natgillin/translations-raw huggingface dataset:
Der skal til dette formål indsendes en forundersøgelse om brugen af eksisterende datakilder til PRAC's evaluering senest 15. juni 2017. 
A feasibility assessment of the use of existing data sources for this purpose should be submitted for PRAC assessment by 15 June 2017.
Grundet deres øgede styrke over for HCV og manglende anti-HBV-aktivitet kan risikoen for HBV-reaktivering være større ved nyere HCV-behandlinger end ved de tidligere godkendte interferon-baserede HCV-behandlinger. 
Given their increased potency against HCV and lack of anti-HBV activity, the risk of HBV reactivation may be greater with newer HCV treatment regimens than with the previously approved interferon-based HCV treatments.
Selvom aktiviteten og progressionen i leversygdom generelt er mere alvorlig ved dobbeltinfektion, hæmmes HBV-replikationen ofte ved HCV co-infektion. 
Although liver disease activity and progression are generally more severe in the presence of double infection, HBV replication is often suppressed in the presence of HCV coinfection.
Reaktiveringen forekom generelt kort tid efter behandlingsstart i et mønster, der antyder en forbindelse med det hurtige fald i HCV-virusbyrden, som karakteriserer virusbyrdens dynamik med DAA'er. 
Generally, the reactivation occurred shortly after the initiation of treatment in a pattern that implies a correlation with the rapid decrease in HCV viral load which characterises the viral load dynamics with DAAs.
Efter yderligere overvejelser hvad angår de foreslåede tidsfrister for indsendelsen af den endelige undersøgelsesrapport og under hensyntagen til, at protokollen skal indsendes senest 15. juni 2017, fandt CHMP, at datoen for indsendelsen af den endelige undersøgelsesrapport skal udsættes til andet kvartal af 2021. 
After further consideration of the timelines proposed for the submission of the final study report and taking into account that the protocol is due to be submitted by 15 June 2017, the CHMP was of the opinion that the date for the submission of the final study report should be postponed to Q2 2021 in order to allow sufficient time for agreement on a joint protocol and for collection of sufficient data to adequately respond to the scientific question.
Protokollen for denne undersøgelse skal indsendes til PRAC senest 15. juni 2017 og undersøgelsens endelige resultater skal indsendes senest i fjerde kvartal af 2019. 
The protocol of this study shall be submitted to the PRAC by 15 June 2017 and the final study results by Q4 2019.
Med hensyn til gennemgangen af HCC med DAA'er, blev indehaverne af markedsføringstilladelserne bedt om at gennemføre en grundig gennemgang af alle tilgængelige data fra kliniske forøg, observationsundersøgelser, spontane rapporter og offentliggjort litteratur om HCC hos patienter med kronisk hepatitis C efter behandling med DAA'er. 
With regards to the review of HCC with DAAs, MAHs were requested to perform a comprehensive review of all available data from clinical trials, observational studies, spontaneous reports and published literature on HCC in patients with chronic hepatitis C after treatment with DAAs.
Samlet set vurderede PRAC, at der var brug for flere undersøgelser for yderligere at kunne karakterisere risikoen for HCC-recidiv i forbindelse med DAA'er for derved at kunne afklare øvrige usikkerhedsmomenter omkring den potentielle risiko og for at kunne drage en konklusion om behovet for eventuel supplerende vejledning omkring klinisk behandling. 
Overall, the PRAC considered that further studies were warranted to further characterise the risk of HCC recurrence associated with DAAs, in order to address remaining uncertainties about this potential risk and conclude on the need for any additional advice on clinical management.
• PRAC var også af den opfattelse, at virkningen af DAA-behandling på incidensen og typen af de novo hepatocellulært carcinom skal undersøges yderligere gennem en prospektiv kohorte undersøgelse hos HCV-inficerede patienter med cirrose. 
• The PRAC was also of the opinion that the impact of DAAs treatment on the incidence and type of de novo hepatocellular carcinoma should be further investigated though a prospective cohort study in HCV infected patients with cirrhosis.
HBV-replikation efter behandlingsstart med DAA'er for HCV-infektion er i øjeblikket ikke beskrevet i produktinformationen for eksisterende godkendte lægemidler og på grund af de alvorlige hændelser, der er beskrevet, behovet for intervention for HBV-replikation og den biologiske sandsynlighed for replikationen, blev det konkluderet, at en nærmere undersøgelse var berettiget. 
HBV replication after starting treatment with DAAs for HCV infection is not currently described in the product information of currently authorised products and in view of the seriousness of the events described, the need for intervention on HBV replication and the biological plausibility of the replication it was considered that further investigation was warranted.
Der skal derudover indsendes foreløbige resultater til PRAC's vurdering senest i fjerde kvartal af 2019. 
In addition, interim results should be submitted for PRAC assessment by Q4 2019.
HCV-infektion vides at forårsage hæmning af HBV-replikation hos coinficerede patienter. 
HCV infection is known to cause suppression of HBV replication in co-infected patients.
Der blev på baggrund af resultaterne fra Reig et al også rejst betænkelighed ved udviklingen af de novo HCC hos cirrotiske HCV-patienter behandlet med DAA, da disse patienter kan have HCC, der ikke er diagnosticeret endnu. 
Based on the findings of Reig et al, concerns on the development of de novo HCC in cirrhotic HCV patients treated with DAA were also raised, as these patients may harbour not yet diagnosed HCC.
• Hvad angår risikoen for HCC-recidiv hos patienter, der bruger DAA'er, fandt PRAC, at der er behov for flere oplysninger om virkningen af behandling med DAA'er på incidensen af HCCrecidiv. 
• Concerning the risk of recurrence of HCC in patients using DAAs, the PRAC considered that further data are required on the impact of DAAs treatment on the incidence of HCC recurrence.
2016), der blev gennemført i perioden oktober 2014 til december 2015 på hepatologiafdelinger på fire spanske universitetshospitaler hos patienter med kronisk hepatitis C, og hvis anamnese inkluderede hepatocellulært carcinom (HCC), og som var behandlet med DAA'er, et uventet, tidligt recidiv af HCC. 
Following the initiation of this review, results from a study (Reig et al. 2016) performed between October 2014 and December 2015 in Hepatology Units of four University Spanish hospitals in patients with chronic hepatitis C and a history of hepatocellular carcinoma (HCC) treated with DAAs suggested unexpected early HCC recurrence.
For a minimere risikoen for HBV-reaktivering anbefalede PRAC, at alle patienter screenes for HBVinfektion inden behandlingsstart med DAA'er, og at patienter med HBV/HVC co-infektion monitoreres og behandles i henhold til de aktuelle kliniske retningslinjer. 
In order to minimise the risk of HBV reactivation, the PRAC recommended that all patients should be screened for HBV infection before initiation of treatment with DAAs and that patients presenting a coinfection HBV/HCV should be monitored and managed according to current clinical guidelines.
Betydningen af karakteristikaene ved kronisk HCV-infektion, som f.eks. HCV-genotype, virusbyrde og histopatologisk stadieinddeling, for risikoen for forekomsten af HBV-reaktivering kunne ikke afklares ud fra de tilgængelige data. 
The impact of chronic HCV infection characteristics, such as HCV genotype, viral load and histopathologic staging, on the risk of occurrence of HBV reactivation could not be clarified from the available data.
• PRAC gennemgik alle indsendte skriftlige data og mundtlige forklaringer fra indehaverne af markedsføringstilladelserne med hensyn til risikoen for hepatitis B-reaktivering og de betænkeligheder dette gav anledning til efter rapporter om hepatocellulært carcinom hos patienter, der bruger DAA'er, samt resultaterne fra mødet, der blev afholdt af den videnskabelige rådgivende gruppe, om hiv-/virussygdomme. 
• The PRAC reviewed the totality of the data submitted in writing and during the oral explanations by the marketing authorisation holders in relation to the risk of hepatitis B reactivation and to the concerns raised following reports of hepatocellular carcinoma in patients using DAAs, as well as the outcome of the meeting of the scientific advisory group on HIV/Viral diseases.
CHMP finder følgeligt, at benefit/risk-forholdet for Daklinza, Exviera, Harvoni, Olysio, Sovaldi og Viekirax fortsat er positivt under forudsætning af, at de nævnte ændringer indføres i produktinformationen og i henhold til ovennævnte betingelser. 
The CHMP, as a consequence, considers that the benefit-risk balance of Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax remains favourable subject to the amendments to the product information and to the conditions described above.
PRAC fandt generelt, at der foreligger bevis for risiko for HBV-reaktivering hos HBV/HCV co-inficerede patienter behandlet med DAA'er, og at HBV-reaktivering hos co-inficerede patienter derfor skal betragtes som en vigtig, identificeret risiko, som skal monitoreres tæt gennem rutinemæssige risikominimerende aktiviteter. 
Overall, the PRAC was of the view that evidence exists of a risk of HBV reactivation in HBV/HCV coinfected patients treated with DAAs and therefore HBV reactivation in co-infected patients should be considered as an important identified risk which should be closely monitored through routine risk minimisation activities.
På grundlag af ovenstående konkluderer PRAC, at benefit/risk-forholdet for direkte aktive antivirale lægemidler fortsat er positivt under forudsætning af, at de foreslåede ændringer indføres i markedsføringstilladelsen. 
In view of the above, the PRAC considers that the benefit-risk balance of direct-acting antivirals remains favourable subject to the amendments to the terms of the marketing authorisations.
• Hvad angår HBV-reaktivering konkluderede PRAC, at de tilgængelige data giver bevis for risikoen for HBV-reaktivering hos patienter co-inficeret med HBV/HCV og behandlet for kronisk hepatitis C med DAA'er. 
• Concerning HBV reactivation, the PRAC concluded that available data provide evidence of a risk of HBV reactivation in patients co-infected with HBV/HCV treated for chronic hepatitis C with DAAs.
CHMP anbefaler derfor ændring af betingelserne for markedsføringstilladelserne for Daklinza, Exviera, Harvoni, Olysio, Sovaldi og Viekirax. 
Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax.
Data fra kliniske forsøg om incidensen af nyopstået HCC viser højere punktestimater for HCC efter opnåelse af vedvarende virologisk respons med IFN-fri behandling sammenlignet med IFN-holdig behandling, også når der stratificeres ifølge forekomst af cirrose. 
Clinical trial data on incidence of new on-set HCC show higher point estimates for HCC after reaching SVR with IFN-free regimens compared to IFN-containing regimens, also when stratifying by presence of cirrhosis.
PRAC medtog i sin vurdering alle data indsendt af indehaverne af markedsføringstilladelserne, samt litteratur og yderligere oplysninger fra en videnskabelig rådgivende gruppe med hensyn til risikoen for hepatitis B-reaktivering og om recidiv og forekomst af hepatocellulært carcinom. 
Overall summary of the scientific evaluation by the PRAC In its assessment, the PRAC considered all the data submitted by the MAHs, as well as literature and additional information from a scientific advisory group in relation to the risk of hepatitis B reactivation and to the recurrence and occurrence of hepatocellular carcinoma.
PRAC anbefaler følgeligt ændringen af betingelserne for markedsføringstilladelserne for Daklinza, Exviera, Harvoni, Olysio, Sovaldi og Viekirax. 
The PRAC, as a consequence, recommends the variation to the terms of the marketing authorisations for Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax.
Afslutningsvist fandt PRAC, at benefit/risk-forholdet for DAA-holdige produkter stadig er positivt, såfremt de anbefalede ændringer blev implementeret i betingelserne i markedsføringstilladelserne. 
In conclusion, the PRAC considered that the benefit-risk balance of DAAs-containing products remained favourable subject to the amendments of the terms of the marketing authorisations.
I overensstemmelse med anbefalingen fra PRAC skal indehaverne af markedsføringstilladelserne, for at kunne vurdere recidiv af hepatocellulært carcinom i forbindelse med direkte aktive antivirale lægemidler, gennemføre og indsende resultaterne af en prospektiv sikkerhedsundersøgelse ved brug af data fra en kohorte bestående af en veldefineret patientgruppe, baseret på en i fællesskab vedtaget protokol med kriterier for inkludering og opfølgning af patienter med hensyn til screeningstidspunkt og -metode. 
In accordance with the PRAC recommendation, in order to evaluate the recurrence of hepatocellular carcinoma associated with direct-acting antivirals, the MAHs shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol setting out criteria for entry and follow-up of patients in terms of timing and method for screening.
Alle indehavere af markedsføringstilladelser til DAA'er skal gennemføre en prospektiv sikkerhedsundersøgelse hos en veldefineret patientgruppe baseret på en i fællesskab vedtaget protokol med kriterier for inkludering og opfølgning. 
All MAHs of DAAs shall conduct a prospective safety study in a well-defined group of patients based on an agreed protocol setting out criteria for entry and follow-up.
Under hensyntagen til alle tilgængelige data fandt PRAC, at indehaverne af markedsføringstilladelserne skal gennemføre og indsende resultaterne af en prospektiv sikkerhedsundersøgelse ved brug af data fra en kohorte bestående af en veldefineret patientgruppe, baseret på en i fællesskab vedtaget protokol med kriterier for inklusion og opfølgning af patienter med hensyn til screeningstidspunkt og -metode. 
Taking all available data into account, the PRAC was of the view that MAHs should conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol setting out criteria for entry and follow-up of patients in terms of timing and method for screening.
En undersøgelse fra Reig et al. (2016) viste et signal for HCC-recidiv hos patienter behandlet med DAA'er. 
A study from Reig et al. (2016) showed a signal of HCC recurrence in patients treated with DAAs; similar results were obtained by Conti et al. (2016).
Med hensyn til risikoen for hepatitis B-reaktivering findes der kun begrænsede oplysninger om hepatitis B-reaktivering fra de gennemførte kliniske forsøg, da kronisk hepatitis B infektion (HbsAg+) generelt blev betragtet som et eksklusionskriterium, og indsamlingen af data mht. HBV-serologi og DNA ikke var obligatorisk i udviklingsprogrammet for DAA-lægemidler. 
With regards to the risk of hepatitis B reactivation, since chronic hepatitis B infection (HbsAg+) was generally considered an exclusion criterion and the collection of data regarding HBV serology and DNA was not mandatory in the development programme of DAAs agents, there is limited information on hepatitis B reactivation obtainable from the completed clinical trials.
De tilgængelige data giver bevis for, at reaktiveringen af HBV-replikation kan forekomme i forbindelse med behandling af kronisk, aktiv HCV-infektion med en hvilken som helst effektiv behandling hos patienter co-inficeret med HBV og HCV. Reaktiveringen kan hovedsageligt forekomme hos patienter med påviseligt HBsAg og aktiv HBV-replikation uanset niveau, vurderet ud fra påviselige niveauer af HBV-DNA, men kan også forekomme hos patienter uden påviseligt HBsAg, dog med påviseligt antiHBc-antistof, og hvor en lille procentdel også kan have aktiv HBV-replikation på forskelligt niveau. 
The reactivation may occur mostly in subjects with detectable HBsAg and active HBV replication of any level, as evaluated by measurable levels of HBV-DNA, but may also occur in subjects without detectable HBsAg though with detectable anti-HBc antibody, of which a small percentage may also present with variable levels of active HBV replication.
Alligevel fandtes det, at DAA-behandlingernes indvirkning på incidensen og typen af de novo HCC skal undersøges nærmere af indehaverne af markedsføringstilladelserne gennem en prospektiv kohorte-undersøgelse. 
Still, it was considered that the impact of DAAs therapies on the incidence and type of de novo HCC should be further investigated by the MAHs through a prospective cohort study to be conducted in HCV infected patients with compensated cirrhosis (CPT-A) without history of HCC and treated with DAAs.
Sådanne virkninger kunne stadig ses efter rekonvalescensperioden på 2 uger. 
Such effects could still be seen after the recovery period of 2 weeks.
Dette er i tillæg til det uddannelsesmateriale, som alle potentielle brugere bør få udleveret. 
This is in addition to the educational material which all potential users should receive.
De specifikke komponenter, der er ansvarlige for denne virkning, er ikke blevet identificeret. 
The specific components responsible for this effect have not been identified.
Du kan blive kontrolleret regelmæssigt for disse reaktioner. 
You may be checked regularly for these conditions.
I gennemsnit var TBSA 10 %. 
Average TBSA was 10%.
Forbrændinger, hvor der er begrænset eller ingen erfaring 
Burns for which there is limited or no experience
Immunsystemet Ikke kendt: 
Immune system disorders Not known:
Allergiske reaktioner kan være svære og kræve medicinsk behandling. 
Allergic reactions can be severe and require medical treatment.
Det vil forberedes umiddelbart før brug og appliceres af en læge eller andet sundhedspersonale. 
It will be prepared directly before use and applied by a doctor or another healthcare professional.
Uddannelsespakken skal indeholde det følgende: 
The educational pack should contain the following:
Såret skal holdes fugtigt i løbet af applikationsproceduren. 
The wound must be kept moist during the application procedure.
Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) - Feber 
Very common side effects (may affect more than 1 in 10 people) - Fever
*Disse sammenligninger bør fortolkes med forsigtighed, da der er baseret på grupper, som ikke er helt randomiserede. 
*These comparisons should be interpreted with caution since they are based on groups that are not fully randomized.
Forberedelse og administration 
Preparation and administration
En anden og efterfølgende applikation anbefales ikke. 
A second and subsequent application is not recommended.
** Informeret samtykkeerklæring 
** Informed Consent Form
Der er begrænsede farmakokinetiske data hos patienter med et TBSA på over 15 %. 
There is limited pharmacokinetic data in patients with TBSA of more than 15%.
Erfaring med NexoBrid hos ældre patienter (>65 år) er begrænset. 
Experience with NexoBrid in elderly patients (>65 years) is limited.
Den følgende tabel viser resultater for blandede sår. 
The following table shows results in mixed wounds.
Du kan få medicin for at forebygge og behandle infektioner. 
You may receive medicines to prevent or treat infections.
Pædiatrisk population Farmakokinetiske parametre og absorptionsgraden er ikke blevet undersøgt hos børn. 
Paediatric population Pharmacokinetic parameters and the extent of absorption have not been studied in children.
- kemiske brandsår. 
- chemical burn wounds.
Da NexoBrid blev tolereret dårligt af parentaldyrene, anses disse studier ikke for at være relevante for human risikovurdering. 
Since NexoBrid was poorly tolerated by the parent animals, these studies are not considered relevant for human risk assessment.
Fra disse data forventes det, at den samlede sikkerhedsprofil hos børn i alderen 4 år og derover og hos unge er sammenlignelig med profilen hos voksne. 
From these data it is expected that the overall safety profile in children 4 years of age and older and in adolescents is similar to the profile in adults.
- Tegn på lokale eller systemiske allergiske reaktioner. 
- Signs of local or systemic allergic reactions.
De følgende definitioner gælder for hyppighedsterminologien, som herefter anvendes: Meget almindelig (≥ 1/10) 
The following definitions apply to the frequency terminology used hereafter: Very common (≥1/10)
Disse patienter skal overvåges nøje. 
These patients should be carefully monitored.
6.6 for instruktioner i forberedelse af NexoBrid gel. 
See section 6.6 for instructions on NexoBrid gel preparation.
Alle sår (ITT 
All wounds (ITT
Der er kun begrænsede sikkerhedsdata fra brugen i den pædiatriske population. 
There is only limited safety data from the use in the paediatric population.
Informationspakken til sundhedspersonale er en trinvis behandlingsguide, der indeholder information om de følgende nøgleelementer: 
The Healthcare Professional information pack should be a step by step treatment guide that includes information on the following key elements:
Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}.> 
This leaflet was last revised in <{MM/YYYY}> <{month YYYY}.>
• Risikoen for øget mortalitet hos patienter med hjerte-lunge-sygdomme 
• The risk of increased mortality in patients with cardiopulmonary diseases
Dette er for at gøre det mindre sandsynligt, at du udvikler en allergisk reaktion over for NexoBrid. 
This is to make it less likely that you develop an allergic reaction to NexoBrid.
Fra et mikrobiologisk synspunkt og da den enzymatiske aktivitet af præparatet reduceres progressivt efter blanding, skal det rekonstituerede præparat anvendes umiddelbart efter forberedelse (i løbet af 15 minutter). 
From a microbiological point of view and as the enzymatic activity of the product decreases progressively following mixing, the reconstituted product should be used immediately after preparation (within 15 minutes).
Hyppigheden af smerter og pyreksi/hypertermi var større uden disse forholdsregler (se nedenfor). 
The frequency of pain and pyrexia/hyperthermia was higher without these precautionary measures (see below).
Tmax for 10 ud af de 15 patienter var 2 timer og hos 5 patienter var Tmax 4 timer. 
Tmax for 10 of the 15 patients was 2 hours and in 5 patients Tmax was 4 hours.
• Passende analgetiske lægemidler skal administreres. 
• Appropriate preventive analgesia medicinal products must be administered.
Hvis du ikke er sikker på, om du tager nogle af de ovenfor nævnte lægemidler, skal du spørge lægen, før NexoBrid bruges. 
If you are not sure whether you are taking any of the medicines mentioned above, ask your doctor before NexoBrid is used.
En stjerne (*) indikerer, at yderligere information om de respektive bivirkninger gives nedenunder listen over bivirkninger. 
An asterisk (*) indicates that additional information on the respective adverse reaction is provided below the list of adverse reactions.
Det bør anvendes i løbet af 15 minutter efter blanding. 
It should be used within 15 minutes after mixing.
48 sår 
48 wounds
- sår, der er forurenet med radioaktive og andre farlige stoffer, for at undgå uforudsete reaktioner med præparatet, og en øget risiko for at sprede det skadelige stof. 
- wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance.
Aldersintervallet i SOC-gruppen var 5,1 til 55,7 år. 
The age range in the SOC group was 5.1 to 55.7 years.
• Behovet for smertebehandling 
• The need for pain management
Pulveret må ikke indåndes. 
The powder should not be inhaled.
En dosisjustering er ikke nødvendig. 
No dose adjustment is required.