FrancophonIA/ELRC3.0 huggingface dataset:
English: The lowest available patch strength is 12.5 μg/h, which is designated as 12μg/h to distinguish it from a 125μg/h dosage that could be prescribed by using multiple patches.
Danish: Den laveste tilgængelige styrke er 12,5 μg/h, der betegnes 12 μg/h for at skelne den fra doseringen 125 μg/h, der kan tænkes ordineret ved brug af flere plastre.
English: The information provided in section 4.2 is partly presented in up to three tables and are only be used to convert from other opioids to Durogesic and not vice versa:
Danish: Oplysningerne i punkt 4.2 er delvis opdelt i indtil tre tabeller og anvendes kun til omregning fra andre opioider til Durogesic, ikke omvendt:
English: The wording in this section has been amended according to the PSUR worksharing (2010), that Durogesic may impair mental and/or physical ability required for the performance of potentially hazardous tasks such as driving or operating machinery.
Danish: Ordlyden af dette punkt er i henhold til PSUR-arbejdsdelingen (2010) ændret til, at Durogesic kan nedsætte den psykiske og/eller fysiske evne til at udføre potentielt farligt arbejde såsom at føre motorkøretøj eller betjene maskiner.
English: According to the EMA Guideline on the Clinical Development of Medicinal Products Intended for the Treatment of Pain (EMA/CHMP/970057/2011, Corr. 11) and the WHO Guideline on Cancer Pain Relief, pain severity can be classified as mild, moderate and severe.
Danish: I henhold til EMA's retningslinjer om klinisk udvikling af lægemidler til smertebehandling ("Guideline on the Clinical Development of Medicinal Products Intended for the Treatment of Pain") (EMA/CHMP/970057/2011, Corr. 11) og WHO's retningslinjer om smertelindring ved kræft ("Guideline on Cancer Pain Relief") kan smerter inddeles i lette, moderate og svære.
English: The efficacy of Durogesic has been shown in six studies in adults with non-malignant pain, of which five were open-label and 3 did not have a comparator arm.
Danish: Virkningen af Durogesic er påvist i seks undersøgelser hos voksne med ikke-maligne smerter, hvoraf fem var åbne og tre var uden sammenligningsarm.
English: The analgesic action of fentanyl is thought to be mediated mainly through µopioid-receptors.
Danish: Den analgetiske virkning af fentanyl antages at medieres hovedsagelig gennem µopioidreceptorer.
English: Opioid-naïve patients
Danish: Opioidnaive patienter
English: Paediatric indication
Danish: Pædiatrisk indikation
English: Section 4.7 - Effects on ability to drive and use machines
Danish: Punkt 4.7 - Virkning på evnen til at føre motorkøretøj og betjene maskiner
English: The proposed listing of most commonly reported adverse reactions from the pooled safety data was considered to be acceptable, with a minor amendment to improve the readability.
Danish: Den foreslåede liste over de hyppigst indberettede bivirkninger baseret på de poolede sikkerhedsdata kunne godtages med en mindre ændring til forbedring af læseligheden.
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC concerning the medicinal product Durogesic transdermal patches;
Danish: • udvalget behandlede indbringelsen i henhold til artikel 30 i direktiv 2001/83/EF vedrørende lægemidlet Durogesic, depotplastre
English: Fentanyl has high lipid solubility and potency, which make it suitable for transdermal administration.
Danish: Fentanyls høje lipidopløselighed og potens gør det velegnet til transdermal administration.
English: For safety reasons, addition of the text that the lowest effective dose should be used has been included this subsection.
Danish: Af hensyn til sikkerheden er det i dette underpunkt tilføjet, at der bør gives den laveste effektive dosis.
English: Overdose of an opioid such as fentanyl could lead to persistent hypotension due to peripheral vasodilation.
Danish: Overdosering med et opioid såsom fentanyl kan medføre vedholdende hypotension på grund af perifer vasodilatation.
English: Information related to studies in the post-operative pain indication in opioid naïve subjects has not been retained since this is not in the indication of Durogesic.
Danish: Oplysninger vedrørende undersøgelser ved indikationen postoperative smerter hos opioidnaive patienter er ikke bibeholdt, da dette ikke indgår i indikationen for Durogesic.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of Durogesic and associated names, the European Commission (EC) notified the European Medicines Agency of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the authorised summary of product characteristics (SmPCs) for the above-mentioned product, and thus to harmonise the SmPCs across the EU.
Danish: På grund af medlemsstaternes divergerende nationale afgørelser om markedsføringstilladelsen for Durogesic og relaterede navne anmeldte Europa-Kommissionen en officiel indbringelse til Det Europæiske Lægemiddelagentur i henhold til artikel 30 i direktiv 2001/83/EF med henblik på at ophæve divergenserne mellem de nationalt godkendte produktresuméer for ovennævnte produkt og dermed harmonisere produktresuméerne i EU.
English: Replacing the patch before 72 hours may result in increased serum concentrations of fentanyl, which could increase the risk for adverse events.
Danish: Skift af depotplaster inden 72 timer kan medføre forhøjet serumkoncentration af fentanyl, som kan øge risikoen for bivirkninger.
English: Major differences between SmPCs regarding the assigned frequencies for individual adverse reactions were discussed and resolved.
Danish: De vigtigste forskelle mellem produktresuméerne hvad angår de anførte hyppigheder for de enkelte bivirkninger blev drøftet og afklaret.
English: Elderly or patients with renal or hepatic impairment should be closely observed and dose reductions made if necessary.
Danish: Ældre og patienter med nedsat nyre eller leverfunktion bør observeres tæt, og dosis om nødvendigt nedsættes.
English: As there were no striking differences in the safety profile between adult and paediatric subjects, the MAH's decision not to include a separate table was considered to be acceptable.
Danish: Da der ikke var nævneværdige forskelle i sikkerhedsprofil mellem voksne og pædiatriske patienter, blev markedsføringstilladelsesindehaverens beslutning om ikke at indsætte en separat tabel godtaget.
English: If hypotension persists after naloxone administration, standard medical care for hypovolemia, including fluid management is recommended to be considered.
Danish: Hvis hypotensionen persisterer efter administration af naloxon, anbefales det at overveje standardbehandling af hypovolæmi, herunder væskebehandling.
English: As the wording about the potential risk of serotonin syndrome has been included in sections 4.4 and 4.5 of the harmonised SmPC, section 4.8 of the harmonised SmPC has also been updated with a statement that cases of serotonin syndrome have been reported when fentanyl-containing products are administered concomitantly with highly serotonergic medicinal products.
Danish: Da ordlyden vedrørende den potentielle risiko for serotoninsyndrom indgår i punkt 4.4 og 4.5 af det harmoniserede produktresumé, er punkt 4.8 i det harmoniserede produktresumé ligeledes ajourført med en erklæring om, at der er indberettet tilfælde af serotoninsyndrom, når lægemidler indeholdende fentanyl administreres sammen med stærkt serotonerge lægemidler.
English: Table 1 - Equianalgesic potency conversion: Due to differences in the relative potency of various opioid analgesics, guidance is necessary regarding equianalgesic doses of various medications.
Danish: Tabel 1 - Omregning til ækvianalgetisk styrke: På grund af forskelle i forskellige opioiders relative potens er vejledning om ækvianalgetiske doser af forskellige lægemidler påkrævet.
English: • The committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the Product Information.
Danish: • udvalget gennemgik alle data, som markedsføringstilladelsesindehaveren har forelagt til underbygning af den foreslåede harmonisering af produktinformationen
English: As outlined in the October 2007 Public Assessment Report regarding paediatric data, the long-term management of severe chronic pain in children from 2 years of age who are receiving opioid therapy is indicated in section 4.1 of the proposed harmonised SmPC, and also present in the majority of SmPCs.
Danish: Som beskrevet i den offentlige vurderingsrapport fra oktober 2007 om pædiatriske data er langtidsbehandling af svære kroniske smerter hos børn på 2 års-alderen, som er i behandling med opioider, indiceret i punkt 4.1 i det foreslåede harmoniserede produktresumé og indgår også i størstedelen af produktresuméerne.
English: In such cases, the potential for life-threatening hypoventilation has been added as a warning.
Danish: Med henblik på sådanne tilfælde er der tilføjet en advarsel om potentialet for livstruende hypoventilation.
English: The transdermal patches were developed as a non-invasive parenteral treatment option to avoid the first pass mechanism and to achieve a constant release and plasma levels.
Danish: Depotplastre blev udviklet som en ikke-invasiv parenteral behandling, der omgår first pass-metabolisering og medfører konstant frigivelse og plasmakoncentration.
English: Durogesic transdermal patch contains fentanyl, which is a potent, synthetic opioid analgesic belonging to the piperidine derivatives.
Danish: Durogesic, depotplastre, indeholder fentanyl, som er et potent syntetisk opioidanalgetikum, der tilhører piperidinderivaterne.
English: Table 2: Designed for adult patients who have a need for rotation of, or conversion from, another opioid regimen (conversion ratio of oral morphine to transdermal fentanyl approximately equal to 150:1).
Danish: Tabel 2: Beregnet for voksne patienter, der behøver skift eller omregning fra et andet opioidregime (omregningsforholdet fra oralt morphin til fentanyl-depotplastre er ca. 150:1).
English: In addition, early patch replacement is only advised in the rare case of a problem with patch adhesion.
Danish: Tidligt skift af depotplaster tilrådes derudover kun i det sjældne tilfælde, hvor plastrets vedhæftning volder problemer.
English: The subjects (N=1667) included had chronic low back pain, osteoarthritis or rheumatoid arthritis or pain of unspecified origin.
Danish: Personerne (N=1 667) i undersøgelserne havde kroniske lændesmerter, osteoartritis eller reumatoid artritis eller smerter af uspecificeret oprindelse.
English: The proposed wording has been developed to align the populations evaluated in clinical studies and to maintain alignment between the indications for both adult and paediatric patients.
Danish: Den foreslåede ordlyd er udformet, så den svarer til de populationer, der er vurderet i de kliniske undersøgelser, og så den opretholder overensstemmelsen mellem indikationerne for voksne og pædiatriske patienter.
English: Children aged 16 years and above follow adult dosage, and for children 2-16 years a table with recommended Durogesic dosages for paediatric patients based upon daily oral morphine dose has been provided.
Danish: Børn på 16 år og derover følger voksendosis, og for børn mellem 2 og 16 år er de anbefalede doseringer af Durogesic til pædiatriske patienter angivet i tabelform på basis af daglig oral morphindosis.
English: The MAH has clarified that only at first application could a patch be replaced after 48 hours when analgesia is insufficient.
Danish: Indehaveren af markedsføringstilladelsen har gjort det klart, at et depotplaster kun ved første påføring kan skiftes efter 48 timer ved utilstrækkelig analgetisk virkning.
English: The MAH has summarised the most commonly reported adverse reactions in this section based on the pooled safety data derived from 11 clinical trials with a total of 1854 participating adult and paediatric subjects.
Danish: Indehaveren af markedsføringstilladelsen har sammenfattet de hyppigst indberettede bivirkninger i dette punkt på grundlag af poolede sikkerhedsdata udledt af 11 kliniske undersøgelser med deltagelse af i alt 1 854 voksne og pædiatriske patienter.
English: In opioid-naïve elderly or patients with renal or hepatic impairment, there may be some instances in which the initiation of opioid treatment with a transdermal formulation is necessary and appropriate (e.g. in cases of difficulties swallowing).
Danish: Hos opioidnaive ældre og patienter med nedsat med nedsat nyre- eller leverfunktion kan der være tilfælde, hvor initiering af transdermal opioidbehandling er nødvendig og hensigtsmæssig (f.eks. ved synkebesvær).
English: A warning for renally impaired patients has been included that careful observation for signs of fentanyl toxicity is warranted (and the dose reduced if necessary) as fentanyl pharmacokinetics has not been evaluated in this patient population.
Danish: For patienter med nedsat nyrefunktion er der indsat en advarsel om, at der kræves nøje observation for tegn på toksicitet af fentanyl (og om nødvendigt nedsat dosis), da farmakokinetikken af fentanyl ikke er undersøgt hos denne patientpopulation.
English: The wording for the subsection ‘Fertility' has been amended to ensure consistency across the different fentanyl-containing medicinal products.
Danish: Ordlyden af underpunktet "Fertilitet" er ændret for at sikre overensstemmelse mellem de forskellige lægemidler indeholdende fentanyl.
English: The results of all pharmacodynamic or efficacy studies conducted in paediatric patients has been included in this section and the number of paediatric patients has been brought in line with the other sections of the harmonised SmPC.
Danish: I dette punkt er medtaget resultaterne af alle undersøgelserne af farmakodynamik og virkning hos pædiatriske patienter, og antallet af pædiatriske patienter er bragt i overensstemmelse med de øvrige punkter i det harmoniserede produktresumé.
English: The wording regarding tolerance and dependence, opioid withdrawal symptoms, and neonatal withdrawal syndrome follow exactly the wording included in the CSP and is considered to be acceptable.
Danish: Ordlyden vedrørende tolerans og afhængighed, opioidabstinenser og neonatalt abstinenssyndrom følger nøje ordlyden i CSP og kan godtages.
English: Other warnings included in section 4.4 are: chronic pulmonary disease, drug dependence and potential for abuse, central nervous system including increased intracranial pressure, cardiac disease, hypotension, hepatic impairment, renal impairment, respiratory depression, serotonin syndrome, accidental exposure by patch transfer, use in elderly patients, gastrointestinal tract, paediatric population, lactation, and patients with myasthenia gravis.
Danish: Andre advarsler, der er indsat i punkt 4.4: kronisk lungesygdom, lægemiddelafhængighed og misbrugspotentiale, centralnervesystemet inklusive forhøjet intrakranielt tryk, hjertesygdom, hypotension, nedsat leverfunktion, nedsat nyrefunktion, respirationsdepression, serotoninsyndrom, utilsigtet eksponering ved plasteroverførsel, anvendelse hos ældre patienter, mave-tarmsystemet, pædiatrisk population, laktation og patienter med myasthenia gravis.
English: Because there are no pharmacokinetic (PK) data available to support the safety of replacing patches at 48hour intervals, the MAH does not recommend dosing intervals of less than 72 hours.
Danish: Da der ikke foreligger farmakokinetiske data til underbygning af sikkerheden af at skifte depotplastret med 48-timers intervaller, fraråder markedsføringstilladelsesindehaveren dosisintervaller på under 72 timer.
English: However a warning has been added that more time would be needed for CYP3A4 inhibitors with a long half-life (such as amiodarone) or CYP3A4 inhibitors with time-dependent or mechanism-based inhibition (such as erythromycin, nicardipine, idelalisib, ritonavir), and that the product information of the CYP3A4 inhibitor must be consulted for the half-life and duration of the inhibitory effect before applying the first Durogesic patch.
Danish: Der er dog tilføjet en advarsel om, at der kræves længere tid for CYP3A4hæmmere med lang halveringstid (såsom af amiodaron) og CYP3A4-hæmmere med tidsafhængig eller mekanismeafhængig hæmning (såsom erythromycin, nicardipin, idelalisib og ritonavir), og at der skal søges oplysninger i produktinformationen for den pågældende CYP3A4-hæmmer med henblik på den hæmmende virknings halveringstid og varighed, før det første Durogesic depotplaster påsættes.
English: anaesthetic since the 1960s.
Danish: Fentanyl har været markedsført som intravenøst anæstetikum siden 1960'erne.
English: • The committee considered the divergences identified in the notification for Durogesic and associated names, as well as the remaining sections of the SmPC, labelling and package leaflet.
Danish: • udvalget behandlede de divergenser der er konstateret i anmeldelsen vedrørende Durogesic og relaterede navne samt de øvrige punkter i produktresuméet, etiketteringen og indlægssedlen
English: These are: pharmacodynamic-related interactions with centrally-acting medicinal products and alcohol, monoamine oxidase inhibitors, serotonergic drugs and concomitant use of mixed opioid agonists/antagonists, and pharmacokinetic-related interactions with CYP3A4 Inhibitors and CYP3A4 inducers.
Danish: Det drejer sig om følgende: Farmakodynamikrelaterede interaktioner med centralt virkende lægemidler og alkohol, monoaminoxidasehæmmere, serotonerge lægemidler og samtidig brug af blandede opioidagonister/-antagonister samt farmakokinetikrelaterede interaktioner med CYP3A4-hæmmere og -induktorer.
English: The table with adverse reactions from clinical trials and post-marketing data for both adult and paediatric subjects together, in line with the current table of adverse reactions in the Core Safety Profile (CSP) was proposed.
Danish: Der blev foreslået en tabel med bivirkninger fra kliniske undersøgelser og data efter markedsføring for voksne og pædiatriske patienter under ét i overensstemmelse med den nuværende tabel over bivirkninger i den centrale sikkerhedsprofil (CSP).
English: The scope of this procedure is limited to Durogesic transdermal patches.
Danish: Denne procedure er begrænset til depotplastre indeholdende Durogesic.
English: As placental passage of fentanyl is known to occur in human pregnancies and the potential risk for humans is unknown, a cautionary statement that Durogesic should not be used during pregnancy unless clearly necessary has been included.
Danish: Fentanyl vides at overføres til placenta ved graviditet hos mennesker, men den potentielle risiko for mennesker er ukendt, og der er tilføjet en advarende sætning om, at Durogesic ikke bør anvendes under graviditet medmindre det er strengt nødvendigt.
English: Although clinical experience is limited with Durogesic in opioid-naïve patients and in general the transdermal route is not recommended in opioid-naïve patients, the MAH recognizes that in exceptional clinical circumstances, the 12 μg/h fentanyl patch could be considered, when commencing with oral opioids is not considered appropriate.
Danish: Skønt de kliniske erfaringer med anvendelse af Durogesic til opioidnaive patienter er begrænsede, og skønt transdermal administration generelt frarådes hos opioidnaive patienter, erkender markedsføringstilladelsesindehaveren, at man i kliniske undtagelsestilfælde kan overveje fentanyl depotplastret 12 μg/h, når det ikke findes hensigtsmæssigt at påbegynde oral behandling med opioider.
English: Revisions were made to the sections; use in opioid-naïve and not opioid-tolerant patients and use during fever or external heat application, and cautionary statements on interchangeability have been deleted as local guidance is required to be followed on the distribution of fentanyl patches, which may differ between Member States.
Danish: Der er foretaget revision af afsnittene om anvendelse hos opioidnaive og ikke-opioidtolerante patienter og anvendelse ved feber/ekstern varmepåvirkning, og de advarende sætninger om skift af produktmærke er slettet, da der kræves lokal vejledning, som skal følges ved udlevering af depotplastre med fentanyl, og som kan afvige mellem medlemsstaterne.
English: The use of fentanyl patches is well established as reflected by the large database, in both malignant and severe non-malignant pain conditions (eg.
Danish: Anvendelsen af depotplastre med fentanyl er almindelig anerkendt, som det afspejler sig i den store database for både maligne og svære ikke-maligne smerter (f.eks. i scenarier såsom svære forbrændinger eller posttraumatiske smerter).
English: Table 3: An alternative conversion Table from oral morphine to fentanyl transdermal therapeutic system (TTS), based on data from a clinical study of fentanyl TTS in subjects tolerant of stable regimens of sustained release (SR) morphine, was proposed in 1996 by Donner et al. (1996)1.
Danish: Tabel 3: Donner et al. foreslog i 1996 en alternativ tabel til omregning fra oralt morphin til et transdermalt terapeutisk system (TTS) med fentanyl baseret på data fra en klinisk undersøgelse af fentanyl TTS hos personer, som er tolerante for et stabilt regime med en depotformulering af morphin.
English: The wording for this subsection has been amended in line with the available information to ensure consistency across the different fentanyl-containing medicinal products.
Danish: Ordlyden af dette underpunkt er ændret for at sikre overensstemmelse med de foreliggende oplysninger og ensartethed mellem de forskellige lægemidler indeholdende fentanyl.
English: The wording proposed for lactation/breast-feeding that was agreed for fentanyl-containing transdermal patches during two previous PSUR-WS procedures, was endorsed by the CHMP.
Danish: CHMP godtog den foreslåede ordlyd vedrørende laktation/amning, der er vedtaget for depotplastre indeholdende fentanyl under de to foregående PSURarbejdsdelingsprocedurer.
English: Contraindications relating to severe respiratory depression, hypersensitivity to the active substance or to any of the excipients use in acute or postoperative pain and use in acute or postoperative pain has been included in the harmonised SmPC.
Danish: I det harmoniserede produktresumé er indsat kontraindikationer vedrørende svær respirationsdepression, hypersensitivitet over for det aktive stof eller et eller flere af hjælpestofferne og anvendelse ved akutte eller postoperative smerter.
English: Therefore the MAH's proposal to give a common broad indication wording, not explicitly differentiating between cancer and non-cancer pain, was endorsed by the CHMP.
Danish: CHMP godtog derfor markedsføringstilladelsesindehaverens forslag om en fælles bred ordlyd af indikationen uden udtrykkelig skelnen mellem kræftsmerter og ikke-kræftsmerter.
English: With regard to the interactions with CYP3A4 inhibitors, although the concomitant use with Durogesic is not recommended, in cases where the benefits outweigh the increased risk of adverse effects, a washout period of 2 days before the first Durogesic patch is applied was considered to be sufficient in most cases.
Danish: Hvad angår interaktioner med CYP3A4-hæmmere blev en udvaskningsperiode på 2 dage før påføring af det første Durogesic depotplaster i de fleste tilfælde anset for tilstrækkelig, skønt anvendelse sammen med Durogesic frarådes.
English: The initially proposed Table 1 was simplified at the request of the CHMP, where the conversion factors from a drug to oral morphine are already provided, with the intention of reducing the risk of errors in conversion from other opioids to oral morphine, due to less calculation.
Danish: Den oprindeligt foreslåede tabel 1 blev på CHMP's anmodning forenklet, hvor der i forvejen er angivet faktorer for omregning fra et lægemiddel til oralt morphin.
English: The PL has been harmonised taking into account all revisions of the SmPC that are relevant to the PL.
Danish: Indlægssedlen er harmoniseret under hensyntagen til alle ændringer af produktresuméet med relevans for indlægssedlen.