FrancophonIA/ELRC3.0 huggingface dataset:
English: A clinically significant interaction with other medicinal products used in the treatment of hypoxic respiratory failure cannot be excluded based on the available data.
Slovenian: Na osnovi razpoložljivih podatkov ne moremo izključiti klinično značilnih interakcij z drugimi zdravili, ki jih uporabljamo pri zdravljenju hipoksične respiratorne odpovedi.
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.
Slovenian: Odmerek je treba postopoma zmanjšati na 1 ppm v 30 minutah, pri čemer je treba skrbno spremljati sistemski in centralni tlak, potem pa sistem izklopiti.
English: The educational material should include information on the following key elements: The risk of rebound effect and the precautions to take when discontinuing the treatment The risk of abrupt discontinuation of INOmax therapy in the event of critical failure of the delivery system and how to prevent it
Slovenian: Izobraževalno gradivo naj vključuje informacije o naslednjih ključnih elementih: • Tveganje povratnega učinka in previdnostni ukrepi, ki jih je treba upoštevati pri prekinitvi zdravljenja.
English: If it is > 2.5 %, the INOmax dose should be decreased and the administration of reducing medicinal products such as methylene blue may be considered.
Slovenian: Če je koncentracija methemoglobina >2,5 %, zmanjšajte odmerek zdravila INOmax, poleg tega pa razmislite o uporabi reducentov, kot je metilen modro.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega citopenijaa methemoglobinemijaa sistema
English: Monitoring formation of methaemoglobin (MetHb) Neonates and infants are known to have diminished MetHb reductase activity compared to adults.
Slovenian: Znano je, da je aktivnost methemoglobin-reduktaze pri novorojenčkih in dojenčkih manjša kot pri odraslih.
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.
Slovenian: Med premeščanjem bolnikov, ki prejemajo zdravilo INOmax, znotraj bolnišnice ali med bolnišnicami morajo biti jeklenke trdno nameščene v pokončen položaj, da bi preprečili padce ali neprimerno spremembo dovajanja.
English: A large portion of nitric oxide for inhalation is absorbed systemically.
Slovenian: Nastajanje methemoglobina Velik delež vdihnjenega dušikovega oksida se absorbira sistemsko.
English: (see section 6 ‘further information' where the full list of ingredients is provided).
Slovenian: Dodatne informacije, ki vsebuje seznam vseh sestavin.
English: The rebound may be seen early as well as late during therapy.
Slovenian: Povratna reakcija lahko nastopi na začetku zdravljenja ali kasneje med zdravljenjem.
English: INOmax should only be delivered according to an anaesthetist's or intensive care physician's prescription.
Slovenian: Zdravilo INOmax se lahko dovaja samo, če ga predpiše anestezist ali zdravnik z intenzivne nege.
English: INOmax should not be used in preterm baby < 34 weeks of gestational age.
Slovenian: Zdravilo INOmax se ne sme uporabljati pri nedonošenčkih, mlajših od 34 tednov nosečnosti.
English: The mean methaemoglobin levels remained below 1 % in the placebo group and in the 5 ppm and 20 ppm INOmax groups, but reached approximately 5 % in the 80 ppm INOmax group.
Slovenian: V skupini s placebom ter v skupinah, ki so prejemale 5 ppm in 20 ppm zdravila INOmax, so se povprečne koncentracije methemoglobina obdržale pod 1 % .
English: Some medicines can affect the ability of blood to carry oxygen.
Slovenian: Nekatera zdravila lahko vplivajo na sposobnost krvi za prenašanje kisika, vključno s prilokainom
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),
Slovenian: V preskušanju INOT27 so 795 nedonošenčkov (gestacijska starost < 29 tednov) s hipoksično odpovedjo dihal naključno razporedili v skupini, ki sta prejemali zdravilo INOmax (n = 395) v odmerku 5 ppm oziroma dušik (placebo n = 400) v prvih 24 urah življenja in ki so se zdravili od 7 do
English: What INOmax looks like and contents of the pack Inhalation gas
Slovenian: Izgled zdravila INOmax in vsebina pakiranja plin za inhaliranje
English: METHOD AND ROUTE(S) OF ADMINISTRATION Endotracheopulmonary use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Endotraheopulmonalna uporaba.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
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.
Slovenian: Pri bolnikih, ki bodo zaradi dodatnega zdravljenja premeščeni v druge ustanove in ki morajo še naprej vdihovati dušikov oksid, poskrbite, da bodo med prevozom imeli neprekinjeno dovajanje dušikovega oksida.
English: In the pivotal clinical trials, the starting dose was 20 ppm.
Slovenian: V ključnih kliničnih preizkušanjih so uporabili začetni odmerek 20 ppm.
English: Store gas cylinders vertically in well-ventilated rooms.
Slovenian: Jeklenke shranjujte pokončno v dobro prezračenih prostorih.
English: The withdrawal of inhaled nitric oxide therapy should be performed in a stepwise manner.
Slovenian: Prekinitev zdravljenja z inhalacijskim dušikovim oksidom je treba opraviti po korakih.
English: In the CINRGI trial, 186 term- and near-term neonates with hypoxic respiratory failure and without lung hypoplasia were randomised to receive either INOmax (n=97) or nitrogen gas (placebo; n=89) with an initial dose of 20 ppm weaning to 5 ppm in 4 to 24 hours with median duration of exposure of 44 hours.
Slovenian: V preskušanju CINRGI so naključno razdelili 186 novorojenčkov s hipoksično respiratorno odpovedjo in brez pljučne hipoplazije, rojenih v roku ali blizu roka, tako da so prejemali bodisi zdravilo INOmax (n = 97) ali dušik v plinasti obliki (placebo; n = 89) v začetnem odmerku 20 ppm, ki so ga zmanjševali do 5 ppm v 4 do 24 urah z mediano trajanja izpostavitve 44 ur.
English: During treatment with nitric oxide, the NO2 concentration should be < 0.5 ppm in the nitric oxide dose range < 20 ppm.
Slovenian: Med zdravljenjem z dušikovim oksidom v odmerku do 20 ppm mora biti koncentracija NO2 <0,5 ppm.
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.
Slovenian: Pri nizki nasičenosti s kisikom se dušikov oksid lahko veže z deoksihemoglobinom in prehodno tvori nitrozilhemoglobin, ki se po izpostavitvi kisiku pretvori v dušikove okside in methemoglobin.
English: Studies show that nitric oxide exhibits pulmonary pharmacodynamic effects at intra-airway concentrations as low as 1 ppm.
Slovenian: Študije so pokazale, da ima dušikov oksid farmakodinamične učinke na pljuča že pri tako nizkih koncentracijah v dihalih,
English: Nitric oxide has an unpaired electron, which makes the molecule reactive.
Slovenian: Molekula dušikovega oksida ima en neparni elektron in je zato zelo reaktivna.
English: Nitrogen dioxide (NO2) is the main substance formed, and may cause airway inflammation and damage.
Slovenian: Večinoma nastaja dušikov dioksid (NO2), ki lahko povzroči vnetje in poškodbe dihalnih poti.
English: No difference in the incidence of IVH or death was however observed in this study.
Slovenian: V tej študiji niso opazili razlike v incidenci intraventrikularne krvavitve ali smrti.
English: Regular monitoring of haemostasis and measurement of bleeding time is recommended during the administration of INOmax for more than 24 hours to patients with functional or quantitative platelet anomalies, a low coagulation factor or receiving anticoagulation treatment.
Slovenian: Kadar se zdravilo INOmax več kot 24 ur daje bolnikom s funkcionalnimi ali kvantitavnimi anomalijami krvnih ploščic, nizkim koagulacijskim faktorjem ali bolnikom, ki se zdravijo z antikoagulanti, se priporoča redno spremljanje hemostaze in merjenje časa krvavitve.
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.
Slovenian: • 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;
English: 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).
Slovenian: (PAP - »pulmonary artery pressure«) in/ali poslabšala oksigenacija krvi (PaO2).
English: INOmax contains Nitrogen
Slovenian: Zdravilo INOmax vsebuje dušik.
English: You should directly inform the personnel if you experience headache while being in close proximity to your child receiving INOmax.
Slovenian: Če dobite glavobol, medtem ko ste v bližini svojega otroka, ki prejema zdravilo INOmax, morate o tem obvestiti osebje.
English: Pulmonary hypertension associated with heart surgery Prescription of nitric oxide should be supervised by a physician experienced in cardiothoracic anaesthesia & intensive care.
Slovenian: Predpisovanje dušikovega oksida mora nadzorovati zdravnik z izkušnjami s kardiotorakalno anestezijo in intenzivno nego.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila INOmax Vsebina pakiranja in dodatne informacije
English: Inhaled nitric oxide may influence the oxygen carrying capacity of the blood.
Slovenian: Vdihavanje dušikovega oksida lahko vpliva na sposobnost krvi za prenašanje kisika.
English: See section 4
Slovenian: De Keten 7
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
Slovenian: - Nastavitev naprave za dovajanje pravilne koncentracije dušikovega oksida - Nastavljanje nadzornih naprav za alarmne signale pri visokih in nizkih koncentracijah NO, NO2
English: Polytrifluorochloroethylene, hexafluoropropene-vinyliden copolymer and polytetraflourethylene have been used extensively with pure nitric oxide and other corrosive gases.
Slovenian: S čistim dušikovim oksidom in drugimi jedkimi plini so pogosto uporabljali politrifluorokloroetilen, heksafluoropropenviniliden kopolimer in politetrafluoretilen.
English: Methaemoglobin disposition has been investigated as a function of time and nitric oxide exposure concentration in neonates with respiratory failure.
Slovenian: Stanje methemoglobina pri novorojenčkih z respiratorno odpovedjo so raziskovali kot funkcijo časa in izpostavljenosti koncentracijam dušikovega oksida.
English: The end medicinal products of nitric oxide that enter the systemic circulation are predominantly methaemoglobin and nitrate.
Slovenian: Končna produkta dušikovega oksida, ki vstopita v krvni obtok, sta večinoma methemoglobin in nitrat.
English: 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).
Slovenian: 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.
English: The monitoring of NO2 formation
Slovenian: • Spremljanje nastajanja NO2.
English: Transport of gas cylinders
Slovenian: Prevoz jeklenk
English: At this level of oxygen saturation, nitric oxide combines predominantly with oxyhaemoglobin to produce methaemoglobin and nitrate.
Slovenian: Pri tej ravni nasičenosti s kisikom se dušikov oksid veže predvsem na oksihemoglobin ter tvori methemoglobin in nitrat.
English: Elevations in methaemoglobinaemia reduce the oxygen delivery capacity of the circulation.
Slovenian: Povečanje methemoglobina zmanjša sposobnost krvnega obtoka za prenašanje kisika.
English: The nitric oxide delivery system for intermittent flow ventilation should be adequate to avoid spikes in nitric oxide concentration.
Slovenian: Sistem za dovajanje dušikovega oksida za predihavanje s prekinitvami pretoka bi moral te dvige koncentracije dušikovega oksida ustrezno odpraviti.
English: Storage in the pharmacy department
Slovenian: Shranjevanje v lekarnah
English: Marketing Authorisation Holder Linde Healthcare AB SE-181 81 Lidingö Sweden
Slovenian: Imetnik dovoljenja za promet z zdravilom Linde Healthcare AB SE-181 81 Lidingö
English: Therapy is usually required for about 4 days in newborn infants with lung failure associated with high blood pressure in the lungs.
Slovenian: Pri novorojenčkih z odpovedjo pljuč, povezano z visokim krvnim tlakom v pljučih, je običajno potrebno približno 4-dnevno zdravljenje.
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.
Slovenian: Bolezni živčevja glavobolc omoticac a. Ugotovljeni v kliničnem preskušanju b. Ugotovljeni v obdobju trženja c. Ugotovljeni v obdobju trženja, poročali zdravstveni delavci po nenamerni izpostavitvi.
English: A 2 litre gas cylinder filled at 155 bar absolute brings 307 litres of gas under pressure of 1 bar at 15oC.
Slovenian: 2-litrska jeklenka, napolnjena pri tlaku 155 bar, vsebuje 307 litrov plina pri tlaku 1 bar in temperaturi 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.
Slovenian: 10-litrska jeklenka, napolnjena pri tlaku 155 bar, vsebuje 1535 litrov plina pri tlaku 1 bar in temperaturi 15 oC.
English: ΛΙΝΤΕ ΕΛΛΑΣ ΜΟΝ ΕΠΕ Θέση Τρύπιο Λιθάρι GR-19600 Μάνδρα Αττικής Τηλ: 0030 211-1045500-510
Slovenian: ΛΙΝΤΕ ΕΛΛΑΣ ΜΟΝ ΕΠΕ Θέση Τρύπιο Λιθάρι GR-19600 Μάνδρα Αττικής
English: No effect of inhaled nitric oxide has been documented in newborn babies with a malformation where the diaphragm is not fully complete, so called ‘congenital diaphragmatic hernia'.
Slovenian: Pri novorojenčkih s prirojeno diafragmalno hernijo, malformacijo, pri kateri diafragma ni popolnoma razvita, niso dokumentirali nobenega učinka zdravljenja z vdihavanjem dušikovega oksida.
English: INOmax therapy must be available for manual ventilation such as suctioning, patient transport, and resuscitation.
Slovenian: Zdravljenje z zdravilom INOmax mora biti pri posegih, kot so sukcija, prevoz bolnika in oživljanje, mogoče tudi z ročnim predihavanjem.
English: 155 bar absolute brings 307 litres of gas under pressure of 1 bar at 15 at 155 bar absolute brings 1535 litres of gas under pressure of 1 bar at 15oC.
Slovenian: napolnjena pri tlaku 155 bar, vsebuje 307 litrov plina pri tlaku 1 bar in temperaturi 15 oC. 10-litrska jeklenka, napolnjena pri tlaku 155 bar, vsebuje 1535 litrov plina pri tlaku 1 bar in temperaturi 15 oC.
English: How to store INOmax
Slovenian: Shranjevanje zdravila INOmax
English: Nitric oxide may react with oxygen forming nitrogen dioxide that may cause airway irritation.
Slovenian: Dušikov oksid lahko reagira s kisikom, pri čemer nastane dušikov dioksid, ki lahko draži dihalne poti.
English: Persistent Pulmonary Hypertension in the Newborn (PPHN) Prescription of nitric oxide should be supervised by a physician experienced in neonatal intensive care.
Slovenian: Predpisovanje dušikovega oksida mora nadzirati zdravnik z izkušnjami v intenzivni negi novorojenčkov.
English: Attempts to wean INOmax should be commenced as soon as the haemodynamics have stabilised in conjunction to weaning from ventilator and inotropic support.
Slovenian: Zdravljenje z zdravilom INOmax ter ventilatorsko in inotropno podporo je treba prekiniti takoj, ko se hemodinamika stabilizira.
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.
Slovenian: reakcije kot sta povečana pljučna vazokonstrikcija in hipoksija, ki so povzročile kardiovaskularni kolaps.
English: This will be monitored by blood samples and if required the INOmax dose will be decreased and the administration of medicines such as vitamin C, methylene blue, or eventually blood transfusion, in order to improve the oxygen carrying capacity, may be considered.
Slovenian: Poleg tega je sposobnost krvi za prenašanje kisika mogoče izboljšati z dajanjem zdravil, kot sta vitamin C in metilen modro, ter s transfuzijo krvi.
English: Inhaled nitric oxide should be used with caution in patients with complex heart defect, where high pressure in the pulmonary artery is of importance for maintaining circulation.
Slovenian: Pri bolnikih s kompleksno srčno okvaro, pri kateri je visok tlak v pljučni arteriji pomemben za vzdrževanje cirkulacije, je treba inhalacijski dušikov oksid uporabljati previdno.
English: Side effects that are very commonly seen (affects more than 1 user in 10) in association with INOmax therapy include:
Slovenian: Med neželenimi učinki, ki se zelo pogosto (pri več kot 1 od 10 bolnikov) pojavijo pri zdravljenju z zdravilom INOmax, so: • majhno število trombocitov.
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.
Slovenian: Tlak v jeklenki z zdravilom INOmax mora biti prikazan, da jo lahko pravočasno zamenjate brez prekinitve zdravljenja.
English: - If you have any further questions, ask your doctor - If you get any side effects, talk to your doctor.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom.
English: NO2 rapidly forms in gas mixtures containing nitric oxide and O2, and nitric oxide may in this way cause airway inflammation and damage.
Slovenian: V zmeseh plinov, ki vsebujejo dušikov oksid in O2, se hitro tvori NO2.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: The other ingredient is nitrogen.
Slovenian: Pomožna snov je dušik.
English: MARKETING AUTHORISATION HOLDER Linde Healthcare AB
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Linde Healthcare AB
English: INOmax contains nitric oxide, a gas used for the treatment of newborn babies with lung failure associated with high blood pressure in the lungs, a condition known as hypoxic respiratory failure.
Slovenian: - novorojenčkov s pljučno odpovedjo, povezano z visokim tlakom v pljučih, stanje, ki ga poznamo kot hipoksično respiratorno odpoved.
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.
Slovenian: Pri bolnikih, ki bodo premeščeni v drugo bolnišnico, zagotovite možnost dovajanja dušikovega oksida med prevozom, da preprečite poslabšanje zdravstvenega stanja ob nenadni prekinitvi dovajanja zdravila INOmax.
English: The active substance in INOmax is nitric oxide 400 ppm mol/mol.
Slovenian: Zdravilna učinkovina v zdravilu INOmax je dušikov oksid 400 ppm mol/mol.
English: Weaning from inhaled nitric oxide should be performed with caution.
Slovenian: Pri prekinitvi vdihovanja dušikovega oksida morate biti previdni.
English: Not relevant.
Slovenian: Navedba smiselno ni potrebna.
English: 6.1 List of excipients
Slovenian: 6.1 Seznam pomožnih snovi dušik
English: NAME OF THE MEDICINAL PRODUCT INOmax 400 ppm mol/mol inhalation gas
Slovenian: IME ZDRAVILA INOmax 400 ppm mol/mol plin za inhaliranje
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.
Slovenian: V primeru stalnega slabšanja ali izostanka izboljšanja glede na trenutne okoliščine pretehtajte možnost uporabe rešilnega sistema, kot je ECMO (zunajtelesna membranska oksigenacija).
English: Intermittent flow neonatal ventilation may be associated with spikes in nitric oxide concentration.
Slovenian: Predihavanje s prekinitvami pretoka pri novorojenčku je lahko povezano z znatnimi dvigi koncentracije dušikovega oksida.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 2 litres gas cylinder
Slovenian: PODATKI NA PRIMARNI OVOJNINI 2-litrska jeklenka
English: Do not discard used gas cylinders.
Slovenian: Uporabljenih jeklenk ne zavrzite.
English: The active substance in INOmax is nitric oxide 800 ppm mol/mol.
Slovenian: Zdravilna učinkovina v zdravilu INOmax je dušikov oksid 800 ppm mol/mol.
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.
Slovenian: V preizkusu NINOS so naključno razdelili 235 novorojenčkov s hipoksično respiratorno odpovedjo tako, da so prejemali 100 % O2 z dušikovim oksidom (n = 114) ali brez njega (n = 121).
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.
Slovenian: Zdravilo INOmax v kombinaciji s snovmi, ki so donorji dušikovega oksida, vključno z natrijevim nitroprusidom in nitroglicerinom, lahko povzroči dodatno tveganje za razvoj methemoglobinemije.
English: AUTHORISATION
Slovenian: Delovanje
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 10 litres gas cylinder
Slovenian: PODATKI NA PRIMARNI OVOJNINI 10-litrska jeklenka
English: Formation of methaemoglobin
Slovenian: Nadzor nastajanja methemoglobina (MetHb)
English: NAME OF THE MEDICINAL PRODUCT INOmax 800 ppm mol/mol inhalation gas
Slovenian: IME ZDRAVILA INOmax 800 ppm mol/mol plin za inhaliranje
English: Inhaled nitric oxide may have a mild but influence on the platelets (components that help the blood to clot) of you or your child and any signs of bleeding and or haematoma should be observed.
Slovenian: (komponente, ki pomagajo pri strjevanju krvi), zato morate biti pozorni na kakršnekoli znake krvavitve ali hematoma.
English: The European Medicines Agency has waived the obligation to submit the results of studies with INOmax in all subsets of the paediatric population in persistent pulmonary hypertension and other pulmonary heart disease.
Slovenian: INOmax pri vseh podskupinah pediatričnih bolnikov s persistentno pljučno hipertenzijo in drugimi pljučnimi srčnimi boleznimi (za podatke o uporabi pri pediatrični populacijiglejte poglavje 4.2).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/194/003, EU/1/01/194/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/01/194/003, EU/1/01/194/004
English: Nervous system disorders
Slovenian: Žilne bolezni hipotenzijaa,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/194/001, EU/1/01/194/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/01/194/001, EU/1/01/194/002