FrancophonIA/ELRC3.0 huggingface dataset:
English: PD-L1 is found on the surface of certain tumour cells, and helps protect them from the immune system (the body's natural defences).
Danish: PD-L1 findes på overfladen af visse tumorceller, og hjælper med at beskytte dem mod immunsystemet (kroppens naturlige forsvar).
English: • The card should also prompt to enter contact details of the physician and include a warning message for healthcare professionals treating the patient at any time, including in conditions of emergency, that the patient is using Bavencio.
Danish: • Kortet skal også indeholde instruktioner i at indtaste kontaktinformation for lægen samt en advarsel til læger og sundhedspersonale, der til enhver tid behandler patienterne, herunder i nødstilfælde, om at patienten bruger Bavencio.
English: Any partially used or empty vials have to be discarded.
Danish: Alle delvist brugte eller tomme hætteglas skal bortskaffes.
English: Do not stop treatment with Bavencio unless you have discussed this with your doctor.
Danish: Du må ikke holde op med behandlingen med Bavencio, medmindre du har diskuteret det med lægen.
English: • Do not co-administer other medicinal products through the same intravenous line.
Danish: • Må ikke administreres sammen med andre lægemidler i den samme intravenøse slange.
English: Although there was no clear dose-response relationship, it cannot be excluded that this finding was related to avelumab treatment.
Danish: Selvom der ikke var noget klart forhold mellem dosis og respons, kan det ikke udelukkes, at dette fund var relateret til avelumab-behandlingen.
English: It is important that you also read the package leaflet for the medicine containing axitinib.
Danish: Det er vigtigt, at du også læser indlægssedlen for lægemidlet, der indeholder axitinib.
English: Three patients were reported to be overdosed with 5% to 10% above the recommended dose of avelumab.
Danish: Tre patienter blev overdoseret med 5 % til 10 % over den anbefalede dosis avelumab.
English: If you experience any of these symptoms when taking Bavencio do not try to treat them on your own with other medicines.
Danish: Hvis du oplever nogle af disse symptomer, mens du bliver behandlet med Bavencio, må du ikke forsøge at behandle dem selv med andre lægemidler.
English: For Part A, an efficacy analysis was conducted in all 88 patients after a minimum follow-up of 36 months.
Danish: En analyse af effekten for del A blev udført hos alle 88 patienter efter en minimumsopfølgning på 36 måneder.
English: The patient educational material should contain
Danish: Uddannelsesmaterialet til patienten skal indeholde
English: • Warning message for patients on the importance of consulting their doctor immediately in case they develop any of the listed signs and symptoms and on the important not attempting to treat themselves.
Danish: • En advarsel til patienterne om vigtigheden af straks at kontakte lægen, hvis de udvikler nogle af de angivne tegn og symptomer, samt om vigtigheden af ikke at forsøge at behandle sig selv.
English: Bavencio acts on your immune system and may cause inflammation in parts of your body (see section 2).
Danish: Bavencio påvirker dit immunsystem, og kan forårsage betændelse i dele af din krop (se punkt 2).
English: What you need to know before you use Bavencio Do not use Bavencio if you are allergic to avelumab or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal du vide, før du begynder at bruge Bavencio Brug ikke Bavencio hvis du er allergisk over for avelumab eller et af de øvrige indholdsstoffer i Bavencio (angivet i punkt 6).
English: Chemical and physical in-use stability of the diluted solution has been demonstrated for 24 hours at 20°C to 25°C and room light.
Danish: Der er blevet påvist kemisk og fysisk stabilitet under brug af den fortyndede opløsning i 24 timer ved 20 °C til 25 °C og under normale lysforhold.
English: The solution pH is in the range of 5.0 - 5.6 and the osmolality is between 270 and 330 mOsm/kg.
Danish: Opløsningens pH er i intervallet fra 5,0 til 5,6, og osmolaliteten er fra 270 til 330 mOsm/kg.
English: Bavencio will be added to an infusion bag containing a sodium chloride solution before use.
Danish: Bavencio vil blive tilsat i en infusionspose, som indeholder en natriumchloridopløsning inden brug.
English: This removes the suppressive effects of PD-L1 on cytotoxic CD8+ T-cells, resulting in the restoration of anti-tumour T-cell responses.
Danish: Dette fjerner de undertrykkende virkninger af PD-L1 på cytotoksiske CD8+ T-celler, hvilket fører til genetablering af T-celle antitumorresponset.
English: The clinical utility of PD-L1 as a predictive biomarker in MCC has not been established.
Danish: Den kliniske anvendelighed af PD-L1 som en prædiktiv biomarkør ved MCC er ikke klarlagt.
English: If the fourth infusion is completed without an infusion-related reaction, premedication for subsequent doses should be administered at the discretion of the physician.
Danish: Hvis den 4. infusion gennemføres uden en infusionsrelateret reaktion, skal præmedicin for efterfølgende doser administreres efter lægens skøn.
English: Do not drive or use machines after you have received Bavencio if you are not feeling well enough.
Danish: Du må ikke føre motorkøretøj eller betjene maskiner, efter du har fået Bavencio, hvis du ikke har det godt nok.
English: Many of the male monkeys used in these studies were sexually immature and thus no explicit conclusions regarding effects on male reproductive organs can be made.
Danish: Mange af hanaberne, der blev anvendt i disse studier, var ikke kønsmodne, og derfor kan der ikke konkluderes noget klart vedrørende virkningerne på de mandlige reproduktionsorganer.
English: • Reminder to carry the Patient Alert Card at all times and to show it to all healthcare professionals that may treat them.
Danish: • En påmindelse om at have patientinformationskortet med hele tiden, og vise det til læger og sundhedspersonale, der evt. behandler dem.
English: Bavencio has a low sodium content
Danish: Bavencio har et lavt natriumindhold
English: For instructions on the preparation and administration of the medicinal product, see section 6.6.
Danish: For instruktioner om forberedelse og administration af lægemidlet, se pkt.
English: Neuropathy peripheral
Danish: Perifer neuropati
English: The elimination half-life (t½) at the recommended dose is 6.1 days based on the population PK analysis.
Danish: Eliminationshalveringstiden (t½) ved den anbefalede dosis er 6,1 dag, baseret på en populationsfarmakokinetisk analyse.
English: Avelumab is primarily metabolised through catabolic pathways, therefore, it is not expected that avelumab will have pharmacokinetic drug-drug interactions with other medicinal products.
Danish: Avelumab metaboliseres primært katabolisk, derfor forventes det ikke, at avelumab vil have farmakokinetiske lægemiddelinteraktioner med andre lægemidler.
English: • withhold the next dose of Bavencio,
Danish: • tilbageholde den næste dosis Bavencio,
English: Sodium hydroxide Water for injections
Danish: Natriumhydroxid Vand til injektionsvæsker
English: It is not recommended to use avelumab during pregnancy unless the clinical condition of the woman requires treatment with avelumab.
Danish: Avelumab bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med avelumab.
English: There was no evidence to suggest a clinically relevant change of avelumab clearance over time in patients with advanced RCC.
Danish: Der var ikke nogen evidens, der tydede på en klinisk relevant ændring af avelumab-clearance med tiden hos patienter med fremskredent RCC.
English: Prior to launch of Bavencio in each Member State the marketing authorisation holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Før Bavencio markedsføres i hvert medlemsland skal indehaveren af markedsføringstilladelsen nå til enighed med den nationale kompetente myndighed om indholdet og formatet af uddannelsesprogrammet, herunder kommunikationsmedier, udleveringskanaler samt alle andre aspekter af programmet.
English: Patients have to be premedicated with an antihistamine and with paracetamol prior to the first 4 infusions of Bavencio.
Danish: Patienterne skal præmedicineres med et antihistamin, og med paracetamol før de første 4 infusioner af Bavencio.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: The patients had no symptoms, did not require any treatment for the overdose, and continued on avelumab therapy.
Danish: Patienterne havde ingen symptomer, havde ikke behov for behandling for overdoseringen, og fortsatte behandlingen med avelumab.
English: For at least the first 4 treatments, you will receive paracetamol and an antihistamine before being given Bavencio, to help to prevent possible side effects related to the infusion.
Danish: I det mindste for de første 4 behandlinger, vil du få paracetamol og et antihistamin, før du får Bavencio for at hjælpe med at forebygge mulige bivirkninger relateret til infusionen.
English: The active substance is avelumab.
Danish: Aktivt stof: avelumab.
English: Overall, there was no evidence of altered pharmacokinetic profile, increased incidence of infusion reactions or effects on efficacy with anti-avelumab antibody development.
Danish: Samlet var der ikke evidens for en ændret farmakokinetisk profil, en øget forekomst af infusionsreaktioner eller påvirkning af virkningen med anti-avelumab-antistofudvikling.
English: Table 1: Guidelines for withholding or discontinuation of Bavencio Treatment-related adverse reaction
Danish: Tabel 1: Retningslinjer for at afbryde eller seponere Bavencio Behandlingsrelateret bivirkning
English: Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of avelumab (see “Description of selected adverse reactions” below).
Danish: De fleste af disse, herunder svære reaktioner, gik væk, efter at der blev påbegyndt passende medicinsk behandling, eller efter at avelumab blev seponeret (se ”Beskrivelse af udvalgte bivirkninger” nedenfor).
English: Patients should be monitored for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders.
Danish: Patienterne skal overvåges for ændringer af tyreoideafunktionen (ved behandlingsstart, periodisk i løbet af behandlingen og som indiceret baseret på klinisk evaluering), og for kliniske tegn og symptomer på tyreoideasygdomme.
English: • Merkel cell carcinoma (MCC), a rare type of skin cancer, when it is metastatic (has spread to other parts of the body).
Danish: • Merkelcellekarcinom (MCC), en sjælden form for hudkræft, når det er metastatisk (har spredt sig til andre dele af kroppen).
English: In the remaining 1.4% (6/439) of patients, infusion-related reactions occurred after the first 4 infusions and all were of Grade 1 or Grade 2.
Danish: Hos de resterende 1,4 % (6/439) af patienterne opstod infusionsrelaterede reaktioner efter de første 4 infusioner, og alle var grad 1 eller grad 2.
English: Forty-seven (53%) of the patients had visceral metastases.
Danish: 47 (53 %) af patienterne havde viscerale metastaser.
English: Store in a refrigerator (2°C to 8°C).
Danish: Opbevares i køleskab (2 °C til 8 °C).
English: If no improvement within 24 hours on corticosteroids, additional immunosuppression (e.g., mycophenolate, infliximab, anti-thymocyte globulin) should be considered.
Danish: Hvis der ikke ses nogen forbedring i løbet af 24 timer med kortikosteroider, skal yderligere immunsuppression (f.eks. mycophenolat, infliximab, anti-thymocytglobulin) overvejes.
English: It is unknown whether avelumab is excreted in human milk.
Danish: Det er ukendt, om avelumab udskilles i human mælk.
English: Serum creatinine more than 6 times ULN Permanently discontinue
Danish: Serumkreatinin på over 6 gange ULN Seponer permanent
English: It is very important for you to keep all your appointments to receive Bavencio.
Danish: Det er meget vigtigt, at du overholder alle dine aftaler for behandling med Bavencio.
English: Axitinib could be interrupted or reduced to 3 mg twice daily and subsequently to 2 mg twice daily to manage toxicity.
Danish: Axitinib kunne afbrydes eller reduceres til 3 mg to gange dagligt og efterfølgende til 2 mg to gange dagligt for at håndtere toksicitet.
English: PD-L1 expression at cut-off of 1%
Danish: PD-L-ekspression ved cut-off på 1 %
English: Patients were included irrespective of prognostic risk groups or tumour PD-L1 expression and had to have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 that was not been previously irradiated.
Danish: Patienter blev inkluderet uanset prognostiske risikogrupper eller ekspression af tumor-PD-L1, og skulle have mindst en målbar læsion, defineret ved Response Evaluation Criteria in Solid Tumours (RECIST)-version 1.1, som ikke tidligere var blevet bestrålet.
English: • Grade 2 or Grade 3 clinical signs or symptoms of an immune-related adverse reaction not described above.
Danish: • Grad 2 eller grad 3 kliniske tegn eller symptomer på en immunrelateret bivirkning, der ikke er beskrevet ovenfor.
English: Bavencio binds to PD-L1, and blocks this protective effect, allowing the immune system to attack the tumour cells.
Danish: Bavencio binder sig til PD-L1, og blokerer denne beskyttende effekt, hvilket giver immunsystemet mulighed for at angribe tumorcellerne.
English: Dosing delay or discontinuation may be required based on individual safety and tolerability; see Table 1.
Danish: Det kan være nødvendigt at udsætte eller afbryde behandlingen, baseret på individuel sikkerhed og tolerabilitet.
English: PD-L1 expression at cut-off of 5%
Danish: PD-L1-ekspression ved cut-off på 5 %
English: Women of childbearing potential/Contraception
Danish: Kvinder i den fertile alder/kontraception
English: Confirmed pancreatitis
Danish: Bekræftet pankreatitis
English: Serum creatinine more than 1.5 and up to 6 times ULN
Danish: Serumkreatinin over 1,5 og op til 6 gange ULN
English: Additional secondary endpoints included objective response (OR), time to response (TTR) and duration of response (DOR).
Danish: Yderligere sekundære endepunkter omfattede objektivt respons (OR), tid til respons (TTR) og varighed af respons (duration of response, DOR).
English: The MAH shall ensure that in each Member State where Bavencio is marketed, all patients/carers who are expected to use Bavencio have access to/are provided with the following educational package:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle patienter/plejere, som forventes at bruge Bavencio, i alle medlemslande, hvor Bavencio markedsføres, har adgang til/har fået følgende uddannelsespakke:
English: Hepatotoxicity (in combination with axitinib)
Danish: Hepatotoksicitet (i kombination med axitinib)
English: Most immune-related adverse reactions with avelumab were reversible and managed with temporary or permanent discontinuation of avelumab, administration of corticosteroids and/or supportive care.
Danish: De fleste immunrelaterede bivirkninger med avelumab var reversible, og blev behandlet med en midlertidig eller permanent seponering af avelumab, administration af kortikosteroider og/eller støttende behandling.
English: Grade 2 pneumonitis
Danish: Grad 2 pneumonitis
English: The observed hazard ratio (HR) for OS was 0.80 (95% CI: 0.616, 1.027) for avelumab in combination with axitinib compared to sunitinib.
Danish: Den observerede hazard ratio (HR) for OS var 0,80 (95 % CI: 0,616; 1,027) for avelumab i kombination med axitinib, sammenlignet med sunitinib.
English: • or stop your treatment with Bavencio altogether.
Danish: • eller stoppe behandlingen med Bavencio helt.
English: • you have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS);
Danish: • du har en infektion med human immundefektvirus (HIV), eller erhvervet immundefektsyndrom
English: The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy.
Danish: PD-1/PD-L1-mekanismen menes at være involveret i at opretholde tolerance over for fosteret i løbet af hele drægtighedsperioden.
English: Tiredness is a very common side effect of Bavencio and can affect your ability to drive or to use machines.
Danish: Træthed er en meget almindelig bivirkning ved Bavencio, og det kan påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: The safety and efficacy of Bavencio in children and adolescents below 18 years of age have not been established.
Danish: Pædiatrisk population Bavencios sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Twenty-two out of 29 (76%) patients with response were reported to have responded within 7 weeks after the first dose of avelumab.
Danish: Toogtyve ud af 29 (76 %) responderende patienter havde respons inden for 7 uger efter den første dosis avelumab.
English: Part B included patients with histologically confirmed metastatic MCC who were treatment-naïve to systemic therapy in the metastatic setting.
Danish: Del B inkluderede patienter med histologisk bekræftet metastatisk MCC, som var behandlingsnaive med hensyn til systemisk behandling af metastatisk sygdom.
English: Administration of avelumab and axitinib was permitted beyond RECIST-defined disease progression based on investigator's assessment of the patient's benefit-risk and clinical condition, including performance status, clinical symptoms, adverse events and laboratory data.
Danish: Administration af avelumab og axitinib var tilladt efter den RECIST-definerede sygdomsprogression, baseret på investigatorens vurdering af patientens benefit/risk-forhold og kliniske tilstand, herunder præstationsstatus, kliniske symptomer, uønskede hændelser og laboratoriedata.
English: • Life threatening or Grade 4 adverse reaction (excluding endocrinopathies controlled with hormone replacement therapy)
Danish: • Livstruende eller grad 4 bivirkning (undtagen endokrinopatier, kontrolleret med hormonbehandling)
English: Of these patients, none experienced immune-related pneumonitis Grade ≥ 3.
Danish: Ud af disse patienter oplevede ingen immunrelateret pneumonitis grad ≥ 3.
English: In patients, whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants may be considered.
Danish: Hos patienter, hvor de immunrelaterede bivirkninger ikke kan kontrolleres med kortikosteroider, kan det overvejes at administrere andre systemiske immunsuppressive midler.
English: The Patient Information brochure shall contain the following key messages:
Danish: Brochuren med patientinformation skal indeholde de følgende nøglebeskeder:
English: • Persistent Grade 2 or Grade 3 immune-mediate adverse reactions lasting 12 weeks or longer
Danish: • Vedvarende grad 2 eller grad 3 immunmedierede bivirkninger, der varer 12 uger eller længere
English: It is unknown if Bavencio passes into your breast milk.
Danish: Det er ukendt, om Bavencio udskilles i brystmælken.
English: Therefore, avelumab has the potential to be transmitted from the mother to the developing foetus.
Danish: Der er derfor risiko for, at avelumab kan transmitteres fra moderen til det udviklende foster.
English: Human IgG1 immunoglobulins are known to cross the placental barrier.
Danish: Humane IgG1-immunoglobuliner vides at krydse placentabarrieren.
English: Steady-state exposure was approximately uniform over a wide range of body weights (30 to 204 kg) for body weight normalised dosing.
Danish: Steady-state-eksponeringen var ca. uniform over en bredt legemsvægtsinterval (30-204 kg) for den legemsvægtnormaliserede dosering.
English: Figure 2 presents the Kaplan-Meier curve for PFS from the subsequent interim analysis with 116 patients enrolled into Part B with a minimum follow-up of 7 months.
Danish: Figur 2 angiver Kaplan-Meier-kurven for PFS fra den efterfølgende interimanalyse med de 116 patienter, der indgik i del B med en minimumsopfølgning på 7 måneder.
English: For Part B, the major efficacy outcome measure was durable response, defined as objective response (complete response (CR) or partial response (PR)) with a duration of at least 6 months; secondary outcome measures included BOR, DOR, PFS, and OS.
Danish: Det primære endepunkt for effekt for del B var respons varighed, defineret som objektivt respons (komplet respons (CR) eller partielt respons (PR)) med en varighed på mindst 6 måneder; sekundære effekt endepunkter omfattede BOR, DOR, PFS og OS.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD-list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Patients received avelumab at a dose of 10 mg/kg every 2 weeks until disease progression or unacceptable toxicity.
Danish: Patienterne fik avelumab med en dosis på 10 mg/kg hver 2. uge indtil sygdomsprogression eller uacceptabel toksicitet.
English: Patients who tolerated axitinib 5 mg twice daily without Grade 2 or greater axitinib-related adverse events for 2 consecutive weeks could increase to 7 mg and then subsequently to 10 mg twice daily.
Danish: Patienter, som tolererede axitinib 5 mg to gange dagligt uden axitinibrelaterede uønskede hændelser af grad 2 eller derover i 2 på hinanden følgende uger, kunne øge dosis til 7 mg og efterfølgende til 10 mg to gange dagligt.
English: • Swelling in the arms, feet or legs
Danish: • Hævelse i arme, fødder eller ben
English: The most common Grade ≥ 3 adverse reactions were anaemia (6.0%), dyspnoea (3.9%), and abdominal pain (3.0%).
Danish: De mest almindelige grad ≥ 3 bivirkninger var anæmi (6,0 %), dyspnø (3,9 %) og abdominalsmerter (3,0 %).
English: Treatment with avelumab should be resumed when metabolic control is achieved on insulin replacement therapy.
Danish: Behandlingen med avelumab bør genoptages, når der er opnået metabolisk kontrol med insulinbehandling.
English: Autoimmune thyroiditis, hypophysitis
Danish: Autoimmun tyroiditis, hypofysitis
English: In 1-month and 3-month repeat-dose toxicology studies in monkeys, there were no notable effects in the female reproductive organs.
Danish: I 1-måneds og 3-måneders toksikologistudier med gentagne doser hos aber, var der ingen bemærkelsesværdig virkning på de hunlige reproduktionsorganer.
English: The median time to response was 6 weeks (range: 6 weeks to 36 weeks) after the first dose of avelumab.
Danish: Mediantiden til respons var 6 uger (interval: 6 uger til 36 uger) efter den første dosis avelumab.
English: Steady-state concentrations of avelumab were reached after approximately 4 to 6 weeks (2 to 3 cycles) of repeated dosing at 10 mg/kg every 2 weeks, and systemic accumulation was approximately 1.25-fold.
Danish: Steady-state-koncentrationen af avelumab blev nået efter ca. 4 til 6 uger (2 til 3 cyklusser) med en gentagen dosering på 10 mg/kg hver 2. uge, og den systemiske akkumulation var ca. 1,25 gange.
English: The Kaplan-Meier curve of PFS of the 88 patients (Part A) with metastatic MCC is presented in Figure 1.
Danish: Kaplan-Meier-kurven over PFS for de 88 patienter (del A) med metastatisk MCC er angivet i figur 1.
English: • Feeling tired or weak
Danish: • Følelse af træthed eller svaghed
English: The efficacy and safety of avelumab was investigated in the study EMR100070-003 with two parts.
Danish: Avelumabs virkning og sikkerhed blev undersøgt i studie EMR100070-003 med to dele.