FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of side effects reported with Dukoral, see the package leaflet.
Estonian: Dukorali kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The other study in Peru showed that after a booster dose, the protective effectiveness of Dukoral during the second year of follow-up was 61%.
Estonian: Teine Peruu uuring näitas, et pärast revaktsineerimisannust oli Dukorali kaitsva toime efektiivsus järelkontrolli teisel aastal 61%.
English: The company also presented information on the use of Dukoral for the prevention of a severe type of traveller's diarrhoea caused by a bacterium called ‘enterotoxigenic Escherichia coli'.
Estonian: Ettevõte esitas ka andmeid Dukorali kasutamise kohta enterotoksigeense bakteri Escherichia coli põhjustatud reisil esineva raskekujulise kõhulahtisuse ennetamisel.
English: Food, drink and other medicines taken by mouth should be avoided for one hour before and one hour after each dose of Dukoral.
Estonian: Ühe tunni jooksul enne ja pärast iga Dukorali annuse manustamist tuleb vältida toidu, jookide ja teiste suukaudsete ravimite manustamist.
English: What benefit has Dukoral shown during the studies?
Estonian: Milles seisneb uuringute põhjal Dukorali kasulikkus?
English: In the study in Bangladesh, the protective effectiveness of Dukoral was 85% over the first six months of follow-up.
Estonian: Bangladeshi uuringus oli Dukorali kaitsva toime efektiivsus järelkontrolli kuue esimese kuu jooksul 85%.
English: In all three studies, Dukoral, given as either two or three doses, was compared with placebo (a dummy vaccine).
Estonian: Kõigis kolmes uuringus võrreldi kahe või kolme annusena manustatud Dukorali efektiivsust platseeboga (näiv vaktsiin).
English: The vaccine is made up by dissolving the granules in a glass of water to prepare an effervescent (sparkling) solution, and adding the contents of the bottle.
Estonian: Vaktsiini valmistamiseks lahustatakse graanulid klaasis vees kihisevaks lahuseks ja lisatakse sellele pudeli sisu.
English: Side effects with Dukoral are not common.
Estonian: Dukorali kasutamisel esineb kõrvalnähte harva.
English: In the first of the two studies in Peru, the protective effectiveness of Dukoral was 85% for the first five months of follow-up.
Estonian: Esimeses kahest Peruu uuringust oli Dukorali kaitsva toime efektiivsus järelkontrolli viie esimese kuu jooksul 85%.
English: Dukoral contains small amounts of inactivated (killed) cholera bacteria and a part of the cholera toxin called the ‘B subunit'.
Estonian: Dukoral sisaldab vähesel hulgal hävitatud koolerabaktereid ja kooleratoksiini osa, nn B-alamühikut.
English: In adults and children from six years of age, Dukoral is given as two doses, one to six weeks apart.
Estonian: Täiskasvanutele ja vähemalt kuueaastastele lastele manustatakse Dukorali kahe annusena (teine annus üks kuni kuus nädalat pärast esimest).
English: In this study, Dukoral was made using cholera toxin extracted from cholera bacteria in place of the newer recombinant toxin.
Estonian: Selles uuringus oli Dukoralis uuema rekombinantse toksiini asemel koolerabakteritest eraldatud kooleratoksiin.
English: For continuous protection against cholera, a single booster dose is recommended within two years for people from six years of age, and within six months for children aged between two and six years.
Estonian: Pidevaks kooleravastaseks kaitseks on soovitatav manustada vähemalt kuueaastastele lastele kahe aasta kestel ning kahe- kuni kuueaastastele lastele kuue kuu kestel ühekordne revaktsineerimisannus.
English: How is Dukoral used?
Estonian: Kuidas Dukorali kasutatakse?
English: The other two studies compared Dukoral (containing recombinant cholera toxin) with placebo in over 22,000 people in Peru.
Estonian: Kahes ülejäänud uuringus võrreldi Dukorali (mis sisaldas rekombinantset kooleratoksiini) platseeboga üle 22 000 patsiendil Peruus.
English: What is Dukoral used for?
Estonian: Milleks Dukorali kasutatakse?
English: Dukoral is a vaccine that is given by mouth.
Estonian: Dukoral on suukaudne vaktsiin.
English: How does Dukoral work?
Estonian: Kuidas Dukoral toimib?
English: In the future, the immune system will be able to produce antibodies more quickly when it is exposed to cholera bacteria.
Estonian: Kui immuunsüsteem puutub koolerabakteritega hiljem uuesti kokku, tekivad antikehad kiiremini.
English: Its use should be postponed in patients with a short-lived illness affecting the stomach or gut, or with a fever.
Estonian: Lühiajalise mao- või soolehaigusega või palavikuga patsientidel tuleb Dukorali kasutamine edasi lükata.
English: How has Dukoral been studied?
Estonian: Kuidas Dukorali uuriti?
English: The course should be repeated in adults who have not been given a booster within two years and in children not given a booster within six months.
Estonian: Kui täiskasvanu ei saanud kahe aasta kestel ja laps kuue kuu kestel kordusvaktsiini, tuleb vaktsineerimiskuuri korrata.
English: The vaccine can only be obtained with a prescription.
Estonian: Dukoral on retseptivaktsiin.
English: Further information on Brinavess can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/brinavess.
Estonian: Lisateave Brinavessi kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/brinavess.
English: What measures are being taken to ensure the safe and effective use of Brinavess?
Estonian: Mis meetmed võetakse, et tagada Brinavessi ohutu ja efektiivne kasutamine?
English: The European Medicines Agency decided that Brinavess's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Brinavessi kasulikkus on suurem kui sellega kaasnevad riskid ja ravimi kasutamise võib ELis heaks kiita.
English: As for all medicines, data on the use of Brinavess are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse Brinavessi kasutamise kohta pidevat järelevalvet.
English: What is Brinavess and what is it used for?
Estonian: Mis on Brinavess ja milleks seda kasutatakse?
English: Brinavess received a marketing authorisation valid throughout the European Union on 01 September
Estonian: Brinavess on saanud müügiloa, mis kehtib kogu ELis, 1. septembril 2010.
English: Patients should not be given more than 5 mg of Brinavess per kg body weight within any 24-hour period, or a maximum of 565 mg in patients weighing more than 113 kg.
Estonian: 24 tunni jooksul ei tohi Brinavessi manustada rohkem kui 5 mg/kg ehk maksimaalselt 565 mg üle 113 kg kaaluvatele patsientidele.
English: The healthcare professional should monitor the patient's blood pressure and heart rate while the medicine is being given and for at least 15 minutes afterwards.
Estonian: Tervishoiutöötaja peab jälgima patsiendi vererõhku ja südame löögisagedust ravimi manustamise ajal ja kuni vähemalt 15 minuti jooksul.
English: Why has Brinavess been authorised in the EU?
Estonian: Miks Brinavess ELis heaks kiideti?
English: Side effects reported with Brinavess are carefully evaluated and any necessary action taken to protect patients.
Estonian: Brinavessi kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Brinavess have also been included in the summary of product characteristics and the package leaflet.
Estonian: Brinavessi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: What are the risks associated with Brinavess?
Estonian: Mis riskid Brinavessiga kaasnevad?
English: If the blood pressure or heart rate suddenly decreases the infusion should be stopped immediately.
Estonian: Vererõhu või südame löögisageduse äkilise vähenemise korral tuleb infusioon kohe katkestada.
English: For more information about using Brinavess, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Brinavessi kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: If the heart rhythm has not returned to normal 15 minutes after the end of the first infusion, a second, smaller dose may be given.
Estonian: Kui normaalne südamerütm ei taastu 15 minuti jooksul pärast esimese infusiooni lõppu, tuleb manustada teine infusioon väiksemas annuses.
English: Other information about Brinavess
Estonian: Muu teave Brinavessi kohta
English: Brinavess can only be obtained with a prescription and should be given by a qualified healthcare professional in a setting where the patient's heart can be properly monitored.
Estonian: Brinavess on retseptiravim ja seda peab manustama pädev tervishoiutöötaja meditsiiniasutuses, kus patsiendi südametegevust saab nõuetekohaselt jälgida.
English: Brinavess must not be used in patients with severe aortic stenosis (narrowing of the aorta), low systolic blood pressure (blood pressure when the heart is contracting), advanced heart failure (when the heart does not pump enough blood around the body), some types of altered electrical activity in the heart or a very slow heart rate.
Estonian: Brinavessi ei tohi kasutada patsiendid, kellel on aordiklapi raske stenoos (aordi ahenemine), madal süstoolne (nn ülemine) vererõhk, kaugelearenenud südamepuudulikkus (süda ei varusta organismi piisavalt verega), südame elektrilise talitluse teatud muutused või südame väga väike löögisagedus.
English: Brinavess is to be used for atrial fibrillation that has started within the last seven days, or within the last three days if the patient had recently had heart surgery.
Estonian: Brinavessi kasutatakse kodade virvenduse korral, mis tekkis viimase 7 ööpäeva jooksul või viimase 3 ööpäeva jooksul, kui patsiendile tehti hiljuti südameoperatsioon.
English: By blocking these channels, vernakalant can prevent abnormal electrical activity that can lead to atrial fibrillation.
Estonian: Neid kanaleid blokeerides takistab vernakalant kodade virvendust põhjustada võivat ebanormaalset elektrilist talitlust.
English: Brinavess contains the active substance vernakalant hydrochloride.
Estonian: Brinavess sisaldab toimeainena vernakalanthüdrokloriidi.
English: In the first two studies, among patients who had recently started having atrial fibrillation, heart rhythm returned to normal in 51% of those receiving Brinavess (118 out of 231) compared with 4% (6 out of 159) of those taking placebo.
Estonian: Kahes esimeses uuringus oli hiljuti tekkinud kodade virvendusega patsientide seas neid, kellel taastus normaalne südamerütm, Brinavessi uuringurühmas 51% (118 patsienti 231st) ja platseeborühmas 4% (6 patsienti 159st).
English: The most common side effects with Brinavess (which may affect more than 1 person in 10) are dysgeusia (taste disturbances) and sneezing.
Estonian: Brinavessi kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on düsgeusia (maitsehäired) ja aevastamine.
English: The main measure of effectiveness was the proportion of patients whose heart rhythm returned to normal.
Estonian: Efektiivsuse põhinäitaja oli taastunud normaalse südamerütmiga patsientide osakaal.
English: Patients on Brinavess must not be given medicines called ‘class I and III anti-arrhythmics' intravenously during the four hours before or after their Brinavess infusion.
Estonian: Brinavessi saavatele patsientidele ei tohi 4 tunni jooksul pärast Brinavessi infusiooni veeni kaudu manustada I ja III klassi antiarütmikume.
English: The company that markets Brinavess will ensure that healthcare professionals expected to use the medicine are provided with educational material explaining how the medicine should be used.
Estonian: Brinavessi tootja tagab, et kõikides liikmesriikides saavad ravimit eeldatavalt kasutavad tervishoiutöötajad ravimi kasutamist kirjeldava õppematerjali.
English: Brinavess is a medicine used to rapidly restore normal heart rhythm in adult patients who have recently started having atrial fibrillation.
Estonian: Brinavessi kasutatakse normaalse südamerütmi kiireks taastamiseks täiskasvanud patsientidel, kel on hiljuti tekkinud kodade virvendus.
English: Brinavess must not be given within 30 days of having acute coronary syndrome (a group of heart problems that include unstable angina and heart attacks).
Estonian: Brinavessi ei tohi manustada 30 päeva jooksul pärast ägedat koronaarsündroomi (südamehaiguste rühm, sh ebastabiilne rinnaangiin (teatud tugev rindkerevalu) ja südameinfarktid).
English: It restores normal heart rhythm by blocking channels through which charged particles of potassium and sodium move in and out of the muscle cells in the atria.
Estonian: Ravim taastab südamerütmi sellega, et blokeerib kodade lihasrakkudesse sisenevate ja nendest väljuvate kaaliumi- ja naatriumiioonide kanalid.
English: How is Brinavess used?
Estonian: Kuidas Brinavessi kasutatakse?
English: In the third study, heart rhythm returned to normal in 47% of the patients receiving Brinavess compared with 14% of those receiving placebo.
Estonian: Kolmandas uuringus oli patsiente, kellel taastus normaalne südamerütm, Brinavessi rühmas 47% ja platseeborühmas 14%.
English: The dose of Brinavess depends on the patient's body weight.
Estonian: Brinavessi annus sõltub patsiendi kehamassist.
English: A third main study compared Brinavess with placebo in 161 adults who had had atrial fibrillation following heart surgery.
Estonian: Kolmandas põhiuuringus võrreldi Brinavessi platseeboga 161 täiskasvanul, kellel oli
English: What benefits of Brinavess have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Brinavessi kasulikkus?
English: How does Brinavess work?
Estonian: Kuidas Brinavess toimib?
English: An overview of Brinavess and why it is authorised in the EU
Estonian: Ülevaade ravimist Brinavess ja ELis müügiloa väljastamise põhjendus
English: In two main studies involving 596 adults with atrial fibrillation, Brinavess was compared with placebo (a dummy treatment).
Estonian: Kahes põhiuuringus võrreldi Brinavessi platseeboga (näiv ravim) kodade virvendusega 596 täiskasvanul.
English: For the full list of side effects of Brinavess, see the package leaflet.
Estonian: Brinavessi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Atrial fibrillation happens when the atria (the upper chambers of the heart) contract irregularly and rapidly, resulting in abnormal heart rhythm.
Estonian: Kodade virvendus tekib, kui südamekojad tõmbuvad kokku kiiresti ja korrapäratult, põhjustades südame rütmihäireid.
English: Brinavess was more effective than placebo at treating patients who had recently started having atrial fibrillation.
Estonian: Brinavess oli hiljuti tekkinud kodade virvendusega patsientide ravis efektiivsem kui platseebo.
English: Brinavess is a solution that is given by infusion (drip) into a vein over a period of 10 minutes.
Estonian: Brinavessi manustatakse 10 minutit kestva veeniinfusioonina.
English: Brinavess contains vernakalant, a type of substance known as an anti-arrhythmic.
Estonian: Brinavessi toimeaine vernakalant on antiarütmikum (südame rütmihäirete ravim).
English: Vernakalant acts mainly in the atria rather than in the ventricles (the lower chambers of the heart).
Estonian: Vernakalant toimib rohkem südamekodades kui -vatsakestes.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mysimba on 26 March 2015.
Estonian: Euroopa Komisjon andis Mysimba müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 26. märtsil
English: What measures are being taken to ensure the safe and effective use of Mysimba?
Estonian: Mis meetmed võetakse, et tagada Mysimba ohutu ja efektiivne kasutamine?
English: A risk management plan has been developed to ensure that Mysimba is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Mysimba võimalikult ohutu kasutamine.
English: The full EPAR and risk management plan summary for Mysimba 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 Mysimba kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Mysimba
Estonian: Muu teave Mysimba kohta
English: Mysimba naltrexone / bupropion
Estonian: Mysimba naltreksoon/bupropioon
English: It will also carry out a further study to assess the effect of the medicine on the heart and blood vessels.
Estonian: Ettevõte viib läbi ka lisauuringu, et hinnata ravimi toimet südamele ja veresoontele.
English: What is Mysimba and what is it used for?
Estonian: Mis on Mysimba ja milleks seda kasutatakse?
English: Why is Mysimba approved?
Estonian: Miks Mysimba heaks kiideti?
English: Treatment with Mysimba is started with a single tablet each morning, with the dose gradually increased over 4 weeks to the recommended dose of two tablets twice a day, preferably taken with food.
Estonian: Ravi Mysimbaga alustatakse ühe tabletiga igal hommikul ja annust suurendatakse nelja nädala jooksul soovitatava annuseni, milleks on kaks tabletti kaks korda ööpäevas, soovitatavalt koos toiduga.
English: Prolonged-release means that naltrexone and bupropion are released slowly from the tablet over a few hours.
Estonian: Toimeaine prolongeeritult vabastamine tähendab, et naltreksoon ja bupropioon vabanevad tabletist aeglaselt mõne tunni jooksul.
English: On the balance of the available evidence the CHMP decided that Mysimba's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Olemasolevate tõendite tasakaalu kohta otsustas inimravimite komitee, et Mysimba kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that although the effectiveness of the medicine in promoting weight loss was limited, it was sufficient to be clinically significant, and mandatory re-assessment of treatment after 4 months should ensure that the medicine only continues to be used in those in whom the medicine provides adequate benefit.
Estonian: Inimravimite komitee oli seisukohal, et kuigi ravimi efektiivsus kaalu langetamisel on piiratud, on see kliiniliselt piisavalt oluline ja ravi kohustuslik taashindamine 4 kuu järel peaks tagama, et ravimi kasutamist jätkavad ainult need, kellele ravim on piisavalt kasulik.
English: • who are overweight (have a BMI between 27 and 30) and have weight-related complications such as diabetes, abnormally high levels of fat in the blood, or high blood pressure.
Estonian: • ülekaalulised (KMI vahemikus 27-30) ja kellel on kehakaaluga seonduvad tüsistused, näiteks diabeet, vere ebaharilikult suur rasvasisaldus, kõrge vererõhk.
English: In the other study, in which patient counselling was also more intensive, the overall weight loss was greater over the study period: 8.1% with Mysimba and 4.9% with placebo.
Estonian: Teises uuringus, kus patsiente nõustati rohkem, oli kaalulangus uuringuperioodi jooksul üldiselt suurem: 8,1% Mysimba ja 4,9% platseebo korral.
English: Mysimba contains the active substances naltrexone and bupropion, which are licensed individually in the EU for other uses.
Estonian: Mysimba sisaldab toimeainena naltreksooni ja bupropiooni, mis on ELis eraldi heaks kiidetud muudel näidustustel.
English: Mysimba should also be stopped if patients have not lost at least 5% of their initial body weight after 4 months of treatment.
Estonian: Mysimba kasutamine tuleb lõpetada ka patsientidel, kes ei ole pärast 4-kuust ravi kaotanud vähemalt 5% oma algsest kehakaalust.
English: Patients should have their response and tolerability to the medicine checked regularly and treatment should be stopped in patients who have certain side effects such as an increase in blood pressure.
Estonian: Patsientide ravivastust ja ravimitaluvust tuleb regulaarselt kontrollida ja ravi tuleb peatada patsientidel, kellel tekib teatud kõrvalnähte, nagu vererõhu tõus.
English: Interim data from an ongoing study of cardiovascular outcomes were reviewed during the assessment although the CHMP also recommended ongoing monitoring of the medicine's cardiovascular effects.
Estonian: Hindamises vaadati läbi käimasoleva kardiovaskulaarsete tulemuste uuringu vaheandmed, kuid inimravimite komitee soovitas siiski ravimi kardiovaskulaarset toimet järjepidevalt seirata.
English: Mysimba is available as prolonged-release tablets containing 7.2 mg naltrexone and 78 mg bupropion and can only be obtained with a prescription.
Estonian: Mysimbat turustatakse toimeainet prolongeeritult vabastavate tablettidena, mis sisaldavad 7,2 mg naltreksooni ja 78 mg bupropiooni.
English: It is not intended to provide practical advice on how to use Mysimba.
Estonian: Hindamisaruandes ei anta Mysimba kasutamise praktilisi nõuandeid.
English: In three of the studies, the average weight loss in patients treated with Mysimba was around 3.7 to 5.7%, compared with 1.3 to 1.9% with placebo; the proportion of Mysimba-treated patients who achieved 5% weight loss ranged from 28 to 42% compared with 12 to 14% with placebo.
Estonian: Neist kolmes uuringus oli Mysimbaga ravitud patsientide keskmine kaalulangus ligikaudu 3,7-5,7% võrreldes 1,3-1,9%-ga platseebo puhul; Mysimbaga ravitud patsientide osakaal, kelle kaal langes 5%, oli vahemikus 28-42% võrreldes 12-14%-ga platseebo puhul.
English: What are the risks associated with Mysimba?
Estonian: Mis riskid Mysimbaga kaasnevad?
English: The exact way that Mysimba works is not fully understood, but the two active substances, naltrexone and bupropion, act on the parts of the brain that control food intake and energy balance, as well as reducing the effect of the part of the brain that controls the pleasure associated with eating food.
Estonian: Mysimba täpne toime ei ole lõplikult selgeks tehtud, kuid kaks toimeainet naltreksoon ja bupropioon avaldavad mõju söömist ja energia tasakaalu kontrollivatele ajupiirkondadele ning vähendavad söömisega seotud naudingut kontrolliva ajupiirkonna toimet.
English: The treatment effect was more marked in patients who completed 56 weeks of treatment, or who had lost at least 5% of their original body weight by 4 months.
Estonian: Ravitoime oli silmatorkavam patsientidel, kes tegid 56-nädalase ravi lõpuni või kes olid 4 kuu jooksul kaotanud vähemalt 5% oma algsest kehakaalust.
English: BMI is a measurement that indicates body weight relative to height.
Estonian: KMI on mõõtühik, mis näitab kehakaalu ja pikkuse suhet.
English: Patients in the studies were given the medicine as part of a weight loss programme involving counselling and advice on diet and exercise.
Estonian: Uuringutes manustati patsientidele ravimit kaalulangetamisprogrammi raames, millesse kuulusid ka nõustamine ning dieedi ja füüsilise koormuse alased nõuanded.
English: The most common side effects with Mysimba (which may affect more than 1 in 10 people) are nausea and vomiting (feeling and being sick) and constipation; dizziness and dry mouth were also common (seen in up to 1 patient in 10).
Estonian: Mysimba kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on iiveldus, oksendamine ja kõhukinnisus; sagedad (esinenud kuni 1 patsiendil 10st) on ka peapööritus ja suukuivus.
English: When given together, their actions reduce appetite and the amount that patients eat, and increase energy expenditure, helping them to stick to a calorie-controlled diet and to reduce their body weight.
Estonian: Toimeaineid koos manustades vähendavad need söögiisu ja patsientide söödavat toidukogust ning suurendavad energiakulu, aidates patsientidel jätkata piiratud kaloraažiga dieeti ja langetada kehakaalu.