FrancophonIA/ELRC3.0 huggingface dataset:
English: Substances known to cause increased methaemoglobin levels should thus be used with caution during therapy with inhaled nitric oxide.
Danish: Stoffer, der vides at forårsage øgede koncentrationer af methæmoglobin, skal derfor anvendes med forsigtighed under behandling med inhaleret nitrogenoxid.
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).
Danish: Der er øget risiko for dannelse af methæmoglobin, hvis lægemidler med kendt tendens til at øge koncentrationerne af methæmoglobin, indgives samtidig med nitrogenoxid (f.eks. alkylnitrater og sulfonamider).
English: When inhaled, nitric oxide produces selective pulmonary vasodilation.
Danish: Når nitrogenoxid inhaleres, skaber det selektiv pulmonal vasodilatation.
English: PHARMACEUTICAL FORM AND CONTENTS Inhalation gas
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Gas til inhalation
English: This gas mixture can improve heart function and increase the flow of blood through the lungs, which may help to increase the amount of oxygen that reaches the blood.
Danish: Denne gasblanding kan forbedre hjertefunktionen og øge blodgennemstrømningen i lungerne, hvilket kan hjælpe til at øge den mængde ilt, der kommer ud i blodet.
English: Driving and using machines Not relevant.
Danish: Trafik- og arbejdssikkerhed Ikke relevant.
English: The nitric oxide delivery system for intermittent flow ventilation should be adequate to avoid spikes in nitric oxide concentration.
Danish: Indgivelsessystemet til nitrogenoxid med intermittent flow-ventilation skal være tilstrækkeligt til at undgå spidser i nitrogenoxidkoncentrationen.
English: Some medicines can affect the ability of blood to carry oxygen.
Danish: Visse lægemidler kan påvirke blodets evne til at transportere ilt.
English: No evidence of a carcinogenic effect was apparent, at inhalation exposures up to the recommended dose (20 ppm), in rats for 20 h/day for up to two years.
Danish: Der var ingen tydelig evidens for en karcinogen effekt ved eksponeringer efter inhalation af op til den anbefalede dosis (20 ppm) hos rotter i 20 timer/dag i op til to år.
English: Gas cylinders are to be stored in wellventilated rooms or in ventilated sheds where they are protected from rain and direct sunlight.
Danish: Gasflasker skal opbevares i godt ventilerede rum eller i godt ventilerede skure, hvor de er beskyttet mod regn og direkte sollys.
English: In one clinical study (NINOS), treatment groups were similar with respect to the incidence and severity of intracranial haemorrhage, Grade IV haemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary haemorrhage, or gastrointestinal haemorrhage.
Danish: I en klinisk undersøgelse (NINOS) var behandlingsgrupperne ens med hensyn til incidens og sværhedsgrad af intrakraniel blødning, Grad IV-blødning, periventrikulær leukomalaci, cerebralt infarkt, krampeanfald, der krævede behandling med anticonvulsivum, pulmonal blødning eller gastrointestinal blødning.
English: Headache, dizziness, dry throat or shortness of breath following accidental ambient air exposure to nitric oxide (e.g. leakage from equipment or cylinder).
Danish: Hovedpine, svimmelhed, tørhed i halsen eller stakåndethed efter utilsigtet udslip af nitrogenoxid til den omgivende luft (f.eks. ved lækage fra udstyret eller flasken).
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.
Danish: INOmax indeholder nitrogenoxid, en gas til behandling af: - Nyfødte med lungesvigt i forbindelse med højt blodtryk i lungerne, en tilstand som kaldes hypoxisk respirationssvigt.
English: Do not use INOmax
Danish: Brug ikke INOmax:
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.
Danish: Der er beskrevet hurtige rebound-reaktioner såsom forværret pulmonal vasokonstriktion og hypoxi, som har udløst kardiovaskulært kollaps, efter pludselig seponering af inhaleret nitrogenoxid.
English: Inside this place, a separate premise should be dedicated to the storage of nitric oxide gas cylinders.
Danish: Indenfor dette sted skal et separat område være specielt beregnet til opbevaring af nitrogenoxidgasflasker.
English: No fertility studies have been performed.
Danish: Der er ikke udført fertilitetsundersøgelser.
English: Store gas cylinders vertically in well-ventilated rooms.
Danish: Opbevar gasbeholderne lodret i godt ventilerede rum.
English: Methaemoglobin disposition has been investigated as a function of time and nitric oxide exposure concentration in neonates with respiratory failure.
Danish: Methæmoglobin-tilbøjelighed er undersøgt som et produkt af tid og eksponeringskoncentration af nitrogenoxid hos nyfødte med respirationssvigt.
English: In the presence of oxygen, nitric oxide is rapidly oxidised to derivatives which are toxic to the bronchial epithelium and alveolo-capillary membrane.
Danish: Ved tilstedeværelse af oxygen iltes nitrogenoxid hurtigt til derivater, som er toksiske for bronkieepitelet og alveole/kapillærmembranen.
English: The lowest effective dose should be administered and the dose should be weaned down to 5 ppm provided that the pulmonary artery pressure and systemic arterial oxygenation remain adequate at this lower dose.
Danish: Den laveste effektive dosis bør indgives, og dosis skal trappes ned til 5 ppm, forudsat at det pulmonale arterielle tryk og den systemiske arterielle iltning er tilstrækkelig ved denne lavere dosis.
English: Store gas cylinders indoors in well-ventilated rooms or outdoors in ventilated sheds where they are protected from rain and direct sunlight.
Danish: Opbevar gasbeholderne i godt ventilerede rum indendørs eller udendørs i godt ventilerede skure, hvor de er beskyttet mod regn og direkte sollys.
English: Prescription should be limited to those neonatal units that have received adequate training in the use of a nitric oxide delivery system.
Danish: Ordinationen skal begrænses til neonatalafsnit, der har modtaget tilstrækkelig uddannelse i anvendelsen af et nitrogenoxid-tilførselssystem.
English: The efficacy of INOmax has been investigated in term and near-term newborns with hypoxic respiratory failure resulting from a variety of aetiologies.
Danish: INOmax's effektivitet er undersøgt hos fuldbårne og næsten fuldbårne neonatale med hypoxisk respirationssvigt som følge af varierende ætiologier.
English: Too rapid weaning from inhaled nitric oxide therapy carries the risk of a re-bound increase in pulmonary artery pressure with subsequent circulatory instability.
Danish: For hurtig afvænning fra behandlingen med inhaleret nitrogenoxid medfører risiko for en re-boundstigning i det pulmonale arterielle tryk med efterfølgende manglende cirkulatorisk stabilitet.
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'.
Danish: Der er ikke dokumenteret effekt af inhaleret nitrogenoxid hos nyfødte børn med en misdannelse, hvor mellemgulvet er defekt, såkaldt ‘medfødt diafragmahernie'.
English: If you stop using INOmax
Danish: Hvis De stopper behandlingen med INOmax
English: INOmax is given in dose of 10 to 20 ppm, (maximal dose 20 ppm in children and 40 ppm in adults) part per million of the gas that you or your child inhale.
Danish: INOmax indgives i doser på 10 til 20 ppm (parts (andele) per million) af den gas, De eller Deres barn inhalerer (maksimaldosis er 20 ppm til børn og 40 ppm til voksne).
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.
Danish: Ved NINOS-forsøget blev 235 neonatale med hypoxisk respirationssvigt randomiseret til at modtage 100 % O2 med (n=114) eller uden (n=121) nitrogenoxid, de fleste med en initiel koncentration på 20 ppm med fravænning hurtigst muligt til lavere doser med en gennemsnitlig eksponeringsvarighed på 40 timer.
English: Prilocaine, whether administered as oral, parenteral, or topical formulations may cause methaemoglobinaemia.
Danish: Prilocain kan forårsage methæmoglobinæmi, uanset om det administreres som orale, parenterale eller topiske formuleringer.
English: Nitric oxide is genotoxic in some test systems.
Danish: I nogle testsystemer er nitrogenoxid genotoksisk.
English: INOmax should not be used in preterm baby < 34 weeks of gestational age.
Danish: INOmax må ikke anvendes til for tidligt fødte børn (< 34 gestationsuger).
English: Transport of gas cylinders
Danish: Transport af gasflasker
English: Your or your child's doctor will undertake monitoring of nitrogen dioxide and in case of elevated values the INOmax therapy will be adjusted, decreased accordingly.
Danish: Lægen vil sørge for at overvåge mængden af nitrogendioxid, og i tilfælde af øgede værdier vil INOmax-behandlingen blive justeret, dvs. reduceret i passende omfang.
English: Intermittent flow neonatal ventilation may be associated with spikes in nitric oxide concentration.
Danish: Neonatal-ventilation med intermittent flow kan være forbundet med spidser i nitrogenoxid-koncentrationen.
English: Nitrogen dioxide (NO2) is the main substance formed, and may cause airway inflammation and damage.
Danish: NO2 er det vigtigste, dannede stof, og det kan forårsage inflammation og skader i luftvejene.
English: Limay Porcheville 3 avenue Ozanne 78440 Porcheville France
Danish: Limay-Porcheville 3 avenue Ozanne 78440 Porcheville Frankrig
English: Common Uncommon Rare Very rare
Danish: Almindelig Ikke almindelig
English: Pulmonary hypertension associated with heart surgery INOmax should be used only after conservative support has been optimised.
Danish: Pulmonal hypertension i forbindelse med hjerteoperation INOmax bør først anvendes, når den konventionelle behandling er optimeret.
English: These effects in turn lead to improved blood circulation and oxygenation in the pulmonary circulation.
Danish: Disse virkninger resulterer i forbedret blodcirkulation og forbedret iltning i lungekredsløbet.
English: No reproduction toxicity studies have been conducted.
Danish: Der er ikke udført reproduktionstoksicitetsundersøgelser.
English: Animal models have shown that nitric oxide may interact with haemostasis, resulting in an increased bleeding time.
Danish: Dyremodeller har vist, at NO kan interagere med hæmostase, hvilket resulterer i øget blødningstid.
English: The physician should have access at the bedside to a reserve nitric oxide delivery system.
Danish: Lægen skal have adgang til et reserve-nitrogenoxid-tilførselssystem ved sengen.
English: When the gas cylinder is empty, it should not be discarded.
Danish: Gascylinderen må ikke kasseres, når den er tom.
English: PHARMACEUTICAL FORM Inhalation gas.
Danish: Inhalationsgas.
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.
Danish: Hovedpinec Svimmelhedc a: Identificeret i det kliniske forsøg b: Identificeret ved erfaring efter markedsføring c: Identificeret ved erfaring efter markedsføring, og erfaring fra sundhedspersonale i forbindelse med utilsigtet eksponering.
English: Prescription should be limited to those cardio-thoracic units that have received adequate training in the use of a nitric oxide delivery system.
Danish: Ordination skal begrænses til hjerte-thorax-afsnit, der har modtaget tilstrækkelig uddannelse i anvendelsen af et nitrogenoxid-tilførselssystem.
English: Side effects that are very commonly seen (affects more than 1 user in 10) in association with INOmax therapy include:
Danish: Meget almindeligt forekommende bivirkninger (forekommer hos flere end 1 ud af 10 brugere) i forbindelse med behandling med INOmax:
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.
Danish: Det anbefales, at patienter, som skal transporteres til andre afdelinger for supplerende behandling, og som behøver fortsat behandling med nitrogenoxid, sikres kontinuerlig behandling med inhaleret nitrogenoxid under transporten.
English: Marketing Authorisation Holder Linde Healthcare AB SE-181 81 Lidingö Sweden
Danish: Indehaver af markedsføringstilladelsen Linde Healthcare AB SE-181 81 Lidingö
English: Storage in the pharmacy department
Danish: Opbevaring på apotekets lager
English: Method of administration For endotracheopulmonary use.
Danish: Indgivelsesmåde Til endotrakeopulmonal anvendelse.
English: When inhaled, this gas mixture can improve the flow of blood through the lungs, which may help to increase the amount of oxygen that reaches your baby's blood.
Danish: Ved indåndning kan denne gasblanding forbedre blodgennemstrømningen i lungerne, hvilket øger den mængde ilt, der kommer ud i blodet hos barnet.
English: Side effects that are commonly seen (affects more than 1 user in 100) in association with INOmax therapy include:
Danish: Almindelige bivirkninger (forekommer hos flere end 1 ud af 100 brugere) i forbindelse med behandling med INOmax:
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
Danish: Informationsmaterialet skal indeholde oplysninger om følgende centrale punkter: Risikoen for reboundfænomener og forsigtighedsforanstaltninger, der skal tages ved seponering af behandlingen
English: Abrupt discontinuation of the administration of inhaled nitric oxide may cause rebound reaction; decrease in oxygenation and increase in central pressure and subsequent decrease in systemic blood pressure.
Danish: Pludselig seponering af inhaleret nitrogenoxid kan forårsage rebound-fænomener, såsom fald i iltningen og øgning af det centrale tryk og efterfølgende fald i det systemiske blodtryk.
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.
Danish: Under transport, mellem afdelinger eller hospitaler, af patienter, der behandles med INOmax, skal gasflaskerne være fast forankret, så gasflaskerne holdes lodrette og således, at man undgår, at gasflasken falder eller tilførslen utilsigtet ændres.
English: Formation of methaemoglobin
Danish: Dannelse af methæmoglobin
English: INOmax should only be delivered according to an anaesthetist's or intensive care physician's prescription.
Danish: INOmax bør kun indgives på ordination af en anæstesiolog eller speciallæge i intensivbehandling.
English: INOmax should be administered under close monitoring of haemodynamics and oxygenation.
Danish: INOmax skal indgives under nøje monitorering af hæmodynamik og iltning.
English: Nitric oxide chemically reacts with oxygen to form nitrogen dioxide.
Danish: Nitrogenoxid reagerer kemisk med ilt og danner nitrogendioxid.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne er anført i pkt.
English: +47 23177200 healthcare@no.aga.com
Danish: Tlf. +47 23177200 healthcare@no.aga.com
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.
Danish: I det pulmonale system kan nitrogenoxid binde sig til ilt og vand for at danne henholdsvis nitrogendioxid og nitrit, som interagerer med oxyhæmoglobin for at danne methæmoglobin og nitrat.
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.
Danish: Der kan være en additiv effekt af INOmax på risikoen for udvikling af methæmoglobinæmi ved nitrogenoxiddonorstoffer omfattende natriumnitroprussid og glyceryltrinitrat.
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.
Danish: Dosis bør nedsættes trinvis til 1 ppm i 30 minutter samtidig med nøje observation af det systemiske og centrale tryk, hvorefter patienten frakobles.
English: Elevations in methaemoglobinaemia reduce the oxygen delivery capacity of the circulation.
Danish: Forhøjelser i methæmoglobinæmi reducerer kredsløbets iltforsyningskapacitet.
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.
Danish: Ved lav iltmætning kan nitrogenoxid binde sig til deoxyhæmoglobin for forbigående at danne nitrosylhæmoglobin, som omdannes til nitrogenoxider og methæmoglobin ved eksponering til ilt.
English: System organ class
Danish: Organ-klasse Meget almindelig
English: Too much of inhaled nitric oxide may influence the oxygen carrying capacity of the blood.
Danish: For meget inhaleret nitrogenoxid kan påvirke blodets evne til at transportere ilt.
English: Pack sizes:
Danish: Emballagestørrelser:
English: Nitric oxide may react with oxygen forming nitrogen dioxide that may cause airway irritation.
Danish: Nitrogenoxid kan reagere med ilt og danne nitrogendioxid, som kan forårsage luftvejsirritation.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (jf. bilag I: Produktresumé; pkt.
English: Inhaled nitric oxide combination with other vasodilators acting by the cGMP or cAMP systems should be done with caution.
Danish: Der skal udvises forsigtighed ved anvendelse af inhaleret nitrogenoxid i kombination med andre vasodilaterende midler, der virker via cGMP- eller cAMP-systemerne.
English: Effects on platelets
Danish: Virkning på trombocytter
English: 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.
Danish: 5 ppm, indtil der ses en forbedring i oxygenmætningen, således at FiO2 (fraktion af inspireret oxygen) er < 0,60.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Endotracheopulmonary use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Endotrakeopulmonal anvendelse.
English: Thus, the end products of nitric oxide that enter the systemic circulation are predominantly methaemoglobin and nitrate.
Danish: Slutprodukterne af nitrogenoxid, som indgår i det systemiske kredsløb, er således fortrinsvis methæmoglobin og nitrat.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 10 litres gas cylinder
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE 10 L GASFLASKE
English: 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.
Danish: Instruktioner vedrørende anvendelse/håndtering af INOmax Ved tilslutning af en INOmax-gasflaske til tilførselssystemet skal det altid sikres, at flaskekoncentrationen er den samme som den, systemet er konfigureret til.
English: Pulmonary hypertension associated with heart surgery Prescription of nitric oxide should be supervised by a physician experienced in cardiothoracic anaesthesia & intensive care.
Danish: Ordinering af nitrogenoxid skal superviseres af en læge, der har erfaring i kardiotorakal anæstesi og intensivbehandling.
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.
Danish: I CINRGI-forsøget blev 186 fuldbårne eller næsten fuldbårne neonatale med hypoxisk respirationssvigt og uden lunge hypoplasi randomiseret til at modtage enten INOmax (n=97) eller nitrogengas (placebo: n=89) med en initiel koncentration på 20 ppm med fravænning til 5 ppm på 424 timer med gennemsnitlig udsættelsesvarighed på 44 timer.
English: The end medicinal products of nitric oxide that enter the systemic circulation are predominantly methaemoglobin and nitrate.
Danish: De slutprodukter af nitrogenoxid, som indgår i det systemiske kredsløb, er fortrinsvis methæmoglobin og nitrat.
English: In adults undergoing heart surgery, methaemoglobin level should be measured within one hour of the initiation of INOmax therapy.
Danish: Niveauet af methæmoglobin skal måles inden for 1 time efter iværksættelse af INOmax-behandling hos voksne, der gennemgår hjerteoperation.
English: Inhaled nitric oxide may influence the oxygen carrying capacity of the blood.
Danish: Inhaleret nitrogenoxid kan påvirke blodets evne til at transportere ilt.
English: At this level of oxygen saturation, nitric oxide combines predominantly with oxyhaemoglobin to produce methaemoglobin and nitrate.
Danish: På dette iltmætningsniveau binder nitrogenoxid sig fortrinsvis til oxyhæmoglobin for at danne methæmoglobin og nitrat.
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
Danish: Betjening - checkliste før brug (en række trin, der skal gennemføres umiddelbart før den enkelte patient initieres for at sikre, at systemet fungerer korrekt, og at systemet er renset for NO2) - Indstilling af enheden til den korrekte koncentration af nitrogenoxid, der skal indgives - Indstilling af NO, NO2 og O2-monitorer for max.- og min.-alarmgrænser - Anvendelse af det manuelle backup-system - Procedurer for korrekt skift af glasflasker og rensning af systemet - Fejlfindingsalarmer - NO, NO2 og O2-monitorkalibrering
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.
Danish: For patienter, der skal overføres til andet sygehus, skal der sørges for adgang til nitrogenoxid (NO) under transporten for at forebygge en forværring af deres tilstand ved akut seponering af INOmax.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 2 litres gas cylinder
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ INDRE EMBALLAGE 2 L GASFLASKE
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.
Danish: Til behandling af nyfødte spædbørn ≥ 34 gestationsuger med hypoxisk respirationssvigt i forbindelse med kliniske eller ekkokardiografiske holdepunkter for pulmonal hypertension, til forbedring af iltningen og reduktion af behovet for iltning via ekstrakorporal membran.