FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity in Cynomolgus monkeys administered intravenously doses of 20, 60 or 140 mg/kg once a week for1 month and 3 months, followed by a 2-month recovery period after the 3-month dosing period.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser hos Cynomolgus-aber, der fik administreret intravenøse doser af 20, 60 eller 140 mg/kg én gang ugentligt i 1 måned og 3 måneder, efterfulgt af en 2-måneders rekonvalescensperiode efter 3-måneders doseringsperioden.
English: Pharmacotherapeutic group: Other antineoplastic agents, monoclonal antibodies, ATC code: L01XC31.
Danish: Farmakoterapeutisk klassifikation: Andre antineoplastiske stoffer, monoklonale antistoffer, ATCkode: L01XC31.
English: • Sunitinib 50 mg once daily orally for 4 weeks followed by 2 weeks off (N=444) until radiographic or clinical progression or unacceptable toxicity.
Danish: • Sunitinib 50 mg en gang dagligt oralt i 4 uger, efterfulgt af 2 uger uden (N = 444) indtil radiografisk eller klinisk progression eller uacceptabel toksicitet.
English: Treatment with avelumab and axitinib continued until RECIST v1.1-defined progression of disease by Blinded Independent Central Review (BICR) assessment or unacceptable toxicity.
Danish: Behandling med avelumab og axitinib fortsatte indtil RECIST v1.1-defineret sygdomsprogression i henhold til vurdering fra en blindet uafhængig central bedømmelse (blinded independent central review, BICR) eller uacceptabel toksicitet.
English: In ADA positive patients, there may be an increased risk for infusion-related reactions (about 40% and 25% in ADA ever-positive and ADA never-positive patients, respectively).
Danish: Hos ADA-positive patienter kan der være en øget risiko for infusionsrelaterede reaktioner (ca. 40 % og 25 % hos hhv. ADA-altid-positive og ADA-aldrig-positive patienter).
English: Patient distribution by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk groups was 21% favourable, 62% intermediate, and 16% poor.
Danish: Patientfordelingens risikogrupper ifølge International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) var 21 % favorabel, 62 % intermediær og 16 % dårlig.
English: Renal cell carcinoma (study B9991003)
Danish: Renalcellekarcinom (studie B9991003)
English: Patients should be monitored for elevated serum creatinine prior to and periodically during treatment.
Danish: Patienterne skal overvåges for øget serumkreatinin før behandlingen, og periodisk under behandlingen.
English: Avelumab has also shown to induce natural killer (NK) cell-mediated direct tumour cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC).
Danish: Avelumab har også vist sig at inducere naturel killer celler (NK) direkte tumorcellelyse via antistofafhængig cellemedieret cytotoksicitet (antibody-dependent cell mediated cytotoxicity, ADCC).
English: Package leaflet: Information for the patient Bavencio 20 mg/mL concentrate for solution for infusion avelumab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Bavencio 20 mg/ml koncentrat til infusionsvæske, opløsning avelumab Dette lægemiddel er underlagt supplerende overvågning.
English: Hazard ratio (95% CI) p-value*
Danish: Hazard ratio (95 % CI) p-værdi*
English: The recommended dose of avelumab is 800 mg every 2 weeks.
Danish: Den anbefalede dosis af avelumab er 800 mg hver 2. uge.
English: The median duration of response was not estimable (95% CI: 4 months, not estimable) with a minimum of 1.2 months to a maximum of 8.3 months duration.
Danish: Den mediane varighed for responset kunne ikke estimeres (95 % CI: 4 måneder, kunne ikke estimeres) med en varighed på minimum 1,2 måneder til maksimum 8,3 måneder.
English: If you get any side effects, talk to your doctor.
Danish: Hvis du oplever bivirkninger bør du tale med din læge.
English: For Grade 1 infusion-related reactions, the infusion rate should be slowed by 50% for the current infusion.
Danish: Ved infusionsrelaterede reaktioner af grad 1 skal infusionshastigheden nedsættes med 50 % for den aktuelle infusion.
English: • Numbness, tingling, weakness, burning sensation in arms or legs
Danish: • Følelsesløshed, prikkende fornemmelse, svaghed, brændende fornemmelse i arme eller ben
English: • The diluted solution should be mixed by gently inverting the bag in order to avoid foaming or excessive shearing of the solution.
Danish: • Den fortyndede opløsning blandes ved at vende posen forsigtigt på hovedet for at undgå skumdannelse eller for kraftig rystning af opløsningen.
English: • Type 1 diabetes, including acid in the blood produced from diabetes (diabetic ketoacidosis);
Danish: • Type 1 diabetes, herunder syre i blodet fra sukkersyge (diabetisk ketoacidose),
English: If persistent (greater than 5 days), corticosteroid therapy with prednisone or equivalent followed by a taper should be considered.
Danish: Hvis vedvarende (længere end 5 dage), skal kortikosteroidbehandling med prednison eller lignende overvejes, efterfulgt af en nedtrapning.
English: Do not breast-feed while receiving Bavencio and for at least 1 month after your last dose.
Danish: Du må ikke amme, mens du får Bavencio, og i mindst 1 måned efter din sidste dosis.
English: The exposure of avelumab increased dose-proportionally in the dose range of 10 mg/kg to 20 mg/kg every 2 weeks.
Danish: Eksponeringen af avelumab blev øget dosisproportionalt i dosisområdet på 10 mg/kg til 20 mg/kg hver 2. uge.
English: IHC: Immunohistochemistry; MCV: Merkel cell polyomavirus; ORR: objective response rate a Based on data from patients evaluable for PD-L1 b Based on data from patients evaluable for MCV by immunohistochemistry (IHC)
Danish: IHC: Immunhistokemi; MCV: Merkelcelle-polyomavirus; ORR: objektiv responsrate a Baseret på data fra patienter, som kunne evalueres for PD-L1 b Baseret på data fra patienter, som kunne evalueres for MCV med immunhistokemi (IHC)
English: The primary efficacy endpoints were progression-free survival (PFS), as assessed by BICR using RECIST v1.1 and overall survival (OS) in the first-line treatment of patients with advanced RCC who have PD-L1-positive tumours (PD-L1 expression level ≥ 1%).
Danish: De primære endepunkter for virkning var progressionsfri overlevelse (progression-free survival, PFS), evalueret ved BICR ved brug af RECIST v1.1 og samlet overlevelse (overall survival, OS) ved førstevalgsbehandling af patienter med fremskredent RCC, som har PD-L1-positive tumorer (PD-L1ekspressionsniveau ≥ 1 %).
English: Patients should be more frequently monitored for changes in liver function and symptoms as compared to when avelumab is used as monotherapy.
Danish: Patienterne skal overvåges hyppigere for ændringer af leverfunktionen og symptomer, sammenlignet med når avelumab anvendes som monoterapi.
English: • Guillain-Barré Syndrome (an immune system disorder that causes nerve inflammation and can result in pain, numbness, muscle weakness and difficulty walking)
Danish: • Guillain-Barrés syndrom (en sygdom i immunsystemet, der kan forårsage nervebetændelse og føre til smerter, svaghed, muskelsvaghed og gangbesvær)
English: In symptomatic patients, obtain cardiologic consultation and laboratory investigations to ensure the initiation of appropriate measures at an early stage.
Danish: Hos symptomatiske patienter skal der udføres en kardiologisk konsultation og laboratorieundersøgelser for at sikre, at de relevante behandlinger påbegyndes på et tidligt stadie.
English: From a microbiological point of view, once opened, the medicinal product should be diluted and infused immediately.
Danish: Fra et mikrobiologisk synspunkt bør lægemidlet fortyndes og straks infunderes umiddelbart efter anbrud.
English: Type 1 diabetes mellitus did not resolve in any of the patients at the time of data cut-off.
Danish: Type 1 diabetes mellitus gik ikke væk hos nogen af patienterne på tidspunktet for data cut-off.
English: Tumour response assessments were performed every 6 weeks, as assessed by an Independent Endpoint Review Committee (IERC) using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Danish: Vurderingen af tumorresponset blev udført hver 6. uge af en uafhængig komité, der gennemgik endepunkterne (Independent Endpoint Review Committee, IERC) ved hjælp af evalueringskriterier for respons i solide tumorer (Response Evaluation Criteria in Solid Tumours, RECIST) v1.1.
English: The Patient Alert Card shall contain the following key messages:
Danish: Patientinformationskortet skal indeholde de følgende nøglebeskeder:
English: Thyroid disorders (hypothyroidism/hyperthyroidism) Thyroid disorders can occur at any time during treatment (see section 4.8).
Danish: Tyreoideasygdomme (hypotyroidisme/hypertyroidisme) Tyreoideasygdomme kan opstå på alle tidspunkter under behandlingen (se pkt.
English: Each mL of concentrate contains 20 mg of avelumab.
Danish: Hver ml koncentrat indeholder 20 mg avelumab.
English: One vial of 10 mL contains 200 mg of avelumab.
Danish: Et hætteglas på 10 ml indeholder 200 mg avelumab.
English: Avelumab should be withheld and antihyperglycaemics in patients with Grade ≥ 3 hyperglycaemia should be administered.
Danish: Avelumab bør afbrydes, og der bør administreres anti-hyperglykæmika til patienter med grad ≥ 3 hyperglykæmi.
English: Drug eruption, erythema multiforme, psoriasis
Danish: Lægemiddeludslæt, erythema multiforme, psoriasis
English: Patient distribution by Memorial Sloan-Kettering Cancer Center (MSKCC) risk groups was 22% favourable, 65% intermediate, and 11% poor.
Danish: Patientfordelingens risikogrupper ifølge Memorial Sloan-Kettering Cancer Center (MSKCC) var 22 % favorabel, 65 % intermediær og 11 % dårlig.
English: The key secondary endpoints were PFS based on BICR assessment per RECIST v1.1 and OS irrespective of PD-L1 expression.
Danish: De vigtigste sekundære endepunkter var PFS baseret på BICRbedømmelse i henhold til RECIST v1.1 og OS uanset PD-L1-ekspression.
English: Tubulo-interstitial nephritis*
Danish: Ikke almindelig Tubulointerstitiel nefritis*
English: Contents of the pack and other information What Bavencio contains
Danish: Pakningsstørrelser og yderligere oplysninger Bavencio indeholder:
English: Bavencio contains the active substance avelumab, a monoclonal antibody (a type of protein) that attaches to a specific target in the body called PD-L1.
Danish: Bavencio indeholder det aktive stof avelumab, et monoklonalt antistof (en form for protein), som binder sig til et specifikt mål i kroppen kaldet PD-L1.
English: • inflammation of your heart (myocarditis);
Danish: • betændelse i hjertet (myokarditis),
English: Merkel cell carcinoma (study EMR100070-003)
Danish: Merkelcellekarcinom (studie EMR100070-003)
English: In patients with ALT ≥ 3 times ULN (Grades 2-4, n=82), ALT resolved to Grades 0-1 in 92%.
Danish: Hos patienter med ALAT ≥ 3 gange ULN (grad 2-4, n = 82) bedredes ALAT til grad 0-1 hos 92 %.
English: Duration of response (DOR)
Danish: Varighed af respons (duration of response, DOR)
English: Table 3: Adverse reactions in patients treated with avelumab in combination with axitinib in clinical studies B9991002 and B9991003
Danish: Tabel 3: Bivirkninger hos patienter i behandling med avelumab i kombination med axitinib i klinisk studie B9991002 og B9991003
English: In case of recurrence of Grade 1 or Grade 2 infusion-related reaction, the patient may continue to receive avelumab under close monitoring, after appropriate infusion rate modification and premedication with paracetamol and antihistamine (see section 4.2).
Danish: I tilfælde af tilbagevendende grad 1 eller grad 2 infusionsrelateret reaktion, kan patienten fortsætte med at få avelumab under nøje overvågning, efter passende modifikation af infusionshastigheden og præmedicinering med paracetamol og antihistamin (se pkt.
English: The efficacy and safety of avelumab in combination with axitinib was demonstrated in study B9991003, a randomised, multicentre, open-label study of avelumab in combination with axitinib in 886 patients with untreated advanced or metastatic RCC with a clear-cell component.
Danish: Avelumabs virkning og sikkerhed i kombination med axitinib blev vist i studie B9991003, et randomiseret, åbent multicenterstudie af avelumab i kombination med axitinib hos 886 patienter med ubehandlet fremskredent eller metastatisk RCC med en clear cell-komponent.
English: • Avelumab 10 mg/kg intravenous infusion every 2 weeks in combination with axitinib 5 mg twice daily orally (N=442).
Danish: • Avelumab 10 mg/kg intravenøs infusion hver 2. uge i kombination med axitinib 5 mg to gange dagligt oralt (N = 442).
English: Bavencio is compatible with polyethylene, polypropylene, and ethylene vinyl acetate infusion bags, glass bottles, polyvinyl chloride infusion sets and in-line filters with polyethersulfone membranes with pore sizes of 0.2 micrometre.
Danish: Bavencio er kompatibelt med infusionsposer af polyethylen, polypropylen og ethylen-vinylacetat, glasflasker, infusionssæt af polyvinylchlorid og in-line-filtre med polyethersulfonmembraner med en porestørrelse på 0,2 mikrometer.
English: Avelumab is most frequently associated with immune-related adverse reactions.
Danish: Avelumab er hyppigst forbundet med immunrelaterede bivirkninger.
English: • Dryness in the mouth
Danish: • Tørhed i munden
English: In both studies, avelumab was administered at 10 mg/kg every 2 weeks.
Danish: I begge studier blev avelumab administreret med 10 mg/kg hver 2. uge.
English: • Feeling cold
Danish: • Kuldefølelse
English: Median, months (range)
Danish: Median, måneder (interval)
English: Part A was a single-arm, multi-centre study conducted in patients with histologically confirmed metastatic MCC, whose disease had progressed on or after chemotherapy administered for distant metastatic disease, with a life expectancy of more than 3 months.
Danish: Del A var et enkelarmet multicenter studie, hvor patienterne var diagnostiseret med histologisk bekræftet metastatisk MCC og sygdomsprogression under eller efter kemoterapi mod metastatisk sygdom, hvor den forventede levetid var over 3 måneder.
English: Inflammation may cause serious damage to your body and some inflammatory conditions may lead to death and need treatment or withdrawal of Bavencio.
Danish: Betændelsen kan forårsage alvorlige skader på kroppen, og nogle betændelsestilstande kan være livstruende og kræve behandling, eller det kan være nødvendigt at stoppe behandlingen med Bavencio.
English: In symptomatic patients, obtain gastroenterology consultation and laboratory investigations (including imaging) to ensure the initiation of appropriate measures at an early stage.
Danish: Hos symptomatiske patienter skal der udføres en gastroenterologikonsultation og laboratorieundersøgelser (herunder billeddannelse) for at sikre, at de relevante behandlinger pågyndes på et tidligt stadie.
English: Breast-feeding women should be advised not to breast-feed during treatment and for at least 1 month after the last dose due to the potential for serious adverse reactions in breast-fed infants.
Danish: Ammende kvinder bør rådes til ikke at amme under behandlingen, og i mindst 1 måned efter den sidste dosis, på grund af risikoen for alvorlige bivirkninger hos ammede spædbørn.
English: When avelumab 10 mg/kg was administered in combination with axitinib 5 mg, the respective exposures of avelumab and axitinib were unchanged compared to the single agents.
Danish: Når avelumab 10 mg/kg blev administreret i kombination med axitinib 5 mg, var de tilhørende eksponeringer for avelumab og axitinib uændrede, sammenlignet med enkeltstofferne.
English: In clinical trials, 98.6% (433/439) of patients with infusion-related reactions had a first infusion-related reaction during the first 4 infusions of which 2.7% (12/439) were Grade ≥ 3.
Danish: I kliniske studier havde 98,6 % (433/439) af patienterne med infusionsrelaterede reaktioner en første infusionsrelateret reaktion i løbet af de første 4 infusioner, hvoraf 2,7 % (12/439) var grad ≥ 3.
English: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 and up to 5 times upper limit of normal (ULN) or total bilirubin greater than 1.5 and up to 3 times ULN
Danish: Aspartataminotransferase (ASAT) eller alaninaminotransferase (ALAT) over 3 og op til 5 gange den øvre normalgrænse (upper limit of normal, ULN) eller totalt bilirubin over 1,5 og op til 3 gange ULN
English: • infusion-related reactions;
Danish: • infusionsrelaterede reaktioner,
English: Corticosteroids should be considered for Grade ≥ 2 events (see section 4.2).
Danish: Kortikosteroider bør overvejes for grad ≥ 2 hændelser (se pkt.
English: Avelumab has not been studied in patients with severe renal impairment (GFR 15 to 29 mL/min).
Danish: Avelumab er ikke blevet undersøgt hos patienter med svært nedsat nyrefunktion (GFR 15-29 ml/min).
English: • problems with your kidneys;
Danish: • problemer med nyrerne,
English: Avelumab has negligible influence on the ability to drive and use machines.
Danish: Avelumab påvirker i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Withhold until adverse reactions recover to Grade 0-1
Danish: Afbryd, indtil bivirkningerne bedres til grad 0-1
English: 10 mL of concentrate in a vial (Type I glass) with a halobutyl rubber stopper and an aluminium seal fitted with a removable plastic cap.
Danish: 10 ml koncentrat i et hætteglas (type I-glas) med en prop af halobutylgummi og en aluminiumsforsegling forsynet med et aftageligt plasticlåg.
English: Table 7: Efficacy results from study B9991003 in patients irrespective of PD-L1 expression Efficacy endpoints (Based on BICR assessment)
Danish: Tabel 7: Virkningsresultater fra studie B9991003 hos patienter uanset ekspression af PD-L1 Effekt endepunkter (Baseret på BICR-bedømmelse)
English: Avelumab binds PD-L1 and blocks the interaction between PD-L1 and the programmed death 1 (PD-1) and B7.1 receptors.
Danish: Avelumab binder sig til PD-L1 og blokerer påvirkningen mellem PD-L1 og receptorer for programmeret celledød 1 (PD-1) og B7.1.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
English: • problems due to inflammation of your lungs (pneumonitis);
Danish: • problemer på grund af betændelse i lungerne (pneumonitis),
English: Perivascular mononuclear cell cuffing was observed in the brain and spinal cord of monkeys treated with avelumab at ≥ 20 mg/kg for 3 months.
Danish: Der blev observeret perivaskulær mononuklær celle-infiltration i hjernen og rygsøjlen hos aber, der blev behandlet med avelumab ved ≥ 20 mg/kg i 3 måneder.
English: These results indicate a potential risk that administration of avelumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth.
Danish: Disse resultater indikerer en mulig risiko for, at administration af avelumab under graviditet kunne forårsage fosterskade, herunder en øget hyppighed for abort eller dødfødsel.
English: Although studies to evaluate the effect of avelumab on fertility have not been conducted, there were no notable effects in the female reproductive organs in monkeys based on 1-month and 3-month repeat-dose toxicity studies (see section 5.3).
Danish: Selvom der ikke er udført studier for at evaluere virkningen på fertilitet, var der ingen bemærkelsesværdig virkning i kønsorganerne hos hunaber, baseret på 1-måneds og 3-måneders toksicitetsstudier med gentagne doser (se pkt.
English: For renal cell cancer, Bavencio is to be used in combination with axitinib.
Danish: For renalcellekræft skal Bavencio anvendes i kombination med axitinib.
English: If you miss a dose of Bavencio
Danish: Hvis du glemmer en dosis Bavencio
English: • Renal cell carcinoma (RCC), a type of kidney cancer, when it is advanced (has spread beyond the kidney or to other parts of the body).
Danish: • Renalcellekarcinom (RCC), en type nyrekræft, når det er fremskredent (har spredt sig videre end nyrerne eller til andre dele af kroppen).
English: If you are a woman who could become pregnant, you must use effective contraceptives while you are being treated with Bavencio and for at least 1 month after your last dose.
Danish: Hvis du er en kvinde, som kan blive gravid, skal du bruge sikker prævention, mens du behandles med Bavencio, og i mindst 1 måned efter din sidste dosis.
English: Other immune-related adverse reactions (including myositis, hypopituitarism, uveitis, Guillain-Barré syndrome)
Danish: Andre immunrelaterede bivirkninger (herunder myositis, hypopituitarisme, uveitis, Guillain-Barrés syndrom)
English: Among the 73 patients who were rechallenged with either avelumab (59%) or axitinib (85%) monotherapy or with both (55%), 66% had no recurrence of ALT ≥ 3 times ULN.
Danish: Blandt de 73 patienter, hvor enten avelumab (59 %) eller axitinib (85 %) blev genstartet som monoterapi eller med begge (55 %) oplevede 66 % ingen tilbagevending til ALT ≥ 3 gange ULN.
English: Based on a population PK analysis for avelumab as monotherapy and in combination with axitinib, there are no expected clinically meaningful differences in exposure of avelumab between settings administered every 2 weeks at 800 mg or 10 mg/kg.
Danish: Baseret på en farmakokinetisk populationsanalyse for avelumab som monoterapi og i kombination med axitinib er der ingen forventede klinisk betydningfulde forskelle i eksponering for avelumab mellem administration hver 2. uge med 800 mg eller 10 mg/kg.
English: These results indicate a potential risk, based on its mechanism of action, that administration of avelumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth.
Danish: Disse resultater indikerer en mulig risiko, baseret på virkningsmekanismen, for at administration af avelumab under graviditet kan medføre fosterskade, herunder en øget hyppighed af aborter eller dødfødsler.
English: Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på hætteglassets etiket og æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Adverse reactions reported for 88 patients with metastatic MCC and for 1,650 patients in a phase I study in solid tumours are presented in Table 2.
Danish: Bivirkninger rapporteret for 88 patienter med metastatisk MCC samt for 1.650 patienter i et fase I-studie af solide tumorer vises i tabel 2.
English: Before you receive Bavencio
Danish: Før du får Bavencio
English: If you have any questions about axitinib, ask your doctor.
Danish: Spørg lægen, hvis du har spørgsmål om axitinib.
English: A population pharmacokinetic analysis suggested no difference in the total systemic clearance of avelumab based on age, gender, race, PD-L1 status, tumour burden, renal impairment and mild or moderate hepatic impairment.
Danish: En populationsfarmakokinetisk analyse tydede ikke på nogen forskel i den totale systemiske clearance af avelumab, baseret på alder, køn, race, PD-L1-status, tumorbyrde, nedsat nyrefunktion og let til moderat nedsat leverfunktion.
English: The recommended dose of Bavencio in combination with axitinib is 800 mg administered intravenously over 60 minutes every 2 weeks and axitinib 5 mg orally taken twice daily (12 hours apart) with or without food until disease progression or unacceptable toxicity.
Danish: Den anbefalede dosis af Bavencio i kombination med axitinib er 800 mg, administreret intravenøst over 60 minutter hver 2. uge, og axitinib 5 mg der tages oralt to gange dagligt (med 12 timers mellemrum) sammen med eller uden mad indtil sygdomsprogression eller uacceptabel toksicitet.
English: Patients received a median of 7 doses of avelumab (range: 1 dose to 95 doses), and the median duration of treatment was 17 weeks (range: 2 weeks to 208 weeks).
Danish: Patienterne fik en median på 7 doser avelumab (interval: 1 dosis til 95 doser), og den mediane behandlingsvarighed var 17 uger (interval: 2 uger til 208 uger).