FrancophonIA/ELRC3.0 huggingface dataset:
English: • High risk - having had within 3 days prior to dialysis an active bleed that stopped at the pre-dialysis phase; or having incurred surgical or traumatic wounds within 3 days prior to dialysis
Danish: • Høj risiko - har i løbet af de 3 seneste dage før dialyse haft enten aktiv blødning, som stoppede i præ-dialysefasen, eller kirurgiske eller traumatiske sår.
English: Flolan is a potent inhibitor of platelet aggregation, therefore, an increased risk for haemorrhagic complications should be considered, particularly for patients with other risk factors for bleeding (see section 4.5).
Danish: Flolan er en potent inhibitor af blodpladeaggregationen, hvorfor der skal tages hensyn til en øget risiko for hæmoragiske komplikationer, især hos patienter med andre risikofaktorer for blødning (se pkt.
English: Blood glucose increased * Associated with the delivery system for Flolan 1 Catheter-related infections caused by organisms not always considered pathogenic (including micrococcus) have been reported.
Danish: * Relateret til udstyr og administrationssystem for Flolan 1 Kateter-relaterede infektioner forårsaget af organismer, som ikke altid anses som patogene (f.eks. mikrokokker), er rapporteret.
English: Flolan Injection comes in different strengths.
Danish: Flolan infusionsvæske findes i forskellige styrker.
English: Flow rates in mL/h b. Diluted: A commonly used dilution is:
Danish: Infusionshastighed i ml/time b. Fortyndet: En ofte anvendt fortynding er:
English: Once the best dose has been found, a permanent tube (line) will be fitted into one of your veins.
Danish: Når lægen har fundet den bedste dosis, vil du få en permanent adgang (et lille kateter) i en af dine blodårer.
English: Sodium Chloride
Danish: Natriumchlorid
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension.
Danish: Behandling må kun initieres og skal superviseres af læger med erfaring i behandling af pulmonal arteriel hypertension.
English: Store Flolan in a dry place.
Danish: Opbevar Flolan på et tørt sted.
English: However, 9 of 27 epoprostenol dialyses were unsuccessful following multiple attempts.
Danish: Selv efter flere forsøg var 9 ud af 27 epoprostenol-dialyser imidlertid ikke vellykkede.
English: A statistically significant increase in CI, and statistically significant decreases in PAPm, RAPm, PVR, and SAPm after 12 weeks of treatment were observed in patients who received epoprostenol chronically compared to those who did not.
Danish: En statistisk signifikant øgning i CI og statistisk signifikante reduktioner i PAPm, RAPm, PVR og SAPm efter 12-ugers behandling blev observeret hos de patienter, som fik kontinuerlig epoprostenol, sammenlignet med dem, som ikke fik.
English: Flolan is indicated for use in haemodialysis in emergency situations when use of heparin carries a high risk of causing or exacerbating bleeding or when heparin is otherwise contraindicated (see section 5.1).
Danish: Flolan er indiceret til brug ved hæmodialyse i akutte situationer, når anvendelse af heparin medfører stor risiko for at forårsage eller forværre blødning, eller når heparin er kontraindiceret (se pkt.
English: Flolan is used to prevent blood clotting during kidney dialysis when heparin cannot be used.
Danish: Flolan anvendes også til at forhindre blodet i at størkne under dialyse, når heparin ikke kan anvendes.
English: Flolan is indicated for the treatment of pulmonary arterial hypertension (PAH) (idiopathic or heritable PAH and PAH associated with connective tissue diseases) in patients with WHO Functional Class III-IV symptoms to improve exercise capacity (see section 5.1).
Danish: Flolan er indiceret til behandling af pulmonal arteriel hypertension (PAH) (idiopatisk eller arvelig PAH og PAH associeret med bindevævssygdom) hos patienter i WHO funktionsklasse III-IV for at forbedre funktionskapaciteten (se pkt.
English: Sixteen patients received 24 epoprostenol dialyses in emergency studies.
Danish: 16 patienter fik 24 epoprostenol-dialyser i akutstudierne.
English: • medicines used to treat high blood pressure
Danish: • medicin til behandling af for højt blodtryk
English: However, the reverse was observed for postdialysis days with epoprostenol (N=1/5) compared to heparin (N=8/16).
Danish: Det modsatte blev imidlertid observeret på post-dialysedagen ved brug af epoprostenol (N=1/5) sammenlignet med heparin (N=8/16).
English: Seek urgent medical attention if you think you have used or been given too much Flolan.
Danish: Kontakt straks læge eller hospital, hvis du tror, at du har taget eller har fået for meget Flolan.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine as your symptoms could worsen during pregnancy.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apoteket til råds, før du bruger dette lægemiddel.
English: The effects of Flolan on heart rate may be masked by concomitant use of drugs which affect cardiovascular reflexes.
Danish: Flolans effekt på hjertefrekvensen kan sløres ved samtidig brug af lægemidler, der påvirker de kardiovaskulære reflekser.
English: Flolan contains Sodium.
Danish: Flolan indeholder natrium.
English: Except for 5 NYHA functional Class II patients, all patients were either functional Class III or Class IV.
Danish: Med undtagelse af 5 patienter, som var klassificeret som NYHA-funktionsklasse II patienter, var alle patienter enten funktionsklasse III eller IV.
English: A short-term dose-ranging procedure administered via either a peripheral or central venous line is required to determine the long-term infusion rate.
Danish: En kortvarig dosistitreringsprocedure administreret via en perifer eller central venøs adgang er nødvendig for at bestemme langtidsinfusionshastigheden.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Danish: Brug altid dette lægemiddel nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Infections and Infestations Common
Danish: Infektioner og parasitære sygdomme Almindelig
English: Increases in dose should be considered if symptoms of pulmonary arterial hypertension persist, or recur after improving.
Danish: Dosisøgning skal overvejes, hvis symptomerne på pulmonal arteriel hypertension vedvarer eller vender tilbage efter at have været forbedret.
English: Symptoms of overdose may include headache, nausea, vomiting, fast heart rate, warmth or tingling, or feeling like you might pass out (feeling faint/dizziness).
Danish: Symptomer på overdosering kan være hovedpine, kvalme, opkastning, hurtig puls, varme eller en kriblende følelse, eller en følelse af, at du skal besvime (mathed/svimmelhed).
English: • stomach discomfort or pain
Danish: • ubehag eller smerter i maven
English: Reconstitution and dilution of Flolan must be carried out under aseptic conditions, immediately prior to clinical use.
Danish: Rekonstitution og fortynding af Flolan skal udføres under aseptiske forhold umiddelbart før anvendelse.
English: Contact the hospital immediately for advice if the area becomes sore, painful or swollen or you notice any blistering or shedding.
Danish: Kontakt straks hospitalet og få rådgivning, hvis huden bliver øm, smertefuld eller hæver, eller hvis du får blærer eller hudafskalning.
English: Because of the high pH of the final infusion solutions, care should be taken to avoid extravasation during their administration and consequent risk of tissue damage.
Danish: På grund af den høje pH-værdi i den færdige infusionsvæske skal der udvises forsigtighed under administrationen for at undgå ekstravasation med efterfølgende risiko for vævsskader.
English: Flolan may either decrease or increase heart rate.
Danish: Flolan kan både øge og nedsætte hjertefrekvensen.
English: Calculation of infusion rate:
Danish: Beregning af infusionshastighed:
English: GENERAL CLASSIFICATION FOR SUPPLY Medicine subject to medicinal prescription
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING Receptpligtigt lægemiddel.
English: Improvements from baseline in cardiac index (0.33 vs. -0.12 L/min/m2), stroke volume (6.01 vs. -1.32 mL/beat), arterial oxygen saturation (1.62 vs. -0.85%), mean pulmonary artery pressure (-5.39 vs. 1.45 mm Hg), mean right atrial pressure (-2.26 vs. 0.59 mm Hg), total pulmonary resistance (-4.52 vs. 1.41 Wood U), pulmonary vascular resistance (-3.60 vs. 1.27 Wood U), and systemic vascular resistance (-4.31 vs. 0.18 Wood U) were statistically different between patients who received epoprostenol chronically and those who did not.
Danish: Forbedringer fra baseline i hjerteindeks (0,33 vs. -0,12 l/min/m2), slagvolumen (6,01 vs. -1,32 ml/slag), arteriel oxygenmætning (1,62 vs. -0,85 %), gennemsnitligt arterietryk (-5,39 vs. 1,45 mmHg), gennemsnitligt højre arterietryk (-2,26 vs. 0,59 mmHg), total pulmonal modstand (-4,52 vs. 1,41 Wood U), pulmonal vaskulær modstand (-3,60 vs. 1,27 Wood U) og systemisk vaskulær modstand (-4,31 vs. 0,18 Wood U) var statistisk forskellige for patienter, som fik kontinuerlig epoprostenol, og dem, som ikke fik.
English: The liquid does not contain a preservative.
Danish: Opløsningsvæsken indeholder ikke konserveringsmiddel.
English: Only vials of the same amount as that included in the initial starter pack may be used to increase the final concentration of solution.
Danish: Kun hætteglas af samme styrke som startpakningen må anvendes til at øge koncentrationen af opløsningen til en højere slutkoncentration.
English: However, more patients in both treatment groups (28/51 [55%] with epoprostenol and 35/48 [73%] with conventional therapy alone) showed no change in functional class, and 2/51 (4%) with epoprostenol and 13/48 (27%) with conventional therapy alone worsened.
Danish: Flere patienter i begge behandlingsgrupper (hhv. 28/51 [55 %] med epoprostenol og 35/48 [73 %] med konventionel behandling) viste imidlertid ingen ændring i funktionsklasse, mens tilstanden hos 2/51 (4 %) af dem, som fik epoprostenol, og hos 13/48 (27 %) af dem, som fik konventionel behandling, forværredes.
English: The infusion should be stopped at the end of dialysis.
Danish: Infusionen skal stoppes, når dialysen er udført.
English: Do not use this medicine after the expiry date which is stated on the label.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: During renal dialysis with Flolan it should be ensured that the cardiac output increases more than minimally so that delivery of oxygen to peripheral tissue is not diminished.
Danish: Under hæmodialyse med Flolan skal det sikres, at minutvolumen øges mere end minimalt, således at ilttilførslen til perifere væv ikke bliver reduceret.
English: Other medicines and Flolan
Danish: Brug af anden medicin sammen med Flolan
English: The change is thought to depend on both the basal heart rate and the concentration of Flolan administered.
Danish: Det antages, at påvirkningen afhænger af både den basale hjertefrekvens og af den administrerede Flolan-koncentration.
English: If you have been fitted with a ‘line' into a vein it is very important to keep this area clean, otherwise you could get an infection.
Danish: Hvordan du rengør injektionsslangen (katetret) Hvis du har fået indsat et kateter i en blodåre, er det meget vigtigt, at du holder dette område rent, da du ellers kan få en infektion.
English: You should stop breastfeeding your child during treatment with Flolan.
Danish: Du skal stoppe amningen af dit barn, mens du er i behandling med Flolan.
English: Flolan widens the blood vessels to lower the blood pressure in the lungs.
Danish: Flolan udvider blodårerne og nedsætter blodtrykket i lungerne.
English: When used in renal dialysis Flolan may be administered as the concentrated solution (a) or in diluted form (b).
Danish: Ved anvendelse i forbindelse med hæmodialyse kan Flolan administreres som den koncentrerede opløsning (a) eller i fortyndet form (b).
English: In general, the need for increases in dose from the initial long-term dose should be expected over time.
Danish: Generelt må det forventes, at der over tid bliver behov for dosisøgning.
English: Epoprostenol is only indicated for continuous infusion by intravenous route.
Danish: Epoprostenol er kun indiceret til kontinuerlig, intravenøs infusion.
English: If you are being given Flolan using an infusion pump, a ‘cold pouch' may be used to maintain the temperature of the solution.
Danish: Hvis du får Flolan ved hjælp af en infusionspumpe, kan du bruge en ”kold pose” for at opretholde temperaturen i opløsningen.
English: Intravenous epoprostenol infusions of up to 15 minutes have been found to produce dose-related increases in cardiac index (CI) and stroke volume (SV), and dose-related decreases in pulmonary vascular resistance (PVR), total pulmonary resistance (TPR) and mean systemic arterial pressure (SAPm).
Danish: Intravenøse infusioner af epoprostenol i op til 15 minutter gav en dosisrelateret øgning af hjerteindeks (cardiac index, CI) og slagvolumen (SV) og et dosisrelateret fald i den pulmonale vaskulære modstand, total pulmonal modstand (TPR) og det gennemsnitlige systemiske arterietryk (SAPm).
English: Powder and Solvent for solution for infusion: 3 years.
Danish: Pulver og solvens til infusionsvæske, opløsning: 3 år.
English: Only the solvent supplied should be used for reconstitution of freeze-dried Flolan and only the recommended infusion solutions, in the stated ratio, should be used for further dilution, otherwise the required pH may not be maintained.
Danish: Kun den medfølgende solvens må benyttes til rekonstitution af det frysetørrede Flolan-pulver, og kun de anbefalede koncentrationer af infusionsvæsker må benyttes til yderligere fortynding, da den nødvendige pH ellers ikke kan opretholdes med sikkerhed.
English: Sterile technique must be adhered to in preparing the drug and in the care of the catheter.
Danish: Der skal anvendes sterilteknik ved opløsning af lægemidlet og i vedligeholdelsen af katetret.
English: In general, dose selection for an elderly patient should be made carefully, reflecting the greater frequency of decreased hepatic, renal (in the case of pulmonary arterial hypertension) or cardiac function and of concomitant disease or other medicine therapy.
Danish: Generelt skal dosis til ældre vælges omhyggeligt, idet der skal tages højde for den øgede frekvens af nedsat lever-, nyre- (ved pulmonal arteriel hypertension) og hjertefunktion samt for ledsagende sygdomme og anden medikamentel behandling.
English: Some medicines may affect how Flolan works, or make it more likely that you'll have side effects.
Danish: Nogle lægemidler kan påvirke Flolans virkning eller medføre en øget risiko for, at du får bivirkninger.
English: There is no specific information on the use of Flolan in patients over 65 years for renal dialysis or pulmonary arterial hypertension.
Danish: Der er ingen specifik information om brugen af Flolan i forbindelse med hæmodialyse eller til behandling af pulmonal arteriel hypertension hos patienter over 65 år.
English: During dialysis: 4 nanograms/kg/min into the arterial inlet of the dialyser
Danish: Under dialyse: 4 nanogram/kg/min via dialyseapparatets arterielle indgang.
English: Store the solvent below 25°C.
Danish: Opbevar solvensen ved temperaturer under 25 °C.
English: The filter must be used once only and then discarded.
Danish: Filteret må kun anvendes én gang og skal derefter kasseres.
English: The infusion rate may be calculated from the following formula:
Danish: Infusionshastigheden kan beregnes ved hjælp af følgende formel:
English: Dosage adjustments:
Danish: Dosisjustering:
English: Sodium Hydroxide (for pH adjustment)
Danish: Natriumhydroxid (til pH -justering)
English: The median baseline value for the conventional therapy group and epoprostenol plus conventional therapy group was 240 meters and 270 meters, respectively.
Danish: Mediane baseline-værdier for den konventionelt behandlede gruppe og for gruppen, som fik epoprostenol + konventionel behandling, var henholdsvis 240 meter og 270 meter.
English: Higher circulating doses of epoprostenol (20 nanograms/kg/min) disperse circulating platelet aggregates and increase by up to two fold the cutaneous bleeding time.
Danish: Højere cirkulerende doser af epoprostenol (20 nanogram/kg/min) dispergerer cirkulerende trombocytaggregater og øger den kutane blødningstid med op til det dobbelte.
English: Abrupt withdrawal of Flolan or sudden large reductions in infusion rates should be avoided due to the risk of potential fatal rebound effect (see section 4.4).
Danish: Brat seponering af Flolan eller pludselige større reduktioner af infusionshastigheden skal undgås på grund af den potentielt letale rebound-effekt (se pkt.
English: Flolan is given by slow infusion (drip) into a vein.
Danish: Flolan gives som en langsom infusion (drop) i en blodåre (vene).
English: It may be diluted with sodium chloride 0.9% w/v solution, provided a ratio of 6 volumes of sodium chloride 0.9% w/v solution to 1 volume of concentrated solution is not exceeded e.g. 50 mL of concentrated solution further diluted with a maximum of 300 mL sodium chloride 0.9% w/v solution.
Danish: Den kan fortyndes med 0,9 % w/v natriumchloridinfusionsvæske, forudsat at forholdet 6:1 (6 dele natriumchloridinfusionsvæske 0,9 % w/v til 1 del koncentreret opløsning) ikke overskrides (f.eks. kan 50 ml koncentreret opløsning fortyndes yderligere med maksimalt 300 ml natriumchloridinfusionsvæske 0,9 % w/v).
English: OTHER SPECIAL WARNING(S), IF NECESSARY Use as directed by your physician EXPIRY DATE
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Anvendes som anvist af lægen UDLØBSDATO
English: Preparation of Flolan intravenous injectable solution:
Danish: Tilberedning af Flolan intravenøs infusionsvæske, opløsning:
English: Major clotting (dialysis permanently suspended, or requiring changing of artificial kidney) occurred in approximately 9% (n=56) of all epoprostenol dialyses and in <1% (n=1) of heparin dialyses in major controlled studies and emergency studies.
Danish: Væsentlig koagulation (permanent afbrydelse af dialysen eller påkrævet udskiftning af den kunstige nyre) forekom ved næsten 9 % (n=56) af alle epoprostenol-dialyserne og ved < 1 % (n=1) af heparindialyserne i de vigtigste kontrollerede studier og akutstudier.
English: Reconstitution:
Danish: Rekonstitution:
English: Skin and Subcutaneous Tissue Disorders Common
Danish: Hud og subkutane væv
English: The amount of sodium present in the reconstituted concentrate solution equals 55.9 mg approximately.
Danish: Mængden af natrium i den rekonstituerede koncentrerede opløsning svarer til ca. 55,9 mg.
English: 10 mL concentrated solution + 40 mL sodium chloride 0.9% w/v solution.
Danish: 10 ml koncentreret opløsning + 40 ml 0,9 % w/v natriumchloridinfusionsvæske.
English: Epoprostenol is the most potent inhibitor of platelet aggregation known.
Danish: Epoprostenol er den mest potente trombocytaggregationshæmmer, som kendes.
English: Where a pack containing 1.5 mg Flolan is reconstituted with 50 mL solvent the resultant concentration is 30,000 nanograms/mL.
Danish: Når en pakning indeholdende 1,5 mg Flolan rekonstitueres med 50 ml solvens, bliver den resulterende koncentration 30.000 nanogram/ml.
English: Stopping Flolan must be done gradually.
Danish: Hvis behandlingen med Flolan skal stoppes, skal det gøres gradvist.
English: Each vial contains either:
Danish: Hvert hætteglas indeholder:
English: The stability of solutions of Flolan is pH dependent.
Danish: Stabiliteten af Flolan-infusionsvæsken er pH-afhængig.
English: Twelve patients at very high risk of haemorrhage received 35 epoprostenol dialyses and 11 patients received 28 heparin dialyses in major controlled studies.
Danish: 12 patienter med meget høj risiko for blødning fik 35 epoprostenol-dialyser og 11 patienter fik 28 heparin-dialyser i de vigtigste kontrollerede studier.
English: Nineteen patients received 51 heparin dialyses and 19 received 44 epoprostenol dialyses in major controlled studies.
Danish: 19 patienter fik 51 heparin-dialyser, og 19 patienter fik 44 epoprostenol-dialyser i de vigtigste, kontrollerede studier.
English: Talk to your doctor or pharmacist or nurse about any other side effects, including those not listed in this leaflet.
Danish: Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke fremgår af denne indlægsseddel.
English: Pulmonary Arterial Hypertension Some patients with pulmonary arterial hypertension have developed pulmonary oedema during doseranging, which may be associated with pulmonary veno-occlusive disease.
Danish: Nogle patienter med pulmonal arteriel hypertension udvikler lungeødem under dosistitreringen, som kan associeres med pulmonal veneokklusionssygdom.
English: Flolan is used to treat a lung condition called ‘pulmonary arterial hypertension'.
Danish: Flolan anvendes til behandling af en sygdom, som kaldes ”pulmonal arteriel hypertension”.
English: Infusion rate (mL/h) = Infusion rate (mL/min) x 60
Danish: Infusionshastighed (ml/time) = Infusionshastighed (ml/min) x 60
English: Abdominal colic, sometimes reported as abdominal discomfort
Danish: Abdominale koliksmerter, nogle gange som abdominal utilpashed Ikke almindelig Mundtørhed
English: METHOD OF ADMINISTRATION Intravenous use
Danish: ADMINISTRATIONSMETODE Intravenøs anvendelse.
English: Following the administration of radiolabelled epoprostenol to humans, the urinary and faecal recoveries of radioactivity were 82% and 4%, respectively.
Danish: Genfundet radioaktivitet i urin og fæces var henholdsvis 82 % og 4 % efter administration af radioaktivt mærket epoprostenol til mennesker.
English: Freshly prepared epoprostenol solutions for the treatment of pulmonary arterial hypertension should be used within 12 hours at 25°C, or stored for up to 40 hours at between 2 to 8°C and then used within 8 hours at
Danish: Nyfremstillet epoprostenol-infusionsvæske til behandling af pulmonal arteriel hypertension skal anvendes inden for 12 timer ved 25 C eller opbevares i højst 40 timer i køleskab (2 C - 8 C) for derefter at blive anvendt inden for 8 timer ved 25 C.
English: When using a ‘cold pouch', the solution can be stored in the pump for up to 24 hours at 2-8oC if necessary.
Danish: Hvis du bruger en ”kold pose”, kan opløsningen om nødvendigt opbevares i pumpen i op til 24 timer ved 2 C - 8 C.
English: Flolan comes as a powder in a glass vial.
Danish: Flolan er et pulver i et hætteglas.
English: Elevated serum glucose levels have been reported (see section 4.8).
Danish: Forhøjet serumglucose er set (se pkt.
English: Pulmonary arterial hypertension
Danish: Pulmonary arteriel hypertension
English: Flolan has been successfully used instead of heparin in renal dialysis but in a small proportion of dialyses clotting has developed in the dialysis circuit, requiring termination of dialysis.
Danish: Flolan er blevet anvendt med succes i stedet for heparin ved hæmodialyse, men i enkelte tilfælde er der under brugen dannet koagler i dialyseapparatet, som krævede dialysestop.
English: If the initial infusion rate of 2 nanograms/kg/min is not tolerated, a lower dose which is tolerated by the patient should be identified.
Danish: Hvis den initiale infusionshastighed på 2 nanogram/kg/min ikke tåles, skal der findes en lavere dosis, der tåles af patienten.
English: Epoprostenol Sodium, the monosodium salt of epoprostenol, a naturally occurring prostaglandin produced by the intima of blood vessels.
Danish: Epoprostenolnatrium (mononatriumsalt af epoprostenol) er et naturligt forekommende prostaglandin, der syntetiseres af blodkarrenes intima.
English: 3 Bradycardia, sometimes accompanied by orthostatic hypotension, has occurred in healthy volunteers at doses of Flolan greater than 5 nanograms/kg/min.
Danish: 3 Bradykardi, sommetider ledsaget af ortostatisk hypotension, er set hos raske ved doser større end 5 nanogram/kg/min.