FrancophonIA/ELRC3.0 huggingface dataset:
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Croatian: Omjer koristi i rizika može se naći u modulu o znanstvenoj raspravi ovog EPAR-a.
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.
Croatian: Nakon što mačka primi cjepivo, imunosni sustav prepoznaje oslabljene ili ubijene viruse, FeLV proteine i oslabljene bakterije koji se nalaze u cjepivu kao „strano tijelo” i proizvodi protutijela protiv njih.
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.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) zaključio je da koristi cjepiva Purevax RCPCh FeLV nadmašuju rizike za odobrene indikacije te preporučuje odobrenje za stavljanje VMP-a Purevax RCPCh FeLV u promet.
English: The cat should be revaccinated for all components one year after the first vaccination course, then every year for chlamydiosis and feline leukaemia, and every three years for rhinotracheitis, calicivirosis and panleucopenia.
Croatian: Mačku treba ponovno cijepiti na sve bolesti godinu dana nakon prvog cijepljenja, a potom svake godine na klamidiozu i mačju leukemiju te svake tri godine na rinotraheitis, kalicivirozu i panleukopeniju.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCPCh FeLV on 23 February 2005.
Croatian: Europska komisija izdala je odobrenje za stavljanje VMP-a Purevax RCPCh FeLV u promet koje je na snazi u Europskoj uniji od 23. veljače 2005.
English: In case of accidental self-injection medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Croatian: U slučaju slučajnog samoinjektiranja potrebno je odmah potražiti liječnički savjet te mu pokazati uputu o VMP-u ili njegovu etiketu.
English: Purevax RCPCh FeLV should not be used in pregnant cats.
Croatian: Purevax RCPCh FeLV ne smije se primjenjivati u gravidnih mačaka.
English: • attenuated Chlamydophila felis (905 strain),
Croatian: • atenuirane bakterije Chlamydophila felis (soj 905)
English: In laboratory conditions, Purevax RCPCh FeLV was demonstrated to provide protection against the diseases listed above.
Croatian: U laboratorijskim je uvjetima dokazano da Purevax RCPCh FeLV osigurava zaštitu protiv prethodno navedenih bolesti.
English: Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) na temelju dostavljene dokumentacije donio preporuke za uvjete primjene.
English: Purevax RCPCh FeLV is used to vaccinate cats from the age of 8 weeks against:
Croatian: Purevax RCPCh FeLV se upotrebljava za cijepljenje mačaka u dobi od osam tjedana nadalje protiv:
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.
Croatian: Na terenu su se ispitivanja cjepiva Purevax RCPCh FeLV fokusirala na temeljni raspored cijepljenja (dvije injekcije u razmaku od tri do četiri tjedna) te na docjepljivanje.
English: • feline leukaemia virus (FeLV) recombinant canarypox virus (vCP97).
Croatian: • virus mačje leukemije (FeLV) te rekombinantni CPNV virus (vCP97).
English: Purevax RCPCh FeLV is available as a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Croatian: Cjepivo Purevax RCPCh FeLV dostupno je kao liofilizat (prašak osušen smrzavanjem) i otapalo koji služe za pripremu suspenzije za injekciju.
English: • attenuated feline panleucopenia virus (PLI IV),
Croatian: • atenuirani virus mačje panleukopenije (PLI IV)
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.
Croatian: Djelotvornost cjepiva Purevax RCPCh FeLV ispitana je u nekoliko ispitivanja u laboratorijskim uvjetima u kojima su mačke cijepljene i zaražene herpesvirusom, kalicivirusom, virusom C. felis, parvovirusom ili virusom leukemije.
English: Purevax RCPCh FeLV contains small amounts of weakened or killed viruses and bacteria that cause feline viral rhinotracheitis, calicivirosis, chlamydiosis and panleucopenia.
Croatian: Purevax RCPCh FeLV sadrži male količine oslabljenih ili mrtvih virusa i bakterija koji uzrokuju mačji virusni rinotraheitis, kalicivirozu, klamidiozu i panleukopeniju.
English: • feline leukaemia (an illness affecting the immune system caused by a retrovirus, feline leukaemia virus).
Croatian: • mačje leukemije (bolesti koja zahvaća imunosni sustav uzrokovan retrovirusom, virusom mačje leukemije).
English: Purevax RCPCh FeLV is a veterinary vaccine that contains:
Croatian: Purevax RCPCh FeLV veterinarsko je cjepivo koje sadrži:
English: • attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain),
Croatian: • atenuirani (oslabljeni) herpesvirus mačjeg rinotraheitisa (soj FHV F2)
English: In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus, calicivirus infection, and feline panleucopenia viruses.
Croatian: U terenskom ispitivanju temeljnog cijepljenja postojao je porast u protutijelima protiv mačjeg herpesvirusa rinotraheitisa, infekcije kalicivirusom te virusa panleukopenije.
English: • feline panleucopenia (a serious illness causing bloody diarrhoea caused by a parvovirus),
Croatian: • mačje panleukopenije (ozbiljne bolesti koja uzrokuje krvavi proljev uzrokovan parvovirusom)
English: Other information about Purevax RCPCh FeLV:
Croatian: Ostale informacije o cjepivu Purevax RCPCh FeLV:
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.
Croatian: U ispitivanju u kojem je ispitivano docjepljivanje, razine protutijela na herpesvirus rinotraheitisa, infekciju kalicivirusom, mačju leukopeniju i C. felis ostale su stabilne pri visokim razinama ili su blago povećane.
English: • feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus),
Croatian: • mačje kaliciviroze (bolesti nalik gripi s upalom usne šupljine koju uzrokuje kalicivirus)
English: Purevax RCPCh FeLV is a vaccine.
Croatian: Purevax RCPCh FeLV je cjepivo.
English: For a full list of the side-effects reported with Purevax RCPCh FeLV, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja pri primjeni cjepiva Purevax RCPCh FeLV potražite u uputi o VMP-u.
English: • feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus),
Croatian: • mačjeg virusnog rinotraheitisa (bolesti nalik gripi koju uzrokuje herpesvirus)
English: What is the risk associated with Purevax RCPCh FeLV?
Croatian: Koji su rizici povezani s cjepivom Purevax RCPCh FeLV?
English: Why has Purevax RCPCh FeLV been approved?
Croatian: Zašto je Purevax RCPCh FeLV odobren?
English: Feline viral rhinotracheitis, feline chlamydiosis, feline panleucopenia (live attenuated), feline leukaemia and feline calicivirosis (inactivated) vaccine
Croatian: Cjepivo protiv mačjeg virusnog rinotraheitisa, mačje klamidioze, mačje panleukopenije (živi atenuirani virus), mačje leukemije i mačje kaliciviroze (inaktivirano)
English: What is Purevax RCPCh FeLV?
Croatian: Što je Purevax RCPCh FeLV?
English: What benefit has Purevax RCPCh FeLV shown during the studies?
Croatian: Koje su koristi od cjepiva Purevax RCPCh FeLV utvrđene u ispitivanjima?
English: • feline chlamydiosis (a flu-like illness caused by the bacterium C. felis),
Croatian: • mačje klamidioze (bolesti nalik gripi koju uzrokuje C. felis)
English: How has Purevax RCPCh FeLV been studied?
Croatian: Kako je Purevax RCPCh FeLV ispitivan?
English: How does Purevax RCPCh FeLV work?
Croatian: Kako djeluje Purevax RCPCh FeLV?
English: What is Purevax RCPCh FeLV used for?
Croatian: Za što se koristi Purevax RCPCh FeLV?
English: EMA/CHMP/472762/2013 EMEA/H/C/003755
Croatian: EMA/472762/2013 EMEA/H/C/003755
English: This summary was last updated in 09-2013.
Croatian: Sažetak je posljednji put ažuriran 09-2013.
English: The contents of the capsules must not be inhaled using any other device.
Croatian: Sadržaj kapsula ne smije se udisati upotrebom drugog uređaja.
English: However, the CHMP considered that its effects on reducing the rate of exacerbations were too small to recommend its use for reducing exacerbations.
Croatian: Međutim, CHMP je smatrao da su njegovi učinci na smanjivanje stope pogoršavanja bili premaleni kako bi se preporučila njegova upotreba za smanjivanje pogoršavanja.
English: The recommended dose is one inhalation once a day of the powder content of a single capsule.
Croatian: Preporučena doza je jedna inhalacija jednom dnevno sadržaja praška jedne kapsule.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Croatian: Objašnjava kako je Agencija ocijenila lijek da bi preporučila njegovo odobrenje u EU te uvjete za njegovu primjenu.
English: Side effects seen in studies were generally benign and were considered manageable.
Croatian: Nuspojave uočene u ispitivanjima općenito su se smatrale dobroćudnim i izlječivim.
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.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za Xoterna Breezhaler može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is used as maintenance (regular) treatment to relieve symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Croatian: Koristi se za održavanje (redovito) liječenje i za olakšavanje simptoma kronične opstruktivne plućne bolesti (KOBP) u odraslih.
English: The combined action of the two active substances helps to keep the airways open and allows the patient to breathe more easily.
Croatian: Kombinirano djelovanje dvije djelatne tvari pomaže u održavanju dišnih putova otvorenim te omogućava da bolesnike lakše diše.
English: When inhaled, indacaterol reaches the receptors in the airways and activates them.
Croatian: Prilikom udisanja, indakaterol stiže do receptora u dišnim putovima i aktivira ih.
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.
Croatian: KOBP je dugotrajna bolest kod koje su dišni putovi i zračne vrećice unutar pluća oštećene ili blokirane što uzrokuje udisanje ili izdisanje zraka iz pluća.
English: It is taken at the same time each day using the Xoterno Breezhaler device.
Croatian: Uzima se svaki dan u isto vrijeme upotrebom uređaja Xoterna Breezhaler.
English: A risk management plan has been developed to ensure that Xoterna Breezhaler is used as safely as possible.
Croatian: Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Xoterna Breezhaler koristi što je sigurnije moguće.
English: It works by blocking some receptors called muscarinic receptors, which control the contraction of muscles.
Croatian: Djeluje blokadom određenih receptora zvanih muskarinski receptori koji kontroliraju kontrakciju mišića.
English: Glycopyrronium is a muscarinic receptor antagonist.
Croatian: Glikopironij je antagonist muskarinskih receptora.
English: Indacaterol is a long-acting beta-2 agonist.
Croatian: Indakaterol je dugodjelujući beta-2-agonist.
English: Xoterna Breezhaler has been studied in two main studies involving a total of 2,667 patients with COPD.
Croatian: Xoterna Breezhaler ispitan je u dva glavna ispitivanja koja uključuju 2 667 bolesnika s KOBP.
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.
Croatian: U oba ispitivanja, glavna mjera djelotvornosti bila je način na koji je Xoterna Breezhaler poboljšao bolesnikove forsirane izdisajne volumene (FEV1, maksimalni volumen zraka koji osoba može izdahnuti u jednoj sekundi) nakon 26 tjedana liječenja.
English: It works by attaching to beta-2-adrenergic receptors found in the muscles of many organs including the airways of the lungs.
Croatian: Djeluje vezivanjem na beta-2-adrenergične receptore koji se nalaze u mišićima mnogih organa uključujuću i pluća.
English: This is a summary of the European public assessment report (EPAR) for Xoterna Breezhaler.
Croatian: Ovo je sažetak Europskog javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Xoterna Breezhaler.
English: Indacaterol / glycopyrronium
Croatian: Indakaterol / glikopironij
English: Xoterna Breezhaler is a medicine that contains two active substances, indacaterol (85 micrograms) and glycopyrronium (43 micrograms).
Croatian: Xoterna Breezhaler je lijek koji sadrži dvije djelatne tvari, indakaterol (85 mikrograma) o glikopironij (43 mikrograma).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xoterna Breezhaler on 19 September 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za Xoterna Breezhaler vrijedi na prostoru Europske unije od 19/09/2013.
English: It is not intended to provide practical advice on how to use Xoterna Breezhaler.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja Xoterna Breezhaler.
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.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da koristi od lijeka Xoterna Breezhaler nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: The effects of Xoterna Breezhaler when used to relieve symptoms of COPD were clinically meaningful.
Croatian: Učinci lijeka Xoterna Breezhaler, kad se koristi za olakšavanje simptoma KOBP, bili su klinički značajni.
English: Xoterna Breezhaler also increased FEV1 by 70 ml more than indacaterol alone and 90 ml than glycopyrronium alone.
Croatian: Xoterna Breezhaler također je povećao FEV1 za 70 ml više od samo indakaterola i za 90 ml više od samog glikopirija.
English: The most common side effects with Xoterna Breezhaler (which may affect more than 1 in 10 people) are upper respiratory tract infections (colds).
Croatian: Najčešće su nuspojave lijeka Xoterna Breezhaler (koje se mogu javiti u više od 1 na 10 osoba) infekcije gornjeg respiratornog trakta (prehlade).
English: The reduction in the rate of exacerbations was 10 to 12% higher with Xoterna Breezhaler than with tiotropium and glycopyrronium.
Croatian: Smanjenje stope pogoršanja bila je 10 do 12 % viša s lijekom Xoterna Breezhaler nego s tiotropijem i glikopironijem.
English: The active substances in Xoterna Breezhaler, indacaterol and glycopyrronium, work in different ways to widen the airways and improve breathing in COPD.
Croatian: Djelatne tvari u Xoterna Breezhaler, indakaterol i glikopironij, djeluju na različite načine kako bi proširili dišne putove i poboljšali disanje u KOBP.
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.
Croatian: Prvo je ispitivanje pokazalo da je liječenje lijekom Xoterna Breezhaler bilo djelotvornije od placeba i da je povećalo FEV1 u prosjeku za 200 ml više.
English: Xoterna Breezhaler is available as capsules containing a powder for inhalation can only be obtained with a prescription.
Croatian: Xoterna Breezhaler dostupan je u obliku koje sadrže prašak za inhalaciju o može se dobiti samo na recept.
English: When glycopyrronium is inhaled, it causes the muscles of the airways to relax.
Croatian: Kad se glikopironij udiše, uzrokuje opuštanje mišića dišnih putova.
English: Muscarinic receptor antagonists and long-acting beta-2-adrenergic agonists are commonly combined in the management of COPD.
Croatian: Antagonisti muskarinskih receptora i dugodjelujući beta-2adrenergični antagonisti često se kombiniraju u liječenju KOBP-a.
English: Regarding its safety, Xoterna Breezhaler is comparable to indacaterol and glycopyrronium used as separate medicines.
Croatian: Vezano uz njegovu sigurnosti, Xoterna Breezhaler može se uspoređivati s indakaterolom i glikopironijem koji se koriste kao zasebni lijekovi.
English: For practical information about using Xoterna Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju Xoterna Breezhaler bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: In the second study the average increase in FEV1 was 140 ml more with Xoterna Breezhaler than with treatment with fluticasone and salmeterol.
Croatian: U drugom ispitivanju prosječan porast u FEV1 bio je 140 ml viši s Xoterna Breezhaler nego s flutikazonom i salmeterolom.
English: What measures are being taken to ensure the safe and effective use of Xoterna Breezhaler?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Xoterna Breezhaler?
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.
Croatian: Dok je jedno ispitivanje uspoređivalo učinke lijeka Xoterna Breezhaler s onima od placeba (slijepa inhalacija) ili samog indakaterola ili glikopirija, drugo je ispitivanje uspoređivalo Xoterna Breezhaler s flutikazonom i salmeterolom, standardnim liječenjem za KOBP.
English: This causes the muscles of the airways to relax.
Croatian: To uzrokuje opuštanje mišića dišnih putova.
English: For more information about treatment with Xoterna Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju s Xoterna Breezhaler pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: In patients with severely reduced kidney function Xoterna Breezhaler should only be used after a careful benefit-risk assessment.
Croatian: U bolesnika s teško oštećenom funkcijom bubrega Xoterna Breezhaler treba koristiti samo nakon pomne procjene omjera koristi i rizika.
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).
Croatian: Treće je ispitivanje proučavalo učinke lijeka Xoterna Breezhaler na stupanj egzarcebacija (pogoršanja) kod bolesnika koji su prošli 64 tjedna liječenja u usporedbi s liječenjem glikopironijem ili tiotropijem (druga liječenja za KOBP).
English: Other information about Xoterna Breezhaler
Croatian: Druge informacije o Xoterna Breezhaler
English: What is Xoterna Breezhaler and what is it used for?
Croatian: Što je Xoterna Breezhaler i za što se koristi?
English: What are the risks associated with Xoterna Breezhaler?
Croatian: Koji su rizici povezani s lijekom Xoterna Breezhaler?
English: Why is Xoterna Breezhaler approved?
Croatian: Za što je Xoterna Breezhaler odobren?
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.
Croatian: Xoterna Breezhaler uključene su sigurnosne informacije uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: For the full list of all side effects reported with Xoterna Breezhaler, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s Xoterna Breezhaler potražite u uputi o lijeku.
English: How is Xoterna Breezhaler used?
Croatian: Kako se Xoterna Breezhaler koristi?
English: What benefits of Xoterna Breezhaler have been shown in studies?
Croatian: Koje su koristi lijeka Xoterna Breezhaler dokazane u ispitivanjima?
English: How does Xoterna Breezhaler work?
Croatian: Kako Xoterna Breezhaler djeluje?
English: Further information on Vyxeos can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Vyxeos nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Vyxeos
Croatian: Ostale informacije o lijeku Vyxeos
English: What measures are being taken to ensure the safe and effective use of Vyxeos?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vyxeos?
English: What is Vyxeos and what is it used for?
Croatian: Što je Vyxeos i za što se koristi?
English: The doctor may delay doses or stop treatment if the patient has severe side effects.
Croatian: Liječnik može odgoditi doze ili zaustaviti liječenje ako se u bolesnika pojave ozbiljne nuspojave.
English: They interfere in different ways with the production of new DNA within cells, which means the cells are unable to grow and multiply, and they eventually die.
Croatian: One na razne načine ometaju proizvodnju novog DNK-a unutar stanica, što znači da stanice ne mogu rasti i umnožavati se te konačnu odumiru.
English: Vyxeos (daunorubicin / cytarabine) EMA/457184/2018
Croatian: Vyxeos (daunorubicin / citarabin) EMA/457184/2018
English: The most common side effects with Vyxeos (which may affect more than 1 in 5 people) are hypersensitivity (allergic reactions, especially rash), febrile neutropenia (low white cell counts with fever), oedema (swelling), diarrhoea, colitis (inflamed bowel), mucositis (inflammation of the moist body surfaces), tiredness, muscle and bone pain, belly pain, decreased appetite, cough, headache, chills, arrhythmias (irregular heart rhythm), fever, sleep disorders and hypotension (low blood pressure).
Croatian: Najčešće nuspojave lijeka Vyxeos (koje se mogu pojaviti u više od 1 na 5 osoba) su preosjetljivost (alergijske reakcije, posebice osip), febrilna neutropenija (nizak broj bijelih krvnih zrnaca uz vrućicu), edem (oticanje), proljev, kolitis (upala crijeva), mukozitis (upala vlažnih tjelesnih površina), umor, bol u mišićima i kostima, bol u trbuhu, smanjen apetit, kašalj, glavobolja, zimica, aritmije (nepravilan srčani ritam), vrućica, poremećaji sna i hipotenzija (nizak krvni tlak).
English: Some 34% of patients given Vyxeos (52 of 153) were able to go on to have a stem cell transplant (a potentially curative procedure where the patient's bone marrow is replaced by stem cells to form new, healthy bone marrow) compared with 25% (39 of 156) given conventional treatment.
Croatian: Približni 34 % bolesnika koji su primali lijek Vyxeos (52 od njih 153) mogli su kasnije biti podvrgnuti transplantaciji matičnih stanica (potencijalno kurativan postupak u kojem se bolesnikova koštana srž zamjenjuje matičnim stanicama sa svrhom stvaranja nove, zdrave koštane srži) u usporedbi s njih 25 % (39 od 156) koji su primili konvencionalno liječenje.
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.
Croatian: Europska agencija za lijekove odlučila je da koristi lijeka Vyxeos nadmašuju s njim povezane rizike te da se može izdati odobrenje za njegovu primjenu u EU-u.