natgillin/translations-raw huggingface dataset:
Der skal anvendes sterilteknik ved opløsning af lægemidlet og i vedligeholdelsen af katetret. 
Sterile technique must be adhered to in preparing the drug and in the care of the catheter.
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. 
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.
Nogle lægemidler kan påvirke Flolans virkning eller medføre en øget risiko for, at du får bivirkninger. 
Some medicines may affect how Flolan works, or make it more likely that you'll have side effects.
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. 
There is no specific information on the use of Flolan in patients over 65 years for renal dialysis or pulmonary arterial hypertension.
Under dialyse: 4 nanogram/kg/min via dialyseapparatets arterielle indgang. 
During dialysis: 4 nanograms/kg/min into the arterial inlet of the dialyser
Opbevar solvensen ved temperaturer under 25 °C. 
Store the solvent below 25°C.
Filteret må kun anvendes én gang og skal derefter kasseres. 
The filter must be used once only and then discarded.
Infusionshastigheden kan beregnes ved hjælp af følgende formel: 
The infusion rate may be calculated from the following formula:
Dosisjustering: 
Dosage adjustments:
Natriumhydroxid (til pH -justering) 
Sodium Hydroxide (for pH adjustment)
Mediane baseline-værdier for den konventionelt behandlede gruppe og for gruppen, som fik epoprostenol + konventionel behandling, var henholdsvis 240 meter og 270 meter. 
The median baseline value for the conventional therapy group and epoprostenol plus conventional therapy group was 240 meters and 270 meters, respectively.
Højere cirkulerende doser af epoprostenol (20 nanogram/kg/min) dispergerer cirkulerende trombocytaggregater og øger den kutane blødningstid med op til det dobbelte. 
Higher circulating doses of epoprostenol (20 nanograms/kg/min) disperse circulating platelet aggregates and increase by up to two fold the cutaneous bleeding time.
Brat seponering af Flolan eller pludselige større reduktioner af infusionshastigheden skal undgås på grund af den potentielt letale rebound-effekt (se pkt. 
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).
Flolan gives som en langsom infusion (drop) i en blodåre (vene). 
Flolan is given by slow infusion (drip) into a vein.
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). 
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.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Anvendes som anvist af lægen UDLØBSDATO 
OTHER SPECIAL WARNING(S), IF NECESSARY Use as directed by your physician EXPIRY DATE
Tilberedning af Flolan intravenøs infusionsvæske, opløsning: 
Preparation of Flolan intravenous injectable solution:
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. 
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.
Rekonstitution: 
Reconstitution:
Hud og subkutane væv 
Skin and Subcutaneous Tissue Disorders Common
Mængden af natrium i den rekonstituerede koncentrerede opløsning svarer til ca. 55,9 mg. 
The amount of sodium present in the reconstituted concentrate solution equals 55.9 mg approximately.
10 ml koncentreret opløsning + 40 ml 0,9 % w/v natriumchloridinfusionsvæske. 
10 mL concentrated solution + 40 mL sodium chloride 0.9% w/v solution.
Epoprostenol er den mest potente trombocytaggregationshæmmer, som kendes. 
Epoprostenol is the most potent inhibitor of platelet aggregation known.
Når en pakning indeholdende 1,5 mg Flolan rekonstitueres med 50 ml solvens, bliver den resulterende koncentration 30.000 nanogram/ml. 
Where a pack containing 1.5 mg Flolan is reconstituted with 50 mL solvent the resultant concentration is 30,000 nanograms/mL.
Hvis behandlingen med Flolan skal stoppes, skal det gøres gradvist. 
Stopping Flolan must be done gradually.
Hvert hætteglas indeholder: 
Each vial contains either:
Stabiliteten af Flolan-infusionsvæsken er pH-afhængig. 
The stability of solutions of Flolan is pH dependent.
12 patienter med meget høj risiko for blødning fik 35 epoprostenol-dialyser og 11 patienter fik 28 heparin-dialyser i de vigtigste kontrollerede studier. 
Twelve patients at very high risk of haemorrhage received 35 epoprostenol dialyses and 11 patients received 28 heparin dialyses in major controlled studies.
19 patienter fik 51 heparin-dialyser, og 19 patienter fik 44 epoprostenol-dialyser i de vigtigste, kontrollerede studier. 
Nineteen patients received 51 heparin dialyses and 19 received 44 epoprostenol dialyses in major controlled studies.
Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke fremgår af denne indlægsseddel. 
Talk to your doctor or pharmacist or nurse about any other side effects, including those not listed in this leaflet.
Nogle patienter med pulmonal arteriel hypertension udvikler lungeødem under dosistitreringen, som kan associeres med pulmonal veneokklusionssygdom. 
Pulmonary Arterial Hypertension Some patients with pulmonary arterial hypertension have developed pulmonary oedema during doseranging, which may be associated with pulmonary veno-occlusive disease.
Flolan anvendes til behandling af en sygdom, som kaldes ”pulmonal arteriel hypertension”. 
Flolan is used to treat a lung condition called ‘pulmonary arterial hypertension'.
Infusionshastighed (ml/time) = Infusionshastighed (ml/min) x 60 
Infusion rate (mL/h) = Infusion rate (mL/min) x 60
Abdominale koliksmerter, nogle gange som abdominal utilpashed Ikke almindelig Mundtørhed 
Abdominal colic, sometimes reported as abdominal discomfort
ADMINISTRATIONSMETODE Intravenøs anvendelse. 
METHOD OF ADMINISTRATION Intravenous use
Genfundet radioaktivitet i urin og fæces var henholdsvis 82 % og 4 % efter administration af radioaktivt mærket epoprostenol til mennesker. 
Following the administration of radiolabelled epoprostenol to humans, the urinary and faecal recoveries of radioactivity were 82% and 4%, respectively.
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. 
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
Hvis du bruger en ”kold pose”, kan opløsningen om nødvendigt opbevares i pumpen i op til 24 timer ved 2 C - 8 C. 
When using a ‘cold pouch', the solution can be stored in the pump for up to 24 hours at 2-8oC if necessary.
Flolan er et pulver i et hætteglas. 
Flolan comes as a powder in a glass vial.
Forhøjet serumglucose er set (se pkt. 
Elevated serum glucose levels have been reported (see section 4.8).
Pulmonary arteriel hypertension 
Pulmonary arterial hypertension
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. 
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.
Hvis den initiale infusionshastighed på 2 nanogram/kg/min ikke tåles, skal der findes en lavere dosis, der tåles af patienten. 
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.
Epoprostenolnatrium (mononatriumsalt af epoprostenol) er et naturligt forekommende prostaglandin, der syntetiseres af blodkarrenes intima. 
Epoprostenol Sodium, the monosodium salt of epoprostenol, a naturally occurring prostaglandin produced by the intima of blood vessels.
3 Bradykardi, sommetider ledsaget af ortostatisk hypotension, er set hos raske ved doser større end 5 nanogram/kg/min. 
3 Bradycardia, sometimes accompanied by orthostatic hypotension, has occurred in healthy volunteers at doses of Flolan greater than 5 nanograms/kg/min.
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. 
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.
Eksempler på nogle koncentrationer, som almindeligvis anvendes ved pulmonal arteriel hypertension, er vist nedenfor. 
Examples for some concentrations commonly used in pulmonary arterial hypertension are shown below.
Meget sjælden Bleghed Luftveje, thorax og mediastinum Ikke kendt 
Respiratory, thoracic and mediastinal disorders Unknown
Rekonstitution og fortynding skal udføres lige inden anvendelse. 
Reconstitution and dilution should be carried out immediately prior to use.
Rekonstituerede opløsninger skal opbevares ved temperaturer under 25 °C og beskyttes mod lys. 
They should be kept under 25°C and protected from light.
Den rekonstituerede infusionsvæske skal inspiceres før administration. 
The reconstituted solution should be examined prior to administration.
Pulmonal arteriel hypertension 
Pulmonary Arterial Hypertension
Kortvarig (akut) dosistitrering: Denne procedure må kun udføres på hospitaler med hensigtsmæssigt nødhjælpsudstyr. 
This procedure should be conducted in a hospital with adequate resuscitation equipment.
Solvensen indeholder ikke konserveringsmiddel; derfor må hætteglasset kun anvendes én gang, hvorefter det kasseres. 
The solvent contains no preservative; consequently a vial should be used once only and then discarded.
Flolan indsprøjtes i en blodåre. 
Flolan is injected into a vein.
Hætteglas af klart (type 1)-glas med syntetisk butylgummiprop og en ekstern aluminiumskrage med ”flip-top” plastiktop. 
Clear (type 1) glass vials with synthetic butyl rubber stoppers and an external aluminium collar with a plastic flip-top cover.
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. 
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.
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). 
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.
Epoprostenol distribueres hurtigt fra blod til væv efter intravenøs administration. 
Intravenously administered epoprostenol is rapidly distributed from blood to tissue.
Øvrige indholdsstoffer er mannitol (E421), glycin, natriumchlorid, natriumhydroxid og vand. 
The other ingredients are Mannitol, Glycine, Sodium Chloride, Sodium Hydroxide and Water.
Rekonstituerede opløsninger må ikke administreres over mere end 12 timer, når de administreres ved stuetemperatur (mellem 15 °C og 25 °C). 
Reconstituted solutions must not be administered over more than 12 hours when they are used at room temperature (between 15°C and 25°C).
Ved samtidig indgift af NSAID eller andre lægemidler, der påvirker blodpladeaggregationen, er der øget blødningsrisiko. 
When NSAIDS or other drugs affecting platelet aggregation are used concomitantly, there is the potential for Flolan to increase the risk of bleeding.
Kontinuerlig langtidsinfusion af Flolan skal gives via et centralt venekateter. 
Long-term continuous infusion of Flolan should be administered through a central venous catheter.
Flolan er en infusionsvæske, der fremstilles ud fra pulver og solvens. 
Flolan is a solution for injection made up of powder and solution.
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). 
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).
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. 
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.
Hvis den maksimale, tålte infusionshastighed er mindre end 5 nanogram/kg/min, skal langtidsinfusionen indledes ved halvdelen af den maksimale, tålte infusionshastighed. 
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.
• ophobning af væske i lungerne (lungeødem) 
• build up of fluid in the lungs (pulmonary oedema)
Rekonstituerede opløsninger, tilberedt i realtime, må ikke administreres over mere end 12 timer ved stuetemperatur (mellem 15 °C og 25 °C). 
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).
Beskadigelse af huden ved injektionsstedet 
Skin damage at the injection site
• i højst 8 timer, hvis infusionsvæsken er tilberedt tidligere og har været opbevaret i køleskab 
• for a maximum of 8 hours if it was made previously and has been stored at 2-8oC.
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. 
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.
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. 
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.
Dosis skal muligvis sættes ned eller behandlingen stoppes. 
Your dose may need to be reduced or your infusion stopped.
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. 
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.
Ved overdosering forstærkes typisk de farmakologiske virkninger af lægemidlet (f.eks. hypotension og komplikationer i forbindelse med hypotension). 
In general, events seen after overdose of Flolan represent exaggerated pharmacological effects of the drug (e.g. hypotension and complications of hypotension).
Det vides ikke, om indholdsstofferne i Flolan bliver udskilt i mælk. 
It is not known whether the ingredients of Flolan can pass into breast-milk.
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. 
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.
Brug kun den medfølgende solvens til rekonstitution. 
Use only the solvent provided for reconstitution.
I tilfælde af overdosering kan hypotension være udtalt og resultere i bevidsthedstab (se pkt. 
Hypotension may be profound in overdose and may result in loss of consciousness (see section 4.9).
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). 
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).
Infusion af 4 nanogram/kg/min i 30 minutter er vist ikke at have signifikant effekt på hjertefrekvensen eller blodtrykket. 
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.
Mængden af natrium i solvens til parenteral anvendelse svarer til ca. 53,2 mg pr. hætteglas. 
The amount of sodium present in the solvent for parenteral use equals 53.2 mg approximately per vial.
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). 
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).
Det er en tilstand med forhøjet tryk i blodårerne i lungerne. 
This is where the pressure is high in the blood vessels in the lungs.
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. 
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.
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 
Decreased platelet count, bleeding at various sites (e.g. pulmonary, gastrointestinal, epistaxis, intracranial, post-procedural, retroperitoneal)
Hæmodialyse Flolan er kun indiceret til kontiunerlig infusion, enten intravenøst eller i blodet via dialyseapparatet. 
Flolan is suitable for continuous infusion only, either intravascularly or into the blood supplying the dialyser.
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). 
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).
Træk den fremstillede epoprostenol-opløsning op i injektionssprøjten og injicer den i den resterende mængde solvens og bland grundigt. 
Draw up the resulting Flolan solution into the syringe, re-inject it into the remaining volume of the solvent and mix thoroughly.
Under langtidsinfusion kan der opstå dosisrelaterede farmakologiske virkninger i lighed med dem, der ses ved dosistitreringen, og en nedsættelse af infusionshastigheden kan være nødvendig. 
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.
Efterfølgende kan der dannes blærer og hudafskalning. 
This may be followed by blistering and shedding of the skin.
• 0,5 mg epoprostenolnatrium 
• 0.5 mg epoprostenol sodium
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. 
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.
Kontinuerlig infusion af Flolan sker via et permanent centralt venekateter med en lille bærbar infusionspumpe. 
Flolan is infused continuously through a permanent indwelling central venous catheter via a small, portable infusion pump.
Amningen skal ophøre under behandling med Flolan. 
Breast-feeding should be discontinued during treatment with Flolan.
Dosis skal nedsættes gradvist med 2 nanogram/kg/min hvert 15. minut eller mere, indtil de dosisbegrænsende virkninger forsvinder. 
Dosage decreases should be made gradually in 2 nanograms/kg/min decrements every 15 min or longer until the dose-limiting effects resolve.
I disse tilfæld må infusionsvæsken ikke administreres over mere end 8 timer, når den administreres ved stuetemperatur. 
In this case, the solutions should not be used over more than 8 hours when administered at room temperature.