FrancophonIA/ELRC3.0 huggingface dataset:
English: Data from intravenous studies with fentanyl suggest that elderly patients may have reduced clearance, a prolonged half-life, and they may be more sensitive to the drug than younger patients.
Danish: Data fra studier med intravenøst fentanyl tyder på, at ældre patienter kan have nedsat clearance og forlænget halveringstid, og at de kan være mere følsomme over for lægemidlet end yngre patienter.
English: Make certain that the edges of the patch are adhering properly.
Danish: Sørg for, at plastrets kanter klæber godt fast.
English: To convert opioid-tolerant patients from oral or parenteral opioids to DUROGESIC refer to Equianalgesic potency conversion below.
Danish: Ved omstilling af opioid-tolerante patienter fra orale eller parenterale opioider til DUROGESIC henvises til nedenstående tabel med ækvianalgetiske doser.
English: Fentanyl is a high clearance active substance and is rapidly and extensively metabolised primarily by CYP3A4 in the liver.
Danish: Fentanyl er et lægemiddelstof med en høj clearance, og det bliver hurtigt og ekstentivt metaboliseret, hovedsageligt af CYP3A4 i leveren.
English: The name of your medicine is DUROGESIC
Danish: Navnet på lægemidlet er DUROGESIC.
English: Rare side effects (may affect up to 1 in 1000 people)
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1000 personer)
English: Serotonin syndrome may include mental-status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (eg, hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhoea).
Danish: Serotoninsyndromet kan omfatte ændringer i den mentale tilstand (f.eks. agitation, hallucinationer, koma), autonom ustabilitet (f.eks. takykardi, labilt blodtryk, hypertermi), neuromuskulære forstyrrelser (f.eks. hyperrefleksi, manglende koordination, rigiditet) og/eller gastrointestinale symptomer (f.eks. kvalme, opkastning, diaré).
English: The concomitant use of transdermal fentanyl with CYP3A4 inducers may result in a decrease in fentanyl plasma concentrations and a decreased therapeutic effect.
Danish: Samtidig anvendelse af transdermalt fentanyl og CYP3A4-induktorer kan resultere i et fald i plasmakoncentrationen af fentanyl og en reduceret terapeutisk virkning.
English: • Medicines used to treat HIV infection (such as ritonavir).
Danish: • Lægemidler til behandling af hiv-infektion (som f.eks. ritonavir)
English: Data from intravenous studies with fentanyl suggest that elderly patients may have reduced clearance, a prolonged half-life, and they may be more sensitive to the active substance than younger patients.
Danish: Data fra studier med i.v.-fentanyl tyder på, at ældre patienter kan have nedsat clearance, forlænget halveringstid, og at de kan være mere følsomme over for det aktive stof end yngre patienter.
English: In a rat study fentanyl did not influence male fertility.
Danish: I et rottestudie påvirkede fentanyl ikke handyrenes fertilitet.
English: DUROGESIC and alcohol Do not drink alcohol while using DUROGESIC unless you have talked to your doctor first.
Danish: Undlad at drikke alkohol, mens du er i behandling med DUROGESIC, medmindre du har talt med lægen om det først.
English: If concomitant use of DUROGESIC with a CYP3A4 inhibitor cannot be avoided, close monitoring for signs or symptoms of increased or prolonged therapeutic effects and adverse effects of fentanyl (in particular respiratory depression) is warranted, and the DUROGESIC dosage must be reduced or interrupted as deemed necessary (see section 4.5).
Danish: Hvis samtidig anvendelse af DUROGESIC og en CYP3A4-hæmmer ikke kan undgås, skal patienten monitoreres nøje for symptomer på øget eller forlænget terapeutisk virkning og bivirkninger af fentanyl (særligt respirationsdepression), og DUROGESIC-dosis skal reduceres eller behandlingen afbrydes efter behov (se pkt.
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}.> [Udfyldes nationalt]
English: Table 4: Recommended DUROGESIC dosage for paediatric patients1 based upon daily oral morphine dose2
Danish: Tabel 4: Anbefalet dosis af DUROGESIC til pædiatriske patienter1 på baggrund af daglig dosis oral morphin2
English: It is recommended that DUROGESIC be used in patients who have demonstrated opioid tolerance.
Danish: Det anbefales, at DUROGESIC anvendes til patienter, som har udviklet opioidtolerans.
English: Fatigue, Oedema peripheral, Asthenia, Malaise, Feeling cold
Danish: Træthed, perifert ødem, asteni, utilpashed, kuldefølelse
English: Used patches should be folded firmly in half so that the sticky side of the patch sticks to itself.
Danish: Brugte plastre skal foldes sammen på midten, så den klæbende side klæber fast til sig selv.
English: • Grasp both sides of the opened sachet and pull apart
Danish: • Tag fat i begge sider af posen og åbn den ved at trække siderne fra hinanden
English: Therefore, patients with fever should be monitored for opioid undesirable effects and the DUROGESIC dose should be adjusted if necessary.
Danish: Derfor bør patienter med feber monitoreres for opioid-bivirkninger, og om nødvendigt skal DUROGESIC-dosis justeres.
English: DUROGESIC should be administered only to opioid-tolerant children age 2 years or older (see section 4.2).
Danish: DUROGESIC bør kun administreres til opioid-tolerante børn i alderen 2 år og derover (se pkt.
English: - see below for more information
Danish: Pakningsstørrelser og yderligere oplysninger
English: What you need to know before you use DUROGESIC
Danish: Det skal du vide, før du begynder at bruge DUROGESIC
English: The risk of side effects increases if you are taking medicines such as certain antidepressants.
Danish: Brug af DUROGESIC sammen med lægemidler mod depression (antidepressiva) Risikoen for bivirkninger øges, hvis du tager lægemidler som f.eks. visse midler mod depression.
English: Do not apply the patch on
Danish: Sæt ikke plastret på
English: The safety of DUROGESIC was evaluated in 3 open-label studies in 289 paediatric subjects with chronic pain, aged 2 to 17 years, inclusive.
Danish: DUROGESICs sikkerhed blev evalueret i 3 åbne studier med 289 pædiatriske forsøgspersoner med kroniske smerter.
English: Dose adjustments should be done in 12 mcg/h steps.
Danish: Dosis bør justeres med 12 mikrog/time ad gangen.
English: Equianalgesic potency conversion In patients currently taking opioid analgesics, the starting dose of DUROGESIC should be based on the daily dose of the prior opioid.
Danish: Ækvianalgetiske doser ved omstilling Startdosis af DUROGESIC til patienter, som aktuelt tager opioid-analgetika, bør baseres på den daglige dosis af det tidligere opioid.
English: Patients should be advised that if accidental patch transfer occurs, the transferred patch must be removed immediately from the skin of the non-patch wearer (see section
Danish: Patienterne skal informeres om, at hvis et plaster ved en fejltagelse overføres til en anden person, skal plastret straks fjernes hos denne person (se pkt.
English: 1 Conversion to DUROGESIC dosages greater than 25 mcg/h is the same for paediatric patients as it is for adult patients
Danish: 1 Omregning til DUROGESIC-doser højere end 25 mikrog/time er ens for voksne og børn (se tabel 2).
English: • While you are wearing the patch do not expose it to direct heat such as heating pads, electric blankets, hot-water bottles, heated water beds, heat or tanning lamps.
Danish: • Mens du bærer plastret, må du ikke udsætte det for direkte varmekilder som f.eks. varmepuder, elektriske tæpper, varmedunke, opvarmede vandsenge eller varme- eller solarielamper.
English: The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic active substances such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with active substances which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]).
Danish: Potentielt livstruende serotoninsyndrom kan udvikles ved samtidig anvendelse af serotonerge lægemidler såsom selektive serotoningenoptagelseshæmmere (SSRI'er) og serotonin- og noradrenalingenoptagelseshæmmere (SNRI'er), og af lægemidler, der nedsætter metaboliseringen af serotonin - herunder monoaminoxidasehæmmere (MAO-hæmmere).
English: How long to keep DUROGESIC for
Danish: Hvor længe kan DUROGESIC holde
English: • You have ever had a brain tumour
Danish: • Hvis du har eller har haft en svulst i hjernen
English: Concomitant use of mixed opioid agonists/antagonists The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended.
Danish: Samtidig anvendelse af partielle opioidagonister/-antagonister Samtidig anvendelse af buprenorphin, nalbuphin eller pentazocin frarådes.
English: • Your child's upper back
Danish: • Øverst på ryggen, hvis patienten er et barn
English: The adverse reactions are presented by System Organ Class and in order of decreasing seriousness within each frequency category.
Danish: Bivirkningerne er opstillet efter systemorganklasse og hyppighed, og de alvorligste bivirkninger i hver hyppighedsgruppe er anført først.
English: • Repeated, long term use of the patches may make the medicine less effective (you become ‘tolerant' to it) or you may become dependent on it. See section 4 for a full list of possible side effects.
Danish: • Gentagen og langvarig brug af plastrene kan gøre medicinen mindre effektiv (du udvikler ‘tolerans' over for den), eller du kan blive afhængig af den.
English: • Stomach pain or indigestion
Danish: • Mavesmerter eller fordøjelsesbesvær
English: Patients may require periodic supplemental doses of a short acting analgesic for “breakthrough” pain.
Danish: Visse patienter kan i perioder have behov for supplement med korttidsvirkende analgetika i tilfælde af gennembrudssmerter.
English: DUROGESIC provides continuous systemic delivery of fentanyl during the 72-hour application period.
Danish: DUROGESIC frigiver fertanyl kontinuerligt til det systemiske kredsløb i en påsætningsperiode på 72 timer.
English: • Keep the empty sachet to dispose of the used patch later
Danish: • Gem den brugte pose, så du kan bruge den, når du senere skal kassere det brugte plaster
English: Central nervous system depressants may increase the respiratory depression (see section 4.5).
Danish: CNS-supprimerende stoffer kan forstærke respirationsdepressionen (se pkt.
English: • Being short of breath (dyspnoea)
Danish: • Kortåndethed (dyspnø)
English: • Loss of contractions of the gut (ileus)
Danish: • Manglende tarmbevægelser (ileus)
English: However, as the influence of renal impairment on the pharmacokinetics of fentanyl has not been evaluated, caution is advised (see sections 4.2 and 4.4).
Danish: Men eftersom indvirkningen af nedsat nyrefunktion på fentanyls farmakokinetik ikke er blevet evalueret, skal der udvises forsigtighed (se pkt.
English: When you are wearing the patch do not expose it to direct heat such as heating pads, electric blankets, hot-water bottles, heated water beds or heat or tanning lamps.
Danish: Når du bærer plastret, må du ikke udsætte det for direkte varmekilder som f.eks. varmepuder, elektriske tæpper, varmedunke, opvarmede vandsenge eller varme- eller solarielamper.
English: There have been very rare reports of newborn infants experiencing neonatal withdrawal syndrome when mothers chronically used DUROGESIC during pregnancy (see section 4.6).
Danish: Meget sjældent er der rapporteret om nyfødte, der oplevede neonatale abstinenssymptomer, når moderen havde brugt DUROGESIC kronisk under graviditeten (se også pkt.
English: Dose titration and maintenance therapy The DUROGESIC patch should be replaced every 72 hours.
Danish: Dosistitrering og vedligeholdelsesbehandling DUROGESIC-plastret bør skiftes hver 72. time.
English: • Excessive sweating
Danish: • Overdreven sveddannelse
English: Insomnia, Depression, Anxiety,
Danish: Insomni, depression, angst, konfusion, hallucination
English: DUROGESIC Dosage (mcg/h)
Danish: Dosis af DUROGESIC (mikrog/time)
English: nausea (35.7%), vomiting (23.2%), constipation (23.1%), somnolence (15.0%), dizziness (13.1%), and headache (11.8%).
Danish: Baseret på de samlede sikkerhedsdata fra disse kliniske studier var de hyppigst rapporterede bivirkninger (forekomst ≥10 %): kvalme (35,7 %), opkastning (23,2 %), obstipation (23,1 %), døsighed (15,0 %), svimmelhed (13,1 %) og hovedpine (11,8 %).
English: Abdominal pain, Abdominal pain upper, Dyspepsia
Danish: Diarré, mundtørhed, abdominalsmerter, smerter i øvre abdomen, dyspepsi
English: • Medicines for relaxing your muscles (such as cyclobenzaprine or diazepam).
Danish: • Muskelafslappende lægemidler (som f.eks. cyclobenzaprin eller diazepam)
English: It is recommended that DUROGESIC is used in patients who have demonstrated opioid tolerance (see section 4.2).
Danish: Det anbefales, at DUROGESIC anvendes til patienter, der har udviklet opioidtolerans (se pkt.
English: The concomitant use of other central nervous system depressants, (including opioids, sedatives, hypnotics, general anaesthetics, phenothiazines, tranquilizers, sedating antihistamines, and alcoholic beverages) and skeletal muscle relaxants, may produce additive depressant effects; hypoventilation, hypotension, profound sedation, coma or death may occur.
Danish: Samtidig anvendelse af andre CNS-supprimerende stoffer (herunder opioider, sedativa, hypnotika, midler til generel anæstesi, phenothiaziner, beroligende midler, sederende antihistaminer og drikkevarer med alkohol) og skeletmuskel-relaksantia kan fremkalde en additiv supprimerende virkning.
English: Patches should be inspected prior to use.
Danish: Plastret skal efterses inden brug.
English: Side effects and DUROGESIC
Danish: Bivirkninger og DUROGESIC
English: After coadministration of weak, moderate or strong CYP3A4 inhibitors with short term intravenous fentanyl administration, decreases in fentanyl clearance were generally ≤25%,
Danish: Efter administration af svage, moderate eller potente CYP3A4-hæmmere sammen med i.v.-administration af korttidsvirkende fentanyl blev fentanyl-clearance generelt nedsat ≤25 %, men med ritonavir (en potent CYP3A4-hæmmer) reduceredes fentanyl-clearance gennemsnitligt med 67 %.
English: • Medicines for helping you sleep (such as temazepam, zaleplon, or zolpidem).
Danish: • Sovemedicin (som f.eks. temazepam, zaleplon eller zolpidem)
English: Bradypnoea
Danish: Bradypnø
English: Eczema, Dermatitis allergic, Skin disorder,
Danish: Eksem, allergisk dermatitis, hudlidelse, dermatitis, kontaktdermatitis
English: A new patch should be applied to a different skin site after removal of the previous transdermal patch.
Danish: Et nyt plaster skal anbringes på et andet sted end det forrige plaster, når det forrige plaster er fjernet.
English: If serotonin syndrome is suspected, treatment with DUROGESIC should be discontinued.
Danish: Ved mistanke om serotoninsyndrom skal DUROGESIC seponeres.
English: PHARMACEUTICAL FORM AND CONTENTS Transdermal patch [To be completed nationally]
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Depotplaster [Udfyldes nationalt]
English: Pharmacodynamic-related interactions
Danish: Farmakodynamisk relaterede interaktioner
English: If the patches are out of date, take them to your pharmacy.
Danish: Plastre, hvor udløbsdatoen er overskredet, skal afleveres på apoteket.
English: DUROGESIC contains a medicine called fentanyl.
Danish: DUROGESIC indeholder det aktive stof fentanyl.
English: The concomitant use of DUROGESIC with cytochrome P450 3A4 (CYP3A4) inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong both the therapeutic and adverse effects, and may cause serious respiratory depression.
Danish: Samtidig anvendelse af DUROGESIC og cytochrom P450 3A4 (CYP3A4)-hæmmere kan resultere i øget plasmakoncentration af fentanyl, hvilket kan øge eller forlænge både den terapeutiske virkning og bivirkninger og forårsage alvorlig respirationsdepression.
English: Concomitant use of mixed opioid agonists/antagonists The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended (see also section 4.5).
Danish: Samtidig anvendelse af partielle opioidagonister/-antagonister Samtidig anvendelse af buprenorphin, nalbuphin eller pentazocin frarådes (se også pkt.
English: • Medicines used to treat an irregular heart beat (such as amiodarone, diltiazem, or verapamil).
Danish: • Lægemidler til behandling af uregelmæssig hjerterytme (som f.eks. amiodaron, diltiazem eller verapamil)
English: To convert paediatric patients from oral or parenteral opioids to DUROGESIC, refer to Equianalgesic potency conversion (Table 1) and Recommended DUROGESIC dosage based upon daily oral morphine dose (Table 4).
Danish: Ved skift fra behandling med orale eller parenterale opioider til DUROGESIC henvises der til tabel 1 for ækvianalgetiske doser ved konvertering og tabel 4 Anbefalet dosis af DUROGESIC på baggrund af daglig dosis oral morphin.
English: • Nausea, vomiting, constipation
Danish: • Kvalme, opkastning, forstoppelse
English: • Some medicines used to treat nausea or motion sickness (such as phenothiazines).
Danish: • Visse lægemidler til behandling af kvalme eller køresyge (som f.eks. phenothiaziner)
English: DUROGESIC and associated names (see Annex I) 12 micrograms/hour transdermal patch DUROGESIC and associated names (see Annex I) 25 micrograms/hour transdermal patch DUROGESIC and associated names (see Annex I) 50 micrograms/hour transdermal patch DUROGESIC and associated names (see Annex I) 75 micrograms/hour transdermal patch DUROGESIC and associated names (see Annex I) 100 micrograms/hour transdermal patch
Danish: DUROGESIC og relaterede navne (se bilag I) 12 mikrog/time depotplaster DUROGESIC og relaterede navne (se bilag I) 25 mikrog/time depotplaster DUROGESIC og relaterede navne (se bilag I) 50 mikrog/time depotplaster DUROGESIC og relaterede navne (se bilag I) 75 mikrog/time depotplaster DUROGESIC og relaterede navne (se bilag I) 100 mikrog/time depotplaster
English: Friday
Danish: Fredag
English: Elderly patients should be observed carefully and the dose should be individualised based upon the status of the patient (see sections 4.4 and 5.2).
Danish: Ældre patienter skal overvåges nøje, og dosis skal fastsættes individuelt på baggrund af patientens status (se pkt.
English: Table 2: Recommended starting dosage of DUROGESIC based upon daily oral morphine dose (for patients who have a need for opioid rotation or for clinically less stable patients: conversion ratio of oral morphine to transdermal fentanyl is approximately equal to 150:1) 1
Danish: Tabel 2: Anbefalet startdosis af DUROGESIC baseret på daglig oral morphin-dosis (for patienter med behov for at skifte til et andet opioid, eller som er klinisk mindre stabile: konvertering af oralt morphin til transdermalt fentanyl er omtrent i forholdet 150:1).1
English: In these cases, only DUROGESIC 12 mcg/h dosage should be considered for initial treatment.
Danish: I disse tilfælde bør behandling kun initieres med en dosis af DUROGESIC på 12 mikrog/time.
English: Patients with renal or hepatic impairment should be observed carefully and the dose should be individualised based upon the status of the patient (see sections 4.4 and 5.2).
Danish: Patienter med nedsat nyre- eller leverfunktion bør observeres nøje, og dosis skal fastsættes individuelt på baggrund af patientens status (se pkt.
English: DUROGESIC should be applied to non-irritated and non-irradiated skin on a flat surface of the torso or upper arms.
Danish: DUROGESIC anbringes på en plan overflade på overkroppen eller overarmen, som ikke er irriteret eller har været udsat for strålebehandling.
English: • Some medicines used to treat heartburn or ulcers (such as cimetidine).
Danish: • Visse lægemidler til behandling af halsbrand eller mavesår (som f.eks. cimetidin)
English: It may harm them, even if their signs of illness are the same as yours
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer,
English: If paralytic ileus is present or suspected, treatment with DUROGESIC should be stopped.
Danish: Ved paralytisk ileus eller mistanke derom skal DUROGESIC seponeres.
English: Take special care with DUROGESIC
Danish: Vær særligt forsigtig med DUROGESIC
English: To derive the DUROGESIC dosage corresponding to the calculated 24-hour, equianalgesic morphine dosage, use dosage-conversion Table 2 or 3 as follows: a. Table 2 is for adult patients who have a need for opioid rotation or who are less clinically stable (conversion ratio of oral morphine to transdermal fentanyl approximately equal to b. Table 3 is for adult patients who are on a stable, and well-tolerated, opioid regimen (conversion ratio of oral morphine to transdermal fentanyl approximately equal to 100:1).
Danish: For at få den dosis DUROGESIC, der svarer til den beregnede ækvianalgetiske 24-timers-morphindosis, bruges tabel 2 eller tabel 3 til at omregne dosis på følgende måde: a. Tabel 2 er for voksne patienter, som har behov for at skifte til et andet opioid, eller som er mindre klinisk stabile (konvertering fra oralt morphin til transdermalt fentanyl omtrent i forholdet 150:1).
English: Wednesday
Danish: Onsdag
English: hydroxyzine, or lorazepam) and medicines for mental conditions (anti-psychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
Danish: • Beroligende lægemidler (som f.eks. alprazolam, clonazepam, diazepam, hydroxyzin eller lorazepam) og lægemidler til behandling af sindslidelser (antipsykotika som f.eks. aripiprazol, haloperidol, olanzapin, risperidon eller phenothiaziner)
English: Neonatal withdrawal syndrome has been reported in newborn infants with chronic maternal use of DUROGESIC during pregnancy.
Danish: Neonatalt abstinenssymptom er blevet rapporteret hos nyfødte børn efter langvarig behandling med DUROGESIC under graviditeten.
English: Table 3: Recommended starting dosage of DUROGESIC based upon daily oral morphine dosage (for patients on stable and well tolerated opioid therapy: conversion ratio of oral morphine to transdermal fentanyl is approximately equal to 100:1)
Danish: Tabel 3: Anbefalet startdosis af DUROGESIC på grundlag af daglig oral morphindosis (for patienter, der er i stabil og veltolereret opioid-behandling (konvertering af oralt morphin til transdermalt fentanyl er omtrent i forholdet 100:1).
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Spørg lægen eller apotekspersonalet, hvis du har yderligere spørgsmål om brugen af dette lægemiddel.
English: Discontinuation of DUROGESIC
Danish: Seponering af DUROGESIC
English: 1a parenteral buprenorphine sublingual parenteral codeine oral parenteral
Danish: Sublingual Parenteral
English: The interval between IV antagonist doses should be carefully chosen because of the possibility of re-narcotization after the patch is removed; repeated administration or a continuous infusion of naloxone may be necessary.
Danish: Intervallerne mellem dosering af i.v.-antagonisten skal vælges med omhu pga. risikoen for re-narkotisering, efter plastret er fjernet.
English: There have been reports also of newborn infants experiencing withdrawal effects after their mothers have used DUROGESIC for a long time during pregnancy.
Danish: Der har også været rapporteret om nyfødte børn med abstinenssymptomer på grund af moderens langvarige brug af DUROGESIC under graviditeten.
English: This may result in increased serum concentrations (see section 5.2) and the patient should be monitored closely.
Danish: Dette kan medføre øgede serumkoncentrationer (se pkt.
English: Anaphylactic reaction, Anaphylactoid reaction
Danish: Anafylaktisk shock, anafylaktisk reaktion, anafylaktoid reaktion
English: • Some antihistamines, especially ones that make you sleepy (such as chlorpheniramine, clemastine,
Danish: • Visse antihistaminer, særligt hvis de gør dig søvning (som f.eks. chlorpheniramin, clemastin, cyproheptadin, diphenhydramin eller hydroxyzin)