FrancophonIA/ELRC3.0 huggingface dataset:
English: Pritor must not be used in women who are more than three months pregnant.
Estonian: Pritorit ei tohi kasutada rasedad pärast esimest kolme raseduskuud.
English: Pritor is used to treat essential hypertension (high blood pressure) in adults.
Estonian: Pritorit kasutatakse essentsiaalse hüpertensiooni (kõrgvererõhutõve) ravimiseks täiskasvanud patsientidel.
English: Side effects with Pritor are not common.
Estonian: Pritori kasutamisel esineb kõrvalnähte harva.
English: For the full list of all side effects reported with Pritor, see the package leaflet.
Estonian: Pritori kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: What benefit has Pritor shown during the studies?
Estonian: Milles seisneb uuringute põhjal Pritori kasulikkus?
English: Pritor is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes.
Estonian: Pritorit kasutatakse ka kardiovaskulaarsete (südame-veresoonkonna) häirete, näiteks infarkti või insuldi ennetamiseks.
English: How has Pritor been studied?
Estonian: Kuidas Pritorit uuriti?
English: What is Pritor used for?
Estonian: Milleks Pritorit kasutatakse?
English: How is Pritor used?
Estonian: Kuidas Pritorit kasutatakse?
English: The medicine can only be obtained with a prescription.
Estonian: Pritor on retseptiravim.
English: By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke.
Estonian: Blokeerides retseptorid, millega angiotensiin II tavaliselt seondub, peatab telmisartaan hormooni toime.
English: How does Pritor work?
Estonian: Kuidas Pritor toimib?
English: 24 January 2014
Estonian: 24. jaanuar 2014
English: For more information, see here.
Estonian: Lisateavet vt siit.
English: What is Winfuran?
Estonian: Mis on Winfuran?
English: Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) EMA/33514/2014
Estonian: Müügiloa taotluse tagasivõtmise teave: Winfuran (nalfurafiin) EMA/33514/2014
English: The main measure of effectiveness was the change in symptoms such as itching intensity and sleep disturbance after 4 weeks of treatment based on a standard scoring system.
Estonian: Efektiivsuse põhinäitaja oli muutus sümptomites, nagu sügeluse intensiivsus ja unehäired, standardse hindamissüsteemi alusel pärast 4 ravinädalat.
English: Withdrawal of the marketing authorisation application for Winfuran (nalfurafine)
Estonian: Müügiloa taotluse tagasivõtmise teave: Winfuran (nalfurafiin)
English: Winfuran activates different opioid receptors, called kappa receptors, which block the activity of the mu-opioid receptors and therefore relieve the itching in patients with uraemic pruritus.
Estonian: Winfuran aktiveerib teistsuguseid opioidretseptoreid, mida nimetatakse kapa-retseptoriteks, mis blokeerivad μ-opioidi retseptorite aktiivsust ja sellega leevendavad sügelust ureemilise sügelusega patsientidel.
English: Uraemic pruritus is a persisting form of itching that occurs in some patients whose kidneys are not functioning properly.
Estonian: Ureemiline sügelus on püsiv sügeluse vorm, mis esineb mõnedel patsientidel, kelle neerud ei tööta korralikult.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes for Winfuran.
Estonian: Ettevõte teatas inimravimite komiteele, et Winfuraniga ei ole jätkuvaid kliinilisi uuringuid ega eriloaga kasutamise programme.
English: Although the exact cause of uraemic pruritus is not known it is thought that the itching is linked to an excessive activity of certain receptors called mu-opioid receptors in the brain and skin.
Estonian: Kuigi ureemilise sügeluse täpne põhjus ei ole teada, arvatakse, et sügelus on seotud ajus ja nahas leiduvate teatud μ-opioidi retseptorite ülemäärase aktiivsusega.
English: Although an additional analysis showed a modest benefit in a subpopulation of patients with a severe form of uraemic pruritus, the CHMP considered that the clinical relevance had not been shown.
Estonian: Kuigi lisaanalüüs näitas tagasihoidlikku kasulikkust ureemilise sügeluse raske vormiga patsientide alampopulatsioonis, leidis inimravimite komitee, et kliinilist asjakohasust ei ole tõendatud.
English: Winfuran was to be used in patients with end-stage renal disease (when the kidneys have stopped working completely) and who are on dialysis (a technique for removing waste products from the blood).
Estonian: Winfurani kavatseti kasutada lõppstaadiumis neeruhaigusega (kui neerud on täielikult lõpetanud töötamise) patsientidel, kes saavad dialüüsi (tehnika jääkainete eemaldamiseks verest).
English: In its official letter, the company stated that its decision to withdraw the application was based on the CHMP's view that the data provided do not allow the Committee to conclude on a positive benefit-risk balance.
Estonian: Oma ametlikus kirjas teatas ettevõte oma otsusest võtta taotlus tagasi, sest inimravimite komitee leidis, et esitatud andmed ei võimaldanud komiteel järeldada positiivset kasulikkuse ja riski tasakaalu.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Winfuran did not outweigh its risks and it concluded that the medicine could not have been approved on the basis of the data presented by the company.
Estonian: Seetõttu oli inimravimite komitee müügiloa taotluse tagasivõtmise ajal arvamusel, et Winfurani kasulikkus ei ole suurem kui sellega kaasnevad riskid, ning otsustas, et ettevõtte esitatud andmete alusel ei saa ravimit heaks kiita.
English: The CHMP's main concern was that the benefits of Winfuran in the treatment of uraemic pruritus had not been sufficiently shown.
Estonian: Inimravimite komitee peamiseks probleemiks oli see, et Winfurani kasulikkust ureemilise sügeluse raviks ei olnud piisavalt tõendatud.
English: The effects of Winfuran were compared with placebo (a dummy treatment) in one main study involving 339 patients with uraemic pruritus who were on regular dialysis.
Estonian: Ühes põhiuuringus võrreldi Winfurani toimeid platseeboga (näiv ravim) 339 ureemilise sügelusega patsiendil, kes said regulaarselt dialüüsi.
English: The main study failed to show that Winfuran was more effective than placebo at relieving itching.
Estonian: Põhiuuring ei näidanud, et Winfuran oleks sügeluse leevendamisel platseebost efektiivsem.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Winfuran for the treatment of severe uraemic pruritus.
Estonian: Tuginedes esitatud andmete analüüsile, oli komitee andnud taotluse tagasivõtmise ajal negatiivse arvamuse ega soovitanud anda ravimile Winfuran raske ureemilise sügeluse raviks müügiluba.
English: On 17 January 2014, Toray International U.K. Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Winfuran, intended for the treatment of severe uraemic pruritus (a form of itching) in patients with end-stage kidney disease on dialysis.
Estonian: Toray International U.K. Limited teatas 17. jaanuaril 2014 ametlikult inimravimite komiteele oma soovist võtta tagasi ravimi Winfuran müügiloa taotlus.
English: Winfuran is a medicine that contains the active substance nalfurafine.
Estonian: Winfuran sisaldab toimeainena nalfurafiini.
English: The effects of Winfuran were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Winfurani toimet muude katsetega.
English: What was Winfuran expected to be used for?
Estonian: Milleks kavatseti Winfurani kasutada?
English: Winfuran was expected to be used for the treatment of patients with severe uraemic pruritus.
Estonian: Winfurani kavatseti kasutada raske ureemilise sügelusega patsientide raviks.
English: How is Winfuran expected to work?
Estonian: Milline on Winfurani eeldatav toime?
English: Winfuran was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 September 2002 for uraemic pruritus.
Estonian: Winfuran nimetati 11. septembril 2002 ureemilise sügeluse harvikravimiks.
English: It was to be available as a concentrate for solution for infusion into a vein.
Estonian: Ravimit kavatseti turustada veeni manustatava infusioonilahuse kontsentraadina.
English: What measures are being taken to ensure the safe and effective use of Olysio?
Estonian: Mis meetmed võetakse, et tagada Olysio ohutu ja efektiivne kasutamine?
English: What is Olysio and what is it used for?
Estonian: Mis on Olysio ja milleks seda kasutatakse?
English: The full EPAR and risk management plan summary for Olysio 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 Olysio kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is one capsule taken once a day with food for 12 or 24 weeks.
Estonian: Soovitatav annus on üks kapsel üks kord ööpäevas koos toiduga 12 või 24 nädala jooksul.
English: Olysio is available as 150 mg capsules.
Estonian: Olysiot turustatakse 150 mg kapslitena.
English: Olysio is used in combination with other medicines.
Estonian: Olysiot kasutatakse koos teiste ravimitega.
English: How does Olysio work?
Estonian: Kuidas Olysio toimib?
English: The European Medicines Agency decided that Olysio's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Euroopa Ravimiamet (EMA) otsustas, et Olysio kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: For the full list of side effects and restrictions, see the package leaflet.
Estonian: Kõrvalnähtude ja piirangute täielik loetelu on pakendi
English: The Agency also considered that the data available support the use of Olysio in combination with sofosbuvir.
Estonian: Lisaks leidis amet, et olemasolevad andmed toetavad Olysio kasutamist koos sofosbuviiriga.
English: Olysio is an antiviral medicine that contains the active substance simeprevir.
Estonian: Olysio on viirusvastane ravim, mis sisaldab toimeainena simepreviiri.
English: It is not intended to provide practical advice on how to use Olysio.
Estonian: Hindamisaruandes ei anta Olysio kasutamise praktilisi nõuandeid.
English: What are the risks associated with Olysio?
Estonian: Mis riskid Olysioga kaasnevad?
English: This is a summary of the European public assessment report (EPAR) for Olysio.
Estonian: See on ravimi Olysio Euroopa avaliku hindamisaruande kokkuvõte.
English: The most common side effects during treatment with Olysio (which may affect more than 1 in 10 people) are nausea (feeling sick), rash, pruritus (itching) and dyspnoea (difficulty breathing).
Estonian: Olysio kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on iiveldus, lööve, kihelus ja düspnoe (raskendatud hingamine).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Olysio have also been included in the summary of product characteristics and the
Estonian: Olysio ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Regarding its safety, Olysio was well tolerated and the side effects were manageable.
Estonian: Ohutuse kohta märgiti, et patsiendid talusid Olysiot hästi ja kõrvalnähud olid juhitavad.
English: Several varieties (genotypes) of hepatitis C virus exist and Olysio is recommended for patients with virus of genotypes 1 and 4.
Estonian: C-hepatiidi viirusel on mitu genotüüpi (varianti), Olysiot soovitatakse viiruse 1. ja 4. genotüübiga patsientidele.
English: Olysio must be used in combination with other medicines used to treat chronic hepatitis C, such as with peginterferon alfa and ribavirin or with sofosbuvir.
Estonian: Olysiot peab kasutama koos teiste kroonilise C-hepatiidi ravimitega, näiteks alfapeginterferooni ja ribaviriiniga või sofosbuviiriga.
English: Three main studies involving 1,178 patients with hepatitis C virus of genotype 1 investigated the combination with peginterferon alfa and ribavirin.
Estonian: Kolmes põhiuuringus, kus osales 1178 C-hepatiidi viiruse 1. genotüübiga patsienti, uuriti ravimi kombinatsiooni alfapeginterferooni ja ribaviriiniga.
English: The study included patients with and without cirrhosis as well as patients who had not responded to previous therapy.
Estonian: Uuringus osalesid ka tsirroosiga ja tsirroosita patsiendid ning varasema ravivastuseta patsiendid.
English: What benefits of Olysio have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Olysio kasulikkus?
English: Prolonging treatment to 24 weeks resulted in a clearance rate of above 90%.
Estonian: Ravi pikendamisel 24 nädalani ei tuvastatud viirust enam kui 90%-l patsientidest.
English: For practical information about using Olysio, patients should read the package leaflet or contact their
Estonian: Kui vajate Olysio kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või
English: It is used to treat adults with chronic (long-term) hepatitis C, an infectious disease that affects the liver caused by the hepatitis C virus.
Estonian: Olysiot kasutatakse kroonilise (pikaajalise) C-hepatiidi (C-hepatiidi viiruse põhjustatud nakkuslik maksahaigus) raviks täiskasvanutel.
English: Several studies show that Olysio in combination with peginterferon alfa and ribavirin or with sofosbuvir is effective in clearing the hepatitis C virus from the blood after 12 or 24 weeks of treatment.
Estonian: Mitu uuringut on tõendanud, et koos alfapeginterferooni ja ribaviriiniga või sofosbuviiriga kasutatav Olysio eemaldab viiruse efektiivselt verest 12 või 24 ravinädala järel.
English: The active substance in Olysio, simeprevir, blocks the action of an enzyme called ‘NS3/4A serine protease' in the hepatitis C virus, which is essential for the virus to multiply.
Estonian: Olysio toimeaine simepreviir blokeerib C-hepatiidi viiruse paljunemisel osaleva ensüümi NS3/4A seriinproteaasi.
English: An analysis of these studies showed that Olysio was less effective in a sub-group of patients infected with hepatitis C virus genotype 1a that has the Q80K mutation.
Estonian: Uuringute analüüs tõendas, et Olysio toime oli nõrgem patsientidel, kes olid nakatunud C-hepatiidi viiruse 1a genotüübiga, millel oli Q80K-mutatsioon.
English: Before starting treatment with Olysio, patients with genotypes 1a should have a blood test to check whether the virus they are infected with has a mutation (a change in the genetic material of the virus) called Q80K, as Olysio is known to be less effective in these patients.
Estonian: Enne Olysio ravi tuleb 1a genotüübiga patsientidel teha vereanalüüs, et tuvastada, kas nende haigust põhjustav viirus on mutatsiooniga (viiruse geenimaterjali muutus) Q80K, sest neil on
English: The European Commission granted a marketing authorisation valid throughout the European Union for
Estonian: Euroopa Komisjon andis Olysio müügiloa, mis kehtib kogu Euroopa Liidus, 14. mail 2014.
English: Olysio can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C.
Estonian: Ravi peab alustama ja jälgima kroonilise C-hepatiidi ravis kogenud arst.
English: For more information about treatment with Olysio, read the package leaflet (also part of the EPAR) or contact
Estonian: Kui vajate Olysioga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The company that markets Olysio will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Olysio.
Estonian: Olysiot turustav ettevõte teeb nende patsientide uuringu, kel oli olnud maksavähk, et hinnata maksavähi taastumise riski pärast ravi selliste vahetu toimega viirusvastaste ravimitega nagu Olysio, sest on andmeid, et varasema maksavähiga patsientide ravimine nende ravimitega võib tekitada neil vähi kiirema taastumise riski.
English: The Agency concluded that, in both previously untreated patients and patients who had already been treated, adding Olysio to treatment with peginterferon alfa and ribavirin considerably increased the number of patients showing no sign of infection.
Estonian: Amet järeldas, et Olysio lisamine alfapeginterferoonile ja ribaviriinile suurendab oluliselt nakkuseta patsientide arvu nii varem ravimata kui ka ravitud patsientide hulgas.
English: In two of the studies, which involved previously untreated patients, around 80% (419 out of 521) of patients taking Olysio tested negative for hepatitis C 12 weeks after the end of treatment, compared with 50% (132 out of 264) of patients on placebo.
Estonian: Kahes uuringus, kus osalesid varem ravimata patsiendid, oli patsiente, kelle vereanalüüs oli 12 nädala järel C-hepatiidi suhtes negatiivne, Olysio uuringurühmas ligikaudu 80% (419 patsienti 521st) ja platseeborühmas 50% (132 patsienti 264st).
English: In two additional studies of simeprevir in combination with sofosbuvir in 413 patients, patients without cirrhosis who were taking Olysio together with sofosbuvir had a clearance rate at 12 weeks of 97%, while patients with cirrhosis had a 12 weeks clearance rate of 83%.
Estonian: Kahes lisauuringus (413 patsienti), kus simepreviiri kasutati koos sofosbuviiriga, oli 12 ravinädala järel viiruseta 97% tsirroosita patsientidest, kes kasutasid Olysiot koos sofosbuviiriga, ning 83% tsirroosiga
English: Additional studies of the combination with peginterferon alfa and ribavirin involving patients with hepatitis C virus of genotype 4 and patients with HIV co-infection showed results consistent with those in patients with genotype 1.
Estonian: C-hepatiidi viiruse 4. genotüübi ja HIV kaasinfektsiooniga patsientidel tehtud Olysio ning alfapeginterferooni ja ribaviriini kombinatsiooni lisauuringute tulemused olid kooskõlas 1. genotüübi patsientide uuringutega.
English: In the third study, involving patients whose infections had come back following treatment with interferon-based therapy, around 80% (206 out of 260) of patients taking Olysio tested negative for hepatitis C 12 weeks after the end of treatment, compared with around 37% (49 out of 133) of
Estonian: Kolmandas uuringus, kus osalesid patsiendid, kelle haigus oli pärast interferoonravi taastunud, oli patsiente, kelle vereanalüüs oli 12 nädala järel C-hepatiidi suhtes negatiivne, Olysio uuringurühmas ligikaudu 80% (206 patsienti 260st) ja platseeborühmas ligikaudu 37% (49 patsienti 133st).
English: Olysio taken together with sofosbuvir was investigated in a study involving 167 patients, which showed that the combination (with or without ribavirin) cleared infection with hepatitis C genotype 1 in around 90% of patients 12 weeks after the end of treatment.
Estonian: Uuringu tulemuste järgi oli selle kombinatsiooni (ribaviriiniga või ilma) kasutamisel patsiente, kellel ei tuvastatud 12 ravinädala järel C-hepatiidi viiruse 1. genotüübi nakkust, ligikaudu 90%.
English: Date of first authorisation: 04 January 2017
Estonian: Müügiloa esmase väljastamise kuupäev: 4. jaanuar 2017
English: Like all medicines, AFSTYLA can cause side effects, although not everybody gets them.
Estonian: Nagu kõik ravimid, võib ka AFSTYLA põhjustada kõrvaltoimeid, kuigi kõigil neid ei teki.
English: ATC code: B02BD02
Estonian: ATC-kood: B02BD02
English: The amount of AFSTYLA you need to take and the duration of treatment depend on:
Estonian: AFSTYLA kogus, mida peate võtma, ja ravi kestus sõltuvad:
English: At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Estonian: Vähemalt 1 päev, kuni verejooksuepisood, mida näitab valu, lõpeb või saavutatakse paranemine.
English: Other medicines and AFSTYLA
Estonian: Muud ravimid ja AFSTYLA
English: The product contain traces of hamster proteins (see also “Do not use AFSTYLA”).
Estonian: Preparaat sisaldab hamstri valkude jälgi (vt ka „Ärge kasutage AFSTYLA't”).
English: Osmolality: 500 - 600 mOsm/kg
Estonian: Osmolaalsus: 500-600 mOsm/kg
English: Check yourself for any side effects that might happen straight away.
Estonian: Jälgige end võimalike kõrvaltoimete suhtes, mis võivad kohe tekkida.
English: Monitoring laboratory tests
Estonian: Laboratoorsete analüüside jälgimine
English: Minor surgery including tooth extraction
Estonian: Operatsioon Väiksem operatsioon sealhulgas hamba väljatõmbamine
English: Do not stop using AFSTYLA without consulting your doctor.
Estonian: Ärge lõpetage AFSTYLA kasutamist oma arstiga nõu pidamata.
English: Frequency of doses (hours) / Duration of therapy (days)
Estonian: Annuste sagedus (tundi) / ravi kestus (päeva)
English: Elderly Clinical studies of AFSTYLA did not include subjects over 65 years of age.
Estonian: Eakad AFSTYLA kliinilistesse uuringutesse ei kaasatud üle 65 aasta vanuseid patsiente.
English: However depending on your body weight and your dose of AFSTYLA, you could receive more than one vial.
Estonian: Kuid olenevalt teie kehakaalust ja teie AFSTYLA annusest võidakse teile manustada rohkem kui üks viaal.
English: - Reconstitution and withdrawal must be carried out under aseptic conditions.
Estonian: - Manustamiskõlblikuks muutmine ja väljavõtmine tuleb sooritada aseptilistes tingimustes.
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Estonian: Bioloogiliste ravimite jälgitavuse parandamiseks tuleb manustatava toote nimi ja partii number selgelt dokumenteerida.
English: Repeat injection every 12 to 24 hours.
Estonian: Korrata süsti iga 12 kuni 24 tunni järel.
English: The AFSTYLA solution must not be diluted.
Estonian: AFSTYLA lahust ei tohi lahjendada.
English: Of note, annualized bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Estonian: Tuleb märkida, et aastane verejooksu määr (ABR) ei ole erinevate faktori kontsentraatide vahel ja erinevate kliiniliste uuringute vahel võrreldav.
English: Do not expose the vials to direct heat.
Estonian: Ärge laske viaalidel otsese kuumusega kokku puutuda.
English: Paediatric population <12 years of age
Estonian: Lapsed vanuses < 12 aastat
English: What AFSTYLA is and what it is used for
Estonian: Mis ravim on AFSTYLA ja milleks seda kasutatakse
English: Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.
Estonian: Seetõttu tohib VIII hüübimisfaktorit raseduse ja imetamise ajal kasutada vaid siis, kui see on selgelt näidustatud.
English: Factor VIII is involved in blood clotting.
Estonian: VIII faktor osaleb vere hüübimises.
English: • If you have been told you have heart disease or are at risk for heart disease, tell your doctor or pharmacist.
Estonian: • Kui teile on öeldud, et teil on südamehaigus või teil on risk südamehaiguse tekkeks, teavitage sellest oma arsti või apteekrit.
English: Your doctor should inform you of the early signs of allergic reactions.
Estonian: Teie arst peab teid teavitama allergiliste reaktsioonide varastest nähtudest.
English: Lack of this factor means that blood does not clot as quickly as it should so there is an increased tendency to bleed.
Estonian: Selle faktori puudumine tähendab, et veri ei hüübi nii kiiresti kui peaks, mistõttu esineb soodumus verejooksude tekkeks.
English: • if you are allergic to hamster proteins.
Estonian: • kui olete hamstri valkude suhtes allergiline.
English: • your clinical condition and response
Estonian: • teie kliinilisest seisundist ja ravivastusest;