FrancophonIA/ELRC3.0 huggingface dataset:
English: You may also receive treatment for hepatitis B.
Estonian: Arst võib teile määrata ka ravi B-hepatiidi vastu.
English: In addition to data on hepatitis B re-activation, EMA also reviewed data suggesting that patients treated with direct-acting antivirals who have previously been treated for liver cancer could be at risk of their cancer returning early.
Estonian: Lisaks B-hepatiidi reaktiveerumise andmetele vaatas EMA läbi ka andmed, mille kohaselt võib otsese toimega viirusevastaseid ravimeid kasutavatel patsientidel, kes on varem saanud maksavähi ravi, olla vähi varase taastumise risk.
English: The CHMP agreed that companies should carry out a study to evaluate the risk of liver cancer returning with direct-acting antivirals.
Estonian: Inimravimite komitee nõustus, et ettevõtted peaksid korraldama uuringu, et hinnata maksavähi taastumise riski otsese toimega viirusevastaste ravimite kasutamisel.
English: The review of direct-acting antivirals was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
Estonian: Kõigepealt vaatas otsese toimega viirusevastaste ravimite teabe läbi EMA ravimiohutuse riskihindamise komitee.
English: Direct-acting antivirals work by blocking the action of proteins which are essential for making new hepatitis C viruses.
Estonian: Otsese toimega viirusevastased ravimid blokeerivad uute C-hepatiidi viiruste tootmiseks vajalike valkude toime.
English: Companies marketing these medicines have been asked to perform a prospective study to assess the risk of recurrence of previously treated hepatocellular carcinoma, and a prospective cohort study in patients with cirrhosis to assess the incidence and type of de novo hepatocellular carcinoma.
Estonian: Nende ravimite turustajad peavad korraldama prospektiivse uuringu, et hinnata varem ravitud hepatotsellulaarse kartsinoomi kordumise riski, ning prospektiivse kohortuuringu tsirroosiga patsientidel, et hinnata esmakordselt diagnoositava hepatotsellulaarse kartsinoomi esinemissagedust ja tüüpi.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Estonian: Ravimiohutuse riskihindamise komitee soovitused saadeti seejärel inimravimitega seotud küsimuste eest vastutavale inimravimite komiteele, kes võttis vastu Euroopa Ravimiameti arvamuse.
English: The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Estonian: Teabe vaatas läbi inimravimite ohutusprobleemide hindamise eest vastutav ravimiohutuse riskihindamise komitee, kes koostas soovitused.
English: These measures aim to minimise the risk of hepatitis B re-activation with direct-acting antivirals.
Estonian: Nende meetmete eesmärk on vähendada B-hepatiidi reaktiveerumise riski otsese toimega viirusevastaste ravimite kasutamisel.
English: • Therapeutic guidelines recommend that, in patients with advanced fibrosis and cirrhosis, surveillance for hepatocellular carcinoma should continue even after sustained viral response has been achieved.
Estonian: • Ravijuhendites soovitatakse kaugelearenenud fibroosi ja tsirroosiga patsiente uurida hepatotsellulaarse kartsinoomi suhtes ka pärast püsiva viirusevastase ravitoime saavutamist.
English: • If you have both hepatitis B and C virus infections, your doctor will monitor you closely during and after treatment with direct-acting antivirals.
Estonian: • Kui olete nakatunud nii B- kui ka C-hepatiidi viirusega, kontrollib arst teid hoolikalt kogu otsese toimega viirusevastaste ravimitega toimuva ravi kestel ja pärast ravi.
English: • Direct-acting antiviral medicines (including Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax) are effective treatments for long-term hepatitis C that can be used without interferons (medicines known to have troublesome side effects).
Estonian: • Otsese toimega viirusevastased ravimid (sh Daklinza, Exviera, Harvoni, Olysio, Sovaldi ja Viekirax) on tõhusad kroonilise C-hepatiidi vastased ravimid, mida on võimalik kasutada ilma interferoonideta (teadaolevalt raskeid kõrvaltoimeid põhjustavad ravimid).
English: Direct-acting antivirals (marketed in the EU as Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax)1 are important medicines for treating chronic (long term) hepatitis C, a disease of the liver caused by hepatitis C virus.
Estonian: Otsese toimega viirusevastased ravimid (mida turustatakse ELis nimetuste Daklinza, Exviera, Harvoni, Olysio, Sovaldi ja Viekirax all)1 on olulised kroonilise (pikaajalise) C-hepatiidi (C-hepatiidi viirusest põhjustatud maksahaiguse) ravimid.
English: On 15 December 2016, the European Medicines Agency (EMA) confirmed its recommendation to screen all patients for hepatitis B before starting treatment with direct-acting antivirals for hepatitis C; patients infected with both hepatitis B and C viruses must be monitored and managed according to current clinical guidelines.
Estonian: 15. detsembril 2016 kinnitas Euroopa Ravimiamet (EMA) oma soovitust kontrollida kõiki patsiente Bhepatiidi suhtes enne, kui neil alustatakse C-hepatiidi ravi otsese toimega viirusevastaste ravimitega.
English: • Further studies are needed to evaluate the risk of recurring or newly diagnosed hepatocellular carcinoma in patients treated with direct-acting antivirals.
Estonian: • Täiendavalt tuleb uurida korduva või esmakordselt diagnoositava hepatotsellulaarse kartsinoomi riski otsese toimega viirusevastaste ravimitega ravitud patsientidel.
English: • All patients should be screened for hepatitis B before starting treatment with direct-acting antivirals for hepatitis C; patients co-infected with hepatitis B and C must then be monitored and managed according to current clinical guidelines.
Estonian: • Enne otsese toimega viirusevastaste ravimite kasutamist C-hepatiidi raviks tuleb kõiki patsiente kontrollida B-hepatiidi suhtes; B- ja C-hepatiidi koinfektsiooniga patsiente tuleb seejärel jälgida ja ravida kooskõlas kehtivate kliiniliste suunistega.
English: • If you also have hepatitis B virus infection, direct-acting antivirals for hepatitis C may cause the hepatitis B infection to become active again.
Estonian: • Kui olete nakatunud ka B-hepatiidi viirusega, võivad C-hepatiidi vastased otsese toimega ravimid põhjustada B-hepatiidi reaktiveerumist.
English: The review covered the following direct-acting antivirals for treating chronic hepatitis C: Daklinza (daclatasvir), Exviera (dasabuvir), Harvoni (sofosbuvir / ledipasvir), Olysio (simeprevir), Sovaldi
Estonian: Läbi vaadati järgmiste kroonilise C-hepatiidi raviks kasutatavate otsese toimega viirusevastaste ravimite teave: Daklinza (daklatasviir), Exviera (dasabuviir), Harvoni (sofosbuviir/ledipasviir), Olysio (simepreviir), Sovaldi (sofosbuviir) ja Viekirax (ombitasviir/paritapreviir/ritonaviir).
English: • You will be tested for hepatitis B before starting treatment with direct-acting antivirals to check if you might be at risk of hepatitis B reactivation.
Estonian: • Enne otsese toimega viirusevastaste ravimitega ravi alustamist testitakse teid B-hepatiidi suhtes, et selgitada välja, kas teil on risk B-hepatiidi reaktiveerumiseks.
English: In this context, further research is also needed on the risk of new liver cancers in patients with chronic hepatitis C and cirrhosis (liver scarring) that are treated with directacting antivirals.
Estonian: esmakordselt diagnoositava maksavähi riski uurimiseks patsientidel, kel on krooniline C-hepatiit ja tsirroos (maksakoe armistumine), mida ravitakse otsese toimega viirusevastaste ravimitega.
English: • Tell your doctor if you have or have had hepatitis B infection.
Estonian: • Kui teil on või on varem olnud B-hepatiidi infektsioon, andke sellest arstile teada.
English: The hepatitis B re-activation is thought to be the consequence of the rapid treatment-induced reduction in hepatitis C virus (as co-infection is known to suppress the hepatitis B virus) and the lack of activity of direct-acting antivirals against hepatitis B virus.
Estonian: B-hepatiidi reaktiveerumine arvatakse olevat põhjustatud C-hepatiidi viiruse koguse kiirest vähenemisest ravi toimel (koinfektsioon teadaolevalt supresseerib B-hepatiidi viirust) ja sellest, et otsese toimega viirusevastastel ravimitel ei ole B-hepatiidi viiruse vastast toimet.
English: • Hepatitis B re-activation is thought to be caused by the rapid treatment-induced reduction in hepatitis C virus (as co-infection is known to suppress the hepatitis B virus) and the lack of antihepatitis B activity of direct-acting antivirals.
Estonian: • B-hepatiidi reaktiveerumine arvatakse olevat põhjustatud C-hepatiidi viiruse koguse kiirest vähenemisest ravi toimel (koinfektsioon teadaolevalt supresseerib B-hepatiidi viirust) ja sellest, et otsese toimega viirusevastastel ravimitel ei ole B-hepatiidi vastast toimet.
English: 1 Since the start of this review, two other direct-acting antivirals, Epclusa (sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir), have been authorised in the EU.
Estonian: 1 Alates läbivaatamismenetluse algatamisest on ELis müügiloa saanud veel kaks otsese toimega viirusevastast ravimit: Epclusa (sofosbuviir/velpatasviir) ja Zepatier (elbasviir/grasopreviir).
English: Since the start of this review, two other direct-acting antivirals, Epclusa (sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir), have been authorised in the EU.
Estonian: Alates läbivaatamismenetluse algatamisest on ELis müügiloa saanud veel kaks otsese toimega viirusevastast ravimit: Epclusa (sofosbuviir/velpatasviir) ja Zepatier (elbasviir/grasopreviir).
English: It looked into cases2 of returning signs and symptoms of previously inactive hepatitis B infection (re-activation) when patients were treated with direct-acting antivirals for hepatitis C.
Estonian: Komitee vaatas läbi juhtumid2, kus C-hepatiidi vastu otsese toimega viirusevastaseid ravimeid saanud patsientidel taastusid varem inaktiveerunud B-hepatiidi nähud ja sümptomid (st viirus reaktiveerus).
English: The PRAC recommendation to include a warning in the prescribing information about hepatitis B reactivation and how to minimise it was endorsed by EMA's Committee for Medicinal Products for Human Use (CHMP).
Estonian: EMA inimravimite komitee kiitis heaks ravimiohutuse riskihindamise komitee soovituse lisada ravimite väljakirjutamisteabesse hoiatus B-hepatiidi reaktiveerumise riski ja selle riski vähendamise kohta.
English: • Cases of hepatitis B re-activation (with severe consequences) have been reported in patients coinfected with hepatitis B and C viruses treated with direct-acting antivirals.
Estonian: • Otsese toimega viirusevastaseid ravimeid saanud B- ja C-hepatiidi viiruse koinfektsiooniga patsientidel on täheldatud B-hepatiidi reaktiveerumist (mis põhjustab raskeid tagajärgi).
English: 31 March 2016 EMA/174254/2016
Estonian: 31. märts 2016. a. EMA/174254/2016
English: If you have any questions about your treatment, contact your doctor, pharmacist or nurse.
Estonian: Kui teil on ravi kohta mingeid küsimusi, pidage nõu oma arsti, apteekri või meditsiiniõega.
English: More information on Exjade, including its indications in full, can be found on the Agency's website: ema.europa.eu/Findmedicine/Human medicines/European public assessment reports.
Estonian: Exjade lisateave, sh kõik näidustused, on Euroopa Ravimiameti veebilehel: ema.europa.eu/Findmedicine/Human medicines/European public assessment reports
English: It has important information about your treatment and how to take the medicine.
Estonian: Selles on olulist teavet teie ravi ja ravimi kasutamise kohta.
English: Dispersed in water, orange juice or apple juice.
Estonian: Dispergeerida vees, apelsini- või õunamahlas.
English: • The summary of product characteristics and the educational materials on the use of Exjade should be followed because they give important information on its use.
Estonian: • Sellele peab järgnema ravimi omaduste kokkuvõte ja Exjade kasutamise teabematerjalid, sest need annavad olulist kasutusalast teavet.
English: • Read the package leaflet and other information you have been given with your tablets.
Estonian: • Lugege pakendi infolehte ja muud teavet, mis on teile koos tablettidega antud.
English: Once daily, must be taken on an empty stomach, at least 30 minutes before food
Estonian: Üks kord ööpäevas, peab võtma tühja kõhuga vähemalt 30 minutit enne söömist
English: This helps to correct iron overload and prevent the extra iron from damaging organs such as the heart and liver.
Estonian: See aitab korrigeerida raualiigsust ja ennetada sellest põhjustatud kahjustusi elunditele, nagu süda ja maks.
English: • You will be given a handbook with information on the two types of tablets and how to take them.
Estonian: • Teile antakse käsiraamat, milles on teave kahte liiki tablettide ja nende võtmise kohta.
English: • Your doctor will have worked out the dose of Exjade you need.
Estonian: • Teie arst arvutab välja teile vajaliku Exjade annuse.
English: How to take tablets
Estonian: Kuidas tablette võtta
English: When to take tablets
Estonian: Millal tablette võtta
English: Not to be chewed or swallowed whole
Estonian: Mitte närida ega tervena alla neelata.
English: Round, white tablets containing 125 mg, 250 mg and 500 mg (all white)
Estonian: Ümarad valged tabletid tugevusega 125 mg, 250 mg ja 500 mg (kõik valged)
English: The two types of tablets can be easily distinguished by their shape, and the design of the outer cartons and blisters.
Estonian: Kahte liiki tablette on lihtne eristada nende kuju ning välispakendi ja blisterpakendi kujunduse alusel.
English: Dispersible tablets (to be discontinued)
Estonian: Dispergeeruv tablett (turustamine lõpetatakse)
English: Healthcare professionals will be notified of the planned date for removing the dispersible tablets from the market.
Estonian: Tervishoiutöötajaid teavitatakse plaanitavast kuupäevast, mil dispergeeruvad tabletid turult eemaldatakse.
English: • Whereas the dispersible tablets have to be taken on an empty stomach 30 minutes before food, the film-coated tablets can be taken on an empty stomach or with a light meal.
Estonian: • Kui dispergeeruvaid tablette tuleb võtta tühja kõhuga 30 minutit enne söömist, siis õhukese polümeerkattega tablette tohib võtta tühja kõhuga või koos kerge einega.
English: Film-coated tablets containing 90, 180 and 360 mg are equivalent to dispersible tablets containing 125, 250 and 500 mg, respectively.
Estonian: Õhukese polümeerkattega 90, 180 ja 360 mg tabletid on võrdväärsed vastavalt 125, 250 ja 500 mg dispergeeruvate tablettidega.
English: The patient may receive too little or too much of the medicine if the dose is not correct when changing from one type of tablet to another.
Estonian: Patsient võib saada ravimit liiga palju või vähe, kui ühelt tabletilt teise üle minnes ei ole annus õige.
English: Once daily, may be taken on an empty stomach or with a light meal
Estonian: Üks kord ööpäevas, tohib võtta tühja kõhuga või koos kerge einega
English: Excipient: lactose
Estonian: Abiaine: laktoos
English: Swallowed whole with some water or crushed and sprinkled on soft food (e.g. yogurt or apple sauce)
Estonian: Neelake tablett koos veega tervelt alla või purustage see ja raputage pehmele toidule (nt jogurtile või õunapüreele)
English: Educational material to raise awareness of dose variation between different types of tablets
Estonian: Teabematerjalid eri liiki tablettide annuselise varieeruvuse teadvustamiseks
English: The dose depends on your weight, the amount of iron in your blood, how well your liver and kidneys work and the amount of blood transfusions you receive.
Estonian: Annus sõltub teie kaalust, rauasisaldusest veres, maksa- ja neerutalitlusest ning teile tehtavate vereülekannete hulgast.
English: Contains lactose
Estonian: Sisaldab laktoosi
English: Measures to avoid medication errors with Exjade
Estonian: Exjadega seotud ravivigade vältimise meetmed
English: This means that it attaches to iron in the body to form a ‘chelate' that can be excreted by the body, mainly in the stool.
Estonian: See tähendab, et see seondub organismis rauaga, moodustades ühendi (kelaadi), mis eritub organismist põhiliselt roojaga.
English: • The following table describes the differences between the two formulations: Film-coated tablets
Estonian: • Järgmine tabel iseloomustab nende kahe ravimi liigi erinevusi: Õhukese polümeerkattega tablett
English: • Exjade dispersible tablets will not be available in the future.
Estonian: • Tulevikus pole Exjade dispergeeruvad tabletid enam saadaval.
English: Exjade contains the active substance deferasirox which is an ‘iron chelator'.
Estonian: Exjade toimeaine deferasiroks on rauda kelaativ aine.
English: The doctor will tell you how much of the new tablet you need to take.
Estonian: millises koguses peate uusi tablette võtma.
English: • To avoid errors, prescriptions for Exjade must specify the type of formulation (dispersible tablets or film-coated tablets), the prescribed dose in mg/kg/day, and the calculated dose per day with the strength of film-coated or dispersible tablets.
Estonian: • Vigade vältimiseks peab Exjade retseptil olema kirjas ravimi liik (dispergeeruvad või õhukese polümeerkattega tabletid), määratud annus milligrammides kehakaalu kilogrammi kohta ööpäevas ja õhukese polümeerkattega või dispergeeruva tableti toimeainesisalduse põhjal arvutatud ööpäevane annus.
English: Does not contain lactose
Estonian: Ei sisalda laktoosi
English: After this time, Exjade dispersible tablets will no longer be marketed.
Estonian: Seejärel Exjade dispergeeruvaid tablette enam ei turustata.
English: Oval, blue tablets containing 90 mg (light blue), 180 mg (medium blue) and 360 mg (dark blue)
Estonian: Kirjeldus ja toimeainesisaldus Ovaalsed sinised tabletid tugevusega 90 mg (helesinine), 180 mg (keskmine sinine) ja
English: Both types of tablets will be available for some time, which will allow doctors to switch patients from dispersible tablets to film-coated tablets.
Estonian: Mõnda aega on mõlemat liiki tabletid saadaval, mis võimaldab arstidel vahetada patsientide dispergeeruvad tabletid õhukese polümeerkattega tablettide vastu.
English: • The dispersible tablets and the new film-coated tablets are to be taken once a day, preferably at the same time each day.
Estonian: • Dispergeeruvaid ja uusi õhukese polümeerkattega tablette tuleb võtta üks kord ööpäevas,
English: • Exjade film-coated tablets have been introduced.
Estonian: • Kasutusele on võetud Exjade õhukese polümeerkattega tabletid.
English: The education material will advise that the doses for the two types of Exjade tablets are different.
Estonian: Teabematerjalid toovad esile Exjade kahe eri liiki tablettide annuste erinevuse.
English: • Bioavailability of film-coated tablets is higher than of the dispersible tablets and the strength of film-coated tablets is correspondingly lower.
Estonian: • Õhukese polümeerkattega tablettide biosaadavus on suurem kui dispergeeruvatel tablettidel ja õhukese polümeerkattega tabletid on vastavalt väiksema toimeainesisaldusega.
English: Exjade is a medicine used to remove excessive iron from the blood of patients with beta thalassemia or other blood disorders which result in excessive iron in the blood.
Estonian: Exjade on beetatalasseemia ja teiste liigsest rauasisaldusest põhjustatud verehaiguste ravim, mis eemaldab patsientide verest liigset rauda.
English: If you are switching from dispersible tablets to the new film-coated tablets, you will need a smaller dose.
Estonian: Kui vahetate dispergeeruvad tabletid uute õhukese polümeerkattega tablettide vastu, on vajalik annus väiksem.
English: Educational material will be given to patients and healthcare professionals using Exjade (deferasirox), following the introduction of a film-coated tablet to the already authorised dispersible tablet.
Estonian: Teabematerjalid antakse Exjadet (deferasiroksi) kasutavatele patsientidele ja tervishoiutöötajatele, kui peale dispergeeruvate tablettide, millel juba on müügiluba, hakatakse turustama õhukese polümeerkattega tablette.
English: Exjade is a medicine used to treat chronic iron overload (an excess of iron in the body) in patients with beta thalassemia or other blood disorders in which patients do not have enough normal haemoglobin in the blood.
Estonian: Exjadet kasutatakse kroonilise raualiigsuse raviks beetatalasseemiaga patsientidel või muu verehaigusega patsientidel, kellel ei ole veres normaalset hemoglobiini piisavalt.
English: • Both types of tablets will be available for a limited period to allow doctors to switch patients from the dispersible tablets to the film-coated tablets.
Estonian: • Piiratud aja jooksul turustatakse mõlemat liiki tablette, mis võimaldab arstidel vahetada patsientide dispergeeruvad tabletid õhukese polümeerkattega tablettide vastu.
English: • Exjade (deferasirox) is now available as film-coated tablets in addition to the already authorised dispersible tablets.
Estonian: • Lisaks heakskiidetud dispergeeruvatele tablettidele turustatakse Exjadet (deferasiroksi) nüüd ka õhukese polümeerkattega tablettidena.
English: A smaller dose is needed of the new film-coated tablets compared to that of the dispersible tablet.
Estonian: Dispergeeruvate tablettidega võrreldes vajatakse uute õhukese polümeerkattega tablettide korral väiksemat annust.
English: The European Commission granted a marketing authorisation valid throughout the EU for CoAprovel on 15 October 1998.
Estonian: Euroopa Komisjon andis CoAproveli müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 15. oktoobril 1998.
English: The full EPAR for CoAprovel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst CoAproveli kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about CoAprovel
Estonian: Muu teave CoAproveli kohta
English: The full list of these medicines is given in the Package Leaflet.
Estonian: Nende ravimite täielik loetelu on pakendi infolehel.
English: The CHMP decided that CoAprovel's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et CoAproveli kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: This is a summary of the European public assessment report (EPAR) for CoAprovel.
Estonian: See on ravimi CoAprovel Euroopa avaliku hindamisaruande kokkuvõte.
English: CoAprovel irbesartan / hydrochlorothiazide
Estonian: CoAprovel irbesartaan / hüdroklorotiasiid
English: For more information about treatment with CoAprovel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate CoAproveliga toimuva ravi kohta lisateavet, lugege pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The most common side effects with CoAprovel (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscle).
Estonian: CoAproveli kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) on peapööritus, iiveldus või oksendamine, urineerimishäired, väsimus, vere uurealämmastiku (BUN, valgu lagunemissaadus), kreatiniini (lihasest vabanev aine) ja kreatiinkinaasi (lihastes leiduv ensüüm) sisalduse suurenemine.
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 CoAprovel.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.