FrancophonIA/ELRC3.0 huggingface dataset:
English: Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis (M. tuberculosis).
Estonian: Tuberkuloos on bakteri Mycobacterium tuberculosis'e (M. tuberculosis) põhjustatud nakkus.
English: Further information on Deltyba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave Deltyba kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The company that markets Deltyba will provide educational material for healthcare professionals, explaining how to use the medicine safely to avoid problems such as the development of resistance and side effects on the heart, as well as the risks in pregnancy or women who are breast-feeding.
Estonian: Deltybat turustav ettevõte edastab tervishoiutöötajatele teabematerjalid, milles selgitatakse ravimi ohutut kasutamist, et vältida selliseid probleeme nagu resistentsuse teke ja südamega seotud kõrvaltoimed, samuti riske rasedatele või imetavatele naistele.
English: Deltyba is given for 6 months together with other tuberculosis medicines.
Estonian: Deltybat manustatakse 6 kuud koos teiste tuberkuloosivastaste ravimitega.
English: The effects of Deltyba have been looked at in one main study involving 481 adults with tuberculosis resistant to standard treatments.
Estonian: Deltyba toimeid on uuritud ühes põhiuuringus, milles osales 481 standardravile resistentse tuberkuloosiga täiskasvanut.
English: Side effects reported with Deltyba are carefully evaluated and any necessary action taken to protect patients.
Estonian: Deltyba kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Other information about Deltyba
Estonian: Muu teave Deltyba kohta
English: As for all medicines, data on the use of Deltyba are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Deltyba kasutamise kohta pidevat järelevalvet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Deltyba have also been included in the summary of product characteristics and the package leaflet.
Estonian: Deltyba ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Since Deltyba has been given conditional authorisation, the company that markets Deltyba will carry out further studies to confirm the long-term effectiveness and safety of Deltyba.
Estonian: Et Deltyba on saanud müügiloa tingimusliku heakskiidu alusel, viib Deltybat turustav ettevõte läbi täiendavaid uuringuid Daltyba pikajalise efektiivsuse ja ohutuse kinnitamiseks.
English: Deltyba must not be used in patients who have low levels of albumin (a blood protein).
Estonian: Deltybat ei tohi kasutada väikese albumiinisisaldusega (ühe verevalgu) patsiendid.
English: It must also not be used in patients who are taking certain other medicines that affect the way Deltyba is broken down in the body.
Estonian: Ravimit ei tohi kasutada ka patsiendid, kes võtavad teatud teisi ravimeid, mis mõjutavad seda, kuid Deltybat organismis lagundatakse.
English: Tuberculosis is rare in the EU, and Deltyba was designated an ‘orphan medicine' (a medicine used in rare diseases) on 1 February 2008.
Estonian: Tuberkuloos esineb ELis harva ja Deltyba nimetati 1. veebruaril 2008 harvikravimiks.
English: For more information about using Deltyba, see the package leaflet or contact a doctor or pharmacist.
Estonian: Lisateavet Deltyba kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: What information is still awaited for Deltyba?
Estonian: Mis teavet Deltyba kohta veel oodatakse?
English: Although the way it works is unclear, delamanid is known to block the production of methoxy-mycolic and ketomycolic acids, two essential components of the cell walls of M. tuberculosis, which will cause the bacteria to die.
Estonian: Kuigi ravimi toimemehhanism on ebaselge, on teada, et delamaniid blokeerib M. tuberculosis'e rakuseina kahe hädavajaliku komponendi - metoksümükool- ja ketomükoolhappe - tootmise, mis põhjustab bakterite surma.
English: Looking at the results of these follow-up studies together, 2 years after starting treatment 75% of patients who received Deltyba for 6 months or more had no bacteria in their sputum compared with 55% of patients who received Deltyba for 2 months or less.
Estonian: Nende jälgimisuuringute koondtulemuste põhjal ei leidunud 2 aastat pärast ravi algust rögas baktereid 75%-l 6 kuud või kauem Deltybat saanud patsientidest ja 55%-l 2 kuud või vähem Deltybat saanud patsientidest.
English: Deltyba contains the active substance delamanid.
Estonian: Deltyba sisaldab toimeainena delamaniidi.
English: What are the risks associated with Deltyba?
Estonian: Mis riskid Deltybaga kaasnevad?
English: Deltyba is a medicine that is used in adults with tuberculosis affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, the two standard tuberculosis medicines).
Estonian: Deltyba on ravim, mida kasutatakse multiresistentse (resistentne vähemalt kahe standardse tuberkuloosivastase ravimi - isoniasiidi ja rifampitsiini - suhtes) kopsutuberkuloosiga täiskasvanud patsientidel.
English: Furthermore the medical need for new agents to treat multi-drug resistant tuberculosis was highlighted.
Estonian: Peale selle rõhutati meditsiinilist vajadust uute multiresistentse tuberkuloosi vastaste ravimite järele.
English: It should be used according to official guidelines on treating multi-drug resistant tuberculosis.
Estonian: Ravimit peab kasutama vastavalt ametlikele multiresistentse tuberkuloosi ravi suunistele.
English: The main measure of effectiveness was the proportion of patients who no longer had the bacteria in their sputum (phlegm).
Estonian: Efektiivsuse põhinäitaja oli patsientide osakaal, kelle röga ei sisaldanud enam baktereid.
English: Deltyba has been given ‘conditional authorisation'.
Estonian: Deltyba on saanud müügiloa tingimusliku heakskiidu alusel.
English: After the main study had finished, patients had the option to receive treatment with Deltyba for 6 months in an extension study.
Estonian: Pärast põhiuuringu lõppu oli patsientidel võimalus jätku-uuringus jätkata Deltyba kasutamist 6 kuu jooksul.
English: The Agency considered that the benefits of Deltyba had been shown for patients with multi-drug resistant tuberculosis affecting the lung.
Estonian: Euroopa Ravimiamet oli arvamusel, et Deltyba kasulikkus on tõendatud multiresistentse kopsutuberkuloosiga patsientidel.
English: For the full list of side effects of Deltyba, see the package leaflet.
Estonian: Deltyba kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: After 2 months of treatment more than 40% of the patients who were taking Deltyba no longer had the bacteria in their sputum compared with 30% of the patients who were taking placebo.
Estonian: 2kuulise ravi järel ei leidunud rögas enam baktereid 40%-l Deltybat kasutanud patsientidest ja 30%-l platseebot kasutanud patsientidest.
English: The active substance in Deltyba, delamanid, is an antibiotic active against M. tuberculosis.
Estonian: Deltyba toimeaine delamaniid on M. tuberculosis'e vastast toimet omav antibiootikum.
English: How is Deltyba used?
Estonian: Kuidas Deltybat kasutatakse?
English: Patients in the study were given Deltyba or placebo (a dummy treatment) for 2 months in addition to their other treatments.
Estonian: Uuringus osalenud patsientidele anti lisaks muudele ravimitele 2 kuud Deltybat või platseebot (näivat ravimit).
English: What benefits of Deltyba have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Deltyba kasulikkus?
English: How does Deltyba work?
Estonian: Kuidas Deltyba toimib?
English: An overview of Deltyba and why it is authorised in the EU
Estonian: Ülevaade ravimist Deltyba ja ELis müügiloa väljastamise põhjendus
English: Treatment with these medicines should continue after Deltyba treatment, as recommended by official guidelines.
Estonian: Lähtuvalt ametlike suuniste soovitustest peab ravi teiste ravimitega jätkuma pärast Deltyba-ravi.
English: Deltyba can only be obtained with a prescription and treatment should be started and monitored by a doctor who is experienced in the treatment of multi-drug resistant tuberculosis.
Estonian: Ravi peab alustama ja jälgima multiresistentse tuberkuloosi ravis kogenud arst.
English: Why is Deltyba authorised in the EU?
Estonian: ELis Deltybale väljastatud müügiloa põhjendus
English: Sixmo (buprenorphine)
Estonian: Sixmo (buprenorfiin)
English: What measures are being taken to ensure the safe and effective use of Sixmo?
Estonian: Mis meetmed võetakse, et tagada Sixmo ohutu ja efektiivne kasutamine?
English: Further information on Sixmo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/sixmo.
Estonian: Lisateave Sixmo kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/sixmo.
English: Other information about Sixmo
Estonian: Muu teave Sixmo kohta
English: The company will also provide an alert card which patients should carry at all times and show to other healthcare professionals before receiving any medical treatment.
Estonian: Turustaja koostab ka hoiatuskaardi, mida patsiendid peavad kogu aeg kaasas kandma ja näitama muudele tervishoiutöötajatele enne mis tahes meditsiinilise ravi saamist.
English: The European Medicines Agency therefore decided that Sixmo's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Sixmo kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: It contains the active substance buprenorphine.
Estonian: See sisaldab toimeainena buprenorfiini.
English: What is Sixmo and what is it used for?
Estonian: Mis on Sixmo ja milleks seda kasutatakse?
English: Sixmo is used in adults who are already stable while taking buprenorphine under the tongue (no more than 8 mg/day), and who are also receiving medical, social and psychological support.
Estonian: Sixmot kasutatakse täiskasvanutel, kes on juba stabiilsed, võttes keelealust buprenorfiini (mitte üle 8 mg ööpäevas), ja kes saavad ka meditsiinilist, sotsiaalset ja psühholoogilist abi.
English: As for all medicines, data on the use of Sixmo are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Sixmo kasutamise kohta pidevat järelevalvet.
English: Sixmo can only be obtained by ‘special' prescription.
Estonian: Sixmot saab üksnes eriretsepti alusel.
English: Three studies involving a total of 627 patients with opioid dependence showed that Sixmo is effective at reducing patients' intake of opioids.
Estonian: Kolm uuringut, milles osales kokku 627 opioidisõltuvusega patsienti, näitasid, et Sixmo on efektiivne patsientide opioidikasutuse vähendamisel.
English: For more information about using Sixmo, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Sixmo kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: What are the risks associated with Sixmo?
Estonian: Mis riskid Sixmoga kaasnevad?
English: The most common side effects related to the insertion and removal of the implant are pain, itching, bruising, bleeding, reddening of the skin and rash at the site of the implant.
Estonian: Implantaadi paigaldamise ja eemaldamisega seotud kõige sagedamad kõrvalnähud on valu, sügelus, verevalumid, veritsus, nahapunetus ja lööve implantaadi paigalduskohal.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sixmo have also been included in the summary of product characteristics and the package leaflet.
Estonian: Sixmo ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Side effects reported with Sixmo are carefully evaluated and any necessary action taken to protect patients.
Estonian: Sixmo kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: The third study compared Sixmo with sublingual buprenorphine in 177 patients whose opioid dependence was already being managed with sublingual buprenorphine at a daily dose of up to 8 mg. After 6 months of treatment, around 96% of patients who received Sixmo responded to treatment (i.e. there was no evidence of opioid use in at least 4 out of 6 months) compared with around 88% in patients on sublingual buprenorphine.
Estonian: Kolmandas uuringus võrreldi Sixmot keelealuse buprenorfiiniga 177 patsiendil, kelle opioidisõltuvust raviti juba keelealuse buprenorfiiniga ööpäevases annuses kuni 8 mg. 6 ravikuu järel tekkis ravivastus ligikaudu 96%-l Sixmot saanud patsientidest (st vähemalt 4 kuul 6-st ei olnud tõendeid opioidikasutusest) ja ligikaudu 88%-l keelealust buprenorfiini saanud patsientidest.
English: The most common side effects with Sixmo (which may affect up to 1 in 10 people) include headache, constipation and difficulty sleeping.
Estonian: Sixmo kõige sagedamad kõrvalnähud (võivad esineda kuni 1 patsiendil 10st) on peavalu, kõhukinnisus ja unetus.
English: In both of these studies, the number of urine tests that were negative for opioid use decreased towards the end of the treatment period, indicating a reduction of the effect of Sixmo over time.
Estonian: Mõlemas uuringus vähenes opioidikasutuse suhtes negatiivsete uriiniproovide arv raviperioodi lõpus, mis viitab Sixmo toime vähenemisele aja jooksul.
English: This means that because the medicine can be misused or cause addiction, it is used under stricter conditions than normal.
Estonian: See tähendab, et ravimit kasutatakse rangematel tingimustel kui tavalisi ravimeid, sest ravimit võidakse kuritarvitada või see võib põhjustada sõltuvust.
English: Sixmo must not be used together with medicines known as ‘opioid antagonists' (naltrexone and nalmefene).
Estonian: Sixmot ei tohi kasutada koos teatud ravimite opioidiantagonistidega (naltreksoon ja nalmefeen).
English: Sixmo is an implant used to treat dependence on opioid drugs such as heroin or morphine.
Estonian: Sixmo on implantaat, mida kasutatakse opioidisõltuvuse, nt heroiini- või morfiinisõltuvuse raviks.
English: The active substance in Sixmo, buprenorphine, is a partial opioid agonist (which means that it acts like an opioid but less powerfully).
Estonian: Sixmo toimeaine buprenorfiin on osaline opioidiagonist (toimib nagu opioid, kuid nõrgemalt).
English: While the effect of the implants tended to wear off with time in patients not previously treated with buprenorphine, it was maintained in patients who were already stable on low doses of buprenorphine and the use of Sixmo is therefore reserved for these patients.
Estonian: Ehkki patsientidel, kes ei olnud varem buprenorfiiniravi saanud, vähenes implantaatide toime aja jooksul, säilis see patsientidel, kes olid juba stabiilsed, võttes buprenorfiini väikestes annustes, ning Sixmo kasutamine on seetõttu näidustatud üksnes nendel patsientidel.
English: The medicine can therefore be used in a controlled way to help prevent withdrawal symptoms and reduce the urge to misuse other opioids.
Estonian: See tähendab, et Sixmot saab kontrollitult kasutada võõrutussümptomite ennetamiseks ja muude opioidide väärkasutamise vähendamiseks.
English: The company that markets Sixmo will set up an educational programme for doctors who are expected to prescribe Sixmo to provide detailed information about the surgical procedure for the insertion and removal of the implant.
Estonian: Sixmo turustaja koostab Sixmot eeldatavasti välja kirjutavatele arstidele koolitusprogrammi, et anda üksikasjalikku teavet implantaadi paigaldamise ja eemaldamise kirurgilise protseduuri kohta.
English: How is Sixmo used?
Estonian: Kuidas Sixmot kasutatakse?
English: It must also not be used by patients who cannot have an MRI scan and by patients who have had an excessive formation of scar tissue, as this would make locating and removing the implants more difficult.
Estonian: Seda ei tohi kasutada ka patsiendid, kellele on MRT vastunäidustatud, ja patsiendid, kellel on tekkinud ulatuslik armkude, sest see võib raskendada implantaatide asukoha tuvastamist ja eemaldamist.
English: The first study compared Sixmo with placebo (dummy) implants in 163 patients who had not received buprenorphine before.
Estonian: Esimeses uuringus võrreldi Sixmot platseeboimplantaatidega (näiv ravim) 163 patsiendil, kes ei olnud varem buprenorfiini saanud.
English: How does Sixmo work?
Estonian: Kuidas Sixmo toimib?
English: Sixmo must not be used by patients with severe respiratory insufficiency (inability to breathe properly), patients with severe liver problems, and patients who are intoxicated with alcohol or are experiencing alcohol withdrawal symptoms.
Estonian: Sixmot ei tohi kasutada raske hingamispuudulikkuse ja raskete maksaprobleemidega patsientidel, samuti alkoholijoobes või alkoholi võõrutusnähtudega patsientidel.
English: In addition, the company will conduct a study to investigate breakages and other complications during the insertion and removal of the implants in clinical practice.
Estonian: Peale selle korraldab turustaja uuringu implantaadi purunemise ja muude tüsistuste kohta implantaatide paigaldamise ja eemaldamise ajal kliinilises praktikas.
English: The main studies showed that Sixmo was more effective than placebo and at least as effective as sublingual buprenorphine at treating opioid dependence.
Estonian: Põhiuuringud näitasid, et Sixmo on opioidisõltuvuse ravis efektiivsem kui platseebo ja vähemalt sama efektiivne kui keelealune buprenorfiin.
English: During the 6 months of treatment, the percentage of negative urine tests for opioids was around 31% for Sixmo, 13% for placebo and 33% for sublingual buprenorphine.
Estonian: 6 ravikuu jooksul oli negatiivseid uriiniproove Sixmo rühmas ligikaudu 31%, platseeborühmas 13% ja keelealuse buprenorfiini rühmas 33%.
English: The insertion and removal of the implant must be performed by a doctor who is experienced in minor surgery and has been trained to carry out the insertion and removal procedures.
Estonian: Implantaate võib paigaldada ja eemaldada arst, kes on pädev tegema väikeseid operatsioone ja kes on saanud paigaldamise ja eemaldamise protseduuri koolituse.
English: During the first 4 months of treatment, the percentage of negative urine tests for opioids was around 40% for patients treated with Sixmo, compared with around 28% for those treated with placebo.
Estonian: Esimese 4 ravikuu ajal olid uriiniproovid opioidide suhtes negatiivsed ligikaudu 40%-l Sixmoga ravitud patsientidest ja 28%-l platseebot saanud patsientidest.
English: The patient receives four implants, which are inserted under local anaesthesia in the inner side of the upper arm and kept in place for 6 months.
Estonian: Patsiendile paigaldatakse lokaalanesteesiat kasutades õlavarre siseküljele 6 kuuks neli implantaati.
English: The second study in 287 patients who had not received buprenorphine before compared Sixmo with placebo implants and with sublingual buprenorphine (given under the tongue).
Estonian: Teises uuringus, kus osales 287 patsienti, kes ei olnud varem buprenorfiini saanud, võrreldi Sixmot platseeboimplantaatidega ja keelealuse buprenorfiiniga.
English: Sixmo is available as an implant to be inserted under the skin, which continuously releases buprenorphine into the body.
Estonian: Sixmot turustatakse nahaaluse implantaadina, mis manustab buprenorfiini pidevalt organismi.
English: What benefits of Sixmo have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Sixmo kasulikkus?
English: Treatment with Sixmo must be under the supervision of a healthcare professional experienced in the management of opioid dependence.
Estonian: Ravi Sixmoga peab toimuma opioidisõltuvuse ravikogemusega meditsiinitöötaja järelevalve all.
English: For the full list of side effects of Sixmo, see the package leaflet.
Estonian: Sixmo kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The side effects of Sixmo are those expected for a buprenorphine medicine and side effects linked to the implant itself are considered manageable.
Estonian: Sixmol on buprenorfiiniravimi tavapärased kõrvalnähud ja implantaadiga seotud kõrvalnähte peetakse hallatavaks.
English: An overview of Sixmo and why it is authorised in the EU
Estonian: Ülevaade ravimist Sixmo ja ELis müügiloa väljastamise põhjendus
English: Why is Sixmo authorised in the EU?
Estonian: ELis Sixmole väljastatud müügiloa põhjendus
English: The European Commission granted a marketing authorisation valid throughout the European Union for NeoRecormon on 17 July 1997.
Estonian: Euroopa Komisjon andis NeoRecormoni müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 17. juulil 1997.
English: • to prevent anaemia in premature babies;
Estonian: • aneemia ennetamine enneaegsetel imikutel;
English: The full EPAR for NeoRecormon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst NeoRecormoni kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: NeoRecormon is available in various strengths from 500 to 50,000 international units (IU).
Estonian: NeoRecormonit turustatakse tugevusega 500-50 000 rahvusvahelist ühikut (RÜ).
English: A risk management plan has been developed to ensure that NeoRecormon is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada NeoRecormoni võimalikult ohutu kasutamine.
English: The multidose formulation of NeoRecormon contains benzyl alcohol and must not be given to children below three years of age.
Estonian: NeoRecormoni mitmeannuseline ravimvorm sisaldab bensüülalkoholi ja seda ei tohi anda alla 3-aastastele lastele.
English: What measures are being taken to ensure the safe and effective use of NeoRecormon?
Estonian: Mis meetmed võetakse, et tagada NeoRecormoni ohutu ja efektiivne kasutamine?
English: NeoRecormon is used in the following situations:
Estonian: NeoRecormonit kasutatakse järgmistel näidustustel:
English: The main measures of effectiveness in most of the studies were whether NeoRecormon increased haemoglobin levels or whether it reduced the need for blood transfusions.
Estonian: Enamikus uuringutest mõõdeti efektiivsust selle alusel, kas NeoRecormon suurendas hemoglobiinisisaldust või vähendas vereülekannete vajadust.
English: The CHMP decided that NeoRecormon's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et NeoRecormoni kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: Other information about NeoRecormon
Estonian: Muu teave NeoRecormoni kohta
English: This is a summary of the European public assessment report (EPAR) for NeoRecormon.
Estonian: See on ravimi NeoRecormon Euroopa avaliku hindamisaruande kokkuvõte.
English: The most common side effects (seen in between 1 and 10 patients in 100) are hypertension (high blood pressure), headache and thromboembolic events (formation of blood clots in the blood vessels).
Estonian: Kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) on hüpertensioon (kõrge vererõhk), peavalu ja trombemboolia juhud (trombidest ehk soonesisestest verehüüvetest põhjustatud probleemid).