FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: Hvis den er > 2,5 %, skal dosis af INOmax sættes ned og indgivelse af reducerende lægemidler såsom methylenblåt overvejes.
English: Correct set-up and connections - Connections to the gas cylinder and to the ventilator patient breathing circuit
Danish: Korrekt opstilling og tilslutning - Tilslutning til gasflasken og til ventilatorens patientåndingskredsløb
English: There is in general no need for scavenging of excess gas, the work place ambient air quality should however be considered and trace concentrations of NO or NO2/NOx must not exceed set national occupational exposure limits.
Danish: Kvaliteten af den omgivende luft på arbejdspladsen bør dog tages i betragtning, og sporkoncentrationerne af NO eller NO2/NOx må ikke overstige de fastlagte nationale arbejdsmedicinske eksponeringsgrænser.
English: There are also animal data suggesting an increased susceptibility to airway infections upon exposure to low levels of NO2.
Danish: Der foreligger desuden dyredata, der tyder på en øget tendens til luftvejsinfektion efter eksponering for lave niveauer af NO2.
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.
Danish: Regelmæssig monitorering af hæmostase og måling af blødningstid anbefales ved indgivelse af INOmax i mere end 24 timer til patienter, der har funktionelle eller kvantitative trombocytanomalier, lav koagulationsfaktor, eller som får behandling med antikoagulantia.
English: INOmax should only be delivered according to a neonatologist's prescription.
Danish: INOmax bør kun indgives på ordination af en neonatal-specialist.
English: Inhaled NO has been given for time periods up to 7 days in the peri-operative setting, but common treatment times are 24 -48 hours.
Danish: Inhaleret nitrogenoxid er blevet givet i op til 7 dage efter den perioperative start, men den sædvanlige behandlingsvarighed er 24-48 timer.
English: Monitoring formation of methaemoglobin (MetHb) Neonates and infants are known to have diminished MetHb reductase activity compared to adults.
Danish: Det er kendt, at neonatale og spædbørn har mindsket MetHb-reduktaseaktivitet sammenlignet med voksne.
English: In patients undergoing heart surgery, an increase in pulmonary artery pressure due to pulmonary vasoconstriction is frequently seen.
Danish: Hos patienter, der gennemgår hjertekirurgi, observeres der ofte en stigning i det pulmonale arterielle tryk, der skyldes pulmonal vasokonstriktion.
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.
Danish: I disse tilfælde er den pulmonale, vaskulære modstand (resistance) (PVR) stor, hvilket resulterer i hypoxæmi sekundært til højre/venstre-shuntning af blodet gennem den åbentstående ductus arteriosus og foramen ovale.
English: In clinical studies, NO2 levels > 3 ppm or methaemoglobin levels > 7 % were treated by reducing the dose of, or discontinuing, INOmax.
Danish: I kliniske undersøgelser blev NO2-koncentrationer på > 3 ppm eller methæmoglobin-koncentrationer på > 7 % behandlet ved reduktion af dosis eller seponering af INOmax.
English: 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.
Danish: Hvis oxygenmætningen falder > 20 %, skal INOmax-behandlingen genoptages ved 5 ppm, og seponering af INOmaxbehandlingen skal overvejes igen efter 12-24 timer.
English: Nitrate is cleared from the plasma by the kidney at rates approaching the rate of glomerular filtration.
Danish: Nitrat renses fra plasma ved hjælp af nyrerne ved rater, der nærmer sig raten for glomerulusfiltration.
English: In neonates with PPHN, INOmax can improve oxygenation (as indicated by significant increases in PaO2).
Danish: Hos nyfødte med PPHN forbedrer INOmax iltningen (hvilket viser sig ved signifikant stigning af PaO2).
English: Cylinders equipped with a standard valve hand-wheel cannot be used with the INOmax DSIR delivery system.
Danish: Cylindere udstyret med et håndhjul til standardventil kan ikke anvendes sammen med INOmax DSIRtilførselssystemet.
English: Methaemoglobinaemia that does not resolve after reduction or discontinuation of therapy can be treated with intravenous vitamin C, intravenous methylene blue, or blood transfusion, based upon the clinical situation.
Danish: Methæmoglobinæmi, som ikke svinder efter reduktion eller seponering af behandlingen, kan behandles med intravenøst vitamin C, intravenøst methylenblåt eller blodtransfusion på baggrund af den kliniske situation.
English: MM/YYYY
Danish: MM/ÅÅÅÅ
English: A particular attention should be also turned to the fastening of the pressure regulator so as to avoid the risks of accidental failures.
Danish: Det skal også sikres, at trykregulatoren er korrekt fastgjort, så utilsigtet svigt kan undgås.
English: The other ingredient is nitrogen.
Danish: Øvrige indholdsstoffer: nitrogen.
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.
Danish: Med en neonatalventilator med et kontinuerligt flow opnås dette i reglen ved at infundere en lille mængde INOmax i ventilatorkredsløbets inspirationsgren.
English: All regulations concerning handling of pressure vessels must be followed.
Danish: Alle regulativer vedrørende håndtering af trykbeholdere skal følges.
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.
Danish: INOmax gasflasketrykket skal vises for at muliggøre gasflaskeskift i tide uden utilsigtet tab af behandling, og back-up gascylindre skal være tilgængelige for at sikre udskiftning i tide.
English: Newborn infants, infants and toddlers, children and adolescents, ages 0-17 years The starting dose of inhaled nitric oxide is 10 ppm(part per million) of inhaled gas.
Danish: Spædbørn, småbørn, børn og unge i alderen fra 0-17 år Initialdosis af inhaleret nitrogenoxid er 10 ppm (parts per million) inhaleret gas.
English: Very common
Danish: Meget sjælden
English: The concentrations of methaemoglobin in the blood should be monitored, see section 4.2.
Danish: Koncentrationen af methæmoglobin i blodet skal kontrolleres, se pkt.
English: This will be monitored by blood samples and if required the dose of inhaled nitric oxide must be reduced.
Danish: Dette overvåges ved hjælp af blodprøver, og om nødvendigt skal den inhalerede dosis af nitrogenoxid mindskes.
English: Deterioration in oxygenation and elevation in PAP may also occur in neonates with no apparent response to INOmax.
Danish: Forringelse af iltningen og forhøjelse af PAP kan også forekomme hos nyfødte, der tilsyneladende ikke reagerer på INOmax.
English: In the event of a system failure or a wall-outlet power failure, a backup battery power supply and reserve nitric oxide delivery system should be available.
Danish: I tilfælde af systemsvigt eller svigt i det centrale gastilførselssystem skal der være adgang til en strømforsyning via et backup-batteri og et reserveforsyningssystem med nitrogenoxid.
English: Rebound reaction is the most commonly adverse reaction in association with the clinical use of INOmax.
Danish: Reboundfænomener er den hyppigste bivirkning i forbindelse med klinisk anvendelse af INOmax.
English: From a corrosion point of view the supply system can be divided into two zones: 1) From the gas cylinder valve to the humidifier (dry gas) and 2) From the humidifier to outlet (moist gas which may contain NO2).
Danish: Ud fra et korrosionsmæssigt synspunkt kan tilførselssystemet opdeles i to zoner: 1) Fra gasflaskeventilen til befugteren (tør gas) og 2) Fra befugteren til udgangen (våd gas, som kan indeholde NO2).Test viser, at tørre NO-blandinger kan anvendes sammen med de fleste materialer.
English: Before initiation of therapy, during set-up, secure that the device setting is in agreement with the cylinder gas concentration.
Danish: Før behandling påbegyndes skal det - i forbindelse med opsætningen - kontrolleres, at anordningens indstilling stemmer overens med flaskens gaskoncentration.
English: In biological tissue, nitric oxide may form peroxynitrite with superoxide (O2-), an unstable compound which may cause tissue damage through further redox reactions.
Danish: I biologisk væv kan nitrogenoxid danne peroxydnitrit med superoxid (O2-), en ustabil blanding, der kan forårsage vævsskader gennem yderligere redox-reaktioner.
English: These include prilocaine (a local anaesthetic used for pain relief in association to minor painful procedures e.g. suturing, and minor surgical or diagnostic procedures) or glyceryl trinitrate (used to treat chest pain).
Danish: Sådanne lægemidler kan være prilocain (et middel til lokalbedøvelse, som benyttes som smertestillende middel i forbindelse med mindre smertefulde procedurer som f.eks. syning og mindre kirurgiske eller diagnostiske procedurer) eller glyceryltrinitrat (til behandling af smerter i brystet).
English: OTHER SPECIAL WARNING(S), IF NECESSARY Ensure that the parent or guardian has read and is aware of the indications and cautions presented in the package leaflet prior to administration to their baby.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Kontroller at forældre/værge har læst og forstået indlægssedlen før indgivelse til barnet.
English: The educational pack should contain the following: Summary of Product Characteristics and Patient Information Leaflet for INOmax
Danish: Informationspakken skal indeholde følgende: Produktresume og indlægsseddel for INOmax.
English: as part of the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.
Danish: Som en del af behandlingen af peri- og postoperativ pulmonal hypertension hos voksne og spædbørn, småbørn, børn og unge i alderen fra 0-17 år i forbindelse med hjertekirurgi for at reducere det pulmonale arterielle tryk selektivt og forbedre højre ventrikelfunktion og iltning.
English: Methaemoglobin level should be measured within one hour after initiation of INOmax therapy, using an analyser which can reliably distinguish between foetal haemoglobin and methaemoglobin.
Danish: Methæmoglobin-koncentrationen skal måles inden for 1 time efter iværksættelse af behandling med INOmax ved hjælp af en analysator, der med sikkerhed kan skelne mellem føtal hæmoglobin og methæmoglobin.
English: In clinical trials INOmax has been given in addition to other standard treatment regimes in the peri-operative setting, including inotropic and vasoactive medicinal products.
Danish: I kliniske forsøg er INOmax blevet givet perioperativt i tilskud til andre standardregimener, herunder inotrope og vasoaktive lægemidler.
English: The starting dose of inhaled nitric oxide is 20 ppm (part per million) of inhaled gas.
Danish: Initialdosis af inhaleret nitrogenoxid er 20 ppm (parts per million) inhaleret gas.
English: Pregnancy and breastfeeding
Danish: Graviditet og amning
English: Linde Gas Therapeutics Benelux B.V. De Keten 7
Danish: Linde Gas Therapeutics Benelux B.V.
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.
Danish: Inhaleret nitrogenoxid skal anvendes med forsigtighed til patienter med komplekse hjertedefekter, hvor et højt tryk i lungearterien er vigtigt for opretholdelse af kredsløbet.
English: 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.
Danish: Startende hurtigst muligt og inden for 4-24 timer efter behandling skal dosis gradvist reduceres til 5 ppm, forudsat at den arterielle iltmætning er tilstrækkelig ved denne lavere dosis.
English: The combined used with other vasodilators (e.g. sildenafil) is not extensively studied.
Danish: Anvendelse samtidig med andre vasodilaterende stoffer (fx sildenafil) er ikke undersøgt nærmere.
English: MARKETING AUTHORISATION HOLDER Linde Healthcare AB
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Linde Healthcare AB
English: INOmax cylinders should be stored secured in order to avoid falling and thus potentially causing harm.
Danish: • INOmax-flasker skal opbevares sikkert, så de ikke vælter og evt. forvolder skade.
English: Atelectasis a
Danish: Atelektase a
English: The dose may be increased up to 40 ppm if the lower dose has not provided sufficient clinical effects.
Danish: Dosis kan øges til højst 40 ppm, hvis den lavere dosis ikke har givet tilstrækkelig klinisk effekt.
English: Nitric oxide has an unpaired electron, which makes the molecule reactive.
Danish: Nitrogenoxid har en uparret elektron, hvilket gør molekylet reaktivt.
English: Therapy is usually required for about 4 days in newborn infants with lung failure associated with high blood pressure in the lungs.
Danish: Den krævede behandlingstid er normalt cirka 4 dage hos nyfødte med lungesvigt i forbindelse med højt blodtryk i lungerne.
English: INOmax is available in 2 litre and 10 litre aluminium gas cylinder.
Danish: INOmax fås i 2 liter og 10 liter aluminiumgascylindre.
English: Inhaled nitric oxide has been shown to selectively reduce pulmonary vascular resistance and reduce the increased pulmonary artery pressure.
Danish: Inhaleret nitrogenoxid er vist at reducere den pulmonale vaskulære modstand selektivt og nedsætte det forhøjede pulmonale arterielle tryk.
English: For you or your child's safety, the delivery systems intended for administration of INOmax are fitted with devices that constantly measure the amount of nitric oxide, oxygen and nitrogen dioxide (a chemical formed when nitric oxide and oxygen are mixed) being delivered to the lungs.
Danish: Af hensyn til Deres og Deres barns sikkerhed er indgivelsessystemet til indgift af INOmax udstyret med anordninger, der konstant måler mængden af nitrogenoxid, ilt og nitrogendioxid (en forbindelse, der dannes, når nitrogenoxid og ilt blandes), som indgives til lungerne.
English: During treatment with nitric oxide, the NO2 concentration should be < 0.5 ppm in the nitric oxide dose range < 20 ppm.
Danish: Under behandling med nitrogenoxid skal NO2-koncentrationen være < 0,5 ppm ved et dosisområde for nitrogenoxid på < 20 ppm.
English: In newborn babies with special malformations of the heart, ‘what doctors calls congenital heart defects' inhaled nitric oxide may cause a worsening of the circulation.
Danish: Hos nyfødte med særlige misdannelser i hjertet, i lægesprog ‘medfødte hjertedefekter', kan inhaleret nitrogenoxid forårsage en forværring af blodcirkulationen.
English: All regulations concerning handling of pressurised gas cylinders must be followed.
Danish: Alle bestemmelser vedrørende håndtering af trykgasflasker skal følges.
English: LIST OF EXCIPIENTS Also contains nitrogen.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også nitrogen.
English: Attempts to wean INOmax should be commenced as soon as the haemodynamics have stabilised in conjunction to weaning from ventilator and inotropic support.
Danish: Forsøg på fravænning fra INOmax bør iværksættes, så snart hæmodynamikken er stabiliseret i forbindelse med afvænning fra ventilator og inotrop støtte.
English: The BALLR1 study, also evaluating the effects of iNO in preterm neonates, but initiating iNO at 7 days and in a dose of 20 ppm, found a significant increase in neonates alive without BPD at gestational week 36, 121 (45 % vs. 95 (35.4 %) p<0.028.
Danish: I BALLR1-forsøget, hvor effekterne af iNO til for tidligt fødte børn ligeledes blev undersøgt, men hvor iNO blev iværksat efter 7 dage og i en dosis på 20 ppm, blev der konstateret en signifikant stigning i antal spædbørn, der var i live uden BPD ved gestationsuge 36, 121 (45 % vs. 95 (35,4 %), p<0,028.
English: The primary outcome, of the combined efficacy endpoints of death or BPD at 36 weeks GA, was not significantly different between groups, even with adjustment for gestational age as a covariate (p = 0.40), or with birth weight as a covariate (p = 0.41).
Danish: Det primære udfald - de kombinerede slutpunkter for dødsfald eller BPD (bronchopulmonal dysplasi) ved 36 gestationsuger - adskilte sig ikke signifikant i grupperne, heller ikke med en justering for gestationsalder som kovariat (p=0,40) eller med fødselsvægt som kovariat (p=0,41).
English: newborn babies, babies, children, teenagers 0-17 years and adults with high blood pressure in the lungs, connected with heart surgery.
Danish: - Nyfødte, spædbørn, børn, unge fra 0-17 år og voksne, der har højt blodtryk i lungerne i forbindelse med en hjerteoperation.
English: 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).
Danish: arbejderbeskyttelseslovgivningen er 25 ppm i 8 timer (30 mg/m3) i de fleste lande, og den tilsvarende grænse for NO2 er 2-3 ppm (4-6 mg/m3).
English: Protect the gas cylinders from shocks, falls, oxidising and flammable materials, moisture, sources of heat or ignition.
Danish: Beskyt gasflaskerne mod stød, fald, oxydering og brændbare materialer, varme- eller antændelseskilder og fugt.
English: Accidental exposure to INOmax in hospital staff has been associated with adverse events (see section 4.8).
Danish: Utilsigtet eksponering for INOmax har været forbundet med bivirkninger hos hospitalspersonalet (se pkt.
English: The dose may be increased up to 20 ppm if the lower dose has not provided sufficient clinical effects.
Danish: Dosis kan forhøjes til højst 20 ppm, hvis den lave dosis ikke har givet tilstrækkelig klinisk effekt.
English: NO2 rapidly forms in gas mixtures containing nitric oxide and O2, and nitric oxide may in this way cause airway inflammation and damage.
Danish: NO2 dannes hurtigt i gasblandinger indeholdende nitrogenoxid og O2, og nitrogenoxid kan på denne måde forårsage inflammation og skader i luftvejene.
English: A large portion of nitric oxide for inhalation is absorbed systemically.
Danish: En stor del af det inhalerede nitrogenoxid absorberes systemisk.
English: It, therefore, is recommended that prior to the administration of nitric oxide, pulmonary artery catheterisation or echocardiographic examination of central haemodynamics be performed.
Danish: Det anbefales derfor, at der før indgivelse af nitrogenoxid foretages lungearterie-kateterisation eller ekkokardiografisk undersøgelse af central hæmodynamik.
English: The gas cylinders should be stored in an airy, clean and locked place, for storage of medicinal gas only.
Danish: Gasflaskerne skal opbevares et udluftet, rent og aflåst sted, som udelukkende er beregnet til opbevaring af medicinske gasser.
English: Acute toxicity is related to anoxia resulting from elevated methaemoglobin levels.
Danish: Akut toksicitet er relateret til anoksi, som er en følge af forhøjede methæmoglobinniveauer.
English: The dose of nitric oxide should be reduced if the concentration of nitrogen dioxide exceeds 0.5 ppm.
Danish: Nitrogenoxid-dosis skal reduceres, hvis koncentrationen af NO2 overskrider 0,5 ppm.
English: Description of selected adverse reactions Inhaled nitric oxide therapy may cause an increase in methaemoglobin.
Danish: Beskrivelse af udvalgte bivirkninger Behandling med inhaleret nitrogenoxid kan forårsage forhøjelse i methæmoglobin.
English: The table below presents adverse reactions (ADRs) that have been reported with the use of INOmax from either the CINRGI trial of 212 neonates or post marketing experience in neonates (<1 months of age)).
Danish: Nedenstående tabel viser bivirkninger (ADR'er), der er indberettet efter anvendelse af INOmax fra enten CINRGI-forsøget med 212 nyfødte eller erfaring efter markedsføring ved anvendelse til nyfødte (i alderen <1 måned).
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
Danish: - en gasflaske, hvis ventil ikke er beskyttet af en hætte eller beskyttelse, må ikke anvendes - der skal anvendes en speciel tilslutning med et 30 mm gevind, der er beregnet til medicinsk brug, og som er i overensstemmelse med ISO 5145, samt en trykregulator, der tillader et tryk på mindst svarende til 1,5 gange det maksimale driftstryk (155 bar) på gasflasken - trykregulatoren skal gennemskylles med nitrogen/nitrogenoxid-blandingen før hver ny anvendelse for at udelukke inhalation af NO2 - trykregulatoren må ikke tilspændes med tang - man risikerer at knuse pakningen
English: INOmax is not recommended for use during pregnancy and breastfeeding.
Danish: Det anbefales ikke at bruge INOmax under graviditet og amning.
English: No difference in the incidence of IVH or death was however observed in this study.
Danish: Der blev dog ikke observeret nogen forskel i forekomsten af intraventrikulær blødning eller dødsfald i dette forsøg.
English: In addition, nitric oxide has affinity to metalloproteins and may also react with SH-groups in protein forming nitrosyl compounds.
Danish: Desuden har nitrogenoxid affinitet over for metalproteiner og kan også reagere med sulfydyl-grupper i proteindannende nitrosylforbindelser.
English: Other medicines and INOmax
Danish: Brug af anden medicin sammen med INOmax
English: Inhaled nitric oxide should also be used with caution in patients with compromised left ventricular function and elevated baseline pulmonary capillary pressure (PCWP) as they may be at an increased risk of developing cardiac failure (e.g. pulmonary oedema).
Danish: Inhaleret nitrogenoxid skal også anvendes med forsigtighed til patienter med kompromitteret venstre ventrikelfunktion og forhøjet pulmonalt kapillærtryk (PCWP) ved baseline, da disse patienter kan have øget risiko for at udvikle hjertesvigt (fx lungeødem).
English: If the fraction of methaemoglobin rises to a level that potentially compromises adequate oxygen delivery, the INOmax dose should be decreased and the administration of reducing medicinal products such as methylene blue may be considered.
Danish: Hvis fraktionen af methæmoglobin stiger til et niveau, som potentielt forhindrer tilstrækkelig tilførsel af ilt, skal dosis af INOmax reduceres, og indgivelse af reducerende lægemidler (fx methylenblåt) kan overvejes.
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.
Danish: Inhaleret nitrogenoxid kan i let grad påvirke Deres eller Deres barns blodplader (blodceller, som hjælper blodet med at størkne), og der skal holdes øje med eventuelle tegn på blødning eller blodansamlinger.
English: Weaning from inhaled nitric oxide should be performed with caution.
Danish: Fravænning fra inhaleret nitrogenoxid skal gennemføres med forsigtighed.
English: In clinical trials, no efficacy has been demonstrated with the use of inhaled nitric oxide in patients with congenital diaphragmatic hernia.
Danish: Der er ikke ved kliniske forsøg påvist nogen effektivitet ved anvendelse af inhaleret NO hos patienter med medfødt diafragmahernie.