natgillin/translations-raw huggingface dataset:
IRR'erne var fortrinsvis lette eller moderate i sværhedsgrad, omend der har været få rapporter om alvorlige reaktioner (grad 3). 
The IRRs were mostly mild or moderate in severity, although there have been a few reports of severe reactions (Grade 3).
Lægen kan standse behandlingen med POTELIGEO, hvis din reaktion er alvorlig. 
Your doctor may stop POTELIGEO treatment if your reaction is severe.
Lægemidlet er beregnet til anvendelse til patienter, der har fået mindst ét lægemiddel indgivet gennem munden eller som en injektion. 
The medicine is for use in patients who have received at least one medicine given by mouth or by injection.
Behandlingen skal initieres og overvåges af en læge med erfaring inden for kræftbehandling og bør kun administreres af sundhedspersonale i omgivelser, hvor genoplivningsudstyr er til rådighed. 
Treatment must be initiated and supervised by physicians experienced in the treatment of cancer, and should only be administered by healthcare professionals in an environment where resuscitation equipment is available.
- nogensinde har haft en alvorlig hudreaktion på grund af dette lægemiddel. 
- ever had a severe skin reaction with this medicine.
Den sikkerhedsprofil, der blev observeret i de 90 dage efter den sidste dosis mogamulizumab, svarer til den sikkerhedsprofil, der blev observeret i studiebehandlingsperioden. 
The safety profile observed in the 90 days following the last dose of mogamulizumab is consistent with the safety profile observed during the study treatment period.
Der deltog 186 patienter i hver behandlingsarm. 
Each arm enrolled 186 patients.
a: P-værdi indhentet fra Cochran-Mantel-Haenszel-test med justering for sygdomstype, sygdomsstadie og område. 
a: P-value was obtained from Cochran-Mantel-Haenszel test adjusting for disease type, disease stage, and region.
• Hvert hætteglas er kun til engangsbrug. 
• Each vial is for single use only.
Kaplan-Meier-kurven for PFS vises i Figur 1. 
The Kaplan-Meier curve for PFS is shown Figure 1.
Patienterne bør monitoreres nøje for symptomer eller tegn, der tyder på SJS eller TEN. 
Patients should be closely monitored for symptoms or signs that suggest SJS or TEN.
Tabel 2 opsummerer ORR og DOR samt respons inddelt efter område. 
Table 2 summarises ORR and DOR, and response by compartment.
- nogensinde har haft en infusionsreaktion på grund af dette lægemiddel (mulige symptomer på en infusionsreaktion er oplyst i afsnit 4). 
- ever had an infusion reaction with this medicine (possible symptoms of an infusion reaction are listed in section 4).
Sikkerhed efter sidste dosis 
Safety post last dose
Patienterne bør monitoreres nøje med relevante laboratorieundersøgelser og kliniske undersøgelser af elektrolytstatus, hydrering og nyrefunktion, især i behandlingens første måned, og behandles i overensstemmelse med bedste medicinske praksis. 
Patients should be monitored closely by appropriate laboratory and clinical tests for electrolyte status, hydration and renal function, particularly in the first month of treatment, and managed according to best medical practice.
Behandlingen bør fortsætte, medmindre du får en alvorlig bivirkning, eller det kutane T-cellelymfom begynder at blive værre. 
Treatment should be continued unless you get serious side effects or the cutaneous T-cell lymphoma starts to get worse.
Svære reaktioner (grad 3) opstod hos 4% af patienterne. 
Severe reactions (Grade 3) were experienced by 4% of patients.
Patienterne skal følges nøje for tidlige tegn på transplantationsrelaterede komplikationer. 
Follow patients closely for early evidence of transplant-related complications.
Den kemiske og fysiske stabilitet efter anbrud til anvendelse er påvist i 24 timer ved stuetemperatur (25 °C) under forhold med omgivende lys. 
Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (at 25°C) under ambient room light.
Kassér eventuel ubrugt mængde i hætteglasset i overensstemmelse med lokale krav. 
Discard any unused portion left in the vial in accordance with local requirements.
Patienter med hurtigt prolifererende tumorer og høj tumorbyrde har risiko for at udvikle TLS. 
Patients with rapidly proliferating tumour and high tumour burden are at risk of TLS.
Behandling med mogamulizumab fortsatte, indtil sygdomsprogression eller uacceptabel toksicitet. 
Treatment with mogamulizumab continued until disease progression or unacceptable toxicity.
Hvis produktet ikke anvendes straks, er opbevaringstider og -betingelser efter anbrud til anvendelse brugerens eget ansvar og bør ikke være mere end 4 timer ved 2 - 8 ºC, forudsat at fortynding er sket under kontrollerede og validerede aseptiske betingelser. 
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than a total of 4 hours at 2°C - 8°C provided that dilution has taken place under controlled and validated aseptic conditions.
I tilfælde af overdosering skal patienten og patientens vitale tegn monitoreres nøje (i mindst 1 time), og om nødvendigt gives der supportiv behandling. 
In case of overdose, the patient, including their vital signs, should be closely monitored (for at least 1 hour) and supportive treatment should be administered if required.
Se afsnit 2 ”POTELIGEO indeholder natrium”. 
See section 2 “POTELIGEO contains sodium”.
Blod (n) 
Blood (n)
Effekt, målt som en forbedring i PFS baseret på en investigatorvurdering, var ikke forbundet med stigende eksponering for mogamulizumab. 
Efficacy, as measured by improvement in PFS based on investigator assessment, was not associated with increasing mogamulizumab exposure.
• Infusionsvæsken skal administreres i et tidsrum på mindst 60 minutter gennem en intravenøs slange, der indeholder et 0,22 mikron (eller tilsvarende) sterilt inline-filter med lav proteinbinding. 
• Administer infusion solution over at least 60 minutes through an intravenous line containing a sterile, low protein binding 0.22 micron (or equivalent) in-line filter.
Under 1% af de patienter, der blev behandlet i studie 0761-010, seponerede behandlingen på grund af infusionsrelaterede reaktioner. 
Less than 1% of patients treated in Study 0761-010 discontinued treatment due to infusion-related reactions.
- har human immundefektvirus (hiv), herpes, cytomegalovirus (CMV) eller hepatitis B- eller C 
- have human immunodeficiency virus (HIV), herpes, cytomegalovirus (CMV), or hepatitis B or
- er allergisk over for mogamulizumab eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6). 
- allergic to mogamulizumab or any of the other ingredients of this medicine (listed in section 6).
Tabel 1: Lægemiddelbivirkninger, der er opstået hos patienter, som fik POTELIGEO (N=184) Systemorganklasse (SOC) 
Table 1: Adverse drug reactions occurring in patients receiving POTELIGEO (N=184) System organ class (SOC)
Se ovenstående anbefalinger i tilfælde af en infusionsrelateret reaktion. 
See above recommendations in case of infusion-related reaction.
Tabel 4: Progressionsfri overlevelse (PFS) inddelt efter behandlingsgruppe og sygdomsstadie (periode med randomiseret behandling) 
Table 4: Progression Free Survival (PFS) by Treatment Group and Disease Stage (Randomised Treatment Period)
Der er rapporteret om øget risiko for transplantationskomplikationer, hvis mogamulizumab gives inden for et kort tidsrum (cirka 50 dage) inden HSCT. 
A higher risk of transplant complications has been reported if mogamulizumab is given within a short time frame (approximately 50 days) before HSCT.
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 (kan ikke estimeres ud fra forhåndenværende data). 
<1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Det overordnede respons blev rapporteret som en kombineret score fra målinger i hvert område, og et respons skulle være påvist ved to overordnede sygdomsvurderinger i træk (med mindst 8 ugers mellemrum i det første år og 16 ugers mellemrum derefter) for at være bekræftet. 
Overall response was reported as a composite score from measures in each compartment, and a response had to be demonstrated at two successive overall disease assessments (at least 8 weeks apart during the first year and 16 weeks apart thereafter) in order to be confirmed.
De fleste IRR'er opstod under eller kort tid efter den første infusion (alle inden for 24 timer efter administration), med et fald i forekomsten over de efterfølgende behandlinger. 
The majority of IRRs occur during or shortly after the first infusion (all within 24 hours of administration), with the incidence decreasing over subsequent treatments.
Mogamulizumab er rettet mod kræftceller, der efterfølgende ødelægges af immunsystemet (kroppens forsvarssystem). 
Mogamulizumab targets cancer cells which are then destroyed by the immune system (the body's defence).
Absorption Mogamulizumab doseres intravenøst og er derfor straks og fuldstændig biotilgængeligt. 
Mogamulizumab is dosed via intravenous route and therefore is immediately and completely bioavailable.
Brug ikke dette lægemiddel, hvis du kan se tegn på nedbrydning, som f.eks. partikler eller misfarvning. 
Do not use this medicine if you notice signs of deterioration, such as particulate matter or discolouration.
Patienterne blev inkluderet i analysen af et bestemt område, hvis de havde sygdom i det pågældende område ved baseline eller havde en vilkårlig responsvurdering af det pågældende område efter baseline. 
Patients were included in the analysis for a specific compartment if they had presence of disease in that compartment at baseline, or had any post-baseline response assessment for that compartment.
Patienterne bør testes for hepatitis B-infektion, inden behandling med mogamulizumab initieres. 
Patients should be tested for hepatitis B infection before initiating treatment with mogamulizumab.
Størstedelen af de behandlingsrelaterede, infusionsrelaterede reaktioner var grad 1 eller 2 og opstod under eller kort tid efter den første infusion. 
The majority of treatment-related infusion-related reactions were Grade 1 or 2 and occurred during or shortly after the first infusion.
Fortæl det til lægen, hvis du får andre bivirkninger. 
Talk to your doctor if you get any other side effects.
- hvis du skal have en stamcelletransplantation, er det muligt, at du kan få komplikationer ("graft versus host disease"), som er svære at behandle. 
- if you go on to have a stem cell transplant, it is possible that you could then develop complications (graft versus host disease) that are difficult to manage.
Den anbefalede dosis er 1 mg POTELIGEO for hvert kilogram legemsvægt. 
The recommended dose is 1mg POTELIGEO for each kg of body weight.
Disse tidsbegrænsninger inkluderer opbevaring af infusionsvæsken i infusionsposen under infusionen. 
These time limits include storage of the infusion solution in the infusion bag through the duration of infusion.
Den fortyndede opløsnings endelige koncentration skal være mellem 0,1 mg/ml og 3,0 mg/ml. 
The final concentration of the diluted solution should be between 0.1 mg/mL to 3.0 mg/mL.
Det er usandsynligt, at POTELIGEO vil påvirke din evne til at køre bil og betjene maskiner. 
POTELIGEO is unlikely to affect your ability to drive and use machines.
Til patienter, der bliver testet positive for aktuel/tidligere hepatitis B-infektion, anbefales det at konsultere en læge med ekspertise inden for behandling af hepatitis B for at få vejledning vedrørende relevante foranstaltninger mod reaktivering af hepatitis B. 
For patients who test positive for current/previous hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended for advice concerning appropriate measures against hepatitis B reactivation.
Der er ikke udført specifikke studier med undersøgelse af de potentielle virkninger på fertiliteten. 
No specific studies have been conducted to evaluate potential effects on fertility.
Der var ingen positive neutraliserende antistofresponser. 
There were no positive neutralising antibody responses.
- har haft tumorlysesyndrom (en komplikation, der indebærer ødelæggelse af kræftceller) efter en tidligere behandling. 
- have had tumour lysis syndrome (a complication involving the destruction of cancer cells) after a previous treatment.
I mogamulizumab-armen var niveauerne af CCR4-ekspression ved baseline tilgængelige for 75% af patienterne (N=140). 
In the mogamulizumab arm, baseline CCR4 expression levels were available in 75% of patients (N=140).
56% af patienterne fik mogamulizumab i mindst 6 cyklusser, og 25% af patienterne fik mogamulizumab i mindst 12 cyklusser. 
56% of patients received mogamulizumab for at least 6 cycles, and 25% of patients received mogamulizumab for at least 12 cycles.
Figur 1: Plot af Kaplan-Meier-kurve over den progressionsfrie overlevelse efter investigatorvurdering (ITT-population) 
Figure 1: Plot of Kaplan-Meier curve of progression-free survival by investigator's assessment (ITT) population
Responset i lymfeknuder og viscera blev undersøgt i 4. uge, derefter hver 8. uge i det første år og efterfølgende hver 16. uge. 
Response in lymph nodes and viscera was evaluated at 4 weeks, then every 8 weeks in the first year, and then every 16 weeks thereafter.
Alvorlige infektioner, herunder sepsis, pneumoni og hudinfektioner, opstod hos 14,3% af de patienter, der har fået mogamulizumab. 
Serious infections, including sepsis, pneumonia and skin infections, were experienced by 14.3% of subjects receiving mogamulizumab.
Ikke almindelig Akut hepatitis, hepatitis 
Uncommon Hepatitis acute, hepatitis
På grund af lægemidlets virkningsmekanisme kan det skade barnet, hvis det gives, mens du er gravid eller ammer. 
Due to the mechanism of action of the medicine, it may harm your baby if it is administered when you are pregnant or breast- feeding.
Det primære effektendepunkt var den progressionsfrie overlevelse (PFS), baseret på en investigatorvurdering, hvor der blev anvendt kriterier for globalt kombineret respons, der tog højde for alle potentielt ramte sygdomsområder (hud, blod, lymfeknuder og viscera). 
The primary efficacy endpoint was progression-free survival (PFS) based on investigator assessment using a global composite response criteria that took into account all potentially affected disease compartments (skin, blood, lymph nodes and viscera).
Der var afbrydelser i infusionen hos cirka 6% af patienterne, hvoraf de fleste (cirka 90%) opstod inden for den første cyklus af behandling med mogamulizumab. 
Infusion interruptions occurred in approximately 6% of patients, most of which (approximately 90%) occurred within the first cycle of treatment with mogamulizumab.
Ødelæggelsen af kræftceller og kroppens reaktion på dette kan i sjældne tilfælde føre til et problem, der kaldes for tumorlysesyndrom. 
The destruction of cancer cells and the body's reaction to it can very occasionally lead to a problem called tumour lysis syndrome.
Patienter med risikofaktorer for hjertesygdom bør monitoreres, og relevante sikkerhedsforanstaltninger bør træffes. 
Patients who have risk factors associated with cardiac disease should be monitored and appropriate precautions taken.
Der er observeret infusionsrelaterede reaktioner hos 33% af de patienter, der er blevet behandlet med POTELIGEO. 
Infusion-related reactions have been observed in 33% of patients treated with POTELIGEO.
Citronsyremonohydrat Glycin 
Citric acid monohydrate Glycine
Hvis der opstår SJS/TEN, foretages relevant medicinsk behandling. 
If SJS/TEN occur, appropriate medical therapy should be administered.
Administration foregår ugentligt på dag 1, 8, 15 og 22 i den første 28dages cyklus efterfulgt af infusioner hver anden uge på dag 1 og 15 i hver efterfølgende 28-dages cyklus indtil sygdomsprogression eller uacceptabel toksicitet. 
Administration is weekly on days 1, 8, 15 and 22 of the first 28-day cycle, followed by infusions every two weeks on Days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity.
Årsagerne til skift til mogamulizumab var sygdomsprogression (109 patienter) og intolerance over for behandlingen (27 patienter). 
Reasons for crossover to mogamulizumab were disease progression (109 patients) and treatment intolerance (27 patients).
Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser. 
Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose toxicity.
Forsinkelsen før bivirkningens indtræden efter den første dosis varierede betydeligt. 
The latency to event onset following the first dose varied considerably.
Det skal du vide, før du begynder at bruge POTELIGEO Brug ikke POTELIGEO, hvis du: 
What you need to know before you use POTELIGEO Do not use POTELIGEO if you are:
Ved studiets baseline havde 38% sygdom i stadie IB-II, 10% havde sygdom i stadie III, og 52% havde sygdom i stadie IV. 
At study baseline, 38% had stage IB-II disease, 10% stage III, 52% stage IV.
Fortæl det straks til lægen, hvis du får nogen af de alvorlige bivirkninger, der er anført i afsnit 4, efter du er startet i behandling med POTELIGEO. 
Tell your doctor immediately if you experience any of the serious side effects listed in Section 4 after starting POTELIGEO treatment.
Studiet viste statistisk signifikante forbedringer i ORR og respons pr. område i blod, hud og lymfeknuder sammenlignet med vorinostat. 
The study demonstrated statistically significant improvements in ORR and response by compartment in the blood, skin, and lymph nodes as compared to vorinostat.
POTELIGEOs sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt. 
The safety and efficacy of POTELIGEO in children and adolescents aged below 18 years has not been established.
Vorinostat blev administreret i en initialdosis på 400 mg oralt én gang dagligt med start på dag 1 i 28-dages cyklusser. 
Vorinostat was administered at a starting dose of 400 mg orally, once daily beginning on day 1 for 28day cycles.
Der blev ikke observeret nogen bekræftede responser hos disse 10 patienter med lav (<10%) CCR4-ekspression. 
No confirmed responses were observed in these 10 subjects with low (<10%) CCR4 expression.
Der er begrænsede effektdata fra patienter med lav (<10%) CCR4-ekspression i huden. 
There are limited efficacy data in patients with low (<10%) CCR4 expression in the skin.
Hvis de opstår, skal POTELIGEO seponeres, og behandlingen bør ikke genoptages, medmindre SJS eller TEN kan udelukkes som årsag, og hudreaktionen er svundet til grad 1 eller derunder. 
If they occur, POTELIGEO should be interrupted and treatment should not restart unless SJS or TEN is ruled out and cutaneous reaction has resolved to Grade 1 or less.
Tabel 2: Respons i perioden med randomiseret behandling i studie 0761-010 (intent-to-treat) Mogamulizumab 
Table 2: Response during randomised treatment period in study 0761-010 (intent-to-treat)
Meget almindelig Hovedpine 
Very common Headache
Advarsler og forsigtighedsregler Kontakt lægen eller sundhedspersonalet, før du bruger POTELIGEO, hvis du: 
Warnings and precautions Talk to your doctor or nurse before using POTELIGEO if you:
Mogamulizumab forventes at blive nedbrudt til små peptider og aminosyrer via katabolske veje på samme måde som endogent IgG. 
Mogamulizumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Fortæl det til lægen eller sundhedspersonalet, hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid. 
You must tell your doctor or nurse if you are pregnant, breast-feeding, think you may be pregnant, or are planning to have a baby.
Præmedicinering med antipyretika og antihistaminer anbefales ved den første infusion af POTELIGEO. 
Pre-medication with anti-pyretic and anti-histamine is recommended for the first POTELIGEO infusion.
Baseret på en farmakokinetisk populationsanalyse blev steady-state-koncentrationerne af mogamulizumab nået efter 12 uger med gentagen dosering, når det blev administreret i det anbefalede regime, og den systemiske akkumulering var 1,7 gange. 
Based on a population PK analysis, the steady-state concentrations of mogamulizumab were reached after 12 weeks of repeated dosing when administered using the recommended regimen, and systemic accumulation was 1.7-fold.
Sikkerheden ved behandling med mogamulizumab efter autolog eller allogen HSCT er ikke undersøgt. 
The safety of treatment with mogamulizumab after autologous or allogeneic HSCT has not been studied.
Tiden indtil respons på områdeniveau hos patienter med sygdom i stadie IB/II var cirka 3 måneder, hvilket svarer til tiden indtil respons for ITT-populationen generelt (cirka 3 måneder). 
Time to compartment level response in Stage IB/II patients was approximately 3 months, which is consistent with time to response for the ITT population overall (approximately 3 months).
Dette lægemiddel indeholder mindre end 1 mmol natrium pr. dosis, dvs. det er i det væsentlige ‘natriumfrit'. 
This medicinal product contains less than 1 mmol sodium per dose, that is to say essentially ‘sodium free'.
POTELIGEO indeholder ingen konserveringsmidler. 
POTELIGEO does not contain a preservative.
Mogamulizumab er et defucosyleret, humaniseret IgG1 kappa-immunglobulin, der binder selektivt til CCR4, en G protein-koblet receptor for CC kemokiner, som er involveret i transporten af lymfocytter til forskellige organer, herunder huden, hvilket medfører depletering af målcellerne. 
Mogamulizumab is a defucosylated, humanised IgG1 kappa immunoglobulin that selectively binds to CCR4, a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs including the skin, resulting in depletion of the target cells.
Samlet responsrate (ORR), n (%) Område: 
Overall response rate (ORR), n (%) Compartment:
Herefter kan POTELIGEO anvendes under amning, hvis der er klinisk behov. 
Afterwards POTELIGEO could be used during breast-feeding if clinically needed.
Det er ukendt, om mogamulizumab udskilles i human mælk. 
It is unknown whether mogamulizumab is excreted in human milk.
POTELIGEO indeholder det aktive stof mogamulizumab, der tilhører en gruppe lægemidler, som kaldes for monoklonale antistoffer. 
POTELIGEO contains the active substance mogamulizumab, which belongs to a group of medicines called monoclonal antibodies.
Alvorlige bivirkninger omfattede respirationsinsufficiens grad 4 (1,1%), og bivirkninger grad 5 var polymyositis og sepsis (hver 0,5%). 
Severe adverse reactions included Grade 4 respiratory failure (1.1%) and Grade 5 reactions were polymyositis and sepsis (0.5% each).
Virkningerne af anvendelse af POTELIGEO under graviditet og amning er ikke kendte. 
The effects of POTELIGEO in pregnancy and breast-feeding are not known.
Hvis du ammer, skal du tale med din læge om, hvorvidt du kan amme under eller efter behandling med POTELIGEO. 
If you are breast-feeding, you should discuss with your doctor whether you can breast-feed during or after treatment with POTELIGEO.
Træk den nødvendige mængde POTELIGEO aseptisk op i sprøjten og overfør til en infusionspose, der indeholder 9 mg pr. ml (0,9%) natriumchlorid injektionsvæske. 
Aseptically withdraw the required volume of POTELIGEO into the syringe and transfer into an infusion bag containing 9mg per ml (0.9%) sodium chloride solution for injection.
POTELIGEO er indiceret til behandling af voksne patienter med mycosis fungoides (MF) eller Sézarys syndrom (SS), der har fået mindst én tidligere systemisk behandling. 
POTELIGEO is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
Dette lægemiddel bruges til behandling af voksne med mycosis fungoides og Sézarys syndrom, som er nogle kræfttyper, der kaldes for kutane T-cellelymfomer. 
This medicine is used to treat adults with mycosis fungoides and Sézary syndrome, which are types of cancers called cutaneous T-cell lymphomas.