natgillin/translations-raw huggingface dataset:
The active substance in Vargatef, nintedanib, blocks the activity of some enzymes known as tyrosine kinases. 
Zdravilna učinkovina v zdravilu Vargatef, nintedanib, zavira dejavnost nekaterih encimov, imenovanih tirozin-kinaze.
Vargatef can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines. 
Izdaja zdravila Vargatef je le na recept, zdravljenje z njim pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
Why is Vargatef approved? 
Zakaj je bilo zdravilo Vargatef odobreno?
What benefits of Vargatef have been shown in studies? 
Kakšne koristi je zdravilo Vargatef izkazalo v študijah?
In a main study involving 1,314 patients with advanced or recurrent non-small cell lung cancer that did not respond to a previous treatment, Vargatef taken in combination with docetaxel was shown to be more effective than docetaxel alone at delaying progression of the cancer. 
V glavni študiji, ki je vključila 1 314 bolnikov z napredovalim ali rekurentnim nedrobnoceličnim pljučnim rakom, ki se niso odzvali na predhodno zdravljenje, so pokazali, da je bilo zdravilo Vargatef v kombinaciji z docetakselom učinkovitejše pri upočasnitvi napredovanja raka kot docetaksel v monoterapiji.
For more information about treatment with Vargatef, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Vargatef preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vargatef, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Vargatef in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Vargatef is a cancer medicine used to treat adults with a type of lung cancer known as non-small cell lung cancer. 
Vargatef je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje odraslih bolnikov z vrsto pljučnega raka, ki se imenuje nedrobnocelični pljučni rak.
Treatment with Vargatef may continue after stopping docetaxel, for as long as the disease improves or remains stable and the side effects are tolerable. 
Po prekinitvi uporabe docetaksela se lahko zdravljenje z zdravilom Vargatef nadaljuje, dokler se bolezen izboljšuje ali ostane stabilna in bolnik prenaša neželene učinke.
The CHMP noted that Vargatef was effective at slowing down disease progression and prolonging life in the subgroup of patients with non-small cell lung cancer of the adenocarcinoma type. 
Odbor CHMP je ugotovil, da je bilo zdravilo Vargatef učinkovito pri upočasnitvi napredovanja bolezni in podaljšanju življenja pri podskupini bolnikov z nedrobnoceličnim pljučnim rakom vrste adenokarcinoma.
It is not intended to provide practical advice on how to use Vargatef. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For the full list of all side effects and restrictions with Vargatef, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Vargatef glejte navodilo za uporabo.
In addition, Vargatef led to an improvement in overall survival (how long patients lived) in the subgroup of patients with non-small cell lung cancer of the adenocarcinoma type: overall survival was 12.6 months in patients treated with Vargatef plus docetaxel, compared with 10.3 months in patients treated with docetaxel alone. 
Poleg tega je zdravilo Vargatef izboljšalo splošno preživetje (kako dolgo so živeli) podskupine bolnikov z nedrobnoceličnim pljučnim rakom tipa adenokarcinoma: splošno preživetje pri bolnikih, zdravljenih z zdravilom Vargatef in docetakselom, je bilo 12,6 meseca, pri bolnikih, zdravljenih s samostojnim docetakselom, pa 10,3 meseca.
For practical information about using Vargatef, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Vargatef naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Regarding its safety, although more side effects were reported in patients treated with Vargatef plus docetaxel than in those treated with docetaxel alone, the side effects were considered manageable with dose reductions, supportive treatments and treatment interruptions. 
Čeprav so glede varnosti pri bolnikih, zdravljenih z zdravilom Vargatef in docetakselom, poročali o več neželenih učinkih kot pri bolnikih, zdravljenih samo z docetakselom, je odbor menil, da so bili neželeni učinki obvladljivi z zmanjšanjem odmerka, podpornim zdravljenjem in prekinitvami zdravljenja.
Progression-free survival (the time patients lived without their disease getting worse) was 3.5 months in patients receiving Vargatef plus docetaxel, compared with 2.7 months in patients receiving docetaxel alone. 
Preživetje brez napredovanja (čas, ko se bolnikova bolezen ni slabšala) je bilo pri bolnikih, ki so prejemali zdravilo Vargatef in docetaksel, 3,5 meseca, pri bolnikih, ki so prejemali docetaksel v monoterapiji, pa 2,7 meseca.
Vargatef contains the active substance nintedanib. 
Zdravilo Vargatef vsebuje zdravilno učinkovino nintedanib.
How does Vargatef work? 
Kako zdravilo Vargatef deluje?
EPAR summary for the public 
Povzetek EPAR za javnost nintedanib
How is Vargatef used? 
Kako se zdravilo Vergatef uporablja?
This summary was last updated in July 2014. 
Povzetek je bil nazadnje posodobljen julija 2014.
The period of protection is 8 weeks. 
Zaščita traja 8 tednov.
These reactions are very rare (affecting less than 1 bird in 10,000). 
Te reakcije so zelo redke (prizadenejo manj kot 1 ptico od 10 000).
The Committee recommended that a further overdose study should be submitted. 
Odbor je priporočil, da se predloži dodatna študija prevelikega odmerjanja.
The effectiveness of the vaccine was first studied in a number of laboratory studies in chickens. 
Učinkovitost cepiva so najprej raziskali v več laboratorijskih študijah pri piščancih.
In the future if the animals are exposed to the virus the immune system will be able to respond more quickly. 
Če so živali kasneje izpostavljene virusu, se lahko imunski sistem nanj hitreje odzove.
Hands and equipment should be washed and disinfected after vaccination to avoid spread of the virus. 
Po cepljenju je treba umiti ter razkužiti roke in opremo, da se prepreči širjenje virusa.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease. 
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako naj se brani pred boleznijo.
This will help protect them against infectious bronchitis. 
To pomaga zaščititi živali pred infekcioznim bronhitisom.
The benefit/risk balance may be found in the scientific discussion module of this EPAR. 
Razmerje med koristmi in tveganji je na voljo v modulu znanstvene razprave v tem povzetku.
The vaccine is to be made up into a suspension for use. 
Cepivo je treba pred uporabo pripraviti v suspenzijo.
The vaccine is given to chickens from 1 day of age or older by spraying onto the chickens or by applying drops into the eyes or nostrils. 
Cepivo se daje piščancem, starim 1 dan ali več, pri čemer ga je treba napršiti po piščancih ali v obliki kapljic nanesti v oči ali nosnice.
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption. 
Obdobje karence je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso, jajca ali mleko uporabi za prehrano ljudi.
Live avian infectious bronchitis virus strain D388 
živ sev virusa aviarnega infekcioznega bronhitisa D388
If vaccinating by spray masks with eye protection should be worn when handling the product. 
Pri nanašanju cepiva s pršilnikom je treba med rokovanjem z zdravilom nositi masko z zaščito za oči.
Nobilis IB Primo QX must not be given to birds which are laying eggs or within 4 weeks before the start of the laying period. 
Zdravilo Nobilis IB Primo QX se ne sme dajati pticam, ki nesejo jajca, in v 4 tednih pred začetkom nesnega obdobja.
The laboratory studies showed that the vaccine had its full effect by three weeks and that protection lasted for eight weeks; protection was not affected by antibodies transmitted from the mother. 
Laboratorijske študije so pokazale, da je imelo cepivo polni učinek po treh tednih in da je zaščita trajala osem tednov; protitelesa, ki so jih piščanci dobili od matere, niso vplivala na zaščito.
The avian infection bronchitis virus in Nobilis IB Primo QX has been attenuated (weakened) so that it does not cause disease. 
Virus aviarnega infekcioznega bronhitisa v zdravilu Nobilis IB Primo QX je bil atenuiran (oslabljen), tako da ne povzroča bolezni.
Control groups of birds were unvaccinated to show the effectiveness of the challenge. 
Ptičev v kontrolnih skupinah niso cepili, da bi dokazali učinkovitost provokacije.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobilis IB Primo QX exceed the risks for the approved indication and recommended that Nobilis IB Primo QX be given a marketing authorisation. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Nobilis IB Primo QX večje od z njim povezanih tveganj za odobreno indikacijo, in priporočil, da se zanj izda dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis IB Primo QX on 4 September 2014. 
Evropska komisija je dovoljenje za promet z zdravilom Nobilis IB Primo QX, veljavno po vsej Evropski uniji, izdala 4. septembra 2014.
The purpose of the studies was to establish how long it took for chickens to be fully protected, the length of time protection lasts against infectious bronchitis due to QX-like variants, as well as the influence of maternal antibodies (transmitted from the mother) on the effectiveness of the vaccine. 
Namen študij je bil ugotoviti, kdaj piščanci postanejo popolnoma zaščiteni pred infekcioznim bronhitisom zaradi različic, podobnih QX, in koliko časa ta zaščita traja ter kako na učinkovitost cepiva vplivajo maternalna protitelesa (ki so jih piščanci dobili od matere).
In a second study 42 broiler chickens were spray vaccinated at 1 day old and challenged 3 weeks after vaccination with a QX strain of the virus. 
V drugi študiji so 42 pitovnih piščancev, starih 1 dan, napršili s cepivom in jih 3 tedne po cepljenju izpostavili sevu virusa QX.
Two groups of 28 birds were challenged with the virus 3 weeks after vaccination, one group with a QX strain and the second group with another strain called M41. 
Tri tedne po cepljenju so dve skupini po 28 ptičev izpostavili virusu, od tega eno skupino sevu QX, drugo pa drugemu sevu, imenovanemu M41.
When Nobilis IB Primo QX is given to chickens the animals' immune system recognises the virus as ‘foreign' and makes antibodies against it. 
Ko piščanci prejmejo cepivo Nobilis IB Primo QX, imunski sistem živali prepozna virus kot „tujek“ ter začne proti njemu tvoriti protitelesa.
In the first study broiler chickens (chickens bred for meat) were spray vaccinated with both Nobilis IB Primo QX and Nobilis IB Ma5, a vaccine against a Massachusetts strain of infectious bronchitis virus. 
V prvi študiji so pitovne piščance (piščance, ki se redijo za meso) napršili s cepivoma Nobilis IB Primo QX in Nobilis IB Ma5, ki je cepivo proti massachusetskemu sevu virusa infekcioznega bronhitisa.
After vaccination a mild short lived reaction in the airways, including a nasal discharge, may occur for at least 10 days. 
Vsaj še 10 dni po cepljenju se lahko pojavijo blage kratkotrajne reakcije v dihalih, vključno z izcedkom iz nosu.
Nobilis IB Primo QX is a veterinary vaccine that contains live attenuated (weakened) avian infectious bronchitis virus strain D388. 
Nobilis IB Primo QX je cepivo za uporabo v veterinarski medicini, ki vsebuje živ atenuiran (oslabljen) sev virusa aviarnega infekcioznega bronhitisa D388.
The effectiveness of Nobilis IB Primo QX was investigated in two field studies. 
Učinkovitost zdravila Nobilis IB Primo QX so raziskali v dveh terenskih študijah.
Nobilis IB Primo QX is used to protect chickens against viral infectious bronchitis caused by strains of infectious bronchitis virus known as QX-like variants, such as strain D388. 
Zdravilo Nobilis IB Primo QX se uporablja za zaščito piščancev pred virusnim infekcioznim bronhitisom, ki ga povzročajo sevi virusa infekcioznega bronhitisa, ki jim pravimo različice, podobne QX, kot je na primer sev D388.
Nobilis IB Primo QX is a vaccine. 
Nobilis IB Primo QX je cepivo.
Unvaccinated chicks were retained as controls to show the effectiveness of the challenge. 
V kontrolnih skupinah so pustili necepljene piščance, da bi lahko dokazali učinkovitost provokacije.
The second field study showed 93% of the Nobilis IB Primo QX vaccinated birds and none of the unvaccinated birds to be protected from the challenge. 
Druga terenska študija je pokazala, da je bilo pred provokacijo zaščitenih 93 % ptic, ki so bile cepljene s cepivom Nobilis IB Primo QX, medtem ko med necepljenimi pticami ni bila zaščitena nobena.
In the first field study 100% of the birds vaccinated with Nobilis IB Primo QX mixed with Nobilis IB Ma5 were protected from the QX strain and 90% were protected from M41, compared with none of the unvaccinated birds. 
V prvi terenski študiji je bilo 100 % piščancev, ki so jih cepili z mešanico cepiva Nobilis IB Primo QX in Nobilis IB Ma5, zaščitenih pred sevom QX in 90 % pred sevom M41, medtem ko med necepljenimi piščanci ni bil zaščiten noben.
Nobilis IB Primo QX is available as a lyophilisate (freeze-dried powder) which may be supplied with a solvent. 
Zdravilo Nobilis IB Primo QX je na voljo v obliki liofilizata (praška, posušenega v zamrznjenem stanju), ki mu je lahko priložen vehikel.
Other information about Nobilis IB Primo QX: 
Druge informacije o zdravilu Nobilis IB Primo QX:
What benefit has Nobilis IB Primo QX shown during the studies? 
Kakšne koristi je zdravilo Nobilis IB Primo QX izkazalo med študijami?
The withdrawal period for Nobilis IB Primo QX for chickens is zero days. 
Karenca za zdravilo Nobilis IB Primo QX pri piščancih je nič dni.
What is the risk associated with Nobilis IB Primo QX? 
Kakšna tveganja so povezana z zdravilom Nobilis IB Primo QX?
Why has Nobilis IB Primo QX been approved? 
Zakaj je bilo zdravilo Nobilis IB Primo QX odobreno?
How has Nobilis IB Primo QX been studied? 
Kako je bilo zdravilo Nobilis IB Primo QX raziskano?
What is Nobilis IB Primo QX? 
Kaj je zdravilo Nobilis IB Primo QX?
How does Nobilis IB Primo QX work? 
Kako zdravilo Nobilis IB Primo QX deluje?
What is Nobilis IB Primo QX used for? 
Za kaj se zdravilo Nobilis IB Primo QX uporablja?
At the request of the European Medicines Agency; 
• na zahtevo Evropske agencije za zdravila;
They were considered so inert that testing was not required. 
Imeli so jih za tako inertne, da preizkušanje ni bilo potrebno.
In order to avoid all incidents, the following instructions should be absolutely respected. 
Da bi se izognili vsem nezgodam, morate dosledno upoštevati naslednja navodila.
Side effects that may be seen but the frequency is not known (frequency cannot be estimated from the available data) are: 
Neželeni učinki, ki se lahko pojavijo, vendar njihova pogostnost ni znana (ni je mogoče oceniti iz razpoložljivih podatkov), so:
Currently available data are described in section 5.1 but no recommendation or posology can be made. 
Podatke, ki so trenutno na voljo, boste našli v poglavju 5.1, vendar priporočil za odmerjanje ni mogoče dati.
The duration of therapy is variable, but typically less than four days. 
Trajanje zdravljenja je različno, vendar je običajno krajše od štirih dni.
Monitoring formation of nitrogen dioxide (NO2) 
Nadzor nastajanja dušikovega dioksida (NO2)
The NO2 concentration should be maintained as low as possible and always < 0.5 ppm. 
Koncentracija NO2 mora biti čim nižja in vedno <0,5 ppm.
If you see any signs or symptoms that may be associated to bleeding you should directly inform the doctor. 
Če vidite kakršnekoli znake ali simptome, ki so morda povezani s krvavitvami, morate o tem obvestiti zdravnika.
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
No signs of any increase adverse effects were noted in this study. 
V tej študiji niso opazili nobenih znakov povečanja neželenih učinkov.
Tell your doctor before treatment with INOmax if you are pregnant, think you could be pregnant or are breastfeeding 
Pred zdravljenjem z zdravilom INOmax povejte zdravniku, če ste noseči, menite, da bi lahko bili noseči, ali če dojite.
Storage is supervised by the specialists at the hospital. 
Shranjevanje nadzoruje strokovnjak v bolnišnici.
Manufacturer Linde France Z.I. 
Izdelovalec Linde France Z.I.
Clinical data supporting the suggested dose in the age range 12-17 years is limited. 
Klinični podatki, ki podpirajo predlagani odmerek pri mladostnikih, starih od 12 do 17 let, so omejeni.
If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time 
Če predložitev PSUR in posodobitev RMP sovpadata, se lahko predložita sočasno.
The power supply for the monitoring equipment should be independent of the delivery device function. 
Napajanje nadzornih naprav mora biti neodvisno od delovanja naprave za dovajanje.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. 
Učinke v nekliničnih študijah so opazili samo pri izpostavljenosti, ki je zadostno presegla največjo izpostavljenost pri človeku, kar kaže majhen pomen za klinično uporabo.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
• Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
EFFECTIVE USE OF THE MEDICINAL PRODUCT 
UČINKOVITO UPORABO ZDRAVILA
However, therapy with INOmax may last longer. 
Vendar lahko zdravljenje z zdravilom INOmax traja dlje.
Among metallic construction materials, only stainless steel can be recommended. 
Od kovinskih materialov se priporoča samo nerjaveče jeklo.
There is in general no need for scavenging of excess gas, the work place ambient air quality should however be considered and trace concentrations of NO or NO2/NOx must not exceed set national occupational exposure limits. 
Navadno odvečnega plina ni treba odvajati, vendar je treba upoštevati kakovost zraka v delovnem okolju, koncentracije sledov NO ali NO2/NOx pa ne smejo preseči predpisanih nacionalnih omejitev za poklicno izpostavljenost.
Nitric oxide is genotoxic in some test systems. 
Dušikov oksid je genotoksičen v nekaterih testnih sistemih.
Elevated NO2 may cause acute lung injury. 
Povečanje NO2 lahko povzroči akutne poškodbe pljuč.
Your doctor will take care to check that the blood can carry enough oxygen when you are taking these medicines. 
Zdravnik bo preverjal, ali lahko kri prenaša dovolj kisika, kadar jemljete taka zdravila.
Ask your doctor or pharmacist for advice before taking any medicine. 
Posvetujte se z zdravnikom ali farmacevtom, preden vzamete katerokoli zdravilo.
No reproduction toxicity studies have been conducted. 
Opravili niso nobenih študij toksičnosti za razmnoževanje.
Nitric oxide is a compound produced by many cells of the body. 
Dušikov oksid je spojina, ki jo proizvajajo mnoge celice v telesu.
Educational material for Healthcare Professionals 
• Izobraževalno gradivo za zdravstvene delavce.
This may increase the right ventricular ejection fraction. 
To lahko poveča iztisni delež desnega prekata.
The safety and efficacy of INOmax in premature infants less than 34 weeks of gestation has not yet been established. 
Varnost in učinkovitost zdravila INOmax pri nedonošenčkih, rojenih po manj kot 34 tednih nosečnosti, še nista ugotovljeni.
Treatment with INOmax should not be stopped suddenly. 
Zdravljenje z zdravilom INOmax se ne sme prekiniti nenadno.
Accidental exposure to INOmax in hospital staff has been associated with adverse events (see section 4.8). 
Nenamerna izpostavitev bolnišničnega osebja zdravilu INOmax je bila povezana z neželenimi dogodki (glejte poglavje 4.8).
Bradycardiab (following abrupt discontinuation of therapy) 
Srčne bolezni bradikardijab (po nenadni prekinitvi zdravljenja)
The displayed frequency categories use the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). 
Kategorije pogostnosti so opredeljene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
If you get any side effects, talk to your doctor or pharmacist or nurse. 
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
However, the presence of nitrogen dioxide and moisture creates an aggressive atmosphere. 
Vendar prisotnost dušikovega dioksida in vlage tvori agresivno ozračje.
The Marketing Authorisation Holder (MAH) should ensure that, at launch of the new indication, all Healthcare Professionals who are expected to use and/or prescribe INOmax as part of the treatment of peri- or post- operative pulmonary hypertension in adults and children in conjunction to heart surgery are provided with an Educational pack. 
Imetnik dovoljenja za promet z zdravilom (MAH) mora zagotoviti, da ob uvedbi nove indikacije vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali in/ali predpisovali zdravilo INOmax v okviru zdravljenja pred- ali pooperativne pljučne hipertenzije pri odraslih in otrocih, povezane s srčnim kirurškim posegom, prejmejo izobraževalno gradivo.
A particular attention should be also turned to the fastening of the pressure regulator so as to avoid the risks of accidental failures. 
Posebej morate biti pozorni na pritrjevanje regulatorja tlaka, da bi preprečili morebitne okvare.
From a corrosion point of view the supply system can be divided into two zones: 1) From the gas cylinder valve to the humidifier (dry gas) and 2) From the humidifier to outlet (moist gas which may contain NO2). 
S stališča rjavenja lahko sistem za dovajanje razdelimo na dva dela: 1) Od ventila jeklenke do vlažilca (suhi plin) in 2) Od vlažilca do izhoda (vlažni plin, ki lahko vsebuje NO2).
The combined used with other vasodilators (e.g. sildenafil) is not extensively studied. 
Kombinirane uporabe z drugimi vazodilatatorji (npr. sildenafila) niso preučevali obsežno.
There are also animal data suggesting an increased susceptibility to airway infections upon exposure to low levels of NO2. 
Podatki iz raziskav na živalih kažejo tudi povečano dovzetnost za okužbe dihalnih poti pri izpostavljenosti majhnim količinam NO2.
Of the 97 patients treated with INOmax, 2(2 %) were withdrawn from study drug due to methaemoglobin levels >4 %. 
Od 97 bolnikov, ki so jih zdravili z zdravilom INOmax, so 2 (2 %) izključili iz študije zaradi koncentracij methemoglobina >4 %.