FrancophonIA/ELRC3.0 huggingface dataset:
English: Probability of PFS
Danish: Sandsynlighed for PFS
English: • you have had an organ transplant;
Danish: • du har gennemgået en organtransplantation
English: PFS and OS results are summarised in Figures 3, 4, 5 and 6.
Danish: PFS- og OS-resultater er sammenfattet i figur 3, 4, 5 og 6.
English: The time to onset was 42 days.
Danish: Tid til debut var 42 dage.
English: Ninety-two percent of patients had received a total dose of 54 to 66 Gy of radiation.
Danish: 92 % af patienterne havde fået en total dosis på 54 til 66 Gy stråling.
English: This 1 patient received insulin.
Danish: Denne ene patient fik insulin.
English: Grade 3 or 4, or any Grade with positive biopsy
Danish: Grad 3 eller 4, eller en hvilken som helst grad med positiv biopsi
English: No changes
Danish: Ingen ændring
English: Common Terminology Criteria for Adverse Events, version 4.03.
Danish: Almindelige terminologikriterier for bivirkninger, version 4.03.
English: Treatment must be initiated and supervised by a physician experienced in the treatment of cancer.
Danish: Behandlingen skal initieres og overvåges af en læge med erfaring i cancerbehandling.
English: Patients with disease control at 12 months were given the option to be re-treated upon disease progression.
Danish: Patienter med sygdommen under kontrol ved 12 måneder fik mulighed for at blive behandlet igen ved sygdomsprogression.
English: The terminal half-life (t1/2), based on baseline CL, was approximately 18 days.
Danish: Den terminale halveringstid (t1/2), baseret på baseline CL, var ca. 18 dage.
English: Events/N (%) IMFINZI
Danish: Hændelser/N (%) IMFINZI
English: • Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Danish: • Fortæl det til lægen, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: If you have any questions about how IMFINZI works or why this medicine has been prescribed for you, ask your doctor or pharmacist.
Danish: Hvis du har spørgsmål om, hvordan IMFINZI virker eller hvorfor denne medicin er ordineret til dig, så spørg din læge eller apotekspersonalet.
English: In humans, antibodies may be transferred to breast milk, but the potential for absorption and harm to the newborn is unknown.
Danish: Hos mennesker kan antistoffer overføres til modermælk, men potentialet for absorption og skade på den nyfødte er ukendt.
English: However, if you have side effects that affect your ability to concentrate and react, you should be careful when driving or operating machines.
Danish: Men hvis du får bivirkninger, som påvirker din evne til at koncentrere dig og reagere, bør du være forsigtig, når du fører motorkøretøj eller betjener maskiner.
English: Preparation and administration of the infusion
Danish: Forberedelse og administration af infusionen
English: Events of pancreatitis have been reported in patients in the clinical study programme.
Danish: Der er rapporteret om tilfælde med pancreatitis hos patienter i det kliniske studieprogram.
English: • Do not co-administer other medicinal products through the same infusion line.
Danish: • Der må ikke administreres andre lægemidler i samme infusionslinje.
English: Adrenal insufficiency
Danish: Adrenal insufficiens
English: o includes pruritus generalised and pruritus.
Danish: o omfatter generaliseret pruritus og pruritus.
English: Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of IMFINZI.
Danish: De fleste af disse, herunder alvorlige reaktioner, forsvandt efter påbegyndelse af passende medicinsk behandling eller seponering af IMFINZI.
English: PFS2 is defined as the time from the date of randomisation until the date of second progression (defined by local standard clinical practice) or death.
Danish: PFS2 er defineret som tidspunktet fra randomiseringsdato til dato for anden progression (defineret efter lokal klinisk standardpraksis) eller død.
English: Pneumonia b,c
Danish: Pneumoni b,c
English: No overall differences in safety were reported between elderly (≥ 65 years) and younger patients.
Danish: Der blev ikke rapporteret om nogen samlet forskel i sikkerhed mellem ældre (≥65 år) og yngre patienter.
English: Patients excluded from clinical trials
Danish: Patienter udelukket fra kliniske forsøg
English: Tumour assessments were conducted every 8 weeks for the first 12 months and then every 12 weeks thereafter.
Danish: Vurdering af tumor blev foretaget hver 8. uge i de første 12 måneder og derefter hver 12. uge.
English: • has responded or stabilised after initial treatment with chemotherapy and radiotherapy.
Danish: • er i bedring eller har stabiliseret sig efter indledende behandling med kemoterapi og strålebehandling.
English: If no improvement within 3 to 5 days despite corticosteroids, promptly start additional immunosuppressive therapy.
Danish: Hvis der ikke er nogen forbedring inden for 3 til 5 dage på trods af kortikosteroider, skal yderligere immunsupprimerende behandling straks indledes.
English: This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}.>
English: In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden på biologiske lægemidler skal navn og batchnummer på det administrerede produkt registreres tydeligt.
English: • has spread within your lung and cannot be removed by surgery, and
Danish: • har spredt sig i lungen og ikke kan fjernes ved operation og
English: • The medicinal product, once diluted, should be used immediately.
Danish: • Lægemidlet skal, når det er fortyndet, anvendes straks.
English: • IMFINZI is single-dose.
Danish: • IMFINZI er enkeltdosis.
English: <Other sources of information>
Danish: Andre informationskilder
English: The demographics and baseline disease characteristics were well balanced between study arms.
Danish: Demografi og sygdomskarakteristika ved baseline var velafbalanceret mellem studiearmene.
English: If you have any further questions about your treatment, ask your doctor.
Danish: Hvis du har yderligere spørgsmål om din behandling, så spørg din læge.
English: Patients were enrolled regardless of their tumour PD-L1 expression level.
Danish: Patienter blev indskrevet uanset deres tumor PD-L1-ekspressionsniveau.
English: Carcinogenicity and mutagenicity The carcinogenic and genotoxic potential of durvalumab has not been evaluated.
Danish: Karcinogenicitet og mutagenicitet Det karcinogene og genotoksiske potentiale af durvalumab er ikke blevet evalueret.
English: Consider increasing dose of corticosteroids and/or using additional systemic immunosuppressants if there is worsening or no improvement.
Danish: Overvej at øge dosis af kortikosteroider og/eller yderligere systemiske immunosuppressiva, hvis der er forværring eller ingen forbedring.
English: The two primary endpoints of the study were progression-free survival (PFS) and overall survival (OS) of IMFINZI vs. placebo.
Danish: Studiets to primære endepunkter var progressionsfri overlevelse (PFS) og samlet overlevelse (OS) for IMFINZI vs. placebo.
English: The diluted solution must not be frozen.
Danish: Den fortyndede opløsning må ikke fryses.
English: Efficacy results for the PACIFIC Study
Danish: Effektresultater af PACIFIC-studiet
English: Talk to your doctor straight away if you get any of the following side effects, that have been reported in clinical trials with durvalumab, and includes the serious side effects listed in section 2:
Danish: Tal med din læge med det samme, hvis du får nogen af de følgende bivirkninger, som er blevet rapporteret i de kliniske forsøg med durvalumab og omfatter de alvorlige bivirkninger, der er anført i afsnit 2:
English: • a condition in which the muscles become weak and there is a rapid fatigue of the muscles (myasthenia gravis).
Danish: • en tilstand, hvor musklerne bliver svage, og hvor de hurtigt bliver trætte (myasthenia gravis).
English: Children and adolescents IMFINZI should not be used in children and adolescents below 18 years of age.
Danish: Børn og unge IMFINZI bør ikke anvendes til børn og unge under 18 år.
English: There are no data on the use of durvalumab in pregnant women.
Danish: Der er ingen data om brugen af durvalumab hos gravide kvinder.
English: It is to be administered as an intravenous infusion solution over 60 minutes (see section 6.6).
Danish: Det skal administreres som en intravenøs infusionsopløsning over 60 minutter (se pkt.
English: Human IgG1 is known to cross the placental barrier and placental transfer of durvalumab was confirmed in animal studies.
Danish: Humant IgG1 er kendt for at passere placenta-barrieren, og placenta-overførsel af durvalumab blev bekræftet i dyrestudier.
English: Grade 3-4 (%)
Danish: Grad 3-4 (%)
English: Any Grade (%)
Danish: Alle grader (%)
English: Data from patients with severe renal impairment are too limited to draw conclusions on this population (see section 5.2).
Danish: Data fra patienter med alvorligt nedsat nyrefunktion er for begrænsede til at drage konklusioner for denne population (se pkt.
English: The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL.
Danish: Den færdige koncentration af den fortyndede opløsning skal være mellem 1 mg/ml og 15 mg/ml.
English: The corresponding frequency category for each ADR is defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Danish: Den tilsvarende frekvenskategori for hver bivirkning defineres som: 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: • if you are allergic to durvalumab or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”).
Danish: • hvis du er allergisk over for durvalumab eller et af de øvrige indholdsstoffer i IMFINZI (angivet i afsnit 6 ”Pakningsstørrelser og yderligere oplysninger”).
English: Data from NSCLC patients 75 years of age or older are limited.
Danish: Data fra NSCLC-patienter i alderen 75 år og ældre er begrænsede.
English: IMFINZI will be given to you in a hospital or clinic and the healthcare professional will be responsible for its storage.
Danish: Du vil få IMFINZI på et hospital eller en klinik, og sundhedspersonalet vil være ansvarlig for opbevaringen.
English: There is no information on overdose with durvalumab.
Danish: Der er ingen information om overdosering med durvalumab.
English: Across all studies, IMFINZI was administered at a dose of 10 mg/kg every 2 weeks.
Danish: I alle studier blev IMFINZI administreret med en dosis på 10 mg/kg hver anden uge.
English: It is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
Danish: Det anbefales at fortsætte behandling af klinisk stabile patienter med indledende tegn på sygdomsprogression, indtil sygdomsprogressionen bekræftes.
English: PFS was assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1.
Danish: PFS blev baseret på blindet uafhængig central vurdering (BICR, Blinded Independent Central Review) ifølge RECIST v1.1.
English: There are insufficient number of patients to determine ADA impact on efficacy.
Danish: Der er et utilstrækkeligt antal patienter til at bestemme ADA-påvirkningen på effekten.
English: Randomisation was stratified by gender, age (< 65 years vs. ≥ 65 years) and smoking status (smoker vs. non-smoker).
Danish: Randomisering blev stratificeret efter køn, alder (<65 år vs. ≥65 år) og rygestatus (ryger vs. ikke-ryger).
English: Fertility There are no data on the potential effects of durvalumab on fertility in humans or animals.
Danish: Der foreligger ingen data om de potentielle virkninger af durvalumab på fertilitet hos mennesker eller dyr.
English: No formal pharmacokinetic (PK) drug-drug interaction studies have been conducted with durvalumab.
Danish: Der er ikke udført nogen formelle farmakokinetiske (PK) lægemiddelinteraktionsstudier med durvalumab.
English: Secondary efficacy endpoints included PFS at 12 months (PFS 12) and 18 months (PFS 18) from randomisation and Time from Randomisation to Second Progression (PFS2).
Danish: Sekundære effektendepunkter inkluderede PFS 12 måneder (PFS 12) og 18 måneder (PFS 18) efter randomisering og tid fra randomisering til anden progression (PFS2).
English: AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center (FMC) 633 Research Court
Danish: AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center (FMC) 633 Research Court Frederick,
English: Dose escalation or reduction is not recommended.
Danish: Det anbefales ikke at øge eller nedsætte dosis.
English: One patient also received mycophenolate treatment.
Danish: En patient fik også mycophenolatbehandling.
English: Warnings and precautions Talk to your doctor before you are given IMFINZI if:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du får IMFINZI, hvis:
English: Withhold dose until clinically stable
Danish: Tilbagehold dosis indtil klinisk stabil
English: IMFINZI treatment modification
Danish: IMFINZI behandlingsmodifikation
English: IMFINZI contains the active substance durvalumab which is a monoclonal antibody, a type of protein designed to recognise a specific target substance in the body.
Danish: IMFINZI indeholder det aktive stof durvalumab, som er et monoklonalt antistof, en type protein designet til at genkende et specifikt målstof i kroppen.
English: • Call your doctor straight away to reschedule your appointment.
Danish: • Ring straks til din læge for at få en ny aftale.
English: Initiate treatment with insulin as clinically indicated
Danish: Initiér behandling med insulin som klinisk indiceret
English: EU/1/18/1322/002 120 mg vial EU/1/18/1322/001 500 mg vial
Danish: EU/1/18/1322/002 120 mg hætteglas EU/1/18/1322/001 500 mg hætteglas
English: Patient-reported symptoms, function and health-related quality of life (HRQoL) were collected using the EORTC QLQ-C30 and its lung cancer module (EORTC QLQ-LC13).
Danish: Patientrapporterede symptomer, funktion og sundhedsrelateret livskvalitet (HRQoL) blev indsamlet ved anvendelse af EORTC QLQ-C30 og dets lungekræftmodul (EORTC QLQ-LC13).
English: Number of patients at risk Month
Danish: Antal patienter i risiko Måneder
English: PK exposure increased more than dose-proportionally (non-linear PK) at doses < 3 mg/kg, and dose proportionally (linear PK) at doses ≥ 3 mg/kg.
Danish: PK-eksponering steg mere end dosisproportionalt (ikke-lineær PK) ved doser på < 3 mg/kg og dosisproportionalt (lineær PK) ved doser på ≥ 3 mg/kg.
English: IMFINZI is used to treat a type of lung cancer called non-small cell lung cancer (NSCLC) in adults.
Danish: IMFINZI bruges til behandling af en type lungekræft, som kaldes ikke-småcellet lungecancer (NSCLC) hos voksne.
English: Of the 713 patients randomised, 63% of patients provided a tissue sample of sufficient quality and quantity to determine PD-L1 expression and 37% were unknown.
Danish: Af de 713 randomiserede patienter gav 63 % af patienterne en vævsprøve af tilstrækkelig kvalitet og kvantitet til at fastslå PD-L1-ekspression, og 37 % var ukendt.
English: • a condition leading to high blood sugar levels (type 1 diabetes mellitus)
Danish: • en tilstand, der medfører højt sukkerindhold i blodet (type 1-diabetes mellitus)
English: When you get IMFINZI, you can have some serious side effects (see section 2).
Danish: Når du får IMFINZI, kan du få nogle alvorlige bivirkninger (se afsnit 2).
English: Durvalumab is produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology.
Danish: Durvalumab fremstilles i mammale celler (ovarieceller fra kinesisk hamster) ved rekombinant DNA-teknologi.
English: Upon improvement to ≤ Grade 1, corticosteroid taper should be initiated and continued over at least 1 month.
Danish: Ved forbedring til ≤Grad 1 bør nedtrapning af kortikosteroid initieres og fortsættes over mindst 1 måned.
English: Eight patients experienced hypothyroidism following hyperthyroidism.
Danish: 8 patienter oplevede hypothyreoidisme efter hyperthyreoidisme.
English: Probability of OS
Danish: Sandsynlighed for OS
English: Given the mechanism of action of IMFINZI, other potential immune-mediated adverse reactions may occur.
Danish: I betragtning af IMFINZIs virkningsmekanisme kan andre potentielle immunmedierede bivirkninger forekomme.
English: The solution has a pH of approximately 6.0 and an osmolality of approximately 400 mOsm/kg.
Danish: Opløsningen har en pH-værdi på cirka 6,0 og en osmolalitet på cirka 400 mOsm/kg.
English: Based on population PK analysis, slightly lower exposure are expected in ADA-positive patients however, the reduction of PK exposure is less than 30% compared to a typical patient and is not considered clinically relevant.
Danish: På baggrund af en farmakokinetisk populationsanalyse forventes lidt lavere eksponering hos ADA-positive patienter, men reduktionen af farmakokinetisk eksponering er under 30 % sammenlignet med en typisk patient og anses ikke for klinisk relevant.
English: The improvements in PFS and OS in favour of patients receiving IMFINZI compared to those receiving placebo were consistently observed in all predefined subgroups analysed, including ethnicity, age, gender, smoking history, EGFR mutation status and histology.
Danish: Forbedringerne i PFS og OS til fordel for patienter, der modtog IMFINZI sammenlignet med dem, der fik placebo, blev konsekvent observeret i alle prædefinerede, analyserede undergrupper, herunder etnicitet, alder, køn, rygestatus, EGFR-mutationsstatus og histologi.
English: The LC13 and C30 were assessed at baseline, every 4 weeks for the first 8 weeks, followed by every 8 weeks until completion of the treatment period or discontinuation of IMFINZI due to toxicity or disease progression.
Danish: LC13 og C30 blev vurderet ved baseline hver 4. uge i de første 8 uger efterfulgt af hver 8. uge indtil afslutning af behandlingsperioden eller ophør af IMFINZI på grund af toksicitet eller sygdomsprogression.
English: c fatal pneumonitis and fatal pneumonia were reported at similar rate between the IMFINZI-treated group and placebo group in the PACIFIC Study; fatal hepatitis and fatal polymyositis were reported in other clinical trials.
Danish: c fatal pneumonitis og fatal pneumoni blev rapporteret med samme frekvens i den IMFINZI-behandlede gruppe og i placebogruppen i PACIFIC-studiet; fatal hepatitis og fatal polymyositis blev rapporteret i andre kliniske studier.
English: IMFINZI should be discontinued for Grade 4 adverse reactions (with the exception of Grade 4 laboratory abnormalities, about which the decision to discontinue should be based on accompanying clinical signs/symptoms and clinical judgment).
Danish: IMFINZI bør seponeres for Grad 4 bivirkninger (med undtagelse af Grad 4 laboratorieabnormiteter, for hvilke beslutningen om seponering bør baseres på ledsagende kliniske tegn/symptomer og klinisk vurdering).
English: • It is not known if IMFINZI passes into human breast milk.
Danish: • Det vides ikke, om IMFINZI passerer over i modermælk.
English: • Ask your doctor if you can breast-feed during or after treatment with IMFINZI.
Danish: • Spørg lægen, om du må amme under eller efter behandling med IMFINZI.
English: ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal.
Danish: ALAT: alaninaminotransferase; ASAT: aspartataminotransferase; ULN: Øvre grænse for normal.
English: May consider pre-medications for prophylaxis of subsequent infusion reactions
Danish: Præmedicinering til profylakse af efterfølgende infusionsreaktioner kan overvejes
English: IMFINZI works by helping your immune system fight your cancer.
Danish: IMFINZI virker ved at hjælpe immunsystemet med at bekæmpe kræften.
English: Oral candidiasis
Danish: Candidiasis oris
English: • Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
Danish: • Parenterale lægemidler bør inspiceres visuelt for partikler og misfarvning før administration.
English: 6545CG Nijmegen, Netherlands
Danish: 6545CG Nijmegen, Nederlandene
English: The following immune-related adverse reactions were reported in less than 1% of patients treated with IMFINZI monotherapy in clinical trials (n = 1889): Myasthenia gravis, myocarditis, myositis, polymyositis.
Danish: Følgende immunmedierede bivirkninger blev rapporteret hos mindre end 1 % af de patienter, der blev behandlet med IMFINZI monoterapi i kliniske forsøg (n = 1889): myasthenia gravis, myokarditis, myositis, polymyositis.
English: g frequency is based on events not observed in the PACIFIC Study but observed in other clinical trials (n=1889).
Danish: g frekvensen er baseret på hændelser, der ikke blev observeret i PACIFIC-studiet, men observeret i andre kliniske studier (n=1889).
English: If not used immediately, the total time from vial puncture to start of the administration should not exceed 24 hours at 2 ºC to 8 ºC or 12 hours at room temperature (up to 25 ºC).
Danish: Hvis den ikke anvendes straks, bør den samlede tid fra hætteglassets anbrud til administrationens start ikke overstige 24 timer ved 2 ºC til 8 ºC eller 12 timer ved stuetemperatur (op til 25 ºC).
English: Throughout the duration of the study to Week 48, there was no clinically meaningful difference between IMFINZI and placebo groups in symptoms, functioning and HRQoL (as assessed by a difference of greater than or equal to 10 points).
Danish: Gennem hele studieperioden indtil uge 48 var der ingen væsentlig klinisk forskel på IMFINZI og placebogrupperne med hensyn til symptomer, funktion og HRQoL (vurderet på en forskel på større end eller lig med 10 point).
English: • If you are a woman who could become pregnant you must use effective birth control while you are being treated with IMFINZI and for at least 3 months after your last dose.
Danish: • Hvis du er en kvinde, der kan blive gravid, skal du bruge effektiv prævention, mens du behandles med IMFINZI og i mindst 3 måneder efter din sidste dosis.
English: IMFINZI will be given to you in a hospital or clinic under the supervision of an experienced doctor.
Danish: Du vil få IMFINZI på et hospital eller en klinik under ledelse af en erfaren læge.
English: One patient also received infliximab treatment.
Danish: En patient fik også infliximabbehandling.
English: 6545 CG Nijmegen The Netherlands
Danish: 6545 CG Nijmegen Nederlandene
English: Talk to your doctor straight away if you get any of the side effects listed above.
Danish: Tal straks med din læge, hvis du får nogen af de ovenstående bivirkninger.
English: IMFINZI should be permanently discontinued for recurrent Grade 3 or 4 (severe or life-threatening) immune-mediated adverse reactions.
Danish: IMFINZI skal seponeres permanent ved tilbagevendende Grad 3 eller 4 (alvorlige eller livstruende) immunmedierede bivirkninger.
English: Corticosteroid treatment unless otherwise specified
Danish: Kortikosteroidbehandling med mindre andet er angivet
English: includes cough and productive cough.
Danish: i omfatter hoste og produktiv hoste.
English: Do not store any unused portion of the infusion solution for re-use.
Danish: Opbevar ikke ubrugt infusionsopløsning til senere brug.
English: PD-L1 can be induced by inflammatory signals (e.g., IFN-gamma) and can be expressed on both tumour cells and tumour-associated immune cells in tumour microenvironment.
Danish: PD-L1 kan induceres af inflammatoriske signaler (f.eks. IFN-gamma) og kan udtrykkes på både tumorceller og tumor-associerede immunceller i tumor-mikromiljø.
English: Within each system organ class, the adverse drug reactions are presented in decreasing frequency.
Danish: Inden for hver systemorganklasse præsenteres bivirkningerne med faldende frekvens.
English: The recommended dose is 10 mg of durvalumab per kilogram of your body weight.
Danish: Den anbefalede dosis er 10 mg durvalumab pr. kilo legemsvægt.