FrancophonIA/ELRC3.0 huggingface dataset:
English: Bosulif received a marketing authorisation valid throughout the EU on 27 March 2013.
Slovenian: Za zdravilo Bosulif je bilo 27. marca 2013 izdano dovoljenje za promet, veljavno po vsej EU.
English: Every year, the Agency will review any new information that becomes available and this summary will be updated as necessary.
Slovenian: Agencija bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo.
English: As for all medicines, data on the use of Bosulif are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Bosulif stalno spremljajo.
English: Bosulif was not compared with another treatment.
Slovenian: Zdravila Bosulif niso primerjali z nobenim drugim zdravljenjem.
English: The side effects of the medicine are considered to be manageable.
Slovenian: Neželeni učinki zdravila veljajo za obvladljive.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bosulif have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Bosulif upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Side effects reported with Bosulif are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Bosulif, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: After one year of treatment, 47% (116 out of 246) of patients treated with Bosulif had a major molecular response, compared with 37% (89 out of 241) of patients treated with imatinib.
Slovenian: Po enem letu zdravljenja je imelo 47 % (116 od 246) bolnikov, zdravljenih z zdravilom Bosulif, pomembni citogenetski odziv, v primerjavi s 37 % (89 od 241) bolnikov, zdravljenih z imatinibom.
English: Effectiveness was also measured in other ways including ‘haematological response' (a return to normal of the number of white cells in the blood).
Slovenian: Učinkovitost so merili tudi drugače, vključno s „hematološkim odzivom‟ (vrnitvijo števila belih krvnih celic na običajno raven).
English: An overview of Bosulif and why it is authorised in the EU
Slovenian: Pregled zdravila Bosulif in zakaj je odobreno v EU
English: Bosulif has been given ‘conditional authorisation'.
Slovenian: Zdravilo Bosulif je pridobilo „pogojno dovoljenje za promet“.
English: Why is Bosulif authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Bosulif odobreno v EU?
English: What benefits of Bosulif have been shown in studies?
Slovenian: Kakšne koristi zdravila Bosulif so se pokazale v študijah?
English: Other information about Bosulif
Slovenian: Druge informacije o zdravilu Bosulif
English: What are the risks associated with Bosulif?
Slovenian: Kakšna tveganja so povezana z zdravilom Bosulif?
English: It blocks the action of enzymes known as Src and Bcr-Abl tyrosine kinases found on leukaemia cells where they are involved in stimulating the cells to divide uncontrollably.
Slovenian: Zavira delovanje encimov, ki jih imenujemo tirozin-kinaze Src in Bcr-Abl in ki jih najdemo na levkemičnih celicah, na katerih sodelujejo pri stimulaciji celic k nenadzorovani delitvi.
English: What is Bosulif and what is it used for?
Slovenian: Kaj je zdravilo Bosulif in za kaj se uporablja?
English: For more information about treatment with Bosulif, read the package leaflet (also part of the EPAR) or contact a doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Bosulif preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Bosulif must not be used in patients with reduced liver function.
Slovenian: Zdravila Bosulif ne smejo uporabljati bolniki z okvaro delovanja jeter.
English: Bosulif was investigated in one main study involving 570 patients with Ph+ CML who had previously been treated with at least one tyrosine kinase inhibitor.
Slovenian: Zdravilo Bosulif so proučevali v eni glavni študiji, ki je vključevala 570 bolnikov s KML Ph+, ki so se predhodno zdravili z vsaj enim zaviralcem tirozin-kinaze.
English: The active substance in Bosulif, bosutinib, is a tyrosine kinase inhibitor.
Slovenian: Zdravilna učinkovina v zdravilu Bosulif, bosutinib, je zaviralec tirozin-kinaze.
English: Among these patients, 36 had chronic phase CML and 16 had either accelerated or blast phase CML.
Slovenian: Med temi bolniki jih je 36 imelo kronično mieloično levkemijo v kronični fazi in 16 v pospešeni ali blastni fazi.
English: A second study in 536 newly diagnosed CML patients in the ‘chronic phase' compared Bosulif with imatinib.
Slovenian: V drugi študiji pri 536 novo diagnosticiranih bolnikih s kronično mieloično levkemijo v „kronični fazi‟ so zdravilo Bosulif primerjali z imatinibom.
English: It can only be obtained with a prescription and treatment should be started by a doctor who is experienced in the diagnosis and treatment of CML.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem kronične mieloične levkemije.
English: Bosulif is a cancer medicine that is used to treat chronic myeloid leukaemia (CML), a cancer of the white blood cells, in adults with a special chromosome in their cells called the Philadelphia chromosome.
Slovenian: Bosulif je zdravilo proti raku, ki se uporablja za zdravljenje kronične mieloične levkemije (KML), tj. raka belih krvnih celic, pri odraslih s posebnim kromosomom v celicah, imenovanim kromosom Philadelphia.
English: Of these, 52 patients were considered to have an unmet medical need, because disease resistance or the risk of severe side effects made other tyrosine kinase inhibitors unsuitable.
Slovenian: Od teh bolnikov jih je bilo 52 opredeljenih kot takšnih, pri katerih zdravstvene potrebe večinoma niso bile izpolnjene, ker so drugi zaviralci tirozin-kinaze zaradi odpornosti bolezni ali tveganja za resne neželene učinke zanje neprimerni.
English: What information is still awaited for Bosulif?
Slovenian: Katere informacije o zdravilu Bosulif še pričakujemo?
English: Bosulif treatment was effective in patients with an unmet medical need: 18 out of 36 patients with chronic phase CML had a ‘major cytogenetic response', while 7 out of the 16 patients with advanced (accelerated or blast phase) CML also had a sufficient response based on other measurements.
Slovenian: Zdravljenje z zdravilom Bosulif je bilo učinkovito pri bolnikih, katerih zdravstvene potrebe večinoma niso bile izpolnjene: 18 od 36 bolnikov s kronično mieloično levkemijo v kronični fazi je imelo „pomembni citogenetski odziv‟, medtem ko je imelo 7 od 16 bolnikov z napredovalo boleznijo (v pospešeni ali blastni fazi) prav tako zadovoljiv odziv na podlagi drugih meritev.
English: The main measure of effectiveness was the number of patients who had at least a ‘major cytogenetic response' (where the proportion of white blood cells with the Philadelphia chromosome fell below 35%) after six months of Bosulif treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, ki so imeli najmanj „pomembni citogenetski odziv“ (pri katerih je delež belih krvnih celic s kromosomom Philadelphia padel pod 35 %) po šestih mesecih zdravljenja z zdravilom Bosulif.
English: For more information about using Bosulif, see the package leaflet or contact a doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Bosulif glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Studies have shown that Bosulif is effective at reducing the proportion of white blood cells with the Philadelphia chromosome.
Slovenian: Študije so pokazale, da je zdravilo Bosulif učinkovito pri zmanjševanju deleža belih krvnih celic s kromosomom Philadelphia.
English: It is used to treat three stages of CML called ‘chronic phase', ‘accelerated phase' and ‘blast phase' in patients who have already been treated with one or more tyrosine kinase inhibitors (medicines for CML which work in a similar way to Bosulif), and when the tyrosine kinase inhibitors called dasatinib, imatinib and nilotinib are not suitable.
Slovenian: Uporablja se za zdravljenje treh faz kronične mieloične levkemije, imenovanih „kronična faza‟, „pospešena faza‟ in „blastna faza‟, pri bolnikih, ki so se že zdravili z enim ali več zaviralci tirozin-kinaze (zdravili za zdravljenje kronične mieloične levkemije, ki delujejo podobno kot zdravilo Bosulif), in kadar zaviralci tirozin-kinaze, imenovani dasatinib, imatinib in nilotinib, niso primerni.
English: The main measure of effectiveness was the number of patients who had a ‘major molecular response' (where the amount in the bone marrow of BCR-ABL, the protein produced by the Philadelphia chromosome, is greatly lowered).
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, ki so imeli „pomembni citogenetski odziv‟ (pri katerih je količina beljakovine BCR-ABL v kostnem mozgu, ki jo proizvaja kromosom Philadelphia, bistveno zmanjšana).
English: The most serious side effects (which may affect more than 1 in 20 people) include thrombocytopenia, anaemia, diarrhoea, rash, neutropenia (low levels of neutrophils, a type of white blood cell) and blood tests suggesting damage to the liver and pancreas.
Slovenian: Najresnejši neželeni učinki (ki se lahko pojavijo pri več kot 1 bolniku od 20) vključujejo trombocitopenijo, anemijo, drisko, izpuščaj, nevtropenijo (nizke vrednosti nevtrofilcev, vrste belih krvnih celic) in izvidi krvnih preiskav, ki kažejo na poškodbo jeter in trebušne slinavke.
English: For the full list of all side effects reported with Bosulif, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Bosulif, glejte navodilo za uporabo.
English: Bosulif has been shown to improve the condition of patients with CML, including by reducing the number of cancer cells with the Philadelphia chromosome and returning white blood cell levels to normal.
Slovenian: Zdravilo Bosulif dokazano izboljša stanje bolnikov s kronično mieloično levkemijo, vključno z zmanjšanjem števila rakavih celic s kromosomom Philadelphia in vrnitvijo ravni belih krvnih celic na normalno.
English: The most common side effects with Bosulif (which may affect more than 1 in 5 people) are diarrhoea, nausea (feeling sick), thrombocytopenia (low blood platelet counts), abdominal pain (belly ache), vomiting, rash, anaemia (low red blood cell counts), tiredness, fever and increased levels of liver enzymes.
Slovenian: Najpogostejši neželeni učinki zdravila Bosulif (ki se lahko pojavijo pri več kot 1 bolniku od 5) so driska, navzeja (siljenje na bruhanje), trombocitopenija (nizko število trombocitov v krvi), bolečine v trebuhu, bruhanje, izpuščaj, anemija (nizko število rdečih krvnih celic), utrujenost, povišana telesna temperatura in povišane vrednosti jetrnih encimov.
English: By blocking their action, Bosulif helps to control cell division, thereby controlling the growth and spread of the leukaemia cells in CML.
Slovenian: Zdravilo Bosulif z zaviranjem delovanja celic pomaga nadzorovati njihovo delitev, s tem pa nadzira rast in širjenje levkemičnih celic pri kronični mieloični levkemiji.
English: Since Bosulif has been granted a conditional approval, the company that markets Bosulif will carry out and submit the results of a larger study with Bosulif in patients with Ph+ CML previously treated with one or more tyrosine kinase inhibitors and for whom dasatinib, imatinib and nilotinib are not considered appropriate treatment options.
Slovenian: Ker je zdravilo Bosulif pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, opravila obsežnejšo študijo z zdravilom Bosulif pri bolnikih s KML Ph+, ki so se predhodno že zdravili z enim ali več zaviralci tirozin-kinaze in za katere se dasatinib, imatinib in nilotinib ne štejejo za primerne možnosti, ter predložila njene rezultate.
English: How is Bosulif used?
Slovenian: Kako se zdravilo Bosulif uporablja?
English: How does Bosulif work?
Slovenian: Kako zdravilo Bosulif deluje?
English: Bosulif is also used to treat newly diagnosed patients who are in the ‘chronic phase' of CML.
Slovenian: Zdravilo Bosulif se uporablja tudi pri novo diagnosticiranih bolnikih s kronično mieloično levkemijo kronični fazi.
English: London, 23 October 2008 Doc.
Slovenian: London, 23. oktobra 2008 Sklic na dok.
English: International non-proprietary name (INN): lacosamide
Slovenian: Mednarodno nelastniško ime (INN): lakosamid
English: This withdrawal has no consequences on Vimpat, for which the balance of benefits and risks remains unchanged.
Slovenian: Umik nima nobenih posledic za zdravilo Vimpat, za katerega razmerje med koristmi in tveganji ostaja nespremenjeno.
English: The main measure of effectiveness was the change in pain levels between the start of the study and the last four weeks on the stable dose.
Slovenian: Glavno merilo učinkovitosti je bila sprememba v ravneh bolečine ob začetku študije ter v zadnjih štirih tednih ob prejemanju stabilnega odmerka.
English: The effectiveness of three doses of Lacosamide Pain UCB Pharma (200, 400 and 600 mg per day) was compared with that of placebo (a dummy treatment) in a total of 1,724 patients in four main studies.
Slovenian: Učinkovitost treh odmerkov zdravila Lacosamide Pain UCB Pharma (200, 400 in 600 mg na dan) so primerjali s placebom (zdravilom brez zdravilne učinkovine) pri skupaj 1 724 bolnikih v štirih glavnih študijah.
English: The exact way in which lacosamide works is still unclear, but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells.
Slovenian: Natančen način delovanja lakosamida še vedno ni jasen, vendar se zdi, da zmanjša dejavnost natrijevih kanalov (por na površini živčnih celic), ki omogočajo, da se električni impulzi prenašajo med živčnimi celicami.
English: Ref. EMEA/522632/2008
Slovenian: EMEA/605943/2008 Error!
English: Lacosamide has been authorised in the European Union (EU) as an anti-epileptic medicine under the trade name Vimpat since August 2008.
Slovenian: Lakosamid je v Evropski uniji odobren kot antiepileptično zdravilo pod lastniškim imenom Vimpat od avgusta 2008.
English: Together, these actions are expected to prevent abnormal electrical activity in nerve cells, reducing pain due to nerve damage.
Slovenian: Pričakuje se, da te dejavnosti skupaj preprečujejo električno dejavnost v živčnih celicah in tako zmanjšujejo bolečino zaradi poškodbe živcev.
English: Pain was measured by the patients on an 11-point scale.
Slovenian: Bolniki so bolečino merili s pomočjo 11-stopenjske lestvice.
English: In all four studies, the dose of Lacosamide Pain UCB Pharma was increased gradually over a few weeks before being maintained at a stable dose for 12 weeks.
Slovenian: V vseh štirih študijah so odmerek zdravila Lacosamide Pain UCB Pharma postopoma povečevali v obdobju nekaj tednov, nato pa 12 tednov vzdrževali na stabilni ravni.
English: The application was at day 181 when the company withdrew.
Slovenian: Družba je vlogo umaknila na 181. dan postopka.
English: The effects of Lacosamide Pain UCB Pharma were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Lacosamide Pain UCB Pharma so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: What is happening with Vimpat used for the treatment of epilepsy?
Slovenian: Kaj to pomeni za nadaljnjo uporabo zdravila Vimpat, ki se uporablja za zdravljenje epilepsije?
English: Lacosamide Pain UCB Pharma was expected to be used in adults to treat pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
Slovenian: Zdravilo Lacosamide Pain UCB Pharma naj bi se uporabljalo pri odraslih za zdravljenje bolečine, ki jo povzroča diabetična periferna nevropatija (poškodbe živcev v okončinah, ki se lahko pojavijo pri bolnikih z diabetesom).
English: Lacosamide is also thought to be involved in the development of nerve cells that have been damaged.
Slovenian: Zdi se, da lakosamid sodeluje tudi pri razvoju živčnih celic, ki so bile poškodovane.
English: On 25 September 2008, UCB Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Lacosamide Pain UCB Pharma, for the treatment of diabetic neuropathic pain in adults.
Slovenian: Družba UCB Pharma S.A. je dne 25. septembra 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Lacosamide Pain UCB Pharma, namenjenim zdravljenju boleče diabetične nevropatije pri odraslih.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Lacosamide Pain UCB Pharma could not have been approved for the treatment of diabetic neuropathic pain in adults.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP v času umika vloge, je imel Odbor zadržke in je začasno menil, da zdravila Lacosamide Pain UCB Pharma ni mogoče odobriti za zdravljenje boleče diabetične nevropatije pri odraslih.
English: Questions and answers on the withdrawal of the marketing application for Lacosamide Pain UCB Pharma
Slovenian: Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Lacosamide Pain UCB Pharma
English: The medicine can also cause side effects affecting the heart and central nervous system (such as dizziness), which are of concern in patients with diabetes.
Slovenian: Zdravilo lahko povzroči tudi neželene učinke, ki vplivajo na srce in osrednji živčni sistem (kot je omotica).
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Lacosamide Pain UCB Pharma?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Lacosamide Pain UCB Pharma?
English: The CHMP was concerned that the studies had not shown a meaningful benefit of Lacosamide Pain UCB Pharma.
Slovenian: CHMP je izrazil pomislek, da študije niso dokazale bistvene koristi zdravila Lacosamide Pain UCB Pharma.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Lacosamide Pain UCB Pharma had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Slovenian: CHMP je zato v času umika menil, da koristi zdravila Lacosamide Pain UCB Pharma niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Lacosamide Pain UCB Pharma.
Slovenian: Družba je obvestila CHMP, da za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe z zdravilom Lacosamide Pain UCB Pharma, ni nobenih posledic.
English: What is Lacosamide Pain UCB Pharma?
Slovenian: Kaj je zdravilo Lacosamide Pain UCB Pharma?
English: Lacosamide Pain UCB Pharma contains the active substance lacosamide.
Slovenian: Zdravilo Lacosamide Pain UCB Pharma vsebuje zdravilno učinkovino lakosamid.
English: How is Lacosamide Pain UCB Pharma expected to work?
Slovenian: Kako naj bi zdravilo Lacosamide Pain UCB Pharma delovalo?
English: What was Lacosamide Pain UCB Pharma expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Lacosamide Pain UCB Pharma uporabljalo?
English: Medicinal product no longer authorised
Slovenian: Številka (EU) dovoljenja za promet
English: Subcutaneous use pre-filled syringe 1.0 ml (150 mg/ml) 3 (3 x 1) pre-filled syringes (multipack)
Slovenian: 1,0 ml (150 mg/ml) 3 (3 x 1) napolnjene injekcijske brizge (večkratno pakiranje)
English: Subcutaneous use pre-filled pen 1.0 ml (150 mg/ml) 3 (3 x 1) pre-filled pens (multipack)
Slovenian: 1,0 ml (150 mg/ml) 3 (3 x 1) napolnjeni injekcijski peresniki (večkratno pakiranje)
English: Subcutaneous use pre-filled syringe 1.0 ml (150 mg/ml) 1 pre-filled syringe
Slovenian: 1,0 ml (150 mg/ml) 1 napolnjena injekcijska brizga
English: Subcutaneous use pre-filled pen 1.0 ml (150 mg/ml) 1 pre-filled pen
Slovenian: 1,0 ml (150 mg/ml) 1 napolnjen injekcijski peresnik
English: Treatment should not be stopped abruptly.
Slovenian: Zdravljenje se ne sme prekiniti nenadoma.
English: The European Commission granted a marketing authorisation valid throughout the European Union for INOmax on 1 August 2001.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom INOmax, veljavno po vsej Evropski uniji, odobrila dne 1. avgusta 2001.
English: In children and adults undergoing heart surgery, treatment usually lasts for 24 to 48 hours.
Slovenian: Pri otrocih in odraslih pred operacijo srca zdravljenje običajno traja od 24 do 48 ur.
English: INOmax nitric oxide
Slovenian: INOmax dušikov oksid
English: This should then be reduced to 5 ppm, provided the blood in the arteries contains enough oxygen.
Slovenian: To je treba kasneje zmanjšati na 5 ppm, če kri v arterijah vsebuje dovolj kisika.
English: The full EPAR for INOmax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo INOmax je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for INOmax.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo INOmax.
English: It also helps to decrease inflammation in the lungs.
Slovenian: Pomaga tudi pri zmanjševanju vnetij v pljučih.
English: The maximum starting dose of INOmax is 20 ppm for children up to 18 years of age, and 40 ppm for adults.
Slovenian: Največji začetni odmerek zdravila INOmax je 20 ppm za otroke do 18. leta starosti in 40 ppm za odrasle.
English: For more information about treatment with INOmax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist..
Slovenian: Za več informacij o zdravljenju z zdravilom INOmax preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What measures are being taken to ensure the safe use of INOmax?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila INOmax?
English: • newborn babies (born after 34 weeks of gestation) with breathing problems associated with pulmonary hypertension (high blood pressure in the lungs).
Slovenian: • novorojenčkih (rojeni po 34. tednu nosečnosti) s težavami pri dihanju zaradi pljučne hipertenzije (visok krvni tlak v pljučih).
English: The company must put in place an educational programme to ensure that doctors who are going to use INOmax for the treatment of patients undergoing heart surgery are aware of the risks and the precautions necessary when using the medicine.
Slovenian: Družba mora pripraviti izobraževalni program za zdravnike, ki bodo zdravilo INOmax uporabljali pri zdravljenju bolnikov pred operacijo srca, ter tako zagotoviti njihovo poznavanje tveganj in previdnostnih ukrepov pri uporabi zdravila.
English: The main measure of effectiveness was the proportion of neonates who died or needed ECMO over the first 120 days in hospital.
Slovenian: Glavno merilo učinkovitosti je bil delež novorojenčkov, ki so umrli ali so potrebovali zunajtelesno membransko oksigenacijo v prvih 120 dneh v bolnišnici.
English: INOmax treatment should be supervised by a doctor who has experience in intensive care or neonatal intensive care if the patient is a newborn baby.
Slovenian: Zdravljenje z zdravilom INOmax mora nadzorovati zdravnik, ki ima izkušnje z intenzivno nego ali intenzivno nego novorojenčkov, če je bolnik novorojenček.