võivad olla entakapooni või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: When patients first add Comtan to their exiting medication, they may need to take a lower daily dose of levodopa, either by changing how often they take it, or by reducing the amount of levodopa taken in each dose.
Estonian: Comtani lisamisel patsiendi olemasolevale ravile võib alguses osutuda vajalikuks kasutada väiksemat levodopa päevaannust, kas muutes levodopa manustamise sagedust või vähendades iga annusega võetavat kogust.
English: The active substance in Comtan, entacapone, works to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Estonian: Comtani toimeaine entakapooni toimel taastub dopamiini sisaldus aju osades, mis juhivad liigutusi ja koordinatsiooni.
English: For the full list of all side effects reported with Comtan, see the Package Leaflet.
Estonian: Comtani kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Comtan's benefits are greater than its risks as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Estonian: Inimravimite komitee jõudis otsusele, et Comtani kasulikkus selle kasutamisel tavapäraste preparaatide levodopa/benserasiidi või levodopa/karbidopa täiendamiseks Parkinsoni tõvega ja annuse lõpu motoorsete kõikumistega patsientidel, keda ei saa nende ravimikombinatsioonidega stabiliseerida, on suurem kui ravimiga kaasnevad riskid.
English: Comtan has been studied in a total of 376 patients with Parkinson's disease, in two six-month studies that measured the effects of adding Comtan or placebo (a dummy medicine) to the patient's combination of levodopa and carbidopa or levodopa and benserazide.
Estonian: Comtani kasutamist uuriti kokku 376-l Parkinsoni tõvega patsiendil kahes kuuekuulises uuringus, milles hinnati Comtani või platseebo (näiva ravimi) toimet nende lisamisel patsiendi olemasolevale ravimikombinatsioonile - kas levodopa koos karbidopaga või levodopa koos benserasiidiga.
English: The most common side effects with Comtan (seen in between 1 and 10 patients in 100) are dyskinesia (uncontrollable movements), nausea (feeling sick) and harmless urine discoloration.
Estonian: Kõige sagedamad kõrvalnähud Comtani kasutamisel (täheldatud ühel kuni kümnel patsiendil sajast) on düskineesia (tahtele allumatud liigutused), iiveldus ja uriini kahjutu värvimuutus.
English: Comtan is used together with levodopa (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patient is having ‘fluctuations' towards the end of the period between two doses of their medication.
Estonian: Comtanit kasutatakse koos levodopaga (kas levodopa ja benserasiidi kombinatsioon või levodopa ja karbidopa kombinatsioon), kui patsiendil esineb haigustunnuste kõikumisi ravimiannuste toime lõpus.
English: Comtan can only be used with conventional combinations of levodopa.
Estonian: Comtanit võib kasutada ainult koos levodopa tavapäraste kombinatsioonidega.
English: How does Comtan work?
Estonian: Kuidas Comtan toimib?
English: What benefit has Comtan shown during the studies?
Estonian: Milles seisneb uuringute põhjal Comtani kasulikkus?
English: The full EPAR for Comtan is available here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Comtani kohta leiate siit.
English: In the second study, the ‘on' time was increased by 35 minutes compared with placebo.
Estonian: Teises uuringus pikenes onseisundi kestus platseeboga võrreldes 35 minutit.
English: Entacapone blocks an enzyme that is involved in the break down of levodopa in the body called catechol-O-methyl transferase (COMT).
Estonian: Entakapoon blokeerib ensüümi katehhool-Ometüültransferaasi, mis osaleb levodopa lagundamisel kehas.
English: What is Comtan used for?
Estonian: Milleks Comtanit kasutatakse?
English: How has Comtan been studied?
Estonian: Kuidas Comtanit uuriti?
English: How is Comtan used?
Estonian: Kuidas Comtanit kasutatakse?
English: * Antigenic mass ELISA units.
Estonian: * Antigeeni mass ELISA ühikud.
English: - L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000)
Estonian: --1 - L. interrogans serogrupp Canicola serotüüp Portland-vere (tüvi Ca-12-000)
English: - L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
Estonian: - L. kirschneri serogrupp Grippotyphosa sertüüp Dadas (tüvi Gr-01-005
English: EMEA Number
Estonian: EL number
English: - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001)
Estonian: 3550-7100 U* - L. interrogans serogrupp Icterohaemorrhagiae serotüüp Copenhageni (tüvi Ic-02-001) 290-1000 U* - L. interrogans serogrupp Australis serotüüp Bratislava (tüvi As-05-073)
English: List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant in the Member States
Estonian: Ravimi(te) nimetuste, ravimvormi(de), tugevus(t)e, manustamisviisi(de), taotleja loetelu liikmesriikides
English: United Kingdom TEVA Pharma B.V. Computerweg 10,
Estonian: Ühendkuningriik TEVA Pharma B.V.
English: Belgium TEVA Pharma B.V. Computerweg 10,
Estonian: Prantsusmaa TEVA Pharma B.V.
English: Ocular use vial (glass)
Estonian: Okulaarne kasutamine viaal (klaas)
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Estonian: Tugevus Farmatseutiline vorm Manustamistee
English: Immediate Packaging Pack size
Estonian: Vahetu pakend
English: An information package for patients and their carers will also be provided.
Estonian: Samuti antakse teabepakett patsientidele ja nende hooldajatele.
English: Luxturna (voretigene neparvovec)
Estonian: Luxturna (voretigeen-neparvovek)
English: What measures are being taken to ensure the safe and effective use of Luxturna?
Estonian: Mis meetmed võetakse, et tagada Luxturna ohutu ja efektiivne kasutamine?
English: Therefore, the European Medicines Agency decided that Luxturna's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Seetõttu otsustas Euroopa Ravimiamet, et Luxturna kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: What is Luxturna and what is it used for?
Estonian: Mis on Luxturna ja milleks seda kasutatakse?
English: The improvement in patients' vision was maintained for at least three years.
Estonian: Patsientidel säilis paranenud nägemine vähemalt 3 aastat.
English: The type of virus used in this medicine (adeno-associated virus) does not cause disease in humans.
Estonian: Ravimis kasutatav viirustüüp (adenoviirusega seotud viirus) ei põhjusta inimese haigestumist.
English: Luxturna will only be available from centres where the educational programme is in place.
Estonian: Luxturnat tohib kasutada üksnes keskustes, kus see koolitusprogramm on kasutusel.
English: Other information about Luxturna
Estonian: Muu teave Luxturna kohta
English: This was considered an important clinical benefit, taking into account the lack of authorised treatments for this progressive, degenerative condition.
Estonian: Seda peetakse oluliseks kliiniliseks eeliseks, arvestades selle progresseeruva degeneratiivse seisundi raviks heakskiidetud ravimeetodite puudumist.
English: The safety of Luxturna was considered acceptable and side effects manageable.
Estonian: Luxturna ohutust peeti vastuvõetavaks ja kõrvalnähte hallatavateks.
English: As for all medicines, data on the use of Luxturna are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Luxturna kasutamise kohta pidevat järelevalvet.
English: The second eye should be treated at least 6 days after the first.
Estonian: Teise silma süstitakse ravimit vähemalt 6 päeva pärast esimesse silma süstimist.
English: This helps the cells in the retina to function better, slowing down the progression of the disease.
Estonian: See soodustab võrkkesta rakkude paremat toimimist ning aeglustab haiguse progresseerumist.
English: In addition, the company will have to follow-up all patients who received Luxturna in the main studies for 15 years, in order to characterise the long-term effectiveness and safety of the medicine, and establish a registry to collect long-term safety data in patients treated with Luxturna.
Estonian: Lisaks peab turustaja jälgima 15 aastat põhiuuringus kõiki Luxturnat saanud patsiente, et kirjeldada ravimi pikaajalist efektiivsust ja ohutust, ning koostama patsiendiregistri, et koguda Luxturnaga ravitud patsientide pikaajalise ohutuse andmeid.
English: Luxturna must not be used in patients with eye infection or inflammation.
Estonian: Luxturnat ei tohi kasutada patsientidel, kellel esineb silmainfektsioon või silmapõletik.
English: Patients should start receiving immunosuppressant medicines (medicines that reduce the activity of the immune system, the body's natural defences) 3 days before Luxturna is injected into the first eye, to lower the risk of the medicine being rejected by the body, and this treatment should continue for 14 days after injection.
Estonian: Patsiendid peavad alustama ravi immunosupressantidega (ravimid, mis vähendavad immuunsüsteemi - organismi looduslike kaitsemehhanismide - aktiivsust) 3 päeva enne Luxturna süstimist esimesse silma, et vähendada ravimi äratõuke riski organismis, ning ravi tuleb jätkata 14 päeva pärast süstimist.
English: Further information on Luxturna can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/luxturna.
Estonian: Lisateave Luxturna kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/luxturna.
English: Further information on the orphan designations can be found on the European Medicines Agency's website ema.europa.eu/medicines/human/orphandesignations.
Estonian: Lisateave harvikravimiks nimetatud ravimi kohta on leitav Euroopa Ravimiameti veebilehel: ema.europa.eu/medicines/human/orphan-designations.
English: The main measure of effectiveness was how well patients performed in a mobility test, where they were required to navigate a route with turns and obstacles under various light settings.
Estonian: Efektiivsuse põhinäitaja oli see, kui hästi sooritasid patsiendid liikumiskatse, milles neil paluti liikuda pöörete ja takistustega teel mitmesugustes valgustingimustes.
English: The company that markets Luxturna will set up an educational programme and prepare educational material aimed at doctors and pharmacists expected to use and handle Luxturna, in order to ensure the correct use of the medicine and minimise the risks associated with the medicine and its administration.
Estonian: Luxturna turustaja koostab koolitusprogrammi ning koostab koolitusmaterjalid arstidele ja apteekritele, kes eeldatavasti kasutavad ja käsitsevad Luxturnat, et tagada ravimi õige kasutamine ja minimeerida ravimi ja selle manustamisega seotud riske.
English: Side effects reported with Luxturna are carefully evaluated and any necessary action taken to protect patients.
Estonian: Luxturna kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Patients were considered to have passed the test if they completed the route within 3 minutes and bumped into no more than 3 obstacles.
Estonian: Patsiendid loeti katse läbinuks, kui nad läbisid katseraja 3 minutiga põrkamata kokku üle kolme takistusega.
English: Inherited retinal dystrophy is rare, and Luxturna was designated an ‘orphan medicine' (a medicine used in rare diseases) for two forms of the disease on various dates (retinitis pigmentosa: 28 July 2015; Leber's congenital amaurosis: 2 April 2012).
Estonian: Pärilik võrkkestadüstroofia esineb harva ja Luxturna nimetati harvikravimiks kahe haigusvormi jaoks eri kuupäevadel (pigmentretiniit: 28. juulil 2015; Leberi kaasasündinud pimedus: 2. aprillil 2012).
English: For more information about using Luxturna, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Luxturna kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: What are the risks associated with Luxturna?
Estonian: Mis riskid Luxturnaga kaasnevad?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Luxturna have also been included in the summary of product characteristics and the package leaflet.
Estonian: Luxturna ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Additionally, 13 of the 21 patients (62%) treated with Luxturna passed the mobility test at the lowest light level of 1 lux (similar to conditions of a poorly lit pavement at night), while none of the patients not given the medicine were able to do so.
Estonian: Lisaks läbisid 13 Luxturnaga ravitud patsienti 21st (62%) liikumiskatse kõige väiksema valgustatusega - valgustihedusel 1 luks (ligikaudu sama kui hämar tee öösel).
English: Luxturna can only be used while patients still have enough functioning cells left in the retina and when the disease is caused by mutations (changes) in the gene RPE65.
Estonian: Luxturnat tohib kasutada üksnes ajal, kui patsiendi võrkkestas on järel veel piisavalt toimivaid rakke ja kui haigust põhjustavad mutatsioonid (muutused) RPE65 geenis.
English: How is Luxturna used?
Estonian: Kuidas Luxturnat kasutatakse?
English: The most common side effects with Luxturna (which may affect more than 1 in 20 people) are conjunctival hyperaemia (increased blood supply to the eye, leading to redness of the eye), cataract (clouding of the lens of the eye) and increased pressure inside the eye. For the full list of side effects of Luxturna, see the package leaflet.
Estonian: Luxturna kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 20st) on sidekesta hüpereemia (silma suurenenud verevarustus, mis põhjustab silma punetust), kae (silmaläätse hägustumine) ja silma suurenenud siserõhk.
English: When Luxturna is injected into the eye the virus carries the RPE65 gene into the retinal cells and enables them to produce the missing enzyme.
Estonian: Kui Luxturnat süstitakse silma, kannab viirus RPE65 geeni võrkkesta rakkudesse, mis võimaldab neil toota puuduvat ensüümi.
English: Luxturna is a medicine that is used to treat adults and children with loss of vision due to inherited retinal dystrophy, a rare genetic disorder of the retina (the light sensitive membrane at the back of the eye).
Estonian: Luxturna on ravim, mida kasutatakse täiskasvanutel ja lastel, kellel on tekkinud nägemislangus päriliku võrkkestadüstroofia tõttu, mis on võrkkesta (valgustundlik membraan silma tagaosas) harvaesinev geneetiline häire.
English: After one year of treatment, patients treated with Luxturna improved their scores by 1.8 points, while patients who were not given Luxturna improved their scores by 0.2 points, meaning that patients treated with Luxturna were able to move better along the route.
Estonian: Pärast üht raviaastat suurenes Luxturnaga ravitud patsientide skoor 1,8 punkti võrra ja Luxturnaga ravimata patsientide skoor paranes 0,2 punkti võrra.
English: Luxturna consists of a virus that contains normal copies of the RPE65 gene.
Estonian: Luxturna sisaldab viirust, milles on RPE65 geeni normaalsed koopiad.
English: Luxturna can only be obtained with a prescription and treatment should be given by a surgeon experienced in performing eye surgery.
Estonian: Luxturna on retseptiravim ja ravi peab alustama silmakirurgias kogenud kirurg.
English: Luxturna was investigated in one main study involving 31 patients with inherited retinal dystrophy due to RPE65 mutations.
Estonian: Luxturnat uuriti põhiuuringus, milles osales 31 patsienti, kellel oli RPE65 mutatsioonide põhjustatud pärilik võrkkestadüstroofia.
English: RPE65 is responsible for the production of an enzyme called all-trans retinyl isomerase, which is necessary for the normal functioning of retinal cells.
Estonian: RPE65 on vajalik ensüümi all-transretinüülisomeraasi tekkeks ning seda ensüümi on vaja võrkkesta rakkude normaalseks talitluseks.
English: Luxturna is given as a single injection into the back of each eye, under the retina.
Estonian: Luxturnat manustatakse ühekordse süstena mõlema silma tagaossa võrkkesta alla.
English: Luxturna has been shown to improve patients' vision and ability to move around obstacles, particularly in dim light, and is expected to improve their quality of life.
Estonian: On tõendatud, et Luxturna parandab patsientide nägemist ja suutlikkust mööduda takistustest, eriti hämaras.
English: An overview of Luxturna and why it is authorised in the EU
Estonian: Ülevaade ravimist Luxturna ja ELis müügiloa väljastamise põhjendus
English: How does Luxturna work?
Estonian: Kuidas Luxturna toimib?
English: Luxturna contains the active substance voretigene neparvovec and is a type of advanced therapy medicine called a ‘gene therapy product'.
Estonian: Luxturna sisaldab toimeainena voretigeen-neparvovekki ja on geeniteraapiaravimite hulka kuuluv uudne ravim.
English: What benefits of Luxturna have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Luxturna kasulikkus?
English: Why is Luxturna authorised in the EU?
Estonian: ELis Luxturnale väljastatud müügiloa põhjendus
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Estonian: Liikmesriigi pädev asutus võib ravimiteavet kaasajastada vastavalt vajadusele koostöös viidatava liikmesriigiga vastavalt protseduurile, mis on kehtestatud direktiivi 2001/83/EÜ III jaotise 4. peatükis.
English: OTHER SPECIAL WARNING(S):
Estonian: TEISED ERIHOIATUSED (VAJADUSEL)
English: Annex III Amendments to relevant sections of the Product Information
Estonian: Lisa III Muudatused, mis tuleb sisse viia ravimiteabe asjakohastes lõikudes
English: MAHs of HES solution for infusion should amend the product information (insertion, replacement or deletion of the text, as appropriate) to reflect the wording as provided below, and in conjunction to the Scientific conclusions:
Estonian: HES infusioonilahuse müügiloa hoidja peab tegema muudatused ravimiteabes (teksti sisestamine, asendamine või kustutamine vastavalt vajadusele), et see vastaks allpool esitatud sõnastusele ja oleks kooskõlas teaduslike järeldustega:
English: These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Estonian: Need muudatused ravimi omaduste kokkuvõtte ja pakendi infolehe asjakohastes lõikudes on koostatud esildismenetluse tulemusel.
English: See situations in which this product should never be used in section 2.
Estonian: Vt lõigust 2 teavet olukordade kohta, kui selle preparaadi kasutamine on keelatud.
English: [This statement below should be strongly emphasised (e.g. capitalized, bold letters or use of colours), the visual details of the warning on the outer and immediate packaging should be agreed with NCAs and be subject to a user test taking into account the "Guideline on the Readability of the labelling and package leaflet on medicinal products for human use" within 1 month from the Commission Decision.]
Estonian: Välis- ja sisepakendil oleva hoiatuse visuaalsed detailid peavad olema kooskõlastatud riiklikus pädevas asutuses ja läbinud tarbijakatsetused, võttes arvesse „Inimtervishoius kasutatava ravimi märgistust ja pakendi infolehe loetavust käsitlevaid suuniseid“, ühe kuu jooksul pärast komisjoni otsust.]
English: PACKAGE LEAFLET [This statement below should be added in a black box at the top of the package leaflet.]
Estonian: PAKENDI INFOLEHT [Alljärgnev tekst tuleb lisada mustas raamis pakendi infolehe päisesse.]