FrancophonIA/ELRC3.0 huggingface dataset:
English: Because the medicine is removed from the body by the kidneys, the dose should be reduced in patients who have moderately or severely reduced kidney function.
Estonian: Et ravim eritub organismist neerude kaudu, tuleb keskmise või raske neerupuudulikkusega patsientidel Doribaxi annust vähendada.
English: It is available as a powder to be made up into a solution for infusion (drip into a vein).
Estonian: Seda turustatakse pulbrina, millest valmistatakse infusioonilahus (veeni tilgutatav lahus).
English: For the full list of all side effects reported with Doribax, see the package leaflet.
Estonian: Doribaxi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Doribax must not be used in people who are hypersensitive (allergic) to doripenem or to other carbapenems.
Estonian: Dorbaxi ei tohi kasutada patsiendid, kes on doripeneemi või muude karbapeneemide suhtes ülitundlikud (allergilised).
English: How does Doribax work?
Estonian: Kuidas Doribax toimib?
English: • one study compared Doribax with levofloxacin in 753 patients with complicated urinary tract
Estonian: • ühes võrreldi Doribaxi levofloksatsiiniga 753 kuseteede komplitseeritud infektsiooniga patsiendil.
English: When treating nosocomial pneumonia, a dose of 1 g every eight hours infused over four hours may be considered for patients who have augmented renal clearance (where the kidneys clear the medicine from the body too quickly) or whose infection is caused by certain types of bacteria.
Estonian: Nosokomiaalse pneumoonia teatud patsientidel (neerude liigtalitluse korral (ravim eritub organismist liiga kiiresti) või kui infektsiooni on põhjustanud teatud bakterid) tohib kasutada 1 g annust iga 8 tunni järel üle 4-tunnise infusioonina.
English: The active substance in Doribax, doripenem, is an antibiotic that belongs to the group ‘carbapenems'.
Estonian: Doribaxi toimeaine doripeneem on karbapeneemide rühma kuuluv antibiootikum.
English: • complicated infections in the abdomen.
Estonian: • Kõhuõõne tüsistunud infektsioonid.
English: • two studies compared Doribax with meropenem in a total of 962 patients with complicated
Estonian: • kahes võrreldi Doribaxi meropeneemiga kokku 962 kõhuõõne komplitseeritud infektsiooniga patsiendil;
English: • looking at the results of the two studies of complicated abdominal infections taken together, 85% of the patients receiving Doribax were cured (275 out of 325), compared with 84% of the patients receiving meropenem (260 out of 309);
Estonian: • mõlemas kõhuõõne tüsistunud infektsiooni uuringus kokku oli paranenud patsientide osakaal Doribaxi saanud patsientidest 85% (275 patsienti 325st) ja meropeneemi saanud patsientidest 84% (260 patsienti 309st);
English: • looking at the results of the two studies in nosocomial pneumonia taken together, 75% of the patients receiving Doribax were cured (195 out of 260), compared with 72% of the patients taking piperacillin/tazobactam or imipenem (174 out of 241);
Estonian: • mõlemas nosokomiaalse pneumoonia uuringus kokku oli paranenud patsientide osakaal Doribaxi saanud patsientidest 75% (195 patsienti 260st) ja piperatsilliini/tasobaktaami või imipeneemi saanud patsientidest 72% (174 patsienti 241st);
English: • in complicated urinary tract infections, 82% of the patients receiving Doribax were cured (230 out of 280), compared with 83% of the patients receiving levofloxacin (221 out of 265).
Estonian: • kuseteede tüsistunud infektsiooni uuringus oli paranenud patsientide osakaal Doribaxi saanud patsientidest 82% (230 patsienti 280st) ja levofloksatiini saanud patsientidest 83% (221 patsienti 265st).
English: The list of bacteria against which Doribax is active can be found in the summary of product characteristics (also part of
Estonian: Doribaxi suhtes tundlike bakterite loetelu on ravimi omaduste kokkuvõttes (samuti Euroopa avaliku hindamisaruande osa).
English: ‘Nosocomial' means that the infection was caught in hospital, including pneumonia caused by the use of a ventilator (a machine that helps a
Estonian: ning mõiste hõlmab ka ventilaatori (hingamisaparaadi) kasutamisest tingitud pneumooniat.
English: What benefit has Doribax shown during the studies?
Estonian: Milles seisneb uuringute põhjal Doribaxi kasulikkus?
English: Doribax has been studied in five main studies that compared Doribax with other antibiotics: • two studies compared Doribax with piperacillin/tazobactam or imipenem in a total of 979 patients
Estonian: • kahes võrreldi Doribaxi piperatsilliini/tasobaktaamiga või imipeneemiga kokku 979 nosokomiaalse pneumooniaga patsiendil;
English: It has been authorised in the European Union since 4 April 2008.
Estonian: Sellel on Euroopa Liidus müügiluba alates 4. aprillist 2008.
English: The full European Public Assessment Report for Effentora can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Effentora kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is a well-known substance, which has been used to control pain for many years.
Estonian: See on tuntud aine, mida on palju aastaid valu reguleerimiseks kasutatud.
English: In all of the studies, the main measure of effectiveness was the change in pain intensity in the 60 minutes after taking the tablet.
Estonian: Kõigis uuringutes oli peamine efektiivsuse tulemusnäitaja muutus valu intensiivsuses 60 minuti jooksul pärast tableti võtmist.
English: Each patient ranked their pain intensity on a scale of 0 to 10.
Estonian: Iga patsient hindas oma valu intensiivsust skaalal 0-10.
English: The duration of treatment was determined by the time needed by each patient to control 9 episodes of breakthrough pain within a 21-day period.
Estonian: Ravi kestus määrati ajaga, mis iga patsient vajas 9 läbilöögivalu episoodi reguleerimiseks 21-päevase perioodi jooksul.
English: The applicant presented data from 3 main studies in adults with breakthrough pain already using opioids.
Estonian: Taotleja esitas andmed 3 põhiuuringu kohta, milles osalesid läbilöögivaluga täiskasvanud, kes juba kasutasid opioide.
English: In its official letter, the company stated that it decided to withdraw the application after the CHMP indicated that the data submitted were not sufficient to address the Committee's concerns.
Estonian: Ettevõte teatas ametlikus kirjas oma otsusest võtta taotlus tagasi pärast seda, kui inimravimite komitee osutas, et esitatud andmed ei olnud komitee tõstatatud probleemide lahendamiseks piisavad.
English: The third study, which lasted for 12 weeks, looked at the effects of Effentora in 148 patients with non-cancer-related longterm pain.
Estonian: Kolmandas uuringus, mis kestis 12 nädalat, vaadeldi Effentora toimeid 148 patsiendil, kellel esines vähiga mitteseotud pikaajaline valu.
English: The effects of Effentora were compared with those of placebo (a dummy treatment) in 79 patients with neuropathic pain (pain due to nerve damage) in one study, and in 77 patients with lowback pain in a second study.
Estonian: Effentora toimet võrreldi platseeboga (näiv ravim) ühes uuringus 79-l neuropaatilise valuga (närvikahjustuse tõttu tekkinud valu) patsiendil ja teises uuringus 77-l alaselja valuga patsiendil.
English: There are no consequences on the use of Effentora in its authorised indication.
Estonian: Tagasivõtmine ei mõjuta Effentora kasutamist lubatud näidustusel.
English: Breakthrough pain is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.
Estonian: Läbilöögivalu korral tunneb patsient äkilist lisavalu hoolimata käimasolevast ravist valuvaigistitega.
English: The CHMP considered that, although the use of Effentora is accepted in cancer patients who have limited survival, further data were needed to support its safe use in adults with non-cancer-related pain, who have normal life expectancy and may need long-term treatment.
Estonian: Inimravimite komitee leidis, et kuigi Effentora kasutamine on heaks kiidetud vähiga patsientidel, kelle elulemus on piiratud, on vaja lisaandmeid selle ravimi ohutu kasutamise toetamiseks vähiga mitteseotud valuga patsientidel, kellel on normaalne eeldatav eluiga ja kes võivad vajada pikaajalist ravi.
English: Effentora is available as ‘buccal tablets' (tablets that dissolve in the mouth).
Estonian: Effentorat turustatakse bukaaltablettidena (suus lahustuvad tabletid).
English: In adults with long-term pain due to causes other than cancer, Effentora was expected to work in the same way as it does in adults with cancer pain.
Estonian: Täiskasvanutel, kellel esineb pikaajaline valu muudel põhjustel peale vähi, on Effentora eeldatav toime samasugune nagu vähivaluga täiskasvanutel.
English: The Committee also had concerns that the patients in the studies had high levels of background pain and might not have been representative of the intended treatment group, which consists of patients with breakthrough pain but whose background pain is otherwise well controlled by regular opioid treatment.
Estonian: Inimravimite komitee pidas probleemiks ka seda, et uuringutes osalenud patsientidel esines kõrge taustvalu tase ja nad ei pruukinud esindada kavatsetavat ravirühma, mis koosneb läbilöögivaluga patsientidest, kelle taustvalu on muus osas regulaarse opioidraviga hästi reguleeritud.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Effentora in patients with non-cancer-related long-term pain did not outweigh its risks.
Estonian: Seetõttu oli inimravimite komitee müügiloa taotluse tagasivõtmise ajal arvamusel, et ravimi Effentora kasulikkus vähiga mitteseotud pikaajalise valuga patsientidel ei ole suurem kui sellega kaasnevad riskid.
English: Once absorbed, fentanyl acts on receptors in the brain and spinal cord to control pain.
Estonian: Pärast imendumist toimib fentanüül valu vaigistamiseks ajus ja seljaajus paiknevatele retseptoritele.
English: The Committee noted that several cases of misuse or abuse of the medicine had been reported in the studies, and was concerned about the risk of addiction in non-cancer patients when using Effentora in the long term.
Estonian: Inimravimite komitee märkis, et uuringutes on teatatud mitmest ravimi väärkasutamise või kuritarvitamise juhust ja oli mures sõltuvuse tekkimise riski pärast Effentora pikaajalisel kasutamisel vähita patsientidel.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Effentora.
Estonian: Taotluse tagasivõtmine ei mõjuta praegu Effentora kliinilistes uuringutes osalevaid patsiente.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Effentora could not have been approved for the treatment of breakthrough pain in adults with long-term pain other than cancer pain.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi komitee taotluse tagasivõtmise ajal põhjust ettevaatlikkuseks ja oli esialgsel seisukohal, et ravimi Effentora kasutamist läbilöögivalu raviks täiskasvanutel, kellel esineb pikaajaline valu muudel põhjustel peale vähi, ei ole võimalik heaks kiita.
English: Effentora was also expected to be used to treat breakthrough pain in adults with long-term persistent pain from causes other than cancer, who were already receiving regular treatment with opioids to control their persistent pain.
Estonian: Effentorat kavatseti kasutada läbilöögivalu raviks täiskasvanutel, kellel esineb pikaajaline püsiv valu muudel põhjustel peale vähi ja kes juba saavad püsiva valu reguleerimiseks regulaarset ravi opioididega.
English: How was Effentora expected to work?
Estonian: Milline on Effentora eeldatav toime?
English: In Effentora, it is given as a buccal tablet, so that fentanyl is absorbed through the lining of the mouth.
Estonian: Effentora on bukaaltablett, milles fentanüül imendub läbi suu limaskesta.
English: What consequences does this withdrawal have for patients in clinical trials?
Estonian: Kuidas mõjutab müügiloa taotluse tagasivõtmine praegu kliinilistes uuringutes või eriloaga kasutamise programmides osalevaid patsiente?
English: It is already used to treat ‘breakthrough' pain in adults with cancer who are using opioid painkillers to control long-term cancer pain.
Estonian: Seda kasutatakse läbilöögivalu raviks vähiga patsientidel, kes kasutavad pikaajalise vähivalu reguleerimiseks opioidvaluvaigisteid.
English: What was Effentora expected to be used for?
Estonian: Milleks kavatseti Effentorat kasutada?
English: What is happening with Effentora for the treatment ‘breakthrough' pain in adults with cancer?
Estonian: Kuidas mõjutab müügiloa taotluse tagasivõtmine Effentora kasutamist vähiga täiskasvanute läbilöögivalu raviks?
English: On 11 July 2013, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Effentora, to extend the treatment for breakthrough pain to adult patients with chronic (long-term) persistent pain from causes other than cancer.
Estonian: teatas 11. juulil 2013 ametlikult inimravimite komiteele oma soovist võtta tagasi ravimi Effentora müügiloa taotlus.
English: Content Package size Withdrawal Period
Estonian: Sisu Pakendi suurus
English: Strength Pharmaceutical Form
Estonian: Nimetus Tugevus Ravimvorm Loomaliigid Manustamisviis Pakend
English: The main studies lasted for two to four weeks.
Estonian: Põhiuuringud kestsid kaks kuni neli nädalat.
English: The marketing authorisation was renewed on 12 March 2004 and on 12 March 2009.
Estonian: Müügiluba pikendati 12. märtsil 2004 ja 12. märtsil 2009.
English: Patients should not take a second dose within a single night.
Estonian: Patsiendid ei tohi võtta teist annust sama öö jooksul.
English: This summary was last updated in 03-2009.
Estonian: Kokkuvõtte viimane uuendus: 03-2009
English: Sonata has been studied in a total of 14 studies, involving nearly 3,500 adults and elderly patients.
Estonian: Sonata kasutamist uuriti kokku 14 uuringus, milles osales ligikaudu 3500 täiskasvanud ja eakat patsienti.
English: It is available as capsules (white and brown: 5 mg; white: 10 mg).
Estonian: Seda turustatakse kapslitena (valget ja pruuni värvi: 5 mg; valged: 10 mg).
English: Treatment with Sonata should be as short as possible and should last for no more than two weeks.
Estonian: Ravi Sonataga peab olema võimalikult lühiajaline ning ei tohi kesta kauem kui kaks nädalat.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sonata on 12 March 1999.
Estonian: Euroopa Komisjon andis Sonatale müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 12. märtsil 1999.
English: The Committee recommended that Sonata be given marketing authorisation.
Estonian: Komitee soovitas anda Sonatale müügiloa.
English: The maximum total daily dose of Sonata is 10 mg.
Estonian: Sonata suurim ööpäevane koguannus on 10 mg.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) SONATA EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE SONATA Kokkuvõte üldsusele
English: The recommended dose is 10 mg, except for the elderly or patients with mild or moderate liver disease, who should take 5 mg.
Estonian: Soovituslik annus on 10 mg, välja arvatud eakatel ja kerge või mõõduka maksahaigusega patsientidel, kelle annus on 5 mg.
English: Sonata is taken immediately before going to bed, or after the patient has gone to bed and is having difficulty falling asleep.
Estonian: Sonatat manustatakse vahetult enne magamaminekut või kui patsient on läinud voodisse ja tal on raske magama jääda.
English: It is a gamma-amino butyric acid (GABA) receptor agonist, which means that it attaches to the receptors for the neurotransmitter GABA and activates them.
Estonian: See on gammaaminovõihappe (GABA) retseptori agonist, s.t ta kinnitub neurotransmitteri gammaaminovõihappe retseptoritele ja aktiveerib need.
English: The main measure of effectiveness was the time taken to fall asleep.
Estonian: Peamiseks efektiivsuse näitajaks oli patsiendil uinumiseks kulunud aeg.
English: Other information about Sonata:
Estonian: Muu teave Sonata kohta
English: It must not be used in patients with severe liver or kidney problems, sleep apnoea syndrome (frequent interruption of breathing during sleep), myasthenia gravis (a disease causing muscle weakness) or severe respiratory insufficiency (breathing disorders), or in patients under 18 years of age.
Estonian: Ravimit ei tohi kasutada patsiendid, kellel on rasked maksa-või neeruprobleemid, uneapnoe sündroom (sagedased hingamispeetused une ajal), myasthenia gravis (lihasnõrkust põhjustav haigus) või raske hingamispuudulikkus (hingamishäired), ega alla 18aastased patsiendid.
English: The powder in Sonata capsules is coloured with an intense dark blue dye, to prevent it being given to someone without their knowledge.
Estonian: Sonata kapslites sisalduv pulber on erksat tumesinist värvi, et seda ei saaks kellelegi manustada nende teadmata.
English: No food should be eaten with or shortly before taking Sonata, because it can reduce the medicine's effects.
Estonian: Veidi aega enne Sonata manustamist ja ravimi manustamise ajal ei tohi süüa, sest see võib vähendada ravimi mõju.
English: Zaleplon is chemically different from the benzodiazepines, but it acts on the same receptors in the brain.
Estonian: Zaleploon erineb keemiliselt bensodiasepiinidest, kuid avaldab ajus toimet samadele retseptoritele.
English: Five of these studies were comparative: Sonata was compared with placebo (a dummy treatment) or with zolpidem or triazolam (other medicines used in insomnia).
Estonian: Viis neist olid võrdlevad uuringud: Sonatat võrreldi platseeboga (näiv ravim) või zolpideemi või triasolaamiga (samuti unetuseravimid).
English: Sonata must not be taken by children or by patients who have severe liver or kidney problems.
Estonian: Sonatat ei tohi kasutada lapsed ega patsiendid, kellel on rasked maksa- või neeruprobleemid.
English: What is Sonata?
Estonian: Mis on Sonata?
English: It is used only when the insomnia is severe, disabling or causing extreme distress.
Estonian: Ravimit kasutatakse ainult juhul, kui unehäire on tõsine, põhjustab jõuetust ja tugevat düstressi.
English: Sonata is a medicine that contains the active substance zaleplon.
Estonian: Sonata on ravim, mis sisaldab toimeainena zaleplooni.
English: Why has Sonata been approved?
Estonian: Miks Sonata heaks kiideti?
English: The most common side effects with Sonata (seen in between 1 and 10 patients in 100) are amnesia (memory problems), paraesthesia (unusual sensations like pins and needles), somnolence (sleepiness) and dysmenorrhoea (painful menstruation).
Estonian: Sonata kõige sagedamad kõrvalnähud (esinenud ühel kuni kümnel patsiendil sajast) on amneesia (mäluhäire), paresteesia (vääraisting, näiteks torkiv valu), unisus ja düsmenorröa (valulik menstruatsioon).
English: Sonata should not be used in people who may be hypersensitive (allergic) to zaleplon or any of the other ingredients.
Estonian: Sonatat ei tohi kasutada patsiendid, kes võivad olla zaleplooni või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: Sonata is used for the treatment of adults with insomnia who have difficulty falling asleep.
Estonian: Sonatat kasutatakse unetuse raviks täiskasvanud patsientidel, kellel on raskusi magama jäämisega.
English: What is the risk associated with Sonata?
Estonian: Mis riskid Sonataga kaasnevad?
English: The active substance in Sonata, zaleplon, belongs to a group of medicines that are related to the benzodiazepines.
Estonian: Sonatas toimeainena sisalduv zaleploon kuulub bensodiasepiinidega seotud ravimite rühma.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Sonata's benefits are greater than its risks for the treatment of patients with insomnia who have difficulty falling asleep, when the disorder is severe, disabling or subjecting the individual to extreme distress.
Estonian: Inimravimite komitee otsustas, et Sonata kasulikkus unetuse ravis patsientidel, kellel on raskusi magama jäämisega, kui unehäire on tõsine, põhjustab jõuetust ja tugevat düstressi, on suurem kui ravimiga kaasnevad riskid.
English: Sonata 10 mg was more effective than placebo in decreasing the time taken to fall asleep and increasing time spent asleep during the first half of the night.
Estonian: Sonata 10 mg lühendas magama jäämiseks kulunud aega ja pikendas uneaega öö esimesel poolel platseebost efektiivsemini.
English: For the full list of all side effects reported with Sonata, see the Package Leaflet.
Estonian: Sonata kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: Neurotransmitters such as GABA are chemicals that allow nerve cells to communicate with each other.
Estonian: Neurotransmitter gammaaminovõihape on keemiline aine, mis vahendab närvirakkudevahelisi signaale.
English: For more information, see the Package Leaflet.
Estonian: Üksikasjalik teave on esitatud pakendi infolehel.
English: Some studies also looked at the time spent asleep and sleeping patterns.
Estonian: Mõnes uuringus vaadeldi ka une kestust ja struktuuri.
English: In elderly patients, the time taken to fall asleep was often decreased with Sonata 5 mg and was always decreased with Sonata 10 mg, when they were compared with placebo in the two-week studies.
Estonian: Eakatel patsientidel lühendas Sonata 5 mg kasutamine magama jäämiseks kulunud aega sageli ja Sonata 10 mg kasutamine tegi seda alati.
English: How does Sonata work?
Estonian: Kuidas Sonata toimib?
English: What benefit has Sonata shown during the studies?
Estonian: Milles seisneb uuringute põhjal Sonata kasulikkus?
English: The time taken to fall asleep was reduced in adults taking Sonata 10 mg, and the effects were maintained for up to four weeks.
Estonian: 10 mg Sonatat kasutatavatel täiskasvanud patsientidel lühenes magama jäämiseks kulunud aeg ning ravitoime püsis kuni neli nädalat.
English: The full EPAR for Sonata is available here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Sonata kohta leiate siit.
English: In the brain, GABA is involved in bringing about sleep.
Estonian: Ajus leiduv gammaaminovõihape aitab kaasa magama jäämisele.
English: How has Sonata been studied?
Estonian: Kuidas Sonatat uuriti?
English: How is Sonata used?
Estonian: Kuidas Sonatat kasutatakse?
English: What is Sonata used for?
Estonian: Milleks Sonatat kasutatakse?
English: By activating its receptors, zaleplon increases GABA's effects, which encourages sleep.
Estonian: Gammaaminovõihappe retseptorite aktiveerimisega suurendab zaleploon gammaaminovõihappe toimet.
English: Sonata also preserved sleep patterns in the studies that measured the time spent in different stages of sleep.
Estonian: Uuringutes, milles mõõdeti une eri faasides oldud aega, säilitas Sonata une struktuuri.
English: Anakinra - Thrombocytopenia (EPITT no 18337)
Estonian: Anakinra - trombotsütopeenia (EPITT nr 18337)
English: Adopted at the 5-8 October 2015 PRAC
Estonian: Vastu võetud riskihindamiskomitee 5.-8. oktoobri 2015 koosolekul
English: In clinical studies in RA and CAPS patients, thrombocytopenia has been reported in 1.9% of treated patients compared to 0.3% in the placebo group.
Estonian: Reumatoidartriidi ja CAPS-sündroomiga patsientide hulgas läbi viidud kliinilistes uuringutes esines trombotsütopeeniat 1,9%-l neist patsientidest, kes said ravi, võrreldes 0,3%-ga platseebogrupis.
English: Thrombocytopenia
Estonian: Trombotsütopeenia
English: Common side effects (may affect up to 1 in 10 people): - Thrombocytopenia (low level of blood platelets).
Estonian: Sageli esinevad kõrvaltoimed (võivad tekkida kuni 1 inimesel 10st): - Trombotsütopeenia (vereliistakute vähesus).
English: The thrombocytopenias have been mild, i.e. platelet counts have been >75 x109/l.
Estonian: Trombotsütopeenia oli neil juhtudel kerge, st trombotsüütide sisaldus on olnud >75·109/l.