FrancophonIA/ELRC3.0 huggingface dataset:
English: No statistical difference in survival over 12 weeks was observed in PAH/SSD patients treated with epoprostenol as compared to those receiving conventional therapy alone.
Danish: I løbet af 12-ugers-perioden blev der ikke observeret nogen statistisk forskel i overlevelse hos de PAH/SSD-patienter, som fik epoprostenol, sammenlignet med dem, som kun fik konventionel behandling.
English: Examples for some concentrations commonly used in pulmonary arterial hypertension are shown below.
Danish: Eksempler på nogle koncentrationer, som almindeligvis anvendes ved pulmonal arteriel hypertension, er vist nedenfor.
English: Respiratory, thoracic and mediastinal disorders Unknown
Danish: Meget sjælden Bleghed Luftveje, thorax og mediastinum Ikke kendt
English: Reconstitution and dilution should be carried out immediately prior to use.
Danish: Rekonstitution og fortynding skal udføres lige inden anvendelse.
English: They should be kept under 25°C and protected from light.
Danish: Rekonstituerede opløsninger skal opbevares ved temperaturer under 25 °C og beskyttes mod lys.
English: The reconstituted solution should be examined prior to administration.
Danish: Den rekonstituerede infusionsvæske skal inspiceres før administration.
English: Pulmonary Arterial Hypertension
Danish: Pulmonal arteriel hypertension
English: This procedure should be conducted in a hospital with adequate resuscitation equipment.
Danish: Kortvarig (akut) dosistitrering: Denne procedure må kun udføres på hospitaler med hensigtsmæssigt nødhjælpsudstyr.
English: The solvent contains no preservative; consequently a vial should be used once only and then discarded.
Danish: Solvensen indeholder ikke konserveringsmiddel; derfor må hætteglasset kun anvendes én gang, hvorefter det kasseres.
English: Flolan is injected into a vein.
Danish: Flolan indsprøjtes i en blodåre.
English: Clear (type 1) glass vials with synthetic butyl rubber stoppers and an external aluminium collar with a plastic flip-top cover.
Danish: Hætteglas af klart (type 1)-glas med syntetisk butylgummiprop og en ekstern aluminiumskrage med ”flip-top” plastiktop.
English: When reconstituted and diluted as directed above, Flolan infusion solutions have a pH of approximately 10 and will retain 90% of their initial potency for approximately 12 hours at 25°C.
Danish: Når Flolan infusionsvæske er rekonstitueret og fortyndet som anvist ovenfor, har infusionsvæsken en pH på ca. 10 og vil beholde 90 % af den initiale potens i ca. 12 timer ved 25 °C.
English: The decision to administer Flolan for pulmonary arterial hypertension should be based upon the patient's understanding that there is a high likelihood that therapy with Flolan will be needed for prolonged periods, possibly years, and the patient's ability to accept and care for a permanent i.v.
Danish: Beslutningen om behandling af pulmonal arteriel hypertension med Flolan skal baseres på patientens forståelse for, at det er overvejende sandsynligt, at behandling med Flolan vil være påkrævet i længere perioder (muligvis år).
English: Intravenously administered epoprostenol is rapidly distributed from blood to tissue.
Danish: Epoprostenol distribueres hurtigt fra blod til væv efter intravenøs administration.
English: The other ingredients are Mannitol, Glycine, Sodium Chloride, Sodium Hydroxide and Water.
Danish: Øvrige indholdsstoffer er mannitol (E421), glycin, natriumchlorid, natriumhydroxid og vand.
English: Reconstituted solutions must not be administered over more than 12 hours when they are used at room temperature (between 15°C and 25°C).
Danish: Rekonstituerede opløsninger må ikke administreres over mere end 12 timer, når de administreres ved stuetemperatur (mellem 15 °C og 25 °C).
English: When NSAIDS or other drugs affecting platelet aggregation are used concomitantly, there is the potential for Flolan to increase the risk of bleeding.
Danish: Ved samtidig indgift af NSAID eller andre lægemidler, der påvirker blodpladeaggregationen, er der øget blødningsrisiko.
English: Long-term continuous infusion of Flolan should be administered through a central venous catheter.
Danish: Kontinuerlig langtidsinfusion af Flolan skal gives via et centralt venekateter.
English: Flolan is a solution for injection made up of powder and solution.
Danish: Flolan er en infusionsvæske, der fremstilles ud fra pulver og solvens.
English: This solution is now referred to as the concentrated solution and contains either 10,000 (for the 0.5 mg strength) or 30,000 nanogram per mL Flolan (for the 1.5 mg strength).
Danish: Denne opløsning kaldes nu den koncentrerede opløsning og indeholder enten 10.000 nanogram Flolan/ml (for styrken 0,5 mg) eller 30.000 nanogram Flolan/ml (for styrken 1.5 mg).
English: Where the infusion pump allows the use of a cold pouch, epoprostenol solution may be used over a 24 hour period, provided that the cold pouch is changed as necessary throughout the day.
Danish: I de tilfælde, hvor det er mulig at anvende en kold pose i infusionspumpen, kan opløsningen administreres over en 24-timers periode, forudsat at den kolde pose skiftes som påkrævet i løbet af dagen.
English: If the maximum tolerated infusion rate is less than 5 nanograms/kg/min, the long-term infusion should be started at one-half the maximum tolerated infusion rate.
Danish: Hvis den maksimale, tålte infusionshastighed er mindre end 5 nanogram/kg/min, skal langtidsinfusionen indledes ved halvdelen af den maksimale, tålte infusionshastighed.
English: • build up of fluid in the lungs (pulmonary oedema)
Danish: • ophobning af væske i lungerne (lungeødem)
English: Reconstituted solutions, prepared in real time, must not be administered over more than 12 hours when they are used at room temperature (between 15°C and 25°C).
Danish: Rekonstituerede opløsninger, tilberedt i realtime, må ikke administreres over mere end 12 timer ved stuetemperatur (mellem 15 °C og 25 °C).
English: Skin damage at the injection site
Danish: Beskadigelse af huden ved injektionsstedet
English: • for a maximum of 8 hours if it was made previously and has been stored at 2-8oC.
Danish: • i højst 8 timer, hvis infusionsvæsken er tilberedt tidligere og har været opbevaret i køleskab
English: The combined baseline 6-minute walk test median values for the conventional therapy group and epoprostenol plus conventional therapy group was 266 meters and 301 meters, respectively.
Danish: De poolede baseline medianværdier for 6-minutters gang (6MWT) for den konventionelt behandlede gruppe og for gruppen, der fik epoprostenol + konventionel behandling, var henholdsvis 266 meter og 301 meter.
English: The effects of epoprostenol on platelet aggregation is dose-related when between 2 and 16 nanograms/kg/min is administered intravenously, and significant inhibition of aggregation induced by adenosine diphosphate is observed at doses of 4 nanograms/kg/min and above.
Danish: Epoprostenols effekt på trombocytaggregationen er dosisrelateret mellem 2 og 16 nanogram/kg/min givet intravenøst, og signifikant hæmning af aggregationen induceret af adenosindifosfat ses ved 4 nanogram/kg/min og derover.
English: Your dose may need to be reduced or your infusion stopped.
Danish: Dosis skal muligvis sættes ned eller behandlingen stoppes.
English: Conventional therapy varied among patients and included some or all of the following: anticoagulants in essentially all patients; oral vasodilators, diuretics, and digoxin in one half to two thirds of patients; and supplemental oxygen in about half the patients.
Danish: Den konventionelle behandling varierede fra patient til patient og inkluderede nogle eller samtlige af følgende behandlinger: antikoagulantia hos næsten alle patienter; orale vasodilatorer, diuretika og digoxin hos halvdelen til to tredjedele af patienterne og supplerende oxygen hos ca. halvdelen af patienterne.
English: In general, events seen after overdose of Flolan represent exaggerated pharmacological effects of the drug (e.g. hypotension and complications of hypotension).
Danish: Ved overdosering forstærkes typisk de farmakologiske virkninger af lægemidlet (f.eks. hypotension og komplikationer i forbindelse med hypotension).
English: It is not known whether the ingredients of Flolan can pass into breast-milk.
Danish: Det vides ikke, om indholdsstofferne i Flolan bliver udskilt i mælk.
English: Conventional therapy varied among patients and included some or all of the following: anticoagulants in essentially all patients, supplemental oxygen and diuretics in two thirds of the patients, oral vasodilators in 40% of the patients, and digoxin in a third of the patients.
Danish: Den konventionelle behandling var forskellig fra patient til patient og inkluderede nogle eller samtlige af følgende behandlinger: antikoagulantia hos næsten alle patienter, supplerende oxygen og diuretika hos to tredjedele af patienterne; orale vasodilatorer hos 40 % af patienterne og digoxin hos en tredjedel af patienterne.
English: Use only the solvent provided for reconstitution.
Danish: Brug kun den medfølgende solvens til rekonstitution.
English: Hypotension may be profound in overdose and may result in loss of consciousness (see section 4.9).
Danish: I tilfælde af overdosering kan hypotension være udtalt og resultere i bevidsthedstab (se pkt.
English: Over 12 weeks, a statistical difference (p<0.001) in the change from baseline for the 6MWT was observed in the group receiving epoprostenol and conventional therapy as compared to the group receiving conventional therapy alone (median: 63.5 vs. -36.0 meters; mean: 42.9 vs. -40.7 meters).
Danish: En statistisk forskel (p < 0,001) i ændringen fra baseline for 6MWT blev observeret i løbet af 12ugers-perioden hos gruppen, som fik epoprostenol + konventionel behandling, sammenlignet med gruppen, som kun fik konventionel behandling (median: 63,5 vs. -36,0 meter; gennemsnit: 42,9 vs.40,7 meter).
English: Infusion of 4 nanograms/kg/min for 30 minutes have been shown to have no significant effect on heart rate or blood pressure, although facial flushing may occur at these levels.
Danish: Infusion af 4 nanogram/kg/min i 30 minutter er vist ikke at have signifikant effekt på hjertefrekvensen eller blodtrykket.
English: The amount of sodium present in the solvent for parenteral use equals 53.2 mg approximately per vial.
Danish: Mængden af natrium i solvens til parenteral anvendelse svarer til ca. 53,2 mg pr. hætteglas.
English: Statistically significant improvement was observed in exercise capacity (p=0.001), as measured by the 6MWT in patients receiving continuous intravenous epoprostenol plus conventional therapy (N=52) for 8 or 12 weeks compared to those receiving conventional therapy alone (N=54) (combined week 8 and 12 change from baseline - median: 49 vs. -4 meters; mean: 55 vs. -4 meters).
Danish: En statistisk signifikant forbedring i funktionskapaciteten (p=0,001), målt ved 6MWT, blev observeret hos patienter, som fik kontinuerlig intravenøs epoprostenol + konventionel behandling (N=52) i 8 eller 12 uger sammenlignet med dem, som kun fik konventionel behandling (N=54) (kombineret ændring fra baseline i uge 8 og 12 - median: 49 vs. -4 meter; gennemsnit: 55 vs. -4 meter).
English: This is where the pressure is high in the blood vessels in the lungs.
Danish: Det er en tilstand med forhøjet tryk i blodårerne i lungerne.
English: Bleeding severity worsened during only 1 dialysis day with epoprostenol (N=1/16) whereas severity worsened during 5 dialysis days (N=5/25) and 2 predialysis days (N=2/13) with heparin.
Danish: Blødningens sværhedsgrad blev kun forværret under 1 dialyse-dag med epoprostenol (N=1/5), mens sværhedsgraden blev forværret under 5 dialyse-dage (N=5/25) og under 2 præ-dialysedage (N=2/13) med heparin.
English: Decreased platelet count, bleeding at various sites (e.g. pulmonary, gastrointestinal, epistaxis, intracranial, post-procedural, retroperitoneal)
Danish: Nedsat antal blodplader, blødning fra forskellige steder (f.eks. pulmonal, gastrointestinal, epistaxis, intrakraniel, post-procedure, retroperitoneal) Det endokrine system Meget sjældne Hypertyreose Psykiske forstyrrelser Almindelig
English: Flolan is suitable for continuous infusion only, either intravascularly or into the blood supplying the dialyser.
Danish: Hæmodialyse Flolan er kun indiceret til kontiunerlig infusion, enten intravenøst eller i blodet via dialyseapparatet.
English: Chronic continuous infusions of epoprostenol in patients with PAH/SSD were studied in a prospective, open, randomised trial of 12 weeks' duration comparing epoprostenol plus conventional therapy (N = 56) to conventional therapy alone (N = 55).
Danish: Kronisk kontinuerlig infusion af epoprostenol hos patienter med PAH/SSD blev undersøgt i et prospektivt, åbent, randomiseret studie af 12-ugers varighed, hvor epoprostenol + konventionel behandling (N=56) blev sammenlignet med konventionel behandling alene (N=55).
English: Draw up the resulting Flolan solution into the syringe, re-inject it into the remaining volume of the solvent and mix thoroughly.
Danish: Træk den fremstillede epoprostenol-opløsning op i injektionssprøjten og injicer den i den resterende mængde solvens og bland grundigt.
English: During long-term infusion, the occurrence of dose-related pharmacological events similar to those observed during the dose-ranging period may necessitate a decrease in infusion rate, but the adverse reactions may occasionally resolve without dosage adjustment.
Danish: Under langtidsinfusion kan der opstå dosisrelaterede farmakologiske virkninger i lighed med dem, der ses ved dosistitreringen, og en nedsættelse af infusionshastigheden kan være nødvendig.
English: This may be followed by blistering and shedding of the skin.
Danish: Efterfølgende kan der dannes blærer og hudafskalning.
English: • 0.5 mg epoprostenol sodium
Danish: • 0,5 mg epoprostenolnatrium
English: Chronic continuous infusions of epoprostenol in patients with idiopathic or heritable PAH were studied in 2 prospective, open, randomised trials of 8 and 12 weeks' duration (N=25 and N=81, respectively) comparing epoprostenol plus conventional therapy to conventional therapy alone.
Danish: Kronisk kontinuerlig infusion af epoprostenol hos patienter med idiopatisk eller arvelig PAH er blevet undersøgt i 2 prospektive, åbne, randomiserede studier af 8 og 12 ugers varighed (henholdsvis N=25 og N=81), hvor epoprostenol + konventionel behandling blev sammenlignet med konventionel behandling alene.
English: Flolan is infused continuously through a permanent indwelling central venous catheter via a small, portable infusion pump.
Danish: Kontinuerlig infusion af Flolan sker via et permanent centralt venekateter med en lille bærbar infusionspumpe.
English: Breast-feeding should be discontinued during treatment with Flolan.
Danish: Amningen skal ophøre under behandling med Flolan.
English: Dosage decreases should be made gradually in 2 nanograms/kg/min decrements every 15 min or longer until the dose-limiting effects resolve.
Danish: Dosis skal nedsættes gradvist med 2 nanogram/kg/min hvert 15. minut eller mere, indtil de dosisbegrænsende virkninger forsvinder.
English: In this case, the solutions should not be used over more than 8 hours when administered at room temperature.
Danish: I disse tilfæld må infusionsvæsken ikke administreres over mere end 8 timer, når den administreres ved stuetemperatur.
English: Changes in the long-term infusion rate should be based on persistence, recurrence or worsening of the patient's symptoms of pulmonary arterial hypertension or the occurrence of adverse reaction due to excessive doses of Flolan.
Danish: Langtidsinfusionshastigheden skal ændres, hvis patientens symptomer på pulmonal arteriel hypertension vedvarer, vender tilbage eller forværres, eller hvis der opstår bivirkninger på grund af en for høj dosis Flolan.
English: 6.6 Special precautions for disposal and other handling Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
English: 4.7 Effects on ability to drive and use machines Pulmonary arterial hypertension and its therapeutic management may affect the ability to drive and operate machinery.
Danish: Pulmonal arteriel hypertension og den terapeutiske behandling heraf kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: The effects of epoprostenol on mean pulmonary artery pressure (PAPm) in patients with PPH were variable and minor.
Danish: Hos patienter med PAH var virkningen af epoprostenol på det gennemsnitlige pulmonale arterietryk (PAPm) mindre og variabelt.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Each vial contains 50ml solvent for parenteral use.
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER Hvert hætteglas indeholder 50 ml solvens til parenteral anvendelse.
English: Solvent for parenteral use: glycine, sodium chloride, sodium hydroxide (for pH adjustment), water for injection
Danish: Solvens til parenteral anvendelse: glycin, natriumchlorid, natriumhydroxid (til pH-justering), vand til injektionsvæsker
English: Kidney dialysis You will be given an infusion of Flolan for the duration of your dialysis.
Danish: Dialyse Flolan vil blive givet som en infusion, mens du er i dialyse.
English: 2 Tachycardia has been reported as a response to Flolan at doses of 5 nanograms/kg/min and below.
Danish: 2 Takykardi er set ved doser på 5 nanogram/kg/min og derunder.
English: When all dialyses were combined, slightly more epoprostenol patients appeared to bleed during the predialysis (N=12/25 vs. 8/32), dialysis (23/44 vs. 14/51) and postdialysis (8/34 vs. 5/44) days compared to heparin patients during the same periods.
Danish: Når samtlige dialyser blev slået sammen, var der en lidt større andel af epoprostenol-patienterne, som blødte i løbet af præ-dialyse- (N=12/25 vs. 8/32), dialyse- (23/44 vs. 14/51) og post-dialyse(8/34 vs. 4/44) dagene, sammenlignet med heparin-patienterne i løbet af de samme perioder.
English: • infection of the blood (septicaemia)
Danish: • infektion i blodet (blodforgiftning)
English: These may affect up to 1 in 1,000 people:
Danish: Disse kan forekomme hos op til 1 ud af 1.000 personer:
English: Independent of technical difficulties which occurred rarely with either treatment, major dialysis-limiting clotting did not occur in 93% of all epoprostenol dialyses and 99% of all heparin dialyses.
Danish: Væsentlig dialyse-begrænsende koagulation forekom ikke ved 93 % af alle epoprostenol-dialyser og heller ikke ved 99 % af alle heparin-dialyser, uafhængigt af de tekniske vanskeligheder, som i sjældne tilfælde opstod ved begge behandlingsmetoder.
English: Dosage (nanograms/ kg/min)
Danish: Dosering (nanogram/ kg/ min)
English: During chronic therapy with Flolan the final concentration of solution may be increased by the addition of a further 0.5 mg or 1.5 mg vial of freezedried Flolan.
Danish: Ved kronisk behandling med Flolan kan koncentrationen af opløsningen øges ved tilsætning af yderligere et hætteglas med 0,5 mg eller 1,5 mg frysetørret Flolan.
English: Flolan can cause your heart to beat faster or slower.
Danish: Flolans virkning på blodtryk og hjertefrekvens (puls) Flolan kan medføre, at dit hjerte slår hurtigere eller langsommere.
English: Sodium Hydroxide (for pH adjustment) Water for Injection
Danish: Natriumhydroxid (til pH- justering) Vand til injektionsvæsker
English: An abrupt interruption of therapy can induce a rebound of pulmonary arterial hypertension resulting in dizziness, asthenia, increase dyspnoea, and may lead to death (see section 4.2).
Danish: Brat seponering kan inducere rebound pulmonal hypertension, som kan resultere i svimmelhed, asteni, øget dyspnø og medføre død.
English: dosage (nanogram/kg/min) x bodyweight (kg)
Danish: dosis (nanogram/kg/min) x legemsvægt (kg)
English: Sepsis, septicaemia (mostly related to delivery system for Flolan)1 Blood and Lymphatic System Disorders Common
Danish: Sepsis (for det meste relateret til udstyr og administrationssystem)1
English: a. Using concentrated solution, i.e. 10,000 nanograms/mL Flolan:
Danish: a. Anvendelse af koncentreret opløsning, dvs. 10.000 nanogram Flolan/ml
English: If you have any further questions, ask your doctor or pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen eller på apoteket.
English: Other common intravenous fluids are unsatisfactory for the dilution of the concentrated solution as the required pH is not attained.
Danish: Andre ofte anvendte intravenøse væsker er ikke egnede til fortynding af den koncentrerede opløsning, da pH kan ændres.
English: The vasodilator effects of Flolan may augment or be augmented by concomitant use of other vasodilators.
Danish: Flolans kardilaterende effekt kan forstærkes ved samtidig brug af andre vasodilatorer.
English: Long-term infusions should be initiated at 4 nanograms/kg/min less than the maximum tolerated infusion rate determined during short-term dose-ranging.
Danish: Langtidsinfusioner skal indledes med 4 nanogram/kg/min under den maksimale, tålte infusionshastighed, bestemt under den kortvarige dosistitrering.
English: Gastrointestinal Disorders Very common Nausea, vomiting, diarrhoea Common
Danish: Meget almindelig Kvalme, opkastning, diaré Almindelig
English: MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING LABEL for powder vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ INDRE EMBALLAGER ETIKET til hætteglas med pulver
English: This should be carried out according to the instructions given for renal dialysis.
Danish: Rekonstitution skal udføres, som beskrevet under instruktionerne ved hæmodialyse.
English: Elevated cAMP levels regulate intracellular calcium concentrations by stimulating calcium removal, and thus platelet aggregation is ultimately inhibited by the reduction of cytoplasmic calcium, upon which platelet shape change, aggregation and the release reaction depends.
Danish: Trombocytaggregationen hæmmes ved reduktionen af cytoplasmisk calcium, som blodpladernes form, aggregation og frigivelsesreaktioner afhænger af.
English: Flolan must not be used chronically in patients who develop pulmonary edema during dose initiation (see section 4.3).
Danish: Flolan må ikke administreres kronisk til patienter, som udvikler lungeødem under dosistitreringen (se pkt.
English: Powder and solvent for solution for infusion Powder for solution for infusion Solvent for parenteral use
Danish: Pulver og solvens til infusionsvæske, opløsning Pulver til infusionsvæske, opløsning Solvens til parenteral anvendelse
English: The amount of sodium present in the powder for solution for infusion equals 2.7 mg approximately per vial.
Danish: Mængden af natrium i pulver til infusionsvæske, opløsning svarer til ca. 2,7 mg pr. hætteglas.
English: • if you start to develop a build-up of fluid in your lungs causing breathlessness after starting this treatment.
Danish: - hvis du efter at være startet i denne behandling får åndenød på grund af begyndende ophobning af væske i lungerne.
English: Except for 2 New York Heart Association (NYHA) functional Class II patients, all patients were either functional Class III or Class IV. As results were similar in the 2 studies, the pooled results are described.
Danish: Med undtagelse af 2 patienter, som var klassificeret som NYHA (New York Heart Association)-funktionsklasse II-patienter, var alle patienter enten funktionsklasse III eller IV.
English: Those patients who continued to bleed were evaluated for changes in bleeding severity.
Danish: Blødningens sværhedsgrad blev undersøgt hos alle patienter, som fortsatte med at bløde.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for parenteral use for Flolan
Danish: LÆGEMIDLETS NAVN Solvens til parenteral anvendelse af Flolan Intravenøs anvendelse
English: • feeling anxious, feeling nervous
Danish: • følelse af angst eller nervøsitet
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON box for powder vials and solvent vials:
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE til hætteglas med pulver og hætteglas med solvens
English: • medicines used to prevent blood clots
Danish: • medicin, som forhindrer blodpropper