FrancophonIA/ELRC3.0 huggingface dataset:
English: Then, the outer membranes that contain the ‘surface antigens' (proteins on the outer membrane of the virus that the body recognises as foreign) were extracted and purified before being included in the vaccine.
Estonian: Seejärel eraldati välismembraanid, mis sisaldavad pinnaantigeene (viiruse välismembraanil olevad valgud, mille keha tunneb ära kui võõra), ja enne vaktsiini lisamist need puhastati.
English: The CHMP was concerned over the way the main clinical study was carried out.
Estonian: Inimravimite komitee ettevaatlikkuse põhjuseks oli peamise kliinilise uuringu läbiviimise viis.
English: It consists of a suspension for injection that contains some parts (outer membranes) of the influenza (flu) virus strain called A/VietNam/1194/2004.
Estonian: See koosneb süstesuspensioonist, mis sisaldab gripiviiruse tüve nimega A/VietNam/1194/2004 teatud osi (väliskesti ehk -membraane).
English: A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Estonian: Gripipandeemia tekib siis, kui esile kerkib gripiviiruse uus tüvi, mis suudab kergesti levida ühelt inimeselt teisele, sest inimestel puudub selle viiruse vastane immuunsus (kaitse).
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Aflunov could not have been approved for the prophylaxis of H5N1 avian influenza.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi inimravimite komitee taotluse tagasivõtmise ajal põhjuseid ettevaatlikkuseks ja oli esialgsel seisukohal, et Aflunovi kasutamist H5N1 linnugripi profülaktikaks ei ole võimalik heaks kiita.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with Aflunov?
Estonian: Kuidas mõjutab tagasivõtmine praegu Aflunovi kliinilistes uuringutes osalevaid patsiente?
English: When a person is given the vaccine, the immune system recognises the parts of the flu virus it contains as ‘foreign' and makes antibodies against them.
Estonian: Kui inimesele manustatakse vaktsiini, tunneb immuunsüsteem, et selles olevad gripiviiruse osad on võõrad ja hakkab tootma selle vastu antikehi.
English: officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Aflunov, for the prophylaxis of H5N1 avian influenza in adults and the elderly.
Estonian: ametlikult inimravimite komiteed oma soovist võtta tagasi müügiloa taotlus ravimi Aflunov kohta, mis oli ette nähtud H5N1 linnugripi profülaktikaks täiskasvanutel ja eakatel patsientidel.
English: Aflunov was expected to be used in adults and the elderly to protect against flu caused by the H5N1 strain (type) of the influenza A virus.
Estonian: Aflunovi plaaniti kasutada täiskasvanutel ja eakatel patsientidel kaitseks gripi A viiruse H5N1 tüve (tüübi) eest.
English: The company informed the CHMP that there are no consequences for individuals currently included in clinical trials with Aflunov.
Estonian: Ettevõte teatas inimravimite komiteele, et praegu Aflunovi kliinilistes uuringutes osalevatele patsientidele tagasivõtmine mõju ei avalda.
English: The immune system will be able to produce antibodies more quickly when it is exposed to flu virus of the same strain.
Estonian: Edaspidi suudab immuunsüsteem gripiviiruse sama tüvega kokkupuutel toota antikehi kiiremini.
English: The effects of Aflunov were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Aflunovi toimet muude katsetega.
English: How is Aflunov expected to work?
Estonian: Milline on Aflunovi eeldatav toime?
English: What was Aflunov expected to be used for?
Estonian: Milleks kavatseti Aflunovi kasutada?
English: The full EPAR for Bondronat can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Bondronati kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Bondronat is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Bondronati võimalikult ohutu kasutamine.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bondronat on 25 June 1996.
Estonian: Euroopa Komisjon andis Bondronati müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 25. juunil
English: What measures are being taken to ensure the safe and effective use of Bondronat?
Estonian: Mis meetmed võetakse, et tagada Bondronati ohutu ja efektiivne kasutamine?
English: Other information about Bondronat
Estonian: Muu teave Bondronati kohta
English: The infusion will normally bring the blood calcium level down to normal levels within a week.
Estonian: Infusioon normaliseerib vere kaltsiumisisalduse tavaliselt ühe nädalaga.
English: Bondronat was not compared with any other treatments in these studies.
Estonian: Ravimit Bondronat nendes uuringutes teiste ravimitega ei võrreldud.
English: The tablet should be taken after the patient has not eaten anything for at least six hours overnight and at least 30 minutes before the first food or drink of the day.
Estonian: Tablett tuleb alati võtta pärast seda, kui patsient on olnud vähemalt 6 tundi öösel söömata, ning vähemalt 30 minutit enne päeva esimest toidu- ja joogikorda.
English: The main measure of effectiveness was based on the number of new bone complications.
Estonian: Efektiivsuse põhinäitaja oli uute luutüsistuste arv.
English: Bondronat is used in adults in the following ways:
Estonian: Ravimit Bondronat kasutatakse täiskasvanud patsientidel järgmiste näidustuste korral:
English: The main measure of effectiveness was the change in blood calcium levels.
Estonian: Efektiivsuse põhinäitaja oli vere kaltsiumisisalduse muutus.
English: The CHMP decided that Bondronat's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Bondronati kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: The tablets must not be used in patients who have abnormalities of the oesophagus or who cannot stand or sit up for at least an hour.
Estonian: Tablette ei tohi kasutada patsiendid, kellel on söögitoru häired või kes ei saa vähemalt tund aega seista või sirgelt istuda.
English: Bondronat reduced the risk of having a skeletal event by about 40% compared with placebo.
Estonian: Bondronat vähendas platseeboga võrreldes luukahjustuste tekke riski ligikaudu 40% võrra.
English: This is a summary of the European public assessment report (EPAR) for Bondronat.
Estonian: See on ravimi Bondronat Euroopa avaliku hindamisaruande kokkuvõte.
English: It is available as a concentrate that is made up into a solution for infusion (drip) into a vein, and as tablets (50 mg).
Estonian: Seda turustatakse infusioonilahuse (veeni tilgutatava lahuse) kontsentraadina ja 50 mg tablettidena.
English: The most serious side effects with Bondronat are anaphylactic reaction (severe allergic reaction), atypical fractures of the femur (an unusual type of fracture of the bone of the upper leg), osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth), and eye inflammation.
Estonian: Bondronati kõige raskemad kõrvalnähud on anafülaktiline reaktsioon (raske allergiareaktsioon), reieluu ebatüüpilised murrud, lõualuu osteonekroos (luukoe kärbumine, mis võib põhjustada valu, suuhaavandeid või hammaste logisemist) ja silmapõletik.
English: For more information about treatment with Bondronat, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Bondronatiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: What is the risk associated with Bondronat?
Estonian: Mis riskid Bondronatiga kaasnevad?
English: Bondronat must not be used in people with hypocalcaemia.
Estonian: Ravimit Bondronat ei tohi kasutada hüpokaltseemiaga patsiendid.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bondronat, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Bondronati omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: In addition, the company that markets Bondronat will provide a card to inform patients receiving Bondronat infusion about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Estonian: Lisaks varustab Bondronati turustaja patsiendid teabekaardiga, milles selgitatakse lõualuu osteonekroosi riski ning soovitatakse sümptomite tekkimisel pöörduda arsti poole.
English: Bondronat treatment should only be started by a doctor who has experience in the treatment of cancer.
Estonian: Ravi Bondronatiga tohib alustada ainult vähiravis kogenud arst.
English: Why has Bondronat been approved?
Estonian: Miks Bondronat heaks kiideti?
English: Bondronat was also effective in treating hypercalcaemia caused by tumours.
Estonian: Bondronat oli efektiivne ka vähi põhjustatud hüperkaltseemia ravis.
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 Bondronat.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: • as an infusion or as a tablet to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone);
Estonian: • infusiooni või tabletina luukahjustuste (luumurrud või ravi vajavad luutüsistused) ennetamiseks patsientidel, kellel on rinnavähk ja luumetastaasid (vähk on levinud luudesse);
English: Bondronat has also been studied in the treatment of hypercalcaemia caused by tumours in three fourweek studies involving a total of 343 patients.
Estonian: Ravimit Bondronat uuriti vähi põhjustatud hüperkaltseemia ravis kolmes 4 nädalat kestnud uuringus, kus osales kokku 343 patsienti.
English: About a half to two-thirds of the patients responded to a 2-mg dose of Bondronat, with blood calcium levels returning to within the normal range.
Estonian: 2 mg Bondronati annusele reageeris umbes pool kuni kaks kolmandikku patsientidest ja kaltsiumisisaldus nende veres normaliseerus.
English: It took longer for patients on Bondronat infusions or tablets to develop a new bone complication (50 to 76 weeks) than for patients on placebo (33 to 48 weeks).
Estonian: Bondronati infusiooni või tablette kasutanud patsientidel tekkisid uued luutüsistused hiljem kui platseeborühma patsientidel (Bondronati korral 50-76 nädalaga, platseebo korral 33-48 nädalaga).
English: Patients with moderate or severe kidney problems should receive Bondronat infusions at a lower dose over an hour, or the tablet every two days or every week.
Estonian: Mõõdukate või raskete neeruprobleemidega patsientidele manustatakse Bondronati infusioon ühe tunni jooksul väiksema annusena või tablett iga kahe päeva järel või kord nädalas.
English: These included spine fractures, fractures outside the spine and any bone complications that needed treatment with radiotherapy or surgery.
Estonian: Tüsistused olid näiteks lülisambamurrud, muud luumurrud ja kõik muud luutüsistused, mis vajasid kiiritusravi või operatsiooni.
English: In the prevention of skeletal events, Bondronat is either given as a 6-mg infusion lasting at least 15 minutes every three to four weeks, or as one tablet once a day.
Estonian: Luukahjustuste ennetamiseks manustatakse patsientidele ravimit Bondronat vähemalt 15 minutit kestva 6 mg infusioonina iga 3 või 4 nädala järel või üks tablett üks kord ööpäevas.
English: In the prevention of skeletal events in patients with breast cancer and bone metastases, Bondronat has been compared with placebo (a dummy treatment) in three main studies lasting two years: one with the infusions in 466 patients and two with the tablets in a total of 846 patients.
Estonian: Ravimit Bondronat uuriti luukahjustuste ennetamisel rinnavähi ja luumetastaasidega patsientidel kolmes 2 aastat kestnud põhiuuringus: ühes infusiooni uuringus (466 patsienti) ning kahes tablettide uuringus (kokku 846 patsienti).
English: In the treatment of hypercalcaemia caused by tumours, Bondronat is given over 2 hours as an infusion of either 2 or 4 mg, depending on how severe the hypercalcaemia is.
Estonian: Kasvaja põhjustatud hüperkaltseemia raviks manustatakse ravimit Bodronat 2 mg või 4 mg 2 tundi kestva infusioonina olenevalt sellest, kas hüperkaltseemia on mõõdukas või raske.
English: About three-quarters responded to a 4-mg dose.
Estonian: 4 mg annusele reageeris ligikaudu kolmveerand patsientidest.
English: This leads to less bone loss.
Estonian: See takistab luukoe hävimist.
English: The active substance in Bondronat, ibandronic acid, is a bisphosphonate.
Estonian: Bondronati toimeaine ibandroonhape on bisfosfonaat.
English: The most common side effects with Bondronat infusions are a rise in body temperature, hypocalcaemia (low blood calcium levels), asthenia (weakness) and headache.
Estonian: Bondronati infusiooni kõige sagedamad kõrvalnähud on kehatemperatuuri tõus, hüpokaltseemia (liiga väike kaltsiumisisaldus veres), asteenia (nõrkus) ja peavalu.
English: For the full list of all side effects and restrictions reported with Bondronat, see the package leaflet.
Estonian: Bondronati kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Estonian: Luukoe hävimist vähendades muudab ravim luud murdudele vastupidavamaks, millega saab ennetada luumurdude teket luumetastaasidega vähipatsientidel.
English: where tap water contains a lot of dissolved calcium, bottled water with a low mineral content may be used).
Estonian: Tablett tuleb võtta klaasitäie veega (kui kraanivesi on kare, st sisaldab palju kaltsiumisooli, võib kasutada vähese mineraalisisaldusega pudelivett).
English: By preventing the breakdown of bones, Bondronat also helps to reduce the amount of calcium released into the blood.
Estonian: Luukoe lagunemist peatades aitab Bondronat vähendada verre eralduva kaltsiumi kogust.
English: Bondronat is a medicine that contains the active substance ibandronic acid.
Estonian: Bondronat on ravim, mis sisaldab toimeainena ibandroonhapet.
English: • as an infusion to treat hypercalcaemia (high levels of calcium in the blood) caused by tumours.
Estonian: • infusioonina kasvaja põhjustatud hüperkaltseemia (vere liigne kaltsiumisisaldus) raviks.
English: What is Bondronat?
Estonian: Mis on Bondronat?
English: Bondronat was more effective than placebo in preventing bone complications.
Estonian: Luutüsistuste ennetamisel oli Bontronat efektiivsem kui platseebo.
English: The most common side effects with the tablets are hypocalcaemia and dyspepsia (heartburn).
Estonian: Tablettide kasutamisel on kõige sagedamad kõrvalnähud hüpokaltseemia ja düspepsia (kõrvetised).
English: What benefit has Bondronat shown during the studies?
Estonian: Milles seisneb uuringute põhjal Bondronati kasulikkus?
English: Patients with tumours can have high levels of calcium in their blood, released from the bones.
Estonian: Kasvaja tõttu võib patsiendi veres olla palju luudest eraldunud kaltsiumi.
English: It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Estonian: Toimeaine pärsib osteoklastide ehk luukoe lagundamises osalevate rakkude aktiivsust.
English: Bondronat ibandronic acid
Estonian: Bondronat ibandroonhape
English: How has Bondronat been studied?
Estonian: Kuidas ravimit Bondronat uuriti?
English: How is Bondronat used?
Estonian: Kuidas ravimit Bondronat kasutatakse?
English: How does Bondronat work?
Estonian: Kuidas Bondronat toimib?
English: What is Bondronat used for?
Estonian: Milleks ravimit Bondronat kasutatakse?
English: Intravenous use vial (glass) 12 (12x1) vials (multipack)
Estonian: 12 viaali (12 x 1) (hulgipakend)
English: (Invented) name Strength Pharmaceutical form
Estonian: Tugevus Ravimvorm Manustamistee Sisepakendi iseloomustus
English: Convincing data to identify a patient population in which the benefits of meprobamate clearly outweigh its identified risks.
Estonian: veenvad andmed patsientide populatsiooni kohta, kellel meprobamaadi kasulikkus ületab selgelt sellega seoses kindlakstehtud riskid.
English: Annex III Conditions for lifting the suspension of the marketing authorisations
Estonian: III lisa Müügilubade peatamise lõpetamise tingimused
English: For the suspension to be lifted, the Marketing Authorisation Holders would need to provide the National Competent Authorities with the following:
Estonian: Müügilubade peatamise otsuse tühistamiseks peavad müügiloa hoidjad esitama riiklikele ravimiametitele:
English: 2 sets of constituents
Estonian: 2 komplekti
English: 1 set of constituents
Estonian: 1 komplekt
English: However, the following efficacy and safety issues were addressed:
Estonian: Samas käsitleti alljärgnevaid efektiivsuse ja ohutuse küsimusi.
English: This should be dealt with as a follow-up request.
Estonian: Sellega tuleks tegelda järeltaotluse raames.
English: Benefit/Risk considerations
Estonian: Kasulikkuse/riski kaalutlused
English: Results continuously improved with increasing experience over the course of 11 years.
Estonian: Tulemused muutusid paremaks kasvavate kogemuste najal 11 aasta jooksul.
English: Austria, Cyprus, Czech Republic, Denmark, Germany, Greece, Spain, Finland, France, Hungary, Ireland, Italy, Norway, Poland, Portugal, Slovakia, Slovenia, Sweden,United Kingdom.
Estonian: Austria, Küpros, Tšehhi Vabariik, Taani, Saksamaa, Kreeka, Hispaania, Soome, Prantsusmaa, Ungari, Iirimaa, Itaalia, Norra, Poola, Portugal, Slovakkia, Sloveenia, Rootsi, Ühendkuningriik.
English: To date, no other relevant epidemiological data are available.
Estonian: Tänaseks päevaks ei ole saadaval muid epidemioloogilisi andmeid.
English: • Safety issues
Estonian: • Ohutusküsimused
English: Belgium, Luxembourg, The Netherlands.
Estonian: Belgia, Luksemburg, Holland.
English: The long-term safety profile of tacrolimus has not been systematically studied.
Estonian: Takroliimuse pikaajalist ohutuseprofiili ei ole süstemaatiliselt uuritud.
English: Distribution and elimination
Estonian: Jaotumine ja eliminatsioon
English: 1640 Nicosia
Estonian: 1640 Nikosia
English: Approximately 2% of the radioactivity was eliminated in the urine.
Estonian: Ligikaudu 2% radioaktiivsusest elimineerus uriiniga.
English: Most of the data supporting this indication are as expected retrospective.
Estonian: Enamik seda näidustust toetavatest andmetest saadakse teadagi retrospektiivselt.
English: 28223 Pozuelo de Alarcón (Madrid) Spain
Estonian: 28223 Pozuelo de Alarcón (Madrid) Hispaania
English: Classification and terminology were amended according to the MedDRA system organ class.
Estonian: Muudeti liigitust ja terminoloogiat vastavalt MedDRA süsteemi organite klassile.
English: Your doctor will tell you exactly how many capsules to take and how often.
Estonian: Arst ütleb teile täpselt, kui palju ja kui sageli peate kapsleid võtma.
English: The three studies demonstrated similar survival rates.
Estonian: Kolm uuringut näitasid sarnast elulemust.
English: The divergences identified at the start of the referral have been resolved.
Estonian: Esildismenetluse algul määratletud lahknevuste küsimus on lahendatud.
English: Your doctor will advise you on the best course of action.
Estonian: Arst soovitab teile parima meetodi.
English: Always take <Invented name> exactly as your doctor has told you.
Estonian: Võtke <(Väljamõeldud) nimetus> alati täpselt nii nagu arst on teile rääkinud.
English: Intravenous therapy should not be continued for more than 7 days.
Estonian: Intravenoosne ravi ei tohi kesta kauem kui 7 päeva.
English: The safety database for tacrolimus is fragmented and uncertain.
Estonian: Takroliimuse ohutuse andmebaas on killustatud ja ebamäärane.
English: 2350 AC Leiderdorp The Netherlands
Estonian: 2350 AC Leiderdorp Holland
English: Middlesex TW18 3AZ United Kingdom
Estonian: Middlesex, TW18 3AZ Ühendkuningriik
English: Your dose depends on your general condition and on which other immunosuppressive medication you are taking.
Estonian: Annus sõltub teie üldseisundist ja sellest, milliseid teisi immunosupressiivseid ravimeid te võtate.
English: 114 rue Victor Hugo 92300 Levallois Perret France
Estonian: 114 rue Victor Hugo 92300 Levallois Perret Prantsusmaa
English: EXP: {MM/YYYY}
Estonian: EXP: {KK/AAAA}
English: The capsules should be swallowed whole with a glass of water.
Estonian: Kapslid tuleb neelata tervelt koos klaasi veega.
English: Capsules should be taken immediately following removal from the blister.
Estonian: Kapslid tuleb võtta vahetult peale blistrist eemaldamist.
English: There is no evidence currently available to indicate that dosing should be adjusted in elderly patients.
Estonian: Hetkel puudub tõendusmaterjal, mis viitaks sellele, et eakatel patsientidel tuleks annustamist vastavalt korrigeerida.
English: Like all medicines, <Invented name> can cause side effects, although not everybody gets them.
Estonian: Nagu kõik ravimid, võib ka <(Väljamõeldud) nimetus> põhjustada kõrvaltoimeid, kuigi kõigil neid ei teki.
English: There are several metabolites identified.
Estonian: Kindlaks on tehtud mitu metaboliiti.
English: The course of preexisting infections may be aggravated.
Estonian: Olemasolevate infektsioonide kulg võib raskeneda.
English: The use of live attenuated vaccines should be avoided.
Estonian: Vältida tuleb nõrgestatud elusvaktsiinide kasutamist.
English: Consequently, your body will not be as good as usual at fighting infections.
Estonian: Seetõttu ei ole teie organism võimeline tavapärasel viisil infektsioonide vastu võitlema.
English: You will receive <Invented name> as a continuous 24-hour infusion and never as a short injection.
Estonian: Te saate <(Väljamõeldud) nimetus> pideva 24-tunnise infusioonina ning mitte kunagi lühiajalise süstena.
English: This medicinal product is authorised in the Member States of the EEA under the following name:
Estonian: Ravimi registreeritud nimetused Euroopa Majanduspiirkonna (EEA) liikmesriikides on järgmised:
English: Metabolism and biotransformation
Estonian: Metabolism ja biotransformatsioon
English: In addition, synergistic/additive nephrotoxic effects can occur.
Estonian: Lisaks võivad tekkida sünergistlikud/aditiivsed nefrotoksilised toimed.
English: United Kingdom Astellas Pharma Ltd. Lovett House, Lovett Road Staines
Estonian: Ühendkuningriik Astellas Pharma Ltd. Lovett House, Lovett Road Staines
English: If you have previously had such a problem, please inform your doctor.
Estonian: Kui teil on varem sellist probleemi esinenud, palun teavitage sellest oma arsti.
English: The half-life of tacrolimus is long and variable.
Estonian: Takroliimuse poolväärtusaeg on pikk ja varieeruv.
English: toxic epidermal necrolysis (Lyell's syndrome)
Estonian: toksiline epidermise nekrolüüs (Lyelli sündroom)