FrancophonIA/ELRC3.0 huggingface dataset:
English: It should be noted that this conversion schedule for children only applies to the switch from oral morphine (or its equivalent) to DUROGESIC patches.
Danish: Det skal bemærkes, at denne omregningstabel for børn kun gælder ved skift fra oral morphin (eller ækvivalente doser) til DUROGESIC-plastre.
English: Patients reach and maintain a steady-state serum concentration that is determined by individual variation in skin permeability and body clearance of fentanyl.
Danish: Patienterne opnår og opretholder en steady state serumkoncentration, der afhænger af de individuelle variationer i hudens permeabilitet og kroppens clearance af fentanyl.
English: Eighty of the children were aged 2 to 6 years, inclusive.
Danish: 80 af børnene var mellem 2 og 6 år gamle.
English: Repeated use of the patches may make the medicine become less effective (you become ‘tolerant' to it) or become dependent on it.
Danish: Gentagen anvendelse af plastrene kan bevirke, at lægemidlet bliver mindre effektivt (du udvikler ‘tolerans' over for det), eller at du bliver afhængig af det.
English: Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations; however, these patients will require monitoring for signs of misuse, abuse, or addiction.
Danish: Patienter med en øget risiko for opioidmisbrug kan stadig behandles passende med opioidformuleringer med modificeret udløsning, men disse patienter skal monitoreres for tegn på forkert brug, misbrug eller afhængighed.
English: For management of respiratory depression, immediate countermeasures include removing the DUROGESIC patch and physically or verbally stimulating the patient.
Danish: Ved respirationsdepression omfatter de øjeblikkelige modforanstaltninger fjernelse af DUROGESIC-plastret og fysisk eller verbal stimulering af patienten.
English: The average bioavailability of fentanyl after application of the transdermal patch is 92%.
Danish: Den gennemsnitlige biotilgængelighed af fentanyl efter påsætning af det transdermale plaster er 92 %.
English: If it does not, or if the patch irritates your skin badly, tell your doctor.
Danish: Hvis de ikke forsvinder, eller hvis plastret virker meget irriterende på huden, skal du fortælle det til lægen.
English: Fold the patch in the middle and remove each half of the liner separately.
Danish: Fold plastret på midten og fjern hver halvdel af beskyttelsesfilmen separat.
English: Patients with a prior history of drug dependence/alcohol abuse are more at risk to develop dependence and abuse in opioid treatment.
Danish: Patienter med tidligere stofafhængighed/alkoholmisbrug har større risiko for at udvikle afhængighed og misbrug i forbindelse med opioidbehandling.
English: This was determined in a human keratinocyte cell assay and in clinical studies in which 92% of the dose delivered from the system was accounted for as unchanged fentanyl that appeared in the systemic circulation.
Danish: Dette blev påvist i et humant keratinocyt-assay og i kliniske forsøg, hvor 92 % af den dosis, der blev frigivet fra plastret, blev påvist som uomdannet fentanyl i den systemiske cirkulation.
English: As for patients with Grade C liver disease (Child-Pugh Score = 12.5), the results indicate that fentanyl concentration accumulates with each administration, leading these patients to have an approximately 3.72 times larger AUC at steady state.
Danish: For patienter med leversygdom i klasse C (Child-Pugh-score = 12,5) tyder resultaterne på, at fentanyl akkumuleres ved hver administration, hvilket medfører, at disse patienter har et cirka 3,72 gange større AUC ved steady state.
English: • It may take some time for the patch to have its maximum effect.
Danish: • Det kan tage en vis tid, før den maksimale virkning opnås.
English: Acute or postoperative pain because there is no opportunity for dose titration during short-term use and because serious or life-threatening hypoventilation could result.
Danish: Akutte eller postoperative smerter, da det ikke er muligt at titrere dosis under korttidsbehandling, og fordi der kan opstå alvorlig eller livstruende hypoventilation.
English: Reversal of the narcotic effect may result in acute onset of pain and release of catecholamines.
Danish: Reversering af den narkotiske effekt kan resultere i akutte smerter og frigørelse af katekolaminer.
English: • If your doctor agrees, you can exercise or play sport while wearing the patch
Danish: • Hvis din læge siger, at det er i orden, kan du dyrke motion eller udøve sport, når du bærer et plaster
English: • Do not use soap or any other cleansers, creams, moisturisers, oils or talc before applying the patch
Danish: • Brug ikke sæbe eller andre hudrensemidler, cremer, fugtighedsgivere, olier eller talkum, før du sætter plastret på
English: Due to accumulation, the AUC and Cmax values over a dosing interval at steady state are approximately 40% higher than after a single application.
Danish: På grund af akkumulering er AUC og Cmax over et doseringsinterval ved steady state cirka 40 % højere end efter en enkelt påsætning.
English: Used patches should be folded so that the adhesive side of the patch adheres to itself and then they should be safely discarded.
Danish: Brugte plastre skal foldes, så den klæbende side af plastret klæber til sig selv, hvorefter de skal bortskaffes på sikker vis.
English: Pharmacotherapeutic group: Analgesics, Opioids, phenylpiperidine derivatives, ATC code: N02AB03
Danish: Farmakoterapeutisk klassifikation: Analgetika, opioider, phenylpiperidin-derivater ATC-kode: N02AB03.
English: Some patients may experience significant respiratory depression with DUROGESIC; patients must be observed for these effects.
Danish: Nogle patienter kan få signifikant respirationsdepression ved anvendelse af DUROGESIC, og patienterne bør observeres for denne virkning.
English: Fentanyl may produce bradycardia and should therefore be administered with caution to patients with bradyarrhythmias.
Danish: Fentanyl kan forårsage bradykardi og bør derfor anvendes med forsigtighed til patienter med bradyarytmi.
English: The minimum effective fentanyl concentration depends on the pain intensity and the previous use of opioid therapy.
Danish: Den mindste effektive fentanylkoncentration afhænger af smerteintensiteten og af tidligere opioidbehandling.
English: Underlying, symptomatic hypotension and/or hypovolaemia should be corrected before treatment with fentanyl transdermal patches is initiated.
Danish: Underliggende symptomatisk hypotension og/eller hypovolæmi skal korrigeres, før behandling med fentanyl transdermalt plaster initieres.
English: This delay is due to the gradual increase in serum fentanyl concentration in the 24 hours following initial patch application.
Danish: Denne forsinkelse skyldes den gradvise øgning af serumkoncentrationen af fentanyl i de første 24 timer efter påsætning.
English: The simulations suggest that the steady-state AUC of patients with Child-Pugh Grade B liver disease (Child-Pugh Score = 8) would be approximately 1.36 times larger compared with that of patients with normal liver function (Grade A; Child-Pugh Score = 5.5).
Danish: Simuleringerne peger på, at steady state AUC for patienter med leversygdom i Child-Pugh klasse B (Child-Pugh-score = 8) vil være cirka 1,36 gange højere sammenlignet med patienter med normal leverfunktion (klasse A; Child-Pugh-score = 5,5).
English: • Decreased feeling or sensitivity, especially in the skin (hypoaesthesia)
Danish: • Nedsat følsomhed, særligt i huden (hypæstesi)
English: Fentanyl accumulates in skeletal muscle and fat and is released slowly into blood.
Danish: Fentanyl akkumuleres i skeletmuskulatur og fedtvæv og frigives langsomt til blodet.
English: Fentanyl can be abused in a manner similar to other opioid agonists.
Danish: Fentanyl kan misbruges på samme måde som andre opioidagonister.
English: In young children, the upper back is the preferred location to minimize the potential of the child removing the patch.
Danish: Hos mindre børn foretrækkes den øverste del af ryggen for at minimere risikoen for, at barnet fjerner plastret.
English: DUROGESIC may impair mental and/or physical ability required for the performance of potentially hazardous tasks such as driving or operating machinery.
Danish: DUROGESIC kan påvirke de fysiske og/eller psykiske evner, der kræves for at kunne udføre potentielt farlige opgaver, som f.eks. at føre motorkøretøj eller betjene maskiner.
English: • Gently tear or cut off the edge of the sachet completely (if you use scissors, cut close to the sealed edge of the sachet to avoid damaging the patch)
Danish: • Riv eller klip forsigtigt kanten af posen helt af (hvis du bruger en saks, skal du klippe tæt på den forseglede kant for at undgå at komme til at klippe i plastret)
English: Oral doses are those recommended when changing from a parenteral to an oral route.
Danish: Orale doser er de anbefalede ved skift fra parenteral til oral dosering.
English: • Swollen hands, ankles or feet (peripheral oedema)
Danish: • Hævede hænder, ankler eller fødder (perifert ødem)
English: Bear in mind that a sticky patch (unused or used) could be tempting to a child and if it sticks to a child's skin or they put it in their mouth, the result may be fatal.
Danish: Husk, at et plaster (ubrugt eller brugt) kan virke fristende for et barn, og hvis det klæber til barnets hud, eller barnet putter det i munden, kan det have dødelige konsekvenser.
English: You should also tell your pharmacist that you are using DUROGESIC if you buy any medicines from your pharmacy.
Danish: Du bør også fortælle det til apotekspersonalet, at du bruger DUROGESIC, hvis du køber andre lægemidler på apoteket.
English: No risk was identified in the paediatric population beyond that expected with the use of opioids for the relief of pain associated with serious illness and there does not appear to be any paediatric-specific risk associated with DUROGESIC use in children as young as 2 years old when used as directed.
Danish: Der blev ikke identificeret nogen risiko for den pædiatriske population udover den, der forventes ved brug af opioider til smertelindring i forbindelse med alvorlig sygdom, og der synes ikke at være nogen specifik risiko forbundet med DUROGESIC til børn ned til 2 år, når lægemidlet anvendes som anvist.
English: Severe and unpredictable interactions with MAOIs, involving the potentiation of opiate effects or the potentiation of serotoninergic effects, have been reported.
Danish: Der er rapporteret om alvorlige og uforudsigelige interaktioner med MAO-hæmmere, som involverede potensering af opiate eller serotonerge virkninger.
English: Patches that are cut, divided, or damaged in any way should not be used.
Danish: Et plaster, der er klippet i, klippet over eller på anden måde beskadiget, må ikke anvendes.
English: The potential risk for humans is unknown, although fentanyl as an IV anaesthetic has been found to cross the placenta in human pregnancies.
Danish: Den potentielle risiko for mennesker er ukendt, selvom fentanyl som i.v.-anæstetikum hos mennesker er vist at kunne krydse placenta under graviditet.
English: Its primary therapeutic actions are analgesia and sedation.
Danish: Fentanyls primære terapeutiske virkning er analgesi og sedation.
English: However, your doctor may still prescribe extra painkillers from time to time
Danish: Lægen kan dog fra tid til anden ordinere yderligere smertestillende midler
English: Hyperhidrosis, Pruritus, Rash, Erythema
Danish: Hyperhidrose, pruritus, udslæt, erytem
English: DUROGESIC should not be used during pregnancy unless clearly necessary.
Danish: DUROGESIC bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: Within 72 hours of IV fentanyl administration, approximately 75% of the dose is excreted into the urine and approximately 9% of the dose into the faeces.
Danish: Inden for 72 timer efter i.v.-administration af fentanyl udskilles cirka 75 % af dosis i urinen og cirka 9 % af dosis i fæces.
English: Soaps, oils, lotions, or any other agent that might irritate the skin or alter its characteristics should not be used.
Danish: Sæbe, olie, lotion eller andet, som kan irritere huden eller påvirke den, må ikke anvendes.
English: The patches are designed to deliver approximately 12, 25, 50, 75, and 100 mcg/h fentanyl to the systemic circulation, which represent about 0.3, 0.6, 1.2, 1.8, and 2.4 mg per day respectively.
Danish: Plastrene er designet til at frigive hhv. ca. 12, 25, 50, 75 og 100 mikrogram fentanyl til det systemiske kredsløb per time, svarende til hhv. ca. 0,3, 0,6, 1,2, 1,8 og 2,4 mg dagligt.
English: Of the 289 subjects enrolled in these 3 studies, 110 initiated DUROGESIC treatment with a dosage of 12 mcg/h.
Danish: Af de 289 forsøgspersoner, der deltog i disse 3 studier, indledte 110 behandling med DUROGESIC med en dosis på 12 mikrog/time.
English: • After this, the patch should help to relieve pain continuously so that you can stop taking other painkillers.
Danish: • Herefter bør plastret alene være tilstrækkeligt til at give en vedvarende lindring af smerterne, så du ikke behøver tage andre smertestilende midler.
English: Using and changing the patches
Danish: Brug og skift af plastre
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <Date of first authorisation: {DD month YYYY}> <Date of latest renewal: {DD month YYYY}>
Danish: TILLADELSEN <Dato for første markedsføringstilladelse: {DD måned ÅÅÅÅ}> <Dato for seneste fornyelse: {DD måned ÅÅÅÅ}> [Udfyldes nationalt]
English: • DUROGESIC is a medicine that could be life-threatening to children, even if the patches have been used.
Danish: • DUROGESIC er et lægemiddel, som kan være livsfarligt for børn, også selv om plastret er brugt.
English: Caution is advised when DUROGESIC is co-administered with medicinal products that affect the serotonergic neurotransmitter systems.
Danish: Forsigtighed tilrådes, når DUROGESIC administreres sammen med lægemidler, der påvirker det serotonerge neurotransmittersystem.
English: The analgesic effect of the first dose of DUROGESIC patches will not be optimal within the first 24 hours.
Danish: Den analgetiske effekt af den første dosis af DUROGESIC-plaster er ikke optimal de første 24 timer.
English: Then wash hands with clean water.
Danish: Vask derefter hænderne med rent vand.
English: DUROGESIC should not be used during childbirth as the medication can affect the breathing of the newborn child.
Danish: DUROGESIC må ikke bruges under fødslen, eftersom lægemidlet kan påvirke det nyfødte barns vejrtrækning.
English: As a result of continued absorption of fentanyl from the skin depot after removal of the patch, the half-life of fentanyl after transdermal administration is about 2- to 3-fold longer than intravenous administration.
Danish: Som følge af den fortsatte absorption af fentanyl fra huden efter fjernelse af plastret er fentanyls halveringstid efter transdermal administration omkring 2 til 3 gange længere end efter i.v.-administration.
English: In particular, tell your doctor or pharmacist if you are taking:
Danish: Det er særligt vigtigt, at du fortæller det til lægen eller apotekspersonalet, hvis du tager:
English: Opioid-tolerant patients
Danish: Opioid-tolerante patienter
English: If the analgesic effect of DUROGESIC is insufficient, supplementary morphine or another short-duration opioid should be administered.
Danish: Hvis DUROGESICs analgetiske effekt er utilstrækkelig, bør der administreres supplerende morphin eller et andet opioid med kort virkningsvarighed.
English: UNIQUE IDENTIFIER - 2D BARCODE <Not applicable>
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE <Ikke relevant.>
English: A lag time of 12 to 24 hours after application of the first patch and after a dose increase must be taken into account.
Danish: Der skal tages højde for en forsinkelse på 12 til 24 timer efter påsætning af det første plaster og efter dosisøgning.
English: Do not use DUROGESIC after the expiry date which is stated on the carton and sachet.
Danish: Brug ikke DUROGESIC efter den udløbsdato, der står på æsken og posen.
English: The dose of DUROGESIC may need to be increased or a switch to another analgesic active substance may be needed.
Danish: Det kan være nødvendigt at øge dosis af DUROGESIC eller at skifte til et analgetikum med et andet aktivt stof.
English: Moreover, because fentanyl passes through the placenta, the use of DUROGESIC during childbirth might result in respiratory depression in the newborn infant.
Danish: Hertil kommer, at fordi fentanyl passerer placenta, kan brug af DUROGESIC under fødslen forårsage respirationsdepression hos det nyfødte barn.
English: Route of Administration
Danish: Administrationsvej
English: DUROGESIC should not be used in children aged less than 2 years because the safety and efficacy have not been established.
Danish: DUROGESIC bør ikke anvendes til børn under 2 år, da sikkerheden og virkningen ikke er klarlagt.
English: Patients who have experienced serious adverse events should be monitored for at least 24 hours after removal of DUROGESIC, or more, as clinical symptoms dictate, because serum fentanyl concentrations decline gradually and are reduced by about 50% 20 to 27 hours later.
Danish: Patienter, som har oplevet alvorlige bivirkninger, skal overvåges i mindst 24 timer efter fjernelse af DUROGESIC-plastret eller længere, hvis de kliniske symptomer indikerer dette, da serumkoncentrationen af fentanyl mindskes gradvist og er reduceret med ca. 50 % efter 20-27 timer.
English: Make sure it sticks well, especially the edges
Danish: Sørg for, at plastret sidder godt fast, især langs kanterne
English: • If a patch falls off before it needs changing, stick a new one on straight away and make note of the day and time.
Danish: • Hvis et plaster falder af, inden det er tid til at skifte det, skal du straks sætte et nyt plaster på og notere dag og tidspunkt.
English: Patients should be advised on measures to prevent constipation and prophylactic laxative use should be considered.
Danish: Patienterne skal informeres om forholdsregler for at forebygge obstipation, og profylaktisk brug af laksantia bør overvejes.
English: If discontinuation of DUROGESIC is necessary, replacement with other opioids should be gradual, starting at a low dose and increasing slowly.
Danish: Hvis seponering af DUROGESIC er nødvendig, bør skiftet til andre opioider foregå gradvist og starte med en lav dosis, som øges langsomt.
English: Use of DUROGESIC in the opioid-naïve patient has been associated with very rare cases of significant respiratory depression and/or fatality when used as initial opioid therapy, especially in patients with non-cancer pain.
Danish: Anvendelse af DUROGESIC hos opioid-naive patienter er blevet sat i forbindelse med meget sjældne tilfælde af signifikant respirationsdepression og/eller dødsfald, når det anvendes som indledende opioidbehandling, særligt hos patienter med ikke-cancerrelaterede smerter.
English: Use in elderly patients
Danish: Brug til ældre patienter
English: Following DUROGESIC application, the skin under the system absorbs fentanyl, and a depot of fentanyl concentrates in the upper skin layers.
Danish: Efter påsætning af DUROGESIC absorberer huden under plastret fentanyl, og et depot af fentanyl koncentreres i de øvre hudlag.
English: The potential for serious or life-threatening hypoventilation exists regardless of the dose of DUROGESIC transdermal system administered.
Danish: Potentialet for alvorlig eller livstruende hypoventilation eksisterer uanset den administrerede dosis af DUROGESIC depotplaster.
English: • You can shower or bathe while wearing a patch, but do not scrub the patch itself
Danish: • Du kan tage bruse- eller karbad, når du bærer et plaster, men du må ikke skrubbe på selve plastret
English: The adverse reactions reported with the use of DUROGESIC from these clinical studies, including the above-mentioned adverse reactions, and from post-marketing experiences are listed below in Table 5.
Danish: De bivirkninger, der er blevet rapporteret ved brug af DUROGESIC fra disse kliniske forsøg, inklusive ovennævnte bivirkninger, og efter markedsføring, er anført nedenfor i tabel 5.
English: DATE OF REVISION OF THE TEXT <{DD month YYYY}> [To be completed nationally]
Danish: DATO FOR ÆNDRING AF TEKSTEN <{DD måned ÅÅÅÅ}> [Udfyldes nationalt]
English: Some patients may require additional or alternative methods of opioid administration when the DUROGESIC dose exceeds 300 mcg/h.
Danish: Nogle patienter kan have behov for yderligere administration af opioid eller andre administrationsveje, når dosis af DUROGESIC overstiger 300 mikrog/time.
English: • If you get a fever while using DUROGESIC, tell your doctor - this may increase the amount of medicine that passes through your skin
Danish: • Hvis du får feber, mens du bruger DUROGESIC, skal du fortælle det til din læge - det kan nemlig medføre, at der trænger mere medicin gennem huden end normalt.
English: This is usually mild and disappears after you have removed the patch.
Danish: Disse gener er normalt lette og forsvinder, når du fjerner plastret.
English: Because fentanyl is metabolised to inactive metabolites in the liver, hepatic impairment might delay its elimination.
Danish: Da fentanyl metaboliseres til inaktive metabolitter i leveren, kan nedsat leverfunktion forsinke eliminationen.
English: The influence of renal impairment on the pharmacokinetics of fentanyl is expected to be limited because urinary excretion of unchanged fentanyl is less than 10% and there are no known active metabolites eliminated by the kidney.
Danish: Indvirkningen af nedsat nyrefunktion på fentanyls farmakokinetik forventes at være begrænset, fordi mindre end 10 % fentanyl udskilles uomdannet i urinen, og der ikke er kendte aktive metabolitter, der elimineres via nyrerne.
English: There is a high inter-subject variability in fentanyl pharmacokinetics, in the relationships between fentanyl concentrations, therapeutic and adverse effects, and in opioid tolerance.
Danish: Der er en høj inter-individuel variabilitet i fentanyls farmakokinetik, i forholdet mellem fentanylkoncentration, terapeutisk virkning og bivirkninger og i opioidtolerans.
English: The skin should be completely dry before the patch is applied.
Danish: Huden skal være fuldstændig tør, før plastret påsættes.
English: • Skin that is very hairy.
Danish: • Hud med kraftig hårvækst.
English: In the circumstance in which commencing with oral opioids is not considered possible and DUROGESIC is considered to be the only appropriate treatment option for opioid-naïve patients, only the lowest starting dose (ie, 12 mcg/h) should be considered.
Danish: I tilfælde, hvor initiering af behandlingen med orale opioider ikke anses for at være mulig, og DUROGESIC anses for at være den eneste egnede behandlingsmulighed for opioidnaive patienter, bør kun den laveste startdosis (dvs. 12 mikrog/time) overvejes.
English: Long term management of severe chronic pain in children from 2 years of age who are receiving opioid therapy.
Danish: Børn Langtidsbehandling af svære kroniske smerter hos børn over 2 år, der er i opioidbehandling.
English: • It may take some time for your first patch to have its maximum effect.
Danish: • Det kan tage en vis tid, før du opnår den maksimale effekt af det første plaster
English: Therefore, your child might need to use other painkillers as well until the patches become effective.
Danish: Derfor kan barnet have behov for at bruge andre smertestillende midler samtidigt, indtil plastret giver effekt.
English: In a study conducted with DUROGESIC, healthy elderly subjects had fentanyl pharmacokinetics which did not differ significantly from healthy young subjects although peak serum concentrations tended to be lower and mean half-life values were prolonged to approximately 34 hours.
Danish: I et studie med DUROGESIC havde raske ældre forsøgspersoner en fentanylfarmakokinetik, som ikke afveg væsentligt fra raske unge menneskers, selv om de maksimale serumkoncentrationer havde en tendens til at være lavere, og den gennemsnitlige halveringstid var forlænget til ca. 34 timer.
English: The serum fentanyl concentrations attained are proportional to the DUROGESIC patch size.
Danish: De opnåede serumkoncentrationer af fentanyl er proportionale med DUROGESIC-plastrets styrke.