natgillin/translations-raw huggingface dataset:
De væsentligste sekundære endepunkter var den overordnede responsrate (ORR), ORR efter præparatskift, responsvarighed (DOR) samt ændringer i forhold til baseline i Skindex-29 Symptoms and Functional Scales samt Functional Assessment of Cancer Therapy-General (FACT-G), Physical and Functional Well-Being domænerne. 
Key secondary endpoints were overall response rate (ORR), ORR after crossover, duration of response (DOR), and changes from baseline of the Skindex-29 Symptoms and Functional Scales, and Functional Assessment of Cancer Therapy-General (FACT-G) Physical and Functional Well-being domains.
Blandt de patienter, der blev randomiseret til vorinostat, skiftede 136 patienter (73,1%) til mogamulizumab under studiet. 
Of the patients randomised to vorinostat, 136 patients (73.1%) crossed over to mogamulizumab during the study.
Den farmakokinetiske populationsanalyse omfattede 444 patienter, der fik mogamulizumab i seks kliniske studier. 
The population PK analysis included 444 patients receiving mogamulizumab in six clinical trials.
De hyppigst indberettede alvorlige bivirkninger var pneumoni, pyreksi, infusionsrelateret reaktion og cellulitis. 
The most frequently reported serious adverse reactions were pneumonia, pyrexia, infusion related reaction and cellulitis.
Responsrate (n, %) 95% CIa 
Response Rate (n, %) 95% CIa
Opbevares i køleskab (2 ºC - 8 ºC). 
Store in a refrigerator (2ºC to 8ºC).
Studiet inkluderede patienter uanset deres niveau af CCR4-ekspression i hudbiopsi ved baseline. 
This study included patients regardless of their baseline level of CCR4 expression in skin biopsy.
Efter klargøring af infusionen 
After preparation of infusion
De mest almindelige tidligere behandlinger, der blev brugt af patienter i Europa, var bexaroten (70%), interferon (59%), methotrexat (49%), ekstrakorporal fotoferese (ECP) (31%) og gemcitabin/gemcitabin-regimer (28%). 
The most common prior systemic therapies used by subjects in Europe were bexarotene (70%), interferon (59%), methotrexate (49%), extracorporeal photopheresis (ECP) (31%) and gemcitabine/gemcitabine regimens (28%).
Patienterne havde en medianalder på 64 år på tidspunktet for screening (inden for intervallet 25 til 101 år); 49,5% var 65 år eller derover, og 58,1% var mænd. 
Patients were a median age of 64 years at the time of screening (range 25 to 101 years), 49.5% were 65 years or older, and 58.1% were male.
• Beregn den mængde POTELIGEO, der skal bruges til at klargøre infusionsvæsken til doseringen på 1 mg/kg, baseret på patientens vægt (se pkt. 
• Calculate the required volume of POTELIGEO needed to prepare the infusion solution for the 1 mg/kg dosage based on patient weight (see section 4.2).
I tilfælde af en IRR skal infusionen afbrydes og relevant medicinsk behandling iværksættes. 
If an IRR occurs, the infusion should be interrupted and appropriate medical management instituted.
Der er ingen data fra anvendelse af mogamulizumab til gravide kvinder. 
There are no data from the use of mogamulizumab in pregnant women.
Almindelig Anæmi, neutropeni, leukopeni, thrombocytopeni 
Anaemia, neutropenia, leukopenia, Thrombocytopenia
• Den fortyndede opløsning kan bruges i infusionsposer af polyvinylchlorid (PVC) eller polyolefin (PO). 
• The diluted solution is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion bags.
Transformation til storcellet lymfom (LCT) Der er begrænsede data vedrørende patienter med LCT. 
Large cell transformation (LCT) There are limited data available on patients with LCT.
- Manglende energi (træthed) - Forstoppelse - Hævede ben eller ankler - Hovedpine 
- Lack of energy (fatigue) - Constipation - Swollen legs or ankles - Headache
Forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet alkalisk phosphatase i blodet, nedsat lymfocyttal 
Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, lymphocyte count decreased
POTELIGEO vil blive indgivet gennem en blodåre (intravenøs infusion) i et tidsrum på mindst 60 minutter. 
POTELIGEO will be given to you through a vein (intravenous infusion) over at least 60 minutes.
Indlægsseddel: Information til patienten POTELIGEO 4 mg/ml koncentrat til infusionsvæske, opløsning mogamulizumab Dette lægemiddel er underlagt supplerende overvågning. 
Package leaflet: Information for the patient POTELIGEO 4 mg/mL concentrate for solution for infusion mogamulizumab This medicine is subject to additional monitoring.
En analyse af eksponering og respons indikerede, at virkningen ikke hang sammen med eksponering for mogamulizumab i det pivotale studie. 
Exposure-Response analysis indicated that efficacy was not correlated with mogamulizumab exposure in the pivotal study.
Medianvarigheden af eksponering for mogamulizumab var 5,6 måneder (inden for intervallet <1 til 45,3 måneder). 
The median duration of exposure with mogamulizumab was 5.6 months (range: <1 to 45.3 months).
Eksponeringen for mogamulizumab steg proportionelt med dosis over dosisintervallet 0,1 til 1,0 mg/kg. 
The exposure to mogamulizumab increased proportionally with dose over the dose range of 0.1 to 1.0 mg/kg.
41 (30,1%) af de 136 patienter, der skiftede præparat, havde enten partielt eller komplet respons med mogamulizumab. 
Fortyone of the 136 cross-over patients (30.1%) responded with either partial or complete response with mogamulizumab.
Hvis der opstår infusionsreaktioner, gives præmedicinering ved de efterfølgende infusioner af POTELIGEO. 
If an infusion reaction occurs, administer pre-medication for subsequent POTELIGEO infusions.
I studiet udelukkedes patienter med aktive autoimmune sygdomme, metastaser i centralnervesystemet samt sygdomme, hvor behandling med systemiske kortikosteroider eller andre immunsupprimerende lægemidler var påkrævet, eller aktive, behandlingskrævende infektioner, herunder hiv eller hepatitis B eller C. Patienter med ECOG performance status ≥2 var ligeledes udelukket. 
The trial excluded patients with active autoimmune diseases, central nervous system metastasis, and medical conditions that required systemic corticosteroids or other immunosuppressive medicinal products, or an active infection requiring therapy, including HIV, or hepatitis B or C. Patients with ECOG performance status ≥2 were also excluded.
I studier af reproduktions- og udviklingstoksiciteten hos dyr viste administration af mogamulizumab til drægtige cynomolgusaber fra organogenesens start til fødsel intet potentiale for letalitet hos embryo/foster, teratogenicitet eller vækstforsinkelse hos fosteret. 
In an animal reproductive and developmental toxicity study, administration of mogamulizumab to pregnant cynomolgus monkeys from the start of organogenesis through delivery did not show a potential for embryo-foetal lethality, teratogenicity, or foetal growth retardation.
Kvinder i den fertile alder/kontraception til mænd og kvinder Kvinder og mænd i den fertile alder skal bruge sikker kontraception under behandling med POTELIGEO og i mindst 6 måneder efter behandlingen. 
Women of childbearing potential/Contraception in males and females Women of childbearing potential and males of reproductive potential should use effective contraception during treatment with POTELIGEO and for at least 6 months after treatment.
Den anbefalede dosis er 1 mg/kg mogamulizumab, der administreres som en intravenøs infusion i et tidsrum på mindst 60 minutter. 
The recommended dose is 1 mg/kg mogamulizumab administered as an intravenous infusion over at least 60 minutes.
Humane IgG'er vides at blive udskilt i modermælk i de første par dage efter fødslen, hvilket kort tid efter falder til lave koncentrationer. 
Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed child cannot be excluded during this short period.
Behandlingen af TLS kan omfatte intensiv hydrering, korrektion af elektrolytanomalier, antihyperurikæmisk behandling samt supportiv behandling. 
Management of TLS may include aggressive hydration, correction of electrolyte abnormalities, anti-hyperuricaemic therapy, and supportive care.
I det kliniske studie (0761-010) var der to indberetninger af respirationsinsufficiens med letalt udfald hos patienter med svær pneumoni, som opstod mere end 9 måneder efter initiering af behandling med mogamulizumab. 
In the clinical trial (0761-010), there were 2 reports of respiratory failure with fatal outcome in patients with severe pneumonia occurring more than 9 months after starting treatment with mogamulizumab.
Natriumhydroxid (til pH-justering) Saltsyre (til justering af pH) Vand til injektionsvæsker 
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Fortæl det straks til den person, der giver dig infusionen, eller søg straks læge, hvis du får en reaktion under eller efter en infusion af POTELIGEO. 
Tell the person giving you the infusion or get medical help straight away if you experience a reaction during or after any POTELIGEO infusion.
Topikale steroider eller lave doser af systemiske kortikosteroider kan anvendes under behandling med mogamulizumab; dog kan risikoen for alvorlig infektion eller reaktivering af virus være højere ved samtidig administration af systemiske immunsupprimerende midler. 
Topical steroids or low doses of systemic corticosteroids may be used during treatment with mogamulizumab; however, the risk of serious infection and/or viral reactivation may be higher in case of concomitant administration with systemic immunosuppressive agents.
Patienter med MF eller SS har forhøjet risiko for alvorlige infektioner på grund af hudsygdommens forstyrrelse af den dermale integritet samt de immunsupprimerende virkninger af ekstrakutan sygdom, og behandling med mogamulizumab kan forhøje denne risiko. 
Patients with MF or SS are at increased risk of serious infection due to the disruption of dermal integrity caused by cutaneous disease, as well as the immunosuppressive effects of extracutaneous disease, and treatment with mogamulizumab may increase that risk.
Mogamulizumab er fremstillet i ovarieceller fra kinesisk hamster ved hjælp af rekombinant DNAteknologi. 
Mogamulizumab is produced in Chinese hamster ovary cells by recombinant DNA technology.
Median-PFS for mogamulizumab-gruppen var 7,70 måneder (95% CI: 5,67; 10,33) og 3,10 måneder (95% CI: 2,87; 4,07) for vorinostat-gruppen med en deraf følgende hazard ratio på 0,53 (95% CI: 0,41; 0,69), p<0,0001 (2-sidet stratificeret log-rank-test). 
Median PFS for the mogamulizumab group was 7.70 months (95% CI: 5.67, 10.33) and 3.10 months (95% CI: 2.87, 4.07) for the vorinostat group with resultant hazard ration of 0.53 (95% CI: 0.41, 0.69), p<0.0001 (2sided, stratified log rank test).
I studie 0761010 var der 10/290 evaluerbare patienter med CCR4-ekspression på <10%, hvoraf 6 blev randomiseret til mogamulizumab, og 4 blev randomiseret til vorinostat og skiftede efterfølgende over til mogamulizumab. 
In Study 0761-010 there were 10/290 evaluable patients with CCR4 expression <10%, of which 6 were randomised to mogamulizumab, and 4 were randomised to vorinostat and subsequently crossed over to mogamulizumab.
≥1% af lymfocytter hos 100% af patienterne, og 96% (134/140) havde CCR4 påvist på ≥10% af hudlymfocytter. 
CCR4 was detected on ≥1% of lymphocytes in 100% of patients, and 96% (134/140) had CCR4 detected on ≥10% of skin lymphocytes.
Sådan gives POTELIGEO 
How POTELIGEO is given
Behandling med mogamulizumab resulterede i 8 bekræftede komplette responser (komplet opheling i alle berørte områder) sammenlignet med 0 patienter i behandling med vorinostat: 4 ud af disse 8 patienter blev oprindeligt randomiseret til mogamulizumab, og 4 var skiftet over til mogamulizumab under studiet. 
Treatment with mogamulizumab resulted in 8 confirmed complete responses (complete clearing of all affected compartments) compared with 0 patients on vorinostat: 4 of these 8 patients were initially randomized to mogamulizumab and 4 had crossed over to mogamulizumab during the study.
Meget almindelig Infektionera 
Very common Infectionsa Common
Hud (n) 
Skin (n)
5 ml opløsning i et 10 ml hætteglas (type I-glas) med gummiprop, aluminiumsforsegling og flip-off låg af polypropylen. 
5 mL solution in a 10 mL glass vial (type I glass) with a rubber stopper, an aluminium seal and a polypropylene flip-off cap.
Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. hætteglas, dvs. det er i det væsentlige ‘natriumfrit'. 
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
6, 12, 18 og 24 måneder efter start af den randomiserede behandling var procentdelen af patienter, som var i live uden sygdomsprogression, højere for mogamulizumab (henholdsvis 55,3%, 38,3%, 28,0% og 14,1%) end for vorinostat (henholdsvis 28,8%, 15,3%, 7,2% og 7,2%). 
At 6, 12, 18 and 24 months after the start of randomised treatment, the percent of subjects alive without disease progression was higher for mogamulizumab (55.3%, 38.3%, 28.0%, and 14.1%, respectively) compared to vorinostat (28.8%, 15.3%, 7.2%, and 7.2%, respectively).
Kombinationen af mogamulizumab og systemiske immunmodulerende lægemidler eller andre godkendte behandlinger mod MF eller SS er ikke undersøgt og anbefales derfor ikke, især på grund af risikoen for alvorlige infektioner hos patienter, der behandles med mogamulizumab. 
The combination of mogamulizumab with systemic immune modulating medicinal products or with other licensed therapies for MF or SS has not been studied and is, therefore, not recommended, especially in consideration of the risk of severe infections in patients treated with mogamulizumab.
Baseret på en farmakokinetisk populationsanalyse var det geometriske, gennemsnitlige [% variationskoefficient (CV%)] centrale distributionsvolumen (Vc) 3,57 l (20,1%). 
Based on a population PK analysis, the geometric mean [% coefficient of variation (CV%)] central volume of distribution (Vc) was 3.57 L (20.1%).
Ud af de 320 patienter, der fik mogamulizumab i studie 0761-010, havde 21 (6,6%) mindst én alvorlige lægemiddelbivirkning (SADR), som opstod inden for 90 dage fra datoen for sidste dosis af studielægemidlet. 
Of the 320 subjects exposed to mogamulizumab in Study 0761-010, 21 (6.6%), experienced at least one serious adverse drug reaction (SADR) that occurred within 90 days from the date of last study drug administration.
CCR4 udtrykkes på overfladen af visse cancerceller, blandt andet T-celle-maligniteter såsom MF og SS, hvori ekspressionen af CCR4 er hyppigt forekommende. 
CCR4 is expressed on the surface of some cancer cells including T cell malignancies, such as MF and SS in which CCR4 expression is inherent.
Meget almindelig Obstipation, diaré, nausea, stomatitis 
Very common Constipation, diarrhoea, nausea, stomatitis
Pakningsstørrelser og yderligere oplysninger POTELIGEO indeholder: 
Contents of the pack and other information What POTELIGEO contains
Selvom mogamulizumab krydser placenta hos cynomolgus aber, indikerer dyrestudier, bortset fra den farmakologiske virkning på fostre, hverken direkte eller indirekte skadelige virkninger hvad angår reproduktionstoksicitet (se pkt. 
Although mogamulizumab crosses the placental barrier in cynomolgous monkey, apart from the pharmacological effect in foetuses, animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Vorinostat-behandlede patienter med sygdomsprogression eller uacceptable toksiciteter fik lov til at skifte til behandling med mogamulizumab. 
Vorinostat patients with disease progression or unacceptable toxicities were permitted to cross over to mogamulizumab therapy.
• POTELIGEO er kun beregnet til intravenøs anvendelse og må ikke administreres subkutant, intramuskulært, som en bolusdosis eller ved hurtig intravenøs administration. 
• POTELIGEO is intended for intravenous use only, and should not be administered subcutaneously, intramuscularly, as a bolus dose or by rapid intravenous administration.
- Betændelse i leveren (hepatitis). 
- Inflammation of the liver (hepatitis)
Responsvarighed (måneder) Median (95% CI) Respons efter område Blod n=124 
Duration of response (months) Median (95% CI) Response by compartment Blood n=124
CCR4-ekspressionen blev vurderet retrospektivt på hudbiopsier (formalinfikserede, paraffinindstøbte) taget inden behandling med anvendelse af immunhistokemi. 
CCR4 expression was assessed retrospectively on pretreatment skin biopsies (formalin fixed paraffin embedded) using immunohistochemistry.
Antal infusioner af mogamulizumab, der blev administreret til patienter, som skiftede præparat, var inden for intervallet 1 til 94 (op til 46 måneders behandling) ved dataafskæringspunktet december 2016. 
The number of infusions of mogamulizumab administered to crossover patients ranged from 1 to 94 (up to 46 months of treatment) as of the December 2016 datacut.
Alle patienter havde en histologisk bekræftet diagnose på mycosis fungoides (MF) - 56,5%, 53,2% eller Sézarys syndrom (SS) - 43,5%, 46,8% i gruppen i behandling med henholdsvis mogamulizumab og vorinostat og havde fået mindst én tidligere systemisk behandling. 
All patients had a histologically confirmed diagnosis of mycosis fungoides (MF), 56.5%, 53.2%, or Sézary Syndrome (SS), 43.5%, 46.8%, in the mogamulizumab and vorinostat groups, respectively, and had received at least one prior systemic therapy.
I tilfælde af en anafylaktisk reaktion skal administration af mogamulizumab seponeres straks og permanent, og patienten gives relevant medicinsk behandling. 
If an anaphylactic reaction occurs, administration of mogamulizumab should be immediately and permanently discontinued and appropriate medical therapy should be administered.
Patienter med sygdom i stadie IB/II, som blev behandlet med mogamulizumab, havde bekræftet ORR på 17,6% sammenlignet med 8,3% for vorinostat, og responsrater på områdeniveau (blod, hud, lymfeknuder), der var højere end for patienter, som fik behandling med vorinostat (Tabel 3). 
Patients with stage IB/II disease treated with mogamulizumab had confirmed ORR of 17.6% compared to 8.3% for vorinostat, and compartment level (blood, skin, lymph node) response rates that were higher than those for vorinostat treated patients (Table 3).
Samlet var medianperioden af progressionsfri overlevelse for patienter med sygdom i stadie IB/II, der blev behandlet med mogamulizumab, 4,7 måneder sammenlignet med 3,9 måneder for vorinostatbehandlede patienter (Tabel 4). 
Overall, the median period of progression free survival for stage IB/II subjects treated with mogamulizumab was 4.7 months compared to 3.9 months for vorinostat-treated patients (Table 4).
Responser på områdeniveau blev observeret hos 3 ud af 10 evaluerbare patienter, der blev behandlet med mogamulizumab i den randomiserede fase eller fasen med skift af præparat. 
Compartmental responses were seen in 3 of 10 evaluable subjects treated with mogamulizumab in the randomised or cross over phase.
Mogamulizumab må ikke infunderes i den samme intravenøse slange som andre lægemidler. 
Mogamulizumab should not be infused concomitantly in the same intravenous line with other medicinal products.
4.2 med information om præmedicinering og dosisændringer. 
See section 4.2 for premedication and dose modification information.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og hætteglasset efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the carton and the vial after “EXP”.
• Kontrollér lægemidlet visuelt inden administration for tegn på partikler og misfarvning. 
• Visually inspect the medicinal product for particulate matter and discolouration prior to administration.
Ud af disse blev SADR'er, som var indberettet for mere end én patient, kodet under systemorganklasserne "Infektioner og parasitære sygdomme" (7 [2,2%] patienter), "Almene symptomer og reaktioner på administrationsstedet" (5 [1,6%] patienter), "Luftveje, thorax og mediastinum" (4 [1,3%] patienter), "Knogler, led, muskler og bindevæv" (3 [0,9%] patienter), "Lever og galdeveje" (2 [0,6%] patienter) samt "Traumer, forgiftninger og behandlingskomplikationer" (2 [0,6%] patienter). 
Of these, SADRs that were reported in more than one patient were coded under the SOCs Infections and infestations (7 [2.2%] patients), General disorders and administration site conditions (5 [1.6%] patients), Respiratory, thoracic and mediastinal disorders (4 [1.3%] patients), Musculoskeletal and connective tissue disorders (3 [0.9%] patients), Hepatobiliary disorders (2 [0.6%] patients), and Injury, poisoning and procedural complications (2 [0.6%] patients).
Lægemidlet skal fortyndes og infunderes straks efter åbning (se pkt. 
Once opened, the medicinal product should be diluted and infused immediately (see section 6.6).
• POTELIGEO må ikke blandes med andre lægemidler eller administreres som en infusion med andre lægemidler. 
• Do not mix POTELIGEO with, or administer as an infusion with, other medicinal products.
Meget almindelig Træthed, perifert ødem, pyreksi 
Very common Fatigue, oedema peripheral, pyrexia
Meget almindelig Infusionsrelateret reaktion 
Very common Infusion related reaction
Generelt vides IgG-molekyler at krydse placenta, og der blev påvist mogamulizumab-koncentrationer i plasma hos fostre. 
In general, IgG molecules are known to cross the placental barrier and mogamulizumab concentrations in foetus plasma were detected.
Mogamulizumabs virkning i behandlingen af patienter med mycosis fungoides (MF) eller Sézarys syndrom (SS) blev fastlagt i et åbent fase 3 multicenterstudie (0761-010) med 372 voksne patienter, som blev randomiseret i forholdet 1:1 til behandling med enten mogamulizumab eller vorinostat. 
The efficacy of mogamulizumab in the treatment of patients with mycosis fungoides (MF) or Sézary syndrome (SS) was established in a Phase 3, multicentre, open-label, study (0761-010) of 372 adult patients randomised 1:1 to treatment with either mogamulizumab or vorinostat.
- Blodmangel (fald i antal røde blodlegemer) - Fald i antal blodplader (thrombocytopeni) - Fald i antal hvide blodlegemer (neutropeni og leukopeni) eller fald i antal lymfocytter - Blodprøver, der viser forhøjede niveauer af leverenzymer - Underaktiv skjoldbruskkirtel 
- Anaemia (reduced red blood cells) - Reduced blood platelets (thrombocytopenia) - Reduced white blood cells (neutropenia and leucopenia) or reduced lymphocytes - Blood tests showing raised liver enzyme levels - Underactive thyroid
POTELIGEO er en klar, farveløs opløsning. 
POTELIGEO is a clear, colourless solution.
Koncentrat til infusionsvæske, opløsning 20 mg/5 ml 
Concentrate for solution for infusion 20 mg/5 mL
Mogamulizumab bør ikke administreres subkutant eller intramuskulært, ved hurtig intravenøs administration eller som en intravenøs bolus. 
Mogamulizumab should not be administered subcutaneously or intramuscularly, by rapid intravenous administration, or as an intravenous bolus.
For en sikkerheds skyld bør mogamulizumab undgås under graviditet. 
As a precautionary measure, it is preferable to avoid the use of mogamulizumab during pregnancy.
En lille procentdel af patienter, der fik POTELIGEO, blev testet positive for anti-mogamulizumab-antistoffer, opstået efter behandlingsstart (inducerede eller forstærkede af behandling). 
A small percentage of patients receiving POTELIGEO tested positive for treatment emergent (treatment induced or treatment boosted) anti mogamulizumab antibodies.
- hudsmerter, kløe, hudblærer, hududslæt eller ømhed i munden, som kan være tegn på, at du er ved at udvikle en alvorlig hudreaktion, for eksempel Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse. 
- skin pain, itching, skin blisters, skin rash or sore mouth, which are possible signs that you may be developing a severe skin reaction, such as Stevens-Johnson syndrome or toxic epidermal necrolysis.
Hvis du kan blive gravid, skal du bruge sikker prævention under behandlingen og i mindst 6 måneder efter behandlingen. 
If you can get pregnant, you will need to use effective contraception during and for at least six months after receiving this treatment.