natgillin/translations-raw huggingface dataset:
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.
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.
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.
Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
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.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Pulmonal arteriel hypertension og den terapeutiske behandling heraf kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
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.
Hos patienter med PAH var virkningen af epoprostenol på det gennemsnitlige pulmonale arterietryk (PAPm) mindre og variabelt.
The effects of epoprostenol on mean pulmonary artery pressure (PAPm) in patients with PPH were variable and minor.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER Hvert hætteglas indeholder 50 ml solvens til parenteral anvendelse.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Each vial contains 50ml solvent for parenteral use.
Solvens til parenteral anvendelse: glycin, natriumchlorid, natriumhydroxid (til pH-justering), vand til injektionsvæsker
Solvent for parenteral use: glycine, sodium chloride, sodium hydroxide (for pH adjustment), water for injection
Dialyse Flolan vil blive givet som en infusion, mens du er i dialyse.
Kidney dialysis You will be given an infusion of Flolan for the duration of your dialysis.
2 Takykardi er set ved doser på 5 nanogram/kg/min og derunder.
2 Tachycardia has been reported as a response to Flolan at doses of 5 nanograms/kg/min and below.
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.
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.
• infektion i blodet (blodforgiftning)
• infection of the blood (septicaemia)
Disse kan forekomme hos op til 1 ud af 1.000 personer:
These may affect up to 1 in 1,000 people:
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.
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.
Dosering (nanogram/ kg/ min)
Dosage (nanograms/ kg/min)
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.
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.
Flolans virkning på blodtryk og hjertefrekvens (puls) Flolan kan medføre, at dit hjerte slår hurtigere eller langsommere.
Flolan can cause your heart to beat faster or slower.
Natriumhydroxid (til pH- justering) Vand til injektionsvæsker
Sodium Hydroxide (for pH adjustment) Water for Injection
Brat seponering kan inducere rebound pulmonal hypertension, som kan resultere i svimmelhed, asteni, øget dyspnø og medføre død.
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).
dosis (nanogram/kg/min) x legemsvægt (kg)
dosage (nanogram/kg/min) x bodyweight (kg)
Sepsis (for det meste relateret til udstyr og administrationssystem)1
Sepsis, septicaemia (mostly related to delivery system for Flolan)1 Blood and Lymphatic System Disorders Common
a. Anvendelse af koncentreret opløsning, dvs. 10.000 nanogram Flolan/ml
a. Using concentrated solution, i.e. 10,000 nanograms/mL Flolan:
Er du i tvivl, så spørg lægen eller på apoteket.
If you have any further questions, ask your doctor or pharmacist or nurse.
Andre ofte anvendte intravenøse væsker er ikke egnede til fortynding af den koncentrerede opløsning, da pH kan ændres.
Other common intravenous fluids are unsatisfactory for the dilution of the concentrated solution as the required pH is not attained.
Flolans kardilaterende effekt kan forstærkes ved samtidig brug af andre vasodilatorer.
The vasodilator effects of Flolan may augment or be augmented by concomitant use of other vasodilators.
Langtidsinfusioner skal indledes med 4 nanogram/kg/min under den maksimale, tålte infusionshastighed, bestemt under den kortvarige dosistitrering.
Long-term infusions should be initiated at 4 nanograms/kg/min less than the maximum tolerated infusion rate determined during short-term dose-ranging.
Meget almindelig Kvalme, opkastning, diaré Almindelig
Gastrointestinal Disorders Very common Nausea, vomiting, diarrhoea Common
MINDSTEKRAV TIL MÆRKNING PÅ INDRE EMBALLAGER ETIKET til hætteglas med pulver
MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING LABEL for powder vial
Rekonstitution skal udføres, som beskrevet under instruktionerne ved hæmodialyse.
This should be carried out according to the instructions given for renal dialysis.
Trombocytaggregationen hæmmes ved reduktionen af cytoplasmisk calcium, som blodpladernes form, aggregation og frigivelsesreaktioner afhænger af.
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.
Flolan må ikke administreres kronisk til patienter, som udvikler lungeødem under dosistitreringen (se pkt.
Flolan must not be used chronically in patients who develop pulmonary edema during dose initiation (see section 4.3).
Pulver og solvens til infusionsvæske, opløsning Pulver til infusionsvæske, opløsning Solvens til parenteral anvendelse
Powder and solvent for solution for infusion Powder for solution for infusion Solvent for parenteral use
Mængden af natrium i pulver til infusionsvæske, opløsning svarer til ca. 2,7 mg pr. hætteglas.
The amount of sodium present in the powder for solution for infusion equals 2.7 mg approximately per vial.
- hvis du efter at være startet i denne behandling får åndenød på grund af begyndende ophobning af væske i lungerne.
• if you start to develop a build-up of fluid in your lungs causing breathlessness after starting this treatment.
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.
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.
Blødningens sværhedsgrad blev undersøgt hos alle patienter, som fortsatte med at bløde.
Those patients who continued to bleed were evaluated for changes in bleeding severity.
LÆGEMIDLETS NAVN Solvens til parenteral anvendelse af Flolan Intravenøs anvendelse
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for parenteral use for Flolan
• følelse af angst eller nervøsitet
• feeling anxious, feeling nervous
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE til hætteglas med pulver og hætteglas med solvens
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON box for powder vials and solvent vials:
• medicin, som forhindrer blodpropper
• medicines used to prevent blood clots
Denne opløsning kaldes nu den koncentrerede opløsning og indeholder 10.000 nanogram Flolan/ml.
This solution is now referred to as the concentrated solution and contains 10,000 nanograms/mL Flolan.
• medicin som opløser blodpropper
• medicines used to dissolve blood clots
Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne:> [Se bilag I - Udfyldes nationalt]
This medicinal product is authorised in the Member States of the EEA under the following names:
INFORMATION I BRAILLESKRIFT [Udfyldes nationalt]
INSTRUCTIONS ON USE [To be completed nationally] INFORMATION IN BRAILLE [To be completed nationally]
For at fortynde den koncentrerede opløsning skal man trække den op i en større injektionssprøjte og derefter fastgøre det vedlagte filter på injektionssprøjten.
To dilute the concentrated solution, draw it up into a larger syringe and then attach the sterile filter provided to the syringe.
Infusionshastigheden kan beregnes ved hjælp af formlen ved hæmodialyse ovenfor.
The infusion rate may be calculated from the formula given above for renal dialysis.
Pakningen, som er egnet til anvendelse ved hæmodialyse, indeholder 0,5 mg frysetørret Flolan og 50 ml solvens.
The pack suitable for use in renal dialysis contains 0.5 mg freeze-dried Flolan plus 50 mL solvent.