FrancophonIA/ELRC3.0 huggingface dataset:
English: • rapidly worsening, severe disease, who have had 2 or more relapses in one year and whose brain scans show certain brain lesions.
Estonian: • kiiresti süvenev raske haigus, millel on ühe aasta jooksul esinenud 2 või enam relapsi, ja kelle ajuskaneeringud näitavad teatavaid ajukahjustusi.
English: Why is Lemtrada authorised in the EU?
Estonian: Miks Lemtrada ELis heaks kiideti?
English: The Agency considered that studies have shown the benefit for patients with highly active disease and rapidly worsening severe disease.
Estonian: Amet leidis, et uuringud on näidanud kasulikkust väga aktiivse ja kiiresti süveneva raske haigusega patsientidele.
English: What are the risks associated with Lemtrada?
Estonian: Mis riskid Lemtradaga kaasnevad?
English: As for all medicines, data on the use of Lemtrada are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse Lemtrada kasutamise kohta pidevat järelevalvet.
English: The company that markets Lemtrada will carry out studies on the safety of the medicine and to assess whether the medicine is used according to the latest recommendations.
Estonian: Lemtrada turustaja teeb ravimi ohutusuuringud ja hindab, kas ravimit kasutatakse uusimate soovituste kohaselt.
English: Over half of patients included in the extension study did not have disease progression and did not need additional Lemtrada infusions.
Estonian: Enam kui pooltel jätku-uuringusse kaasatud patsientidel ei olnud haigus progresseerunud ja nad ei vajanud Lemtrada lisainfusioone.
English: Side effects reported with Lemtrada are carefully evaluated and any necessary action taken to protect patients.
Estonian: Lemtrada kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: The way alemtuzumab acts in multiple sclerosis is not fully understood, but it is believed that its effect on lymphocytes reduces the immune system's damaging activity.
Estonian: Alemtuzumabi toimemehhanism hulgiskleroosi korral ei ole täielikult selge, kuid arvatakse, et selle mõju lümfotsüütidele vähendab immuunsüsteemi kahjustavat toimet.
English: The company will ensure that doctors expected to prescribe the medicine receive educational materials containing important safety information, and a checklist covering the necessary screening, medicines to reduce side effects, monitoring before, during and after infusion, and long-term monitoring of patients.
Estonian: Ettevõte tagab, et ravimit määravad arstid saavad teabematerjalid, mis sisaldavad olulist ohutusteavet, ning kontroll-loetelu, mis hõlmab vajalikke sõeluuringuid, kõrvalnähtude vähendamise ravimeid, infusioonieelset, -aegset ja -järgset seiret ning patsientide pikaajalist jälgimist.
English: Lemtrada is used for patients with:
Estonian: Lemtradat kasutatakse patsientidel, kellel on:
English: For more information about using Lemtrada, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Lemtrada kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: For those patients who needed one or two additional infusions with Lemtrada, the number of relapses was lower, and disability progression was slower, compared with the previous year.
Estonian: Patsientidel, kes vajasid üht või kaht Lemtrada lisainfusiooni, oli relapside arv väiksem ja puude progresseerumine aeglasem kui eelnenud aastal.
English: CD52 is found on lymphocytes, white blood cells that are part of the immune system.
Estonian: Valku CD52 leidub lümfotsüütide, immuunsüsteemi osaks olevate valgevererakkude pinnal.
English: How is Lemtrada used?
Estonian: Kuidas Lemtradat kasutatakse?
English: Lemtrada must not be used in patients with HIV and in patients with severe infections.
Estonian: Lemtradat ei tohi kasutada HIV-ga nakatunud patsientidel ega raskete infektsioonidega patsientidel.
English: Lemtrada has been studied in two main studies involving 1,421 patients with relapsing-remitting multiple sclerosis.
Estonian: Lemtradat uuriti kahes põhiuuringus, milles osales 1421 relapseeruva-remiteeruva hulgiskleroosiga patsienti.
English: In both studies, the main measure of effectiveness was based on the number of relapses the patients had each year and the progression of disability after two years of treatment.
Estonian: Mõlemas uuringus põhines efektiivsuse põhinäitaja relapside arvul, mis patsientidel igal aastal esines, ja puude progresseerumisel pärast 2-aastast ravi.
English: ‘Relapsing-remitting' means that the patient has attacks (relapses) between periods with few or no symptoms (remissions).
Estonian: „Relapseeruv-remiteeruv“ tähendab, et patsiendil esinevad relapside ehk haiguse ägenemiste vahel remissioonid ehk väheste sümptomitega või sümptomiteta perioodid.
English: It is initially given in two courses of treatment: a first course of 12 mg daily for 5 days, followed 12 months later by a second course of 12 mg daily for 3 days.
Estonian: Esialgu manustatakse Lemtradat kahe ravikuurina: esimene ravikuur annuses 12 mg ööpäevas 5 päeva jooksul, millele järgneb 12 kuu möödudes teine ravikuur annuses 12 mg ööpäevas 3 päeva jooksul.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lemtrada have also been included in the summary of product characteristics and the package leaflet.
Estonian: Lemtrada ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Lemtrada is given as an infusion (drip) into a vein over about 4 hours.
Estonian: Lemtradat manustatakse veeniinfusioonina ligikaudu 4 tunni jooksul.
English: The first study involved previously untreated patients, while the second study involved patients whose disease had relapsed despite treatment.
Estonian: Esimeses uuringus osalesid varem ravimata patsiendid ja teises uuringus patsiendid, kelle haigus oli varasemast ravist hoolimata ägenenud.
English: Patients involved in the two main studies were followed-up for at least four years in an extension study, during which they were given up to two additional doses of Lemtrada, at one-year intervals, if their disease progressed.
Estonian: Kahes põhiuuringus osalenud patsiente jälgiti vähemalt 4 aasta vältel jätku-uuringus, mille kestel said patsiendid kuni kaks Lemtrada lisaannust (aastase vahega), kui nende haigus oli progresseerunud.
English: Patients will receive a patient alert card and a guide explaining the risks with the medicine and symptoms of Lemtrada's serious side effects.
Estonian: Patsientidele antakse patsiendi hoiatuskaart ja juhend, milles selgitatakse ravimiga kaasnevaid riske ja Lemtrada raskete kõrvalnähtude sümptomeid.
English: Treatment should only be started and supervised by a neurologist experienced in treating MS.
Estonian: Ravi peab alustama ja jälgima hulgiskleroosi ravis kogenud neuroloog.
English: Up to two additional courses, each of 12 mg daily for 3 days, can be given at 12-month intervals.
Estonian: Teha tohib veel kuni kaks ravikuuri (12 mg ööpäevas 3 päeva jooksul) 12-kuulise vahega.
English: Other information about Lemtrada
Estonian: Muu teave Lemtrada kohta
English: The most common side effects with Lemtrada (which may affect more than 1 in 5 people) are rash, headache, fever and respiratory tract infections (throat and chest infections).
Estonian: Lemtrada kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 5st) on lööve, peavalu, palavik ja hingamisteede infektsioonid (neelu- ja rindkereinfektsioonid).
English: In the first study, the average number of relapses per year in patients given Lemtrada was less than half the number in patients given interferon beta-1a (0.18 versus 0.39), but there was no meaningful effect in terms of progression of disability.
Estonian: Esimeses uuringus oli relapside keskmine arv aastas Lemtradat saanud patsientidel enam kui kaks korda väiksem kui beeta-1a-interferooni saanud patsientidel (0,18 vs 0,39), kuid puude progresseerumisele olulist toimet ei täheldatud.
English: What benefits of Lemtrada have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Lemtrada kasulikkus?
English: When alemtuzumab attaches to the lymphocytes, it causes them to die, and they are replaced by new lymphocytes.
Estonian: Alemtuzumabi seondumine lümfotsüütidega hävitab need ja asemele tekivad uued lümfotsüüdid.
English: Patients should receive certain medicines before or during treatment to reduce the side effects.
Estonian: Enne ravi või ravi ajal peavad patsiendid kõrvalnähtude leevendamiseks saama teatud ravimeid.
English: It should be given in a hospital with access to intensive care, as well as equipment and specialist staff for managing serious reactions and side effects that can occur with Lemtrada.
Estonian: Ravimit tohib manustada ainult intensiivravivõimalustega, vastavate seadmete ja spetsialistidest töötajatega haiglas juhuks, kui tuleb reageerida Lemtradaga kaasneda võivatele rasketele reaktsioonidele ja kõrvalnähtudele.
English: The most important side effects with Lemtrada are autoimmune conditions (where the body's defence system attacks normal tissue), including thyroid gland disorders, immune thrombocytopenic purpura (a bleeding disorder caused by low blood platelet counts) and kidney damage, as well as low blood cell counts, reactions to the infusion and infections.
Estonian: Lemtrada kõige olulisemad kõrvalnähud on autoimmuunhaigused (kui organismi kaitsesüsteem ründab normaalseid kudesid), sealhulgas kilpnäärmehäired, immuunne trombotsütopeeniline purpur (ITP; trombotsüütide vähesusest põhjustatud veritsushäire), neerukahjustus ja üldine vererakkude vähesus, infusioonireaktsioonid ja infektsioonid.
English: With regards to safety, Lemtrada has rare but serious side effects, including disorders of the heart, blood vessels and immune system and measures have been put in place to minimise this risk.1
Estonian: kuid rasked kõrvalnähud, sealhulgas südame-, veresoonte ja immuunsüsteemi häired, ning selle riski vähendamiseks on võetud meetmeid.1
English: The active substance in Lemtrada, alemtuzumab, is a type of protein called a monoclonal antibody that has been designed to attach to another protein called CD52.
Estonian: Lemtrada toimeaine alemtuzumab on monoklonaalne antikeha (teatud valk), mis seondub valguga CD52.
English: For the full list of side effects of Lemtrada, see the package leaflet.
Estonian: Lemtrada kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Lemtrada must not be used in patients with coagulopathy (problems with blood clotting) or in patients who are taking anti-platelet or anti coagulant therapy.
Estonian: Lemtradat ei tohi kasutada koagulopaatiaga (vere hüübimishäiretega) patsientidel ega trombotsüütide või koagulantide vastase raviga patsientidel.
English: In both studies, Lemtrada was compared with another medicine for multiple sclerosis, interferon beta-1a.
Estonian: Mõlemas uuringus võrreldi Lemtradat beeta-1a-interferooniga (samuti hulgiskleroosi ravim).
English: It must not be used in patients with uncontrolled hypertension (high blood pressure), patients who have had arterial dissection (tears) of the cervicocephalic arteries (blood vessels in the head and neck), stroke, angina pectoris (pains to the chest, jaw and back, brought on by physical effort and due to problems with the blood flow to the heart) or myocardial infarction (heart attack).
Estonian: Lemtradat ei tohi kasutada ohjamata hüpertensiooniga (kõrgvererõhk) patsientidel ja patsientidel, kellel on olnud pea- ja kaelapiirkonna arterite dissektsioon (lõhustumine), insult, stenokardia (füüsilisest pingutusest ja südamelihase verevarustuse probleemidest tingitud valu rindkeres, lõuas ja seljas) või müokardiinfarkt (südamelihase infarkt).
English: An overview of Lemtrada and why it is authorised in the EU
Estonian: Ülevaade ravimist Lemtrada ja ELis müügiloa väljastamise põhjendus
English: In the second study, the average number of relapses per year in patients given Lemtrada was half the number in patients given interferon beta-1a (0.26 versus 0.52), and around 13% of patients given Lemtrada had a sustained progression of disability compared with around 21% of patients given interferon beta-1a.
Estonian: Teises uuringus oli relapside keskmine arv aastas Lemtradat saanud patsientidel ligikaudu kaks korda väiksem kui beeta-1a-interferooni saanud patsientidel (0,26 vs 0,52).
English: How does Lemtrada work?
Estonian: Kuidas Lemtrada toimib?
English: Lemtrada can only be obtained with a prescription.
Estonian: Lemtrada on retseptiravim.
English: Lemtrada is a medicine that is used to treat adults with relapsing-remitting multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves as well as the nerves themselves.
Estonian: Hulgiskleroos on haigus, mille korral kahjustab põletik närve ümbritsevat kaitsekesta ja ka närve.
English: The medicine must not be used in patients with autoimmune diseases besides MS. For the full list of restrictions, see the package leaflet.
Estonian: Ravimit ei tohi kasutada muude autoimmuunhaiguste kui hulgiskleroosiga patsientidel.
English: Lemtrada contains the active substance alemtuzumab.
Estonian: Lemtrada sisaldab toimeainena alemtuzumabi.
English: It is available as tablets (100 mg).
Estonian: Ravimit turustatakse tablettidena (100 mg).
English: The full EPAR for Lamivudine Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Lamivudine Teva kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lamivudine Teva on 23 October 2009.
Estonian: Euroopa Komisjon andis Lamivudine Teva müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 23. oktoobril 2009.
English: Lamivudine stops the virus making DNA and prevents it from multiplying and spreading.
Estonian: Lamivudiin peatab viiruse DNA moodustumise ning takistab selle replikatsiooni ja levikut.
English: Lamivudine Teva is not suitable for patients who require doses below 100 mg.
Estonian: Lamivudine Teva ei sobi patsientidele, kes vajavad 100 mg-st väiksemaid annuseid.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Lamivudine Teva.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Because the hepatitis B virus can become resistant to Lamivudine Teva, the doctor should only consider prescribing Lamivudine Teva if other treatments that are less likely to lead to resistance cannot be used.
Estonian: Et B-hepatiidi virus võib muutuda Lamivudine Teva suhtes resistentseks, tuleb arstil määrata Lamivudine Tevat ainult juhul, kui muid raviviise, mis tekitavad resistentsust vähem tõenäoliselt, ei saa kasutada.
English: If the hepatitis B virus can still be found in the blood after six months of treatment, the doctor should consider changing treatment to reduce the risk of resistance.
Estonian: Kui kuus kuud kestnud ravi järel on patsiendi veres veel B-hepatiidi viirust, peab arst kaaluma ravi muutmist, et vähendada resistentsuse tekke riski.
English: Other information about Lamivudine Teva
Estonian: Muu teave Lamivudine Teva kohta
English: EPAR summary for the public lamivudine
Estonian: Kokkuvõte üldsusele lamivudiin
English: For more information about treatment with Lamivudine Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Lamivudine Tevaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The Committee recommended that Lamivudine Teva be given marketing authorisation.
Estonian: Komitee soovitas anda Lamivudine Teva müügiloa.
English: This is a summary of the European public assessment report (EPAR) for Lamivudine Teva.
Estonian: See on ravimi Lamivudine Teva Euroopa avaliku hindamisaruande kokkuvõte.
English: Because Lamivudine Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Estonian: Et Lamivudine Teva on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: It is used in patients with compensated liver disease (when the liver is damaged but functions normally), who also show signs that the virus is still multiplying, and have signs of liver damage (raised levels of the liver enzyme ‘alanine aminotransferase' [ALT] and signs of damage when liver tissue is examined under a microscope).
Estonian: Seda kasutatakse kompenseeritud maksahaigusega patsientidel (maks on kahjustatud, kuid selle talitlus on normaalne), kellel on viiruse edasise replitseerumise ning maksakahjustuse nähud (maksaensüümi alaniinaminotransferaasi (ALT) sisalduse suurenemine veres ja maksakoe mikroskoopuuringutel ilmnevad kahjustusnähud).
English: Therefore, the CHMP's view was that, as for Zeffix, the benefit outweighs the identified risk.
Estonian: Seetõttu arvas inimravimite komitee, et nagu ka Zeffixi korral, ületab Lamivudine Teva kasulikkus sellega kaasnevad riskid.
English: This means that Lamivudine Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zeffix.
Estonian: See tähendab, et Lamivudine Teva on sarnane võrdlusravimiga Zeffix, millel juba on Euroopa Liidus müügiluba.
English: Lamivudine Teva is used to treat adult patients who have chronic (long term) hepatitis B (a disease of the liver due to an infection by the hepatitis B virus).
Estonian: Lamivudine Tevat kasutatakse kroonilise (pikaajalise) B-hepatiidi (B-hepatiidi viiruse nakkusest põhjustatud maksapõletik) raviks täiskasvanutel.
English: The CHMP concluded that, in accordance with EU requirements, Lamivudine Teva has been shown to have comparable quality and to be bioequivalent to Zeffix.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Lamivudine Teva võrdväärne kvaliteet ja bioekvivalentsus ravimiga Zeffix.
English: What is Lamivudine Teva?
Estonian: Mis on Lamivudine Teva?
English: Patients infected with a virus that has the ‘YMDD mutation' (a change in the virus's DNA that is often found after treatment with lamivudine) should take Lamivudine Teva in combination with another medicine against hepatitis B. For more information, please see the Summary of Product Characteristics (also part of the EPAR).
Estonian: Patsiendid, kes on nakatunud viirusega, millel on YMDD-mutatsioon (viiruse DNA muudatus, mida leidub sageli pärast ravi lamivudiiniga), peavad võtma Lamivudine Tevat koos B-hepatiidi muu ravimiga.
English: Lamivudine Teva is a ‘generic medicine'.
Estonian: Lamivudine Teva on geneeriline ravim.
English: Lamivudine Teva is a medicine that contains the active substance lamivudine.
Estonian: Lamivudine Teva on ravim, mis sisaldab toimeainena lamivudiini.
English: The dose needs to be lowered for patients who have problems with their kidneys.
Estonian: Neeruprobleemidega patsientidel on
English: Why has Lamivudine Teva been approved?
Estonian: Miks Lamivudine Teva heaks kiideti?
English: Because Lamivudine Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Zeffix.
Estonian: Et Lamivudine Teva on geneeriline ravim, piirdusid uuringud katsetega, milles näidati Lamivudine Teva bioekvivalentsust võrdlusravimiga Zeffix.
English: The active substance in Lamivudine Teva, lamivudine, is an antiviral agent belonging to the class of the nucleoside analogues.
Estonian: Lamivudine Teva toimeaine lamivudiin on nukleosiidianaloogide klassi kuuluv viiruseravim.
English: Lamivudine interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA.
Estonian: Lamivudiin häirib viiruse DNA moodustumisel osaleva viiruseensüümi DNA-polümeraasi toimet.
English: What are the benefits and risks of Lamivudine Teva?
Estonian: Milles seisneb Lamivudine Teva kasulikkus ja mis riskid ravimiga kaasnevad?
English: How has Lamivudine Teva been studied?
Estonian: Kuidas Lamivudine Tevat uuriti?
English: How is Lamivudine Teva used?
Estonian: Kuidas Lamivudine Tevat kasutatakse?
English: What is Lamivudine Teva used for?
Estonian: Milleks Lamivudine Tevat kasutatakse?
English: Treatment with Lamivudine Teva should be initiated by a doctor who has experience in the management of chronic hepatitis B. The recommended dose of Lamivudine Teva is 100 mg once a day.
Estonian: Ravi Lamivudine Tevaga tohib alustada üksnes kroonilise B-hepatiidi ravis kogenud arst.
English: How does Lamivudine Teva work?
Estonian: Kuidas Lamivudine Teva toimib?
English: It should be given twice a week for 12 weeks, and then once a week for 24 weeks.
Estonian: Ravimit tuleb manustada kaks korda nädalas 12 nädala jooksul ja seejärel üks kord nädalas 24 nädala jooksul.
English: The patients were followed up for up to 10 years.
Estonian: Patsiente jälgiti kuni 10 aastat.
English: Mepact mifamurtide
Estonian: Mepact mifamurtiid
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mepact on 6 March 2009.
Estonian: Euroopa Komisjon andis Mepacti müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 6. märtsil 2009.
English: The most common side effects with Mepact (seen in more than 1 patient in 10) are anaemia (low red blood cell counts), loss of appetite, headache, dizziness, tachycardia (rapid heartbeat), hypertension (high blood pressure), hypotension (low blood pressure), dyspnoea (difficulty breathing), tachypnoea (rapid breathing), cough, vomiting, diarrhoea, constipation, abdominal pain (stomach ache), nausea, hyperhidrosis (excessive sweating), myalgia (muscle pain), arthralgia (joint pain), back pain, pain in extremity (the arms and legs), fever, chills, fatigue (tiredness), hypothermia (low body temperature), general pain, malaise (feeling unwell), asthenia (weakness) and chest pain.
Estonian: Mepacti kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on aneemia (vere punaliblede vähesus), isutus, peavalu, peapööritus, tahhükardia (südamekloppimine), hüpertensioon (kõrge vererõhk), hüpotensioon (madal vererõhk), düspnoe (õhupuudustunne), tahhüpnoe (sage hingamine), köha, oksendamine, kõhulahtisus, kõhukinnisus, kõhuvalu, iiveldus, hüperhidroos (liigne higistamine), müalgia (lihasevalu), artralgia (liigesevalu), seljavalu, jäsemevalu, palavik, külmavärinad, väsimus, hüpotermia (madal kehatemperatuur), üldine valu, halb enesetunne, asteenia (nõrkus) ja rindkerevalu.
English: The main measure of effectiveness was the number of patients who survived without the disease coming back.
Estonian: Efektiivsuse põhinäitaja oli nende ellujäänud patsientide arv, kelle haigus ei taastunud.
English: The risk of dying was also reduced by 28% in patients receiving Mepact.
Estonian: Surma risk vähenes Mepacti saanud patsientidel 28% võrra.
English: ‘High grade' means that the cancer is of a severe type, and ‘non-metastatic' means that it is at an early stage and has not spread far within the body.
Estonian: „Kõrgmaliigne” tähendab, et vähk on agressiivset tüüpi, ning „mittemetastaatiline”, et vähk on varajases staadiumis ega ole levinud organismis mujale.