FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition there were concerns that, since Levonelle is available without prescription in many EU Member States, any new advice issued could lead to medication errors as there may not always be a consultation with a healthcare professional prior to taking the medicine.
Estonian: Lisaks märgiti, et kuna Levonelle on paljudes ELi liikmesriikides müügil ilma retseptita, võivad kõik uued nõuanded põhjustada annustamisvigu, sest enne ravimi võtmist ei peeta alati tervishoiutöötajaga nõu.
English: It is available as a single tablet containing 1500 microgram levonorgestrel or as two tablets each containing 750 microgram levonorgestrel.
Estonian: Ravimit turustatakse ühe tabletina, mis sisaldab 1500 µg levonorgestreeli, või kahe tabletina, mis mõlemad sisaldavad 750 µg levonorgestreeli.
English: Levonelle is an emergency contraceptive used to prevent unintended pregnancy when taken within 72 hours (3 days) of unprotected intercourse or failure of a contraceptive method.
Estonian: Levonelle on erakorraline kontratseptiiv, mida võetakse soovimatu raseduse vältimiseks 72 tunni (3 päeva) jooksul pärast kaitsmata suguühet või kui rasestumisvastane meetod ebaõnnestus.
English: This could mean that the contraceptive effects of Levonelle are reduced.
Estonian: See võib nõrgendada Levonelle kontratseptiivset toimet.
English: On 1 October 2015, the UK referred the matter to the CHMP for arbitration.
Estonian: 1. oktoobril 2015 tegi Ühendkuningriik inimravimite komiteele vahekohtumenetluse esildise.
English: On 26 May 2016, the European Medicines Agency completed a review for the emergency contraceptive Levonelle (levonorgestrel, 1500 microgram tablets) and associated names.
Estonian: 26. mail 2016 lõpetas Euroopa Ravimiamet erakorralise kontratseptiivi Levonelle (levonorgestreel, 1500 µg tabletid) ja sarnaste nimetuste läbivaatamise.
English: The grounds for the referral were concerns from Italy that there are insufficient clinical data to support doubling the dose of Levonelle in cases where the woman is also taking a medicine that interacts with Levonelle.
Estonian: Esildise aluseks olid Itaalia kahtlused, et puuduvad piisavad kliinilised andmed, mis toetaksid Levonelle annuse kahekordistamist juhul, kui naine võtab ravimit, millel on koostoimed Levonellega.
English: Based on data on interactions with these medicines, which all increase the activity of the liver enzyme CYP3A4, as well as data on combined hormonal contraceptives, the CHMP concluded that interactions between these medicines and Levonelle may prevent Levonelle from working effectively and could lead to contraceptive failure.
Estonian: Lähtudes nende ravimitega (mis kõik suurendavad maksaensüümi CYP3A4 aktiivsust) esinevate koostoimete andmetest, samuti kombineeritud hormonaalsete kontratseptiivide andmetest, järeldas inimravimite komitee, et koostoimed nende ravimite ja Levonelle vahel võivad takistada Levonelle õiget toimimist ja põhjustada kontratseptsiooni ebaõnnestumist.
English: Although the Member States agreed that efavirenz interacts with levonorgestrel and that this information should be included in the product information, the Member States were unable to reach an agreement on how this interaction should be managed and whether specific recommendations such as dose adjustment were required for women taking Levonelle while on efavirenz or other medicines which also reduce levonorgestrel levels.
Estonian: Kuigi liikmesriigid nõustusid, et efavirensil esineb koostoime levonorgestreeliga ja et see teave tuleks lisada ravimiteabesse, ei jõudnud liikmesriigid kokkuleppele, kuidas seda koostoimet hallata ja kas naistele, kes võtavad Levonellet ravi ajal efavirensi või teiste ravimitega, mis samuti vähendavad levonorgestreeli sisaldust, tuleks anda konkreetseid soovitusi, näiteks annuse kohandamise kohta.
English: However, when this is not an option, the CHMP considered that doubling the dose of Levonelle from 1500 to 3000 microgram is recommended to compensate for the reduction in blood levonorgestrel levels.
Estonian: Kui see ei ole võimalik, soovitab inimravimite komitee kahekordistada Levonelle annust 1500 µg-lt 3000 µg-le, et kompenseerida levonorgestreeli sisalduse vähenemist veres.
English: Feedback was sought from patients and relevant healthcare professionals to ensure that women could identify when to use a double dose versus a single dose based on the information provided.
Estonian: Patsientidelt ja asjaomastelt tervishoiutöötajatelt küsiti tagasisidet, et olla kindel, et naised oskavad esitatud teabe alusel kindlaks teha, millal kasutada kahekordset annust, mitte ühekordset annust.
English: On 17 September 2014, the company for Levonelle applied for a change to the marketing authorisation to include the HIV medicine efavirenz as an interacting medicine in the product information.
Estonian: 17. septembril 2014 taotles Levonelle ettevõte müügiloa muutmist, et lisada HIV-i ravim efavirens ravimiteabesse koostoimet omava ravimina.
English: No increased risk of side effects is expected from the higher dose.
Estonian: Suurem annus ei suurenda eeldatavalt kõrvalnähtude riski.
English: The European Commission issued an EU-wide legally binding decision to implement the CHMP recommendations on Levonelle on 01/08/2016.
Estonian: Euroopa Komisjon tegi inimravimite komitee Levonellet käsitlevate soovituste alusel 01.08.2016 õiguslikult siduva otsuse, mis kehtib kogu Euroopa Liidus.
English: However, Levonelle should only be used with these medicines when a non-hormonal emergency contraceptive (i.e. a copper intrauterine device) is not an option.
Estonian: Siiski tohib Levonellet kasutada koos nende ravimitega ainult siis, kui mittehormonaalset erakorralist kontratseptiivi (st vaske sisaldavat emakasisest vahendit) ei saa kasutada.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that when Levonelle is taken together with certain interacting medicines (including the HIV medicine efavirenz and ritonavir, certain medicines for tuberculosis and epilepsy and herbal medicines containing St John's wort) the dose of Levonelle should be doubled.
Estonian: Euroopa Ravimiameti inimravimite komitee soovitas, et Levonelle võtmisel koos teatud koostoimivate ravimitega (sealhulgas HIV-i ravim efavirens ja ritonaviir, teatud tuberkuloosi- ja epilepsiaravimid ning naistepuna sisaldavad taimsed ravimid) tuleb Levonelle annust kahekordistada.
English: The CHMP recommended that women who use liver enzyme inducers should instead use a non-hormonal emergency contraceptive (i.e. a copper intrauterine device) which is not affected by liver enzyme inducing medicines.
Estonian: Inimravimite komitee soovitas, et naised, kes kasutavad maksaensüümide indutseerijaid, peaksid kasutama hoopis mittehormonaalset erakorralist kontratseptiivi (st vaske sisaldavat emakasisest vahendit), mida maksaensüüme indutseerivad ravimid ei mõjuta.
English: The application was based on a study that showed that blood levels of levonorgestrel were reduced by
Estonian: Taotlus põhines uuringul, mis näitas, et levonorgestreeli sisaldus veres vähenes ligikaudu 50% võrra naistel, kes võtsid efavirensit.
English: The CHMP noted that the reductions in blood levels of levonorgestrel seen with efavirenz were similar to those seen with other medicines (so-called liver enzyme inducers) that interact with levonorgestrel (including certain medicines for tuberculosis and epilepsy and herbal medicines containing St John's wort).
Estonian: Inimravimite komitee märkis, et efavirens vähendab levonorgestreeli sisaldust veres samamoodi kui teised ravimid (nn maksaensüümide indutseerijad), millel on koostoimed levonorgestreeliga (sealhulgas teatud tuberkuloosi- ja epilepsiaravimid ning naistepuna sisaldavad taimsed ravimid).
English: In order to ensure the correct use of Levonelle, the CHMP also recommended including advice on when to take a double dose on the medicine's outer carton as well as in the package leaflet.
Estonian: Levonelle õige kasutamise tagamiseks soovitas inimravimite komitee samuti lisada ravimi väliskarbile ja pakendi infolehele nõuande, millal võtta kahekordne annus.
English: In order to ensure the correct use of Levonelle, the CHMP recommended including advice on when to take a double dose on the medicine's outer carton as well as in the package leaflet.
Estonian: Levonelle õige kasutamise tagamiseks soovitas inimravimite komitee lisada ravimi väliskarbile ja pakendi infolehele nõuande, millal võtta kahekordne annus.
English: around 50% in women taking efavirenz, which is known to increase the activity of a particular liver enzyme (CYP3A4) which is involved in the breakdown of levonorgestrel.
Estonian: Efavirens suurendab maksaensüümi CYP3A4 aktiivsust, mis osaleb levonorgestreeli lagundamises.
English: EMA/353887/2016
Estonian: Levonelle ja sarnaste nimetuste teave (levonorgestreel, 1500 µg tabletid) EMA/353887/2016
English: The applicant requested a re-examination of the opinion.
Estonian: Taotleja soovis arvamuse taasläbivaatamist.
English: EMA/311892/2014 EMEA/H/C/002546
Estonian: 23. mai 2014 EMA/405459/2014 EMEA/H/C/002546
English: What is Nerventra?
Estonian: Mis on Nerventra?
English: The company that applied for authorisation is Teva Pharma GmbH.
Estonian: Müügiluba taotles Teva Pharma GmbH.
English: If you are taking part in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Estonian: Kui te osalete ravimi kliinilises uuringus ja vajate oma ravi kohta lisateavet, pöörduge palun arsti poole, kes teile ravi määras.
English: The CHMP opinion has no consequences on these trials.
Estonian: Inimravimite komitee arvamus neid uuringuid ei mõjuta.
English: In addition, the Committee was not convinced about the effectiveness of the company's proposed measures to prevent pregnancies in women who would take the medicine.
Estonian: Ka ei olnud komitee veendunud ettevõtte kavandatud rasestumisvastaste meetmete efektiivsuses, mille eesmärk oli vältida ravimit manustavate naiste rasestumist.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 22 May 2014.
Estonian: Pärast taotluse põhjenduste kaalumist vaatas inimravimite komitee oma algse arvamuse uuesti läbi ja kinnitas müügiloa andmisest keeldumist 22. mail 2014.
English: The expert group advised that the risks seen in animal studies could have been acceptable if a clear benefit was seen in clinical studies, although a strict pregnancy prevention scheme would have been required.
Estonian: Eksperdirühm soovitas, et loomuuringutes ilmnenud riskid oleksid vastuvõetavad, kui kliinilistes uuringutes täheldataks selget kasulikkust, kuigi vaja oleks ranget raseduse vältimise kava.
English: Nerventra is a medicine that contains the active substance laquinimod.
Estonian: Nerventra on ravim, mis sisaldab toimeainena lakvinimoodi.
English: What consequences does this refusal have for patients in clinical trials or compassionate use programmes?
Estonian: Kuidas mõjutab keeldumine praegu kliinilistes uuringutes või ravimi eriloa alusel kasutamise programmides osalevaid patsiente?
English: The exact way Nerventra works is not known, but it is believed to have a modulator effect on the immune system (the body's defences).
Estonian: Nerventra täpne toimemehhanism ei ole teada, kuid arvatavasti moduleerib see immuunsüsteemi (organismi kaitsesüsteemi).
English: On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Nerventra, intended for the treatment of multiple sclerosis.
Estonian: 23. jaanuaril 2014 võttis inimravimite komitee vastu negatiivse arvamuse, soovitades hulgiskleroosi (sclerosis multiplex) raviks kasutatava ravimi Nerventa müügiloa andmisest keelduda.
English: Both studies lasted two years and the main measure of effectiveness was based on the reduction in the number of relapses per patient per year (what is known as the ‘annualised relapse rate').
Estonian: Mõlemad uuringud kestsid kaks aastat ning efektiivsuse põhinäitaja aluseks oli patsiendi aastase relapsisageduse vähenemine.
English: Refusal of the marketing authorisation for Nerventra (laquinimod)
Estonian: Nerventra (lakvinimood) müügiloa andmisest keeldumine
English: At the time of the initial recommendation, the CHMP had concerns about results from animal studies showing a higher occurrence of cancers after long-term exposure to the medicine and noted that a similar long-term cancer risk could not be excluded in humans, especially when considering that the way the medicine works in the body is unclear.
Estonian: Esialgse soovituse ajal väljendas inimravimite komitee ettevaatlikkust seoses loomuuringute tulemustega, mis näitasid vähkkasvajate sagenemist pärast pikaajalist kokkupuudet ravimiga, ning märkis, et sarnast pikaajalist vähiriski ei saa välistada ka inimestel, eelkõige seepärast, et ravimi toimemehhanism organismis on ebaselge.
English: The company also provided results of two main studies in patients with relapsing-remitting MS. One of the studies involving 1,106 patients compared Nerventra with placebo (a dummy treatment), while the second study in 1,331 patients compared Nerventra with placebo and another medicine used to treat MS, interferon-beta 1a.
Estonian: Ühes uuringus (1106 patsienti) võrreldi Nerventrat platseeboga (näiv ravim) ning teises uuringus (1331 patsienti) võrreldi Nerventrat platseebo ja beeta-1a-interferooniga (samuti hulgiskleroosi ravim).
English: The CHMP noted that the effect of the medicine in preventing relapses was modest, and though its effect in slowing the worsening of disability was encouraging it still needed to be confirmed.
Estonian: Inimravimite komitee märkis, et ravimi toime relapside ennetamisel oli tagasihoidlik ning kuigi toime puude süvenemise aeglustamisel oli soodsam, on seda vaja veel kinnitada.
English: How is Nerventra expected to work?
Estonian: Milline on Nerventra eeldatav toime?
English: Refusal of the marketing authorisation for Nerventra (laquinimod) EMA/311892/2014
Estonian: Nerventra (lakvinimood) müügiloa andmisest keeldumine EMA/405459/2014
English: Therefore the Committee concluded that the benefits of Nerventra at the dose studied were not sufficient to outweigh the potential risks in patients with relapsing remitting MS and maintained its recommendation that the medicine be refused marketing authorisation.
Estonian: Nendel põhjustel järeldas komitee, et Nerventra kasulikkus uuritud annuses ei olnud piisav, et ületada võimalikke riske hulgiskleroosi relapseeruva-remiteeruva vormiga patsientidel, ning jäi varasema soovituse juurde ravimi müügiloa andmisest keelduda.
English: During the re-examination, the CHMP considered advice from an expert group in neurology.
Estonian: Taasläbivaatamise ajal arutas inimravimite komitee neuroloogia eksperdirühma arvamust.
English: The company informed the CHMP that there are a number of ongoing and planned clinical trials with Nerventra in patients with multiple sclerosis.
Estonian: Ettevõte teatas inimravimite komiteele, et praegu toimub ja kavatsetakse korraldada mitu Nerventra kliinilist uuringut hulgiskleroosiga patsientidel.
English: Nerventra was expected to be used to treat multiple sclerosis (MS), a disease in which the immune system malfunctions, causing inflammation that destroys the protective sheath around the nerves in the brain and spinal cord.
Estonian: Hulgiskleroos (sclerosis multiplex) on haigus, mille korral on immuunsüsteemi talitlus häiritud ja tekib põletik, milles hävib pea- ja seljaaju närve ümbritsev kaitsekest.
English: Nerventra was to be used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Estonian: Nerventrat kavatseti kasutada hulgiskleroosi relapseeruva-remiteeruva vormi raviks (kui patsiendil vahelduvad haiguse ägenemised (relapsid) ja sümptomiteta perioodid (remissioonid)).
English: There was also a possible risk (again from animal studies) of effects on the unborn baby when the medicine is taken by pregnant women.
Estonian: Ühtlasi oli olemas (samuti loomuuringute tulemuste järgi) võimalik lootekahjustuste risk, kui ravimit kasutatakse raseduse ajal.
English: The effects of Nerventra were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Nerventra toimet muude katsetega.
English: The CHMP noted that the risk could not be excluded with current data and that animal studies suggest that some of the harmful effects may be delayed and only seen later on in the child's life.
Estonian: Inimravimite komitee märkis, et praeguste andmete alusel ei saa riski välistada ja loomuuringute järgi võivad kahjulikud toimed avalduda alles hiljem.
English: control the inflammation and the damage to nerves, thus helping to reduce symptoms and the worsening of disability in patients with MS.
Estonian: Immuunsüsteemi moduleerides osaleb see eeldatavasti põletiku ja närvikahjustuste piiramisel, aidates seega leevendada hulgiskleroosiga patsientidel sümptomeid ja puude süvenemist.
English: What was Nerventra expected to be used for?
Estonian: Milleks kavatseti Nerventrat kasutada?
English: EMA/510659/2015
Estonian: Fexeric EMA/510659/2015
English: What is Fexeric and what is it used for?
Estonian: Mis on Fexeric ja milleks seda kasutatakse?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom seejärel eritub organismist väljaheitega.
English: The full EPAR and risk management plan summary for Fexeric 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 Fexerici kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The maximum dose is 12 tablets per day.
Estonian: Suurim annus on 12 tabletti ööpäevas.
English: A risk management plan has been developed to ensure that Fexeric is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Fexerici võimalikult ohutu kasutamine.
English: The overall safety profile was considered acceptable and comparable to other phosphate binders.
Estonian: Üldist ohutusprofiili peeti vastuvõetavaks ja võrreldavaks muude fosfaati
English: Fexeric is available as 1 g tablets.
Estonian: Fexerici turustatakse 1 g tablettidena.
English: Serious side effects were uncommon and mainly affected the gut and stomach.
Estonian: Rasked kõrvalnähud olid väga harvad ning mõjutasid peamiselt soolestikku ja magu.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Fexeric's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Fexerici kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: In the second study, 149 patients who were not on dialysis received either Fexeric or placebo for 3 months.
Estonian: Teises uuringus osales 149 dialüüsi mittesaavat patsienti, kellele anti 3 kuu jooksul kas Fexerici või platseebot.
English: Blood-phosphate levels should be monitored regularly during treatment.
Estonian: Vere fosfaadisisaldust tuleb ravi ajal korrapäraselt jälgida.
English: What are the risks associated with Fexeric?
Estonian: Mis riskid Fexericiga kaasnevad?
English: In addition, the company that markets Fexeric will carry out a study to gain further information on the long-term safety of Fexeric, particularly in older patients.
Estonian: Lisaks viib Fexerici turustav ettevõte läbi uuringu, et saada lisateavet Fexerici pikaajalise ohutuse kohta, eelkõige eakamatel patsientidel.
English: What measures are being taken to ensure the safe and effective use of
Estonian: Mis meetmed võetakse, et tagada Fexerici ohutu ja efektiivne kasutamine?
English: The recommended starting dose is 3 to 6 tablets per day, taken in divided doses together with meals.
Estonian: Selle soovitatav algannus on 3-6 tabletti ööpäevas ning seda tuleb võtta jagatud annustena koos toiduga.
English: Both studies looked at the change in the amount of phosphate in the blood, measured in mg/dl.
Estonian: Mõlemas uuringus hinnati vere fosfaadisisalduse muutust, mõõdetuna väärtuses mg/dl.
English: In the first study, Fexeric was as effective as sevelamer carbonate, an approved medicine, in lowering phosphate levels in 359 patients with long-term kidney disease: after 12 weeks both treatments resulted in a reduction in phosphate levels of around 2 mg/dl.
Estonian: Esimeses uuringus oli Fexeric pikaajalise neeruhaigusega 359 patsiendi vere fosfaadisisalduse vähendamisel sama efektiivne kui sevelameerkarbonaat (heakskiidetud ravim): pärast 12-nädalast ravi andsid mõlemad ravimid tulemuseks fosfaadisisalduse vähenemise ligikaudu 2 mg/dl.
English: This is a summary of the European public assessment report (EPAR) for Fexeric.
Estonian: See on ravimi Fexeric Euroopa avaliku hindamisaruande kokkuvõte.
English: The most common side effects with Fexeric (which may affect more than 1 in 10 people) are changes in bowel movements (diarrhoea or constipation) and discoloured faeces.
Estonian: Fexerici kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on sooletegevuse muutused (kõhulahtisus või kõhukinnisus) ja väljaheite värvuse muutus.
English: It is not intended to provide practical advice on how to use Fexeric.
Estonian: Hindamisaruandes ei anta Fexerici kasutamise praktilisi nõuandeid.
English: This prevents the phosphate from being absorbed into the body and helps to keep down the phosphate levels in the blood.
Estonian: See takistab fosfaadi imendumist organismi ning aitab hoida vere fosfaadisisalduse väiksena.
English: When taken with meals, the iron contained in Fexeric binds to phosphate from food in the gut, forming a compound that is then eliminated in the stools.
Estonian: Koos toiduga võtmisel seondub Fexericis sisalduv raud seedetraktis toidus sisalduva fosfaadiga ja moodustab ühendi, mis
English: The study showed that blood-phosphate levels fell on average by 0.7 mg/dl with Fexeric compared with 0.3 mg/dl with placebo.
Estonian: Uuringust nähtus, et Fexericiga langes vere fosfaadisisaldus keskmiselt 0,7 mg/dl ning
English: Fexeric is a medicine used to control hyperphosphataemia (high levels of phosphate in the blood) in adults with long-term kidney disease.
Estonian: Fexeric on ravim, mida kasutatakse hüperfosfateemia (vere suur fosfaadisisaldus) reguleerimiseks pikaajalise neeruhaigusega täiskasvanutel.
English: Fexeric must not be used in patients with low blood-phosphate levels, patients who have severe problems with the stomach and gut (such as bleeding from the gut), and those with iron accumulation disorders such as haemochromatosis.
Estonian: Fexerici ei tohi kasutada patsientidel, kelle vere fosfaadisisaldus on väike, kellel on raske mao- või soolehaigus (näiteks sooleverejooks) ning kellel on raua kogunemise häired, näiteks hemokromatoos.
English: Patients should keep to their prescribed low
Estonian: Patsiendid peavad järgima neile määratud väikese fosfaadisisaldusega dieete.
English: What benefits of Fexeric have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Fexerici kasulikkus?
English: A build-up of phosphate leads to hyperphosphataemia and in the long-term can cause complications such as heart
Estonian: Fosfaadi kogunemisel tekib hüperfosfateemia, mis võib aja jooksul tekitada tüsistusi, näiteks südame- ja luuhaigusi.
English: Patients with severe kidney disease have difficulty eliminating phosphate from their bodies.
Estonian: Raske neeruhaigusega patsientide organism ei suuda fosfaati väljutada.
English: For practical information about using Fexeric, patients should read the package leaflet or contact their
Estonian: Kui vajate Fexerici kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti
English: It contains the active substance ferric citrate coordination
Estonian: See sisaldab toimeainena raud(III)tsitraadi koordinatiivset