FrancophonIA/ELRC3.0 huggingface dataset:
English: In children and adults with high blood pressure in the lungs, connected with heart surgery, INOmax is usually given for 24-48 hours.
Danish: Hos børn og voksne med højt blodtryk i lungerne i forbindelse med hjertekirurgi gives INOmax normalt i 24-48 timer.
English: INOmax should be used in ventilated newborn infants expected to require support >24 hours.
Danish: INOmax bør anvendes hos ventilerede nyfødte spædbørn, der forventes af kræve støtte i >24 timer.
English: In clinical studies treatment was often initiated before separation from Cardio Pulmonary Bypass.
Danish: I kliniske forsøg blev behandlingen ofte iværksat inden separation fra kardiopulmonal bypass.
English: INOmax therapy must be available for manual ventilation such as suctioning, patient transport, and resuscitation.
Danish: INOmaxbehandlingen skal være tilgængelig ved manuel ventilation, så som sug, patient-transport og genoplivning.
English: Your doctor will decide how long you or your child should be treated with INOmax.
Danish: Deres læge vil bestemme, hvor længe De eller Deres barn skal behandles med INOmax
English: Significantly fewer neonates in the INOmax group required ECMO compared to the control group (31 % vs. 57 %, p<0.001).
Danish: Signifikant færre neonatale i INOmax-gruppen havde behov for ECMO sammenlignet med kontrolgruppen (31 % kontra 57 %, p<0,001).
English: BRAILLE Justification for not including Braille accepted
Danish: INFORMATION I BRAILLE-SKRIFT Begrundelse for ikke at anvende Braille-skrift er accepteret.
English: INOmax has been safely administered with tolazoline, dopamine, dobutamine, steroids, surfactant, and high-frequency ventilation.
Danish: INOmax er blevet indgivet sammen med tolazolin, dopamin, dobutamin, steroider, surfaktant og højfrekvent ventilation.
English: For patient safety, appropriate alarms must be set for INOmax (± 2 ppm of the prescribed dose), NO2 (1 ppm), and FiO2 (± 0.05).
Danish: Af hensyn til patientens sikkerhed skal egnede alarmer være indstillet til INOmax (± 2 ppm af den ordinerede dosis), NO2 (1 ppm) og FiO2 (± 0,05).
English: The potential risk of bleeding and haemostasis disorders The potential risks if used in combination with other vasodilators which act on cGMP or cAMP
Danish: Den potentielle risiko for blødning og hæmostaseforstyrrelser De potentielle risici ved anvendelse samtidig med andre vasodilatatorer der virker på cGMP eller cAMP
English: The installation of a nitric oxide pipeline system with supply station of gas cylinders, fixed network and terminal units is forbidden.
Danish: Installation af et nitrogenoxid-rørsystem med forsyningsstationer for gasflasker, fast kredsløb og terminalenheder er forbudt.
English: Special patient populations
Danish: Særlige patientpopulationer
English: Neonates with less than a full response at 20 ppm were evaluated for a response to 80 ppm nitric oxide or control gas.
Danish: Neonatale med mindre end komplet respons ved 20 ppm blev evalueret for respons på 80 ppm nitrogenoxid eller kontrolgas.
English: Empty gas cylinders will be collected by the supplier.
Danish: Tomme gascylindere indsamles af leverandøren.
English: Attempts to wean INOmax should be made after the ventilator support is substantially decreased or after 96 hours of therapy.
Danish: Forsøg på afvænning fra INOmax skal foretages efter, at ventilationsstøtten er betydeligt reduceret eller efter 96 timers behandling.
English: At the end of treatment, the doctor will slowly lower the amount of INOmax being given to you or your child, so that the circulation in the lungs is able to adjust to oxygen/air without INOmax.
Danish: I slutningen af behandlingen vil lægen langsomt nedsætte den mængde INOmax, der gives til Dem eller Deres barn, så cirkulationen i lungerne er i stand til at tilpasse sig oxygen/luft uden INOmax.
English: This includes optimising tidal volume/pressures and lung recruitment (surfactant, high frequency ventilation, and positive end expiratory pressure).
Danish: Dette omfatter optimering af tidalvolumen/tryk og lungetilgang (surfaktant, højfrekvent ventilation og positivt sluteksspirationstryk).
English: Data further suggested a lack of additional benefit for the higher dose of nitric oxide.
Danish: Data tydede endvidere på, at der ikke var yderligere fordel ved den høje nitrogenoxid-dosis.
English: The inspired INOmax concentration must be measured continuously in the inspiratory limb of the circuit near the patient.
Danish: Den inspirerede INOmax-koncentration skal måles kontinuert i kredsløbets inspirationsgren nær patienten.
English: Methaemoglobin concentrations increase during the first 8 hours of nitric oxide exposure.
Danish: Methæmoglobinkoncentrationerne stiger i løbet af de første 8 timers nitrogenoxideksponering.
English: The Marketing Authorisation Holder (MAH) should ensure that, at launch of the new indication, all Healthcare Professionals who are expected to use and/or prescribe INOmax as part of the treatment of peri- or post- operative pulmonary hypertension in adults and children in conjunction to heart surgery are provided with an Educational pack.
Danish: Indehaveren af markedsføringstilladelsen skal ved lanceringen af den nye indikation sikre, at alt sundhedspersonale, som forventes at bruge og/eller ordinere INOmax som led i behandlingen af perieller postoperativ pulmonal hypertension hos voksne eller børn i forbindelse med hjertekirurgi, modtager en informationspakke.
English: Tell your doctor before treatment with INOmax if you are pregnant, think you could be pregnant or are breastfeeding
Danish: Fortæl lægen, før De får INOmax, hvis De er gravid eller måske er gravid, eller hvis De ammer.
English: The doctor will decide when to treat you or your child with INOmax and with other medicines, and will carefully supervise the treatment.
Danish: Lægen vil afgøre, hvornår De eller Deres barn skal behandles med INOmax og med andre lægemidler og vil omhyggeligt overvåge behandlingen.
English: Manufacturer Linde France Z.I.
Danish: Linde France Z.I.
English: The safety and efficacy of INOmax in premature infants less than 34 weeks of gestation has not yet been established.
Danish: INOmax' sikkerhed og virkning hos præmature spædbørn under 34 uger er endnu ikke klarlagt.
English: When the decision is made to discontinue inhaled nitric oxide therapy, the dose should be reduced to 1 ppm for 30 minutes to one hour.
Danish: Når der træffes beslutning om at ophøre med inhalationsbehandling med nitrogenoxid, skal dosen reduceres til 1 ppm i 30 minutter til en time.
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.
Danish: Fortæl altid lægen, hvis De (som patient) eller Deres barn (som patient) bruger anden medicin eller har brugt det for nylig.
English: Treatment may be initiated at any time point in the peri-operative course to lower pulmonary pressure.
Danish: Behandlingen kan initieres når som helst i det perioperative forløb med henblik på at sænke det pulmonale tryk.
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.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med INOmax hos alle undergrupper af den pædiatriske population ved persisterende pulmonal hypertension og andre pulmonale hjertesygdomme (se pkt.
English: The combined incidence of death and/or initiation of ECMO (the prospectively defined primary endpoint) showed a significant advantage for the nitric oxide treated group (46 % vs. 64 %, p=0.006).
Danish: Den kombinerede forekomst af død og/eller initiering af EMCO (det prospektivt definerede primære slutpunkt) viste en signifikant fordel for gruppen behandlet med nitrogenoxid (46 % kontra 64 %, p=0,006).
English: If you or your child receive more INOmax than you should
Danish: Hvis De eller Deres barn får for meget INOmax
English: You should directly inform the personnel if you experience headache while being in close proximity to your child receiving INOmax.
Danish: Kontakt straks personalet, hvis De får hovedpine, mens De befinder Dem i nærheden af Deres barn, som får INOmax.
English: Overdose with INOmax will be manifest by elevations in methaemoglobin and NO2.
Danish: Overdosering med INOmax vil manifestere sig ved forhøjelser i methæmoglobin og NO2.
English: If at any time the NO2 concentration exceeds 1 ppm, the nitric oxide dose should immediately be reduced.
Danish: Hvis NO2-koncentrationen på noget tidspunkt overstiger 1 ppm, skal dosis af nitrogenoxid omgående reduceres.
English: Most of it traverses the pulmonary capillary bed where it combines with haemoglobin that is 60 % to 100 % oxygen-saturated.
Danish: Det meste krydser den pulmonale kapillærbane, hvor det binder sig til hæmoglobin, som er 60 % til 100 % iltmættet.
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).
Danish: INOmax bør ikke seponeres pludseligt, da dette kan medføre forhøjelse af det pulmonale arterielle tryk (PAP) og/eller forværring af iltningen af blodet (PaO2).
English: The INOmax group had significantly improved oxygenation as measured by PaO2, OI, and alveolar-arterial gradient (p<0.001 for all parameters).
Danish: INOmax-gruppen havde signifikant forbedret iltning målt efter PaO2, OI og alveolær-arteriel gradient (p<0,001) for alle parametre).
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TILSIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Hypoxia b,d
Danish: ,b,d
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Prior to launch of the new indication of the product in each Member State, the Marketing Authorisation Holder shall agree the content and format of the educational material with the national competent authority.
Danish: • Yderligere risikominimeringsforanstaltninger Før lancering af produktets nye indikation i medlemslandet skal indehaveren af markedsføringstilladelsen aftale indhold og udformning af informationsmaterialet med den relevante nationale myndighed.
English: In the presence of oxygen NO rapidly forms NO2, see section 4.5.
Danish: I nærværelse af oxygen danner NO hurtigt NO2, se afsnit 4.5.
English: The clinical significance of the chemical reactivity of nitric oxide in tissue is unknown.
Danish: Den kliniske betydning af nitrogenoxids kemiske reaktivitet i væv er ikke kendt.
English: The INOT25 trial, studying the effects of iNO in hypoxic preterm neonates, did not show improvement in alive without BPD.
Danish: INOT25forsøget med undersøgelse af effekterne af iNO til hypoxiske for tidligt fødte børn viste ingen forbedring hos spædbørn, der var i live uden BPD.
English: The gas cylinders should be transported with appropriate material in order to protect them from risks of shocks and falls.
Danish: Gasflaskerne skal transporteres med passende udstyr for at beskytte dem mod risici for stød og fald.
English: The pharmacokinetics of nitric oxide has been studied in adults.
Danish: Nitrogenoxids farmakokinetik er blevet undersøgt hos voksne.
English: Your doctor will decide the correct dose of INOmax and will administer INOmax to you or your child's lungs through a system designed for delivering this gas.
Danish: Deres læge vil bestemme den korrekte dosis af INOmax, der skal gives til Dem eller Deres barn, og vil indgive INOmax til Deres eller Deres barns lunger gennem et system, der er beregnet til indgivelse af denne gas.
English: Treatment with inhaled nitric oxide might aggravate cardiac insufficiency in a situation with left-toright shunting.
Danish: Behandling med inhaleret nitrogenoxid kan forværre kardiel insufficiens i en situation med venstre/højre-shuntning.
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.
Danish: De gennemsnitlige methæmoglobinkoncentrationer forblev under 1 % i placebogruppen og i grupperne med 5 ppm og 20 ppm INOmax, men nåede ca. 5 % i gruppen med 80 ppm INOmax.
English: In the pivotal clinical trials, the starting dose was 20 ppm.
Danish: Ved de centrale kliniske forsøg var startdosis 20 ppm.
English: What INOmax contains
Danish: INOmax indeholder
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.
Danish: Data hos voksne mennesker er modstridende, og der har ikke været nogen stigning i blødningskomplikationer i randomiserede, kontrollerede undersøgelser hos fuldbårne og næsten fuldbårne nyfødte med hypoxisk respirationssvigt.
English: Studies show that nitric oxide exhibits pulmonary pharmacodynamic effects at intra-airway concentrations as low as 1 ppm.
Danish: Undersøgelser har vist, at nitrogenoxid udviser pulmonale farmokodynamiske virkninger ved intra-luftvejskoncentrationer på helt ned til 1 ppm.
English: If there is an unexpected change in INOmax concentration, the delivery system should be assessed for malfunction and the analyser should be recalibrated.
Danish: Hvis der sker en uventet ændring af INOmax-koncentrationen, skal tilførselssystemet vurderes for fejlfunktion, og analysatoren skal rekalibreres.
English: Treatment can be maintained up to 96 hours or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from INOmax therapy.
Danish: Behandlingen kan opretholdes i op til 96 timer eller indtil den underliggende manglende iltmætning er svundet, og den nyfødte er klar til at blive vænnet fra INOmax-behandlingen.
English: Low blood pressure or a rebound increase in pressure in the lungs has been known to occur if treatment with INOmax is stopped suddenly without first lowering the dose.
Danish: Det er tidligere set, at der er opstået lavt blodtryk eller en tilbagevendende stigning i trykket i lungerne, hvis behandlingen med INOmax ophører pludseligt, uden at dosis først nedsættes.
English: Storage in the medical department
Danish: Opbevaring i den medicinske afdeling
English: Polytrifluorochloroethylene, hexafluoropropene-vinyliden copolymer and polytetraflourethylene have been used extensively with pure nitric oxide and other corrosive gases.
Danish: Polytrifluorchlorethylen, hexafluorpropen-vinyliden-copolymer og polytetrafluorethylen har været anvendt i stor udstrækning sammen med ren nitrogenoxid og andre korroderende gasser.
English: Nitric oxide is absorbed systemically after inhalation.
Danish: Nitrogenoxid absorberes systemisk efter inhalation.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: In cases of failure to respond to inhaled nitric oxide, see section 4.4.
Danish: Dersom barnet ikke reagerer på den inhalerede nitrogenoxid, se afsnit 4.4.
English: The overall occurrence of intraventricular haemorrhage was 114 (28.9 %) among the iNO treated as compared to 91 (22.9 %) among the control neonates.
Danish: Den samlede forekomst af intraventrikulær blødning var 114 (28,9 %) hos de iNO-behandlede sammenlignet med 91 (22,9 %) hos nyfødte i kontrolgruppen.
English: Nitrate has been identified as the predominant nitric oxide metabolite excreted in the urine, accounting for > 70 % of the nitric oxide dose inhaled.
Danish: Nitrat blev bestemt som den vigtigste nitrogenoxid-metabolit, der blev udskilt i urinen, idet den tegnede sig for > 70 % af den inhalerede dosis nitrogenoxid.
English: The delivery system must provide a constant inhaled INOmax concentration irrespective of the ventilator.
Danish: Tilførselssystemet skal give en konstant inhaleret INOmax-koncentration uafhængigt af ventilatoren.
English: All equipment, including connectors, tubing, and circuits, used in the delivery of nitric oxide must be made of materials compatible with the gas.
Danish: Alt udstyr, inklusive samlinger, slanger og kredsløb, der anvendes til indgivelse af nitrogenoxid, skal være fremstillet af materialer, der er kompatible med gassen.
English: What you need to know before you begin a treatment with INOmax
Danish: Det skal De vide, før De begynder behandling med INOmax
English: Neonates known to be dependent on right-to-left, or significant left-to-right, shunting of blood.
Danish: Nyfødte vides at være afhængige af højre/venstre-shuntning eller betydelig venstre/højre-shuntning af blodet.
English: Available data suggest additive effects on central circulation, pulmonary artery pressure and right ventricular performance.
Danish: De tilgængelige data tyder på en additiv virkning på det centrale kredsløb, det pulmonale arterielle tryk og højre ventrikelfunktion.
English: - the good condition of the material should be checked before use - the gas cylinders should be fixedly stowed away in order to avoid untimely fall - the valve should be fully open when used but not be opened with violence - a defective valve should neither be used nor be repaired.
Danish: - inden brug skal det nøje kontrolleres, at alt materiel er i god stand - gasflaskerne skal stuves ad vejen i fastgjort stand for at undgå utilsigtet fald - ventilen skal være helt åben under anvendelse men må ikke forceres åben - en defekt ventil må ikke anvendes eller repareres.
English: INOmax appears to increase the partial pressure of arterial oxygen (PaO2) by dilating pulmonary vessels in better ventilated areas of the lung, redistributing pulmonary blood flow away from lung regions with low ventilation/perfusion (V/Q) ratios toward regions with normal ratios.
Danish: INOmax synes at øge det partielle, arterielle ilttryk (PaO2) ved at dilatere pulmonale kar i bedre ventilerede områder af lungerne, og derved flytte det pulmonale blodflow bort fra lungeregioner med lave ventilations-/perfusions-ratioer (V/Q-ratioer) mod områder med normale ratioer.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01/08/2001
Danish: Dato for første tilladelse: 01/08/2001 Fornyelse af tilladelsen: 01/06/2006
English: It relaxes vascular smooth muscle by binding to the haeme moiety of cytosolic guanylate cyclase, activating guanylate cyclase and increasing intracellular levels of cyclic guanosine 3',5'-monophosphate, which then leads to vasodilation.
Danish: Det afslapper den glatte muskulatur i karrene ved at binde sig til hæm-delen af cytosolguanylatcyclase, idet det aktiverer guanylatcyclase og forøger de intracellulære koncentrationer af cyklisk guanosin 3',5'-monophosphat, som så medfører vasodilatation.
English: The average time to reach peak methaemoglobin was 10 ± 9 (SD) hours (median, 8 hours) in these 13 patients; but one patient did not exceed 7 % until 40 hours.
Danish: Den gennemsnitlige tid til at opnå maksimale koncentrationer af methæmoglobin var 10 ± 9 (SD) timer (median 8 timer) hos disse 13 patienter; men 1 patient overskred ikke 7 % før efter 40 timer.
English: If there is no change in oxygenation during administration of INOmax at 1 ppm, the FiO2 should be increased by 10 %, the INOmax is discontinued, and the neonates monitored closely for signs of hypoxaemia.
Danish: Hvis der ikke forekommer nogen ændring i oxygenmætningen under indgivelse af INOmax ved 1 ppm, skal FiO2 øges med 10 %, INOmax seponeres, og den nyfødte monitoreres nøje for tegn på hypoxæmi.
English: INOmax should not be used during pregnancy or breastfeeding.
Danish: INOmax bør ikke anvendes under graviditet eller amning.
English: Persistent pulmonary hypertension of the newborn (PPHN) occurs as a primary developmental defect or as a condition secondary to other diseases such as meconium aspiration syndrome (MAS), pneumonia, sepsis, hyaline membrane disease, congenital diaphragmatic hernia (CDH), and pulmonary hypoplasia.
Danish: Persisterende, pulmonal hypertension hos nyfødte (PPHN) optræder som en primær udviklingsdefekt eller som en tilstand sekundær til andre sygdomme så som mekonium-aspirationssyndrom (MAS), pneumoni, sepsis, hyalinmembran-sygdom, medfødt diafragmahernie (congenital diaphragmatic hernia (CDH)) og pulmonal hypoplasi.
English: However, the presence of nitrogen dioxide and moisture creates an aggressive atmosphere.
Danish: Derimod danner tilstedeværelse af nitrogendioxid og fugt en aggressiv atmosfære.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Linde Healthcare AB
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Linde Healthcare AB
English: This is due to unwanted pulmonary vasodilation caused by inhaled nitric oxide, resulting in a further increase of already existing pulmonary hyperperfusion thus potentially giving raise to forward or backward failure.
Danish: Dette skyldes uønsket, pulmonal vasodilatation forårsaget af inhaleret nitrogenoxid, hvilket resulterer i yderligere øgning af allerede eksisterende pulmonal hyperperfusion, der således potentielt kan forårsage fremadrettet eller bagudrettet svigt.
English: INOmax should be used and administered only by personnel specially trained in the use and handling of INOmax.
Danish: • INOmax må kun administreres af personale, der er specielt trænet i brug og håndtering af INOmax.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: INOmax should be used only after respiratory support has been optimised.
Danish: INOmax bør kun anvendes efter, at respirationsstøtten er optimeret.
English: Side effects that may be seen but the frequency is not known (frequency cannot be estimated from the available data) are: Bradycardia (low cardiac frequency) or too low amount of oxygen in the blood (oxygen desaturation/hypoxemia) due to sudden withdrawal of the treatment
Danish: Bivirkninger med ukendt hyppighed (hyppigheden kan ikke vurderes ud fra de tilgængelige data): Lav hjertefrekvens (bradykardi) eller for lav iltmængde i blodet (lav iltmætning/hypoxæmi) som følge af pludseligt behandlingsstop.
English: The effects of inhaled nitric oxide are rapid, decrease in pulmonary artery pressure and improved oxygenation is seen within 5-20 minutes.
Danish: Virkningerne af inhaleret nitrogenoxid indtræder hurtigt; fald i det pulmonale arterielle tryk og forbedret iltning ses inden for 5-20 minutter.
English: Nitric oxide is delivered to the patient via mechanical ventilation after dilution with an oxygen/air mixture using an approved (CE-marked) nitric oxide delivery system.
Danish: Nitrogenoxid gives til patienten via mekanisk ventilation efter fortynding med en ilt/luftblanding ved hjælp af et godkendt (CE-mærket) nitrogenoxid-tilførselsssystem.
English: If the NO2 is > 0.5 ppm, the delivery system should be assessed for malfunction, the NO2 analyser should be recalibrated, and the INOmax and/or FiO2 should be reduced if possible.
Danish: Hvis NO2 er > 0,5 ppm, skal tilførselssystemet vurderes for fejlfunktion, NO2-analysatoren skal rekalibreres og INOmax og/eller FiO2 skal om muligt reduceres .
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.
Danish: Dette indgivelsessystem vil sikre, at der gives den korrekte mængde nitrogenoxid ved at fortynde INOmax med en ilt-/luftblanding umiddelbart inden indgivelse.