FrancophonIA/ELRC3.0 huggingface dataset:
English: a: P-value was obtained from Cochran-Mantel-Haenszel test adjusting for disease type, disease stage, and region.
Danish: a: P-værdi indhentet fra Cochran-Mantel-Haenszel-test med justering for sygdomstype, sygdomsstadie og område.
English: • Each vial is for single use only.
Danish: • Hvert hætteglas er kun til engangsbrug.
English: The Kaplan-Meier curve for PFS is shown Figure 1.
Danish: Kaplan-Meier-kurven for PFS vises i Figur 1.
English: Patients should be closely monitored for symptoms or signs that suggest SJS or TEN.
Danish: Patienterne bør monitoreres nøje for symptomer eller tegn, der tyder på SJS eller TEN.
English: Table 2 summarises ORR and DOR, and response by compartment.
Danish: Tabel 2 opsummerer ORR og DOR samt respons inddelt efter område.
English: - ever had an infusion reaction with this medicine (possible symptoms of an infusion reaction are listed in section 4).
Danish: - nogensinde har haft en infusionsreaktion på grund af dette lægemiddel (mulige symptomer på en infusionsreaktion er oplyst i afsnit 4).
English: Safety post last dose
Danish: Sikkerhed efter sidste dosis
English: 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.
Danish: 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.
English: Treatment should be continued unless you get serious side effects or the cutaneous T-cell lymphoma starts to get worse.
Danish: Behandlingen bør fortsætte, medmindre du får en alvorlig bivirkning, eller det kutane T-cellelymfom begynder at blive værre.
English: Severe reactions (Grade 3) were experienced by 4% of patients.
Danish: Svære reaktioner (grad 3) opstod hos 4% af patienterne.
English: Follow patients closely for early evidence of transplant-related complications.
Danish: Patienterne skal følges nøje for tidlige tegn på transplantationsrelaterede komplikationer.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (at 25°C) under ambient room light.
Danish: Den kemiske og fysiske stabilitet efter anbrud til anvendelse er påvist i 24 timer ved stuetemperatur (25 °C) under forhold med omgivende lys.
English: Discard any unused portion left in the vial in accordance with local requirements.
Danish: Kassér eventuel ubrugt mængde i hætteglasset i overensstemmelse med lokale krav.
English: Patients with rapidly proliferating tumour and high tumour burden are at risk of TLS.
Danish: Patienter med hurtigt prolifererende tumorer og høj tumorbyrde har risiko for at udvikle TLS.
English: Treatment with mogamulizumab continued until disease progression or unacceptable toxicity.
Danish: Behandling med mogamulizumab fortsatte, indtil sygdomsprogression eller uacceptabel toksicitet.
English: 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.
Danish: 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.
English: 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.
Danish: I tilfælde af overdosering skal patienten og patientens vitale tegn monitoreres nøje (i mindst 1 time), og om nødvendigt gives der supportiv behandling.
English: See section 2 “POTELIGEO contains sodium”.
Danish: Se afsnit 2 ”POTELIGEO indeholder natrium”.
English: Blood (n)
Danish: Blod (n)
English: Efficacy, as measured by improvement in PFS based on investigator assessment, was not associated with increasing mogamulizumab exposure.
Danish: Effekt, målt som en forbedring i PFS baseret på en investigatorvurdering, var ikke forbundet med stigende eksponering for mogamulizumab.
English: • 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.
Danish: • 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.
English: Less than 1% of patients treated in Study 0761-010 discontinued treatment due to infusion-related reactions.
Danish: Under 1% af de patienter, der blev behandlet i studie 0761-010, seponerede behandlingen på grund af infusionsrelaterede reaktioner.
English: - have human immunodeficiency virus (HIV), herpes, cytomegalovirus (CMV), or hepatitis B or
Danish: - har human immundefektvirus (hiv), herpes, cytomegalovirus (CMV) eller hepatitis B- eller C
English: - allergic to mogamulizumab or any of the other ingredients of this medicine (listed in section 6).
Danish: - er allergisk over for mogamulizumab eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: Table 1: Adverse drug reactions occurring in patients receiving POTELIGEO (N=184) System organ class (SOC)
Danish: Tabel 1: Lægemiddelbivirkninger, der er opstået hos patienter, som fik POTELIGEO (N=184) Systemorganklasse (SOC)
English: See above recommendations in case of infusion-related reaction.
Danish: Se ovenstående anbefalinger i tilfælde af en infusionsrelateret reaktion.
English: Table 4: Progression Free Survival (PFS) by Treatment Group and Disease Stage (Randomised Treatment Period)
Danish: Tabel 4: Progressionsfri overlevelse (PFS) inddelt efter behandlingsgruppe og sygdomsstadie (periode med randomiseret behandling)
English: A higher risk of transplant complications has been reported if mogamulizumab is given within a short time frame (approximately 50 days) before HSCT.
Danish: Der er rapporteret om øget risiko for transplantationskomplikationer, hvis mogamulizumab gives inden for et kort tidsrum (cirka 50 dage) inden HSCT.
English: <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: 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).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Mogamulizumab targets cancer cells which are then destroyed by the immune system (the body's defence).
Danish: Mogamulizumab er rettet mod kræftceller, der efterfølgende ødelægges af immunsystemet (kroppens forsvarssystem).
English: Mogamulizumab is dosed via intravenous route and therefore is immediately and completely bioavailable.
Danish: Absorption Mogamulizumab doseres intravenøst og er derfor straks og fuldstændig biotilgængeligt.
English: Do not use this medicine if you notice signs of deterioration, such as particulate matter or discolouration.
Danish: Brug ikke dette lægemiddel, hvis du kan se tegn på nedbrydning, som f.eks. partikler eller misfarvning.
English: 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.
Danish: 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.
English: Patients should be tested for hepatitis B infection before initiating treatment with mogamulizumab.
Danish: Patienterne bør testes for hepatitis B-infektion, inden behandling med mogamulizumab initieres.
English: The majority of treatment-related infusion-related reactions were Grade 1 or 2 and occurred during or shortly after the first infusion.
Danish: Størstedelen af de behandlingsrelaterede, infusionsrelaterede reaktioner var grad 1 eller 2 og opstod under eller kort tid efter den første infusion.
English: Talk to your doctor if you get any other side effects.
Danish: Fortæl det til lægen, hvis du får andre bivirkninger.
English: - 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.
Danish: - hvis du skal have en stamcelletransplantation, er det muligt, at du kan få komplikationer ("graft versus host disease"), som er svære at behandle.
English: The recommended dose is 1mg POTELIGEO for each kg of body weight.
Danish: Den anbefalede dosis er 1 mg POTELIGEO for hvert kilogram legemsvægt.
English: These time limits include storage of the infusion solution in the infusion bag through the duration of infusion.
Danish: Disse tidsbegrænsninger inkluderer opbevaring af infusionsvæsken i infusionsposen under infusionen.
English: The final concentration of the diluted solution should be between 0.1 mg/mL to 3.0 mg/mL.
Danish: Den fortyndede opløsnings endelige koncentration skal være mellem 0,1 mg/ml og 3,0 mg/ml.
English: POTELIGEO is unlikely to affect your ability to drive and use machines.
Danish: Det er usandsynligt, at POTELIGEO vil påvirke din evne til at køre bil og betjene maskiner.
English: 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.
Danish: 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.
English: No specific studies have been conducted to evaluate potential effects on fertility.
Danish: Der er ikke udført specifikke studier med undersøgelse af de potentielle virkninger på fertiliteten.
English: There were no positive neutralising antibody responses.
Danish: Der var ingen positive neutraliserende antistofresponser.
English: - have had tumour lysis syndrome (a complication involving the destruction of cancer cells) after a previous treatment.
Danish: - har haft tumorlysesyndrom (en komplikation, der indebærer ødelæggelse af kræftceller) efter en tidligere behandling.
English: In the mogamulizumab arm, baseline CCR4 expression levels were available in 75% of patients (N=140).
Danish: I mogamulizumab-armen var niveauerne af CCR4-ekspression ved baseline tilgængelige for 75% af patienterne (N=140).
English: 56% of patients received mogamulizumab for at least 6 cycles, and 25% of patients received mogamulizumab for at least 12 cycles.
Danish: 56% af patienterne fik mogamulizumab i mindst 6 cyklusser, og 25% af patienterne fik mogamulizumab i mindst 12 cyklusser.
English: Figure 1: Plot of Kaplan-Meier curve of progression-free survival by investigator's assessment (ITT) population
Danish: Figur 1: Plot af Kaplan-Meier-kurve over den progressionsfrie overlevelse efter investigatorvurdering (ITT-population)
English: 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.
Danish: Responset i lymfeknuder og viscera blev undersøgt i 4. uge, derefter hver 8. uge i det første år og efterfølgende hver 16. uge.
English: Serious infections, including sepsis, pneumonia and skin infections, were experienced by 14.3% of subjects receiving mogamulizumab.
Danish: Alvorlige infektioner, herunder sepsis, pneumoni og hudinfektioner, opstod hos 14,3% af de patienter, der har fået mogamulizumab.
English: Uncommon Hepatitis acute, hepatitis
Danish: Ikke almindelig Akut hepatitis, hepatitis
English: 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.
Danish: På grund af lægemidlets virkningsmekanisme kan det skade barnet, hvis det gives, mens du er gravid eller ammer.
English: 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).
Danish: 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).
English: Infusion interruptions occurred in approximately 6% of patients, most of which (approximately 90%) occurred within the first cycle of treatment with mogamulizumab.
Danish: 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.
English: The destruction of cancer cells and the body's reaction to it can very occasionally lead to a problem called tumour lysis syndrome.
Danish: Ødelæggelsen af kræftceller og kroppens reaktion på dette kan i sjældne tilfælde føre til et problem, der kaldes for tumorlysesyndrom.
English: Patients who have risk factors associated with cardiac disease should be monitored and appropriate precautions taken.
Danish: Patienter med risikofaktorer for hjertesygdom bør monitoreres, og relevante sikkerhedsforanstaltninger bør træffes.
English: Infusion-related reactions have been observed in 33% of patients treated with POTELIGEO.
Danish: Der er observeret infusionsrelaterede reaktioner hos 33% af de patienter, der er blevet behandlet med POTELIGEO.
English: Citric acid monohydrate Glycine
Danish: Citronsyremonohydrat Glycin
English: If SJS/TEN occur, appropriate medical therapy should be administered.
Danish: Hvis der opstår SJS/TEN, foretages relevant medicinsk behandling.
English: 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.
Danish: 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.
English: Reasons for crossover to mogamulizumab were disease progression (109 patients) and treatment intolerance (27 patients).
Danish: Årsagerne til skift til mogamulizumab var sygdomsprogression (109 patienter) og intolerance over for behandlingen (27 patienter).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose toxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser.
English: The latency to event onset following the first dose varied considerably.
Danish: Forsinkelsen før bivirkningens indtræden efter den første dosis varierede betydeligt.
English: What you need to know before you use POTELIGEO Do not use POTELIGEO if you are:
Danish: Det skal du vide, før du begynder at bruge POTELIGEO Brug ikke POTELIGEO, hvis du:
English: At study baseline, 38% had stage IB-II disease, 10% stage III, 52% stage IV.
Danish: Ved studiets baseline havde 38% sygdom i stadie IB-II, 10% havde sygdom i stadie III, og 52% havde sygdom i stadie IV.
English: Tell your doctor immediately if you experience any of the serious side effects listed in Section 4 after starting POTELIGEO treatment.
Danish: 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.
English: The study demonstrated statistically significant improvements in ORR and response by compartment in the blood, skin, and lymph nodes as compared to vorinostat.
Danish: Studiet viste statistisk signifikante forbedringer i ORR og respons pr. område i blod, hud og lymfeknuder sammenlignet med vorinostat.
English: The safety and efficacy of POTELIGEO in children and adolescents aged below 18 years has not been established.
Danish: POTELIGEOs sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Vorinostat was administered at a starting dose of 400 mg orally, once daily beginning on day 1 for 28day cycles.
Danish: Vorinostat blev administreret i en initialdosis på 400 mg oralt én gang dagligt med start på dag 1 i 28-dages cyklusser.
English: No confirmed responses were observed in these 10 subjects with low (<10%) CCR4 expression.
Danish: Der blev ikke observeret nogen bekræftede responser hos disse 10 patienter med lav (<10%) CCR4-ekspression.
English: There are limited efficacy data in patients with low (<10%) CCR4 expression in the skin.
Danish: Der er begrænsede effektdata fra patienter med lav (<10%) CCR4-ekspression i huden.
English: 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.
Danish: 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.
English: Table 2: Response during randomised treatment period in study 0761-010 (intent-to-treat)
Danish: Tabel 2: Respons i perioden med randomiseret behandling i studie 0761-010 (intent-to-treat) Mogamulizumab
English: Very common Headache
Danish: Meget almindelig Hovedpine
English: Warnings and precautions Talk to your doctor or nurse before using POTELIGEO if you:
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller sundhedspersonalet, før du bruger POTELIGEO, hvis du:
English: Mogamulizumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Danish: Mogamulizumab forventes at blive nedbrudt til små peptider og aminosyrer via katabolske veje på samme måde som endogent IgG.
English: 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.
Danish: Fortæl det til lægen eller sundhedspersonalet, hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: Pre-medication with anti-pyretic and anti-histamine is recommended for the first POTELIGEO infusion.
Danish: Præmedicinering med antipyretika og antihistaminer anbefales ved den første infusion af POTELIGEO.
English: 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.
Danish: 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.
English: The safety of treatment with mogamulizumab after autologous or allogeneic HSCT has not been studied.
Danish: Sikkerheden ved behandling med mogamulizumab efter autolog eller allogen HSCT er ikke undersøgt.
English: 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).
Danish: 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).
English: This medicinal product contains less than 1 mmol sodium per dose, that is to say essentially ‘sodium free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium pr. dosis, dvs. det er i det væsentlige ‘natriumfrit'.
English: POTELIGEO does not contain a preservative.
Danish: POTELIGEO indeholder ingen konserveringsmidler.
English: 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.
Danish: 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.
English: Overall response rate (ORR), n (%) Compartment:
Danish: Samlet responsrate (ORR), n (%) Område:
English: Afterwards POTELIGEO could be used during breast-feeding if clinically needed.
Danish: Herefter kan POTELIGEO anvendes under amning, hvis der er klinisk behov.
English: It is unknown whether mogamulizumab is excreted in human milk.
Danish: Det er ukendt, om mogamulizumab udskilles i human mælk.
English: POTELIGEO contains the active substance mogamulizumab, which belongs to a group of medicines called monoclonal antibodies.
Danish: POTELIGEO indeholder det aktive stof mogamulizumab, der tilhører en gruppe lægemidler, som kaldes for monoklonale antistoffer.
English: Severe adverse reactions included Grade 4 respiratory failure (1.1%) and Grade 5 reactions were polymyositis and sepsis (0.5% each).
Danish: Alvorlige bivirkninger omfattede respirationsinsufficiens grad 4 (1,1%), og bivirkninger grad 5 var polymyositis og sepsis (hver 0,5%).
English: The effects of POTELIGEO in pregnancy and breast-feeding are not known.
Danish: Virkningerne af anvendelse af POTELIGEO under graviditet og amning er ikke kendte.
English: If you are breast-feeding, you should discuss with your doctor whether you can breast-feed during or after treatment with POTELIGEO.
Danish: Hvis du ammer, skal du tale med din læge om, hvorvidt du kan amme under eller efter behandling med POTELIGEO.
English: 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.
Danish: Træk den nødvendige mængde POTELIGEO aseptisk op i sprøjten og overfør til en infusionspose, der indeholder 9 mg pr. ml (0,9%) natriumchlorid injektionsvæske.
English: 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.
Danish: POTELIGEO er indiceret til behandling af voksne patienter med mycosis fungoides (MF) eller Sézarys syndrom (SS), der har fået mindst én tidligere systemisk behandling.
English: This medicine is used to treat adults with mycosis fungoides and Sézary syndrome, which are types of cancers called cutaneous T-cell lymphomas.
Danish: Dette lægemiddel bruges til behandling af voksne med mycosis fungoides og Sézarys syndrom, som er nogle kræfttyper, der kaldes for kutane T-cellelymfomer.