FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Thymanax on 19 February 2009.
Estonian: Euroopa Komisjon andis Thymanaxi müügiloa, mis kehtib kogu Euroopa Liidus, 19. veebruaril 2009.
English: Thymanax agomelatine
Estonian: Thymanax agomelatiin
English: The full EPAR for Thymanax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Thymanaxi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Patients with depression should be treated for at least six months to make sure that they are free of symptoms.
Estonian: Depressiooniga patsiente peab ravima vähemalt 6 kuud, et tagada sümptomitest vabanemine.
English: The active comparator groups were included to check that the study was able to measure the effectiveness of medicines in treating depression.
Estonian: Aktiivse võrdlusravimi rühmad lisati selleks, et kontrollida, kas uuringuga saab mõõta ravimite efektiivsust depressiooni ravimisel.
English: It works in two ways, by stimulating the MT1 and MT2 receptors and by blocking the 5-HT2C receptors in the brain.
Estonian: See toimib kahel viisil: stimuleerides MT1 ja MT2 retseptoreid ja blokeerides 5-HT2C retseptoreid ajus.
English: This is thought to lead to increases in the levels of the neurotransmitters dopamine and noradrenaline.
Estonian: Arvatakse, et see suurendab neurotransmitterite dopamiini ja noradrenaliini sisaldust.
English: What measures are being taken to ensure the safe and effective use of Thymanax?
Estonian: Mis meetmed võetakse, et tagada Thymanaxi ohutu ja efektiivne kasutamine?
English: If there is no improvement in symptoms after two weeks, the doctor may increase the dose to two tablets taken together at bedtime.
Estonian: Kui sümptomid 2 nädala pärast ei parane, võib arst suurendada annust kahe tabletini, mis võetakse korraga enne magamaminekut.
English: The main measure of effectiveness was the number of patients whose symptoms returned during 24 to 26 weeks of treatment.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kelle sümptomid 24-26-nädalase ravi ajal taastekkisid.
English: Thymanax might also help to normalise the patient's sleep patterns.
Estonian: Thymanax võib aidata normaliseerida ka patsiendi unerütmi.
English: Symptoms often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, a feeling of being slowed down, feelings of anxiety and changes in weight.
Estonian: Depressiooni sümptomid on sügav kurvameelsus, kasutuse tunne, huvi kadumine oma lemmiktegevuste vastu, unehäired, loidus, ärevus ja kehakaalu muutused.
English: The recommended dose is one tablet once a day, taken at bedtime.
Estonian: Soovitatav annus on üks tablett üks kord ööpäevas enne magamaminekut.
English: ‘Neurotransmitters' are chemicals that allow nerve cells to communicate with each other.
Estonian: Neurotransmitterid on keemilised ained, mis vahendavad närvirakkude vahelisi signaale.
English: Therefore, the CHMP decided that Thymanax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Seepärast otsustas inimravimite komitee, et Thymanaxi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: Since dopamine and noradrenaline are involved in the control of mood, their increase between nerve cells in the brain is believed to help relieve the symptoms of depression.
Estonian: Kuna dopamiin ja noradrenaliin reguleerivad meeleolu, arvatakse, et nende suurem osalus aju närvirakkude signaalide vahendamisel aitab leevendada depressiooni sümptome.
English: This material explains the safety of the medicine, its interactions with other medicines, and includes guidance on the monitoring of liver function and management of possible symptoms of liver problems.
Estonian: Nendes selgitatakse ravimi ohutust, selle koostoimet teiste ravimitega ja antakse juhiseid maksatalitluse jälgimiseks ja maksaprobleemide võimalike sümptomite haldamiseks.
English: The main measure of effectiveness in these five studies was the change in symptoms after six weeks, as measured on a standard scale for depression called the Hamilton Depression Rating Scale (HAM D).
Estonian: Efektiivsuse põhinäitaja nimetatud viies uuringus oli sümptomite muutus 6 nädala pärast, mõõdetuna depressiooni standardskaalal - Hamiltoni depressiooniskaalal (HAM D).
English: Treatment should be discontinued immediately if the patient develops symptoms or signs of potential liver injury.
Estonian: Ravi tuleb koheselt katkestada, kui patsiendil tekivad võimaliku maksakahjustuse sümptomid.
English: However, the second study showed that symptoms returned in 21% of the patients taking Thymanax over 24 weeks (34 out of 165), compared with 41% of the patients taking placebo (72 out of 174).
Estonian: Teises uuringus oli nende patsientide osakaal, kelle sümptomid 24 nädala jooksul taastekkisid, Thymanaxi rühmas 21% (34 patsienti 165st) ja platseeborühmas 41% (72 patsienti 174st).
English: The most common side effects with Thymanax (seen in more than 1 patient in 100) are headache, nausea (feeling sick) and dizziness.
Estonian: Thymanaxi kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 100st) on peavalu, iiveldus ja peapööritus.
English: However, no effect of fluoxetine or paroxetine was seen in two of these studies, making the results difficult to interpret.
Estonian: Neis kahes uuringus ei täheldatud ka fluoksetiini ja paroksetiini toimet, mis muudab tulemuste tõlgendamise keerukaks.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Thymanax have also been included in the summary of product characteristics and the package leaflet.
Estonian: Thymanaxi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Most side effects were mild or moderate in intensity, happened within the first two weeks of treatment and were temporary.
Estonian: Enamik kõrvalnähte olid kerged kuni mõõdukad, esinesid 2 esimese ravinädala jooksul ja olid mööduvad.
English: What is Thymanax and what is it used for?
Estonian: Mis on Thymanax ja milleks seda kasutatakse?
English: This is a summary of the European public assessment report (EPAR) for Thymanax.
Estonian: See on ravimi Thymanax Euroopa avaliku hindamisaruande kokkuvõte.
English: Other information about Thymanax
Estonian: Muu teave Thymanaxi kohta
English: It must also not be used in patients who are taking medicines that slow down the breakdown of Thymanax in the body, such as fluvoxamine (another antidepressant) and ciprofloxacin (an antibiotic).
Estonian: Ravimit ei tohi kasutada ka patsiendid, kes kasutavad ravimeid, mis aeglustavad Thymanaxi lagunemist organismis, näiteks fluvoksamiini (samuti antidepressant) ja tsiprofloksatsiini (teatud antibiootikum).
English: Thymanax can only be obtained with a prescription and is available as tablets (25 mg).
Estonian: Thymanax on retseptiravim ja seda turustatakse 25 mg tablettidena.
English: Two other main studies compared the ability of Thymanax and placebo to prevent symptoms returning in 706 patients whose depression had already been controlled with Thymanax.
Estonian: Kahes teises põhiuuringus võrreldi Thymanaxi ja platseebo suutlikkust ennetada sümptomite taasteket 706 patsiendil, kellel depressioon juba allus ravile Thymanaxiga.
English: Thymanax is a medicine used to treat major depression in adults.
Estonian: Thymanaxi kasutatakse raske depressiooni raviks täiskasvanutel.
English: In the first study, there was no difference between Thymanax and placebo in preventing symptoms from returning during 26 weeks of treatment.
Estonian: Esimeses uuringus puudus erinevus Thymanaxi ja platseebo vahel sümptomite taastekke ennetamisel 26-nädalase ravi ajal.
English: Thymanax has been compared with placebo (a dummy treatment) in five main short-term studies involving a total of 1,893 adults with major depression.
Estonian: Thymanaxi võrreldi platseeboga (näiva ravimiga) viies lühiajalises põhiuuringus, milles osales kokku 1893 raske depressiooniga täiskasvanud patsienti.
English: Major depression is a condition in which patients have mood disturbances that interfere with their everyday life.
Estonian: Raske depressiooni korral esinevad patsientidel nende igapäevaelu mõjutavad meeleoluhäired.
English: In the two studies where no active comparator was used Thymanax was seen to be more effective than placebo.
Estonian: Kahes uuringus, kus ei kasutatud aktiivset võrdlusravimit, osutus Thymanax efektiivsemaks kui platseebo.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Thymanax's benefits in terms of treating depression might be lower than seen with other antidepressants.
Estonian: Inimravimite komitee märkis, et depressiooni ravimisel võib Thymanaxi kasulikkus olla väiksem kui muudel antidepressantidel.
English: The company also presented the results of a further study comparing Thymanax with sertraline (another antidepressant), which showed that Thymanax was more effective than sertraline, with a reduction in HAM D scores after six weeks.
Estonian: Ettevõte esitas ka lisauuringu andmed, milles võrreldi Thymanaxi sertraliiniga (samuti antidepressant) ja mille kohaselt oli Thymanax HAM D punktisumma vähendamisel kuue ravinädala järel sertraliinist efektiivsem.
English: Thymanax must not be used in patients who have problems with their liver, such as cirrhosis (scarring of the liver) or active liver disease, nor in patients whose level of transaminases (liver enzymes) in the blood is more than three times the normal level.
Estonian: Ravimit ei tohi kasutada patsiendid, kellel on maksaprobleemid, näiteks tsirroos (maksakoe sidekoestumine) või aktiivne maksahaigus, samuti patsiendid, kelle transaminaaside (maksaensüümide) sisaldus veres on tavapärasest üle kolme korra suurem.
English: Why is Thymanax approved?
Estonian: Miks Thymanax heaks kiideti?
English: It is not intended to provide practical advice on how to use Thymanax.
Estonian: Hindamisaruandes ei anta Thymanaxi kasutamise praktilisi nõuandeid.
English: For practical information about using Thymanax, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Thymanaxi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Treatment should not be started or should be stopped in patients with abnormal liver enzyme levels in the blood (more than three times the normal level).
Estonian: Ravi ei tohi alustada või tuleb peatada, kui patsiendi maksaensüümide sisaldus on ebanormaalselt suur (tavapärasest üle kolme korra suurem).
English: For more information about treatment with Thymanax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Thymanaxiga toimuva ravi kohta lisateavet, lugege pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The patient's liver function should be checked with blood tests before starting treatment and when the dose is increased, followed by further tests around 3, 6, 12 and 24 weeks later.
Estonian: Pärast annuse suurendamist tuleb teha lisaanalüüse ligikaudu 3, 6, 12 ja 24 nädala järel.
English: A patient booklet will also be distributed to all patients who are prescribed Thymanax so that they are aware of the risk to the liver, the importance of monitoring liver function and the signs of liver problems to look out for.
Estonian: Thymanaxi saavatele patsientidele antakse ka patsiendi infoleht, kus selgitatakse maksaprobleemide tekke riski ja maksaprobleemide sümptome ning rõhutatakse vajadust jälgida maksatalitlust.
English: The company that markets Thymanax will supply educational material for doctors prescribing Thymanax.
Estonian: Thymanaxi tootja saadab seda ravimit määravatele arstidele teabematerjalid.
English: What are the risks associated with Thymanax?
Estonian: Mis riskid Thymanaxiga kaasnevad?
English: The active substance in Thymanax, agomelatine, is an antidepressant.
Estonian: Thymanaxi toimeaine agomelatiin on antidepressant.
English: Three of these studies included some patients treated with other antidepressants, either fluoxetine or paroxetine, as an ‘active comparator'.
Estonian: Kolmes uuringus anti osale patsientidest aktiivse võrdlusravimina teisi antidepressante, kas fluoksetiini või paroksetiini.
English: How does Thymanax work?
Estonian: Kuidas Thymanax toimib?
English: For the full list of all side effects reported with Thymanax, see the package leaflet.
Estonian: Thymanaxi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: In the other three studies, which did include an active comparator, there were no differences in scores between the patients taking Thymanax and those taking placebo.
Estonian: Ülejäänud kolmes uuringus, milles kasutati ka aktiivset võrdlusravimit, ei erinenud Thymanaxi ja platseebot kasutanud patsientide punktisummad.
English: What benefits of Thymanax have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Thymanaxi kasulikkus?
English: However, since the medicine has a different mode of action, few side effects and a different safety profile to existing antidepressants, the Committee concluded that Thymanax could be a valuable treatment for some patients as long as their liver function is tested frequently.
Estonian: Et aga ravimil on seniste antidepressantidega võrreldes erinev toimemehhanism, vähem kõrvalnähte ja teistsugune ohutusprofiil, järeldas inimravimite komitee, et
English: How is Thymanax used?
Estonian: Kuidas Thymanaxi kasutatakse?
English: Thymanax contains the active substance agomelatine.
Estonian: Ravim sisaldab toimeainena agomelatiini.
English: The marketing authorisation was renewed on 23 April 2002 and on 23 April 2007.
Estonian: Müügiluba pikendati 23. aprillil 2002 ja 23. aprillil 2007.
English: This summary was last updated in 01-2009.
Estonian: Kokkuvõtte viimane uuendus: 01-2009.
English: Vistide should not be injected directly into the eye.
Estonian: Vistidet ei tohi süstida vahetult silma.
English: Other information about Vistide:
Estonian: Muu teave Vistide kohta
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vistide on 23 April 1997.
Estonian: Euroopa Komisjon andis Vistide müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 23. aprillil 1997.
English: In both studies, the main measure of effectiveness was the time taken for the disease to get worse.
Estonian: Efektiivsuse põhinäitaja mõlemas uuringus oli haiguse süvenemiseni kulunud aeg.
English: Then, during the ‘maintenance' phase, it is given once every two weeks.
Estonian: Seejärel säilitusravi etapil manustatakse Vistidet üks kord iga kahe nädala järel.
English: The marketing authorisation holder is Gilead Sciences International.
Estonian: Müügiloa omanik on Gilead Sciences International.
English: It should only be used when other medicines are unsuitable.
Estonian: Ravimit võib kasutada vaid sel juhul, kui muid ravimeid kasutada ei saa.
English: The Committee recommended that Vistide be given marketing authorisation.
Estonian: Komitee soovitas anda Vistidele müügiloa.
English: When the virus cannot produce DNA, it cannot reproduce, slowing down the spread of infection.
Estonian: Kui viirus ei saa DNA-d paljundada, ei paljune ka viirus ise, mis aeglustab nakkuse levikut.
English: What is the risk associated with Vistide?
Estonian: Mis riskid kaasnevad Vistidega?
English: It contains the active substance cidofovir (75 mg/ml).
Estonian: Ravim sisaldab toimeainena tsidofoviiri (75 mg/ml).
English: The most common side effects with Vistide (seen in more than 1 patient in 10) are neutropenia (low white blood cell counts), headache, nausea (feeling sick), vomiting, alopecia (hair loss), rash, proteinuria (protein in the urine), increased blood creatinine levels (a breakdown product of muscles), asthenia (weakness) and fever.
Estonian: Vistide kõige sagedamad kõrvalnähud (esinenud enam kui ühel patsiendil kümnest) on neutropeenia (valgeliblede vähesus), peavalu, iiveldus, oksendamine, alopeetsia (juuste väljalangemine), lööve, proteinuuria (valgu sisaldumine uriinis), vere kreatiniinisisalduse suurenemine (kreatiniin tekib lihaste lagunemisel), asteenia (nõrkus) ja palavik.
English: What is Vistide?
Estonian: Mis on Vistide?
English: In the maintenance study, the 5-mg/kg dose was more effective than the 3-mg/kg dose (115 days and 49 days, respectively).
Estonian: Säilitusravi uuringus oli annus 5 mg/kg efektiivsem kui annus 3 mg/kg (vastavalt 115 ja 49 päeva).
English: To reduce the risk of kidney damage, patients must also take another medicine called probenecid (2 g three hours before the infusion, then 1 g two and eight hours after the infusion) and receive an infusion of one litre of saline solution one hour before the infusion of Vistide.
Estonian: Neerukahjustuse riski vähendamiseks peab patsientidele manustama ka teist ravimit, probenetsiidi (2 g kolm tundi enne infusiooni, seejärel 1 g kaks ja kaheksa tundi pärast infusiooni), ning üks tund enne Vistide infusiooni tuleb manustada infusioonina üks liiter soolalahust.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) VISTIDE EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE VISTIDE Kokkuvõte üldsusele
English: It should also not be used in patients who have kidney disease or who are taking other medicines that might be harmful to the kidneys, or in patients who cannot take probenecid or other ‘sulfa-containing' medicines.
Estonian: Vistidet ei tohi kasutada ka patsiendid, kellel on neeruhaigus või kes kasutavad teisi ravimeid, mis võivad neerusid kahjustada, samuti patsiendid, kes ei saa kasutada probenetsiidi ega muid sulfoonamiidravimeid.
English: Vistide is used in patients with acquired immunodeficiency syndrome (AIDS) who do not have kidney disease.
Estonian: Vistidet kasutatakse omandatud immuunpuudulikkuse sündroomiga (AIDS) patsientidel, kellel ei ole neeruhaigust.
English: Probenecid is used because it prevents cidofovir building up in the kidneys, and saline is used to prevent dehydration.
Estonian: Probenetsiidi kasutamise eesmärk on vältida tsidofoviiri kogunemist neerudesse ja soolalahust kasutatakse dehüdratsiooni ennetamiseks.
English: Treatment with Vistide should be prescribed by a doctor who has experience in the management of human immunodeficiency virus (HIV) infection.
Estonian: Ravi Vistidega peab määrama inimese immuunpuudulikkuse viiruse (HIV) nakkuse ravis kogenud arst.
English: Before receiving Vistide, the patient's kidneys must be checked, as the medicine must not be given to patients with kidney disease.
Estonian: Enne Vistidega ravi alustamist tuleb kontrollida patsiendi neerutalitlust, sest neeruhaigusega patsientidel seda ravimit kasutada ei tohi.
English: The effects of Vistide in CMV retinitis in AIDS patients were studied in one treatment study and one maintenance study.
Estonian: Vistide toimet AIDSi-patsientide tsütomegaloviirusest põhjustatud retiniidi ravis uuriti ühes raviuuringus ja ühes säilitusravi uuringus.
English: Why has Vistide been approved?
Estonian: Miks Vistide heaks kiideti?
English: The maintenance study compared two maintenance doses of Vistide (5 and 3 mg/kg body weight) in 100 patients who had stopped responding to, or could not receive other medicines for CMV retinitis (ganciclovir or foscarnet).
Estonian: Säilitusravi uuringus võrreldi kaht Vistide säilitusravi annust (5 ja 3 mg kehakaalu kg kohta) 100 patsiendil, kellel tsütomegaloviirusest põhjustatud retiniit enam ravile ei allunud või kes ei saanud teisi ravimeid kasutada (gantsükloviir või foskarnet).
English: The active substance in Vistide, cidofovir, is an antiviral medicine that belongs to the class ‘nucleotide analogues'.
Estonian: Vistides toimeainena sisalduv tsidofoviir on nukleotiidianaloogide klassi kuuluv viiruseravim.
English: What benefit has Vistide shown during the studies?
Estonian: Milles seisneb uuringute põhjal Vistide kasulikkus?
English: For the full list of all side effects reported with Vistide, see the Package Leaflet.
Estonian: Vistide kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: Vistide should not be used in people who may be hypersensitive (allergic) to cidofovir or any of the other ingredients.
Estonian: Vistidet ei tohi kasutada patsiendid, kes võivad olla tsidofoviiri või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: How has Vistide been studied?
Estonian: Kuidas Vistidet uuriti?
English: Treatment is continued for as long as recommended in local guidelines on the management of HIV-infected patients.
Estonian: Ravi jätkatakse vastavalt HIV-nakkusega patsientide ravikohas kehtivates ravisuunistes soovitatud kestusele.
English: During the ‘induction' phase, Vistide is given as a one-hour infusion of 5 mg per kilogram body weight once a week for the first two weeks.
Estonian: Induktsioonravi (nn sissejuhatava ravi) etapil ravi kahel esimesel nädalal manustatakse Vistidet üks kord nädalas ühe tunni kestva infusioonina annuses 5 mg kehakaalu kilogrammi kohta.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Vistide's benefits are greater than its risks for the treatment of CMV retinitis in patients with AIDS and without kidney disease.
Estonian: Inimravimite komitee otsustas, et Vistide kasulikkus tsütomegaloviirusest (CMV) põhjustatud retiniidi raviks AIDSiga patsientidel, kellel ei ole neeruhaigust, on suurem kui sellega kaasnevad riskid.
English: What is Vistide used for?
Estonian: Milleks Vistidet kasutatakse?
English: It took an average of 120 days for CMV retinitis to get worse in patients receiving Vistide, compared with 22 days in those who did not receive any treatment.
Estonian: Vistidet kasutanud patsientidel kulus tsütomegaloviirusest põhjustatud retiniidi süvenemiseni keskmiselt 120 päeva, ravita jäänud patsientidel 22 päeva.
English: How is Vistide used?
Estonian: Kuidas Vistidet kasutatakse?
English: Vistide is a concentrate that is made up into a solution for infusion (drip into a vein).
Estonian: Vistide on viaalis turustatav kontsentraat, millest valmistatakse infusioonilahus (veeni tilgutatav lahus).
English: In the treatment study, Vistide was more effective than no treatment.
Estonian: Vistide oli raviuuringus ravita jäämisest efektiivsem.
English: The treatment study compared Vistide with no treatment in 48 patients who had not been treated with any medicine for CMV retinitis before.
Estonian: 48 patsiendil, kellel ei olnud tsütomegaloviirusest (CMV) põhjustatud retiniiti varem ravitud.
English: This disease can cause loss of vision.
Estonian: Võrkkest on valgustundlik pind silma tagaosas ja selle viirusnakkus võib põhjustada nägemise kaotust.
English: It blocks the activity of enzymes called ‘DNA polymerases' in CMV, which the virus uses to produce DNA.
Estonian: Ravim blokeerib tsütomegaloviiruse DNA paljundamisel osalevate ensüümide DNA polümeraaside toime.
English: Vistide is used to treat cytomegalovirus (CMV) retinitis, a viral infection of the retina (the lightsensitive surface at the back of the eye).
Estonian: Vistidet kasutatakse tsütomegaloviirusest (CMV) põhjustatud retiniidi (võrkkestapõletiku) raviks.
English: How does Vistide work?
Estonian: Kuidas Vistide toimib?
English: The full EPAR for Vistide is available here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Vistide kohta leiate siit.
English: Syrup
Estonian: Siirup
English: treatment initiation pack: 14 tablets + 14 tablets + 14 tablets + 14 tablets
Estonian: Ravi stardipake nd: 14 tabletti + 14 tabletti tabletti + 14 tabletti
English: 1 bottle + 1 measuring cup + 1 oral syringe
Estonian: 1 pudel + 1 mõõtetopsik + 1 suusüstal
English: Oral use bottle (glass)
Estonian: Pudel (klaas) 200 ml