FrancophonIA/ELRC3.0 huggingface dataset:
English: Starting dosages of 25 mcg/h and higher were used by the remaining 179 subjects, 174 (97.2%) of whom had been on opioid doses of at least 45 mg of oral morphine equivalents per day.
Danish: Startdoser på 25 mikrog/time og højere blev brugt af de resterende 179 patienter, hvoraf 174 (97,2 %) før havde været i behandling med daglige opioiddoser på mindst 45 mg orale morphinækvivalenter.
English: After the first DUROGESIC application, serum fentanyl concentrations increase gradually, generally leveling off between 12 and 24 hours and remaining relatively constant for the remainder of the 72-hour application period.
Danish: Efter den første påsætning af DUROGESIC stiger serumkoncentrationen af fentanyl gradvist, indtil denne stigning flader ud 12-24 timer efter påsætningen, hvorefter koncentrationen forbliver relativt konstant i resten af de 72 timer.
English: Severe respiratory depression.
Danish: Alvorlig respirationsdepression.
English: DUROGESIC is indicated for management of severe chronic pain that requires continuous long term opioid administration.
Danish: DUROGESIC er indiceret til behandling af svære kroniske smerter, som kræver kontinuerlig langtidsbehandling med opioider.
English: • As soon as you take a patch off, fold it firmly in half so that the sticky side sticks to itself
Danish: • Straks efter, du har taget plastret af, skal du folde det sammen på midten, så den klæbende side klæber fast til sig selv
English: • Constricted pupils (miosis)
Danish: • Sammentrukne pupiller (miosis)
English: Therefore, the concomitant use of DUROGESIC and CYP3A4 inhibitors is not recommended unless the benefits outweigh the increased risk of adverse effects.
Danish: Derfor frarådes samtidig anvendelse af DUROGESIC og CYP3A4-hæmmere, medmindre fordelene opvejer den øgede risiko for bivirkninger.
English: • Feeling unusually drowsy, breathing that is more slow or shallow than expected.
Danish: • Følelse af usædvanlig sløvhed, og/eller, en vejrtrækning, der er langsommere eller mere overfladisk end normalt.
English: Some studies in rats have revealed reduced fertility and enhanced embryo mortality at maternally toxic doses (see section 5.3).
Danish: Visse rottestudier har vist reduceret fertilitet og øget embryo-mortalitet ved maternelt toksiske doser (se pkt.
English: • Tear or cut open the sachet at the notch, shown by the arrow
Danish: • Riv eller klip posen op ved hakket, der er markeret med en pil
English: • Medicines to treat tuberculosis (such as rifampicin).
Danish: • Lægemidler til behandling af tuberkulose (som f.eks. rifampicin)
English: Skin temperature elevation may enhance the absorption of transdermally-applied fentanyl (see section 4.4).
Danish: Forhøjelse af hudtemperaturen kan øge absorptionen af transdermalt administreret fentanyl (se pkt.
English: Therefore, DUROGESIC should not be used within 14 days after discontinuation of treatment with MAOIs.
Danish: Derfor bør DUROGESIC ikke anvendes inden for 14 dage efter seponering af en MAO-hæmmer.
English: • Some medicines used to treat cancer of the blood (such as idelalisib).
Danish: • Visse lægemidler til behandling af blodkræft (som f.eks. idelalisib).
English: In two paediatric studies, the required fentanyl transdermal patch dose was calculated conservatively: 30 mg to 44 mg oral morphine per day or its equivalent opioid dose was replaced by one DUROGESIC 12 mcg/h patch.
Danish: I to pædiatriske studier blev den nødvendige dosis af fentanyl transdermalt plaster beregnet konservativt: 30-44 mg oralt morphin dagligt eller opioid-doser ækvivalent hermed blev erstattet af et DUROGESIC-plaster på 12 mikrog/time.
English: Several days should elapse before a new patch is applied to the same area of the skin.
Danish: Der bør gå flere dage, før et nyt plaster sættes på et tidligere anvendt sted på huden.
English: • Some medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
Danish: • Visse lægemidler til behandling angina pectoris (brystsmerter) eller forhøjet blodtryk (som f.eks. nicardipin)
English: Try not to touch the sticky side of the patch
Danish: Undlad at berøre den klæbende side af plastret
English: • Loss of appetite
Danish: • Appetitmangel
English: CYP3A4 Inducers
Danish: CYP3A4-induktorer
English: • DUROGESIC may make you unusually drowsy, and make your breathing more slow or shallow.
Danish: • DUROGESIC kan gøre dig mere sløv end normalt og gøre din vejrtrækning langsommere eller mere overfladisk.
English: Examples of active substances that may increase fentanyl concentrations include: amiodarone, cimetidine, clarithromycin, diltiazem, erythromycin, fluconazole, itraconazole, ketoconazole, nefazodone, ritonavir, verapamil and voriconazole (this list is not exhaustive).
Danish: Eksempler på stoffer, der kan øge fentanylkoncentrationen, er: amiodaron, cimetidin, clarithromycin, diltiazem, erythromycin, fluconazol, itraconazol, ketoconazol, nefazodon, ritonavir, verapamil og voriconazol (listen er ikke udtømmende).
English: Serotonergic medicinal products
Danish: Serotonerge lægemidler
English: Opioids increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract.
Danish: Opioider øger tonus og nedsætter de fremaddrivende kontraktioner i den glatte muskulatur i mave-tarm-kanalen.
English: Hypoaesthesia, Convulsion (including clonic convulsions and grand mal convulsion), Amnesia, Depressed level of consciousness, Loss of consciousness
Danish: Tremor, paræstesi Hypæstesi, konvulsioner (herunder kloniske konvulsioner og grand mal anfald), amnesi, bevidsthedssvækkelse, bevidsthedstab
English: • Remove the other part of the backing and press the whole patch onto the skin with the palm of your hand
Danish: • Fjern den anden halvdel af beskyttelsesfilmen og pres hele plastret fast på huden med håndfladen
English: In general, the discontinuation of opioid analgesia should be gradual in order to prevent withdrawal symptoms (see section 4.8).
Danish: Generelt bør seponering af opioid foregå gradvist for at undgå seponeringssymptomer (se pkt.
English: • Your upper body or arm
Danish: • Overkroppen eller overarmen
English: If you do, you may increase the amount of medicine you get from the patch.
Danish: Hvis du ikke overholder dette, kan det medføre, at den mængde medicin, du får fra plastret, øges.
English: Very rarely these breathing problems can be life-threatening or even fatal, especially in people who have not used strong opioid painkillers (like DUROGESIC or morphine) before.
Danish: I meget sjældne tilfælde kan disse vejrtrækningsproblemer være livstruende eller endog dødelige, særligt hos personer, som ikke før har brugt stærke smertestillende opioidholdige lægemidler (som DUROGESIC eller morphin).
English: • Press this sticky part of the patch onto the skin
Danish: • Pres denne klæbende side af plastret fast på huden
English: Do not use DUROGESIC if you are breastfeeding.
Danish: Brug ikke DUROGESIC, hvis du ammer.
English: Therefore, the product information of the CYP3A4 inhibitor must be consulted for the active substance's half-life and duration of the inhibitory effect before applying the first DUROGESIC patch.
Danish: Der henvises derfor til produktinformationen for CYP3A4-hæmmeren for oplysninger om det aktive stofs halveringstid og varigheden af den hæmmende virkning, før det første DUROGESIC-plaster påsættes.
English: The effects of the inducer decline gradually and may result in increased fentanyl plasma concentrations, which could increase or prolong both the therapeutic and adverse effects, and may cause serious respiratory depression.
Danish: Induktorens virkning falder gradvist og kan resultere i øgede plasmakoncentrationer af fentanyl, som kan øge eller forlænge både terapeutisk virkning og bivirkninger og forårsage alvorlig respirationsdepression.
English: Examples of active substance that may decrease fentanyl plasma concentrations include: carbamazepine, phenobarbital, phenytoin and rifampicin (this list is not exhaustive).
Danish: Eksempler på stoffer, der kan nedsætte plasmakoncentrationen af fentanyl, er: carbamazepin, phenobarbital, phenytoin og rifampicin (listen er ikke udtømmende).
English: Apnoea, Hypoven tilation
Danish: Apnø, hypoventilation
English: Step 2: Open the sachet
Danish: Trin 2: Åbn den beskyttende pose
English: Skin does not appear to metabolise fentanyl delivered transdermally.
Danish: Det lader ikke til, at huden metaboliserer fentanyl administreret transdermalt.
English: Cases of serious respiratory depression after coadministration of CYP3A4 inhibitors with transdermal fentanyl have been reported, including a fatal case after coadministration with a moderate CYP3A4 inhibitor.
Danish: Der er rapporteret tilfælde af alvorlig respirationsdepression efter samtidig administration af CYP3A4-hæmmere og transdermal fentanyl, herunder et tilfælde med dødelig udgang efter samtidig administration med en moderat CYP3A4-hæmmer.
English: There is a potential for temperature-dependent increases in fentanyl released from the system resulting in possible overdose and death.
Danish: Der er risiko for en øget temperatur-afhængig frigivelse af fentanyl fra depotplastret, hvilket kan resultere i overdosering og død.
English: • Medicines used to treat fungal infection (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
Danish: • Lægemidler til behandling af svampeinfektioner (som f.eks. itraconazol, ketoconazol, fluconazol eller voriconazol)
English: Fentanyl concentrations may increase if the skin temperature increases (see section 5.2).
Danish: Koncentrationen af fentanyl kan øges, hvis hudtemperaturen stiger (se pkt.
English: These actions can be followed by administration of a specific opioid antagonist such as naloxone.
Danish: Efterfølgende kan der gives en specifik opioidantagonist såsom naloxon.
English: If you or your partner, or carer, notice any of the following about the person wearing the patch, take the patch off and call a doctor, or go to your nearest hospital, straight away.
Danish: Hvis du, din partner eller omsorgsperson bemærker, at noget af det følgende gælder for den person, der bærer plastret, skal I tage plastret af og straks søge lægehjælp eller tage til det nærmeste hospital.
English: This is because fentanyl concentrations fall gradually after DUROGESIC is removed.
Danish: Dette skyldes, at plasmakoncentrationen af fentanyl falder gradvist, efter at DUROGESIC-plastret er fjernet.
English: • If you are very late changing your patch, you should talk to your doctor because you might need some extra painkillers, but do not apply an extra patch.
Danish: • Hvis du skifter plastret meget sent, skal du fortælle det til din læge, da det kan være nødvendigt, at du får ekstra smertestillende midler.
English: Previous analgesic therapy should therefore be gradually phased out after the initial dose application until analgesic efficacy with DUROGESIC is attained.
Danish: Tidligere analgetisk behandling bør derfor seponeres gradvist efter den første dosis, indtil der opnås analgetisk effekt af DUROGESIC.
English: Cases of serotonin syndrome have been reported when fentanyl was administered concomitantly with highly serotonergic drugs (see sections 4.4. and 4.5).
Danish: Der er rapporteret tilfælde af serotoninsyndrom, når fentanyl blev administreret samtidigt med udpræget serotonerge lægemidler (se pkt.
English: Data in subjects with cirrhosis and simulated data in subjects with different grades of impaired liver function treated with transdermal fentanyl suggest that fentanyl concentrations may be increased, and fentanyl clearance may be decreased compared to subjects with normal liver function.
Danish: Data for forsøgspersoner med cirrose og simulerede data fra forsøgspersoner med forskellige grader af nedsat leverfunktion, der blev behandlet med transdermal fentanyl, antyder, at fentanylkoncentrationen kan være forhøjet og fentanyl-clearance nedsat sammenlignet med forsøgspersoner med normal leverfunktion.
English: Dosage titration should normally be performed in 12 mcg/h or 25 mcg/h increments, although the supplementary analgesic requirements (oral morphine 45/90 mg/day ≈ DUROGESIC 12/25 mcg/h) and pain status of the patient should be taken into account.
Danish: Dosistitrering bør normalt ske i trin på 12 mikrog/time eller 25 mikrog/time, men der skal tages hensyn til patientens brug af supplerende analgetika (oral morphin 45/90 mg/dag svarer til DUROGESIC 12/25 mikrog/time) og patientens smertestatus.
English: If you use too many patches or the wrong strength patch If you have stuck on too many patches or the wrong strength patch, take the patches off and contact a doctor straight away.
Danish: Hvis du har klæbet for mange plastre på huden eller brugt et plaster med en forkert styrke, skal du tage plastrene/plastret af og straks søge læge.
English: Therefore after a dose increase, patients should wear the higher dose patch through two 72-hour applications before any further increase in dose level is made.
Danish: Derfor skal patienten bære et depotplaster med den højere dosis i to perioder på 72 timer, før dosis justeres yderligere.
English: • Put it back in its original sachet and dispose of the sachet as instructed by your pharmacist
Danish: • Læg derefter plastret i posen, som du har gemt, og bortskaf posen i henhold til apotektspersonalets anvisninger
English: Generally, a patient should wait for 2 days after stopping treatment with a CYP3A4 inhibitor before applying the first DUROGESIC patch.
Danish: Generelt bør patienten vente i 2 dage efter afslutning af behandling med en CYP3A4-hæmmer, før det første DUROGESIC-plaster påsættes.
English: The concomitant use of CYP3A4 inhibitors and DUROGESIC is not recommended, unless the patient is closely monitored (see section 4.4).
Danish: Samtidig anvendelse af CYP3A4-hæmmere og DUROGESIC frarådes, medmindre patienten overvåges tæt (se pkt.
English: Respiratory depression, Respiratory distress
Danish: Respirationsdepression, åndenød
English: Monitoring of the patient for adverse events, which may include hypoventilation, is recommended for at least 48 hours after initiation of DUROGESIC therapy or up-titration of the dose (see section 4.4).
Danish: Det anbefales at monitorere patienten for bivirkninger, herunder hypoventilation, i mindst 48 timer efter indledning af behandling med DUROGESIC eller optitrering af dosis (se pkt.
English: If the site of DUROGESIC application requires cleansing prior to application of the patch, this should be done with clear water.
Danish: Hvis det er nødvendigt at vaske påsætningsstedet inden påsætning af DUROGESIC, skal dette ske med rent vand.
English: 0.4b tapentadol oral parenteral tramadol oral parenteral a The oral/IM potency for morphine is based on clinical experience in patients with chronic pain.
Danish: Oral Parenteral a Oral / i.m.-potensforholdet for morphin er baseret på klinisk erfaring fra patienter med kroniske smerter.
English: Fentanyl is an opioid analgesic, interacting predominantly with the µ opioid receptor.
Danish: Fentanyl er et opioid-analgetikum, som overvejende påvirker μ-opioidreceptoren.
English: These subjects received at least one dose of DUROGESIC and provided safety data (see section 5.1).
Danish: Disse forsøgspersoner fik mindst 1 dosis DUROGESIC og frembragte dermed sikkerhedsdata (se pkt.
English: Generally, the transdermal route is not recommended in opioid-naïve patients.
Danish: Generelt frarådes transdermal administration til opioid-naive patienter.
English: To calculate the appropriate starting dose of DUROGESIC, follow the steps below.
Danish: Den egnede startdosis af DUROGESIC beregnes ved at følge trinnene nedenfor.
English: Where to apply the patch
Danish: Hvor skal plastret sættes på
English: A fentanyl dose decrease and careful monitoring is warranted in anticipation of stopping concomitant treatment with a CYP3A4 inducer.
Danish: Nedsættelse af fentanyldosis og omhyggelig overvågning tilrådes forud for seponering af samtidig behandling med en CYP3A4-induktor.
English: BATCH NUMBER
Danish: FREMSTILLERENS BATCHNUMMER Batch:
English: • DUROGESIC patches are for long-term pain.
Danish: • DUROGESIC-plastrene er beregnet til vedvarende smerter.
English: Pharmacokinetic/Pharmacodynamic Relationships
Danish: Farmakokinetiske/farmakodynamiske forhold
English: Avoid touching the adhesive side of the patch.
Danish: Undlad at røre ved plastrets klæbende side.
English: The expiry date refers to the last date of that month.
Danish: Udløbsdatoen er den sidste dag i den nævnte måned (efter EXP).
English: Tables 1, 2, and 3 should only be used to convert from other opioids to DUROGESIC and not from DUROGESIC to other therapies to avoid overestimating the new analgesic dose and potentially causing overdose.
Danish: Tabel 1, 2 og 3 må kun anvendes til at omstille fra andre opioider til DUROGESIC og ikke fra DUROGESIC til andre behandlinger.
English: DUROGESIC should not be used during pregnancy unless you have discussed this with your doctor.
Danish: DUROGESIC må ikke bruges under graviditet, medmindre du har aftalt det med lægen.
English: DUROGESIC should be used with caution in patients with brain tumours.
Danish: DUROGESIC skal anvendes med forsigtighed til patienter med hjernetumorer.
English: Do not use DUROGESIC if:
Danish: Brug ikke DUROGESIC:
English: Central Nervous System conditions including increased intracranial pressure DUROGESIC should be used with caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention such as those with evidence of increased intracranial pressure, impaired consciousness, or coma.
Danish: Lidelser i centralnervesystemet, herunder forhøjet intrakranielt tryk DUROGESIC bør anvendes med forsigtighed til patienter, som kan være specielt følsomme over for den intrakranielle effekt af CO2-retention.
English: In opioid-naïve patients with renal or hepatic impairment, treatment should only be considered if the benefits outweigh the risks.
Danish: Behandling af opioid-naive patienter med nedsat nyre- eller leverfunktion bør kun overvejes, hvis fordelene opvejer risiciene.
English: Palpitations, Tachycardia
Danish: Palpitationer, Takykardi
English: Pharmacokinetic-related interactions
Danish: Farmakokinetisk relaterede interaktioner
English: Initial evaluation of the maximum analgesic effect of DUROGESIC cannot be made before the patch is worn for 24 hours.
Danish: Initial vurdering af den maksimale analgetiske effekt af DUROGESIC kan tidligst foretages, når et plaster har været påsat i 24 timer.
English: Table 1: Conversion Table - Multiplication Factors for Converting the Daily Dose of Prior Opioids to the Equianalgesic 24-hour Oral Morphine Dose (mg/day Prior Opioid x Factor = Equianalgesic 24-hour Oral Morphine Dose) Prior Opioid
Danish: Tabel 1: Konverteringstabel - Multiplikationsfaktorer til konvertering af den daglige dosis af tidligere opioider til den ækvianalgetiske 24-timers-dosis af oral morphin (mg/dag tidligere opioid x faktor = ækvianalgetisk 24-timers-dosis af oral morphin) Tidligere opioid
English: Opioid withdrawal symptoms are possible in some patients after conversion or dose adjustment.
Danish: 4.8) kan forekomme hos nogle patienter efter konvertering eller dosisjustering.
English: Respiratory depression may persist beyond the removal of the DUROGESIC patch.
Danish: Respirationsdepression kan vare ved, efter at DUROGESIC-plastret er fjernet.
English: DUROGESIC should not be administered to opioid-naïve paediatric patients (see section 4.2).
Danish: DUROGESIC bør ikke administreres til opioid-naive pædiatriske patienter (se pkt.
English: (frequency cannot be estimated from the available data.)
Danish: Dette kan være tegn på en alvorlig allergisk reaktion (hyppigheden kan ikke beregnes ud fra tilgængelige data.)
English: Co-administration of fentanyl with a serotonergic medicinal products, such as a Selective Serotonin Re-uptake Inhibitor (SSRI) or a Serotonin Norepinephrine Re-uptake Inhibitor (SNRI) or a Monoamine Oxidase Inhibitor (MAOI), may increase the risk of serotonin syndrome, a potentially life threatening condition.
Danish: Samtidig administration af fentanyl og et serotonergt lægemiddel såsom en selektiv serotoningenoptagelseshæmmer (SSRI), en serotonin- og noradrenalingenoptagelseshæmmer (SNRI) eller en monoaminoxidasehæmmer (MAO-hæmmer) kan øge risikoen for serotoninsyndrom, som er en potentielt livstruende tilstand.
English: DUROGESIC can make you drowsy or breathe more slowly.
Danish: DUROGESIC kan gøre dig sløv og gøre, at du trækker vejret langsommere.
English: 6.6 Special precautions for disposal and other handling Instructions for disposal:
Danish: 6.6 Regler for bortskaffelse og anden håndtering
English: Opioid withdrawal symptoms (such as nausea, vomiting, diarrhoea, anxiety, and shivering) are possible in some patients after conversion from their previous opioid analgesic to DUROGESIC or if therapy is stopped suddenly (see section 4.2).
Danish: Opioide seponeringssymptomer (såsom kvalme, opkastning, diarré, angst og kuldegysninger) kan opstå hos nogle patienter efter skift fra et andet opioidt analgetikum til DUROGESIC, eller hvis behandlingen seponeres pludseligt (se pkt.
English: • Other medicines for pain, such as other opioid painkillers (such as buprenorphine, nalbuphine, or pentazocine).
Danish: • Andre smertestillende lægemidler, som f.eks. andre smertestillende opioid-holdige lægemidler (som f.eks. buprenorphin, nalbuphin eller pentazocin)
English: Fentanyl, a high clearance active substance, is rapidly and extensively metabolised mainly by CYP3A4.
Danish: Fentanyl er et aktivt stof med høj clearance, der metaboliseres hurtigt og ekstensivt hovedsageligt af CYP3A4.
English: • The patches are waterproof
Danish: • Plastrene tåler vand
English: Extra caution should be used in patients with chronic constipation.
Danish: Der skal udvises ekstra forsigtighed hos patienter med kronisk obstipation.
English: If you think that you are going to receive anaesthesia tell your doctor or dentist that you are using DUROGESIC.
Danish: Operationer Hvis du tror, at du skal bedøves, skal du fortælle din læge eller tandlæge, at du bruger DUROGESIC.
English: • You are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6)
Danish: • hvis du er allergisk over for fentanyl eller et af de øvrige indholdsstoffer i DUROGESIC (angivet i afsnit 6)
English: • Feeling anxious or confused
Danish: • Følelse af angst eller forvirring
English: 1 In clinical studies these ranges of daily oral morphine doses were used as a basis for conversion to DUROGESIC.
Danish: 1 I kliniske studier blev disse dosisintervaller for daglig oralt morphin brugt som grundlag for konvertering til DUROGESIC.
English: • Some medicines used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin).
Danish: • Visse lægemidler til behandling af epilepsi (som f.eks. carbamazepin, phenobarbital eller phenytoin)
English: You may notice rashes, redness or slight itching of the skin at the site of the patch.
Danish: Det kan være, at du oplever udslæt, rødme eller let kløe på det sted på huden, hvor plastret sidder.
English: • Feeling agitated or disoriented
Danish: • Følelse af uro eller desorientering
English: • Muscle tremors or spasms
Danish: • Muskelkramper eller muskelsitren
English: Among the remaining 5 subjects with a starting dosage of at least 25 mcg/h whose prior opioid doses were <45 mg of oral morphine equivalents per day, 1 (0.6%) had previously been receiving <30 mg of oral morphine equivalents per day and 4 (2.2%) had been receiving 30 to 44 mg of oral morphine equivalents per day (see section 4.8).
Danish: Blandt de resterende 5 forsøgspersoner med en startdosis på mindst 25 mikrog/time, hvis tidligere opioiddosis var <45 mg orale morphinækvivalenter dagligt, havde 1 (0,6 %) tidligere fået <30 mg orale morphinækvivalenter dagligt, og 4 (2,2 %) havde fået 30 til 44 mg orale morphinækvivalenter dagligt (se pkt.