FrancophonIA/ELRC3.0 huggingface dataset:
English: In the second study, after 14 weeks, 35% of patients who received Simponi alone (54 out of 153) achieved 20% reductions in the number and severity of symptoms compared with 18% of patients who received placebo (28 out of 155).
Estonian: Teises uuringus oli patsiente, kelle sümptomite arv vähenes 14 nädala järel 20%, ainsa ravimina Simponit kasutanud uuringurühmas 35% (54 patsienti 153st) ja platseeborühmas 18% (28 patsienti 155st).
English: In the first study, around 51% of patients receiving induction treatment with Simponi (starting at 200 mg) responded to treatment after 6 weeks, compared with around 30% of patients given placebo.
Estonian: Esimeses uuringus oli patsiente, kellel tekkis 6 nädala järel ravivastus, Simponi 200 mg algannuse uuringurühmas ligikaudu 51% ja platseeborühmas ligikaudu 30%.
English: Simponi is available as pre-filled pens and syringes containing a solution for injection under the skin.
Estonian: Simponit turustatakse naha alla süstitava lahusena eeltäidetud pensüstaldes ja süstaldes.
English: • moderately to severely active ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut).
Estonian: • Mõõdukas kuni raske aktiivne haavandiline koliit (soole limaskesta põletikku ja haavandeid tekitav haigus).
English: Of the patients who received Simponi, 71% (69 out of 97) had 20% reductions in the number and severity of symptoms after 16 weeks, compared with 40% of patients who were given placebo (40 out of 100).
Estonian: Simponi rühmas oli patsiente, kellel sümptomite arv ja raskus vähenesid 20% 16 nädala järel, 71% (69 patsienti 97st) ja platseeborühmas 40% (40 patsienti 100st).
English: Of the patients who received Simponi, 51% (74 out of 146) had 20% reductions in the number and severity of symptoms after 14 weeks, compared with 9% of patients who were given placebo (10 out of 113).
Estonian: Simponi rühmas oli patsiente, kellel sümptomite arv ja raskus vähenesid 20% 14 nädala järel, 51% (74 patsienti 146st) ja platseeborühmas 9% (10 patsienti 113st).
English: Why is Simponi authorised in the EU?
Estonian: Simponi Euroopa Liidus heakskiitmise põhjused
English: Xeplion paliperidone
Estonian: Xeplion paliperidoon
English: The full EPAR for Xeplion can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Xeplioni kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as a prolongedrelease suspension for injection in pre-filled syringes (25, 50, 75, 100 and 150 mg).
Estonian: Seda turustatakse toimeainet prolongeeritult vabastava süstesuspensioonina eeltäidetud süstaldes (25, 50, 75, 100 ja 150 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xeplion on 4 March 2011.
Estonian: Euroopa Komisjon andis Xeplioni müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 4. märtsil
English: This is a summary of the European public assessment report (EPAR) for Xeplion.
Estonian: See on ravimi Xeplion Euroopa avaliku hindamisaruande kokkuvõte.
English: Other information about Xeplion
Estonian: Muu teave Xeplioni kohta
English: Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Estonian: Skisofreenia on vaimuhaigus, millel on mitmesugused sümptomid, sealhulgas mõtlemis- ja kõnehäired, hallutsinatsioonid (ebareaalsete asjade nägemine või kuulmine), kahtlustamine ja luulud.
English: The Committee decided that Xeplion's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Xeplioni kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: It is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Estonian: Toimeainet nimetatakse ebatüüpiliseks antipsühhootikumiks, sest see erineb vanematest, alates 1950. aastatest turustatud antipsühhootikumidest.
English: The main measure of effectiveness in the studies was the change in the patients' symptoms after nine or 13 weeks assessed using a standard scale for schizophrenia.
Estonian: Efektiivsuse põhinäitaja oli patsientide sümptomites pärast 9- või 13-nädalast ravi standardse skisofreeniaskaala põhjal toimunud muutus.
English: Six short-term studies were carried out with Xeplion.
Estonian: Xeplioniga toimus kuus lühiajalist uuringut.
English: What is Xeplion?
Estonian: Mis on Xeplion?
English: In two other studies (one long- and one short-term), Xeplion was not proven to be as effective as risperidone.
Estonian: Kahes muus uuringus (üks neist pikaajaline ja teine lühiajaline) ei tõestatud Xeplionil sama suurt efektiivsust kui risperidoonil.
English: For more information about treatment with Xeplion, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Xeplioniga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: This study looked at how well Xeplion prevented the relapse of severe symptoms.
Estonian: Uuringus jälgiti, kui hästi ennetas Xeplion raskete sümptomite relapsi (taasteket).
English: Because paliperidone has already been authorised in the EU as Invega, the company used some of the data from Invega to support the use of Xeplion.
Estonian: Et paliperidoon on Euroopa Liidus juba heaks kiidetud ravimina Invega, kasutas ettevõte Xeplioni kasutamise toetamiseks mõningaid Invega andmeid.
English: Xeplion is used for the maintenance treatment of schizophrenia in adults whose disease has already been stabilised on treatment with paliperidone or risperidone.
Estonian: Xeplioni kasutatakse skisofreenia säilitusravina täiskasvanutel, kelle haigus on juba stabiliseeritud paliperidooni- või risperidooniraviga.
English: The CHMP noted that the studies comparing Xeplion with placebo and risperidone showed that the medicine is beneficial to patients with schizophrenia.
Estonian: Inimravimite komitee märkis, et Xeplioni platseeboga ja risperidooniga võrrenud uuringud näitasid, et Xeplion on skisofreeniaga patsientidele kasulik.
English: (day 1) followed by 100 mg on day 8.
Estonian: Esimese süsti annus on 150 mg (1. päeval) ja teise süsti annus 100 mg (8. päeval).
English: The most frequently reported side effects are insomnia (difficulty sleeping), headache, anxiety, upper respiratory tract infection (colds), reactions at the site of injection, parkinsonism (neurological symptoms including tremor and impaired muscular control), increased weight, akathisia (restlessness), agitation, somnolence (sleepiness), nausea, constipation, dizziness, muscle and bone pain, tachycardia (rapid heartbeat), tremor (shaking), abdominal pain (stomach ache), vomiting diarrhoea, fatigue (tiredness) and dystonia (involuntary muscle contractions).
Estonian: Kõige sagedamad kõrvalnähud on unetus, peavalu, ärevus, ülemiste hingamisteede nakkus (külmetus), süstekoha reaktsioonid, parkinsonism (neuroloogilised sümptomid, sh treemor (värin) ja lihaste tahtele allumise häired), kehakaalu suurenemine, akatiisia (motoorne rahutus), rahutus, unisus,
English: Why has Xeplion been approved?
Estonian: Miks Xeplion heaks kiideti?
English: Two long-term studies lasting about a year were carried out with Xeplion.
Estonian: Xeplioniga toimus kaks pikaajalist uuringut (ligikaudu üks aasta).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xeplion.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: The injections on days 1 and 8 are into the upper part of the shoulder (deltoid muscle), while the maintenance doses can be given in the buttocks or the deltoid muscle.
Estonian: 1. ja 8. päeva süst tehakse õla ülaosasse (deltalihasesse), säilitusannuse süstid tuharasse või deltalihasesse.
English: Prolonged-release means that the active substance is released slowly over a few weeks after being injected.
Estonian: Toimeaine prolongeeritud (pikaajaline) vabastamine tähendab, et pärast süstimist vabaneb toimeaine aeglaselt mõne nädala jooksul.
English: Because the medicine is a prolonged release suspension, it also has the advantage of being given at monthly intervals.
Estonian: Ravimvormi tõttu (toimeainet prolongeeritult vabastav suspensioon) on ravimi eeliseks ka see, et seda manustatakse kord kuus.
English: Paliperidone is an active breakdown product (metabolite) of risperidone, another antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s.
Estonian: Paliperidoon on risperidooni aktiivne metaboliit (ainevahetussaadus); risperidoon on samuti antipsühhootikum, mida on kasutatud skisofreenia ravimiseks alates 1990. aastatest.
English: Xeplion is a medicine that contains the active substance paliperidone.
Estonian: Xeplion on ravim, mis sisaldab toimeainena paliperidooni.
English: What is the risk associated with Xeplion?
Estonian: Mis riskid Xeplioniga kaasnevad?
English: The dose may be adjusted depending on the medicine's benefit to the patient and how the patient tolerates the treatment.
Estonian: 75 mg. Annust tohib kohandada vastavalt sellele, kuidas patsient ravile reageerib ja ravi talub.
English: Of these, akathisia and somnolence appear to be related to the dose.
Estonian: Kõrvalnähtudest näivad akatiisia ja unisus olevat seotud annusega.
English: The second study, involving 749 adults, compared Xeplion with risperidone long-acting injection (taken with oral risperidone supplements) and looked at the change in the patients' symptoms.
Estonian: Teises uuringus, milles osales 749 patsienti, võrreldi Xeplioni risperidooni pikatoimelise süstiga (millele lisaks võeti suukaudset risperidooni) ja jälgiti patsientide sümptomite muutumist.
English: Paliperidone has been authorised in the European Union as Invega since 2007 as an oral treatment for schizophrenia.
Estonian: Paliperidoonil kui toimeainel on Euroopa Liidus müügiluba alates 2007. aastast, mil kiideti heaks skisofreenia suukaudne ravim Invega.
English: Xeplion must not be given to people who are hypersensitive (allergic) to paliperidone or any of the other ingredients, or to risperidone.
Estonian: Xeplioni ei tohi kasutada patsiendid, kes on paliperidooni või selle ravimi mis tahes muu koostisaine või risperidooni suhtes ülitundlikud (allergilised).
English: For the full list of all side effects reported with Xeplion, see the package leaflet.
Estonian: Xeplioni kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Two studies, involving 1,178 patients, compared Xeplion with risperidone long-acting injection (taken with oral risperidone supplements).
Estonian: Kahes uuringus, milles osales 1178 patsienti, võrreldi Xeplioni risperidooni pikatoimelise süstiga (millele lisaks võeti suukaudset risperidooni).
English: Paliperidone acts mainly by blocking receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin), which are involved in schizophrenia.
Estonian: Paliperidoon avaldab põhiliselt toimet skisofreeniaga seotud neurotransmitterite dopamiini ja 5-hüdroksütrüptamiini (serotoniini) retseptoreid blokeerides, millega aitab ajutalitlust normaliseerida ja sümptomeid leevendada.
English: One of the studies, involving 410 adults, compared Xeplion with placebo.
Estonian: Nendest ühes, milles osales 410 patsienti, võrreldi Xeplioni platseeboga.
English: Xeplion treatment starts with two injections, one week apart, to bring the blood levels of paliperidone up, followed by monthly maintenance injections.
Estonian: Xeplioni-ravi alguses tehakse patsiendile nädalase vahega kaks süsti, mis tekitavad veres vajaliku paliperidoonisisalduse, ja seejärel kord kuus toimeainesisaldust säilitav süst.
English: In Xeplion, paliperidone has been attached to a fatty acid that allows it to be released slowly after being injected.
Estonian: Xeplionis on paliperidoon seotud rasvhappega, mille tõttu vabaneb toimeaine süsti järel aeglaselt.
English: In the brain, it attaches to several different receptors on the surface of nerve cells.
Estonian: See kinnitub ajus närvirakkude pinnal mitmele retseptorile, mis häirib neurotransmitterite (virgatsainete) vahendatavaid närvisignaale.
English: Xeplion was also shown to be effective in preventing relapses in the longterm, with fewer patients in the Xeplion group having a relapse compared with the placebo group.
Estonian: Xeplion oli relapside ennetamisel efektiivne ka pikaajalistes uuringutes: patsiente, kellel esines relapse, oli Xeplioni saanute seas vähem kui platseeborühmas.
English: The active substance in Xeplion, paliperidone, is an antipsychotic medicine.
Estonian: Xeplioni toimeaine paliperidoon on antipsühhootikum (psühhoosiravim).
English: Four of the studies, involving 1,774 adults with schizophrenia, compared Xeplion with placebo (a dummy treatment).
Estonian: Neist neljas, milles osales 1774 skisofreeniaga täiskasvanut, võrreldi Xeplioni platseeboga (näiv ravim).
English: Some patients whose symptoms have not yet been stabilised may still be given Xeplion if they have responded well to oral paliperidone or risperidone in the past, their symptoms are mild to moderate and a long-acting injectable treatment is needed.
Estonian: Xeplioni tohib anda ka nendele veel stabiliseerumata sümptomidega patsientidele, kellel on varem tekkinud piisav ravivastus suukaudsele paliperidoonile või risperidoonile, kelle sümtomid on vähesed kuni mõõdukad ja kes vajavad pikaajalise toimega süstitavat ravimit.
English: This allows for the injection to have a long duration of action.
Estonian: Selle tõttu on süstil pikk toimeaeg.
English: For more information on the use of Xeplion including how to adjust the doses, see the summary of product characteristics (also part of the EPAR).
Estonian: Xeplioni kasutamise, sealhulgas annuste kohandamise üksikasjalik teave on ravimi omaduste kokkuvõttes, mis on samuti Euroopa avaliku hindamisaruande osa.
English: How has Xeplion been studied?
Estonian: Kuidas Xeplioni uuriti?
English: What benefit has Xeplion shown during the studies?
Estonian: Milles seisneb uuringute põhjal Xeplioni kasulikkus?
English: In four short-term studies the reductions in symptom scores were greater for patients receiving Xeplion than for those receiving placebo.
Estonian: Neljas lühiajalises uuringus vähenesid Xeplioni saanud patsientidel sümptomipunktid rohkem kui platseebot saanutel.
English: What is Xeplion used for?
Estonian: Milleks Xeplioni kasutatakse?
English: How is Xeplion used?
Estonian: Kuidas Xeplioni kasutatakse?
English: How does Xeplion work?
Estonian: Kuidas Xeplion toimib?
English: The medicine can only be obtained with a prescription.
Estonian: Xeplion on retseptiravim.
English: Xeplion was more effective than placebo in reducing schizophrenia symptoms in the short-term.
Estonian: Lühiajalistes uuringutes oli Xeplion skisofreeniasümptomite vähendamisel efektiivsem kui platseebo.
English: Xeplion was shown to be as effective as risperidone long-acting injection in reducing schizophrenia in one of the short-term studies.
Estonian: Ühes lühiajalises uuringus oli Xeplion skisofreeniasümptomite vähendamisel sama efektiivne kui risperidooni pikatoimeline süst.
English: 17 June 2015
Estonian: 17. juuni 2015
English: Implementation of the agreement by the Member States (submission of the variation type IB by the Marketing Authorisation Holder):
Estonian: Kokkuleppe rakendamine liikmesriikides (müügiloa hoidja esitab IB tüüpi muudatuse taotluse):
English: 16 October 2015
Estonian: 16. oktoober 2015
English: Transmission to National Competent Authorities of the translations of the annexes to the agreement:
Estonian: Kokkuleppe lisade tõlgete edastamine riiklikele pädevatele asutustele:
English: May 2015 CMDh meeting
Estonian: kooskõlastusrühma 2015. aasta mai koosolek
English: Adoption of CMDh agreement:
Estonian: Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühma kokkuleppe vastuvõtmine:
English: It is used in the following ways:
Estonian: Seda tohib kasutada järgmiselt:
English: It is available as tablets (50 mg/850 mg and 50 mg/1,000 mg).
Estonian: Seda turustatakse tablettidena (50 mg / 850 mg ja 50 mg / 1000 mg).
English: Doses of vildagliptin above 100 mg are not recommended.
Estonian: Üle 100 mg vildagliptiini annust ei soovitata.
English: The full EPAR for Eucreas can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Eucrease kohta on ameti veebilehel: website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Eucreas on 14 November 2007.
Estonian: Euroopa Komisjon andis Eucrease müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 14. novembril 2007.
English: The recommended dose of Eucreas is one tablet twice a day, with one tablet taken in the morning and one in the evening.
Estonian: Eucreast soovitatakse võtta üks tablett kaks korda ööpäevas: üks tablett hommikul ja teine õhtul.
English: It should also not be used in patients with alcohol intoxication (excessive alcohol consumption) or alcoholism, or during breastfeeding.
Estonian: Ravimit ei tohi kasutada ka alkoholimürgistuse (liigne alkoholitarbimine) või alkoholismi korral ega ka imetamise ajal.
English: Other information about Eucreas
Estonian: Muu teave Eucrease kohta
English: It should also not be used in patients who have diabetic ketoacidosis (high levels of ketones and acids in the blood), diabetic pre-coma, problems with their kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Estonian: Ravimit ei tohi samuti kasutada patsiendid, kellel on diabeetiline ketoatsidoos (ketoonide ja hapete rohkus veres), diabeetilise kooma eelseisund, neeru- või maksaprobleemid, neere mõjutada võivad haigusseisundid või haigus, mis vähendab kudede hapnikuvarustust, näiteks südame- või kopsupuudulikkus või hiljutine südameinfarkt.
English: Therefore, the Committee decided that the benefits of Eucreas are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas seetõttu, et Eucrease kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: Vildagliptin on its own was approved by the European Union (EU) in September 2007 under the name Galvus, and metformin has been available in the EU since 1959.
Estonian: Vildagliptiin eraldi sai Euroopa Liidus müügiloa septembris 2007 ravimina Galvus ja metformiini on Euroopa Liidus turustatud alates 1959. aastast.
English: Eucreas contains two active substances, which each have a different mode of action.
Estonian: Eucreas sisaldab kaht toimeainet, mille toimemehhanismid erinevad.
English: The applicant also presented the results of two studies showing that the active substances in the two strengths of Eucreas were absorbed in the body in the same way as when they were taken as separate tablets.
Estonian: Müügiloa taotleja esitas ka kahe uuringu tulemused, mis näitasid, et Eucrease kahes tugevuses toimeained imendusid organismis samal viisil kui eraldi tablettidena manustatuna.
English: This is a summary of the European public assessment report (EPAR) for Eucreas.
Estonian: See on ravimi Eucreas Euroopa avaliku hindamisaruande kokkuvõte.
English: The most common side effects with Eucreas (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite.
Estonian: Eucrease kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on iiveldus, oksendamine, kõhulahtisus, kõhuvalu ja isutus.
English: As a result of the action of both substances, the blood glucose is reduced and this helps to control type 2 diabetes.
Estonian: Nende kahe toimeaine tulemusena vere glükoosisisaldus väheneb ja see aitab ravida II tüüpi diabeeti.
English: For more information about treatment with Eucreas, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Eucreasega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Elderly patients taking Eucreas should have their kidney function monitored regularly.
Estonian: Eucreast kasutavate eakate patsientide neerutalitlust tuleb regulaarselt kontrollida.
English: • in patients who are already taking the combination of vildagliptin and metformin as separate tablets;
Estonian: • patsientidel, kes juba saavad vildagliptiini ja metformiini eraldi tablettidena;
English: Eucreas is a medicine that contains the active substances vildagliptin and metformin hydrochloride.
Estonian: Eucreas on ravim, mis sisaldab toimeainetena vildagliptiini ja metformiinvesinikkloriidi.
English: Vildagliptin / metformin hydrochloride
Estonian: Eucreas vildagliptiin/metformiinvesinikkloriid
English: Taking Eucreas with or just after food may reduce any stomach problems caused by metformin.
Estonian: Eucrease manustamine söögi ajal või kohe pärast sööki võib vähendada metformiini tõttu tekkivaid maohäireid.
English: Vildagliptin, which is a dipeptidyl peptidase 4 (DPP-4) inhibitor, works by blocking the breakdown of ‘incretin' hormones in the body.
Estonian: Vildagliptiin on ensüümi dipeptidüülpeptidaas-4 (DPP-4) inhibiitor, mille toime seisneb inkretiinhormoonide organismis lagunemise blokeerimises.
English: The CHMP concluded that vildagliptin taken with metformin reduces blood glucose levels and the combination of the two active substances in one tablet may help patients to stick to their treatment.
Estonian: Inimravimite komitee järeldas, et vildagliptiin manustatuna koos metformiiniga vähendab vere glükoosisisaldust ja nende kahe toimeaine kombinatsioon ühes tabletis võib aidata patsientidel järgida raviskeemi.
English: Patients already taking vildagliptin and metformin should switch to Eucreas containing the same amounts of each active substance.
Estonian: Patsiendid, kes juba võtavad vildagliptiini ja metformiini, peaksid alustama Eucrease ravi tablettidega, mis sisaldavad kumbagi toimeainet samas koguses.
English: Vildagliptin can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Estonian: Vildagliptiini tohib kasutada koos metformiiniga II tüüpi diabeedi raviks patsientidel, kelle haigus ei allu rahuldavalt ravile ainult metformiiniga.
English: For the full list of all side effects reported with Eucreas, see the package leaflet.
Estonian: Eucrease kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: What is the risk associated with Eucreas?
Estonian: Mis riskid Eucreasega kaasnevad?
English: Patients adding vildagliptin had falls in HbA1c levels of 0.88 percentage points after 24 weeks from a starting level of 8.38%.
Estonian: Vildagliptiini lisaravimina saanud patsientidel langes 24 nädala järel HbA1c-sisaldus veres 0,88% (HbA1c sisaldus ravi alguses oli 8,38%).
English: What is Eucreas?
Estonian: Mis on Eucreas?
English: Eucreas should not be used in patients who have moderate or severe problems with their kidneys or who have problems with their liver.
Estonian: Eucreast ei tohi kasutada mõõdukate või raskete neeruprobleemidega või maksahäiretega patsiendid.