natgillin/translations-raw huggingface dataset:
In the event of either being observed, discard the container.
Če opazite kar koli od tega, vsebnik zavrzite.
INOmax is a gas for inhalation that contains the active substance nitric oxide diluted in nitrogen gas at 400 parts per million (ppm).
Zdravilo INOmax je plin za inhaliranje, ki vsebuje zdravilno učinkovino dušikov oksid, razredčen v plinu dušiku v koncentraciji 400 delcev na milijon (ppm).
INOmax is used to treat newborn babies with hypoxic respiratory failure who have evidence of pulmonary hypertension (lung failure associated with high blood pressure in the lungs).
Zdravilo INOmax se uporablja za zdravljenje novorojenčkov s hipoksično respiratorno odpovedjo, povezano z dokazom pljučne hipertenzije (pljučno odpovedjo, povezano z visokim krvnim tlakom v pljučih).
It is used in combination with artificial ventilation and other medicines in babies from 34 weeks gestation (time since conception).
Uporablja se v kombinaciji z umetnim predihavanjem in drugimi zdravili pri dojenčkih, rojenih po vsaj 34 tednih nosečnosti (čas od zanositve dalje).
INOmax is used to improve oxygen levels and reduce the need for extracorporeal membrane oxygenation (ECMO, a technique to oxygenate the blood outside the body using a device similar to a heart-lung machine).
Zdravilo INOmax se uporablja za izboljšanje koncentracije kisika in zmanjšanje potrebe po zunajtelesni membranski oksigenaciji (ECMO, tehniki za oksigenizacijo krvi zunaj telesa z uporabo naprave, podobne aparatu srce- pljuča).
INOmax treatment should be supervised by a doctor who has experience in neonatal (newborn) intensive care.
Zdravljenje z zdravilom INOmax mora nadzorovati zdravnik, ki ima izkušnje z intenzivno nego novorojenčkov.
INOmax should only be used in neonatal units where staff have been trained in the use of a nitric oxide delivery system after prescription by a specialist neonatal doctor.
Zdravilo INOmax se lahko uporablja samo v neonatalnih enotah (enotah za novorojenčke), katerih osebje je usposobljeno za uporabo sistema za dovajanje dušikovega oksida, ki ga je predpisal specialist neonatolog.
INOmax is used in babies who are undergoing artificial ventilation, once the ventilation is optimised, and provided that the baby will remain ventilated for at least 24 hours.
Zdravilo INOmax se uporablja pri dojenčkih, pri katerih se izvaja umetno predihavanje, po optimizaciji predihavanja in pod pogojem, da se le- to pri dojenčku izvaja najmanj 24 ur.
INOmax is given after being diluted in the oxygen/ air mixture supplied to the baby through the ventilator.
Zdravilo INOmax se daje razredčeno v mešanici kisika/ zraka, ki se dojenčku dovaja skozi ventilator.
The maximum recommended concentration of INOmax is 20 ppm.
Najvišja priporočljiva koncentracija zdravila INOmax je 20 ppm.
Within four to 24 hours after the start of treatment, this should be reduced to 5 ppm, provided that the blood in the arteries contains enough oxygen.
V štirih do 24 urah po začetku zdravljenja jo je treba zmanjšati na 5 ppm, pod pogojem, da kri v arterijah vsebuje dovolj kisika.
Treatment can be continued at this dose until there is improvement in oxygen levels, for a maximum of 96 hours.
Zdravljenje s tem odmerkom se lahko nadaljuje, dokler se koncentracija kisika ne izboljša, vendar ne sme trajati več kot 96 ur.
Treatment should not be stopped abruptly.
Zdravljenja se ne sme prekiniti nenadoma.
The active substance in INOmax, nitric oxide, is a naturally-occurring chemical in the body, which causes the muscles in the lining of the blood vessels to relax.
Zdravilna učinkovina zdravila INOmax, dušikov oksid, je kemična snov, ki je v telesu naravno prisotna in povzroča sproščanje mišic v steni krvnih žil.
When given by inhalation, it allows the vessels in the lungs to dilate (widen), reducing pulmonary hypertension and allowing blood to get to the tissues more easily, improving the supply of oxygen and removal of waste carbon dioxide.
Kadar se dovaja z inhaliranjem, povzroči širjenje žil v pljučih, s čimer zmanjša pljučno hipertenzijo in omogoči lažje dovajanje krvi v tkiva, s čimer se izboljša oskrba s kisikom in pospeši odstranjevanje odvečnega ogljikovega dioksida.
It also helps to send blood to the areas of the lung containing the most oxygen and to decrease inflammation in the lungs.
Pomaga tudi pri dovajanju krvi v predele pljuč, ki vsebujejo največ kisika, in zmanjševanju vnetij v pljučih.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has INOmax been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo INOmax raziskano?
Because nitric oxide is well-known chemical, the company used data from the published literature to support the use of INOmax.
Ker je dušikov oksid dobro znana kemična snov, je podjetje v podporo uporabi zdravila INOmax uporabilo podatke iz objavljene literature.
INOmax has also been studied in 421 neonates from 34 weeks gestation with pulmonary hypertension in two main studies.
Zdravilo INOmax so preučevali tudi v dveh glavnih študijah s 421 novorojenčki s pljučno hipertenzijo, rojenimi po vsaj 34 tednih nosečnosti.
The main measure of effectiveness was the proportion of neonates who died or needed ECMO over the first 120 days in hospital.
Glavno merilo učinkovitosti je bil delež novorojenčkov, ki so umrli ali so potrebovali zunajtelesno membransko oksigenacijo tekom prvih 120 dni v bolnišnici.
What benefit has INOmax shown during the studies?
Kakšne koristi je zdravilo INOmax izkazalo med raziskavami?
INOmax was more effective than placebo.
Zdravilo INOmax je bilo učinkovitejše od placeba.
In the first main study, 52 (46%) of the 114 neonates receiving INOmax died or needed ECMO, compared with 77 (64%) of the 121 receiving placebo.
V prvi študiji je umrlo ali potrebovalo zunajtelesno membransko oksigenacijo 52 (46%) izmed 114 novorojenčkov, ki so prejemali zdravilo INOmax, v primerjavi s 77 (64%) izmed 121 novorojenčkov, ki so prejemali placebo.
This was mainly due to a reduction in the need for ECMO, rather than a reduction in death rates.
Razlika je bila v pretežni meri pogojena z zmanjšanjem potrebe po zunajtelesni membranski oksigenaciji in ne zmanjšanjem smrtnosti.
In the second main study, 30 (31%) of the neonates receiving INOmax needed ECMO, compared with 51 (57%) of the 89 receiving placebo.
V drugi glavni študiji je zunajtelesno membransko oksigenacijo potrebovalo 30 (31%) novorojenčkov, ki so prejemali zdravilo INOmax, v primerjavi z 51 (57%) izmed 89 novorojenčkov, ki so prejemali placebo.
The most common side effect with INOmax (seen in more than 1 patient in 10) is thrombocytopenia (low blood platelet counts).
Najpogostejši neželeni učinek zdravila INOmax (opažen pri več kot 1 bolniku izmed 10) je trombocitopenija (nizka koncentracija trombocitov v krvi).
For a more complete list of the side effects reported with INOmax, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila INOmax, glejte Navodilo za uporabo.
INOmax should not be used in babies who may be hypersensitive (allergic) to nitric oxide or the other ingredient (nitrogen).
Zdravila INOmax se ne sme uporabljati pri dojenčkih, ki utegnejo biti preobčutljivi za (alergični na) dušikov oksid ali drugo sestavino (dušik).
It should also not be used in babies who have right-to-left or significant left-to- right shunting of blood (abnormal circulation of blood in the heart).
Prav tako se ga ne sme uporabljati pri dojenčkih, ki imajo obvod krvi z desne na levo ali izrazit obvod krvi z leve na desno (nenormalen obtok krvi v srcu).
The Committee for Medicinal Products for Human Use (CHMP) decided that INOmax’ s benefits are greater than its risks for the treatment of newborns at or more than 34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila INOmax pri zdravljenju novorojenčkov, rojenih po vsaj 34 tednih nosečnosti, s hipoksično respiratorno odpovedjo, povezano s kliničnim ali ehokardiogramskim dokazom pljučne hipertenzije, večje od z njim povezanih tveganj.
The Committee recommended that INOmax be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo INOmax odobri dovoljenje za promet.
Other information about INOmax:
Druge informacije o zdravilu INOmax:
The marketing authorisation was renewed on 1 August 2006.
Dovoljenje za promet z zdravilom je bilo podaljšano 1. avgusta 2006.
The marketing authorisation holder is INO Therapeutics AB.
Imetnik dovoljenja za promet z zdravilom je družba INO Therapeutics AB.
The full EPAR for INOmax can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo INOmax je na voljo tukaj.
EU Number EU/ 1/ 01/ 194/ 001 EU/ 1/ 01/ 194/ 002
Številka EU
Invented name INOmax INOmax
Izmišljeno ime
Strength 400 ppm 400 ppm
Jakost
Pharmaceutical form Inhalation gas Inhalation gas
Farmacevtska oblika Pot uporabe
Route of administration Endotracheopulmonary use Endotracheopulmonary use
Ovojnina
Packaging Gas cylinder (aluminium) Gas cylinder (aluminium)
Velikost pakiranja
INOmax 400 ppm mol/ mol inhalation gas
INOmax 400 ppm mol/ mol plin za inhaliranje
Nitric oxide (NO) 400 ppm mol/ mol.
Dušikov oksid (NO) 400 ppm mol/ mol
A 2 litre gas cylinder filled at 155 bar absolute brings 307 litres of gas under pressure of 1 bar at 15oC.
2- litrska jeklenka, napolnjena pri tlaku 155 bar, vsebuje 307 litrov plina pri tlaku 1 bar in temperaturi 15 oC.
A 10 litre gas cylinder filled at 155 bar absolute brings 1535 litres of gas under pressure of 1 bar at 15oC.
10- litrska jeklenka, napolnjena pri tlaku 155 bar, vsebuje 1535 litrov plina pri tlaku 1 bar in temperaturi 15 oC.
Inhalation gas
Plin za inhaliranje
INOmax, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of newborns ≥ 34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation.
Zdravilo INOmax je, skupaj s podporo dihanju in drugimi ustreznimi učinkovinami, namenjeno zdravljenju novorojenčkov, rojenih po vsaj 34 tednih nosečnosti, s hipoksično respiratorno odpovedjo, povezano s kliničnim ali ehokardiogramskim dokazom pljučne hipertenzije, z namenom izboljšanja oksigenacije in zmanjšanja potrebe po zunajtelesni membranski oksigenaciji.
INOmax should only be delivered according to a neonatologist’ s prescription.
Zdravilo INOmax se sme dovajati le, če ga predpiše neonatolog.
INOmax should be used in ventilated infants expected to require support > 24 hours.
Zdravilo Inomax uporabljajte pri predihavanju novorojenčkov, ki potrebujejo podporo > 24 ur.
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).
INOmax should be used only after respiratory support is optimised, including the use of surfactant.
Zdravilo INOmax lahko uporabljate šele po optimizaciji podpore dihanju, vključno z uporabo surfaktanta.
The maximum recommended dose of INOmax is 20 ppm and this dose should not be exceeded.
Največji priporočeni odmerek Zdravilo INOmax je 20 ppm in tega odmerka ne smete prekoračiti.
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.
Inhaled nitric oxide therapy should be maintained at 5 ppm until there is improvement in the neonate’ s oxygenation such that the FiO2 (fraction of inspired oxygen) < 0.60.
Zdravljenje z vdihavanjem dušikovega oksida obdržite na 5 ppm dokler se oksigenacija novorojenčka ne izboljša tako, da je FiO2 (delež vdihnjenega kisika) < 0, 60.
The duration of therapy is variable, but typically less than four days.
Zdravljenje lahko traja do 96 ur, oziroma dokler obstoječa desaturacija s kisikom ni odpravljena in je novorojenček pripravljen na prekinitev zdravljenja z zdravilom INOmax.
In cases of failure to respond to inhaled nitric oxide, see section 4.4.
Trajanje zdravljenja je
2 Weaning
2 različno, vendar je običajno krajše od štirih dni.
If there is no change in oxygenation during administration of INOmax at 1 ppm, the FiO2 should be increased by 10%, the INOmax is discontinued, and the neonates monitored closely for signs of hypoxaemia.
Če se med uporabo zdravila INOmax v odmerku 1 ppm oksigenacija ne spremeni, povečajte FiO2 za 10%, prekinite uporabo zdravila INOmax in pri novorojenčku skrbno opazujte morebiten pojav znakov hipoksemije.
If oxygenation falls > 20%, INOmax therapy should be resumed at 5 ppm and discontinuation of INOmax therapy should be reconsidered after 12 to 24 hours.
Če se oksigenacija zniža za > 20%, morate znova uvesti zdravljenje z zdravilom INOmax v odmerku 5 ppm, o možnosti prekinitve zdravljenja pa znova premislite po 12 do 24 urah.
Nitric oxide is delivered to the patient via mechanical ventilation after dilution with an oxygen/ air mixture using an approved (CE-marked) nitric oxide delivery system.
Dušikov oksid dovajamo bolnikom z mehanskim predihavanjem po razredčenju z mešanico kisika/ zraka z uporabo odobrenega (z oznako CE) sistema za dovajanje dušikovega oksida.
Intermittent flow neonatal ventilation may be associated with spikes in nitric oxide concentration.
Novorojenčkovo predihavanje s prekinitvami pretoka je lahko povezano z znatnimi dvigi koncentracije dušikovega oksida.
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).
The INOmax gas cylinder pressure must be displayed to allow timely gas cylinder replacement without inadvertent loss of therapy and backup gas cylinders must be available to provide timely replacement.
Vedno imejte pri roki nadomestne jeklenke, da bi zagotovili pravočasno zamenjavo.
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).
Training in Administration
Usposabljanje za uporabo
- Connections to the gas cylinder and to the ventilator patient breathing circuit
- Priključitev na jeklenko in na napeljavo respiratorja za dihanje.
- Pre-use check list procedure (a series of steps required immediately prior to each patient initiation
- Postopek preverjanja pred uporabo (niz korakov, potrebnih tik pred začetkom uporabe pri vsakem
to ensure that the system is working properly and that the system is purged of NO2)
bolniku, da se prepričate, ali sistem deluje pravilno in je očiščen NO2)
- Setting the device for the correct concentration of nitric oxide to be administered
- Nastavitev naprave za dovajanje pravilne koncentracije dušikovega oksida
- Setting the NO, NO2 and O2 monitors for high and low alarm limits
- Nastavljanje nadzornih naprav za alarmne signale pri visokih in nizkih koncentracijah NO, NO2 in
- Using the manual backup delivery system
- Uporaba ročnega nadomestnega sistema za dovajanje
- Procedures for correctly switching gas cylinders and purging system
- Postopki pravilne menjave jeklenk in čiščenja sistema
- Troubleshooting alarms
- Alarmi za odpravljanje napak
- NO, NO2 and O2 monitor calibration
- Umerjanje nadzornih naprav za NO, NO2 in O2
- Monthly system performance check-up procedures
- Mesečno preverjanje delovanja sistema
3 Monitoring formation of Methaemoglobin
Nadzor nastajanja methemoglobina
Neonates are known to have diminished MetHb reductase activity compared to adults.
Znano je, da je aktivnost methemoglobin- reduktaze pri novorojenčkih manjša kot pri odraslih.
If it is > 2.5%, the INOmax dose should be decreased and the administration of reducing agents such as methylene blue may be considered.
Če je koncentracija methemoglobina > 2, 5%, zmanjšajte odmerek zdravila INOmax, poleg tega pa razmislite o uporabi reducentov, kot je metilen modro.
Monitoring formation of Nitrogen Dioxide
Nadzor nastajanja dušikovega dioksida
Immediately prior to each patient initiation, proper procedure must be applied to purge the system of NO2.
Tik pred začetkom uporabe na vsakem bolniku morate opraviti pravilen postopek, s katerim sistem očistite 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 the NO2 is > 0.5 ppm, the delivery system should be assessed for malfunction, the NO2 analyser should be recalibrated, and the INOmax and/ or FiO2 should be reduced if possible.
Če je koncentracija NO2 > 0, 5 ppm, je treba oceniti motnje v delovanju sistema, ponovno umeriti analizator NO2 ter po možnosti znižati koncentracijo zdravila INOmax in/ ali FiO2.
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, upoštevajte naslednje.
Rescue, such as ECMO where available, should be considered based on continued deterioration or failure to improve, defined by criteria based on local circumstances.
V primeru stalnega slabšanja ali izostanka izboljšanja glede na trenutne okoliščine pretehtajte možnost uporabe rešilnega sistema, kot je ECMO (zunajtelesna membranska oksigenacija).
In clinical trials, no efficacy has been demonstrated with the use of inhaled nitric oxide in patients with Congenital Diaphragmatic Hernia.
V kliničnih raziskavah niso dokazali učinkovitosti vdihovanja dušikovega oksida pri bolnikih s prirojeno diafragmalno hernijo.
Discontinuation of Therapy:
Prekinitev zdravljenja:
The INOmax dose should not be discontinued abruptly as it may result in an increase in pulmonary artery pressure (PAP) and/ or worsening of blood oxygenation (PaO2).
Odmerka zdravila INOmax ne smete nenadno prekiniti, ker bi se lahko povečal tlak v pljučni arteriji (PAP – » pulmonary artery pressure «) in/ ali poslabšala oksigenacija krvi (PaO2).
A large portion of nitric oxide for inhalation is absorbed systemically.
4 Velik delež vdihnjenega dušikovega oksida se absorbira sistemsko.
The end products of nitric oxide that enter the systemic circulation are predominantly methaemoglobin and nitrate.
Končna produkta dušikovega oksida, ki vstopita v krvni obtok, sta večinoma methemoglobin in nitrat.
The concentrations of methaemoglobin in the blood should be monitored (see section 4.2).
Koncentracijo methemoglobina v krvi morate nadzorovati (glejte poglavje 4. 2).
NO2 rapidly forms in gas mixtures containing nitric oxide and O2, and nitric oxide may in this way cause airway inflammation and damage.
Dušikov oksid lahko na ta način povzroči vnetja in poškodbe dihalnih poti.
The dose of nitric oxide should be reduced if the concentration of nitrogen dioxide exceeds 0.5 ppm.
Če koncentracija dušikovega dioksida preseže 0, 5 ppm, morate zmanjšati odmerek dušikovega oksida.
It, therefore, is
Vzrok je neželena pljučna vazodilatacija, ki jo povzroča vdihnjeni dušikov oksid, kar lahko pripelje do nadaljnjega povečanja že obstoječe pljučne hiperperfuzije.
4 recommended that prior to the administration of nitric oxide, pulmonary artery catheterisation or echocardiographic examination of central haemodynamics be performed.
Zato je pred uporabo dušikovega oksida priporočljivo opraviti kateterizacijo pljučne arterije ali ehokardiografsko preiskavo osrednje hemodinamike.
INOmax has not been shown to be of benefit in premature (< 34 weeks) infants.
Zdravilo INOmax se ni izkazalo koristno pri nedonošenčkih < 34. tednov.
No interaction studies have been performed.
Uradne raziskave interakcij z zdravili niso bile opravljene.
A clinically significant interaction with other medications used in the treatment of hypoxic respiratory failure cannot be excluded based on the available data.
Na osnovi razpoložljivih podatkov ne moremo izključiti klinično značilnih interakcij z drugimi zdravili, ki jih uporabljamo pri zdravljenju hipoksične respiratorne odpovedi.
There may be an additive effect with INOmax on the risk of developing methaemoglobinemia with nitric oxide donor compounds, including sodium nitroprusside and nitroglycerin.
Zdravilo INOmax v kombinaciji s spojinami, ki so donorji dušikovega oksida, vključno z natrijevim nitroprusidom in nitroglicerinom, lahko povzroči dodatno tveganje za razvoj methemoglobinemije.
Experimental studies have suggested that nitric oxide and also nitrogen dioxide may react chemically with surfactant and/ or surfactant proteins.
Eksperimentalne študije so pokazale, da dušikov oksid kot tudi dušikov dioksid lahko kemično reagirata s surfaktantom in/ ali surfaktantnimi beljakovinami.
There is an increased risk of methaemoglobin formation if substances with a known tendency to increase methaemoglobin concentrations are administered concomitantly with nitric oxide (e. g. alkyl nitrates and sulphonamides).
Pri sočasni uporabi dušikovega oksida in snovi, za katere je znano, da povečajo koncentracije methemoglobina (npr. alkilni nitrati in sulfonamidi), obstaja povečano tveganje za tvorbo methemoglobina.
Care must be taken when INOmax is given at the same time as medicines containing prilocaine.
Potrebna je previdnost pri dajanju zdravila INOmax hkrati z zdravili, ki vsebujejo prilokain.
In the presence of oxygen, nitric oxide is rapidly oxidised to derivatives which are toxic to the bronchial epithelium and alveolo-capillary membrane. nitrogen dioxide (NO2) is the main compound formed, and during treatment with nitric oxide, the NO2 concentration should be < 0.5 ppm in the nitric oxide dose range < 20 ppm.
Večinoma nastaja dušikov dioksid (NO2). Med zdravljenjem z dušikovim oksidom v odmerku do 20 ppm mora biti koncentracija NO2 < 0, 5 ppm.
See section 4.2 for information on monitoring for NO2.
Informacije o nadzorovanju koncentracije NO2 boste našli v poglavju 4. 2.
INOmax is not intended for adults.
Zdravilo INOmax ni namenjeno odraslim.
Passive exposure to nitric oxide in humans during pregnancy and lactation should be avoided.
Nosečnice in doječe ženske naj se izogibajo pasivni izpostavljenosti dušikovemu oksidu.
Formation of methaemoglobinaemia > 5% has been observed despite administration at appropriate concentrations.
Pri > 5% bolnikov se je kljub uporabi ustreznih koncentracij pojavila methemoglobinemija.
Neonates have diminished MetHb reductase activity and could therefore be at greater risk of developing methaemoglobinaemia.
Novorojenčki imajo zmanjšano aktivnost methemoglobin- reduktaze, zato je pri njih večje tveganje nastanka methemoglobinemije.
Rapid rebound reactions such as intensified pulmonary vasoconstriction and hypoxaemia after sudden withdrawal of inhaled nitric oxide therapy have been described, precipitating cardiopulmonary collapse.
Po nenadni prekinitvi zdravljenja z vdihovanjem dušikovega oksida so bili opisani primeri hitrih povratnih reakcij, kot sta povečana pljučna vazokonstrikcija in hipoksemija, ki lahko pripeljejo do kardiopulmonalnega kolapsa.