FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: Of the patients randomised to vorinostat, 136 patients (73.1%) crossed over to mogamulizumab during the study.
Danish: Blandt de patienter, der blev randomiseret til vorinostat, skiftede 136 patienter (73,1%) til mogamulizumab under studiet.
English: The population PK analysis included 444 patients receiving mogamulizumab in six clinical trials.
Danish: Den farmakokinetiske populationsanalyse omfattede 444 patienter, der fik mogamulizumab i seks kliniske studier.
English: The most frequently reported serious adverse reactions were pneumonia, pyrexia, infusion related reaction and cellulitis.
Danish: De hyppigst indberettede alvorlige bivirkninger var pneumoni, pyreksi, infusionsrelateret reaktion og cellulitis.
English: Response Rate (n, %) 95% CIa
Danish: Responsrate (n, %) 95% CIa
English: Store in a refrigerator (2ºC to 8ºC).
Danish: Opbevares i køleskab (2 ºC - 8 ºC).
English: This study included patients regardless of their baseline level of CCR4 expression in skin biopsy.
Danish: Studiet inkluderede patienter uanset deres niveau af CCR4-ekspression i hudbiopsi ved baseline.
English: After preparation of infusion
Danish: Efter klargøring af infusionen
English: 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%).
Danish: 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%).
English: 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.
Danish: 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.
English: • 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).
Danish: • Beregn den mængde POTELIGEO, der skal bruges til at klargøre infusionsvæsken til doseringen på 1 mg/kg, baseret på patientens vægt (se pkt.
English: If an IRR occurs, the infusion should be interrupted and appropriate medical management instituted.
Danish: I tilfælde af en IRR skal infusionen afbrydes og relevant medicinsk behandling iværksættes.
English: There are no data from the use of mogamulizumab in pregnant women.
Danish: Der er ingen data fra anvendelse af mogamulizumab til gravide kvinder.
English: Anaemia, neutropenia, leukopenia, Thrombocytopenia
Danish: Almindelig Anæmi, neutropeni, leukopeni, thrombocytopeni
English: • The diluted solution is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion bags.
Danish: • Den fortyndede opløsning kan bruges i infusionsposer af polyvinylchlorid (PVC) eller polyolefin (PO).
English: Large cell transformation (LCT) There are limited data available on patients with LCT.
Danish: Transformation til storcellet lymfom (LCT) Der er begrænsede data vedrørende patienter med LCT.
English: - Lack of energy (fatigue) - Constipation - Swollen legs or ankles - Headache
Danish: - Manglende energi (træthed) - Forstoppelse - Hævede ben eller ankler - Hovedpine
English: Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, lymphocyte count decreased
Danish: Forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet alkalisk phosphatase i blodet, nedsat lymfocyttal
English: POTELIGEO will be given to you through a vein (intravenous infusion) over at least 60 minutes.
Danish: POTELIGEO vil blive indgivet gennem en blodåre (intravenøs infusion) i et tidsrum på mindst 60 minutter.
English: Package leaflet: Information for the patient POTELIGEO 4 mg/mL concentrate for solution for infusion mogamulizumab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten POTELIGEO 4 mg/ml koncentrat til infusionsvæske, opløsning mogamulizumab Dette lægemiddel er underlagt supplerende overvågning.
English: Exposure-Response analysis indicated that efficacy was not correlated with mogamulizumab exposure in the pivotal study.
Danish: En analyse af eksponering og respons indikerede, at virkningen ikke hang sammen med eksponering for mogamulizumab i det pivotale studie.
English: The median duration of exposure with mogamulizumab was 5.6 months (range: <1 to 45.3 months).
Danish: Medianvarigheden af eksponering for mogamulizumab var 5,6 måneder (inden for intervallet <1 til 45,3 måneder).
English: The exposure to mogamulizumab increased proportionally with dose over the dose range of 0.1 to 1.0 mg/kg.
Danish: Eksponeringen for mogamulizumab steg proportionelt med dosis over dosisintervallet 0,1 til 1,0 mg/kg.
English: Fortyone of the 136 cross-over patients (30.1%) responded with either partial or complete response with mogamulizumab.
Danish: 41 (30,1%) af de 136 patienter, der skiftede præparat, havde enten partielt eller komplet respons med mogamulizumab.
English: If an infusion reaction occurs, administer pre-medication for subsequent POTELIGEO infusions.
Danish: Hvis der opstår infusionsreaktioner, gives præmedicinering ved de efterfølgende infusioner af POTELIGEO.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: The recommended dose is 1 mg/kg mogamulizumab administered as an intravenous infusion over at least 60 minutes.
Danish: Den anbefalede dosis er 1 mg/kg mogamulizumab, der administreres som en intravenøs infusion i et tidsrum på mindst 60 minutter.
English: 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.
Danish: Humane IgG'er vides at blive udskilt i modermælk i de første par dage efter fødslen, hvilket kort tid efter falder til lave koncentrationer.
English: Management of TLS may include aggressive hydration, correction of electrolyte abnormalities, anti-hyperuricaemic therapy, and supportive care.
Danish: Behandlingen af TLS kan omfatte intensiv hydrering, korrektion af elektrolytanomalier, antihyperurikæmisk behandling samt supportiv behandling.
English: 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.
Danish: 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.
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Danish: Natriumhydroxid (til pH-justering) Saltsyre (til justering af pH) Vand til injektionsvæsker
English: Tell the person giving you the infusion or get medical help straight away if you experience a reaction during or after any POTELIGEO infusion.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Mogamulizumab is produced in Chinese hamster ovary cells by recombinant DNA technology.
Danish: Mogamulizumab er fremstillet i ovarieceller fra kinesisk hamster ved hjælp af rekombinant DNAteknologi.
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: CCR4 was detected on ≥1% of lymphocytes in 100% of patients, and 96% (134/140) had CCR4 detected on ≥10% of skin lymphocytes.
Danish: ≥1% af lymfocytter hos 100% af patienterne, og 96% (134/140) havde CCR4 påvist på ≥10% af hudlymfocytter.
English: How POTELIGEO is given
Danish: Sådan gives POTELIGEO
English: 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.
Danish: 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.
English: Very common Infectionsa Common
Danish: Meget almindelig Infektionera
English: Skin (n)
Danish: Hud (n)
English: 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.
Danish: 5 ml opløsning i et 10 ml hætteglas (type I-glas) med gummiprop, aluminiumsforsegling og flip-off låg af polypropylen.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. hætteglas, dvs. det er i det væsentlige ‘natriumfrit'.
English: 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).
Danish: 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%).
English: 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.
Danish: 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.
English: Based on a population PK analysis, the geometric mean [% coefficient of variation (CV%)] central volume of distribution (Vc) was 3.57 L (20.1%).
Danish: Baseret på en farmakokinetisk populationsanalyse var det geometriske, gennemsnitlige [% variationskoefficient (CV%)] centrale distributionsvolumen (Vc) 3,57 l (20,1%).
English: 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.
Danish: 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.
English: 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.
Danish: CCR4 udtrykkes på overfladen af visse cancerceller, blandt andet T-celle-maligniteter såsom MF og SS, hvori ekspressionen af CCR4 er hyppigt forekommende.
English: Very common Constipation, diarrhoea, nausea, stomatitis
Danish: Meget almindelig Obstipation, diaré, nausea, stomatitis
English: Contents of the pack and other information What POTELIGEO contains
Danish: Pakningsstørrelser og yderligere oplysninger POTELIGEO indeholder:
English: 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).
Danish: 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.
English: Vorinostat patients with disease progression or unacceptable toxicities were permitted to cross over to mogamulizumab therapy.
Danish: Vorinostat-behandlede patienter med sygdomsprogression eller uacceptable toksiciteter fik lov til at skifte til behandling med mogamulizumab.
English: • POTELIGEO is intended for intravenous use only, and should not be administered subcutaneously, intramuscularly, as a bolus dose or by rapid intravenous administration.
Danish: • POTELIGEO er kun beregnet til intravenøs anvendelse og må ikke administreres subkutant, intramuskulært, som en bolusdosis eller ved hurtig intravenøs administration.
English: - Inflammation of the liver (hepatitis)
Danish: - Betændelse i leveren (hepatitis).
English: Duration of response (months) Median (95% CI) Response by compartment Blood n=124
Danish: Responsvarighed (måneder) Median (95% CI) Respons efter område Blod n=124
English: CCR4 expression was assessed retrospectively on pretreatment skin biopsies (formalin fixed paraffin embedded) using immunohistochemistry.
Danish: CCR4-ekspressionen blev vurderet retrospektivt på hudbiopsier (formalinfikserede, paraffinindstøbte) taget inden behandling med anvendelse af immunhistokemi.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: If an anaphylactic reaction occurs, administration of mogamulizumab should be immediately and permanently discontinued and appropriate medical therapy should be administered.
Danish: I tilfælde af en anafylaktisk reaktion skal administration af mogamulizumab seponeres straks og permanent, og patienten gives relevant medicinsk behandling.
English: 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).
Danish: 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).
English: 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).
Danish: 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).
English: Compartmental responses were seen in 3 of 10 evaluable subjects treated with mogamulizumab in the randomised or cross over phase.
Danish: 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.
English: Mogamulizumab should not be infused concomitantly in the same intravenous line with other medicinal products.
Danish: Mogamulizumab må ikke infunderes i den samme intravenøse slange som andre lægemidler.
English: See section 4.2 for premedication and dose modification information.
Danish: 4.2 med information om præmedicinering og dosisændringer.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og hætteglasset efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • Visually inspect the medicinal product for particulate matter and discolouration prior to administration.
Danish: • Kontrollér lægemidlet visuelt inden administration for tegn på partikler og misfarvning.
English: 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).
Danish: 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).
English: Once opened, the medicinal product should be diluted and infused immediately (see section 6.6).
Danish: Lægemidlet skal fortyndes og infunderes straks efter åbning (se pkt.
English: • Do not mix POTELIGEO with, or administer as an infusion with, other medicinal products.
Danish: • POTELIGEO må ikke blandes med andre lægemidler eller administreres som en infusion med andre lægemidler.
English: Very common Fatigue, oedema peripheral, pyrexia
Danish: Meget almindelig Træthed, perifert ødem, pyreksi
English: Very common Infusion related reaction
Danish: Meget almindelig Infusionsrelateret reaktion
English: In general, IgG molecules are known to cross the placental barrier and mogamulizumab concentrations in foetus plasma were detected.
Danish: Generelt vides IgG-molekyler at krydse placenta, og der blev påvist mogamulizumab-koncentrationer i plasma hos fostre.
English: 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.
Danish: 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.
English: - 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
Danish: - 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
English: POTELIGEO is a clear, colourless solution.
Danish: POTELIGEO er en klar, farveløs opløsning.
English: Concentrate for solution for infusion 20 mg/5 mL
Danish: Koncentrat til infusionsvæske, opløsning 20 mg/5 ml