natgillin/translations-raw huggingface dataset:
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.
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