natgillin/translations-raw huggingface dataset:
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. 
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.
Depotplastret påsættes den intakte hud, hvorved det aktive stof med konstant hastighed afgives til det systemiske kredsløb. 
Transdermal patches are applied to intact skin in order to deliver at a constant rate the active substance to the systemic circulation.
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. 
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.
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. 
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.
Det hastighedskontrollerende trin i forbindelse med absorptionstiden for lægemidlet er typisk hudens permeabilitet. 
The rate controlling step of drug absorption is commonly the permeation through the skin.
Det nuværende dobbeltlagsplaster afviger kun fra de tidligere enkeltlagsplastre i kraft af det ekstra reservoirlag. 
The current bilayer patch differs from the earlier monolayer formulation only by the additional insertion of a reservoir layer.
Teknologien med fentanyldepotplastre er blevet anvendt til klinisk smertelindring siden 1991. 
The transdermal fentanyl patch technology has been used clinically to provide analgesia since 1991.
På baggrund af biotilgængelighedsundersøgelserne blev det påvist, at Fentrixplastrene er sammenlignelige med referencelægemidlet Dorogesic SMAT. 
Based on the bioequivalence studies, Fentrix patches have confirmed comparability to the reference medicinal product, Dorogesic SMAT.
I dag anvendes fentanyl i udbredt grad som bedøvende og smertestillende middel. 
Today fentanyl is extensively used as an anaesthetic and analgesic.
Derfor blev det fremført, at der også bør tages højde for de ikkekliniske undersøgelser af enkeltlagsudgaven, når den lokale tolerabilitet vurderes. 
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.
Begrundelsen for dette var, at vurderingen af den lokale tolerance efter gentagne doser var blevet udført under flerdosisbioækvivalensundersøgelsen hos mennesker. 
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.
- Det blev betragtet som rimeligt og etisk at vurdere hudtolerabilitet for depotplastre indeholdende opioider som en del af sammenlignende biotilgængelighedsundersøgelser. 
- it was considered to be reasonable and ethical to assess skin tolerability of opioid containing transdermal patches as part of comparative bioavailability studies
Det afgørende donorlag er dog fuldstændig identisk i enkeltlags- og dobbeltlagsplastrene. 
Nevertheless, the crucial donor layer has the identical composition in both monolayer and bilayer patches.
Ansøgerens begrundelse var, at vurderingen af den lokale tolerance efter gentagne doser er blevet udført under flerdosisbioækvivalensundersøgelsen hos mennesker. 
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.
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, 
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.
Referencemedlemsstaten vurderede, at det var rimeligt og etisk at vurdere hudtolerabilitet for depotplastre indeholdende opioider som en del af sammenlignende biotilgængelighedsundersøgelser. 
The RMS considered it to be reasonable and ethical to assess skin tolerability of opioid containing transdermal patches as part of comparative bioavailability studies.
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. 
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.
- 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). 
- 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).
Fentrix 75 µ/h Transdermales Pflaster 75 µg/h depotplaster 
Fentrix 75 µ/h Transdermales Pflaster
Fentrix 50 µ/h Transdermales Pflaster 50 µg/h depotplaster 
Fentrix 50 µ/h Transdermales Pflaster
Fentrix 100 µ/h Transdermales Pflaster 100 µg/h depotplaster 
Fentrix 100 µ/h Transdermales Pflaster
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. 
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.
Medlemsstaterne træffer aftale med indehaveren af markedsføringstilladelsen om enkelthederne i et program for begrænset adgang og et sygdomsregister. 
The Member States shall agree the details of a restricted access programme and a disease registry with the MAH.
Fire situationer kræver særlig opmærksomhed: 
There are four situations that require special attention:
Observeret difference (95 % CI) 
Observed difference (95% CI)
Følg lægens anvisninger omhyggeligt. 
Follow your doctor's instruction carefully.
Hvis det er muligt, bør alternativer som azithromycin overvejes. 
Where possible, alternatives such as azithromycin should be considered.
Sådanne reaktioner er typisk observeret inden for de første uger eller måneder efter initiering af CART. 
Typically, such reactions have been observed within the first weeks or months of initiation of CART.
Alternativer bør overvejes, navnlig ved langtidsbehandling. 
Alternatives should be considered, particularly for long-term use.
Fortæl det straks til lægen, hvis du er gravid eller planlægger at blive gravid. 
Tell your doctor immediately if you are pregnant or if you plan to become pregnant.
Dato for første markedsføringstilladelse: 28. november 2011 Dato for seneste fornyelse: 22. juli 2016 
Date of first authorisation: 28 November 2011 Date of latest renewal: 22 July 2016
Uge 240 N=32 
Week 240 N=32
Studierne var identiske med hensyn til design bortset fra baggrundsregimet (BR). 
The trials were identical in design, with the exception of the background regimen (BR).
N = antal forsøgspersoner pr. behandlingsgruppe. 
N=number of subjects per treatment group.
Måltidet er vigtigt, for at du kan få det rette niveau af det aktive stof i kroppen. 
A meal is important to get the right levels of active substance in your body.
* Intent-to-treat tid til tab af virologisk respons. 
* Intent-to-treat time to loss of virologic response.
Det anbefales, at den filmovertrukne tablet synkes hel med vand og ikke tygges eller knuses. 
It is recommended that the film-coated tablet be swallowed whole with water and not be chewed or crushed.
Du må ikke holde op med at tage EDURANT uden først at tale med lægen. 
Do not stop using EDURANT without talking to your doctor first.
Alternativt kan et skift til et andet ART-regimen overvejes. 
Alternatively, switching to another ART regimen could be considered.
Middeleksponeringsvarigheden for patienterne var 63,5 uger. 
The median duration of exposure for patients was 63.5 weeks.
Resultat af analysen i uge 96 
Outcome in the week 96 analysis
f.eks. tabt for opfølgning, manglende compliance, samtykke trukket tilbage. 
e.g. lost to follow-up, non-compliance, withdrew consent.
En ernæringsdrik (f.eks. en proteindrik) alene kan ikke erstatte et måltid. 
A nutritional drink (e.g. protein-rich) alone does not replace a meal.
Selv om du har det bedre, må du ikke holde op med at tage EDURANT eller din anden hiv-medicin. 
Even if you feel better, do not stop taking EDURANT or your other HIV medicines.
Hvis du gør det, øges risikoen for, at virussen udvikler resistens. 
Doing so could increase the risk of the virus developing resistance.
Hiv-behandling kurerer ikke hiv-infektionen! 
HIV treatment does not cure HIV infection!
Frekvenser defineres som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10) og ikke almindelig (≥ 1/1.000 til < 1/100). 
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Baseret på tilnærmelse til normal fordeling 
Based on normal approximation.
Den absolutte biotilgængelighed af EDURANT kendes ikke. 
The absolute bioavailability of EDURANT is unknown.
Undlad at køre eller betjene maskiner, hvis du føler dig træt, svimmel eller sløv, mens du tager EDURANT. 
Do not drive or operate machinery if you feel tired, dizzy or drowsy while taking EDURANT.
Rekombinante kliniske isolater 
Recombinant clinical isolates
Læs følgende punkter, og fortæl det til lægen, hvis nogen af dem gælder for dig. 
Make sure that you check the following points and tell your doctor if any of these apply to you.
Postpartum (6-12 uger) (n=11) 
Postpartum (6-12 Weeks) (n=11)
Site-directed NNRT-mutant virus 
Site-directed NNRTI mutant virus
Det kan åbnes ved at trykke skruelåget ned, samtidig med at det drejes mod uret. 
It can be opened by pushing the screw cap down while turning it anti-clockwise.
De almindeligste mutationer var de samme i uge 48- og uge 96-analyserne. 
The most common mutations were the same in the week 48 and week 96 analyses.
Hos rotter var der ingen lægemiddelrelaterede neoplasmer. 
In rats, there were no drug-related neoplasms.
BR = baggrundsregime 
BR=background regimen
Der blev ikke identificeret sikkerhedsproblemer i uge 240-analyserne. 
There were no safety concerns identified in the week 240 analyses.
Der blev ikke identificeret nye bivirkninger i forhold til dem, der ses hos voksne. 
No new ADRs were identified compared to those seen in adults.
Når EDURANT blev taget kun sammen med en proteinrig ernæringsdrik, var eksponeringen 50 % lavere end, når det blev taget sammen med et måltid. 
When EDURANT was taken with only a protein-rich nutritional drink, exposures were 50% lower than when taken with a meal.
Fastslåede og teoretiske interaktioner med udvalgte antiretrovirale og non-antiretrovirale lægemidler er angivet i tabel 1. 
Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in table 1.
EDURANT påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner. 
EDURANT has no or negligible influence on the ability to drive and use machines.
De fleste bivirkninger var af grad 1 eller 2. 
Most ADRs were Grade 1 or 2.
Alle inflammatoriske symptomer bør evalueres, og behandling iværksættes efter behov. 
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Virologisk svigt og udvikling af resistens 
Virologic failure and development of resistance
EDURANT er ikke beregnet til børn under 12 år, da det ikke er undersøgt tilstrækkeligt hos disse patienter. 
EDURANT is not for use in children less than 12 years of age, because it has not been sufficiently studied in these patients.
EDURANT bør kun anvendes under graviditet, hvis de potentielle fordele opvejer de potentielle risici. 
Edurant should be used during pregnancy only if the potential benefit justifies the potential risk.
Vigtig information om nogle af de øvrige indholdsstoffer i EDURANT EDURANT indeholder lactose. 
Important information about some of the ingredients of EDURANT EDURANT contains lactose.
Resistens var defineret som enhver mutation forbundet med resistens ved svigt. 
Resistance was defined as the emergence of any resistance-associated mutation at failure.
Der sås ingen overførsel fra moder til barn hos nogen af de 10 fødte spædbørn til de mødre, som gennemførte studiet, og for hvem hiv-statussen var tilgængelig. 
No mother to child transmission occurred in all 10 infants born to the mothers who completed the trial and for whom the HIV status was available.
(reduceret absorption pga. stigning i gastrisk pH) 
(reduced absorption due to gastric pH increase)
Den kliniske betydning af dette fund kendes ikke for tiden. 
The clinical implications of this finding are currently unknown.
Til resistensanalysen anvendtes en bredere definition på virologisk svigt end i den primære effektanalyse. 
For the resistance analysis, a broader definition of virologic failure was used than in the primary efficacy analysis.
Hos hunde er der set kolestaselignende virkninger. 
In dogs, cholestasis-like effects were noted.
Der foreligger dog rapporter om træthed, svimmelhed og døsighed hos nogle patienter, der fik EDURANT, og dette bør tages i betragtning ved vurdering af en patients evne til at køre bil eller betjene maskiner. 
However, fatigue, dizziness and somnolence have been reported in some patients taking EDURANT and should be considered when assessing a patient's ability to drive or operate machinery.
Rilpivirin er ca. 99,7 % bundet til plasmaproteiner in vitro, primært til albumin. 
Rilpivirine is approximately 99.7% bound to plasma proteins in vitro, primarily to albumin.
Hvis du tager didanosin (medicin til behandling af hiv-infektion), er der ikke behov for justering af dosis. 
If you take didanosine (a medicine to treat HIV infection), no dose adjustment is required.
Rilpivirin metaboliseres og elimineres primært af leveren. 
Rilpivirine is primarily metabolised and eliminated by the liver.
Der var ingen teratogenicitet med rilpivirin hos rotter eller kaniner. 
There was no teratogenicity with rilpivirine in rats and rabbits.
C-rilpivirin kunne gennemsnitligt 85 % og 6,1 % af radioaktiviteten genfindes i henholdsvis fæces og urin. 
C-rilpivirine, on average 85% and 6.1% of the radioactivity could be retrieved in faeces and urine, respectively.
Denne analyse inkluderede 36 patienter, der havde gennemført mindst 48 ugers behandling eller havde afbrudt behandlingen tidligere. 
This analysis included 36 patients who had completed at least 48 weeks of treatment or discontinued earlier.
Pædiatrisk population (under 18 år) 
Paediatric population (less than 18 years of age)
E138K-substitutionen fremkom hyppigst under behandling med rilpivirin og sædvanligvis i kombination med M184I-substitutionen. 
The E138K substitution emerged most frequently during rilpivirine treatment, commonly in combination with the M184I substitution.
Efter peroral indgift opnås den maksimale plasmakoncentration af rilpivirin normalt inden for 4-5 timer. 
After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within 4-5 hours.
Vejledning i brug til voksne og unge (fra 12 til under 18 år) Den sædvanlige dosis af EDURANT er én tablet dagligt. 
Instructions for proper use in adults and adolescents (12 to less than 18 years of age) The recommended dose of EDURANT is one tablet once a day.
Fluconazol Itraconazol Posaconazol Voriconazol 
Fluconazole Itraconazole Posaconazole Voriconazole
De 36 forsøgspersoner havde en gennemsnitsalder på 14,5 år (interval 12 til 17 år) og omfattede 55,6 % kvinder, 88,9 % sorte og 11,1 % asiater. 
The 36 subjects had a median age of 14.5 years (range: 12 to 17 years), and were 55.6% female, 88.9% Black and 11.1% Asian.
Denne analyse omfattede 690 patienter i ECHO og 678 patienter i THRIVE, som havde gennemført 96 ugers behandling, eller som var udtrådt tidligere. 
This analysis included 690 patients in ECHO and 678 patients in THRIVE who had completed 96 weeks of treatment or discontinued earlier.
De hyppigste alvorlige behandlingsrelaterede bivirkninger blev rapporteret hos 7 (1,0 %) patienter, der fik rilpivirin. 
The most frequent serious treatment-related ADRs were reported in 7 (1.0%) patients receiving rilpivirine.
Hepatitis B- og/eller hepatitis C-virus co-infektion 
Hepatitis B and/or hepatitis C virus co-infection
Interaktionen mellem rilpivirin og lægemidlet blev vurderet i et klinisk studie. 
* The interaction between rilpivirine and the medicinal product was evaluated in a clinical study.
Nogle former for medicin kan påvirke niveauet af EDURANT i blodet, når de samtidig tages med EDURANT. 
Some medicines may affect the levels of EDURANT in the blood when they are taken at the same time as EDURANT.
Kun spor af uforandret rilpivirin (< 1 % af dosis) blev påvist i urin. 
Only trace amounts of unchanged rilpivirine (< 1% of dose) were detected in urine.
EDURANT er kun blevet anvendt til et begrænset antal patienter over 65 år. 
EDURANT has only been used in a limited number of patients of 65 years or older.
EDURANT virker ved at reducere mængden af hiv-virus i kroppen. 
EDURANT works by reducing the amount of HIV in your body.
Kun H2receptorantagonister, der kan doseres en gang dagligt, bør anvendes. 
Only H2-receptor antagonists that can be dosed once daily should be used.
Der findes ingen specifik modgift mod overdosering af EDURANT. 
There is no specific antidote for overdose with EDURANT.
En beholder med børnesikret lukning, der indeholder 30 filmovertrukne tabletter. 
A bottle with child resistant closure containing 30 film-coated tablets.
- Fortæl det til lægen, hvis du har eller har haft leverproblemer, herunder hepatitis B og/eller C (leverbetændelse) og/eller nyreproblemer. 
- Tell your doctor if you have or have had problems with your liver, including hepatitis B and/or C, and/or problems with your kidneys.
Hver karton indeholder en beholder med 30 tabletter. 
Each carton contains one bottle of 30 tablets.
Klinisk monitorering anbefales dog, da det hos nogle patienter kan være nødvendigt at justere vedligeholdelsesbehandling med methadon. 
However, clinical monitoring is recommended as methadone maintenance therapy may need to be adjusted in some patients.
Almindelige nedsat appetit forhøjede triglycerider (fastende) 
common decreased appetite increased triglycerides (fasted)
Virkningen af EDURANT eller af anden medicin kan blive påvirket, hvis du tager EDURANT sammen med nedenstående medicin. 
The effects of EDURANT or other medicines might be influenced if you take EDURANT together with any of the following medicines.
Patienter med sjældne arvelige problemer med galactoseintolerans, Lapp lactase mangel eller glucose/galactosemalabsorption bør ikke tage dette lægemiddel. 
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Behandlingen af overdosering med rilpivirin består af generelle understøttende tiltag, herunder monitorering af vitale tegn og EKG (QT-interval) samt observation af klinisk status. 
Treatment of overdose with rilpivirine consists of general supportive measures including monitoring of vital signs and ECG (QT interval) as well as observation of the clinical status of the patient.
EDURANT skal tages i forbindelse med et måltid for at opnå optimal absorption. 
EDURANT must be taken with a meal to obtain optimal absorption.
Der er begrænset dokumentation for brugen af EDURANT til patienter > 65 år. 
There is limited information regarding the use of EDURANT in patients > 65 years of age.
Denne indlægsseddel blev senest ændret{ MM/ÅÅÅÅ } 
This leaflet was last revised in {MM/YYYY}.
Farmakoterapeutisk klassifikation: Antiviralt middel til systemisk brug, non-nukleosid reverse transcriptasehæmmere, ATC-kode: J05AG05. 
Pharmacotherapeutic group: Antiviral for systemic use, non-nucleoside reverse transcriptase inhibitors, ATC code: J05AG05.
EDURANT bør anvendes med forsigtighed til denne population. 
EDURANT should be used with caution in this population.
Fordelingen af rilpivirin i andre kompartmenter end plasma (f.eks. cerebrospinalvæske, genitalsekreter) er ikke vurderet hos mennesker. 
The distribution of rilpivirine into compartments other than plasma (e.g., cerebrospinal fluid, genital tract secretions) has not been evaluated in humans.
Hiv-inficerede kvinder må ikke amme, da der er risiko for, at hiv-smitten kan blive overført til barnet via modermælken. 
HIV infected mothers must not breastfeed, as there is a possibility of infecting the baby with HIV via breast milk.
60-100 mg x 1, individuel dosis 
60-100 mg once daily, individualised dose
Lægen vil rådgive dig om, hvilken hiv-medicin du kan kombinere med EDURANT, så I sammen kan finde frem til den kombination, der bedst dækker dine behov. 
Your doctor will advise on which HIV medicines can be combined with EDURANT and together you will decide which combination fits your needs best.
Alle andre viste lægemiddelinteraktioner er forventede. 
All other drug-drug interactions shown are predicted.
Renal elimination af rilpivirin er ubetydelig. 
Renal elimination of rilpivirine is negligible.
Lægen vil vurdere, hvor alvorlig din lever- eller nyresygdom er, før vedkommende beslutter, om du kan tage EDURANT. 
Your doctor may evaluate how severe your liver or kidney disease is before deciding if you can take EDURANT.
Pædiatrisk population (fra 12 til under 18 år) 
Paediatric population (12 to less than 18 years of age)
GLUKOKORTIKOIDER Dexamethason (systemisk, undtagen ved enkeltdosering) 
GLUCOCORTICOIDS Dexamethasone (systemic, except for single dose use)
Metabolisme og ernæring meget almindelige forhøjet totalkolesterol (fastende) forhøjet LDL-kolesterol (fastende) 
Metabolism and nutrition disorders very common increased total cholesterol (fasted) increased LDL cholesterol (fasted)
Der er kun begrænsede oplysninger tilgængelige om muligheden for en farmakodynamisk interaktion mellem rilpivirin og lægemidler, der forlænger QTc-intervallet på EKG'et. 
There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and medicinal products that prolong the QTc interval of the ECG.
NARKOTISKE ANALGETIKA Methadon* 
NARCOTIC ANALGESICS Methadone*
Nogle patienter kan blive trætte, svimle eller sløve under behandlingen med EDURANT. 
Some patients may experience tiredness, dizziness or drowsiness during treatment with EDURANT.