FrancophonIA/ELRC3.0 huggingface dataset:
English: The cardiovascular effects during infusion disappear within 30 min of the end of administration.
Danish: Den kardiovaskulære effekt forsvinder inden for 30 min efter afsluttet administration.
English: • bleeding at various sites and bruising more easily than normal, for example from the nose or gums
Danish: • blødning fra forskellige steder og blå mærker, som opstår oftere end normalt, f.eks. fra næse eller tandkød
English: Flolan is a potent pulmonary and systemic vasodilator.
Danish: Flolan er en potent pulmonal og systemisk vasodilator.
English: The powder is white or off-white and the solution is clear and colourless.
Danish: Pulveret er hvidt eller off-white, og solvensen er klar og farveløs.
English: Bleeding risk was defined as: • Very high risk - presence of active bleeding at the time of dialysis initiation
Danish: Blødningsrisiko blev defineret som: • Meget høj risiko - aktiv blødning ved tidspunktet for dialysestart.
English: 4.6 Fertility, pregnancy,and lactation
Danish: 4.6 Fertilitet, graviditet og amning
English: Your doctor will decide how much Flolan is right for you.
Danish: Lægen vil bestemme, hvor meget Flolan du har behov for.
English: Tell your doctor or nurse immediately, as these may be signs of infection of the blood or low blood pressure or serious bleeding:
Danish: Fortæl det straks til lægen eller sundhedspersonalet, da nedennævnte symptomer kan være tegn på infektion i blodet, lavt blodtryk eller alvorlig blødning:
English: • medicines to treat inflammation or pain (also called ‘NSAIDs')
Danish: • medicin mod vævsirritation eller smerter (også kaldet NSAID'er)
English: Increases in exercise capacity were accompanied by statistically significant improvements in dyspnoea, as measured by the Borg Dyspnea Index.
Danish: Den øgede funktionskapacitet blev ledsaget af statistisk signifikante forbedringer af dyspnø (målt ved Borg Dyspnea Index).
English: • if you have heart failure.
Danish: - hvis du har hjertesvigt.
English: You will start with an infusion of Flolan.
Danish: Du vil starte med at få en infusion med Flolan.
English: Your doctor or nurse will show you how to clean your ‘line' and the area around it.
Danish: Lægen eller sundhedspersonalet vil vise dig, hvordan du rengør katetret og området omkring.
English: At the end of the treatment period in the 12 weeks study, survival was improved in NYHA functional Class III and Class IV patients.
Danish: Ved slutningen af behandlingsperioden i 12-ugersstudiet var overlevelsen forbedret hos NYHA-funktionsklasse III og IV patienter.
English: Epoprostenol potentiates the anticoagulant activity of heparin by approximately 50%, possibly reducing the release of heparin neutralising factor.
Danish: Epoprostenol forstærker heparins antikoagulantionsaktivitet med ca. 50 %, muligvis ved at reducere frigivelsen af heparin-neutraliserende faktor.
English: • increase in sugar (glucose) in the blood
Danish: • forhøjet indhold af sukker (glucose) i blodet.
English: Common side effects that may show up in blood tests • decrease in the number of blood platelets (cells that help the blood to clot)
Danish: Almindelige bivirkninger, som kan ses i blodprøver • nedsat antal blodplader (celler som hjælper blodet med at størkne)
English: Therefore, this SmPC, labelling and package leaflet may not necessarily represent the current text.
Danish: Derfor repræsenterer dette produktresumé, denne etikettering og denne indlægsseddel ikke nødvendigvis den aktuelle tekst.
English: Frequencies are defined as follows: very common ≥1/10 (≥10%); common ≥1/100 and <1/10 (≥1% and <10%); uncommon ≥1/1000 and <1/100 (≥0.1% and <1%); rare ≥1/10,000 and <1/1000 ( ≥0.01% and <0.1%); very rare <1/10,000 (< 0.01%) and not known (cannot be estimated from the available data).
Danish: Frekvenserne er defineret som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Even brief interruptions in the delivery of Flolan may result in rapid symptomatic deterioration.
Danish: Selv kort afbrydelse i infusionen af Flolan kan medføre hastig symptomatisk forværring.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet samt reproduktions- og udviklingstoksicitet.
English: If you stop taking Flolan
Danish: Hvis du holder op med at tage Flolan
English: Your dose may be increased or decreased depending on how well you respond to treatment.
Danish: Dosis kan blive sat op eller ned afhængigt af, hvordan du reagerer på behandlingen.
English: Given the absence of alternative medicines, epoprostenol can be used in those women who choose to continue their pregnancy, despite the known risk of pulmonary arterial hypertension during pregnancy.
Danish: På grund af manglende alternative lægemidler kan epoprostenol administreres til kvinder, som vælger at fortsætte graviditeten på trods af den kendte risiko ved pulmonal arteriel hypertension under graviditet.
English: Flolan solutions are less stable at low pH.
Danish: Flolan er mindre stabilt ved lav pH.
English: Abrupt withdrawal or interruption of infusion must be avoided, except in life-threatening situations.
Danish: Brat ophør af behandling eller afbrydelse af infusion skal undgås, bortset fra ved livstruende situationer.
English: It is unknown if epoprostenol or its metabolites are excreted in human milk.
Danish: Det er ukendt, om epoprostenol eller dets metabolitter udskilles i human mælk.
English: The cold pouch must be regularly changed throughout the day, to maintain the temperature of the solution.
Danish: Den kolde pose skal udskiftes regelmæssigt i løbet af dagen for at opretholde temperaturen i opløsningen.
English: Initially a pack containing solvent for parenteral use must be used.
Danish: Initialt skal der bruges en pakning med solvens til parenteral anvendelse.
English: The symptoms of low blood pressure include dizziness and fainting.
Danish: Symptomer på lavt blodtryk er f.eks. svimmelhed og besvimelse.
English: Using Flolan at home (only for treatment of Pulmonary Arterial Hypertension) If you are treating yourself at home, your doctor or nurse will show you how to prepare and use Flolan.
Danish: Anvendelse af Flolan hjemme (kun ved behandling af pulmonal arteriel hypertension) Hvis du skal behandle dig selv hjemme, vil lægen eller sundhedspersonalet vise dig, hvordan du klargør og anvender Flolan.
English: There is a limited amount of data from the use of epoprostenol in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af epoprostenol til gravide kvinder.
English: This SmPC, labelling and package leaflet is the version valid at the time of Commission decision.
Danish: Dette produktresumé, denne etikettering og denne indlægsseddel er den udgave, som er gyldig på tidspunktet for Kommissionens afgørelse.
English: If excessive hypotension occurs during administration of Flolan, the dose should be reduced or the infusion discontinued.
Danish: Hvis ekstrem hypotension forekommer under administration af Flolan, skal dosis reduceres eller infusionen afbrydes.
English: Most epoprostenol dialyses (67%) that required replacement of artificial kidney were completed subsequently with epoprostenol without clotting.
Danish: De fleste epoprostenol-dialyser (67 %), som krævede udskiftning af den kunstige nyre, blev efterfølgende fuldført med epoprostenol uden koagulation.
English: Due to the chemical instability, high potency and short half-life of epoprostenol, no precise and accurate assay has been identified as appropriate for quantifying epoprostenol in biological fluids.
Danish: På grund af epoprostenols kemiske ustabilitet, høje potens og korte halveringstid findes der ingen analysemetode, som er tilstrækkelig præcis og nøjagtig til at kvantificere epoprostenol i biologiske væsker.
English: • digoxin (used to treat heart disease).
Danish: • digoxin (til behandling af hjertesygdom)
English: For further instructions on reconstitution and dilution of the medicinal product before administration, (see section 6.6).
Danish: For instruktioner om rekonstitution og fortynding af lægemidlet før administration, (se pkt.
English: Flolan can also affect how some other medicines work if taken at the same time.
Danish: Flolan kan også påvirke virkningen af andre lægemidler, hvis de tages samtidigt.
English: Pharmacotherapeutic group: Antithrombotic Agents; Platelet aggregation inhibitors excl. heparin, ATC code: B01AC09
Danish: Farmakoterapeutisk klassifikation: Antitrombotiske midler; Blodpladeaggregationshæmmere eksklusive heparin, ATC-kode: B01AC09
English: The dose will be increased, until your symptoms are relieved, and any side effects are manageable.
Danish: Dosis øges, indtil dine symptomer er lindret, og eventuelle bivirkninger er acceptable.
English: • You have fevers or chills.
Danish: • Du får feber eller kulderystelser.
English: The recommended dose for renal dialysis should be exceeded only with careful monitoring of patient blood pressure.
Danish: Den anbefalede dosis ved hæmodialyse må kun overskrides under nøje monitorering af patientens blodtryk.
English: EXP Read the package leaflet for the shelf-life of the reconstituted/diluted product
Danish: EXP Læs indlægssedlen for oplysninger om holdbarheden af det rekonstituerede/fortyndede produkt
English: Improvements were apparent in some patients at the end of the first week of therapy.
Danish: Forbedringerne var tydelige hos nogle patienter efter den første behandlingsuge.
English: Mean systemic arterial pressure was not significantly different between the two groups (-4.33 vs. -3.05 mm Hg).
Danish: Det gennemsnitlige systemiske arterietryk var ikke signifikant forskelligt for de to behandlingsgrupper (-4,33 vs. -3,05 mmHg).
English: At normal physiological pH and temperature, epoprostenol breaks down spontaneously to 6-oxoprostaglandin F1 alpha, although there is some enzymatic degradation to other products.
Danish: Ved normal fysiologisk pH og temperatur nedbrydes epoprostenol spontant til 6-oxo-prostaglandin F1 alfa, om end noget også nedbrydes enzymatisk til andre produkter.
English: The amount you are given is based on your body weight, and your type of illness.
Danish: Dosis vil afhænge af din kropsvægt, og hvilken slags sygdom du har.
English: If you have problems with the infusion pump or injection line that stops, or prevents treatment with Flolan, contact your doctor, nurse or hospital immediately.
Danish: Hvis du har problemer med, at infusionspumpen eller injektionsslangen stopper til eller forhindrer behandlingen med Flolan, skal du straks kontakte lægen, sundhedspersonalet eller hospitalet.
English: If you are not using a ‘cold pouch', the solution can be stored in the pump:
Danish: Hvis du ikke bruger en ”kold pose”, kan opløsningen opbevares i pumpen:
English: You can then be treated using an infusion pump.
Danish: Herefter kan du behandles med en infusionspumpe.
English: Reproductive studies in animals have shown no effects on fertility (see section 5.3).
Danish: Reproduktionsstudier hos dyr har ikke vist påvirkning af fertiliteten (se pkt.
English: If the treatment is stopped too quickly you may get serious side effects, including dizziness, feeling weak and breathing difficulties.
Danish: Hvis behandlingen stoppes for hurtigt, kan du få alvorlige bivirkninger, herunder svimmelhed, en følelse af kraftesløshed og vejrtrækningsbesvær.
English: Minor clotting (sufficient to require intervention, but not permanently suspending dialysis or requiring changing of the artificial kidney) was reported more frequently during epoprostenol than during heparin dialyses.
Danish: Mindre koagulation (tilstrækkeligt til at kræve intervention, men ikke permanent afbrydelse af dialysen eller påkrævet udskiftning af den kunstige nyre) blev rapporteret hyppigere ved epoprostenoldialyserne end ved heparin-dialyserne.
English: The concentrated solution is normally further diluted before use.
Danish: Den koncentrerede opløsning fortyndes normalt yderligere før anvendelse.
English: Only this concentrated solution is suitable for further dilution prior to use.
Danish: Det er kun denne koncentrerede opløsning, som er egnet til yderligere fortynding før anvendelse.
English: PHARMACEUTICAL FORM Powder for concentrate for solution for infusion: - White or off-white freeze dried powder Solvent for parenteral use: - Clear, colourless solution (pH 10.3 - 10.8)
Danish: LÆGEMIDDELFORM Pulver til koncentrat til infusionsvæske, opløsning: - Hvidt eller offwhite frysetørret pulver Solvens til parenteral anvendelse: - Klar, farveløs opløsning (pH 10,3-10,8)
English: Epoprostenol must not be administered as a bolus injection
Danish: Epoprostenol må ikke administreres som en bolusinjektion.
English: Extreme caution is advised in patients with coronary artery disease.
Danish: Det anbefales at udvise den yderste forsigtighed hos patienter med koronararteriesygdom.
English: There are no data on the effects of epoprostenol on fertility in humans.
Danish: Der er ingen data om virkningen af epoprostenol på fertiliteten hos mennesker.
English: If overdose occurs reduce the dose or discontinue the infusion and initiate appropriate supportive measures as necessary; for example plasma volume expansion and/or adjustment to pump flow.
Danish: Ved overdosering reduceres dosis eller infusionen afbrydes og passende understøttende behandling initieres om nødvendigt, f.eks. plasmaekspansion og/eller justering til pumpeflow.
English: Except in life-threatening situations (e.g. unconsciousness, collapse, etc) infusion rates of Flolan should be adjusted only under the direction of a physician.
Danish: Bortset fra livstruende situationer (bevidstløshed, kollaps mv.) må justering af Flolans infusionshastighed kun ske under lægelig vejledning.
English: Each patient was randomly assigned to a sequence of heparin or epoprostenol dialyses and received up to 6 dialyses per entry in one study and up to 3 dialyses per entry in another study.
Danish: Hver patient blev randomiseret til en sekvens med heparin- eller epoprostenol-dialyser og fik op til 6 dialyser ved deltagelse i det ene studie og op til 3 dialyser ved deltagelse i det andet studie.
English: Patients who did not have clear evidence of bleeding just prior to their first study dialysis, but who bled within 3 days prior were classified as high risk of haemorrhage.
Danish: Patienter, som ikke viste entydige tegn på blødning lige før første studie-dialyse, men som havde blødt inden for 3 dage før dialysen, blev klassificeret som havende høj risiko for blødning.
English: Store in the original outer carton, to protect from light.
Danish: Opbevares i den originale yderpakning for at beskytte mod lys.
English: General Disorders and Administration Site Conditions Very common Pain (unspecified) Common
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig Smerter (uspecifikke) Almindelig
English: Unlike many other prostaglandins, epoprostenol is not metabolised during passage through the pulmonary circulation.
Danish: I modsætning til mange andre prostaglandiner metaboliseres epoprostenol ikke ved passage gennem lungekredsløbet.
English: Animal studies did not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger hvad angår reproduktionstoksicitet (se pkt.
English: Sodium chloride 0.9% w/v solution must not be used when Flolan is to be used for the treatment of pulmonary arterial hypertension.
Danish: 0,9 % w/v natriumchloridinfusionsvæske må ikke bruges, når Flolan anvendes til behandling af pulmonal arteriel hypertension.
English: Any cold pouch used must be capable of maintaining the temperature of the reconstituted solution.
Danish: Alle ”kolde poser” som anvendes, skal være i stand til at opretholde temperaturen af den rekonstituerede opløsning.
English: Only the solvent provided may be used for the further dilution of reconstituted Flolan.
Danish: Kun den medfølgende solvens må benyttes til yderligere fortynding af den rekonstituerede Flolan.
English: Blood pressure and heart rate should be monitored during administration of Flolan.
Danish: Blodtryk og hjertefrekvens skal kontrolleres under administrationen af Flolan.
English: Very common Facial flushing (seen even in the anaesthetised patient) Common
Danish: Meget almindelig Ansigtsrødme (også set hos patienter i narkose) Almindelig
English: Eight of 40 (20%) patients receiving conventional therapy alone died, whereas none of the 41 patients receiving epoprostenol died (p=0.003).
Danish: 8 ud af 40 (20 %) patienter, som kun fik konventionel behandling, døde, mens ingen af de 41 patienter, som fik epoprostenol, døde (p=0,003).
English: Visible clotting (not necessitating intervention) was reported in another 31% of epoprostenol dialyses and 5% of heparin dialyses.
Danish: Synlig koagulation (som ikke krævede intervention) blev rapporteret ved yderligere 31 % af epoprostenol-dialyserne og ved 5 % af heparin-dialyserne.
English: Primary measurements of efficacy included intradialytic removal of BUN and creatinine, intradialytic removal of fluid (ultrafiltration), and clotting within the extracorporeal circuit.
Danish: Primære effektmålepunkter inkluderede intradialytisk fjernelse af BUN og kreatinin, intradialytisk fjernelse af væske (ultrafiltrering) og koagulation i den ekstrakorporale cirkulation.
English: INFORMATION FOR HEALTHCARE PROFESSIONALS
Danish: Information til læger og sundhedspersonale
English: For administration using a pump capable of delivering small volume constant infusions, suitable aliquots of concentrated solution may be diluted with sterile sodium chloride 0.9% w/v solution.
Danish: Ved administration ved hjælp af en pumpe, som kan give små infusioner med konstant volumen, kan passende mængder af den koncentrerede opløsning fortyndes med steril natriumchloridopløsning 0,9 % w/v.
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest revideret {MM/ÅÅÅÅ} [Udfyldes nationalt]
English: Higher infusion rates, and therefore, more concentrated solutions may be necessary with long-term administration of Flolan.
Danish: Højere infusionshastigheder (og dermed mere koncentrerede opløsninger) kan være nødvendige ved langvarig administration af Flolan.
English: • with congestive heart failure arising from severe left ventricular dysfunction.
Danish: • hos patienter med kongestiv hjerteinsufficiens på grund af svær venstre ventrikel dysfunktion.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 4.2.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: At the end of the treatment period, 4 of 56 (7%) patients receiving epoprostenol died, whereas 5 of 55 (9%) patients receiving conventional therapy alone died.
Danish: Ved slutningen af behandlingsperioden var 4 ud af 56 (7 %) af de patienter, som fik epoprostenol, døde, mens 5 ud af 55 (4 %) af de patienter, som kun fik konventionel behandling, var døde.
English: Pain at the injection site*, chest pain
Danish: Smerter ved injektionsstedet*, brystsmerter
English: As reported with other prostaglandin analogues, Flolan may reduce the thrombolytic efficacy of tissue plasminogen activator (t-PA) by increasing hepatic clearance of t-PA.
Danish: Som set ved andre prostaglandinanaloger kan Flolan reducere den trombolytiske effekt af vævsplasminogenaktivator (t-PA) ved at øge den hepatiske clearance af t-PA.
English: To establish that renal dialysis patients at increased risk of haemorrhage bleed less frequently with epoprostenol than heparin, 2 major prospectively controlled studies were conducted.
Danish: For at fastslå, at hæmodialyse-patienter med øget risiko for blødning bløder mindre med epoprostenol end med heparin, blev 2 store, prospektivt kontrollerede studier udført.
English: Once Flolan powder has been dissolved, and diluted, it should ideally be used immediately.
Danish: Når Flolan-pulveret er opløst og fortyndet, skal det helst bruges straks.
English: At week 12, NYHA functional class improved in 21 of 51 (41%) patients treated with epoprostenol compared to none of the 48 patients treated with conventional therapy alone.
Danish: Ved uge 12 var NYHA-funktionsklassen forbedret hos 21 ud af 51 (41 %) af patienterne, som blev behandlet med epoprostenol, sammenlignet med hos ingen af de 48 patienter, som kun fik konventionel behandling.
English: A sequential stimulation of adenylate cyclase, followed by activation of phosphodiesterase, has been described in human platelets.
Danish: En sekventiel stimulering af adenylatcyklase efterfulgt af aktivering af fosfodiesterase er beskrevet for humane trombocytter.
English: Thus, therapy with Flolan requires commitment by the patient to sterile drug reconstitution, drug administration, care of the permanent central venous catheter, and access to intense and ongoing patient education.
Danish: Derfor kræver behandling med Flolan, at patienten er indstillet på steril rekonstitution og administration af lægemidlet, vedligeholdelse af det permanente centrale venekateter samt intensiv og fortløbende patientuddannelse.
English: None of the dialyses using heparin and 5% (n=32) of dialyses using epoprostenol had minor clotting.
Danish: Ved ingen af dialyserne med heparin og ved 5 % (n=32) af dialyserne med epoprostenol forekom mindre koagulation.
English: The active substance is epoprostenol sodium.
Danish: Det aktive stof er epoprostenolnatrium.
English: The half-life for the spontaneous breakdown to 6-oxo-prostaglandin F1 alpha in man is expected to be no more than 6 minutes, and may be as short as 2 to 3 minutes, as estimated from in vitro rates of degradation of epoprostenol in human whole blood.
Danish: Halveringstiden for den spontane nedbrydning til 6-oxo-prostaglandin F1 alfa hos mennesker forventes at være højst 6 minutter, men kan være så kort som 2-3 minutter (estimeret fr nedbrydningshastigheden for epoprostenol i fuldblod hos mennesker).
English: It is also a potent vasodilator.
Danish: Epoprostenol er også en potent vasodilator.
English: When Flolan is used alone, measurements such as activated whole blood clotting time may not be reliable.
Danish: Når Flolan gives alene, kan målinger som aktiveret koagulationstid være upålidelige.
English: infusions may be used until central access is established.
Danish: Midlertidige perifere intravenøse infusioner kan gives, indtil en central adgang er etableret.
English: Many of the actions of epoprostenol are exerted via the stimulation of adenylate cyclase, which leads to increased intracellular levels of cyclic adenosine 3'5' monophosphate (cAMP).
Danish: Mange af epoprostenols virkninger udøves via stimulation af adenylatcyklase, som medfører en øget intracellulær koncentration af cyklisk adenosin-3,5-monofosfat (cAMP).
English: Improvements were apparent as early as the first week of therapy.
Danish: Forbedringerne var tydelige allerede efter den første behandlingsuge.
English: Following establishment of a new infusion rate, the patient should be observed, and erect and supine blood pressure and heart rate monitored for several hours to ensure that the new dose is tolerated.
Danish: Når en ny infusionshastighed er fastlagt, skal patienten observeres i flere timer, og stående og liggende blodtryk samt hjertefrekvens måles for at sikre, at den nye dosis tåles.
English: Once Flolan has been dissolved and diluted, any unused solution can be stored at 25oC and used within 12 hours.
Danish: Når Flolan-pulveret er opløst og fortyndet, skal alle opløsninger, som ikke er brugt, opbevares ved 25 °C og bruges inden for 12 timer.