natgillin/translations-raw huggingface dataset:
Follow-up exams at 18-24 months of age were similar between the two groups with respect to mental, motor, audiologic, and neurologic evaluations. 
Pregledi pri starosti 18-24 mesecev so pokazali podobnosti v oceni duševnega, motoričnega, avdiološkega in nevrološkega stanja pri obeh skupinah.
The installation of a nitric oxide pipeline system with supply station of gas cylinders, fixed network and terminal units is forbidden. 
Namestitev sistema cevi za dušikov oksid iz skladišča za jeklenke, fiksnega omrežja in terminalnih enot je prepovedana.
Immediately prior to each patient initiation, proper procedure must be applied to purge the system of NO2. 
Tik pred začetkom uporabe pri vsakem bolniku morate opraviti pravilen postopek, s katerim sistem očistite NO2.
Most of it traverses the pulmonary capillary bed where it combines with haemoglobin that is 60 % to 100 % oxygen-saturated. 
Večina ga prehaja skozi pljučne kapilare, kjer se veže na hemoglobin, ki je od 60 % do 100 % nasičen s kisikom.
Pregnancy and breastfeeding 
Nosečnost in dojenje
Infants who cannot be weaned off INOmax by 4 days should undergo careful diagnostic work-up for other diseases. 
Pri otrocih, pri katerih zdravljenja z zdravilom INOmax ne morete prekiniti po 4 dneh, opravite temeljit pregled za diagnosticiranje drugih obolenj.
The upper limit of exposure (mean exposure) to nitric oxide for personnel defined by worker's legislation is 25 ppm for 8 hours (30 mg/m3) in most countries and the corresponding limit for NO2 is 2-3 ppm (4-6 mg/m3). 
Zgornja meja izpostavljenosti (srednja izpostavljenost) dušikovemu oksidu za osebje, ki jo določa delavska zakonodaja v večini držav, je 25 ppm v 8 urah (30 mg/m3) in ustrezna omejitev za NO2 je 2-3 ppm (4-6 mg/m3).
If you or your child receive more INOmax than you should 
Če ste vi ali vaš otrok prejeli večji odmerek zdravila INOmax, kot bi smeli
Empty gas cylinders will be collected by the supplier. 
Prazne jeklenke mora prevzeti dobavitelj.
The frequency and number of adverse events were similar in the two study groups. 
Pogostnost in število neželenih učinkov sta bila v obeh skupinah podobna.
The prospectively defined primary endpoint was the receipt of ECMO. 
Vnaprej določeni primarni rezultat je bil začetek zdravljenja z ECMO.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, even after you or your child leave the hospital, please tell your doctor. 
Če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, tudi ko vi ali vaš otrok zapustite bolnišnico, obvestite otrokovega zdravnika.
Low blood pressure or a rebound increase in pressure in the lungs has been known to occur if treatment with INOmax is stopped suddenly without first lowering the dose. 
Znano je, da se pojavi nizek krvni tlak ali povratno povišanje tlaka v pljučih, če se zdravljenje z zdravilom INOmax prekine nenadno, ne da bi najprej postopoma manjšali odmerek.
Methaemoglobin concentrations increase during the first 8 hours of nitric oxide exposure. 
Koncentracije methemoglobina narastejo v prvih 8 urah izpostavitve dušikovemu oksidu.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. 
Pred začetkom uporabe natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
The nitrogen dioxide (NO2) concentration and FiO2 must also be measured at the same site using calibrated and approved (CE-marked) monitoring equipment. 
Na istem mestu merite tudi koncentracijo dušikovega dioksida (NO2) in FiO2 z uporabo umerjenih in odobrenih (z oznako CE) nadzornih naprav.
Other medicines and INOmax 
Druga zdravila in zdravilo INOmax
Deterioration in oxygenation and elevation in PAP may also occur in neonates with no apparent response to INOmax. 
Poslabšanje oksigenacije in povišanje PAP se lahko pojavita tudi pri novorojenčkih, pri katerih ni očitnega odziva na zdravilo INOmax.
INOmax should be used in ventilated newborn infants expected to require support >24 hours. 
Zdravilo INOmax uporabljajte pri predihavanju novorojenčkov, ki potrebujejo podporo >24 ur.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN
All gas cylinders should be returned to the supplier for disposal. 
Vse jeklenke morate vrniti dobavitelju, da jih bo odstranil.
Care must be taken when INOmax is given at the same time as medicinal products containing prilocaine. 
Potrebna je previdnost pri dajanju zdravila INOmax hkrati z zdravili, ki vsebujejo prilokain.
In children and adults with high blood pressure in the lungs, connected with heart surgery, INOmax is usually given for 24-48 hours. 
Otrokom in odraslim, ki imajo visok krvni tlak v pljučih, povezan s kirurškim posegom na srcu, se zdravilo INOmax običajno daje 24-48 ur.
For patient safety, appropriate alarms must be set for INOmax (± 2 ppm of the prescribed dose), NO2 (1 ppm), and FiO2 (± 0.05). 
Zaradi bolnikove varnosti poskrbite za ustrezne alarme za zdravilo INOmax (± 2 ppm predpisanega odmerka), NO2 (1 ppm) in FiO2 (± 0,05).
Treatment can be maintained up to 96 hours or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from INOmax therapy. 
Zdravljenje lahko traja do 96 ur, oziroma dokler obstoječa desaturacija s kisikom ni odpravljena in je novorojenček pripravljen na prekinitev zdravljenja z zdravilom INOmax.
The concentrations of methaemoglobin in the blood should be monitored, see section 4.2. 
Koncentracijo methemoglobina v krvi morate nadzorovati (glejte poglavje 4.2).
Persistent Pulmonary Hypertension in the Newborn (PPHN) The maximum recommended dose of INOmax is 20 ppm and this dose should not be exceeded. 
Persistentna pljučna hipertenzija pri novorojenčkih (PPHN) Največji priporočeni odmerek zdravila INOmax je 20 ppm in tega odmerka ne smete prekoračiti.
If you have any other questions on the use of this medicine, ask your doctor. 
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom.
Special patient populations 
Posebne skupine bolnikov
The INOT25 trial, studying the effects of iNO in hypoxic preterm neonates, did not show improvement in alive without BPD. 
Preskušanje INOT25, ki je preučevalo učinke iNO pri hipoksičnih nedonošenčkih, ni pokazalo izboljšanja glede živih novorojenčkov brez BPD.
This includes optimising tidal volume/pressures and lung recruitment (surfactant, high frequency ventilation, and positive end expiratory pressure). 
To vključuje optimiziranje dihalnega volumna/tlaka in okrepitev pljuč (surfaktant, visokofrekvenčno predihavanje ter pozitivni in ekspiratorni tlak).
Formation of NO2 
Nastajanje NO2
INOmax has been safely administered with tolazoline, dopamine, dobutamine, steroids, surfactant, and high-frequency ventilation. 
Zdravilo INOmax so varno uporabljali skupaj s tolazolinom, dopaminom, dobutaminom, steroidi, surfaktantom in pri visokofrekvenčnem predihavanju.
The overall occurrence of intraventricular haemorrhage was 114 (28.9 %) among the iNO treated as compared to 91 (22.9 %) among the control neonates. 
Skupna pojavnost intraventrikularne krvavitve je bila 28,9-odstotna (114) pri skupini, ki so jo zdravili z iNO, v primerjavi z 22,9-odstotno (91) pri kontrolnih novorojenčkih.
Storage in the medical department 
Shranjevanje v medicinskih oddelkih
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V 
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
Not known 
Neznana
There are no adequate data from the use of nitric oxide in pregnant women. 
Ni zadostnih podatkov o uporabi dušikovega oksida pri nosečnicah.
The gas cylinders should be transported with appropriate material in order to protect them from risks of shocks and falls. 
Jeklenke morate prevažati z ustrezno opremo, da bi jih zaščitili pred nevarnostjo padcev in udarcev.
Available data suggest additive effects on central circulation, pulmonary artery pressure and right ventricular performance. 
Razpoložljivi podatki kažejo na dodatne učinke na centralno cirkulacijo, tlak v pljučni arteriji in delovanje desnega prekata.
Methaemoglobin levels > 7 % were attained only in patients receiving 80 ppm, where they comprised 35 % of the group. 
Koncentracije methemoglobina so bile >7 % le pri bolnikih, ki so prejemali 80 ppm, in sicer pri 35 % bolnikov v skupini.
If at any time the NO2 concentration exceeds 1 ppm, the nitric oxide dose should immediately be reduced. 
Če koncentracija NO2 kadarkoli preseže 1 ppm, nemudoma zmanjšajte odmerek dušikovega oksida.
If it is judged that clinical response is inadequate at 4-6 hours after starting INOmax, the following should be considered. 
Če ocenite, da je klinični odziv po 4-6 urah po začetku zdravljenja z zdravilom INOmax neustrezen,
In clinical studies treatment was often initiated before separation from Cardio Pulmonary Bypass. 
V kliničnih študijah se je zdravljenje pogosto začelo pred ločitvijo od srčno-pljučnega obvoda.
The combined incidence of death and/or initiation of ECMO (the prospectively defined primary endpoint) showed a significant advantage for the nitric oxide treated group (46 % vs. 64 %, p=0.006). 
Kombinirana incidenca smrti in/ali začetka zdravljenja z ECMO (vnaprej določen primarni rezultat) je pokazala značilno prednost pri skupini, ki so jo zdravili z dušikovim oksidom (46 % proti 64 %, p = 0,006).
Attempts to wean INOmax should be made after the ventilator support is substantially decreased or after 96 hours of therapy. 
Uporabo zdravila INOmax prekinite po znatnem zmanjšanju podpore dihanju oziroma po 96 urah zdravljenja.
Higher exposures have not been investigated. 
Izpostavljenosti večjim odmerkom niso raziskali.
The overall number of death at week 36 was slightly higher in the iNO group; 53/395 (13.4 %) as compared to control 42/397 (10.6 %). 
Skupno število smrti pri 36. tednu je bilo nekoliko večje v skupini, ki je prejemala iNO: 53/395 (13,4 %), v primerjavi s kontrolno skupino
Your doctor will decide the correct dose of INOmax and will administer INOmax to you or your child's lungs through a system designed for delivering this gas. 
Zdravnik bo določil pravilni odmerek zdravila INOmax in ga bo vam ali vašemu otroku v pljuča dovajal prek sistema, zasnovanega za dovajanje tega plina.
Inhaled nitric oxide combination with other vasodilators acting by the cGMP or cAMP systems should be done with caution. 
Kombinacije dušikovega oksida in drugih vazodilatatorjev, ki delujejo na sisteme cGMP ali cAMP, je treba uporabljati previdno.
When the gas cylinder is empty, it should not be discarded. 
Ko je jeklenka prazna, se ne sme zavreči.
The clinical significance of the chemical reactivity of nitric oxide in tissue is unknown. 
Klinična pomembnost kemične reaktivnosti dušikovega oksida v tkivih ni znana.
Neonates with less than a full response at 20 ppm were evaluated for a response to 80 ppm nitric oxide or control gas. 
Pri novorojenčkih, ki se niso polno odzivali pri vrednosti 20 ppm, so ocenili odzivnost pri 80 ppm dušikovega oksida ali kontrolnega plina.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Methaemoglobin level should be measured within one hour after initiation of INOmax therapy, using an analyser which can reliably distinguish between foetal haemoglobin and methaemoglobin. 
Koncentracijo methemoglobina morate meriti eno uro po začetku zdravljenja z zdravilom INOmax z uporabo analizatorja, ki zanesljivo razločuje med fetalnim hemoglobinom in methemoglobinom.
Training in administration The key elements that need to be covered in training hospital personnel are as follows. 
Ključni elementi, ki jih je treba zajeti pri usposabljanju zdravstvenega osebja, so opisani v nadaljevanju.
The INOmax group had significantly improved oxygenation as measured by PaO2, OI, and alveolar-arterial gradient (p<0.001 for all parameters). 
Skupina, ki je prejemala zdravilo INOmax, je imela značilno izboljšano oksigenacijo, ki so jo izmerili kot PaO2, OI (kisikov indeks) in alveolo-arterijski gradient (p < 0,001 za vse parametre).
In case of insufficient response the dose may be titrated after a minimum of 10 minutes. 
Če odziv ni zadosten, se lahko odmerek titrira po najmanj 10 minutah.
Rebound reaction is the most commonly adverse reaction in association with the clinical use of INOmax. 
Povratna reakcija je najpogostejši neželeni učinek, povezan s klinično uporabo zdravila INOmax.
Cylinders equipped with a standard valve hand-wheel cannot be used with the INOmax DSIR delivery system. 
Jeklenk, opremljenih s standardnim ročnim kolesom ventila, ni mogoče uporabljati s sistemom za dovajanje INOmax DSIR.
The doctor will decide when to treat you or your child with INOmax and with other medicines, and will carefully supervise the treatment. 
Zdravnik se bo odločil, kdaj naj vi ali vaš otrok prejemate zdravilo INOmax in druga zdravila, in bo pozorno spremljal zdravljenje.
Inhaled nitric oxide may not always be effective and thus other therapies may be considered necessary for you or your child. 
Vdihavanje dušikovega oksida ne bo vedno učinkovito, zato boste vi ali vaš otrok morda potrebovali druge vrste zdravljenja.
Prilocaine, whether administered as oral, parenteral, or topical formulations may cause methaemoglobinaemia. 
Prilokain, dan bodisi v peroralni, parenteralni ali topikalni obliki, lahko povzroči methemoglobinemijo.
Protect the gas cylinders from shocks, falls, oxidising and flammable materials, moisture, sources of heat or ignition. 
Jeklenke zaščitite pred udarci, padci, oksidirajočimi in vnetljivimi materiali, vlago, viri toplote ali vžiga.
Tests show that dry nitric oxide mixtures can be used with most materials. 
Preizkusi so pokazali, da suhe mešanice dušikovega oksida lahko uporabljamo z večino materialov.
In neonates with PPHN, INOmax can improve oxygenation (as indicated by significant increases in PaO2). 
Pri novorojenčkih s PPHN lahko zdravilo INOmax izboljša oksigenacijo (na kar kaže značilno povečanje PaO2).
Butyl rubber, polyamide, and polyurethane should not be used. 
Ne uporabljajte butilne gume, poliamida in poliuretana.
The gas cylinders should be stored in an airy, clean and locked place, for storage of medicinal gas only. 
Jeklenke shranjujte v zračnih, čistih in zaklenjenih prostorih, namenjenih le shranjevanju plinov za medicinske namene.
The primary outcome, of the combined efficacy endpoints of death or BPD at 36 weeks GA, was not significantly different between groups, even with adjustment for gestational age as a covariate (p = 0.40), or with birth weight as a covariate (p = 0.41). 
Primarni rezultat kombiniranih končnih točk za učinkovitost glede smrti ali BPD po 36 tednih gestacijske starosti med skupinama ni bil pomembno drugačen, celo s prilagoditvijo za gestacijsko starost kot kovariato (p = 0,40) ali telesno maso kot kovariato (p = 0,41).
If you stop using INOmax 
Če ste prenehali uporabljati zdravilo INOmax
In clinical trials INOmax has been given in addition to other standard treatment regimes in the peri-operative setting, including inotropic and vasoactive medicinal products. 
V kliničnih preskušanjih se je zdravilo INOmax dajalo v kombinaciji z drugimi standardnimi režimi zdravljenja v predoperacijskem okolju, vključno z inotropnimi in vazoaktivnimi zdravili.
Before initiation of therapy, during set-up, secure that the device setting is in agreement with the cylinder gas concentration. 
Med pripravo pred začetkom zdravljenja se prepričajte, da nastavitev naprave ustreza koncentraciji plina v jeklenki.
In the presence of oxygen NO rapidly forms NO2, see section 4.5. 
V prisotnosti kisika iz NO hitro nastaja NO2 (glejte poglavje 4.5).
Discontinuation of therapy 
Prekinitev zdravljenja
Do not use this medicine after the expiry date which is stated on the label after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
INOmax is available in 2 litre and 10 litre aluminium gas cylinder. 
Zdravilo INOmax je na voljo v 2-litrskih in 10-litrskih aluminijastih jeklenkah.
Instruction for disposal of gas cylinder 
Navodila za odstranjevanje jeklenke
Your doctor will decide how long you or your child should be treated with INOmax. 
Zdravnik se bo odločil, koliko časa boste vi ali vaš otrok zdravljeni z zdravilom INOmax.
It is unknown whether nitric oxide is excreted in human milk. 
Ni znano, ali se dušikov oksid izloča v materino mleko.
Data further suggested a lack of additional benefit for the higher dose of nitric oxide. 
Podatki so pokazali tudi pomanjkanje dodatnega učinka pri višjih odmerkih dušikovega oksida.
Date of last renewal: 01/06/2006 
Datum prve odobritve: 01. 08. 2001 Datum zadnjega podaljšanja: 01. 06. 2006
The dose may be increased up to 40 ppm if the lower dose has not provided sufficient clinical effects. 
Odmerek se lahko poveča do 40 ppm, če uporabljeni odmerek nima zadostnih kliničnih učinkov.
The effects of inhaled nitric oxide are rapid, decrease in pulmonary artery pressure and improved oxygenation is seen within 5-20 minutes. 
Učinki inhaliranega dušikovega oksida so hitri, saj se znižanje tlaka v pljučni arteriji in izboljšanje oksigenacije pojavita v 5-20 minutah.
The objective of this double-blind, randomised, placebo controlled trial was to determine whether inhaled nitric oxide would reduce the occurrence of death and/or initiation of extracorporeal membrane oxygenation (ECMO). 
Namen tega dvojno slepega, randomiziranega, s placebom nadzorovanega preizkusa je bil določiti, ali vdihani dušikov oksid zniža smrtnost in/ali potrebo po zdravljenju z zunajtelesno membransko oksigenacijo (ECMO - »extracorporeal membrane oxygenation«).
Pulmonary hypertension associated with heart surgery INOmax should be used only after conservative support has been optimised. 
Pljučna hipertenzija, povezana s srčnim kirurškim posegom Zdravilo INOmax se lahko uporablja šele po optimizaciji konservativne podpore.
At the end of treatment, the doctor will slowly lower the amount of INOmax being given to you or your child, so that the circulation in the lungs is able to adjust to oxygen/air without INOmax. 
Na koncu zdravljenja bo zdravnik količino zdravila INOmax, ki se bo dovajala vam ali vašemu otroku, počasi zmanjševal, da se bo obtok v pljučih lahko prilagodil kisiku/zraku brez zdravila
Although it is unusual for the methaemoglobin level to increase significantly if the first level is low, it is prudent to repeat methaemoglobin measurements every one to two days. 
Čeprav se koncentracija methemoglobina po nizki začetni vrednosti redko znatno poveča, iz previdnosti ponovite merjenje methemoglobina vsak dan ali vsaka dva dneva.
Starting as soon as possible and within 4-24 hours of therapy, the dose should be weaned to 5 ppm provided that arterial oxygenation is adequate at this lower dose. 
Začnite takoj ko je mogoče, in v 4 do 24 urah zdravljenja omejite odmerek na 5 ppm, pod pogojem, da je arterijska oksigenacija pri tem najnižjem odmerku ustrezna.
What INOmax is and what it is used for What you need to know before you begin a treatment with INOmax How INOmax is given 
Kaj je zdravilo INOmax in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo INOmax Kako uporabljati zdravilo INOmax
- the good condition of the material should be checked before use - the gas cylinders should be fixedly stowed away in order to avoid untimely fall - the valve should be fully open when used but not be opened with violence - a defective valve should neither be used nor be repaired. 
- pred uporabo preverite, ali je oprema v dobrem stanju - jeklenke morajo biti pritrjene, da preprečite padce - ob uporabi mora biti ventil do konca odprt, vendar ga ne odpirajte na silo - okvarjenega ventila ne uporabljajte in ne popravljajte.
In cases of failure to respond to inhaled nitric oxide, see section 4.4. 
V primeru neodzivanja na vdihovanje dušikovega oksida glejte poglavje 4.4.
Newborn infants, infants and toddlers, children and adolescents, ages 0-17 years The starting dose of inhaled nitric oxide is 10 ppm(part per million) of inhaled gas. 
Novorojenčki, otroci in mladostniki, stari od 0 do 17 let Začetni odmerek inhalacijskega dušikovega oksida je 10 ppm (delcev na milijon) vdihanega plina.
In clinical studies, NO2 levels > 3 ppm or methaemoglobin levels > 7 % were treated by reducing the dose of, or discontinuing, INOmax. 
V kliničnih študijah so koncentracije NO2 >3 ppm ali koncentracije methemoglobina >7 % zdravili z zmanjšanjem odmerka ali prekinitvijo zdravljenja z zdravilom INOmax.
If there is an unexpected change in INOmax concentration, the delivery system should be assessed for malfunction and the analyser should be recalibrated. 
Če pride do nepričakovane spremembe v koncentraciji zdravila INOmax, je treba oceniti motnje v delovanju sistema in ponovno umeriti analizator.
Please tell your doctor if you (as the patient) or your child (as the patient) are taking or have recently taken or used any other medicines, including medicines obtained without a prescription. 
Obvestite zdravnika, če vi ali vaš otrok jemljete ali ste pred kratkim jemali ali uporabljali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Treatment may be initiated at any time point in the peri-operative course to lower pulmonary pressure. 
Zdravljenje se začne kadarkoli med predoperacijskim delovnim potekom, da se zmanjša pljučni tlak.
In these states, pulmonary vascular resistance (PVR) is high, which results in hypoxemia secondary to right-to-left shunting of blood through the patent ductus arteriosus and foramen ovale. 
Pri teh boleznih je pljučni vaskularni upor (PVR - »pulmonary vascular resistance«) visok, kar povzroča hipoksemijo kot posledico obvoda krvi z desne na levo stran skozi ductus arteriosus in foramen ovale bolnika.
INOmax should be used only after respiratory support has been optimised. 
Zdravilo INOmax lahko uporabljate šele po optimizaciji podpore dihanju.
Method of administration For endotracheopulmonary use. 
Za endotraheopulmonalno uporabo.
Correct set-up and connections - Connections to the gas cylinder and to the ventilator patient breathing circuit 
Pravilna namestitev in priključitev - Priključitev na jeklenko in na napeljavo respiratorja za dihanje.
INOmax should be administered under close monitoring of haemodynamics and oxygenation. 
INOmax je treba skrbno spremljati hemodinamiko in oksigenacijo.
The BALLR1 study, also evaluating the effects of iNO in preterm neonates, but initiating iNO at 7 days and in a dose of 20 ppm, found a significant increase in neonates alive without BPD at gestational week 36, 121 (45 % vs. 95 (35.4 %) p<0.028. 
Študija BALLR1, ki je prav tako ocenjevala učinke iNO pri nedonošenčkih, vendar se je iNO uvedel po 7 dnevih v odmerku 20 ppm, je ugotovila pomembno povečano število živih novorojenčkov brez BPD v 36. in 121. gestacijskem tednu (45 % v primerjavi s 95 (35,4 %) p < 0,028).
INOmax is not recommended for use during pregnancy and breastfeeding. 
Uporaba zdravila INOmax se v obdobju nosečnosti in dojenja ne priporoča.
The dose may be increased up to 20 ppm if the lower dose has not provided sufficient clinical effects. 
Odmerek se lahko poveča do 20 ppm, če uporabljeni odmerek nima zadostnih kliničnih učinkov.
When connecting an INOmax cylinder to the delivery system, always secure that the cylinder concentration is of the same concentration for which the system is configured. 
Ko priklapljate jeklenko INOmax na sistem za dovajanje, se vedno prepričajte, da koncentracija v jeklenki ustreza tisti, na katero je nastavljen sistem.
INOmax should not be used during pregnancy or breastfeeding. 
Zdravilo INOmax se ne sme uporabljati v obdobju nosečnosti ali dojenja.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)