FrancophonIA/ELRC3.0 huggingface dataset:
English: If this happens, do not drive or use any tools or machines.
Danish: Hvis dette sker, må du ikke køre motorkøretøj eller bruge redskaber eller maskiner.
English: The tendency of tolerance development varies widely among individuals.
Danish: Tendensen til toleransudvikling varierer meget fra person til person.
English: • in adults who need continuous pain treatment
Danish: • hos voksne, som har brug for vedvarende smertebehandling
English: This is because the medicine may pass into breast milk.
Danish: Dette skyldes, at lægemidlet kan gå over i mælken.
English: Careful monitoring should be continued until stable drug effects are achieved.
Danish: Omhyggelig overvågning skal fortsættes, indtil der opnås en stabil lægemiddelvirkning.
English: Everyday activities while using the patches
Danish: Dagligdags aktiviteter, når du bruger plaster
English: • You have ever abused or been dependent on alcohol, prescription medicines or illegal drugs.
Danish: • Hvis du nogensinde har misbrugt eller været afhængig af alkohol, receptpligtige lægemidler eller ulovlige stoffer
English: • Difficulty getting and keeping an erection (impotence) or problems having sex
Danish: • Vanskeligheder med at opnå og fastholde erektion (impotens) eller problemer med at dyrke sex
English: You might need a different patch strength when you restart
Danish: Du skal muligvis bruge et plaster med en anden styrke, når du begynder igen
English: • You should change your patch every third day, unless your doctor has told you differently.
Danish: • Du skal skifte plastret hver tredje dag, medmindre lægen har sagt noget andet.
English: • You have pain which lasts only for a short period, such as sudden pain or pain after having an operation
Danish: • hvis du har smerter, som kun varer i en kort periode, som f.eks. akutte smerter eller smerter efter en operation
English: Your doctor will decide which strength of DUROGESIC is most suitable for you, taking into account the severity of your pain, your general condition and type of pain treatment that you have received so far.
Danish: Din læge vil beslutte, hvilken styrke af DUROGESIC der er bedst egnet til dig, under hensyntagen til, hvor svære dine smerter er, din generelle tilstand og typen af smertebehandling, du hidtil har fået.
English: • Seeing, feeling, hearing, or smelling things that are not there (hallucinations)
Danish: • Oplevelse af at se, føle, høre eller lugte ting, som ikke er der (hallucinationer)
English: • If you are using more than one patch, change all your patches at the same time.
Danish: • Hvis du bruger mere end ét plaster, skal du skifte dem alle på samme tidspunkt.
English: An optimal therapeutic concentration range of fentanyl can therefore not be established.
Danish: Et optimalt terapeutisk koncentrationsinterval for fentanyl kan derfor ikke fastsættes.
English: The patch should be used only on the skin of the person for whom it has been prescribed.
Danish: Plastret må kun bruges på huden på den person, som det er blevet ordineret til.
English: The patches help relieve pain that is very bad and long-lasting:
Danish: Plastrene hjælper med at lindre smerter, som er meget stærke og langvarige:
English: • Talk to your doctor before you stop using these patches
Danish: • Tal med din læge, før du holder op med at bruge disse plastre
English: {Name and address} <{tel}> <{fax}> <{e-mail}> <This medicinal product is authorised in the Member States of the EEA under the following names:> <{Name of the Member State}> <{Name of the medicinal product}> <{Name of the Member State}> <{Name of the medicinal product}> [See Annex I - To be completed nationally]
Danish: <Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: > <{Medlemslandets navn}> <{Lægemidlets navn}>
English: Your doctor will be able to tell you how long you can expect to use the patches
Danish: Lægen kan fortælle dig, hvor lang tid du skal forvente at skulle bruge plastrene
English: • Inspect the patch for any damage
Danish: • Kontrollér plastret for eventuel beskadigelse
English: • Each patch is sealed in its own sachet
Danish: • Hvert enkelt plaster er forseglet i sin egen pose
English: • Feeling of body temperature change
Danish: • Følelse af ændret kropstemperatur
English: • Take the patch out and use straight away
Danish: • Tag plastret ud og brug det med det samme
English: Depending on the additional analgesic needs and the pain status of the child, it may be decided to increase the dose.
Danish: Afhængigt af det yderligere behov for analgetika samt barnets smertestatus kan det besluttes at øge dosis.
English: A mutagenic risk for the use of therapeutic doses seems unlikely since effects appeared only at high concentrations.
Danish: En mutagen risiko ved anvendelse af terapeutiske doser forekommer at være usandsynlig, eftersom virkningen kun sås ved høje koncentrationer.
English: • Watch your child very closely for 48 hours after: - The first patch has been put on - A higher dose patch has been put on
Danish: • Hold barnet under nøje opsyn i 48 timer efter: - det første plaster er blevet sat på - et plaster med en højere styrke er blevet sat på
English: Centrally-acting medicinal products and alcohol
Danish: Centralt virkende lægemidler og alkohol
English: Effects on the embryo were due to maternal toxicity and not to direct effects of the substance on the developing embryo.
Danish: Virkningerne på embryonet skyldtes maternel toksicitet og ikke en direkte indvirkning af stoffet på det udviklende embryon.
English: Children 2 to 16 years old
Danish: Børn i alderen 2-16 år
English: Dosage must not be increased in intervals of less than 72 hours.
Danish: Dosis må ikke øges med intervaller mindre end 72 timer.
English: Stopping suddenly may make you feel unwell
Danish: Hvis du pludseligt holder op, kan det medføre, at du vil føle dig utilpas
English: • If you stop using the patches, don't start again without asking your doctor first.
Danish: • Hvis du holder op med at bruge plastrene, må du ikke begynde at bruge dem igen uden først at spørge lægen til råds.
English: • It is important that your child does not remove the patch and put it in their mouth as this could be life threatening or even fatal.
Danish: • Det er vigtigt, at barnet ikke fjerner plastret og putter det i munden, da dette kan være livsfarligt eller endog dødeligt.
English: • Do not stick a patch on straight after a hot bath or shower
Danish: • Lad være med at sætte plastret på umiddelbart efter et varmt bad eller brusebad
English: • Areas that you move a lot (joints), skin that is irritated or with cuts.
Danish: • Områder, som du bevæger meget (led), eller hud, der er irriteret eller har rifter.
English: If there is hair, do not shave it (shaving irritates the skin).
Danish: Hvis der er hår, skal du ikke barbere huden (barbering irriterer huden).
English: You may need to be closely monitored if you are taking some of the types of medicines listed below or if you stop taking some of the types of medicines listed below, as this may affect the strength of DUROGESIC you need.
Danish: Det kan være nødvendigt med tæt opfølgning, hvis du tager nogle af de lægemiddeltyper, der er anført herunder, eller hvis du holder op med at tage visse af de nedenfor anført typer af lægemidler, fordi det kan have indflydelse på, hvilken styrke af DUROGESIC du har brug for.
English: If you forget to change your patch
Danish: Hvis du glemmer at skifte plastret
English: It belongs to a group of strong painkillers called opioids.
Danish: Det tilhører en gruppe stærke smertestillende lægemidler, som kaldes opioider.
English: If you want to stop using the patches
Danish: Hvis du gerne vil holde op med at bruge plastrene
English: Do not drive while using this medicine until you know how it affects you.
Danish: Lad være med at køre, indtil du ved, hvordan det påvirker dig.
English: Both the minimum effective concentration and the toxic concentration increase with tolerance.
Danish: Både den mindste effektive koncentration og den toksiske koncentration øges ved toleransudvikling.
English: Step 5: Wash • Always wash your hands after you have handled the patch using clean water only
Danish: Trinp 5: Vask • Vask altid hænderne, efter du har håndteret et plaster.
English: Fever/external heat application
Danish: Feber/ekstern varmepåvirkning
English: Other factors to be considered are the current general condition and medical status of the patient, including body size, age, and extent of debilitation as well as degree of opioid tolerance.
Danish: Andre faktorer, der bør tages i betragtning, er patientens almentilstand og medicinske status, herunder legemsstørrelse, alder og grad af svækkelse samt graden af opioidtolerans.
English: • Always apply the patch to the upper back to make it difficult for your child to reach it or take it off.
Danish: • Sæt altid plastret fast på den øverste del af ryggen for at gøre det vanskeligt for barnet at nå det eller tage det af.
English: Therefore, the use of any of these medicinal products concomitantly with DUROGESIC requires special patient care and observation.
Danish: Derfor kræver anvendelse af ethvert af disse lægemidler samtidigt med DUROGESIC særlig patientomsorg og observation.
English: Opioids may cause hypotension, especially in patients with acute hypovolaemia.
Danish: Opioider kan medføre hypotension, specielt hos patienter med akut hypovolæmi.
English: If a patch falls off
Danish: Hvis et plaster falder af
English: • Feeling extremely happy (euphoria)
Danish: • Følelse af ekstrem lykke (eufori)
English: Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Danish: Tal med din læge eller apotekspersonalet, hvis du er usikker på, om det er sikkert for dig at køre, mens du bruger dette lægemiddel.
English: The major metabolite, norfentanyl, and other metabolites are inactive.
Danish: Hovedmetabolitten, norfentanyl, og andre metabolitter er inaktive.
English: In a study in cancer patients treated with transdermal fentanyl, plasma protein binding was on average 95% (range 77-100%).
Danish: I et studie med cancerpatienter, der blev behandlet med transdermalt fentanyl, var plasmaproteinbindingen i gennemsnit 95 % (interval 77-100 %).
English: • in children above 2 years of age who are already using opioid medication and who need continuous pain treatment.
Danish: • hos børn over 2 år, som allerede bruger medicin, der indeholder opioid, og som har brug for vedvarende smertebehandling.
English: Apply the patch to the skin by applying light pressure with the palm of the hand for about 30 seconds.
Danish: Sæt plastret på huden ved at trykke let med håndfladen i ca. 30 sekunder.
English: After an increase in dose, it may take up to 6 days for the patient to reach equilibrium on the new dose level.
Danish: Efter en øgning af dosis kan det tage op til 6 dage, før patienten når ækvilibrium ved det nye dosisniveau.
English: This effect could either be due to altered maternal care or a direct effect of fentanyl on the pups.
Danish: Denne virkning kan enten skyldes ændringer i moderdyrets pleje eller en direkte indvirkning af fentanyl på ungerne.
English: • Feeling very tired, weak or generally unwell
Danish: • Følelse af at være meget træt, svag eller generelt utilpas
English: Abuse or intentional misuse of DUROGESIC may result in overdose and/or death.
Danish: Misbrug eller forsætlig fejlagtig anvendelse af DUROGESIC kan resultere i overdosering og/eller død.
English: Calculate the 24-hour dose (mg/day) of the opioid currently being used.
Danish: Beregn 24-timers-dosis (mg/dag) af det opioid, der aktuelt anvendes.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Transdermal Use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Transdermal anvendelse
English: There are no adequate data from the use of DUROGESIC in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af DUROGESIC til gravide kvinder.
English: • Blue colour to the skin caused by low oxygen in the blood (cyanosis)
Danish: • Blåfarvning af huden på grund af lavt indhold af ilt i blodet (cyanose)
English: • Use each patch once only
Danish: • Brug kun plastret én gang
English: In such patients, opioids may decrease respiratory drive and increase airway resistance.
Danish: Hos sådanne patienter kan opioider nedsætte det respiratoriske drive og øge modstanden i luftvejene.
English: Standard reproductive and developmental toxicity studies have been carried out using parenteral administration of fentanyl.
Danish: Der er udført standardstudier af reproduktions- og udviklingstoksicitet med parenteral administration af fentanyl.
English: How long will you use the patches for?
Danish: Hvor længe skal jeg bruge plastrene?
English: Effects on somatic development and behaviour of the offspring were not observed.
Danish: Der sås ingen indvirkning på afkommets somatiske udvikling og adfærd.
English: • Always change your patch at the same time of day every 3 Days (72 hours).
Danish: • Skift altid plastret på det samme tidspunkt hver tredje dag (72 timer).
English: • If your pain gets worse while you are using these patches, your doctor may try a higher strength patch, or give you additional painkillers (or both)
Danish: • Hvis smerterne bliver værre, mens du bruger disse plastre, kan lægen forsøge med et plaster med en højere styrke eller give dig yderligere smertestillende midler (eller begge dele)
English: Adjustment of the individual fentanyl dose must be based on the patient's response and level of tolerance.
Danish: Justering af den individuelle fentanyldosis skal baseres på patientens respons og toleransniveau.
English: • You have a condition called ‘myasthenia gravis' in which muscles become weak and tire easily.
Danish: • Hvis du har en lidelse, der kaldes ‘myasthenia gravis', hvor musklerne bliver slappe og nemt bliver trætte
English: • Make sure your skin is completely dry, clean and cool before you put the patch on
Danish: • Sørg for, at huden er fuldstændig tør, ren og afkølet, før du sætter plastret på
English: The safety profile in children and adolescents treated with DUROGESIC was similar to that observed in adults.
Danish: Sikkerhedsprofilen hos børn og unge i behandling med DUROGESIC svarede til den, der sås hos voksne.
English: Children aged 16 years and above Follow adult dosage.
Danish: Børn på 16 år og derover Dosering som hos voksne.
English: Change the patch again after 3 days (72 hours) as usual.
Danish: Skift derefter plastret igen efter 3 dage (72 timer) som normalt.
English: • Let your doctor know this has happened and leave the patch on for another 3 days (72 hours) or as directed by your doctor, before changing the new patch as usual
Danish: • Fortæl lægen, hvad der er sket, og lad det nye plaster sidde i 3 dage (72 timer) eller i henhold til lægens anvisninger, før du skifter det som sædvanligt
English: The displayed frequency categories use the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Danish: De viste hyppighedsgrupper bruger følgende konvention: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • This medicine has been prescribed for you (or your child) only.
Danish: • Lægen har ordineret dette lægemiddel til dig (eller dit barn) personligt.
English: Fentanyl then becomes available to the systemic circulation.
Danish: Fentanyl bliver herefter tilgængeligt for det systemiske kredsløb.
English: Adjusting for body weight, clearance (L/h/kg) appears to be approximately 80% higher in children 2 to 5 years old and 25% higher in children 6 to 10 years old when compared to children 11 to 16 years old, who are expected to have a similar clearance as adults.
Danish: Justeret for legemsvægt synes clearance (l/time/kg) at være cirka 80 % højere hos børn i alderen 2 til 5 år og 25 % højere hos børn i alderen 6 til 10 år sammenlignet med børn i alderen 11 til 16 år, som forventes at have en clearance, der svarer til voksnes.
English: Your doctor will know which medicines are safe to take with DUROGESIC.
Danish: Din læge kan fortælle dig, hvilke lægemidler der er sikre at tage sammen med DUROGESIC.
English: • There is enough medicine in each patch to last 3 days (72 hours).
Danish: • Hvert enkelt plaster indeholder tilstrækkelig medicin til 3 dage (72 timer).
English: Erectile dysfunction, Sexual dysfunction
Danish: Erektil dysfunktion, Seksuel dysfunktion
English: • The following table shows you when to change your patch:
Danish: • Nedenstående skema viser dig, hvornår du skal skifte plastret:
English: Oral 24-hour morphine (mg/day)
Danish: Oral 24-timers morphin (mg/dag)
English: Patch sticking to another person
Danish: Hvis et plaster klæber fast til en anden person
English: Fentanyl is rapidly distributed to various tissues and organs, as indicated by the large volume of distribution (3 to 10 L/kg after intravenous dosing in patients).
Danish: Fentanyl fordeles hurtigt til forskellige væv og organer, som antydet af det store distributionsvolumen (3 til 10 l/kg efter intravenøs administration til patienter).
English: In a study on pre- and postnatal development the survival rate of offspring was significantly reduced at doses which slightly reduced maternal weight.
Danish: I et studie af præ- og postnatal udvikling sås en signifikant nedsat overlevelsesrate for afkommet ved doser, der medførte en lille reduktion i moderdyrets vægt.
English: Therefore, they must keep all patches out of the sight and reach of children, both before and after use.
Danish: Derfor skal alle plastre opbevares utilgængeligt for børn, både før og efter brug.
English: The pharmacokinetics of transdermal fentanyl do not change with repeated application.
Danish: Farmakokinetikken af transdermal fentanyl ændres ikke ved gentagen applikation.
English: This includes medicines that you buy without a prescription or herbal medicines.
Danish: Dette gælder også lægemidler købt uden reccept og naturmedicin.
English: b Based on single-dose studies in which an IM dose of each active substance listed was compared with morphine to establish the relative potency.
Danish: b Baseret på enkeltdosis-studier, hvor en i.m.-dosis af hvert af de anførte stoffer blev sammenlignet med morphin for at fastsætte den relative potens.
English: • Do not use the patch if it has been divided, cut or looks damaged
Danish: • Lad være med at bruge plastret, hvis der er blevet klippet i det, det er blevet delt, eller hvis det ser ud til at være beskadiget
English: High inter-subject variability in plasma concentrations has been observed.
Danish: Der er observeret store inter-individuelle forskelle i plasmakoncentrationen.
English: • Do not take the patch out of its sachet until you are ready to use it
Danish: • Lad være med at tage plastret ud af den beskyttende pose, før du er klar til at bruge det
English: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
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 apotekspersonalet til råds, før du bruger dette lægemiddel.
English: There are no clinical data on the effects of fentanyl on fertility.
Danish: Der er ingen kliniske data om indvirkningen af fentanyl på fertilitet.
English: After intravenous administration, fentanyl mean total clearance values across studies range in general between 34 and 66 L/h.
Danish: Efter intravenøs administration ligger de gennemsnitlige værdier for fentanyls samlede clearance på tværs af studierne generelt mellem 34 og 66 l/time.
English: It may take 20 hours or more for the fentanyl serum concentrations to decrease 50%.
Danish: Det kan tage 20 timer eller mere, før serumkoncentrationen af fentanyl er faldet med 50 %.
English: • Your doctor may give you other painkillers as well for the first day or so
Danish: • Lægen kan give dig andre smertestillende midler samtidigt den første dags tid
English: • Slow heart beat (bradycardia) or low blood pressure
Danish: • Langsom puls (bradykardi) eller lavt blodtryk
English: Follow the advice above and keep the person who was wearing the patch moving and talking as much as possible.
Danish: Følg ovenstående råd og hold personen, der bar plastret, i bevægelse og hold så vidt muligt gang i en samtale med personen.
English: • Every so often check that the patch remains stuck to the skin.
Danish: • Kontrollér med jævne mellemrum, at plastret stadig sidder fast på huden.
English: A carcinogenicity study (daily subcutaneous injections of fentanyl hydrochloride for two years in Sprague Dawley rats) did not induce any findings indicative of oncogenic potential.
Danish: Et karcinogenicitetsstudie (daglige subkutane injektioner af fentanylhydrochlorid i to år hos Sprague Dawley-rotter) gav ingen resultater, der kunne tyde på et onkogent potentiale.
English: • Always remove the old patch before applying a new one.
Danish: • Tag altid det gamle plaster af, før du sætter et nyt på.
English: Adequate body temperature and fluid intake should be maintained.
Danish: Passende kropstemperatur samt væskeindtagelse bør opretholdes.
English: • Make sure that the patch will be covered by loose clothing and not stuck under a tight or elasticated band
Danish: • Sørg for, at plastret placeres på et sted, hvor det vil være dækket af løstsiddende tøj og ikke under et stramt eller elastisk bånd
English: • Apply the patch on a flat part of your upper body or arm (not over a joint).
Danish: • Sæt plastret på en flad del af overkroppen eller overarmen (ikke over et led).
English: * the assigned frequency (uncommon) is based on analyses of incidence including only adult and paediatric clinical study subjects with non-cancer pain.
Danish: * Den tildelte hyppighed (ikke almindelig) er udelukkende baseret på analyser af forekomsten i kliniske studier hos børn og voksne med ikke-cancerrelaterede smerter.
English: • Make a note of the day, date and time you apply a patch, to remind you when you need to change your patch.
Danish: • Notér tidspunktet, dagen og datoen, hvor du sætter plastret på, for at minde dig selv om, hvornår du skal skifte plastret.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA <Not applicable>
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA <Ikke relevant.>
English: Hair at the application site (a non-hairy area is preferable) should be clipped (not shaved) prior to application.
Danish: Eventuelle hår på påsætningsstedet (et ubehåret område er at foretrække) skal klippes (ikke barberes) af før påsætning.
English: Bradycardia, Cyanosis
Danish: Bradykardi, cyanose
English: Excretion occurs primarily, as metabolites, with less than 10% of the dose excreted as unchanged active substance.
Danish: Udskillelsen sker primært som metabolitter, og mindre end 10 % af dosis udskilles som uomdannet aktivt stof.
English: A pharmacokinetic model has suggested that serum fentanyl concentrations may increase by 14% (range 0-26%) if a new patch is applied after 24 hours rather than the recommended 72-hour application.
Danish: En farmakokinetisk model peger på, at serumkoncentrationen af fentanyl kan øges med 14 % (interval 0-26 %), hvis et nyt plaster påsættes efter 24 timer i stedet for efter de anbefalede 72 timer.
English: Mutagenicity testing in bacteria and in rodents yielded negative results.
Danish: Tests af mutagenicitet i bakterier og gnavere gav negative resultater.
English: Caution should be exercised when treating patients with myasthenia gravis.
Danish: Der skal udvises forsigtighed ved behandling af patienter med myasthenia gravis.
English: • You have ever had persistent headaches or a head injury
Danish: • Hvis du nogensinde har lidt af vedvarende hovedpine eller er kommet til skade med hovedet
English: DUROGESIC has not been studied in children under 2 years of age.
Danish: DUROGESIC er ikke undersøgt hos børn under 2 år.