FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCPCh FeLV on 23 February 2005.
Estonian: Euroopa Komisjon andis vaktsiini Purevax RCPCh FeLV müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 23. veebruaril 2005.
English: • inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains),
Estonian: • inaktiveeritud (hävitatud) kalitsiviroosi antigeenid (FCV 431 ja G1 tüvi),
English: It also helps to reduce viral excretion in case of calicivirus infection for one year after vaccination.
Estonian: Kalitsiviirusnakkuse korral aitab see vähendada ka viiruse eritumist ühe aasta vältel pärast vaktsineerimist.
English: The main measure of effectiveness was the level of antibodies in the blood against the viruses and bacteria in the vaccine, with the exception of the FeLV component, whose effectiveness in preventing infection had already been demonstrated in other studies.
Estonian: Efektiivsuse põhinäitaja oli vaktsiinis sisalduvate viiruste ja bakterite vastaste antikehade sisaldus veres, välja arvatud kasside leukeemia viiruse komponendi korral, mille efektiivsus nakkuse ennetamisel oli juba tõendatud teistes uuringutes.
English: The vaccine should not be handled by people with a weak immune system.
Estonian: Nõrgenenud immuunsüsteemiga inimesed ei tohi vaktsiini käsitseda.
English: In case of accidental self-injection medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Estonian: Juhusliku enesesüstimise korral tuleb pöörduda kohe arsti poole ja näidata talle pakendi infolehte või etiketti.
English: When exposed to any of these viruses or bacteria later in life, the cat will either not become infected or have a much less serious infection.
Estonian: Nende viiruste või bakteritega hiljem elu jooksul kokku puutudes kass ei nakatu või on nakkus märksa kergem.
English: • feline leukaemia virus (FeLV) recombinant canarypox virus (vCP97).
Estonian: • kasside leukeemia viiruse (FeLV) rekombinantne kanaarilinnu rõugete viirus (vCP97).
English: • attenuated Chlamydophila felis (905 strain),
Estonian: • nõrgestatud Chlamydophila felis (tüvi 905),
English: It was not possible to detect a rise in antibodies against C. felis because of high levels of antibodies in the cats at the beginning of the study.
Estonian: C. felis'e vastaste antikehade sisalduse suurenemist ei olnud võimalik tuvastada, sest kassidel oli uuringu alguses nende antikehade sisaldus suur.
English: Occasionally, cats will develop temporary apathy (loss of interest in surroundings) and anorexia (loss of appetite), as well as hyperthermia (elevated body temperature) lasting for one or two days.
Estonian: Aeg-ajalt esineb kassidel mööduvat apaatiat (huvipuudus ümbritseva vastu) ja anoreksiat (isukaotus), samuti hüpertermiat (kehatemperatuuri tõus), mis taandub paari päevaga.
English: There may be a local reaction at the injection site, with slight pain on touching, itching or oedema (swelling), which disappears within one or two weeks.
Estonian: Samuti võib tekkida süstekohal lokaalne reaktsioon, millega kaasneb puudutamisel vähene valu, kihelus või turse, mis möödub ühe või kahe nädalaga.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCPCh FeLV exceed the risks for the approved indications and recommended that Purevax RCPCh FeLV be given a marketing authorisation.
Estonian: Veterinaarravimite komitee järeldas, et heakskiidetud näidustustel on vaktsiini Purevax RCPCh FeLV kasulikkus suurem kui sellega kaasnevad riskid, ja soovitas anda vaktsiini Purevax RCPCh FeLV müügiloa.
English: When a cat is given the vaccine, the immune system recognises the weakened or killed viruses, the FeLV proteins, and the weakened bacteria as ‘foreign' and makes antibodies against them.
Estonian: Kui kassile antakse vaktsiini, peab looma immuunsüsteem nõrgestatud või hävitatud viirusi, kasside leukeemia viiruse valke ja nõrgestatud baktereid võõraks ning tekitab nende vastu antikehi.
English: The vaccine is given as two doses injected under the skin.
Estonian: Vaktsiini manustatakse kahe nahaaluse süstina.
English: In the field, the studies of Purevax RCPCh FeLV looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and the booster vaccination.
Estonian: Vaktsiini Purevax RCPCh FeLV väliuuringutes vaadeldi esmast vaktsineerimisskeemi (2 süsti 3-4 nädalase vahega) ja revaktsineerimisskeemi.
English: The first injection should be given in kittens aged at least eight weeks, with a second injection three to four weeks later.
Estonian: Esimene süst tuleb teha kassipoegadele alates 8. elunädalast ning teine süst 3-4 nädalat hiljem.
English: To protect against feline leukaemia, the vaccine contains two genes from the FeLV called env and gag, which have been inserted into another vector (carrier) virus called canarypox using ‘recombinant DNA technology'.
Estonian: Kasside leukeemia eest kaitsmiseks sisaldab vaktsiin kaht kasside leukeemia viiruse geeni, env- ja gag-geeni, mis on rekombinant-DNA-tehnikaga viidud teise vektorviirusesse (kandjaviirusesse), milleks on kanaarilinnu rõugete viirus.
English: In laboratory conditions, Purevax RCPCh FeLV was demonstrated to provide protection against the diseases listed above.
Estonian: Laboritingimustes tõendati vaktsiini Purevax RCPCh FeLV efektiivsust kasside kaitsmisel eespool nimetatud haiguste eest.
English: The effectiveness of Purevax RCPCh FeLV has been studied in several trials in laboratory conditions where cats were vaccinated and infected with herpesvirus, calicivirus, C. felis, parvovirus or leukaemia virus.
Estonian: Vaktsiini Purevax RCPCh FeLV efektiivsust uuriti mitmes laborikatses, milles kasse vaktsineeriti ning nakatati herpesviiruse, kalitsiviiruse, C. felis'e, parvoviiruse või leukeemiaviirusega.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Estonian: Ravimi kasulikkuse ja riski suhe on käesoleva Euroopa avaliku hindamisaruande teadusliku arutelu kokkuvõttes.
English: If self-injection does occur in these people, the doctor should be told that self-injection with a live chlamydial vaccine has occurred.
Estonian: Juhusliku enesesüstimise korral peavad need inimesed arstile teatama, et on süstinud endale klamüüdia elusvaktsiini.
English: The canarypox viruses do not spread or multiply in the cat but they do produce proteins from the FeLV genes.
Estonian: Kanaarilinnu rõugete viirused ei levi ega paljune kassi organismis, kuid tekitavad kasside leukeemia viiruse geenidest valke.
English: Purevax RCPCh FeLV is used to vaccinate cats from the age of 8 weeks against:
Estonian: Vaktsiini Purevax RCPCh FeLV kasutatakse vähemalt 8 nädala vanuste kasside vaktsineerimiseks järgmiste haiguste vastu:
English: Purevax RCPCh FeLV contains small amounts of weakened or killed viruses and bacteria that cause feline viral rhinotracheitis, calicivirosis, chlamydiosis and panleucopenia.
Estonian: Purevax RCPCh FeLV sisaldab väikeses koguses nõrgestatud või hävitatud viirusi ja baktereid, mis põhjustavad kasside viiruslikku rinotrahheiiti, kalitsiviroosi, klamüdioosi ja panleukopeeniat.
English: • attenuated feline panleucopenia virus (PLI IV),
Estonian: • kasside nõrgestatud panleukopeenia viirus (PLI IV),
English: Purevax RCPCh FeLV is a vaccine.
Estonian: Purevax RCPCh FeLV on vaktsiin.
English: Purevax RCPCh FeLV should not be used in pregnant cats.
Estonian: Vaktsiini Purevax RCPCh FeLV ei tohi kasutada tiinetel kassidel.
English: • feline leukaemia (an illness affecting the immune system caused by a retrovirus, feline leukaemia virus).
Estonian: • kasside leukeemia (kasside leukeemia viiruse (teatav retroviirus) põhjustatud haigus, mis kahjustab immuunsüsteemi).
English: Purevax RCPCh FeLV is a veterinary vaccine that contains:
Estonian: Purevax RCPCh FeLV on veterinaarvaktsiin, mis sisaldab järgmisi toimeaineid:
English: • attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain),
Estonian: • kasside nõrgestatud rinotrahheiidi herpesviirus (FHV F2 tüvi),
English: • feline panleucopenia (a serious illness causing bloody diarrhoea caused by a parvovirus),
Estonian: • kasside panleukopeenia (parvoviirusest põhjustatud raske haigus, mis tekitab verist kõhulahtisust),
English: In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses or bacteria.
Estonian: Kui immuunsüsteem puutub nende viiruste või bakteritega hiljem uuesti kokku, tekivad antikehad kiiremini.
English: Why has Purevax RCPCh FeLV been approved?
Estonian: Miks Purevax RCPCh FeLV heaks kiideti?
English: What is Purevax RCPCh FeLV?
Estonian: Mis on Purevax RCPCh FeLV?
English: • feline chlamydiosis (a flu-like illness caused by the bacterium C. felis),
Estonian: • kasside klamüdioos (bakteri C. felis põhjustatud gripilaadne haigus),
English: In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection, feline panleucopenia and C. felis remained stable at a high level or increased slightly.
Estonian: Revaktsineerimise uuringus püsis loomadel rinotrahheiidi herpesviiruse, kalitsiviirusnakkuse, kasside panleukopeenia viiruse ja C. felis'e vastaste antikehade sisaldus suur või suurenes mõnevõrra.
English: Purevax RCPCh FeLV is available as a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Estonian: Vaktsiini Purevax RCPCh FeLV turustatakse süstesuspensiooni lüofilisaadi (külmkuivatatud graanulid) ja lahustina.
English: For a full list of the side-effects reported with Purevax RCPCh FeLV, see the package leaflet.
Estonian: Vaktsiini Purevax RCPCh FeLV kohta teatatud kõrvaltoimete täielik loetelu on pakendi infolehel.
English: In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus, calicivirus infection, and feline panleucopenia viruses.
Estonian: Esmase vaktsineerimise väliuuringus suurenes loomadel kasside rinotrahheiidi herpesviiruse, kalitsiviirusnakkuse ja kasside panleukopeenia viiruse vastaste antikehade sisaldus.
English: • feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus),
Estonian: • kasside viiruslik rinotrahheiit (herpesviirusest põhjustatud gripilaadne haigus),
English: Feline viral rhinotracheitis, feline chlamydiosis, feline panleucopenia (live attenuated), feline leukaemia and feline calicivirosis (inactivated) vaccine
Estonian: kasside viirusliku rinotrahheiidi, kasside klamüdioosi, kasside panleukopeenia (nõrgestatud elus-), kasside leukeemia ja kasside kalitsiviroosi (inaktiveeritud) vaktsiin
English: How does Purevax RCPCh FeLV work?
Estonian: Kuidas Purevax RCPCh FeLV toimib?
English: What is the risk associated with Purevax RCPCh FeLV?
Estonian: Millised riskid vaktsiiniga Purevax RCPCh FeLV kaasnevad?
English: How has Purevax RCPCh FeLV been studied?
Estonian: Kuidas vaktsiini Purevax RCPCh FeLV uuriti?
English: Other information about Purevax RCPCh FeLV:
Estonian: Muu teave vaktsiini Purevax RCPCh FeLV kohta
English: • feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus),
Estonian: • kasside kalitsiviroos (kalitsiviirusest põhjustatud gripilaadne haigus, millega kaasneb suupõletik),
English: What is Purevax RCPCh FeLV used for?
Estonian: Milleks vaktsiini Purevax RCPCh FeLV kasutatakse?
English: What benefit has Purevax RCPCh FeLV shown during the studies?
Estonian: Milles seisneb uuringute põhjal vaktsiini Purevax RCPCh FeLV kasulikkus?
English: EMA/CHMP/472762/2013 EMEA/H/C/003755
Estonian: EMA/472762/2013 EMEA/H/C/003755
English: This summary was last updated in 09-2013.
Estonian: Kokkuvõtte viimane uuendus: 09-2013.
English: The contents of the capsules must not be inhaled using any other device.
Estonian: Kapslite sisu ei tohi inhaleerida muude seadmetega.
English: Side effects seen in studies were generally benign and were considered manageable.
Estonian: Uuringutes täheldatud kõrvalnähud olid üldiselt healoomulised ja hallatavad.
English: The full EPAR for Xoterna Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Xoterna Breezhaleri kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xoterna Breezhaler on 19 September 2013.
Estonian: Euroopa Komisjon andis Xoterna Breezhaleri müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 19. septembril 2013.
English: However, the CHMP considered that its effects on reducing the rate of exacerbations were too small to recommend its use for reducing exacerbations.
Estonian: Komitee järeldas siiski, et ravimi toime ägenemiste sageduse vähenemisel oli liiga vähene, et soovitada seda ägenemiste vähendamiseks.
English: The combined action of the two active substances helps to keep the airways open and allows the patient to breathe more easily.
Estonian: Mõlema toimeaine kombineeritud toime aitab hoida hingamisteid avatuna, nii et patsiendil on kergem hingata.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Xoterna Breezhaler's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Xoterna Breezhaleri kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: Xoterna Breezhaler is a medicine that contains two active substances, indacaterol (85 micrograms) and glycopyrronium (43 micrograms).
Estonian: Xoterna Breezhaler on ravim, mis sisaldab kaht toimeainet - indakaterooli (85 mikrogrammi) ja glükopürrooniumi (43 mikrogrammi).
English: A risk management plan has been developed to ensure that Xoterna Breezhaler is used as safely as possible.
Estonian: Töötati välja riskijuhtimisstrateegia, et tagada Xoterna Breezhaleri võimalikult ohutu kasutamine.
English: What measures are being taken to ensure the safe and effective use of Xoterna Breezhaler?
Estonian: Mis meetmeid võetakse, et tagada Xoterna Breezhaleri ohutu ja efektiivne kasutamine?
English: It is used as maintenance (regular) treatment to relieve symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Estonian: Seda kasutatakse säilitusravina (regulaarse ravina) kroonilise obstruktiivse kopsuhaiguse sümptomite leevendamiseks täiskasvanutel.
English: In both studies, the main measure of effectiveness was how Xoterna Breezhaler improved patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 26 weeks of treatment.
Estonian: Mõlemas uuringus oli efektiivsuse põhinäitaja see, kuidas Xoterna Breezhaler parandas patsientide forsseeritud ekspiratoorset mahtu (FEV1, suurim õhukogus, mida inimene suudab 1 s jooksul välja hingata) pärast 26-nädalast ravi.
English: Xoterna Breezhaler has been studied in two main studies involving a total of 2,667 patients with COPD.
Estonian: Ravimit Xoterna Breezhaler uuriti kahes põhiuuringus, kus osales kokku 2667 kroonilise obstruktiivse kopsuhaigusega patsienti.
English: The most common side effects with Xoterna Breezhaler (which may affect more than 1 in 10 people) are upper respiratory tract infections (colds).
Estonian: Xoterna Breezhaleri kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on ülemiste hingamisteede nakkused (külmetused).
English: In patients with severely reduced kidney function Xoterna Breezhaler should only be used after a careful benefit-risk assessment.
Estonian: Neerude raske talitlushäirega patsiendid tohivad ravimit Xoterna Breezhaler kasutada ainult pärast kasulikkuse ja riski hoolikat hindamist.
English: Xoterna Breezhaler also increased FEV1 by 70 ml more than indacaterol alone and 90 ml than glycopyrronium alone.
Estonian: Xoterna Breezhaler suurendas FEV1 väärtust 70 ml võrra rohkem kui ainult indakaterool ja 90 ml võrra rohkem kui ainult glükopürroonium.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xoterna Breezhaler, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Strateegiast lähtudes lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Xoterna Breezhaleri ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: The effects of Xoterna Breezhaler when used to relieve symptoms of COPD were clinically meaningful.
Estonian: Xoterna Breezhaleri toimed kroonilise obstruktiivse kopsuhaiguse sümptomite leevendamisel olid kliiniliselt olulised.
English: The first study showed that treatment with Xoterna Breezhaler was more effective than placebo and increased FEV1 by an average of 200 ml more.
Estonian: Esimeses uuringus oli ravi Xoterna Breezhaleriga efektiivsem kui platseeboga ja suurendas FEV1 väärtust keskmiselt 200 ml võrra.
English: This is a summary of the European public assessment report (EPAR) for Xoterna Breezhaler.
Estonian: See on ravimi Xoterna Breezhaler Euroopa avaliku hindamisaruande kokkuvõte.
English: For practical information about using Xoterna Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Xoterna Breezhaleri kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: It is not intended to provide practical advice on how to use Xoterna Breezhaler.
Estonian: Hindamisaruandes ei anta Xoterna Breezhaleri kasutamise praktilisi nõuandeid.
English: Other information about Xoterna Breezhaler
Estonian: Muu teave Xoterna Breezhaleri kohta
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing air in and out of the lungs.
Estonian: Krooniline obstruktiivne kopsuhaigus on krooniline haigus, mis kahjustab või ummistab hingamisteid ja kopsude alveoole ning tekitab raskusi õhu sisse- ja väljahingamisel.
English: What is Xoterna Breezhaler and what is it used for?
Estonian: Mis on Xoterna Breezhaler ja milleks seda kasutatakse
English: For more information about treatment with Xoterna Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Xoterna Breezhaleriga toimuva ravi kohta lisateavet, lugege pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The reduction in the rate of exacerbations was 10 to 12% higher with Xoterna Breezhaler than with tiotropium and glycopyrronium.
Estonian: Xoterna Breezhaleri kasutamisel vähenesid ägenemised 10-12% rohkem kui tiotroopiumi ja glükopürrooniumi korral.
English: In the second study the average increase in FEV1 was 140 ml more with Xoterna Breezhaler than with treatment with fluticasone and salmeterol.
Estonian: Teises uuringus suurenes FEV1 väärtus Xoterna Breezhaleri kasutamisel keskmiselt 140 ml rohkem kui flutikasooni ja salmeterooli kasutamisel.
English: For the full list of all side effects reported with Xoterna Breezhaler, see the package leaflet.
Estonian: Xoterna Breezhaleri kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Why is Xoterna Breezhaler approved?
Estonian: Miks Xoterna Breezhaler heaks kiideti?
English: It works by attaching to beta-2-adrenergic receptors found in the muscles of many organs including the airways of the lungs.
Estonian: Indakaterool on pikatoimeline beeta-2-agonist, mis kinnitub β2-adrenergiliste retseptorite külge, mida leidub paljudes elundites, sealhulgas kopsude hingamisteedes.
English: While one study compared the effects of Xoterna Breezhaler with those of placebo (a dummy treatment), or indacaterol or glycopyrronium alone, the other study compared Xoterna Breezhaler with fluticasone plus salmeterol, a standard treatment for COPD.
Estonian: Ühes uuringus võrreldi ravimit Xoterna Breezhaler platseeboga (näiv ravim) või eraldi indakaterooli või glükopürrooniumiga ning teises võrreldi ravimit Xoterna Breezhaler flutikasooni ja salmeterooli kombinatsiooniga, mis on kroonilise obstruktiivse kopsuhaiguse standardravi.
English: The active substances in Xoterna Breezhaler, indacaterol and glycopyrronium, work in different ways to widen the airways and improve breathing in COPD.
Estonian: Xoterna Breezhaleri toimeained indakaterool ja glükopürroonium toimivad kumbki eri viisil, laiendades hingamisteid ja soodustades kroonilise obstruktiivse kopsuhaiguse korral hingamist.
English: What are the risks associated with Xoterna Breezhaler?
Estonian: Mis riskid Xoterna Breezhaleriga kaasnevad?
English: A third study studied the effects of Xoterna Breezhaler on the rate of exacerbations (flare-ups) patients experienced during 64 weeks of treatment when compared with treatment with glycopyrronium or tiotropium (other treatments for COPD).
Estonian: Kolmas uuring hindas Xoterna Breezhaleri toimet ägenemiste sagedusele 64 ravinädala jooksul võrreldes glükopürrooniumi- või tiotroopiumiraviga (samuti kroonilise obstruktiivse kopsuhaiguse ravimid).
English: When glycopyrronium is inhaled, it causes the muscles of the airways to relax.
Estonian: Inhaleeritud glükopürroonium lõõgastab hingamisteede lihaseid.
English: Muscarinic receptor antagonists and long-acting beta-2-adrenergic agonists are commonly combined in the management of COPD.
Estonian: Muskariiniretseptori antagonistide ja pika toimeajaga beeta-2-adrenergiliste agonistide koos kasutamine on kroonilise obstruktiivse kopsuhaiguse ravis tavaline.
English: Regarding its safety, Xoterna Breezhaler is comparable to indacaterol and glycopyrronium used as separate medicines.
Estonian: Xoterna Breezhaleri ohutus on võrreldav indakaterooli ja glükopürrooniumi ohutusega nende kasutamisel eraldi.
English: It works by blocking some receptors called muscarinic receptors, which control the contraction of muscles.
Estonian: Glükopürroonium on muskariiniretseptori antagonist, mis blokeerib muskariiniretseptoriteks nimetatavaid retseptoreid, mis juhivad lihaste kokkutõmbumist.
English: When inhaled, indacaterol reaches the receptors in the airways and activates them.
Estonian: Inhaleeritud indakaterool jõuab hingamisteede retseptoriteni ja aktiveerib need, mis lõõgastab hingamisteede lihaseid.
English: How is Xoterna Breezhaler used?
Estonian: Kuidas Xoterna Breezhalerit kasutatakse?
English: The recommended dose is one inhalation once a day of the powder content of a single capsule.
Estonian: Soovitatav annus on ühe kapsli pulbri üks inhalatsioon üks kord ööpäevas, iga päev samal kellaajal ja ravimi Xoterno Breezhaler inhalaatori abil.
English: How does Xoterna Breezhaler work?
Estonian: Kuidas Xoterna Breezhaler toimib?
English: Indacaterol / glycopyrronium
Estonian: Xoterna Breezhaler indakaterool/glükopürroonium
English: What benefits of Xoterna Breezhaler have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Xoterna Breezhaleri kasulikkus?
English: Xoterna Breezhaler is available as capsules containing a powder for inhalation can only be obtained with a prescription.
Estonian: Ravimit Xoterna Breezhaler turustatakse inhalatsioonipulbri kapslitena.
English: Further information on Vyxeos can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave Vyxeose kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Vyxeos?
Estonian: Mis meetmed võetakse, et tagada Vyxeose ohutu ja efektiivne kasutamine?
English: The European Medicines Agency decided that Vyxeos's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Vyxeose kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.