FrancophonIA/ELRC3.0 huggingface dataset:
English: Oracea, 40 mg, modified release capsules is an antibiotic (doxycycline), indicated for the reduction of papulopustular lesions in adult patients with facial rosacea.
Estonian: Toimeainet modifitseeritult vabastavate 40 mg kapslitena turustatav Oracea on antibiootikum (doksütsükliin), mis on ette nähtud paapulite ja mädavillide raviks rosaatseat põdevatel täiskasvanutel.
English: During their April 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the objections that triggered the Article 29 Referral should not prevent the granting of a Marketing Authorisation for Oracea and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Estonian: Arvestades kõiki esitatud andmeid ja komitees toimunud teaduslikku arutelu, jõudis inimravimite komitee 2008. aasta aprillis peetud koosolekul järeldusele, et vastuväited, mille alusel koostati artikli 29 kohane esildis, ei ole takistavaks asjaoluks Oraceale müügiloa andmisel, ning et viiteliikmesriigi ravimi omaduste kokkuvõtet, märgistust ja pakendi infolehte tuleb muuta.
English: The list of the medicinal product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Estonian: Teaduslikud järeldused on esitatud II lisas ning ravimi omaduste kokkuvõte III lisas.
English: Perjeta (pertuzumab)
Estonian: Perjeta (pertusumaab)
English: Perjeta is used in the following situations:
Estonian: Perjetat kasutatakse järgmistel juhtudel:
English: Perjeta received a marketing authorisation valid throughout the European Union on 4 March 2013.
Estonian: Perjeta on saanud müügiloa, mis kehtib kogu ELis, 4. märtsil 2013.
English: What measures are being taken to ensure the safe and effective use of Perjeta?
Estonian: Mis meetmed võetakse, et tagada Perjeta ohutu ja efektiivne kasutamine?
English: The full EPAR for Perjeta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Perjeta kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Perjeta and what is it used for?
Estonian: Mis on Perjeta ja milleks seda kasutatakse?
English: The recommended first dose is 840 mg given over one hour.
Estonian: Soovitatav esimene annus on 840 mg, mis manustatakse ühe tunni jooksul.
English: As for all medicines, data on the use of Perjeta are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Perjeta kasutamise kohta pidevat järelevalvet.
English: It also activates cells of the immune system (the body's natural defences), which then kill the cancer cells.
Estonian: See aktiveerib ka immuunsüsteemi (organismi loomuliku kaitsesüsteemi) rakud, mis hävitavad seejärel vähirakud.
English: Other information about Perjeta
Estonian: Muu teave Perjeta kohta
English: The Agency considered that, despite the side effects of Perjeta, the overall safety profile was acceptable.
Estonian: Ravimiamet oli arvamusel, et vaatamata Perjeta kõrvalnähtudele on ravimi üldine ohutusprofiil vastuvõetav.
English: The most common severe side effect (affecting more than 1 in 10 people) is neutropenia, with or without fever.
Estonian: Kõike sagedam raske kõrvalnäht (esineb enam kui 1 patsiendil 10st) on neutropeenia koos palavikuga või ilma.
English: What are the risks associated with Perjeta?
Estonian: Mis riskid Perjetaga kaasnevad?
English: Side effects reported with Perjeta are carefully evaluated and any necessary action taken to protect patients.
Estonian: Perjeta kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Perjeta have also been included in the summary of product characteristics and the package leaflet.
Estonian: Perjeta ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: This is followed by a dose of 420 mg every three weeks, with each dose given over half an hour to one hour.
Estonian: Sellele järgneb poole kuni ühe tunni jooksul manustatav 420 mg annus iga kolme nädala järel.
English: In these studies, Perjeta was given with trastuzumab or chemotherapy or both.
Estonian: Nendes uuringutes manustati Perjetat koos trastusumaabi või keemiaraviga või mõlemaga.
English: Patients were treated until their disease got worse or the side effects of treatment became unmanageable.
Estonian: Patsiente raviti kuni haiguse süvenemiseni või kuni kõrvalnähud muutusid talumatuks.
English: The most common side effects (affecting more than 3 in 10 people) with Perjeta when given with trastuzumab and chemotherapy are neutropenia (low levels of neutrophils, a type of white blood cell important for fighting infections), diarrhoea, nausea (feeling sick), vomiting, hair loss and tiredness.
Estonian: Kõige sagedamad kõrvalnähud (esinevad enam kui 3 patsiendil 10st) Perjeta kasutamisel koos trastusumaabi ja keemiaraviga on neutropeenia (neutrofiilide ehk nakkuste vastu võitlevate teatud vere valgeliblede vähesus), kõhulahtisus, iiveldus, oksendamine, juuste väljalangemine ja väsimus.
English: Perjeta can only be obtained with a prescription and treatment should be started under the supervision of a doctor who is experienced in using cancer medicines and in a hospital setting where resuscitation equipment is available.
Estonian: Perjeta on retseptiravim ja ravi sellega peab alustama vähiravimite kasutamises kogenud arsti järelevalve all ja haiglakeskkonnas, kus on olemas elustamisvahendid.
English: HER2-positive breast cancer is an aggressive form of breast cancer which occurs in around one in five cases.
Estonian: HER2-positiivne rinnavähk on agressiivne vähivorm, mis moodustab ligikaudu viiendiku kõigist rinnavähijuhtudest.
English: • treatment of metastatic breast cancer (cancer that has spread to other parts of the body) that has not already been treated with chemotherapy medicines or medicines designed to target HER2, or for breast cancer that has come back locally after treatment and cannot be removed by surgery.
Estonian: • metastaatiline rinnavähk (kui vähk on levinud organismis ka mujale), mida ei ole veel ravitud keemiaravi ravimitega või HER2 vastu suunatud ravimitega, või kui rinnavähk on pärast ravi paikselt taastunud ning seda ei saa kirurgiliselt eemaldada.
English: Patients treated with Perjeta lived for 18.5 months without their disease getting worse, compared with 12.4 months for patients given placebo.
Estonian: Perjetaga ravitud patsiendid elasid haiguse süvenemiseta 18,5 kuud ja platseebot saanud patsiendid 12,4 kuud.
English: The main measure of effectiveness was progression-free survival (how long the patients lived without their disease getting worse).
Estonian: Efektiivsuse põhinäitaja oli progresseerumiseta elumus (aeg haiguse süvenemiseni).
English: For more information about using Perjeta, see the package leaflet or contact a doctor or pharmacist.
Estonian: Lisateavet Perjeta kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Perjeta has also been studied in two main studies involving a total of 642 patients with earlier stages of breast cancer who were to undergo surgery.
Estonian: Perjetat uuriti ka kahes põhiuuringus, milles osales kokku 642 varajases staadiumis rinnavähiga patsienti, kellele pidi tehtama operatsioon.
English: How is Perjeta used?
Estonian: Kuidas Perjetat kasutatakse?
English: A fourth ongoing study compared Perjeta with placebo (both given with trastuzumab and chemotherapy) in 4,805 women with early breast cancer who had had surgery to remove the cancer.
Estonian: Neljandas käimasolevas uuringus võrreldi Perjetat platseeboga (mõlemat manustati koos trastusumaabi ja keemiaraviga) 4805 varajases staadiumis rinnavähiga naisel, kellele oli vähi eemaldamiseks tehtud operatsioon.
English: The studies looked at how many patients responded to treatment (i.e. patients who had no cancer cells in the breast after surgery).
Estonian: Uuringutes vaadeldi ravivastusega patsientide arvu (st patsiendid, kellel ei olnud pärast operatsiooni rinnas vähirakke).
English: Perjeta has been studied in one main study involving 808 adults with previously untreated HER2positive metastatic breast cancer.
Estonian: Perjetat uuriti ühes põhiuuringus 808 täiskasvanul, kellel esines varem ravimata HER2-positiivne metastaatiline rinnavähk.
English: An overview of Perjeta and why it is authorised in the EU
Estonian: Ülevaade ravimist Perjeta ja ELis müügiloa väljastamise põhjendus
English: For the full list of all side effects and restrictions with Perjeta, see the package leaflet.
Estonian: Perjeta kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: What benefits of Perjeta have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Perjeta kasulikkus?
English: The company that markets Perjeta will carry out a study to assess the effects of using Perjeta and trastuzumab together with a type of cancer medicines called taxanes, in previously untreated patients with HER2-positive metastatic or locally advanced breast cancer.
Estonian: Perjeta turustaja korraldab uuringu, et hinnata Perjeta ja trastusumaabi ning teatud tüüpi vähiravimite taksaanide kooskasutuse toimet varem ravimata HER2-positiivse metastaatilise või paikselt levinud rinnavähiga patsientidel.
English: The European Medicines Agency considered that Perjeta has been shown to benefit patients with metastatic cancer by extending the amount of time patients lived without their disease getting worse as well as how long they lived.
Estonian: Euroopa Ravimiamet oli arvamusel, et Perjeta on tõendatult kasulik metastaatilise vähiga patsientidele, pikendades nii progresseerumiseta kui ka üldist elumust.
English: The effects of Perjeta were compared with placebo (a dummy treatment) when given together with other cancer medicines (trastuzumab and docetaxel).
Estonian: Perjetat võrreldi platseeboga (näiv ravim) manustamisel koos teiste vähiravimitega (trastusumaab ja dotsetakseel).
English: Perjeta was shown to be of benefit in patients whose cancer was at a high risk of coming back: after 4 years, the disease had not spread in 90% of patients with ‘node-positive' cancer treated with Perjeta compared with 87% of those receiving placebo; for those with ‘hormone-receptor negative' cancer, this figure was 91% of patients treated with Perjeta, and 89% of patients given placebo.
Estonian: Perjeta oli kasulik neile patsientidele, kellel oli suur vähi taastumise risk: 4 aasta pärast polnud vähk edasi levinud 90%-l patsientidest, kellel oli esinenud lümfisõlmedesse levinud vähk ja kes olid saanud ravi Perjetaga, võrreldes 87%-ga platseebot saanud patsientidest.
English: It considered that this would provide an additional benefit when added to other medicines for HER2-positive cancer, notably trastuzumab.
Estonian: Komitee leidis, et Perjeta lisamine teistele HER2-positiivse vähi ravimitele, eriti trastusumaabile, suurendab ravi kasulikkust.
English: How does Perjeta work?
Estonian: Kuidas Perjeta toimib?
English: pertuzumab stops HER2 producing signals that cause the cancer cells to grow.
Estonian: HER2-ga seondudes peatab pertusumaab HER2 signaalid, mis stimuleerivad vähirakkude kasvu.
English: In the first study, 46% of the patients treated with Perjeta plus trastuzumab and docetaxel responded to treatment, compared with 29% of patients who received trastuzumab and docetaxel alone.
Estonian: Esimeses uuringus oli ravivastusega patsiente Perjetat koos trastusumaabi ja dotsetakseeliga kasutanute seas 46% ning üksnes trastusumaabi ja dotsetakseeli kasutanute seas 29%.
English: • treatment of locally advanced, inflammatory or early-stage breast cancer at high risk of coming back, in combination with trastuzumab and chemotherapy, before the patient undergoes surgery;
Estonian: • paikselt levinud, põletikulise või suure taastumise riskiga varase staadiumi rinnavähi ravi koos trastusumaabi ja keemiaraviga enne operatiivset ravi;
English: In these cases, Perjeta is used with trastuzumab and docetaxel (other cancer medicines);
Estonian: Sellistel juhtudel kasutatakse Perjetat koos trastusumaabi ja dotsetakseeliga (samuti vähiravimid);
English: The active substance in Perjeta, pertuzumab, is a monoclonal antibody, a type of protein that has been designed to attach to HER2, a protein found on HER2-positive cancer cells.
Estonian: Perjeta toimeaine pertusumaab on monoklonaalne antikeha (teatud valk), mis seondub HER2positiivsete vähirakkude pinnal leiduva valguga HER2.
English: Response to treatment in the second study ranged from 57% to 66% where Perjeta was given with trastuzumab and chemotherapy medicines.
Estonian: Teises uuringus, kus Perjetat manustati koos trastusumaabi ja keemiaravi ravimitega, varieerus ravivastus vahemikus 57% kuni 66%.
English: Perjeta is a cancer medicine for treating adults with ‘HER2-positive' breast cancer (where a protein called HER2 is found on the cancer cells).
Estonian: Perjeta on vähiravim, mida kasutatakse HER2-positiivse (kasvajarakkude pinnal esineb valk HER2) rinnavähiga täiskasvanute raviks.
English: Perjeta is given by infusion (drip) into a vein.
Estonian: Perjetat manustatakse veeniinfusioonina.
English: Treatment with Perjeta should be interrupted or stopped permanently if the patient gets certain side effects.
Estonian: Teatud kõrvalnähtude ilmnemisel tuleb ravi Perjetaga katkestada või lõpetada.
English: • treatment of early breast cancer at high risk of coming back, in combination with trastuzumab and chemotherapy, after the patient has had surgery.
Estonian: • suure taastumise riskiga varase staadiumi rinnavähi ravi koos trastusumaabi ja keemiaraviga pärast operatiivset ravi.
English: Perjeta has also been shown to improve the outcome of patients with earlier stages of breast cancer, when used with trastuzumab and chemotherapy.
Estonian: Lisaks on tõestatud, et koos trastusumaabi ja keemiaraviga parandab Perjeta varajases staadiumis rinnavähiga patsientide ravi ravitulemust.
English: Perjeta contains the active substance pertuzumab.
Estonian: Perjeta sisaldab toimeainena pertusumaabi.
English: Why is Perjeta authorised in the EU?
Estonian: ELis Perjetale väljastatud müügiloa põhjendus
English: Blister (PVC/aluminium) 70x1 tablets
Estonian: Blister (PVC/alumiinium) 70x1 tabletti
English: EU number administration
Estonian: Müügiloa nr Euroopa Liidus Ravimi väljamõeldud nimetus Tugevus Ravimvorm
English: Side effects are mostly mild or moderate.
Estonian: Kõrvalnähud on üldiselt kerged või mõõdukad.
English: The full EPAR for Reagila can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Reagila kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Because the medicine's effects may take time to show, patients should be monitored for several weeks after starting treatment or changing the dose.
Estonian: Kuna ravimi toime avaldumiseks võib kuluda aega, tuleb patsiente jälgida mitme nädala jooksul alates ravi alustamisest või annuse muutmisest.
English: What measures are being taken to ensure the safe and effective use of Reagila?
Estonian: Mis meetmed võetakse, et tagada Reagila ohutu ja efektiivne kasutamine?
English: Reagila cariprazine
Estonian: Reagila kariprasiin
English: Therefore, the European Medicines Agency decided that Reagila's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Seetõttu otsustas Euroopa Ravimiamet, et Reagila kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: What is Reagila and what is it used for?
Estonian: Mis on Reagila ja milleks seda kasutatakse?
English: Other information about Reagila
Estonian: Muu teave Reagila kohta
English: The PANSS score, which ranges from a minimum of 30 (no symptoms) to a maximum of 210 (severest symptoms), was around 96 at the start of treatment.
Estonian: PANSS-skoor, mis ulatub miinimumskoorist 30 (sümptomid puuduvad) maksimumskoorini 210 (raskeimad sümptomid), oli ravi alustamisel umbes 96.
English: Why is Reagila approved?
Estonian: Miks Reagila heaks kiideti?
English: The dose can be increased by 1.5 mg at a time up to a maximum of 6 mg per day.
Estonian: Annust võib suurendada 1,5 mg võrra igal manustamiskorral maksimaalse annuseni 6 mg ööpäevas.
English: This reduces symptoms of schizophrenia and prevents them from returning.
Estonian: See vähendab skisofreenia sümptomeid ja takistab nende taastumist.
English: After 6 weeks, depending on the study, the PANSS score fell by 17 to 23 points with Reagila compared with 9 to 14 points with placebo.
Estonian: 6 nädala möödudes oli PANSS-skoor olenevalt uuringust langenud Reagilaga 17-23 punkti võrra ja platseeboga 9-14 punkti võrra.
English: Reagila is an antipsychotic medicine used to treat schizophrenia in adults.
Estonian: Reagila on antipsühhootikum, mida kasutatakse skisofreenia raviks täiskasvanutel.
English: Reagila is available as capsules (1.5, 3, 4.5 and 6 mg) to be taken by mouth.
Estonian: Reagilat turustatakse suukaudsete kapslitena (1,5, 3, 4,5 ja 6 mg).
English: This is a summary of the European public assessment report (EPAR) for Reagila.
Estonian: See on ravimi Reagila Euroopa avaliku hindamisaruande kokkuvõte.
English: The recommended starting dose is 1.5 mg once a day.
Estonian: Soovitatav algannus on 1,5 mg üks kord ööpäevas.
English: As well as studies showing that Reagila improves the positive symptoms of schizophrenia both in the short and longer term, one study also showed that the medicine improved the negative symptoms of the disease which have a large impact on patients' quality of life.
Estonian: Peale selle, et Reagila osutus uuringutes efektiivseks skisofreenia positiivsete sümptomite parandamisel nii lühikeses kui ka pikemas perspektiivis, nähtus ühest uuringust ühtlasi, et ravim parandas negatiivseid haigussümptomeid, millel on oluline mõju patsiendi elukvaliteedile.
English: Schizophrenia is a mental illness with symptoms such as delusions, disorganised thinking and speech, suspiciousness and hallucinations (hearing or seeing things that are not there).
Estonian: Skisofreenia on vaimuhaigus, mille sümptomite hulgas on luulud, häiritud mõtted ja kõne, kahtlustamine ja hallutsinatsioonid (patsient näeb või kuuleb asju, mida pole olemas).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Reagila have been included in the summary of product characteristics and the package leaflet.
Estonian: Reagila ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: A fourth main study in 461 patients who mostly had ‘negative' symptoms (such as lack of drive, social withdrawal, and problems with attention and memory) and only few ‘positive' symptoms (such as delusions and hallucinations) showed that Reagila was effective at treating negative symptoms: after 26 weeks of treatment Reagila lowered the PANSS score for negative symptoms by around 9 points compared with around 7 points with another medicine, risperidone.
Estonian: Neljandas põhiuuringus 461 patsiendil, kel olid suuremas osas nn negatiivsed sümptomid (tahtetus, sotsiaalne eraldumine, tähelepanu- ja mäluprobleemid) ja vaid mõni nn positiivne sümptom (nt luulud ja hallutsinatsioonid), oli Reagila efektiivne negatiivsete sümptomite ravimisel - pärast 26 ravinädalat langes negatiivsete sümptomite PANSS-skoor Reagilaga umbes 9 punkti võrra ja teise ravimiga (risperidoon) umbes 7 punkti võrra.
English: Reagila must not be taken at the same time as certain other medicines called strong or moderate CYP3A4 inhibitors or inducers.
Estonian: Reagilat ei tohi võtta samal ajal tugeva või mõõduka toimega CYP3A4 inhibiitorite või indutseerijatega (teatavad teised ravimid).
English: Most of the side effects are as expected with antipsychotic medicines and many can be treated.
Estonian: Enamik kõrvalnähte on ootuspärased antipsühhootikumide kõrvalnähud ja paljud neist on ravitavad.
English: It is not intended to provide practical advice on how to use Reagila.
Estonian: Hindamisaruandes ei anta Reagila kasutamise praktilisi nõuandeid.
English: Over a 72 week period, symptoms returned in a quarter of patients taking Reagila compared with around half of those taking placebo.
Estonian: 72-nädalase perioodi vältel taastusid sümptomid veerandil Reagilat saanud patsientidest ja umbes pooltel platseebot saanud patsientidest.
English: Since dopamine and serotonin play a role in schizophrenia, by attaching to their receptors, cariprazine helps normalise the activity of the brain.
Estonian: Kuna dopamiin ja serotoniin mängivad rolli skisofreenia tekkes, aitab kariprasiin neurotransmitterite retseptoritele kinnitudes normaliseerida ajutegevust.
English: Finally, a fifth main study in 200 patients showed that Reagila was more effective than placebo at preventing symptoms from coming back after initial treatment.
Estonian: Viiendas põhiuuringus, milles osales 200 patsienti, aitas Reagila võrreldes platseeboga efektiivsemalt ära hoida sümptomite taastumist pärast algset ravi.
English: The lowest dose that works well for the patient should be maintained.
Estonian: Säilitada tuleb väikseim patsiendile efektiivne annus.
English: For practical information about using Reagila, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Reagila kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: For the full list of all side effects and restrictions with Reagila, see the package leaflet.
Estonian: Reagila kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: The most common side effects with Reagila are akathisia (a constant urge to move) and parkinsonism (effects similar to Parkinson's disease such as shaking, muscle stiffness and slow movement).
Estonian: Reagila kõige sagedamad kõrvalnähud on akatiisia (füüsiline paigalpüsimatus) ja parkinsonism (Parkinsoni tõve sümptomeid meenutavad nähud, nagu värisemine, lihasjäikus ja aeglased liigutused).
English: The active substance in Reagila, cariprazine, attaches to receptors (targets) in the brain for two neurotransmitters called dopamine and serotonin, which nerve cells use to communicate with neighbouring cells.
Estonian: Reagila toimeaine kariprasiin kinnitub ajus dopamiini ja serotoniini retseptoritele; dopamiin ja serotoniin on neurotransmitterid, mille abil närvirakud suhtlevad naaberrakkudega.
English: Studies showed that Reagila improves symptoms of schizophrenia and prevents symptoms from returning.
Estonian: Uuringutes tõendati, et Reagila vähendab skisofreenia sümptomeid ja takistab nende taastumist.
English: For more information about treatment with Reagila, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Reagilaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: How does Reagila work?
Estonian: Kuidas Reagila toimib?
English: In three main studies in a total of 1,795 adults, Reagila was more effective than placebo (a dummy treatment) at reducing symptoms on a standard rating scale called PANSS (positive and negative syndrome scale).
Estonian: Kolmes põhiuuringus, milles osales kokku 1795 täiskasvanut, osutus Reagila standardsel hindamisskaalal PANSS (positiivse ja negatiivse sündroomi skaala) hinnatuna sümptomite vähendamisel efektiivsemaks kui platseebo (näiv ravim).
English: What benefits of Reagila have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Reagila kasulikkus?