FrancophonIA/ELRC3.0 huggingface dataset:
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 Travatan.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: For more information about treatment with Travatan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Travataniga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: By lowering the pressure, Travatan reduces the risk of
Estonian: Rõhku vähendades vähendab Travatan kahjustuste riski.
English: For the full list of all side effects and restrictions with Travatan, see the package leaflet.
Estonian: Travatani kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: The most common side effects when using Travatan (seen in more than 1 patient in 10) are ocular hyperaemia (increased blood supply to the eye, leading to eye irritation and redness) and iris hyperpigmentation (darkening of the colour of the iris).
Estonian: Travatani kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on silma hüpereemia (silma verevarustuse suurenemine, mis põhjustab silma ärritust ja punetust) ja vikerkesta hüperpigmentatsioon (vikerkesta värvuse tumenemine).
English: The combined treatment with Travatan plus timolol produced an additional decrease of intraocular pressure in patients who were not controlled with timolol alone.
Estonian: Samaaegne ravi Travatani ja timolooliga vähendas täiendavalt silma siserõhku patsientidel, kelle seisund ainult timolooliga ei paranenud.
English: What benefit has Travatan shown during the studies?
Estonian: Milles seisneb uuringute põhjal Travatani kasulikkus?
English: It is used in adults who have open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) and in adults with ocular hypertension (when the pressure in the eye is higher than normal).
Estonian: Ravimit kasutatakse täiskasvanud patsientidel, kellel on avatud nurga glaukoom (haigus, mille korral silma siserõhk suureneb, sest silma sisevedelik ei saa silmast ära voolata) või okulaarne hüpertensioon (silma siserõhk on normaalsest suurem).
English: What is the risk associated with Travatan?
Estonian: Mis riskid Travataniga kaasnevad?
English: The main measure of effectiveness in all studies was the reduction in intraocular pressure
Estonian: Kõigis uuringutes oli efektiivsuse põhinäitaja silma siserõhu vähenemine.
English: Why has Travatan been approved?
Estonian: Miks Travatan heaks kiideti?
English: One of the three trials also included a comparison with latanoprost (another prostaglandin analogue used for glaucoma).
Estonian: Ühes kolmest uuringust võrreldi ravimit ka latanoprostiga (samuti prostaglandiini analoog, mida kasutatakse glaukoomi raviks).
English: Travatan is a clear eye drop solution that contains the active substance travoprost.
Estonian: Travatan on selge silmatilkade lahus, mis sisaldab toimeainena travoprosti.
English: All three studies compared travoprost with timolol, which is the standard treatment for glaucoma.
Estonian: Kõigis kolmes uuringus võrreldi travoprosti glaukoomi standardravimi timolooliga.
English: This is a summary of the European public assessment report (EPAR) for Travatan.
Estonian: See on ravimi Travatan Euroopa avaliku hindamisaruande kokkuvõte.
English: Travatan was at least as effective as timolol and as effective as latanoprost in reducing intraocular pressure.
Estonian: Travatan vähendas silma siserõhku vähemalt sama efektiivselt kui timolool ja sama efektiivselt kui latanoprost.
English: What is Travatan?
Estonian: Mis on Travatan?
English: Travatan is used to reduce intraocular pressure (pressure inside the eye).
Estonian: Travatani kasutatakse intraokulaarse rõhu ehk silma siserõhu vähendamiseks.
English: The active substance in Travatan, travoprost, is a prostaglandin analogue (a man-made copy of a prostaglandin, one of a group of substances naturally found in the body).
Estonian: Travatani toimeaine travoprost on prostaglandiini analoog (loodusliku prostaglandiini sünteetiline variant).
English: Other information about Travatan
Estonian: Muu teave Travatani kohta
English: In the eye, prostaglandins increase the drainage of the watery fluid (aqueous humour) out of the eyeball.
Estonian: Prostaglandiinid suurendavad vesivedeliku väljavoolu silmast.
English: Travatan acts in the same way and increases the flow of fluid out of the eye.
Estonian: Travatanil on samasugune toime ja see suurendab vedeliku väljavoolu silmast.
English: When intraocular pressure is raised, it causes damage to the retina (the light-sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
Estonian: Silma siserõhu suurenemine kahjustab võrkkesta (valgustundlik kelme silma tagaosas) ja silmanärvi, mille kaudu liiguvad närvisignaalid silmast ajju.
English: How is Travatan used?
Estonian: Kuidas Travatani kasutatakse?
English: What is Travatan used for?
Estonian: Milleks Travatani kasutatakse?
English: Travatan travoprost
Estonian: TRAVATAN
English: How has Travatan been studied?
Estonian: Kuidas Travatani uuriti?
English: EU/1/15/994/001 Kengrexal
Estonian: EU/1/15/994/001
English: 50 mg Powder for concentrate for solution for injection / infusion
Estonian: 50 mg süste-/infusioonilahuse kontsentraadi pulber
English: 10 vials
Estonian: Viaal (klaas) 10 viaali
English: It is used:
Estonian: Seda kasutatakse:
English: The remaining 16 patients did not fall into either group.
Estonian: Ülejäänud 16 patsienti ei kuulunud kummassegi rühma.
English: What measures are being taken to ensure the safe and effective use of Arzerra?
Estonian: Mis meetmed võetakse, et tagada Arzerra ohutu ja efektiivne kasutamine?
English: Arzerra ofatumumab
Estonian: Arzerra ofatumumaab
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Arzerra on 19 April 2010.
Estonian: Euroopa Komisjon andis Arzerra tingimusliku müügiloa, mis kehtib kogu Euroopa Liidus, 19. aprillil 2010.
English: Other information about Arzerra
Estonian: Muu teave Arzerra kohta
English: The European Medicines Agency decided that the medicine's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Euroopa Ravimiamet otsustas, et ravimi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: To reduce the risk of these reactions, infusions are started slowly (particularly when first starting treatment) and then speeded up every 30 minutes if no reactions occur.
Estonian: Infusioonireaktsioonide riski vähendamiseks tuleb infusiooni alustada aeglaselt (eelkõige ravi alguses) ja seejärel iga 30 minuti järel kiirendada, kui reaktsioone ei teki.
English: This was switched to a full marketing authorisation on 24 April 2015.
Estonian: Tingimuslik müügiluba muudeti tavaliseks müügiloaks 24. aprillil 2015.
English: What is Arzerra and what is it used for?
Estonian: Mis on Arzerra ja milleks seda kasutatakse?
English: Why is Arzerra approved?
Estonian: Miks Arzerra heaks kiideti?
English: It is given using an infusion pump.
Estonian: Seda manustatakse infusioonipumbaga.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Arzerra can also be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Arzerra kohta on samuti ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: The full EPAR for Arzerra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Arzerra kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European Public Assessment Report (EPAR) for Arzerra.
Estonian: See on ravimi Arzerra Euroopa avaliku hindamisaruande kokkuvõte.
English: The main measure of effectiveness was the number of patients who ‘responded' to treatment.
Estonian: Efektiivsuse põhinäitaja oli ravivastusega patsientide arv.
English: The dosing schedule depends on whether the patient has been treated before and whether the patient's disease has come back.
Estonian: Annustamisskeem sõltub patsiendi varasemast ravist ja sellest, kas haigus on taastunud.
English: Arzerra was originally given ‘conditional approval', because there was more evidence to come about the medicine.
Estonian: Arzerra müügiluba anti esialgu tingimuslikult, sest ravimi toetuseks oodati täiendavaid andmeid.
English: • in patients whose disease has come back after previous treatment (known as relapsed disease).
Estonian: • patsientidel, kelle haigus on pärast varasemat ravi taastunud (relapseerunud ehk taastunud haigus).
English: It is not intended to provide practical advice on how to use of Arzerra.
Estonian: Hindamisaruandes ei anta Arzerra kasutamise praktilisi nõuandeid.
English: Arzerra was not compared with any other treatments in this study.
Estonian: Uuringus ei võrreldud Arzerrat ühegi muu ravimiga.
English: Arzerra can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in treating cancer and in a place where facilities for resuscitating patients are readily available.
Estonian: Arzerra on retseptiravim ja seda peab manustama vähiravis kogenud arsti järelevalve all ning kohas, kus on olemas patsientide elustamise võimalused.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arzerra have been included in the summary of product characteristics and the package leaflet.
Estonian: Arzerra ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: By attaching to CD20, ofatumumab stimulates the body's immune system to attack the cancerous cells, helping to control the disease.
Estonian: CD20-ga seondudes stimuleerib ofatumumaab organismi immuunsüsteemi vähirakke ründama, aidates nii haigust reguleerida.
English: For practical information about using Arzerra, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Arzerra kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Before each infusion, the patient receives medicines, such as a corticosteroid, an antihistamine and paracetamol, to help to prevent infusion reactions (such as rash, fever, allergic reactions and difficulty breathing).
Estonian: Patsiendile peab enne iga infusiooni andma ravimeid, nagu kortikosteroidi, antihistamiini ja paratsetamooli, mis aitavad ennetada infusioonireaktsioone (nt löövet, palavikku, allergilisi reaktsioone ja hingamisraskusi).
English: • in previously untreated patients who cannot be treated with fludarabine; in these patients it is used together with chlorambucil or bendamustine (other cancer medicines);
Estonian: • varem ravimata patsientidel, keda ei saa ravida fludarabiiniga; neil kasutatakse Arzerrat koos kloorambutsiili või bendamustiiniga (samuti vähiravimid);
English: What are the risks associated with Arzerra?
Estonian: Mis riskid Arzerraga kaasnevad?
English: How does Arzerra work?
Estonian: Kuidas Arzerra toimib?
English: In these patients Arzerra is used together with fludarabine and cyclophosphamide.
Estonian: Neil patsientidel kasutatakse Arzerrat koos fludarabiini ja tsüklofosfamiidiga.
English: The most common side effects with Arzerra (seen in more than 1 patient in 10) are lower respiratory tract infection (infection of the lungs such as pneumonia), upper respiratory tract infection (nose and throat infection), neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts), nausea (feeling sick), fever, rash, dyspnoea (difficulty breathing), cough, diarrhoea and tiredness.
Estonian: Arzerra kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on alumiste hingamisteede infektsioon (kopsuinfektsioon, nt kopsupõletik), ülemiste hingamisteede infektsioon (nina- ja kurguinfektsioonid), neutropeenia (neutrofiilide ehk teatud valgeliblede vähesus), aneemia (erütrotsüütide ehk vere punaliblede vähesus), iiveldus, palavik, lööve, düspnoe (hingamisraskused), köha, kõhulahtisus ja väsimus.
English: For the full list of side effects and restrictions with Arzerra, see the package leaflet.
Estonian: Arzerra kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Because the number of patients with CLL is low, the disease is considered ‘rare', and Arzerra was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 November 2008.
Estonian: Et kroonilise lümfotsüütleukeemiaga patsientide arv on väike ja see haigus esineb harva, nimetati Arzerra 7. novembril 2008 harvikravimiks.
English: In patients whose previous treatment with both fludarabine and alemtuzumab had failed, 49% (47 out of 95) responded to treatment with Arzerra.
Estonian: Patsientidest, kelle varasem ravi fludarabiini ja alemtusumaabiga oli ebaõnnestunud, tekkis Arzerraga ravivastus 49%-l (47 patsienti 95st).
English: Arzerra has been investigated in one main study involving 223 patients with CLL whose disease had not responded to previous treatment.
Estonian: Arzerrat uuriti ühes põhiuuringus, milles osales 223 kroonilise lümfotsüütleukeemiaga patsienti, kellel ei olnud tekkinud varasema raviga ravivastust.
English: In 95 of these patients, the disease had not responded to both fludarabine and alemtuzumab, and in 112, treatment with fludarabine had failed but the patients had not been treated with alemtuzumab because this medicine was not suitable for them.
Estonian: 95 patsiendil ei tekkinud fludarabiini ega alemtusumaabiga ravivastust ning 112 patsiendil oli ravi fludarabiiniga ebaõnnestunud ja nad ei saanud kasutada alemtusumaabi ravimi sobimatuse tõttu.
English: The response rate was slightly lower in patients whose treatment with fludarabine had failed but who were not suitable for treatment with alemtuzumab (43%).
Estonian: Ravivastus oli veidi väiksem patsientidel, kelle varasem ravi fludarabiiniga oli ebaõnnestunud ja kellele alemtusumaab ei sobinud (43%).
English: The Agency also noted that patients with CLL who had not responded to previous treatment have limited treatment options.
Estonian: Ravimiamet märkis ka, et kroonilise lümfotsüütleukeemiaga patsientidel, kellel varasema raviga ravivastust ei tekkinud, on ravivõimalused piiratud.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.
Estonian: Arzerra toimeaine ofatumumaab on monoklonaalne antikeha (teatud tüüpi valk), mis tunneb ära teatud antigeeni (organismi rakkudes leiduva spetsiifilise struktuuri) ja seondub sellega.
English: The response to treatment was assessed by looking at the patients' symptoms, the number of lymphocytes in their blood, results of blood and bone marrow tests and the size of their lymph nodes, liver and spleen.
Estonian: Ravivastust hinnati järgmiste näitajate järgi: patsientide sümptomid, lümfotsüütide sisaldus veres, vere ja luuüdi analüüside tulemused ning lümfisõlmede, maksa ja põrna suurus.
English: What benefits of Arzerra have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Arzerra kasulikkus?
English: One main study involving 365 patients whose cancer had come back compared the combination of Arzerra plus fludarabine and cyclophosphamide with fludarabine and cyclophosphamide used alone.
Estonian: Põhiuuringus, kus osales 365 taastunud vähiga patsienti, võrreldi Arzerra ning fludarabiini ja tsüklofosfamiidi kombinatsiooni fludarabiini ja tsüklofosfamiidi kombinatsiooniga.
English: One main study involving 447 previously untreated patients who could not be treated with fludarabinebased therapy compared a combination of Arzerra plus chlorambucil with chlorambucil given alone.
Estonian: Põhiuuringus, milles osales 447 varem ravimata patsienti, kellel ei saanud kasutada fludarabiinipõhist ravi, võrreldi Arzerra ja kloorambutsiili kombinatsiooni kloorambutsiili monoteraapiaga.
English: Arzerra plus fludarabine and cyclophosphamide was effective at increasing progression-free survival, with patients living on average for 28.9 months without their disease getting worse, compared with 18.8 months in patients given fludarabine and cyclophosphamide alone.
Estonian: Arzerra koos fludarabiini ja tsüklofosfamiidiga oli efektiivne, pikendades progresseerumiseta elumust keskmiselt 28,9 kuud, fludarabiini ja tsüklofosfamiidi kombinatsiooni kasutamisel oli sama näitaja 18,8 kuud.
English: The Agency noted that Arzerra was shown to be effective at treating patients with CLL (previously untreated patients, patients who had not responded to previous treatment with fludarabine and alemtuzumab and patients whose cancer had come back after previous treatment).
Estonian: Ravimiamet märkis, et Arzerra efektiivsus kroonilise lümfotsüütleukeemia ravis on tõendatud varem ravimata patsientidel, neil, kel varasema fludarabiini- ja alemtusumaabiraviga ravivastust ei tekkinud, ja varasema ravi järel taastunud vähiga patsientidel.
English: Arzerra plus chlorambucil was effective at increasing progression-free survival (how long the patients lived without their disease getting worse), with patients living on average for 22.4 months without their disease getting worse, compared with 13.1 months in patients given chlorambucil alone.
Estonian: Arzerra ja kloorambutsiili kombinatsioon oli efektiivne progresseerumiseta elumuse pikendamisel (kui kaua patsiendid elasid haiguse süvenemiseta): see oli Arzerra ja kloorambutsiili kombinatsiooni kasutamisel keskmiselt 22,4 kuud ja ainult kloorambutsiili kasutamisel keskmiselt 13,1 kuud.
English: How is Arzerra used?
Estonian: Kuidas Arzerrat kasutatakse?
English: Previously untreated CLL
Estonian: Varem ravimata krooniline lümfotsüütleukeemia
English: If reactions occur, treatment is interrupted and may be restarted at a slower rate when the patient has recovered or stopped permanently if a serious allergic reaction occurs.
Estonian: Reaktsiooni korral ravi katkestatakse ja reaktsiooni möödumisel võib alustada manustamist väiksemal kiirusel.
English: Arzerra is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Estonian: Arzerrat turustatakse infusioonilahuse (veeni tilgutatava lahuse) kontsentraadina.
English: Ofatumumab has been designed to attach to a protein called CD20 that is found on the surface of lymphocytes, including the cancerous lymphocytes seen in CLL.
Estonian: Ofatumumaab seondub valguga CD20, mida leidub lümfotsüütide pinnal, sh kroonilise lümfotsüütleukeemia korral vähiga lümfotsüütide pinnal.
English: For more information on how Arzerra is used, see the summary of product characteristics (also part of the EPAR).
Estonian: Üksikasjalik teave Arzerra kasutamise kohta on ravimi omaduste kokkuvõttes, mis on samuti Euroopa avaliku hindamisaruande osa.
English: Refractory CLL
Estonian: Refraktoorne krooniline lümfotsüütleukeemia
English: Relapsed CLL
Estonian: Relapseerunud krooniline lümfotsüütleukeemia
English: Arzerra is a cancer medicine used to treat adults with chronic lymphocytic leukaemia (CLL), a cancer of a type of white blood cells called lymphocytes.
Estonian: Arzerrat kasutatakse kroonilise lümfotsüütleukeemiaga (CLL) täiskasvanute raviks.
English: • in patients whose disease has not responded to previous treatment (known as refractory disease)
Estonian: • patsientidel, kellel ei tekkinud varasema fludarabiini- ja alemtusumaabiraviga ravivastust
English: For more information about treatment with Arzerra, read the Package Leaflet (also part of the EPAR).
Estonian: Ravimi kasutamise üksikasjalik teave on pakendi infolehel, mis on samuti Euroopa avaliku hindamisaruande osa.
English: The potential clinical consequences of such interactions have not been investigated.
Estonian: Nende koostoimete võimalikke kliinilisi tagajärgi ei ole uuritud.
English: Date of first authorisation: 27/07/2005.
Estonian: Esmase müügiloa väljastamise kuupäev: 27/07/2005.
English: Do not administer orally or parenterally.
Estonian: Mitte manustada suukaudselt ega parenteraalselt.
English: Do not smoke, eat or drink during application.
Estonian: Manustamise ajal mitte suitsetada, süüa ega juua.
English: ATCvet code: QP52AA51.
Estonian: ATCvet kood: QP52AA51.
English: The tablets can be divided into equal halves.
Estonian: Tablette on võimalik poolitada võrdseteks osadeks.
English: Wash hands after use.
Estonian: Pärast kasutamist pesta käed.
English: Keep children away from treated animals during that time.
Estonian: Sel ajal hoida lapsed lahus ravitud loomadest.
English: The symptoms were completely reversible.
Estonian: Sümptomid olid täielikult pöörduvad.
English: In the interests of good hygiene, wash your hands after administering the tablets to the dog.
Estonian: Hea hügieeni huvides peske oma käsi pärast tablettide manustamist koerale.
English: Maximum concentrations were reached 2 hours after treatment for both active substances.
Estonian: Maksimaalsed kontsentratsioonid saavutatakse 2 tunni jooksul ravi järgselt mõlema toimeaine puhul.
English: No food should be given until 4 hours after treatment.
Estonian: Mitte anda süüa kuni 4 tundi pärast ravimi manustamist.
English: For external use only.
Estonian: Ainult välispidiseks kasutamiseks.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Estonian: Üksikasjalikku teavet antud veterinaarravimi kohta leiab Euroopa Ravimiameti koduleheküljelt (http://www.ema.europa.eu/).
English: [Multi-dose bottle]
Estonian: [Mitmedoosiline pudel]
English: [Single-dose pipettes]
Estonian: [Ühedoosilised pipetid]
English: The excretion of emodepside has not been investigated in dogs.
Estonian: Emodepsiidi väljutamist koertel ei ole uuritud.
English: Highest concentration levels are found in the fat.
Estonian: Kõrgeimad kontsentratsioonid on rasvas.
English: Remove screw cap (2).
Estonian: Eemaldada keeratav kork (2).
English: Pharmacotherapeutic group: therapeutic antiparasitic agent.
Estonian: Farmakoterapeutiline rühm: terapeutiline antiparasitaarne aine.
English: Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
Estonian: Parasiidi resistentsus igale antihelmintikumile võib välja kujuneda sagedaste, korduvate selle klassi anthelmintikumide manustamisel.
English: No studies have been performed with severely debilitated dogs or individuals with seriously compromised kidney or liver function.
Estonian: Ei ole tehtud katseid tõsiselt kurnatud koertel või loomadel, kellel on tugevalt häirunud neeru- või maksafunktsioon.
English: Remove one pipette from package.
Estonian: Eemaldada üks pipett pakendist.
English: Both active substances were then eliminated from the plasma with a half-life of 1.4 to 1.7 hours.
Estonian: Seejärel elimineeritakse mõlemad toimeained plasmast poolestusajaga 1,4 kuni 1,7 tundi.
English: Studies in many different species show that praziquantel is rapidly metabolised in the liver.
Estonian: Paljudel erinevatel liikidel tehtud katsed näitavad, et prasikvanteel metaboliseeritakse kiiresti maksas.
English: Emodepside is a semi-synthetic compound belonging to the new chemical group of depsipeptides.
Estonian: Emodepsiid on poolsünteetiline aine, mis kuulub uude depsipeptiidide keemilisse gruppi.
English: Date of last renewal: 01/07/2010.
Estonian: Müügiloa viimase uuendamise kuupäev: 01/07/2010.