natgillin/translations-raw huggingface dataset:
Der er ikke observeret nogen fordel hvad angår PFS eller OS hos patienter med én risikofaktor for recidiv eller progression. 
No benefit in terms of PFS or OS has been observed in patients with one risk factor for relapse or progression.
Et monoklonalt antistof er et protein, der genkender visse kræftceller. 
A monoclonal antibody is a protein which recognises certain cancer cells.
I dette studie med 36 patienter er der ikke rapporteret ændringer til lægemidlets sikkerhedsprofil. 
In this study in 36 patients, no new safety concerns were reported.
• når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering er nået. 
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
MMAE er et substrat af CYP3A4 og muligvis CYP2D6. 
MMAE is a substrate of CYP3A4 and possibly CYP2D6.
Patienter skal nøje monitoreres under behandlingen for mulige opstående alvorlige og opportunistiske infektioner. 
Patients should be carefully monitored during treatment for the emergence of possible serious and opportunistic infections.
Disse patienter skal nøje monitoreres og behandles i henhold til bedste medicinske praksis. 
These patients should be monitored closely and managed according to best medical practice.
Allerede eksisterende leversygdom, comorbiditet og samtidig medicinering kan også forøge risikoen. 
Pre-existing liver disease, comorbidities, and concomitant medications may also increase the risk.
• Ekstranodal involvering på tidspunktet for recidiv før ASCT, herunder ekstranodal ekstension af nodale masser i nærliggende vitale organer 
• Extranodal involvement at time of pre-ASCT relapse, including extranodal extension of nodal masses into adjacent vital organs
Den mediane tid fra initiel sALCL-diagnose til første dosis med ADCETRIS var 16,8 måneder. 
The median time from initial sALCL diagnosis to first dose with ADCETRIS was 16.8 months.
2 for yderligere oplysninger om natrium. 
See section 2 for further information about sodium.
Alternativt kan behandlingen startes med den sidst tolererede dosis (se pkt. 
Alternatively, treatment may be started at the last tolerated dose (see section 5.1).
ADCETRIS sikkerhedsprofil er baseret på de tilgængelige data fra kliniske forsøg, udleveringstilladelser (Named Patient Program (NPP)) og postmarketing-erfaringen til dato. 
The safety profile of ADCETRIS is based on available clinical trial data, the Named Patient Program (NPP), and post-marketing experience to date.
Du må ikke bruge denne medicin, hvis du er gravid, medmindre du og din læge beslutter, at den gavn, du har af medicinen, opvejer den mulige risiko for dit ufødte barn. 
You should not use this medicine if you are pregnant unless you and your doctor decide that the benefit to you outweighs the potential risk to the unborn baby.
Hvis der udvikles neutropeni under behandlingen, skal den behandles med dosis udsættelse. 
If neutropenia develops during treatment it should be managed by dose delays.
Af de 33 patienter, som fik RP2D, kunne respons evalueres hos de 32. 
Of these 33 patients who received the RP2D, 32 were evaluable for response.
Sikkerhedsprofilen hos ældre patienter svarede til den for voksne patienter. 
The safety profile in elderly patients was consistent with that of adult patients.
Af de 329 patienter blev 165 patienter randomiseret til behandlingsarmen, og 164 patienter blev randomiseret til placeboarmen. 
Of the 329 patients, 165 patients were randomised to the treatment arm and 164 patients were randomised to the placebo arm.
Median ADC AUC hos børn og unge i dette studie var ca. henholdsvis 14 % og 3 % lavere end hos voksne patienter, mens MMAE-eksponering var henholdsvis 53 % lavere og 13 % højere end hos voksne patienter. 
Median ADC AUC in children and adolescents from this study was approx. 14% and 3% lower than in adult patients, respectively, while MMAE exposures were 53% lower and 13% higher, respectively, than in adult patients.
For yderligere virkningsresultater henvises til Tabel 12 og figur 5. 
For further efficacy results, see Table 12 and Figure 5.
Grad 3 (påvirker almindelige dagligdags aktiviteter) 
Grade 3 (interfering with activities of daily living)
Bivirkninger for ADCETRIS er opstillet efter MedDRA Systemorganklasse og foretrukken term (se Tabel 3). 
Adverse reactions for ADCETRIS are listed by MedDRA System Organ Class and Preferred Term (see Table 3).
Hvis du får infusionsreaktioner (som angivet ovenfor), kan din læge måske stoppe med at give dig denne medicin og påbegynde en støttebehandling. 
If you develop infusion reactions (as stated previously), your doctor may stop giving this medicine and start support treatment.
Lægens valg (methotrexat eller bexaroten) n = 64 
Physician's Choice (Methotrexate or Bexarotene) n = 64
Mindst en metabolit af MMAE har vist sig aktiv in vivo. 
At least one metabolite of MMAE has been shown to be active in vitro.
Der blev ikke observeret nogen forskel i livskvalitet mellem behandlings- og placeboarmen. 
No differences were observed in quality of life between the treatment and placebo arms.
Akut pancreatitis er blevet observeret hos patienter i behandling med ADCETRIS. 
Acute pancreatitis has been observed in patients treated with ADCETRIS.
Betydningen af dette resultat hos patienter med stadie IV HL uden ekstranodal sygdom er ikke vist pga. det lille antal patienter og den lave rate af tilfælde (14 tilfælde). 
The significance of this finding in stage IV HL patients with no extranodal disease is not established due to small patient numbers and low event rates (14 events).
Disse resultater var overensstemmende med den farmakologiske virkning af MMAE på det mitotiske apparat (nedbrydning af mikrotubulus-netværket) i celler. 
These results were consistent with the pharmacological effect of MMAE on the mitotic apparatus (disruption of the microtubule network) in cells.
• Recidiverende eller progredierende HL, som forekom < 12 måneder efter afslutningen af primærbehandlingen 
• Relapsed or progressive HL that occurred <12 months from the end of frontline treatment
Efter den første dosis af Adcetris i kombination med kemoterapi vil din læge muligvis også give dig et lægemiddel, der vil hjælpe med at forhindre eller nedsætte sværhedsgraden af neutropeni (nedsat antal hvide blodlegemer), som kan øge risikoen for infektion. 
After the first dose of Adcetris in combination with chemotherapy, your doctor may also give you a medicine that will help prevent development or reduce the severity of neutropenia (decrease of white blood cell count) which can increase the risk of infection.
Patienter med stadie IV-sygdom 
Patients with Stage IV Disease
Umiddelbare og forsinkede infusionsrelaterede reaktioner (IRR) samt anafylaktiske reaktioner er blevet rapporteret. 
Immediate and delayed infusion-related reactions (IRR), as well as anaphylactic reactions, have been reported.
Selvom der ikke er etableret en kausal sammenhæng med ADCETRIS, kan risikoen for lungetoksicitet ikke udelukkes. 
Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out.
Ni og halvtreds procent (59 %) af patienterne havde fremskreden sygdomsstadie (stadie III eller IV) ved initial diagnose. 
Fifty nine percent (59%) of patients had advanced stage disease (Stage III or IV) at initial diagnosis.
Følgende bivirkninger er rapporteret med Adcetris alene: 
The following side effects have been reported with Adcetris alone:
ADCETRIS bør ikke anvendes under graviditet, medmindre fordelen for moderen vejer tungere end den potentielle risiko for fosteret. 
ADCETRIS should not be used during pregnancy unless the benefit to the mother outweighs the potential risks to the foetus.
Denne præsentation er uafhængig af sygdommens fase, behandlingstypen eller transplantation status. 
This expression is independent of disease stage, line of therapy or transplant status.
• PR eller SD (stabil sygdom) som bedste respons på den seneste salvage-behandling fastlagt med CT- og/eller PET-scanning 
• Best response of PR or SD to most recent salvage therapy as determined by CT and/or PET scanning
Febril neutropeni (feber af ukendt oprindelse uden klinisk eller mikrobiologisk dokumenteret infektion med et absolut neutrofiltal på <1,0 x 10 
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection with an absolute neutrophil count < 1.0 x 10
ADCETRIS-induceret perifer neuropati er typisk et resultat af kumulativ eksponering for dette lægemiddel, og det er i de fleste tilfælde reversibelt. 
ADCETRIS-induced peripheral neuropathy is typically an effect of cumulative exposure to this medicinal product and is reversible in most cases.
Der blev ikke observeret betydende forskel i livskvalitet (vurderet med EQ-5D [EuroQol-spørgeskema med fem dimensioner] og FACT-G [Functional Assessment of Cancer Therapy-General]) mellem behandlingsarmene. 
No meaningful differences in quality of life (assessed by the EuroQol five dimensions questionnaire [EQ-5D] and Functional Assessment of Cancer Therapy-General [FACT-G]) were observed between the treatment arms.
Antal dødsfald (%) 
Number of deaths (%)
Stratificeret log-rank-test blev ikke udført for PFS iht. 
Stratified log-rank test was not performed for PFS per Investigator.
40,5 måneder 
40.5 months
Leversygdom og andre medicinske tilstande, som kan have eksisteret, før du begyndte at få behandling med Adcetris, og visse lægemidler, du tager kan øge risikoen for leverskader. 
Liver disease and other medical conditions that may have been present before you start taking Adcetris and some medications that you are currently taking might increase the risk of liver injury.
27,9 måneder 
27.9 months
Den bedste overordnede responsrate (ORR) ifølge Independent Review Facility (IRF) blev analyseret på tværs af begge studiefaser ved RP2D. 
The best overall response rate (ORR) per independent review facility (IRF) was analysed across both study phases at the RP2D.
Træthed, pyreksi, infusionsrelaterede reaktioner 
Fatigue, pyrexia, infusion-related reactions
Alvorlige tilfælde af levertoksicitet, inkluderende dødelige udgange, er også forekommet. 
Serious cases of hepatotoxicity, including fatal outcomes, have also occurred.
På tidspunktet for analyse var den mediane opfølgningstid for modificeret PFS for begge arme 24,6 måneder Data fra en foreløbig OS-analyse 
At the time of analysis, the median modified PFS follow-up time for both arms was 24.6 months Data from an interim OS analysis
Doxorubicin, vinblastin og dacarbazin (AVD) 
Doxorubicin, vinblastine and dacarbazine (AVD)
Det mediane antal behandlingsserier var cirka 12 behandlingsserier i ADCETRIS-armen. 
The median number of cycles was approximately 12 cycles in the ADCETRIS arm.
Enhver patient, der oplever en hyperglykæmisk hændelse, skal have serum-glucose nøje monitoreret. 
However, any patient who experiences an event of hyperglycaemia should have their serum glucose closely monitored.
Inden for hver Systemeorganklasse er bivirkninger angivet under frekvenskategorierne: Meget almindelig (≥ 1/10), Almindelig (≥ 1/100 til < 1/10), Ikke almindelig (≥ 1/1.000 til < 1/100), Sjælden (≥ 1/10.000 til < 1/1.000); Meget sjælden (< 1/10.000); Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data). 
Within each System Organ Class, adverse reactions are listed under frequency categories of: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000); not known (cannot be estimated from the available data).
Patienter, der udvikler lymfopeni i Grad 3 eller Grad 4, kan fortsætte behandlingen uden afbrydelse. 
Patients who develop Grade 3 or Grade 4 lymphopenia may continue treatment without interruption.
Den rekonstituerede opløsning skal kontrolleres visuelt for eventuelle fremmed partikler og/eller misfarvning. 
The reconstituted solution should be inspected visually for any foreign particulate matter and/or discolouration.
Leverfunktionen bør testes, før behandling igangsættes og monitoreres rutinemæssigt hos patienter, der behandles med ADCETRIS. 
Liver function should be tested before initiating the treatment and routinely monitored in patients receiving ADCETRIS.
CTCL er en form for kræft i en bestemt type hvide blodlegemer kaldet "T-celler", som hovedsagelig påvirker huden. 
CTCL is a cancer of a certain type of white blood cell called a ‘T-cell' that mainly affects the skin.
Symptomer på en anafylaktisk reaktion kan omfatte, men er ikke begrænset til urticaria, angioødem, hypotension og bronkospasme. 
Symptoms of an anaphylactic reaction may include, but are not limited to, urticaria, angioedema, hypotension and bronchospasm.
MMAE inducerede ikke nogen vigtigere CYP-enzymer i primære kulturer af humane hepatocytter. 
MMAE did not induce any major CYP450 enzymes in primary cultures of human hepatocytes.
Behandling med ADCETRIS bør starte efter restitution fra ASCT på baggrund af klinisk vurdering. 
ADCETRIS treatment should start following recovery from ASCT based on clinical judgment.
Det er usandsynligt, at MMAE erstatter eller erstattes af stærkt protein-bundne lægemidler. 
MMAE is not likely to displace or to be displaced by highly protein-bound medicines.
In vitro var MMAE et substrat af P-gp og var ikke en P-gp-hæmmer ved kliniske koncentrationer. 
In vitro, MMAE was a substrate of P-gp and was not an inhibitor of P-gp at clinical concentrations.
Adcetris bruges til at behandle CTCL, hvis der er en bestemt type protein til stede på cellernes overflade. 
Adcetris is used to treat CTCL where a specific type of protein is present on the cells' surface.
Der er rapporteret PML hos patienter, der modtog behandling efter at have fået flere forudgående kemoterapiregimer. 
PML has been reported in patients who received this treatment after receiving multiple prior chemotherapy regimens.
6,7 måneder 
6.7 months
Patienterne blev inddelt efter disse sygdomstyper og randomiseret 1:1 til at få enten ADCETRIS eller lægens valg af enten methotrexat eller bexaroten. 
Patients were stratified by these disease types and randomised 1:1 to receive either ADCETRIS or the physician's choice of either methotrexate or bexarotene.
Piramal Healthcare UK Ltd. Earls Road, Grangemouth Stirlingshire, Scotland FK3 8XG Storbritannien 
Piramal Healthcare UK Ltd. Earls Road, Grangemouth Stirlingshire, Scotland FK3 8XG United Kingdom
Takeda Austria GmbH St. Peter-Straβe 25 A-4020 Linz Østrig 
Takeda Austria GmbH St. Peter-Straβe 25 A-4020 Linz Austria
Den rekonstituerede opløsning i hætteglasset er en klar til let uklar, farveløs opløsning med en endelig pH på 6,6. 
The reconstituted solution in the vial is a clear to slightly opalescent, colourless solution with a final pH of 6.6.
Infusionen kan genstartes ved lavere hastighed efter, at symptomerne er ophørt. 
The infusion may be restarted at a slower rate after symptom resolution.
Tidligere ASCT 
Prior ASCT
Farmakokinetikken for ADCETRIS i kombination med AVD blev evalueret i et enkelt fase 3-studie med 661 patienter. 
The pharmacokinetics of ADCETRIS in combination with AVD were evaluated in a single phase 3 study in 661 patients.
Klassisk Hodgkins lymfom udtrykker specifikke proteiner på celleoverfladen, som adskiller sig fra ikke-klassisk Hodgkins lymfom. 
Classical Hodgkin lymphoma expresses specific proteins on the cell surface that are different from non-classical Hodgkin lymphoma.
Dette lægemiddel indeholder 13,2 mg natrium (hovedkomponent i madlavnings-/bordsalt) pr. hætteglas. 
This medicine contains 13.2 mg sodium (main component of cooking/table salt) in each vial.
Baseret på et populationfarmakokinetisk skøn var MMAE's typiske tilsyneladende centrale distributionsvolumen 35,5 l. 
Based on population PK estimation the typical apparent central volume of distribution of MMAE was 35.5 l
Inde i cellen frisættes en enkelt defineret aktiv art, MMAE via proteolytisk spaltning. 
Within the cell, a single defined active species, MMAE, is released via proteolytic cleavage.
Patienterne skal nøje monitoreres under og efter en infusion. 
Patients should be carefully monitored during and after infusion.
I tilfælde af overdosering bør patienten nøje monitoreres for bivirkninger, specielt neutropeni, og støttebehandling bør administreres (se pkt. 
In case of overdose, the patient should be closely monitored for adverse reactions, particularly neutropenia, and supportive treatment should be administered (see section 4.4).
4.8, 5.1 og 5.2, men der kan ikke gives en anbefaling om dosering. 
Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Din læge kan nedsætte startdosis til 1,2 mg/kg, hvis du har nyre- eller leverproblemer. 
Your doctor may lower your starting dose to 1.2 mg/kg if you have kidney or liver problems.
Hvis du mener, at du tidligere har haft en tilsvarende reaktion, skal du fortælle lægen om det, FØR du får medicinen. 
If you think you have previously had a similar reaction, tell your doctor BEFORE you are given this medicine.
Præmedicineringen kan omfatte paracetamol, antihistamin og corticosteroid. 
Premedication may include paracetamol, an antihistamine and a corticosteroid.
Farmakokinetik hos specielle populationer 
Pharmacokinetics in special populations
Mindre end halvdelen af patienterne i den pivotale fase 2-population med Grad 3 eller Grad 4 neutropeni havde midlertidigt associerede infektioner, og størstedelen af de midlertidigt associerede infektioner var Grad 1 eller Grad 2. 
Less than half of the patients in the pivotal phase 2 population with Grade 3 or Grade 4 neutropenia had temporally associated infections, and the majority of temporally associated infections were Grade 1 or Grade 2.
Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler undtagen dem nævnt i pkt. 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Følgende bivirkninger er rapporteret med Adcetris i kombination med kemoterapi-lægemidler: 
The following side effects have been reported with Adcetris in combination with chemotherapy medicines:
Lægen skal være specielt opmærksom på symptomer, der tyder på PML, som patienten måske ikke selv opdager (fx kognitive, neurologiske eller psykiatriske symptomer). 
The physician should be particularly alert to symptoms suggestive of PML that the patient may not notice (e.g., cognitive, neurological, or psychiatric symptoms).
Der blev rapporteret flere alvorlige bivirkninger og dosismodifikationer (herunder udsat dosering, reduktioner og seponeringer) hos ældre patienter sammenlignet med den samlede studiepopulation. 
More serious adverse events and dose modifications (including dose delays, reductions, and discontinuations) were reported in the older patients compared with the overall study population.
John Cunningham virus (JCV) reaktivering, som medfører progredierende multifokal leukoencefalopati (PML) og død, kan forekomme hos patienter behandlet med ADCETRIS. 
John Cunningham virus (JCV) reactivation resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in ADCETRIS-treated patients.
Figur 5: Kaplan-Meier-plot af OS 
Figure 5: Kaplan-Meier Plot of OS
Analyse af anvendte medicinske ressourcer (MRU) viste, at hospitalsindlæggelser og ambulante besøg samt arbejdsdage/andre aktiviteter, som patienter og omsorgspersoner ikke kunne deltage i, var lavere med ADCETRIS sammenlignet med placebo for patienter med HL med øget risiko for recidiv. 
Medical resource utilization (MRU) analysis showed that hospitalizations and outpatient visits, as well as working days/other activities missed by patients and caregivers were lower with ADCETRIS compared with placebo in patients with HL at increased risk of relapse.
Behandlingen bør fortsættes indtil sygdomsprogression eller uacceptabel toksicitet (se pkt. 
Treatment should be continued until disease progression or unacceptable toxicity(see section 4.4).
Adcetris bruges også for at mindske sandsynligheden for, at klassisk Hodgkins lymfom vender tilbage efter en autolog stamcelletransplantation hos patienter med visse risikofaktorer. 
Adcetris is also used to lower the likelihood of classical Hodgkin Lymphoma coming back after an autologous stem cell transplant in patients with certain risk factors.
ADCETRIS skal administreres gennem et dedikeret intravenøst kateter og må ikke blandes med andre lægemidler (se pkt. 
ADCETRIS should be administered through a dedicated intravenous line and it must not be mixed with other medicinal products (see section 6.2).
For en reduceret dosis benyttes 1,2 mg/kg til beregningen. 
For a reduced dose, use 1.2 mg/kg for the calculation.
Ingen patienter havde behov for dosisreduktion eller stoppede med behandlingen på grund af neutropeni. 
No patients required dose reduction or discontinued treatment for neutropenia.
Udslæt a, pruritus 
Rash a, pruritus
I tilfælde af at nogle af delene observeres, skal lægemidlet kasseres. 
In the event of either being observed, discard the medicinal product.
To procent af patienterne havde behov for dosisreduktion, og < 1 % stoppede med behandlingen med et eller flere af forsøgslægemidlerne som følge af neutropeni. 
Two percent of patients required dose reduction and < 1% discontinued one of more of the study drugs due to neutropenia.
Træthed, pyreksi 
Fatigue, pyrexia
E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER BETINGEDE OMSTÆNDIGHEDER 
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Spørgeskemaet EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life 30-Item) viste ingen klinisk betydningsfuld forskel mellem de to arme i både ITT- og stadie IV-populationerne. 
The European Organization for Research and Treatment of Cancer Quality of Life 30-Item Questionnaire (EORTC-QLQ-C30) showed no clinically meaningful difference between the two arms in both the ITT and Stage IV population.
Den mediane observationsstid (tid indtil død eller sidste kontakt) fra første dosis var 71,4 måneder. 
The median observation time (time to death or last contact) from first dose was 71.4 months.
Artralgi, myalgi 
Arthralgia, myalgia
Tilbageværende rester i hætteglasset, efter optrækket af volumet til fortyndingen, skal bortskaffes i henhold til lokale retningslinjer. 
Any portion left in the vial, after withdrawal of the volume to be diluted, must be disposed of in accordance with local requirements.
Patienterne bør overvåges nøje for nye eller forværrede abdominalsmerter, hvilket kan være tegn på akut pancreatitis. 
Patients should be closely monitored for new or worsening abdominal pain, which may be suggestive of acute pancreatitis.
Herpes zoster, pneumocystis jiroveci pneumoni 
Herpes zoster, Pneumocystis jiroveci pneumonia
Grad 4 (sensorisk neuropati som er invaliderende eller motorisk neuropati som er livstruende eller medfører paralyse) 
Grade 4 (sensory neuropathy which is disabling or motor neuropathy that is life threatening or leads to paralysis)
3,6 hætteglas a. 
3.6 vials a.
Data for patienter med HL, som ikke er kandidater til stamcelletransplantation (ASCT). 
Data in HL Patients Who Are Not Stem Cell Transplant (SCT) Candidates
Tabel 5 viser effektresultaterne for modificeret PFS og samlet overlevelse (OS) i ITT-populationen og patienter med stadie IV-sygdom. 
Table 5 provides the efficacy results for modified PFS and overall survival (OS) in the ITT population and patients with Stage IV disease.
Undersøgelser Meget almindelig 
Investigations Very common:
Tidligere kemoterapi-regimer Tid fra ASCT til første recidiv efter transplantation 
Prior chemotherapy Regimens Time from ASCT to first post-transplant relapse