FrancophonIA/ELRC3.0 huggingface dataset:
English: Results of in vitro studies reveal that CYP 450-dependent metabolism plays only a minor role in the biotransformation of iloprost.
Danish: Resultater af in vitro-studier afslørede, at CYP 450-afhængig metabolisme kun spiller en mindre rolle i biotransformationen af iloprost.
English: An accumulation of iloprost following treatment over several days is not likely due to the overnight break in administration of the medicinal product.
Danish: Akkumulering af iloprost efter flere dages behandling er ikke sandsynlig, da lægemidlet ikke administreres om natten.
English: • talk to your doctor
Danish: Tale med din læge
English: Follow carefully the instructions that come with the nebuliser especially the instructions on hygiene and cleaning of the nebuliser.
Danish: Følg omhyggeligt de instruktioner, der følger med nebulisatoren, især instruktionerne vedrørende hygiejne og rengøring af nebulisatoren.
English: Efficacy in adult patients with pulmonary hypertension
Danish: Effekt hos voksne patienter med pulmonal hypertension
English: A subgroup analysis showed that no treatment effect was observed as compared to placebo on the 6-minute walk test in the subgroup of patients with secondary pulmonary hypertension.
Danish: En analyse af undergruppen vist, at der ikke blev observeret nogen effekt sammenlignet med placebo ved den 6 minutters gangtest i undergruppen af patienter med sekundær pulmonal hypertension.
English: The most frequently observed adverse reactions (≥ 20 %) in clinical trials include vasodilatation (including hypotension), headache and cough.
Danish: De hyppigste bivirkninger (≥20 %), der er set i kliniske forsøg, omfatter vasodilatation (herunder hypotension), hovedpine og hoste.
English: You should administer the dose 6 to 9 times per day according to individual needs and tolerability.
Danish: Du bør administrere dosen 6 til 9 gange dagligt, i henhold til det individuelle behov og tolerabiliteten.
English: Stop using Ventavis and tell your doctor immediately.
Danish: Hold op med at tage Ventavis og kontakt straks din læge.
English: Patients with concomitant acute pulmonary infections, COPD and severe asthma should be carefully monitored.
Danish: Patienter med samtidige akutte pulmonale infektioner, KOL og svær astma bør overvåges omhyggeligt.
English: In rats, passage of low levels of iloprost and/or metabolites into the milk was observed (less than 1% of iloprost dose given intravenously).
Danish: Hos rotter blev der observeret udskillelse af lave niveauer af iloprost og/eller metabolitter i mælken (mindre end 1 % af iloprost-dosen givet intravenøst).
English: Ventavis is used to treat moderate cases of primary pulmonary hypertension (PPH) in adult patients.
Danish: Ventavis anvendes til at behandle moderate tilfælde af primær pulmonal hypertension (PPH) hos voksne patienter.
English: Improved blood flow leads to a better supply of oxygen to the body and reduced strain on the heart.
Danish: En forbedret blodgennemstrømning medfører en bedre ilttilførsel til kroppen og en nedsat belastning af hjertet.
English: Fill the medication chamber with Ventavis immediately before use.
Danish: Fyld medicineringskammeret med Ventavis umiddelbart før brug.
English: • Do NOT let Ventavis solution come into contact with your skin or eyes.
Danish: • Lad IKKE Ventavis-opløsningen komme i kontakt med din hud eller dine øjne.
English: The pulmonary vasodilatory effect of each single inhalation levels off within one to two hours.
Danish: Den pulmonale vasodilatoriske virkning af hver enkelt inhalation finder sit niveau inden for én til to timer.
English: In an intravenous study, results were obtained involving 8 patients suffering from liver cirrhosis.
Danish: I et studie, hvor der blev anvendt intravenøs infusion, blev der opnået resultater, der involverede 8 patienter, der led af levercirrose.
English: In addition, instructions for hygiene and cleaning of the nebulisers provided by the device manufacturers should be followed carefully.
Danish: Desuden skal de anvisninger omkring hygiejne og rengøring af nebulisatorerne, der følger med fra fabrikanterne af udstyret, følges omhyggeligt.
English: Animal studies have shown reproductive effects (see section 5.3).
Danish: Dyrestudier har påvist reproduktionspåvirkning (se pkt.
English: No data from controlled clinical trials are available.
Danish: Der foreligger ingen data fra kontrollerede studier.
English: The adverse reactions reported below are based on pooled clinical trial data from phase II and III clinical trials involving 131 patients taking the medicinal product and on data from post-marketing surveillance.
Danish: Bivirkningerne nedenfor er baseret på de samlede data fra fase II og III kliniske studier med 131 patienter, som tog lægemidlet, og på data fra overvågningen efter markedsføringen.
English: Total plasma protein binding of iloprost is concentration-independent in the range of 30 to 3,000 picogram/ml and amounts to approximately 60%, of which 75% is due to albumin binding.
Danish: Den totale plasmaproteinbinding af iloprost er uafhængig af koncentrationen i området 30 til 3.000 pikogram/ml og er cirka 60 %, af hvilke 75 % skyldes albuminbinding.
English: The duration of an inhalation session with Breelib nebuliser is approximately 3 minutes, which reflects the higher delivery rate of the Breelib compared to other nebulisers.
Danish: Varigheden af en inhalationsbehandling med Breelib-nebulisatoren er ca. 3 minutter, hvilket afspejler den højere tilførselshastighed fra Breelib sammenlignet med andre nebulisatorer.
English: No tumourigenic potential of iloprost was observed in tumourigenicity studies in rats and mice.
Danish: Der blev ikke set noget tumorigent potentiale af iloprost i tumorigenicitetsstudier hos rotter og mus.
English: If you tend to faint as soon as you get out of bed, it may be helpful to take your first dose of the day while you are still lying down.
Danish: - Hvis du har tendens til at besvime, så snart du står ud af sengen, kan det hjælpe, hvis du tager dagens første dosis, mens du stadig ligger ned.
English: Undesirable exposure to Ventavis
Danish: Uønsket udsættelse for Ventavis
English: Your doctor may change the dosage.
Danish: Din læge vil måske ændre dosis.
English: Suitable inhalation device (nebuliser) to be used
Danish: Egnet inhalationssystem (nebulisator), der skal anvendes
English: The increased occurrence of syncope can reflect therapeutic gaps, insufficient effectiveness and/or deterioration of the disease.
Danish: Den øgede forekomst af synkope kan afspejle terapeutiske huller, utilstrækkelig virkning og/eller forværring af sygdommen.
English: Serum glucose levels
Danish: Serumglukose-niveauer
English: Very low levels of iloprost into milk were observed in rats (see section 5.3).
Danish: Der blev set meget lave niveauer af iloprost i mælken hos rotter (se pkt.
English: Not known (cannot be estimated from the available data):
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data):
English: They should both have the same colour, either red for the 2.5 microgram dose or purple for the 5 microgram dose.
Danish: De skal begge have den samme farve, enten rød for 2,5 mikrogram-dosis, eller lilla for 5 mikrogram-dosis.
English: In clinical trials peripheral oedema was reported in 12.2% of patients on iloprost and 16.2% of patients on placebo.
Danish: I kliniske forsøg sås perifert ødem hos 12,2 % af patienterne på iloprost og 16,2 % af patienter på placebo.
English: Food or drink is not expected to affect Ventavis.
Danish: Mad og drikke forventes ikke at påvirke Ventavis.
English: It is not known whether iloprost/metabolites are excreted in human breast milk.
Danish: Det er ukendt, om iloprost/metabolitter udskilles i human mælk.
English: The pulmonary vasodilatory effect of inhaled iloprost is of short duration (one to two hours).
Danish: Den pulmonale vasodilatoriske effekt af inhaleret iloprost er kortvarig (én til to timer).
English: For each medication chamber there is a corresponding colour coded control disc:
Danish: For hvert medicineringskammer er der en tilsvarende farvekodet kontroldisk:
English: Tell your doctor if you have a lung infection, severe asthma, or chronic lung disease (chronic obstructive pulmonary disease).
Danish: Fortæl lægen, hvis du har en lungeinfektion, alvorlig astma eller en kronisk lungesygdom (kronisk obstruktiv lungesygdom).
English: If a pregnancy occurs, taking into account the potential maternal benefit, the use of Ventavis during pregnancy may be considered, only following careful benefit-risk evaluation, in those women who choose to continue their pregnancy, despite the known risks of pulmonary hypertension during pregnancy.
Danish: Hvis en graviditet forekommer, kan behandling med Ventavis under graviditet overvejes, under hensyntagen til den potentielle fordel for moderen og kun efter omhyggelig vurdering af risk/benefit-forholdet, til de kvinder, der vælger at fortsætte graviditeten på trods af de kendte risici, som pulmonal hypertension har under graviditet.
English: Blood pressure should be checked while initiating Ventavis.
Danish: Blodtrykket skal kontrolleres, når Ventavis-behandlingen påbegyndes.
English: Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease.
Danish: Pulmonale vasodilatorer kan i betydelig grad forværre den kardiovaskulære status hos patienter med pulmonal veno-okkulusiv sygdom.
English: Following intravenous infusion, the apparent steady-state volume of distribution was 0.6 to 0.8 l/kg in healthy subjects.
Danish: Efter intravenøs infusion var det tilsyneladende steady state fordelingsvolumen 0,6 til 0,8 l/kg hos sunde forsøgspersoner.
English: Ventavis contains ethanol
Danish: Ventavis indeholder ethanol
English: The efficacy and tolerability of inhaled iloprost when administered with other nebulising systems, which provide different nebulisation characteristics of iloprost solution, have not been established.
Danish: Effekten af og tolerabiliteten over for inhaleret iloprost, når den administreres med andre nebulisatorsystemer, som giver andre forstøvningskarakteristika af iloprost-opløsningen, er ikke klarlagt.
English: Considering the high pharmacological potency of iloprost and the absolute doses required for therapeutic purposes the results obtained in acute toxicity studies do not indicate a risk of acute adverse effects in humans.
Danish: Når den høje farmakologiske potens af iloprost og de absolutte doser, som terapeutiske formål kræver, tages i betragtning, indikerer resultaterne fra studierne omhandlende akut toksicitet ikke en risiko for akutte bivirkninger hos mennesker.
English: • Do NOT drink or swallow Ventavis solution.
Danish: • Du må IKKE drikke eller synke Ventavis-opløsningen.
English: Ventavis is used to improve exercise capacity (the ability to carry out physical activity) and symptoms.
Danish: Ventavis anvendes til at forbedre arbejdsevnen (evnen til at udføre fysisk aktivitet) og mindske sygdomssymptomerne.
English: Iloprost, the active substance of Ventavis, is a synthetic prostacyclin analogue.
Danish: Iloprost, det aktive stof i Ventavis, er en syntetisk prostacyclin-analog.
English: Venta-Neb prompts the patient to inhale by an optical and an acoustic signal.
Danish: Venta-Neb giver patienten besked på at inhalere ved hjælp af et visuelt og akustisk signal.
English: Control disc
Danish: Kontroldisk
English: The acute adverse effects in patients receiving concomitant bosentan and iloprost were consistent with those observed in the larger experience of the phase 3 study in patients receiving only iloprost.
Danish: De akutte bivirkninger hos patienter, som samtidig fik bosentan og iloprost, svarede til de bivirkninger, der blev set i det mere omfattende fase 3-studie med patienter, der kun fik iloprost.
English: In patients with low systemic blood pressure and in patients with postural hypotension or receiving medicinal products known to reduce blood pressure levels, care should be taken to avoid further hypotension.
Danish: Hos patienter med lavt systemisk blodtryk eller postural hypotension, eller som får lægemidler, der er kendt for at sænke blodtrykket, skal der udvises forsigtighed for at undgå yderligere hypotension.
English: The pharmacological effects after inhalation of Ventavis are:
Danish: De farmakologiske virkninger efter inhalation af Ventavis er:
English: The active substance of Ventavis is iloprost.
Danish: Det aktive stof i Ventavis er iloprost.
English: The adverse reactions identified only during post-marketing surveillance, and for which a frequency could not be estimated from clinical trial data, are listed under "Frequency not known".
Danish: De bivirkninger, der er set efter markedsføringen, og hvor hyppigheden ikke har kunnet fastslås ud fra data fra de kliniske studier, er anført under "Hyppighed ikke kendt".
English: Your doctor will adjust Venta-Neb to the programme you need to receive the dose prescribed for you.
Danish: Lægen vil justere Venta-Neb til det program, du skal tage for at få den ordinerede dosis.
English: • if your pulmonary hypertension is due to a blocked or narrowed vein (venous occlusive disease).
Danish: • hvis din pulmonale hypertension skyldes en blokeret eller forsnævret vene (venøs okklusiv sygdom).
English: In comparable embryotoxicity studies in rabbits and monkeys no such digit anomalies or other gross-structural anomalies were observed even after considerably higher dose levels which exceeded the human dose multiple times.
Danish: I lignende embryotoksicitetsstudier hos kaniner og aber blev der ikke observeret sådanne anomalier i digiti eller andre større strukturelle abnormiteter, heller ikke efter betydeligt højere doser, som oversteg dosis til mennesker flere gange.
English: The mean daily inhaled dose was 27 microgram and the mean number of inhalations per day was 5.6.
Danish: Den gennemsnitlige inhalerede dosis pr. dag var 27 mikrogram, og det gennemsnitlige antal inhalationer pr. dag var 5,6.
English: I-Neb AAD Estimated inhalation time
Danish: I-Neb AAD Estimeret inhalationstid
English: Limited data are available on the use of the Breelib nebuliser.
Danish: Der er begrænsede data om anvendelse af Breelib-nebulisatoren.
English: The total clearance of iloprost is about 20 ml/kg/min, which indicates extrahepatic contribution to the metabolism of iloprost.
Danish: Den totale clearance af iloprost er ca. 20 ml/kg/min., hvilket tyder på ekstrahepatisk bidrag til metaboliseringen af iloprost.
English: These alterations are not considered as teratogenic effects, but are most likely related to iloprost induced growth retardation in late organogenesis due to haemodynamic alterations in the foetoplacental unit.
Danish: Disse forandringer betragtes ikke som teratogene effekter, men er sandsynligvis relateret til iloprostinduceret væksthæmning i den sene organogenese på grund af føtoplacentale hæmodynamiske ændringer.
English: Ventavis should not be initiated in patients with systolic blood pressure less than 85 mmHg.
Danish: Ventavis-behandling bør ikke påbegyndes hos patienter med et systolisk blodtryk på under 85 mmHg.
English: In vitro (bacterial, mammalian cells, human lymphocytes) and in vivo studies (micronucleus test) for genotoxic effects have not produced any evidence for a mutagenic potential.
Danish: In vitro- (bakterieceller, pattedyrsceller, humane lymfocytter) og in vivo-studier (mikronukleustest) vedrørende genotoksiske effekter har ikke vist tegn på mutagent potentiale.
English: Ventavis nebuliser solution should not come into contact with skin and eyes; oral ingestion of Ventavis solution should be avoided.
Danish: Ventavis-inhalationsopløsning til nebulisatorer bør ikke komme i kontakt med hud og øjne; oral indtagelse af Ventavis-opløsning bør undgås.
English: Should signs of pulmonary oedema occur, the possibility of associated pulmonary veno-occlusive disease should be considered and treatment with Ventavis should be discontinued.
Danish: Hvis der opstår tegn på pulmonalt ødem, bør muligheden for associeret pulmonal veno-okklusiv sygdom overvejes og behandling med Ventavis bør seponeres.
English: 108 of the patients included were diagnosed with primary pulmonary hypertension, 95 were diagnosed with secondary pulmonary hypertension of which 56 were associated with chronic thromboembolic disease, 34 with connective tissue disease (including CREST and scleroderma) and 4 were considered appetite suppressant medicinal product related.
Danish: 108 af de inkluderede patienter havde diagnosen primær pulmonal hypertension, 95 havde sekundær pulmonal hypertension, hvoraf 56 var forbundet med kronisk tromboembolisk sygdom, 34 med bindevævssygdom (herunder CREST og sklerodermi) og 4 betragtedes som relateret til appetitdæmpende lægemiddel.
English: Thereafter, your doctor may cautiously shorten the dosing intervals depending on how you tolerate the treatment.
Danish: Derefter kan lægen forsigtigt afkorte tiden mellem doserne afhængigt af, hvordan du tåler behandlingen.
English: Within 30 minutes to 2 hours after the end of inhalation, iloprost is not detectable in the central compartment (limit of quantification 25 picogram/ml).
Danish: Inden for 30 minutter til 2 timer efter afslutning på inhalationen kan iloprost ikke påvises i det centrale rum (kvantificeringsgrænse 25 pikogram/ml).
English: • if you are allergic to iloprost or any of the other ingredients of this medicine (listed in section 6),
Danish: • hvis du er allergisk over for iloprost eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6),
English: Very rarely, fatal cases including bleeding in the brain (cerebral and intracranial haemorrhage) have been reported.
Danish: Der er meget sjældent blevet rapporteret tilfælde med dødelig udgang, herunder blødning i hjernen (cerebral og intrakraniel).
English: The primary efficacy endpoint defined for this study, was a combined response criterion consisting of improvement in exercise capacity (6-minute walk test) at 12 weeks by at least 10% versus baseline, and improvement by at least one NYHA class at 12 weeks versus baseline, and no deterioration of pulmonary hypertension or death at any time before 12 weeks.
Danish: Det primære effekt-endpoint, der var defineret for dette studie, var et samlet responskriterium bestående af en bedring af motionskapaciteten (6 minutters gangtest) efter 12 uger med mindst 10% i forhold til baseline, og en bedring med mindst én NYHA-klasse efter 12 uger i forhold til baseline, samt hverken forværring af den pulmonale hypertension eller død inden for de 12 uger.
English: After intravenous administration, iloprost is extensively metabolised via ß-oxidation of the carboxyl side chain.
Danish: Efter intravenøs administration metaboliseres iloprost ekstensivt via ß-oxydering af carboxylsidekæden.
English: • If you have liver problems or very severe kidney problems, requiring dialysis, tell your doctor.
Danish: • Hvis du har leverproblemer eller meget alvorlige nyreproblemer, der kræver dialysebehandling, skal du fortælle det til lægen.
English: Treatment of adult patients with primary pulmonary hypertension, classified as NYHA functional class III, to improve exercise capacity and symptoms.
Danish: Til behandling af voksne patienter med primær pulmonal hypertension, klassificeret som NYHA funktionsklasse III, for at forbedre arbejdsevnen og mindske sygdomssymptomerne.
English: − Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
Danish: - Medfødte eller erhvervede klapdefekter med klinisk relevante forstyrrelser af myokardiefunktionen, som ikke er relateret til pulmonal hypertension.
English: In subjects with normal renal and hepatic function, the disposition of iloprost following intravenous infusion is characterised in most cases by a two-phase profile with mean half-lives of 3 to 5 minutes and 15 to 30 minutes.
Danish: Hos forsøgspersoner med normal nyre- og leverfunktion karakteriseres dispositionen af iloprost efter intravenøs infusion i de fleste tilfælde af en tofaset profil med gennemsnitlige halveringstider på 3 til 5 minutter og 15 til 30 minutter.
English: The mean clearance of iloprost is estimated to be 10 ml/minute/kg.
Danish: Iloprosts middel-clearance vurderes til at være 10 ml/minut/kg.
English: I-Neb AAD 2.5 microgram 5 microgram
Danish: I-Neb AAD 2,5 mikrogram 5 mikrogram
English: If you have very severe kidney problems and require dialysis or if you have liver problems, your doctor will introduce you to Ventavis gradually and possibly prescribe fewer daily inhalations.
Danish: Hvis du har alvorlige nyreproblemer og er i dialyse, eller hvis du har leverproblemer, vil din læge gradvist vænne dig til Ventavis og muligvis ordinere færre daglige inhalationer.
English: Ventavis has major influence on the ability to drive and use machines for patients experiencing hypotensive symptoms such as dizziness.
Danish: Ventavis påvirker i væsentlig grad evnen til at føre motorkøretøj og betjene maskiner hos patienter, der oplever symptomer på hypotension, som f.eks. svimmelhed.
English: Before taking any medicine ask your doctor or pharmacist, who has more information on medicines to be careful with or avoid when using Ventavis.
Danish: Før du tager nogen form for medicin, skal du tale med lægen eller apoteket, som har mere information om lægemidler, som du skal passe på med, eller som du skal undgå, når du tager Ventavis.
English: In the iloprost group the NYHA class was improved in 26% of patients (placebo: 15%) (p = 0.032), unchanged in 67.7% of patients (placebo: 76%) and deteriorated in 6.3% of patients (placebo: 9%).
Danish: I iloprost-gruppen bedredes NYHA-klassen hos 26 % af patienterne (placebo: 15 %) (p=0,032), var uændret hos 67,7 % af patienterne (placebo: 76 %) og forværredes hos 6,3 % af patienterne (placebo:
English: What Ventavis is used for
Danish: Hvad Ventavis anvendes til
English: Ventavis lowers blood pressure and may cause dizziness or light-headedness in some people.
Danish: Ventavis nedsætter blodtrykket og kan hos nogle forårsage svimmelhed eller uklarhed.
English: If any of these happen when you have used more Ventavis than you should:
Danish: Hvis noget af dette skulle ske, efter du har taget for meget Ventavis, skal du:
English: Following inhalation of these doses with the Breelib the maximum plasma concentrations (Cmax) and systemic exposures (AUC (0-tlast)) increased dose-proportionally.
Danish: Efter inhalation af disse doser med Breelib sås en dosisproportionel forøgelse af de maksimale plasmakoncentrationer (Cmax) og systemiske eksponeringer (AUC (0-tlast)).
English: • If you suffer from a weak heart condition such as right heart failure, and feel that your disease is worsening, tell your doctor.
Danish: • Hvis du har et svagt hjerte, som f.eks. højresidigt hjertesvigt, og synes, at din sygdom bliver værre, skal du kontakte din læge.
English: Your doctor will supervise your treatment when you start using the Breelib nebuliser to ensure that you tolerate dose and speed of inhalation well.
Danish: Din læge vil føre tilsyn med din behandling, når du starter med at bruge Breelib-nebulisatoren, for at sikre, at du tåler dosen og inhalationshastigheden.
English: Patients who experience syncope in association with pulmonary hypertension should avoid any exceptional straining, for example during physical exertion.
Danish: Patienter, som oplever synkoper i forbindelse med pulmonal hypertension, bør undgå usædvanlig anstrengelse, f.eks. under motion.
English: Multipacks containing:
Danish: Multipakninger indeholdende:
English: Intravenous infusion of iloprost has no effect either on the pharmacokinetics of multiple oral doses of digoxin or on the pharmacokinetics of co-administered tissue plasminogen activator (t-PA) in patients.
Danish: Intravenøs infusion af iloprost har hverken virkning på farmakokinetikken af multiple orale doser af digoxin eller på farmakokinetikken af samtidigt administreret vævs-plasminogenaktivator (t-PA) hos patienter.
English: Most people will have 6 to 9 inhalation sessions spread throughout the day.
Danish: De fleste patienter skal have 6 til 9 inhalationsbehandlinger fordelt på hele dagen.