FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose should be incrementally reduced to 1 ppm for 30 minutes with close observation of systemic and central pressure, and then turned off. Weaning should be attempted at least every 12 hours when the patient is stable on a low dose of INOmax.
Croatian: Doza se mora postupno smanjivati na 1 ppm tijekom 30 minuta uz promatranje sistemskog i središnjeg tlaka, a zatim isključiti.
English: 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.
Croatian: Tlak u spremniku s plinom INOmax mora biti prikazan na zaslonu, a također moraju biti dostupni rezervni spremnici s plinom kako bi se omogućila pravovremena zamjena spremnika bez neželjenog prekida terapije.
English: Store gas cylinders indoors in well-ventilated rooms or outdoors in ventilated sheds where they are protected from rain and direct sunlight.
Croatian: Spremnike s plinom čuvati u prostorijama s dobrom ventilacijom ili na otvorenom, u ventiliranim natkrivenim spremištima, gdje će biti zaštićeni od kiše i izravne sunčeve svjetlosti.
English: The INOmax group had significantly improved oxygenation as measured by PaO2, OI, and alveolar-arterial gradient (p<0.001 for all parameters).
Croatian: (oksidacijski index) te alveolarno-arterijski gradijent (p<0,001 za sve parametre).
English: See section 4
Croatian: De Keten 7
English: The physician should have access at the bedside to a reserve nitric oxide delivery system.
Croatian: Liječnik koji je u pratnji bolesnika mora imati pristup rezervnom sustavu za dopremu dušikovog (II) oksida.
English: Nitric oxide chemically reacts with oxygen to form nitrogen dioxide.
Croatian: Dušikov (II) oksid kemijski reagira s kisikom i nastaje dušikov dioksid.
English: This delivery system will ensure that the correct amount of nitric oxide is delivered by diluting INOmax with an oxygen/air mixture immediately before giving it to you.
Croatian: Ovaj sustav za dopremu osigurava dopremu odgovarajuće količine dušikovog (II) oksida razrjeđivanjem INOmax-a sa smjesom kisika i zraka neposredno prije dopreme.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 10 litres gas cylinder
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Spremnik s plinom od 10 litara
English: During inter- or within-hospital transfers of patients treated with INOmax, the gas cylinders should be fixedly stowed away in order to hold the gas cylinders vertically and to avoid the risk of fall or untimely modifying output.
Croatian: Tijekom prijevoza bolesnika koji dobivaju INOmax između dvije bolničke ustanove ili unutar jedne ustanove spremnici s plinom moraju biti fiksirani u okomitom položaju kako bi se izbjegla opasnost od pada ili neprimjerenog izlaska plina.
English: Description of selected adverse reactions Inhaled nitric oxide therapy may cause an increase in methaemoglobin.
Croatian: Opis odabranih nuspojava Terapija inhalacije dušikovog (II) oksida može dovesti do povećanja koncentracije methemoglobina.
English: This includes optimising tidal volume/pressures and lung recruitment (surfactant, high frequency ventilation, and positive end expiratory pressure).
Croatian: INOmax se smije primjenjivati samo nakon postizanja optimalne respiratorne potpore uključujući optimiziranje vrijednosti tidalnog volumena/tlakova i otvaranje kolabiranih regija pluća (primjenom surfaktanta, ventilacijom visoke frekvencije i primjenom pozitivnog tlaka na kraju izdisaja).
English: With a continuous flow neonatal ventilator, this may be achieved by infusing a low flow of INOmax into the inspiratory limb of the ventilator circuit.
Croatian: Pri upotrebi neonatalnog respiratora s kontinuiranimprotokom, to se postiže ubrizgavanjem INOmax-a s niskim protokom u inspiratorni krak sustava respiratora.
English: (see section 6 ‘further information' where the full list of ingredients is provided).
Croatian: oksid ili bilo koji drugi sastojak INOmax-a (pogledajte dio 6 „druge informacije“ u kojima je naveden potpuni popis sastojaka).
English: Tell your doctor before treatment with INOmax if you are pregnant, think you could be pregnant or are breastfeeding
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili dojite, obratite se svom liječniku za savjet prije liječenja INOmax-om.
English: Read the package leaflet before use.
Croatian: Prije primjene pročitajte uputu o lijeku.
English: Educational material for Healthcare Professionals
Croatian: Edukacija o primjeni lijeka
English: Dizziness c a: Identified from the clinical trial b: Identified from Post-Marketing experience c: Identified from Post-Marketing experience, experienced by healthcare personnel following accidental exposure d: Post Marketing Safety Surveillance (PMSS) data, effects associated with acute withdrawal of the medicinal product, and /or delivery system failures.
Croatian: c: Podaci iz iskustva nakon stavljanja lijeka u promet, iskustvo medicinskih radnika nakon slučajnog izlaganja d: Podaci iz ispitivanja sigurnosti nakon stavljanja lijeka u promet (PMSS, engl.
English: The nitric oxide delivery system for intermittent flow ventilation should be adequate to avoid spikes in nitric oxide concentration.
Croatian: Sustav za dopremu dušikovog (II) oksida za ventilaciju s intermitentnim protokom mora se podesiti tako da se izbjegnu skokovi u vrijednostima koncentracije dušikovog (II) oksida.
English: Store gas cylinders vertically in well-ventilated rooms.
Croatian: Spremnike s plinom čuvajte u okomitom položaju u dobro ventiliranim prostorijama.
English: INOmax, in conjunction with ventilatory support and other appropriate active substances, is indicated: for the treatment of newborn infants ≥ 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.
Croatian: INOmax je indiciran, u kombinaciji s ventilacijskom potporom i drugim odgovarajućim djelatnim tvarima, u sljedećim slučajevima: za liječenje novorođenčadi gestacijske dobi ≥ 34 tjedna s hipoksičnom respiratornom insuficijencijom povezanom s klinički ili ehokardiografski dokazanom plućnom hipertenzijom,
English: The gas cylinder should be put in an equipped site with appropriate material in order to hold the cylinder vertically.
Croatian: Spremnik s plinom mora se postaviti na mjesto s odgovarajućom opremom koja osigurava njegovo čuvanje u okomitom položaju.
English: Nitric oxide may react with oxygen forming nitrogen dioxide that may cause airway irritation.
Croatian: Dušikov (II) oksid može reagirati s kisikom, čime se stvara dušikov dioksid koji može prouzročiti nadraživanje dišnih putova.
English: Prescription should be limited to those neonatal units that have received adequate training in the use of a nitric oxide delivery system.
Croatian: Propisivanje se treba ograničiti na one jedinice za neonatologiju koje su odgovarajuće osposobljene za rad sa sustavom za dopremu dušikovog (II) oksida.
English: 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.
Croatian: U tim stanjima povišeni pulmonalni vaskularni otpor uzrokuje desno lijevi šant kroz foramen ovale ili otvoreni ductus arteriosus,što za posljedicu ima hipoksemiju.
English: ΛΙΝΤΕ ΕΛΛΑΣ ΜΟΝ ΕΠΕ Θέση Τρύπιο Λιθάρι GR-19600 Μάνδρα Αττικής Τηλ: 0030 211-1045500-510
Croatian: ΛΙΝΤΕ ΕΛΛΑΣ ΜΟΝ ΕΠΕ Θέση Τρύπιο Λιθάρι GR-19600 Μάνδρα Αττικής
English: Thus, the end products of nitric oxide that enter the systemic circulation are predominantly methaemoglobin and nitrate.
Croatian: Stoga su krajnji produkti dušikovog (II) oksida koji ulaze u sistemsku cirkulaciju uglavnom methemoglobin i nitrat.
English: Prescription should be limited to those cardio-thoracic units that have received adequate training in the use of a nitric oxide delivery system.
Croatian: Propisivanje se treba ograničiti na one kardiotorakalne jedinice koje su odgovarajuće osposobljene za rad sa sustavom za dopremu dušikovog (II) oksida.
English: Rapid rebound reactions such as intensified pulmonary vasoconstriction and hypoxia after sudden withdrawal of inhaled nitric oxide therapy has been described, precipitating cardiovascular collapse.
Croatian: Opisane su brze povratne (rebound) reakcije nakon naglog prekida terapije inhalacije dušičnog oksida; jaka pulmonarna vazokonstrikcija i hipoksija koja je prethodila kardiovaskularnom kolapsu.
English: Formation of methaemoglobin
Croatian: Stvaranje methemoglobina
English: Inhaled nitric oxide may influence the oxygen carrying capacity of the blood.
Croatian: Inhalacija dušikovog (II) oksida može utjecati na kapacitet prenošenja kisika u krvi.
English: MARKETING AUTHORISATION HOLDER Linde Healthcare AB
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Linde Healthcare AB
English: Marketing Authorisation Holder Linde Healthcare AB SE-181 81 Lidingö Sweden
Croatian: Nositelj odobrenja za stavljanje u promet Linde Healthcare AB SE-181 81 Lidingö
English: You should directly inform the personnel if you experience headache while being in close proximity to your child receiving INOmax.
Croatian: Ako osjetite glavobolju tijekom zadržavanja u blizini djeteta koje dobiva INOmax, odmah o tome obavijestite bolničko osoblje.
English: In the INOT27 trial, 795 preterm infants (GA<29 weeks) with hypoxic respiratory failure were randomised to receive either INOmax (n=395) in a dose of 5 ppm or nitrogen (placebo n=400),
Croatian: U ispitivanju INOT27, 795 nedonoščadi (gestacijska dob<29 tjedana) s hipoksičnom respiratornom insuficijencijom bilo je randomizirano u skupine koje su primale INOmax (n=395) u dozi od 5 ppm ili dušik (placebo n=400), liječenje je započeto u prva 24 sata života i trajalo je najmanje 7 dana, do najviše 21 dan.
English: Return to distributor / manufacturer - a gas cylinder whose valve is not protected by a cap or a shell should not be used - a specific connection, with a 30 mm thread which is designated for medical use, complying with ISO 5145 and a pressure regulator which admits a pressure at least equal to 1.5 the maximum operating pressure (155 bar) of the gas cylinder should be used - the pressure regulator should be purged by the nitrogen-nitric oxide mixture before each new use in order to preclude nitrogen dioxide inhalation - the pressure regulator should not be tightened with pliers, at the risk of crushing the gasket
Croatian: - mora se koristiti poseban priključak s navojem od 30 mm, namijenjen za medicinsku upotrebu, u skladu s normom ISO 5145, i regulator tlaka koji omogućuje tlak najmanje jednak 1,5 puta maksimalnom radnom tlaku (155 bara) u spremniku s plinom
English: The end medicinal products of nitric oxide that enter the systemic circulation are predominantly methaemoglobin and nitrate.
Croatian: Krajnji produkti dušikovog (II) oksida koji ulaze u sistemsku cirkulaciju su methemoglobin i nitrat.
English: The nitrogen dioxide (NO2) concentration and FiO2 must also be measured at the same site using calibrated and approved (CE-marked) monitoring equipment.
Croatian: Na istom mjestu moraju se mjeriti i koncentracija dušikovog dioksida (NO2) i FiO2
English: Methaemoglobi naemiaa
Croatian: Methemoglobinemijaa
English: When the gas cylinder is empty, it should not be discarded.
Croatian: Nakon pražnjenja spremnik za plin ne smije se baciti.
English: Within the pulmonary system, nitric oxide can combine with oxygen and water to produce nitrogen dioxide and nitrite, respectively, which interact with oxyhaemoglobin to produce methaemoglobin and nitrate.
Croatian: oksid može se vezati s kisikom i vodom te stvoriti dušikov dioksid i nitrit, koji međusobno djeluju s oksihemoglobinom te stvaraju methemoglobin i nitrat.
English: Nitrogen
Croatian: Trombocitopenijaa
English: At low oxygen saturation, nitric oxide can combine with deoxyhaemoglobin to transiently form nitrosylhaemoglobin, which is converted to nitrogen oxides and methaemoglobin upon exposure to oxygen.
Croatian: Pri niskoj zasićenosti kisikom dušikov(II) oksid se veže s deoksihemoglobinom i prijelazno stvara nitrozilhemoglobin, koji se nakon izlaganja kisiku pretvara u dušikove okside i methemoglobin.
English: - Setting the NO, NO2 and O2 monitors for high and low alarm limits - Using the manual backup delivery system - Procedures for correctly switching gas cylinders and purging system - Troubleshooting alarms - NO, NO2 and O2 monitor calibration - Monthly system performance check-up procedures
Croatian: - podešavanje ispravne koncentracije dušikovog (II) oksida koji se treba primijeniti - podešavanje gornjih i donjih vrijednosti alarma za NO, NO2 i O2
English: For patients transported to other facilities for additional treatment, who need to continue with inhaled nitric oxide, arrangements should be made to ensure the continuous supply of inhaled nitric oxide during transportation.
Croatian: U slučaju bolesnika koji se moraju prevesti u druge ustanove radi dodatnog liječenja, a moraju nastaviti s inhalacijom dušikovog (II)
English: Nitrate has been identified as the predominant nitric oxide metabolite excreted in the urine, accounting for > 70 % of the nitric oxide dose inhaled.
Croatian: Utvrđeno je da je nitrat predominantni metabolit dušikovog (II) oksida koji se izlučuje urinom i čini
English: At this level of oxygen saturation, nitric oxide combines predominantly with oxyhaemoglobin to produce methaemoglobin and nitrate.
Croatian: Pri toj zasićenosti kisikom dušikov (II) oksid se prvenstveno veže s oksihemoglobinom te stvara methemoglobin i nitrat.
English: Dizziness c a: Identified from the clinical trial b: Identified from Post Marketing experience c: Identified from Post-Marketing experience, experienced by healthcare personnel following accidental exposure d: Post Marketing Safety Surveillance (PMSS) data, effects associated with acute withdrawal of the medicinal product, and /or delivery system failures.
Croatian: Glavoboljac Omaglicac a: Podaci iz kliničkih ispitivanja b: Podaci iz iskustva nakon stavljanja lijeka u promet.
English: Weaning
Croatian: Odvikavanje
English: 6.1 List of excipients
Croatian: 6.1 Popis pomoćnih tvari dušik
English: Τηλ.
Croatian: oksida.
English: Driving and using machines Not relevant.
Croatian: Upravljanje vozilima i strojevima
English: Rescue, such as Extra Corporeal Membrane Oxygenation (ECMO) where available, should be considered based on continued deterioration or failure to improve, defined by criteria based on local circumstances.
Croatian: oksida tijekom transporta kako bi se spriječilo pogoršanje stanja nakon akutnog prekida primjene INOmax-a, U slučaju progresivnog pogoršanja ili izostanka poboljšanja, definiranog lokalnim kriterijima, potrebno je razmotriti sustav za spašavanje kao što je izvantjelesna membranska oksigenacija (ECMO, engl.
English: 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.
Croatian: - ako ste Vi (kao bolesnik) ili Vaše dijete (kao bolesnik) alergični (preosjetljivi) na dušikov (II)
English: 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.
Croatian: Mjerenja methemoglobina treba ponavljati svakih dan ili dva, iako porast koncentracije methemoglobina u nastavku liječenja, ako je prva koncentracija niska, nije uobičajen.
English: A 2 litre gas cylinder filled at 155 bar absolute brings 307 litres of gas under pressure of 1 bar at 15oC.
Croatian: Spremnik za plin od 2 litre napunjen pod apsolutnim tlakom od 155 bara daje 307 litara plina pod tlakom od 1 bara pri temperaturi od 15 oC.
English: A 10 litre gas cylinder filled at 155 bar absolute brings 1535 litres of gas under pressure of 1 bar at 15oC.
Croatian: Spremnik za plin od 10 litara napunjen pod apsolutnim tlakom od 155 bara daje 1535 litara plina pod tlakom od 1 bara pri temperaturi od 15 oC.
English: In the NINOS trial, 235 neonates with hypoxic respiratory failure were randomised to receive 100 % O2 with (n=114) or without (n=121) nitric oxide most with an initial concentration of 20 ppm with weaning as possible to lower doses with a median duration of exposure of 40 hours.
Croatian: U ispitivanju NINOS, 235 novorođenčadi s hipoksičnom respiratornom insuficijencijom bilo je randomizirano u skupine koje su primale 100% O2 (n=114) s dušikovim (II) oksidom ili bez (n=121)
English: NAME OF THE MEDICINAL PRODUCT INOmax 400 ppm mol/mol inhalation gas
Croatian: NAZIV LIJEKA INOmax 400 ppm mol/mol plin inhalata
English: ul.
Croatian: Tel.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/194/003, EU/1/01/194/004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/194/003, EU/1/01/194/004
English: A 10 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a INOmeter device equipped valve hand-wheel.
Croatian: napunjen pod tlakom od 155 bara, opremljen ventilom od nehrđajućeg čelika za pozitivni tlak (rezidualni) s posebnim izlaznim priključkom i ručicom ventila opremljenom uređajem INOmeter.
English: Inhaled nitric oxide combination with other vasodilators acting by the cGMP or cAMP systems should be done with caution.
Croatian: Potreban je poseban oprez u kombinacijama inhalacije dušikovog (II) oksida s drugim vazodilatatorima koji djeluju putem sustava cikličkog gvanozinmonofosfata (cGMP) ili cikličkog adenozinmonofosfata (cAMP).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/194/001, EU/1/01/194/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/194/001, EU/1/01/194/002
English: Therapy is usually required for about 4 days in newborn infants with lung failure associated with high blood pressure in the lungs.
Croatian: U novorođenčadi sa zatajenjem pluća povezanim s visokim krvnim tlakom u plućima liječenje obično traje 4 dana.
English: Your doctor will decide how long you or your child should be treated with INOmax.
Croatian: Liječnik će odrediti trajanje liječenja INOmax-om za Vas ili Vaše dijete.
English: NAME OF THE MEDICINAL PRODUCT INOmax 800 ppm mol/mol inhalation gas
Croatian: NAZIV LIJEKA INOmax 800 ppm mol/mol plin inhalata
English: NO2 rapidly forms in gas mixtures containing nitric oxide and O2, and nitric oxide may in this way cause airway inflammation and damage.
Croatian: Stvaranje dušikovog dioksida (NO2) NO2 brzo se stvara u plinskim mješavinama koje sadržavaju dušikov (II) oksid i O2, a dušikov (II)
English: The active substance in INOmax is nitric oxide 400 ppm mol/mol.
Croatian: Djelatna tvar u INOmax-u jest dušikov (II) oksid 400 ppm mol/mol.
English: The active substance in INOmax is nitric oxide 800 ppm mol/mol.
Croatian: Djelatna tvar u INOmax-u jest dušikov (II) oksid 800 ppm mol/mol.
English: Training in administration The key elements that need to be covered in training hospital personnel are as follows.
Croatian: Edukacija bolničkog medicinskog osoblja mora uključivati sljedeće ključne elemente: Ispravno postavljanje i priključivanje
English: A 10 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a standard valve hand-wheel.
Croatian: napunjen pod tlakom od 155 bara, opremljen ventilom od nehrđajućeg čelika za pozitivni tlak (rezidualni) s posebnim izlaznim priključkom i standardnom ručicom ventila.
English: 6.6 Special precautions for disposal and other handling
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Upute za upotrebu/rukovanje INOmax-om
English: How to store INOmax
Croatian: Moguće nuspojave Kako čuvati INOmax
English: The monitoring of Methaemoglobin level
Croatian: Praćenje koncentracije methemoglobina (MetHb)
English: For patients who are to be referred to another hospital, to prevent worsening of their condition on acute discontinuation of INOmax, the availability of nitric oxide during transport should be assured.
Croatian: Bolesnicima koji će nastaviti liječenje u drugoj ustanovi treba osigurati dostupnost dušikovog (II)
English: Posology
Croatian: Atelektazaa
English: In clinical studies, NO2 levels > 3 ppm or methaemoglobin levels > 7 % were treated by reducing the dose of, or discontinuing, INOmax.
Croatian: U kliničkim ispitivanjima razine NO2 > 3 ppm ili methemoglobina
English: INOmax 400 ppm mol/mol inhalation gas Nitric oxide
Croatian: INOmax 400 ppm mol/mol plin inhalata dušikov (II) oksid
English: : +32 70 233 826 info.healthcare.be@linde.com
Croatian: B-1850 Grimbergen Tél/Tel.: +32 70 233 826 info.healthcare.be@linde.com
English: Thrombocytopeniaa
Croatian: Razine methemoglobina
English: INOmax 800 ppm mol/mol inhalation gas Nitric oxide
Croatian: INOmax 800 ppm mol/mol plin inhalata dušikov (II) oksid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Nitric oxide (NO) 400 ppm mol/mol.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Dušikov (II) oksid (NO) 400 ppm mol/mol.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Nitric oxide (NO) 800 ppm mol/mol.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Dušikov (II) oksid (NO) 800 ppm mol/mol.
English: The educational pack should contain the following: Summary of Product Characteristics and Patient Information Leaflet for INOmax
Croatian: • Sažetak opisa svojstava i Uputu o lijeku za INOmax • Edukacijski materijal za zdravstvene radnike
English: PHARMACEUTICAL FORM AND CONTENTS Inhalation gas
Croatian: Plin inhalata
English: There may be an additive effect with INOmax on the risk of developing methaemoglobinemia with nitric oxide donor substances, including sodium nitroprusside and nitroglycerin.
Croatian: Zajednička primjena donora dušikovog oksida, uključujući natrijev nitroprusid i nitroglicerin s INOmax-om može imati aditivni učinak na razvoj methemoglobinemije.
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/01/194/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/194/002
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/01/194/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/194/003
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Nitric oxide (NO) 400 ppm mol/mol.
Croatian: Dušikov (II) oksid (NO) 400 ppm mol/mol.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Nitric oxide (NO) 800 ppm mol/mol.
Croatian: Dušikov (II) oksid (NO) 800 ppm mol/mol.
English: Data in adult humans are conflicting, and there has been no increase in bleeding complications in randomised controlled trials in term and near-term neonates with hypoxic respiratory failure.
Croatian: U randomiziranim kontroliranim ispitivanjima na donošenoj novorođenčadi i kasnoj nedonoščadi s hipoksičnom respiratornom insuficijencijom nije zabilježeno povećanje broja komplikacija s krvarenjem.
English: ANNEX I
Croatian: PRILOG III.
English: NAME OF THE MEDICINAL PRODUCT INOmax 800 ppm mol/mol inhalation gas Nitric oxide
Croatian: Uputa o lijeku: Informacije za korisnika INOmax 800 ppm mol/mol plin inhalata dušikov (II) oksid
English: NAME OF THE MEDICINAL PRODUCT INOmax 400 ppm mol/mol inhalation gas Nitric oxide
Croatian: Uputa o lijeku: Informacije za korisnika INOmax 400 ppm mol/mol plin inhalata dušikov (II) oksid
English: Inadequate response
Croatian: Način primjene
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 January 2018
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26. siječnja 2018.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Croatian: Dva su lijeka bioekvivalentna ako proizvode iste razine djelatne tvari u tijelu i stoga se očekuje da imaju isti učinak.