FrancophonIA/ELRC3.0 huggingface dataset:
English: Fentanyl is a synthetic opioid analgesic, belonging to the piperidine derivatives, and is chemically related to pethidine.
Danish: Fentanyl er et syntetisk opioidanalgetikum, der hører under piperidinderivaterne, og som er kemisk forbundet med petidin.
English: However, the objecting Concerned Member State (CMS) considered that the authorisation of this medicinal product Fentrix, transdermal patch, may present a potential serious risk to public health on the grounds of non-clinical and clinical safety.
Danish: Den berørte medlemsstat, der havde gjort indsigelser, var dog af den opfattelse, at godkendelsen af lægemidlet Fentrix, depotplastre, kan udgøre en potentiel alvorlig risiko for folkesundheden for så vidt angår ikkeklinisk og klinisk sikkerhed.
English: On the contrary, the visual inspection of the data was suggestive of a worse skin irritation potential.
Danish: Tværtimod antydede den visuelle inspektion af dataene en større risiko for hudirritation.
English: Fentanyl has a high lipid solubility which makes it suitable for transdermal administration.
Danish: Fentanyl har en høj lipid opløselighed, hvilket gør det velegnet til transdermal indgivelse.
English: Once the patch is applied to the skin the drug diffuses in the subcutaneous tissues and forms a reservoir.
Danish: Når plastret er påsat huden, breder lægemidlet sig i det subkutane væv og danner et reservoir.
English: Performing this model, statistically significant differences were found between treatments in both studies (the single dose study and the multiple dose study), and the point estimate of the odds ratio was 8.35 in the single dose study and 1.45 in the multiple dose study.
Danish: Under udførelsen af denne model blev der fundet statistiske forskelle mellem behandlingerne i begge undersøgelser (enkeltdosisundersøgelsen og flerdosisundersøgelsen), og pointoverslaget over odds ratioen var 8,35 i enkeltdosisundersøgelsen og 1,45 i flerdosisundersøgelsen.
English: From experience, these values were considered to be well in line with the results of other fentanyl generic patches.
Danish: Disse værdier anses på baggrund af de gængse erfaringer for at være i overensstemmelse med resultaterne for andre generiske plastre indeholdende fentanyl.
English: The McNemar test was then used investigating whether significant differences between the test and the reference in the number of patients who suffered adverse events were observed or not.
Danish: McNemartesten blev derefter anvendt til at undersøge, hvorvidt der blev observeret signifikante forskelle mellem testproduktet og referenceproduktet i forhold til antallet af patienter, der led af bivirkninger.
English: The dermal tolerability of the current bilayer patch formulation was non-clinically analysed in comparison to the reference product “Dorogesic 25” in rabbits as part of the pharmacokinetic studies A/PK 02-P012 and A/PK 02-P013.
Danish: Det nuværende dobbeltlagsplasters dermale tolerabilitet blev i en ikkeklinisk analyse sammenlignet med referencelægemidlet "Dorogesic 25" hos kaniner som en del af de farmakokinetiske undersøgelser A/PK 02-P012 og A/PK 02-P013.
English: This test does not take into account the temporal evolution of events - only if the subject suffered adverse events with the test, or with reference, or with both, or with none.
Danish: Testen tager ikke højde for hændelsernes tidsmæssige udvikling, men kun for, om forsøgspersonen led af bivirkninger i forbindelse med testproduktet, referenceproduktet, begge produkter eller ingen af produkterne.
English: The OR estimates are close to the ones reported by the objecting CMS, although not exactly identical.
Danish: OR-estimaterne ligger tæt på dem, der er rapporteret af de berørte medlemsstater, der havde gjort indsigelse, men er dog ikke helt identiske med dem.
English: It is an accepted clinical reality that for transdermal therapy a skin irritation score of 1 is common and without further clinical relevance.
Danish: Det er en almindeligt anerkendt klinisk realitet, at når det gælder transdermal terapi, er en hudirritationsscore på 1 almindelig og uden videre klinisk relevans.
English: As absence of any sensitising potential is also well-known for the active substance and all other excipients of the patch and could be clinically confirmed (see below), no new information can be reasonably expected from additional studies in animals.
Danish: Da det er fastslået, at der ikke er risiko for hudoverfølsomhed ved det aktive stof og alle andre af plastrets hjælpestoffer, hvilket blev bekræftet under kliniske forhold (se nedenfor), kan der ikke forventes at fremkomme flere oplysninger fra yderligere dyreforsøg.
English: Therefore, the objecting CMS performed a new statistical analysis based on a logistic regression mixed model where the likelihood of having an AE depended both on the number of observations and treatments (fixed effects) and subject (as a random effect).
Danish: Derfor udførte de berørte medlemsstater, der havde gjort indsigelse, en ny statistisk analyse baseret på en blandet logistisk regressionsmodel, hvor sandsynligheden for at få en bivirkning afhang af både antallet af observationer og behandlinger (faste effekter) og forsøgsperson (som en randomiseret effekt).
English: Taking all these aspects into consideration, the CHMP accepted the argument that the available nonclinical data sufficiently demonstrate the comparable local tolerability of Fentrix and Dorogesic.
Danish: CHMP medtog alle disse aspekter i sine overvejelser og godtog argumentet om, at de tilgængelige kliniske data i tilstrækkelig grad påviser den sammenlignelige lokale tolerabilitet hos Fentrix og Dorogesic.
English: SAS User Group International (SUGI) Conference Proceedings 27, Paper 261-27 (2002)), the Applicant recalculated the logistic mixed model using the SAS Procedure NLMIXED (SAS Version 9.1.3).
Danish: Baseret på Kuss' tilgang (Kuss, O.: "How to use SAS for logistic regression with correlated data", SAS User Group International (SUGI) Conference Proceedings 27, Paper 261-27 (2002)) genberegnede ansøgeren den blandede logistiske model i henhold til SAS-proceduren NLMIXED (SAS Version 9.1.3).
English: Each of the clinical pharmacokinetic studies (single dose (SD) as well as multiple dose (MD)), confirmed that for the Fentrix patch, the percentage of skin irritation scores of 0 (no irritation) and score 1 (minimal erythema, barely perceptible, scoring according to the FDA Guidance for industry, Skin Irritation and Sensitization Testing of Generic Transdermal Products) reached more than 90 %.
Danish: I hver af de kliniske farmakokinetiske undersøgelser (enkeltdosis- såvel som flerdosisundersøgelsen) bekræftedes det, at for Fentrixplastret var procentdelen af en hudirritationsscore på 0 (ingen irritation), og scoren 1 (minimalt erytem, næsten ikke synligt, scoren beregnes i henhold til FDA's branchevejledning "Skin Irritation and Sensitization Testing of Generic Transdermal Products") nået op på over 90 %.
English: Single dose study: the mean score for test was 0.39 and 0.25 for the reference.
Danish: Enkeltdosisundersøgelse: Den gennemsnitlige score var 0,39 for testproduktet og 0,25 for referenceproduktet.
English: Nordkanalstrasse 28 20097 Hamburg Germany transdermico
Danish: Nordkanalstrasse 28 20097 Hamburg Tyskland anvendelse
English: In principle, the non-clinical data on local tolerance of the bilayer patch should have been complemented by an analysis of its sensitisation potential.
Danish: I princippet skulle de ikkekliniske data om lokal tolerance af dobbeltlagsplastret have været suppleret af en analyse af risikoen for overfølsomhed.
English: The Applicant acknowledged that only non-clinical single dose studies have been performed in spite of the fact that section 4.2 “Dermal tolerance testing” of the Note for Guidance on Non-clinical Tolerance Testing of Medicinal Products (CPMP/SWP/2145/00), indicates that dermal tolerance is tested by a single and repeat dose administration and an evaluation of the sensitising potential.
Danish: Ansøgeren erkendte, at der kun er blevet udført ikkekliniske enkeltdosisundersøgelser, til trods for at punkt 4.2 "Dermal tolerance testing" i "Note for Guidance on Non-clinical Tolerance Testing of Medicinal Products" (CPMP/SWP/2145/00) angiver, at dermal tolerance skal testes med enkelte og gentagne doser samt en vurdering af risikoen for overfølsomhed.
English: Both clinical pharmacokinetic studies, single dose (SD) as well as multiple dose (MD), confirmed that the Fentrix patch is in general well tolerated when applied to the human skin.
Danish: Begge kliniske farmakokinetiske undersøgelser, enkeltdosis- såvel som flerdosisundersøgelser, bekræftede, at Fentrixplastret generelt er veltolereret på menneskelig hud.
English: Multiple dose study: the number of observations with skin irritation above score 1 was 77 for the test and 56 for the reference, in the same number (26) of subjects with skin irritation.
Danish: Flerdosisundersøgelse: Antallet af observationer af hudirritation med en score over 1 var 77 for testproduktet og 56 for referenceproduktet, hvor antallet af forsøgspersoner med hudirritation var det samme (26).
English: However, the predominant constituents of the patch - mainly two of the adhesives, were not found to be sensitive to the skin of guinea pigs when tested alone according to guidelines CPMP/SWP/2145/00 and OECD 406 (Buehler method).
Danish: Plastrets fremherskende bestanddele - hovedsageligt to af klæbestofferne - virkede ikke irriterende på marsvins hud, når de blev testet alene i henhold til retningslinjerne CPMP/SWP/2145/00 og OECD 406 (Buehlermetoden).
English: However it was the view of the objecting Member States (MS) that the excipients in this application are qualitatively different to those of the reference product and that the Applicant had used the monolayer instead of the bilayer version of the patch in some non-clinical investigations.
Danish: De medlemsstater, der havde gjort indsigelser, mente dog, at hjælpestofferne i denne ansøgning afviger kvalitativt fra referenceproduktets hjælpestoffer, og at ansøgeren havde anvendt enkeltlags- i stedet for dobbeltlagsudgaven af plastret i visse ikkekliniske undersøgelser.
English: Transdermal patches are applied to intact skin in order to deliver at a constant rate the active substance to the systemic circulation.
Danish: Depotplastret påsættes den intakte hud, hvorved det aktive stof med konstant hastighed afgives til det systemiske kredsløb.
English: Choosing the binary endpoint ("skin reaction > 1") included treatment (test vs. reference) and observation (in h from first administration) as fixed explanatory variables and a random subject effect.
Danish: Valget af det binære endepunkt ("hudreaktioner > 1") indeholdt behandling (testprodukt over for referenceprodukt) og observation (i timer fra første indgivelse) som faste forklarende variabler og en randomiseret effekt på forsøgspersonerne.
English: In Study A/PK 02-P013, skin reactions were assessed in compliance with existing guidance on single dermal tolerance tests (CPMP/SWP/2145/00) and were rated negligible to slightly irritant for both test item and reference patch.
Danish: I undersøgelsen A/PK 02-P013 blev en række hudreaktioner vurderet i overensstemmelse med de aktuelle retningslinjer for enkelte test af dermal tolerance (CPMP/SWP/2145/00) og blev bedømt som negligerbare til let irriterende for både testobjektet og referenceplastret.
English: The rate controlling step of drug absorption is commonly the permeation through the skin.
Danish: Det hastighedskontrollerende trin i forbindelse med absorptionstiden for lægemidlet er typisk hudens permeabilitet.
English: The current bilayer patch differs from the earlier monolayer formulation only by the additional insertion of a reservoir layer.
Danish: Det nuværende dobbeltlagsplaster afviger kun fra de tidligere enkeltlagsplastre i kraft af det ekstra reservoirlag.
English: The transdermal fentanyl patch technology has been used clinically to provide analgesia since 1991.
Danish: Teknologien med fentanyldepotplastre er blevet anvendt til klinisk smertelindring siden 1991.
English: Based on the bioequivalence studies, Fentrix patches have confirmed comparability to the reference medicinal product, Dorogesic SMAT.
Danish: På baggrund af biotilgængelighedsundersøgelserne blev det påvist, at Fentrixplastrene er sammenlignelige med referencelægemidlet Dorogesic SMAT.
English: Today fentanyl is extensively used as an anaesthetic and analgesic.
Danish: I dag anvendes fentanyl i udbredt grad som bedøvende og smertestillende middel.
English: For this reason, it was argued that the non-clinical studies testing the monolayer version should also be accounted for when the local tolerability is assessed.
Danish: Derfor blev det fremført, at der også bør tages højde for de ikkekliniske undersøgelser af enkeltlagsudgaven, når den lokale tolerabilitet vurderes.
English: The justification for this was that the evaluation of the local tolerance after repeat dose administration had been carried out during the multiple dose bioequivalence study in humans.
Danish: Begrundelsen for dette var, at vurderingen af den lokale tolerance efter gentagne doser var blevet udført under flerdosisbioækvivalensundersøgelsen hos mennesker.
English: - it was considered to be reasonable and ethical to assess skin tolerability of opioid containing transdermal patches as part of comparative bioavailability studies
Danish: - Det blev betragtet som rimeligt og etisk at vurdere hudtolerabilitet for depotplastre indeholdende opioider som en del af sammenlignende biotilgængelighedsundersøgelser.
English: Nevertheless, the crucial donor layer has the identical composition in both monolayer and bilayer patches.
Danish: Det afgørende donorlag er dog fuldstændig identisk i enkeltlags- og dobbeltlagsplastrene.
English: The Applicant's justification was that the evaluation of the local tolerance after repeat dose administration has been carried out during the multiple dose bioequivalence study in humans.
Danish: Ansøgerens begrundelse var, at vurderingen af den lokale tolerance efter gentagne doser er blevet udført under flerdosisbioækvivalensundersøgelsen hos mennesker.
English: In the statistical analysis performed by the objecting CMS, only a small percentage of incidences of skin irritations, calculated as 3.28 % (SD)/8.46%(MD) for the Fentrix patch and 0.64 % (SD)/5.93%(MD) for the reference patch, have been included to evaluate the comparability of the safety profile.
Danish: I den statistiske analyse udført af de berørte medlemsstater, der havde gjort indsigelse, er kun en lille procentdel af forekomsterne af hudirritation, beregnet til 3,28 % (enkeltdosis)/8,46 % (flerdosis) for Fentrixplastret og 0,64 % (enkeltdosis)/5,93 % (flerdosis) for referenceplastret,
English: The RMS considered it to be reasonable and ethical to assess skin tolerability of opioid containing transdermal patches as part of comparative bioavailability studies.
Danish: Referencemedlemsstaten vurderede, at det var rimeligt og etisk at vurdere hudtolerabilitet for depotplastre indeholdende opioider som en del af sammenlignende biotilgængelighedsundersøgelser.
English: Therefore, the elimination half-life is longer compared to other administration routes, with about 17 h for fentanyl after transdermal administration, compared to parenteral and transmucosal administered drug of 7 h. The release of the drug from the patch is controlled without membrane.
Danish: Den er omkring 17 timer for fentanyl efter transdermal indgivelse sammenlignet med parenterale lægemidler og lægemidler, der indgives via slimhinderne, hvor den er på syv timer.
English: - the Fentrix transdermal patch was shown to be well tolerated and comparable to the reference medicinal product Dorogesic the CHMP has recommended the granting of the Marketing Authorisation for which the Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Fentrix and associated names (see Annex I).
Danish: - Det blev påvist, at Fentrix depotplastre var veltolererede og sammenlignelige med referencelægemidlet Dorogesic anbefaler CHMP, at der udstedes markedsføringstilladelse for Fentrix og tilknyttede navne (se bilag I).
English: Fentrix 75 µ/h Transdermales Pflaster
Danish: Fentrix 75 µ/h Transdermales Pflaster 75 µg/h depotplaster
English: Fentrix 50 µ/h Transdermales Pflaster
Danish: Fentrix 50 µ/h Transdermales Pflaster 50 µg/h depotplaster
English: Fentrix 100 µ/h Transdermales Pflaster
Danish: Fentrix 100 µ/h Transdermales Pflaster 100 µg/h depotplaster
English: Fentanyl Helm Pharmaceuticals 100µg/h Pleister voor transdermaal gebruik/Dispositif
Danish: Fentanyl Helm Pharmaceuticals 100µg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster
English: They shall ensure that Glybera is only supplied if the healthcare professionals involved in the treatment of a patient have received the educational pack and if the prescriber confirms that the patient agrees to participate in the registry.
Danish: Medlemsstaterne sikrer, at Glybera kun udleveres under forudsætning af, at de sundhedspersoner, der er inddraget i patientens behandling, har modtaget informationspakken, og at den ordinerende læge bekræfter at patienten samtykker i at deltage i registret.
English: The Member States shall agree the details of a restricted access programme and a disease registry with the MAH.
Danish: Medlemsstaterne træffer aftale med indehaveren af markedsføringstilladelsen om enkelthederne i et program for begrænset adgang og et sygdomsregister.
English: There are four situations that require special attention:
Danish: Fire situationer kræver særlig opmærksomhed:
English: Observed difference (95% CI)
Danish: Observeret difference (95 % CI)
English: Follow your doctor's instruction carefully.
Danish: Følg lægens anvisninger omhyggeligt.
English: Where possible, alternatives such as azithromycin should be considered.
Danish: Hvis det er muligt, bør alternativer som azithromycin overvejes.
English: Typically, such reactions have been observed within the first weeks or months of initiation of CART.
Danish: Sådanne reaktioner er typisk observeret inden for de første uger eller måneder efter initiering af CART.
English: Alternatives should be considered, particularly for long-term use.
Danish: Alternativer bør overvejes, navnlig ved langtidsbehandling.
English: Tell your doctor immediately if you are pregnant or if you plan to become pregnant.
Danish: Fortæl det straks til lægen, hvis du er gravid eller planlægger at blive gravid.
English: Date of first authorisation: 28 November 2011 Date of latest renewal: 22 July 2016
Danish: Dato for første markedsføringstilladelse: 28. november 2011 Dato for seneste fornyelse: 22. juli 2016
English: Week 240 N=32
Danish: Uge 240 N=32
English: The trials were identical in design, with the exception of the background regimen (BR).
Danish: Studierne var identiske med hensyn til design bortset fra baggrundsregimet (BR).
English: N=number of subjects per treatment group.
Danish: N = antal forsøgspersoner pr. behandlingsgruppe.
English: A meal is important to get the right levels of active substance in your body.
Danish: Måltidet er vigtigt, for at du kan få det rette niveau af det aktive stof i kroppen.
English: * Intent-to-treat time to loss of virologic response.
Danish: * Intent-to-treat tid til tab af virologisk respons.
English: It is recommended that the film-coated tablet be swallowed whole with water and not be chewed or crushed.
Danish: Det anbefales, at den filmovertrukne tablet synkes hel med vand og ikke tygges eller knuses.
English: Do not stop using EDURANT without talking to your doctor first.
Danish: Du må ikke holde op med at tage EDURANT uden først at tale med lægen.
English: Alternatively, switching to another ART regimen could be considered.
Danish: Alternativt kan et skift til et andet ART-regimen overvejes.
English: The median duration of exposure for patients was 63.5 weeks.
Danish: Middeleksponeringsvarigheden for patienterne var 63,5 uger.
English: Outcome in the week 96 analysis
Danish: Resultat af analysen i uge 96
English: e.g. lost to follow-up, non-compliance, withdrew consent.
Danish: f.eks. tabt for opfølgning, manglende compliance, samtykke trukket tilbage.
English: A nutritional drink (e.g. protein-rich) alone does not replace a meal.
Danish: En ernæringsdrik (f.eks. en proteindrik) alene kan ikke erstatte et måltid.
English: Even if you feel better, do not stop taking EDURANT or your other HIV medicines.
Danish: Selv om du har det bedre, må du ikke holde op med at tage EDURANT eller din anden hiv-medicin.
English: Doing so could increase the risk of the virus developing resistance.
Danish: Hvis du gør det, øges risikoen for, at virussen udvikler resistens.
English: HIV treatment does not cure HIV infection!
Danish: Hiv-behandling kurerer ikke hiv-infektionen!
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Danish: Frekvenser defineres som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10) og ikke almindelig (≥ 1/1.000 til < 1/100).
English: Based on normal approximation.
Danish: Baseret på tilnærmelse til normal fordeling
English: The absolute bioavailability of EDURANT is unknown.
Danish: Den absolutte biotilgængelighed af EDURANT kendes ikke.
English: Do not drive or operate machinery if you feel tired, dizzy or drowsy while taking EDURANT.
Danish: Undlad at køre eller betjene maskiner, hvis du føler dig træt, svimmel eller sløv, mens du tager EDURANT.
English: Recombinant clinical isolates
Danish: Rekombinante kliniske isolater
English: Make sure that you check the following points and tell your doctor if any of these apply to you.
Danish: Læs følgende punkter, og fortæl det til lægen, hvis nogen af dem gælder for dig.
English: Postpartum (6-12 Weeks) (n=11)
Danish: Postpartum (6-12 uger) (n=11)
English: Site-directed NNRTI mutant virus
Danish: Site-directed NNRT-mutant virus
English: It can be opened by pushing the screw cap down while turning it anti-clockwise.
Danish: Det kan åbnes ved at trykke skruelåget ned, samtidig med at det drejes mod uret.
English: The most common mutations were the same in the week 48 and week 96 analyses.
Danish: De almindeligste mutationer var de samme i uge 48- og uge 96-analyserne.
English: In rats, there were no drug-related neoplasms.
Danish: Hos rotter var der ingen lægemiddelrelaterede neoplasmer.
English: BR=background regimen
Danish: BR = baggrundsregime
English: There were no safety concerns identified in the week 240 analyses.
Danish: Der blev ikke identificeret sikkerhedsproblemer i uge 240-analyserne.
English: No new ADRs were identified compared to those seen in adults.
Danish: Der blev ikke identificeret nye bivirkninger i forhold til dem, der ses hos voksne.
English: When EDURANT was taken with only a protein-rich nutritional drink, exposures were 50% lower than when taken with a meal.
Danish: Når EDURANT blev taget kun sammen med en proteinrig ernæringsdrik, var eksponeringen 50 % lavere end, når det blev taget sammen med et måltid.
English: Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in table 1.
Danish: Fastslåede og teoretiske interaktioner med udvalgte antiretrovirale og non-antiretrovirale lægemidler er angivet i tabel 1.
English: EDURANT has no or negligible influence on the ability to drive and use machines.
Danish: EDURANT påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Most ADRs were Grade 1 or 2.
Danish: De fleste bivirkninger var af grad 1 eller 2.
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Danish: Alle inflammatoriske symptomer bør evalueres, og behandling iværksættes efter behov.
English: Virologic failure and development of resistance
Danish: Virologisk svigt og udvikling af resistens
English: EDURANT is not for use in children less than 12 years of age, because it has not been sufficiently studied in these patients.
Danish: EDURANT er ikke beregnet til børn under 12 år, da det ikke er undersøgt tilstrækkeligt hos disse patienter.