natgillin/translations-raw huggingface dataset:
Brinavess is a medicine used to rapidly restore normal heart rhythm in adult patients who have recently started having atrial fibrillation.
Brinavessi kasutatakse normaalse südamerütmi kiireks taastamiseks täiskasvanud patsientidel, kel on hiljuti tekkinud kodade virvendus.
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).
Brinavessi ei tohi manustada 30 päeva jooksul pärast ägedat koronaarsündroomi (südamehaiguste rühm, sh ebastabiilne rinnaangiin (teatud tugev rindkerevalu) ja südameinfarktid).
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.
Ravim taastab südamerütmi sellega, et blokeerib kodade lihasrakkudesse sisenevate ja nendest väljuvate kaaliumi- ja naatriumiioonide kanalid.
How is Brinavess used?
Kuidas Brinavessi kasutatakse?
In the third study, heart rhythm returned to normal in 47% of the patients receiving Brinavess compared with 14% of those receiving placebo.
Kolmandas uuringus oli patsiente, kellel taastus normaalne südamerütm, Brinavessi rühmas 47% ja platseeborühmas 14%.
The dose of Brinavess depends on the patient's body weight.
Brinavessi annus sõltub patsiendi kehamassist.
A third main study compared Brinavess with placebo in 161 adults who had had atrial fibrillation following heart surgery.
Kolmandas põhiuuringus võrreldi Brinavessi platseeboga 161 täiskasvanul, kellel oli
What benefits of Brinavess have been shown in studies?
Milles seisneb uuringute põhjal Brinavessi kasulikkus?
How does Brinavess work?
Kuidas Brinavess toimib?
An overview of Brinavess and why it is authorised in the EU
Ülevaade ravimist Brinavess ja ELis müügiloa väljastamise põhjendus
In two main studies involving 596 adults with atrial fibrillation, Brinavess was compared with placebo (a dummy treatment).
Kahes põhiuuringus võrreldi Brinavessi platseeboga (näiv ravim) kodade virvendusega 596 täiskasvanul.
For the full list of side effects of Brinavess, see the package leaflet.
Brinavessi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
Atrial fibrillation happens when the atria (the upper chambers of the heart) contract irregularly and rapidly, resulting in abnormal heart rhythm.
Kodade virvendus tekib, kui südamekojad tõmbuvad kokku kiiresti ja korrapäratult, põhjustades südame rütmihäireid.
Brinavess was more effective than placebo at treating patients who had recently started having atrial fibrillation.
Brinavess oli hiljuti tekkinud kodade virvendusega patsientide ravis efektiivsem kui platseebo.
Brinavess is a solution that is given by infusion (drip) into a vein over a period of 10 minutes.
Brinavessi manustatakse 10 minutit kestva veeniinfusioonina.
Brinavess contains vernakalant, a type of substance known as an anti-arrhythmic.
Brinavessi toimeaine vernakalant on antiarütmikum (südame rütmihäirete ravim).
Vernakalant acts mainly in the atria rather than in the ventricles (the lower chambers of the heart).
Vernakalant toimib rohkem südamekodades kui -vatsakestes.
The European Commission granted a marketing authorisation valid throughout the European Union for Mysimba on 26 March 2015.
Euroopa Komisjon andis Mysimba müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 26. märtsil
What measures are being taken to ensure the safe and effective use of Mysimba?
Mis meetmed võetakse, et tagada Mysimba ohutu ja efektiivne kasutamine?
A risk management plan has been developed to ensure that Mysimba is used as safely as possible.
Töötati välja riskijuhtimiskava, et tagada Mysimba võimalikult ohutu kasutamine.
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.
Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Mysimba kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Mysimba
Muu teave Mysimba kohta
Mysimba naltrexone / bupropion
Mysimba naltreksoon/bupropioon
It will also carry out a further study to assess the effect of the medicine on the heart and blood vessels.
Ettevõte viib läbi ka lisauuringu, et hinnata ravimi toimet südamele ja veresoontele.
What is Mysimba and what is it used for?
Mis on Mysimba ja milleks seda kasutatakse?
Why is Mysimba approved?
Miks Mysimba heaks kiideti?
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.
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.
Prolonged-release means that naltrexone and bupropion are released slowly from the tablet over a few hours.
Toimeaine prolongeeritult vabastamine tähendab, et naltreksoon ja bupropioon vabanevad tabletist aeglaselt mõne tunni jooksul.
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.
Olemasolevate tõendite tasakaalu kohta otsustas inimravimite komitee, et Mysimba kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
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.
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.
• 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.
• ülekaalulised (KMI vahemikus 27-30) ja kellel on kehakaaluga seonduvad tüsistused, näiteks diabeet, vere ebaharilikult suur rasvasisaldus, kõrge vererõhk.
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.
Teises uuringus, kus patsiente nõustati rohkem, oli kaalulangus uuringuperioodi jooksul üldiselt suurem: 8,1% Mysimba ja 4,9% platseebo korral.
Mysimba contains the active substances naltrexone and bupropion, which are licensed individually in the EU for other uses.
Mysimba sisaldab toimeainena naltreksooni ja bupropiooni, mis on ELis eraldi heaks kiidetud muudel näidustustel.
Mysimba should also be stopped if patients have not lost at least 5% of their initial body weight after 4 months of treatment.
Mysimba kasutamine tuleb lõpetada ka patsientidel, kes ei ole pärast 4-kuust ravi kaotanud vähemalt 5% oma algsest kehakaalust.
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.
Patsientide ravivastust ja ravimitaluvust tuleb regulaarselt kontrollida ja ravi tuleb peatada patsientidel, kellel tekib teatud kõrvalnähte, nagu vererõhu tõus.
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.
Hindamises vaadati läbi käimasoleva kardiovaskulaarsete tulemuste uuringu vaheandmed, kuid inimravimite komitee soovitas siiski ravimi kardiovaskulaarset toimet järjepidevalt seirata.
Mysimba is available as prolonged-release tablets containing 7.2 mg naltrexone and 78 mg bupropion and can only be obtained with a prescription.
Mysimbat turustatakse toimeainet prolongeeritult vabastavate tablettidena, mis sisaldavad 7,2 mg naltreksooni ja 78 mg bupropiooni.
It is not intended to provide practical advice on how to use Mysimba.
Hindamisaruandes ei anta Mysimba kasutamise praktilisi nõuandeid.
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.
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.
What are the risks associated with Mysimba?
Mis riskid Mysimbaga kaasnevad?
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.
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.
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.
Ravitoime oli silmatorkavam patsientidel, kes tegid 56-nädalase ravi lõpuni või kes olid 4 kuu jooksul kaotanud vähemalt 5% oma algsest kehakaalust.
BMI is a measurement that indicates body weight relative to height.
KMI on mõõtühik, mis näitab kehakaalu ja pikkuse suhet.
Patients in the studies were given the medicine as part of a weight loss programme involving counselling and advice on diet and exercise.
Uuringutes manustati patsientidele ravimit kaalulangetamisprogrammi raames, millesse kuulusid ka nõustamine ning dieedi ja füüsilise koormuse alased nõuanded.
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).
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.
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.
Toimeaineid koos manustades vähendavad need söögiisu ja patsientide söödavat toidukogust ning suurendavad energiakulu, aidates patsientidel jätkata piiratud kaloraažiga dieeti ja langetada kehakaalu.
Regarding safety, although the CHMP had some concerns about possible effects on the heart and blood vessels (cardiovascular outcomes) and a slightly increased risk of seizures (fits), the most common side effects were largely manageable, as patients could stop taking the medicine if they were bothersome.
Kuigi inimravimite komitee pidas ohutusega seoses murettekitavaks võimalikku toimet südamele ja veresoontele (kardiovaskulaarsed tulemused) ning pisut suurenenud krambihoogude riski, leiti, et kõige sagedamad kõrvalnähud on enamjaolt kontrollitavad, sest ravi tülikaks muutumisel on patsientidel võimalus see katkestada.
The effects of Mysimba in reducing body weight have been shown in 4 main studies involving around 4,500 obese or overweight patients, in which Mysimba was compared with placebo (a dummy treatment).
Mysimba toime kehakaalu langetamisel on tõendatud neljas põhiuuringus, milles osales ligikaudu 4500 rasvunud või ülekaalulist patsienti ja milles Mysimbat võrreldi platseeboga (näiv ravim).
Mysimba is a medicine used along with diet and exercise to help manage weight in adults:
Mysimba on ravim, mida kasutatakse koos dieedi ja füüsilise koormusega kehakaalu langetamiseks täiskasvanutel, kes on
The degree of improvement with Mysimba over placebo was similar using different methods of analysis, although the benefits were smallest with the most conservative methods that assumed patients who did not complete the study would not have seen any improvement.
Eri analüüsimeetodeid kasutades olid edusammud Mysimba manustamisel võrreldes platseeboga sarnased, kuigi kasulikkus oli väikseim kõige konservatiivsemate meetodite korral, kus eeldati, et uuringus osalemise katkestanud patsiendid ei tee edusamme.
In addition, the company that markets Mysimba will produce an information pack for doctors prescribing the medicine, including guidance on stopping treatment in patients who do not respond or if there are concerns about side effects.
Peale selle varustab Mysimbat turustav ettevõte ravimit määravad arstid teabematerjaliga, kuhu kuuluvad juhised nende patsientide ravi katkestamise kohta, kes ravile ei allu või kellele tekitavad probleeme kõrvalnähud.
For the full list of all side effects reported with Mysimba, see the package leaflet.
Mysimba kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
• who are obese (have a body-mass index - BMI - of 30 or more);
• rasvunud (kehamassiindeks (KMI) on 30 või suurem);
For practical information about using Mysimba, patients should read the package leaflet or contact their doctor or pharmacist.
Kui vajate Mysimba kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Mysimba, including the appropriate precautions to be followed by healthcare professionals and patients.
Selle alusel lisati Mysimba omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
How does Mysimba work?
Kuidas Mysimba toimib?
This is a summary of the European public assessment report (EPAR) for Mysimba.
See on ravimi Mysimba Euroopa avaliku hindamisaruande kokkuvõte.
For more information about treatment with Mysimba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Kui vajate Mysimbaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
What benefits of Mysimba have been shown in studies?
Milles seisneb uuringute põhjal Mysimba kasulikkus?
About 13 to 22% of those taking Mysimba achieved at least a 10% reduction in weight, while 5 to 6% of placebotreated patients did so.
Mysimbat manustanud patsientidest ligikaudu 13-22%-l langes kehakaal vähemalt 10%, platseebot saanud patsientidest aga 5-6%-l.
How is Mysimba used?
Kuidas Mysimbat kasutatakse?
Some 46% and 30% of patients given Mysimba achieved 5 and 10% weight reductions respectively, compared with 34% and 17% respectively with placebo.
Kehakaal langes 5% ja 10% vastavalt ligikaudu 46% ja 30% Mysimbat saanud patsientidel, platseebo korral olid need näitajad vastavalt 34% ja 17%.
those who have ever had seizures (fits), certain psychological problems or who have a brain tumour or are undergoing withdrawal from alcohol or certain drugs.
Mysimbat ei tohi manustada suure kõrvalnähtude riskiga patsientidele, sh patsientidele, kellel on väga raske neeru- või maksapuudulikkus või ravile allumatu kõrge vererõhk, kellel on olnud krambihoogusid või teatud psühholoogilisi probleeme, kellel on ajukasvaja või kes on alkoholi või teatud uimastite võõrutusravil.
The main measures of effectiveness were the percentage reduction in body weight over 28 or 56 weeks of treatment, and the proportion of patients who achieved at least a 5% weight reduction; the studies also looked at the number of patients who achieved at least a more stringent 10% reduction in weight, and the results were analysed using various methods to take account of the number of patients who did not complete the studies (around 50% over one year).
Tulemusi analüüsiti mitme meetodiga, et võtta arvesse nende patsientide arvu, kes uuringutes lõpuni ei osalenud (ligikaudu 50% ühe aasta jooksul).
26 July 2012
26. juuli 2012
The full European Public Assessment Report for Velcade can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Euroopa avaliku hindamisaruande täistekst Velcade kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
It has been authorised in the EU since April 2004.
Velcadel on Euroopa Liidus müügiluba alates 2004. aasta aprillist.
The main measure of effectiveness was progression free survival (how long the patients lived without their disease getting worse).
Peamine efektiivsuse näitaja oli haiguse progresseerumisvaba elulemus (näitab, kui kaua patsiendid haiguse süvenemiseta elasid).
After the CHMP had assessed the company's responses to its first round of questions, there were still some unresolved issues.
Pärast seda, kui inimravimite komitee oli tutvunud ettevõtte vastustega esimese ringi küsimustele, olid mõned probleemid endiselt lahendamata.
When the proteins in cancer cells, such as the proteins that control the growth of the cells, are not broken down, the cells are affected and eventually die.
Kui vähirakus olevaid valke, näiteks rakkude kasvu kontrollivaid valke, ei lagundata, kahjustab see rakke ja lõpuks rakud hävivad.
The CHMP questioned the relevance of the study results which showed that, overall, patients treated with Velcade plus rituximab lived without their disease getting worse for an average of 1.8 months longer than patients treated with rituximab alone (12.8 months compared with 11 months).
Inimravimite komitee kahtles uuringu nende tulemuste olulisuses, millest selgus, et üldiselt elasid Velcadet koos rituksimabiga saanud patsiendid haiguse süvenemiseta keskmiselt 1,8 kuud kauem kui patsiendid, keda raviti üksnes rituksimabiga (12,8 kuud võrreldes 11 kuuga).
It blocks the proteasome, which is a system within cells that breaks down proteins when they are no longer needed.
Bortesomiib blokeerib proteasoomi ehk rakkudes oleva süsteemi, mis lagundab valke, kui neid enam ei vajata.
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Taotlus võeti tagasi pärast seda, kui inimravimite komitee oli hinnanud ettevõtte poolt esitatud andmeid ja edastanud ettevõttele oma küsimused.
In its official letter, the company stated that it decided to withdraw the application because the CHMP considered that the data provided did not support a positive benefit-risk balance.
Oma ametlikus kirjas teatas ettevõte otsusest taotlus tagasi võtta, sest inimravimite komitee arvates ei kinnitanud esitatud andmed ravimi kasulikkuse ja riski positiivset suhet.
The Committee considered that this difference was unlikely to be relevant and was not convinced that a sub-group of patients had been identified who would benefit more from the addition of Velcade to rituximab.
Inimravimite komitee arvates ei ole see erinevus tõenäoliselt oluline ning komitee ei olnud veendunud, et on kindlaks tehtud patsientide alarühm, kes saaks Velcade kasutamisest koos rituksimabiga rohkem kasu.
The CHMP had concerns about the methodology used to analyse the results, which left some uncertainties about the size of the effect seen.
Inimravimite komiteel kahtles uuringu tulemuste analüüsimisel kasutatud metodoloogias, sest mõne toime ulatus jäi ebaselgeks.
It is also used on its own in patients whose disease is progressive and who have failed to respond to at least one other treatment and have already had, or cannot undergo, a bone marrow transplant.
Samuti kasutatakse Velcadet ainsa ravimina patsientidel, kelle haigus progresseerub ja ravivastus vähemalt ühele muule ravile puudub ning kellele on juba siiratud luuüdi või kellele ei saa luuüdi siirata.
Velcade was also expected to be used in follicular non-Hodgkin lymphoma (a cancer of the lymph tissue (part of the immune system) that affects a type of white blood cell called B lymphocytes, or B cells), in combination with another medicine called rituximab in patients whose disease had relapsed (returned after treatment).
Velcadet kavatseti kasutada koos rituksimabiga follikulaarse mitte-Hodgkini lümfoomi (lümfisüsteemi (üks immuunsüsteemi osa) kasvaja, mis mõjutab B-lümfotsüüte ehk B-rakke (teatud valgelibled)) raviks patsientidel, kellel haigus on relapseerunud (pärast ravi naasnud).
Velcade is a medicine given by injection that contains the active substance bortezomib.
Velcade on süstena manustatav ravim, mis sisaldab toimeainena bortesomiibi.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Velcade in the treatment of relapsed follicular non-Hodgkin lymphoma did not outweigh its risks.
Seetõttu oli inimravimite komitee taotluse tagasivõtmise ajal arvamusel, et Velcade kasulikkus relapseerunud follikulaarse mitte-Hodgkini lümfoomi ravis ei ole suurem kui sellega kaasnevad riskid.
On 2 July 2012, Janssen-Cilag International N.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation of Velcade, which would have extended its use to patients with relapsed follicular non-Hodgkin lymphoma.
teatas 2. juulil 2012 ametlikult inimravimite komiteele oma soovist võtta tagasi taotlus muuta ravimi Velcade müügiluba, et laiendada ravimi kasutamist relapseerunud follikulaarse mitte-Hodgkini lümfoomiga patsientidele.
It is given in combination with melphalan and prednisone (other medicines for multiple myeloma) to patients who have not been treated before and who are not suitable for high-dose chemotherapy with a bone marrow transplant.
Velcadet kasutatakse koos melfalaani ja prednisooniga (teised hulgimüeloomi ravimid) varem ravimata patsientide raviks, kui patsiendil ei saa kasutada suureannuselist keemiaravi koos luuüdi siirdamisega.
The CHMP was also concerned that the combination of Velcade and rituximab caused more side effects than rituximab alone.
Peale selle valmistas inimravimite komiteele muret asjaolu, et Velcade kombineerimine rituksimabiga põhjustas rohkem kõrvaltoimeid kui ainult rituksimabi kasutamine.
Based on the review of the data and the company's response to the CHMP's questions, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Velcade could not have been approved for the treatment of patients with relapsed follicular non-Hodgkin lymphoma.
Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, oli inimravimite komitee taotluse tagasivõtmise ajal esialgsel arvamusel, et Velcadet ei saa relapseerunud follikulaarse mitte-Hodgkini lümfoomiga patsientide raviks heaks kiita.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Velcade.
Ettevõtte teatas inimravimite komiteele, et praegu Velcade kliinilistes uuringutes osalevaid patsiente taotluse tagasivõtmine ei mõjuta.
In relapsed follicular non-Hodgkin lymphoma, Velcade was expected to work in the same way as it does in its existing indications.
Velcade eeldatav toime follikulaarse mitte-Hodgkini lümfoomi korral on samalaadne mis olemasolevate näidustuste korral.
There are no consequences on the use of Velcade in its authorised indications.
Müügiloa laiendamise taotluse tagasivõtmine ei mõjuta Velcade kasutamist heakskiidetud näidustustel.
What is happening with Velcade for the treatment of multiple myeloma?
Kuidas mõjutab taotluse tagasivõtmine Velcade kasutamist hulgimüeloomi raviks?