FrancophonIA/ELRC3.0 huggingface dataset:
English: Study 1540 was a phase 2, open-label, multi-centre study that had enrolled 193 patients with mCSCC or laCSCC with a combined median follow-up time of 9.4 months total.
Danish: Studie 1540 var et åbent, fase-II multicenterstudie, der inkluderede 193 patienter med mCSCC eller laCSCC med en kombineret median opfølgningsperiode på i alt 9,4 måneder.
English: Clear to slightly opalescent, colourless to pale yellow solution with a pH of 6.0 and osmolality between 300 and 360 mmol/kg.
Danish: Klar til let opaliserende, farveløs til svagt gul opløsning med en pH-værdi på 6,0 og en osmolalitet på mellem 300 og 360 mmol/kg.
English: d. Myocarditis is a composite term that includes autoimmune myocarditis and myocarditis.
Danish: d. Myocarditis er en sammensat term, der omfatter autoimmun myocarditis og myocarditis.
English: No clinical data are available on the possible effects of cemiplimab on fertility.
Danish: Der foreligger ingen kliniske data om cemiplimabs mulige påvirkning af fertilitet.
English: The use of systemic corticosteroids or immunosuppressants before starting cemiplimab, except for physiological doses of systemic corticosteroid (≤10 mg/day prednisone or equivalent), should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of cemiplimab.
Danish: Anvendelse af systemiske kortikosteroider eller immunosuppressiva før opstart med cemiplimab, med undtagelse af fysiologiske doser af systemisk kortikosteroid (≤10 mg/dag prednison eller tilsvarende), bør undgås på grund af deres potentielle interaktion med cemiplimabs farmakodynamiske aktivitet og virkning.
English: Efficacy results for Study 1540 are presented in Table 3.
Danish: Effektresultater for Studie 1540 er vist i tabel 3.
English: The increase of spontaneous abortion and/or resorption in animals with restricted PD-L1 expression (knock-out or anti-PD1 / PD-L1 monoclonal antibodies) has been shown in both mice and monkeys.
Danish: En stigning i spontan abort og/eller resorption hos dyr med begrænset PD-L1-ekspression (knock-out eller anti-PD1 / PD-L1-monoklonale antistoffer) er vist i både mus og aber.
English: No clinically important differences in the exposure of cemiplimab were found between patients with renal impairment and patients with normal renal function.
Danish: Der blev ikke påvist klinisk betydningsfulde forskelle i eksponering for cemiplimab mellem patienter med nedsat nyrefunktion og patienter med normal nyrefunktion.
English: Among patients with mCSCC, 76.5% had distant metastases, and 22.6% had only nodal metastases.
Danish: Blandt patienterne med mCSCC havde 76,5 % fjernmetastaser, og 22,6 % havde kun lymfemetastaser.
English: There was no evidence of an altered pharmacokinetic or safety profile with anti-cemiplimab antibody development.
Danish: Der sås ingen tegn på ændringer i den farmakokinetiske profil eller i sikkerhedsprofilen med udvikling af anti-cemiplimab-antistof.
English: The MAH should investigate biomarkers in order to confirm that PD-L1 expression is not predictive of efficacy.
Danish: Indehaveren af markedsføringstilladelsen skal undersøge biomarkører for at bekræfte, at PD-L1-ekspression ikke er en prædiktiv faktor for virkning.
English: If you miss an appointment
Danish: Hvis du har glemt en behandling
English: In Study 1540, patients received cemiplimab until progression of disease, unacceptable toxicity or completion of planned treatment [3 mg/kg every 2 weeks for 96 weeks or 350 mg every 3 weeks for 54 weeks].
Danish: I Studie 1540 fik patienterne cemiplimab indtil sygdomsprogression, uacceptabel toksicitet eller afslutning af den planlagte behandling [3 mg/kg hver 2. uge i 96 uger eller 350 mg hver 3. uge i 54 uger].
English: Hyperthyroidism should be managed according to standard medical practice (see section 4.2).
Danish: Hyperthyreoidisme bør håndteres i henhold til medicinsk standardpraksis (se pkt.
English: Preparation and administration
Danish: Klargøring og administration
English: Initiate treatment with anti-hyperglycaemics as clinically indicated
Danish: Initiér behandling med antihyperglykæmika som klinisk indiceret
English: From time of preparation by diluting in an intravenous bag, LIBTAYO can be stored before use for no more than 8 hours at temperatures up to 25°C, and no more than 24 hours in a refrigerator (2°C to 8°C).
Danish: Efter fortynding i en intravenøs infusionspose kan LIBTAYO inden anvendelse opbevares i højst 8 timer ved op til 25°C og i højst 24 timer i køleskab (2°C - 8°C).
English: b Observed with LIBTAYO or with other anti-PD-1/PD-L1 monoclonal antibodies
Danish: Observeret med LIBTAYO eller med andre monoklonale anti-PD-1-/anti-PD-L1-antistoffer
English: • diarrhoea (loose stools).
Danish: • diarré (løs afføring).
English: No dose adjustment is recommended for elderly patients.
Danish: Der er ikke behov for dosisjustering til ældre patienter.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: In patients with mild hepatic impairment (n= 5) (total bilirubin [TB] greater than 1.0 to 1.5 times the upper limit of normal [ULN] and any aspartate aminotransferase [AST]); no clinically important differences in the exposure of cemiplimab were found compared to patients with normal hepatic function.
Danish: Hos patienter med let nedsat leverfunktion (n= 5) (total bilirubin [TB] højere end 1,0 til 1,5 gange den øvre normalværdi [ULN] og enhver aspartataminotransferase [ASAT]) blev der ikke påvist nogen klinisk betydningsfulde forskelle i eksponering for cemiplimab sammenlignet med patienter med normal leverfunktion.
English: Prior to launch of LIBTAYO in each Member State, the 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: Inden markedsføring af LIBTAYO i hver medlemsstat skal indehaveren af markedsføringstilladelsen blive enig med den nationale myndighed om indholdet og udformningen af uddannelsesmaterialet, herunder kommunikationsmedier, distributionsmetoder og eventuelle andre aspekter af programmet.
English: Detailed guidelines for the management of immune-related adverse reactions are described in Table 1.
Danish: Udførlige retningslinjer for behandling af immunrelaterede bivirkninger er beskrevet i Tabel 1.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: Your doctor will test your blood for certain side effects during your treatment.
Danish: Din læge vil tage blodprøver i løbet af behandlingen for at holde øje med bestemte bivirkninger.
English: o The importance of carrying the Patient Alert Card at all times and to show it at all medical visits to healthcare professionals other than the prescriber (e.g. emergency healthcare professionals).
Danish: o Vigtigheden af altid at have patientkortet på sig og vise det ved alle besøg hos andet sundhedspersonale (f.eks. sundhedspersonale på skadestue) end den ordinerende læge.
English: Immune thrombocytopenic purpura
Danish: Immun trombocytopenisk purpura
English: Grade ≥3 with AST or ALT >5×ULN or total bilirubin >3×ULN
Danish: Grad ≥ 3 med ASAT eller ALAT >5×ULN eller total bilirubin >3×ULN
English: Look out for these side effects while you are having LIBTAYO.
Danish: Du skal holde øje med disse bivirkninger, mens du får LIBTAYO.
English: Your doctor also may delay your next dose of LIBTAYO or stop your treatment.
Danish: Din læge vil muligvis også udsætte den næste dosis LIBTAYO eller helt stoppe din behandling med LIBTAYO.
English: Grade 2 with AST or ALT >3 and ≤5×ULN or total bilirubin >1.5 and ≤3×ULN
Danish: Grad 2 med ASAT eller ALAT >3 og ≤5×ULN eller total bilirubin >1,5 og ≤3×ULN
English: After preparation of infusion
Danish: Efter klargøring af infusion
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne anført efter, hvor alvorlige de er.
English: The recommended dose is 350 mg cemiplimab, every 3 weeks, administered as an intravenous infusion over 30 minutes.
Danish: Den anbefalede dosis cemiplimab er 350 mg hver 3. uge administreret som intravenøs infusion over en periode på 30 minutter.
English: With 350 mg every 3 weeks, the mean steady-state concentration of cemiplimab ranged between Cmax of 168 mg/l and a Ctrough of 61 mg/l.
Danish: Med 350 mg hver 3. uge var gennemsnitlig steady state-koncentration af cemiplimab mellem Cmax på 168 mg/l og Ctrough på 61 mg/l.
English: Resolution of nephritis had occurred in all patients at the time of data cut-off.
Danish: Nefritis havde fortaget sig hos alle patienterne på tidspunktet for data cut-off.
English: Adverse reactions were serious in 8.6% patients and led to permanent discontinuation of cemiplimab in 5.8% of patients.
Danish: Bivirkninger var alvorlige hos 8,6 % af patienterne og medførte permanent seponering af cemiplimab hos 5,8 % af patienterne.
English: The effect of renal impairment on the exposure of cemiplimab was evaluated by a population PK analysis in patients with mild (CLcr 60 to < 89 ml/min; n= 197), moderate (CLcr 30 to < 60 ml/min; n= 90), or severe (CLcr <30 ml/min; n= 4) renal impairment.
Danish: Effekten af nedsat nyrefunktion på eksponering for cemiplimab blev vurderet ud fra en farmakokinetisk populationsanalyse med patienter med let (CLcr 60 til <89 ml/min; n= 197), moderat (CLcr 30 til <60 ml/min; n= 90) eller svært (CLcr <30 ml/min; n= 4) nedsat nyrefunktion.
English: L-histidine
Danish: L-histidin
English: Cemiplimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with its ligands PD-L1 and
Danish: Cemiplimab er et fuldt humant immunglobulin G4 (IgG4) monoklonalt antistof, som bindes til programmeret celledød-1 (PD-1) receptoren og blokerer dens interaktion med dens ligander PD-L1 og PD-L2.
English: Most immune-related reactions initially manifest during treatment with cemiplimab; however, immune-related adverse reactions can occur after discontinuation of cemiplimab.
Danish: De fleste immunrelaterede reaktioner opstår initialt under behandling med cemiplimab; imidlertid kan immunrelaterede bivirkninger også opstå efter seponering af cemiplimab.
English: No pharmacokinetic drug-drug interaction studies have been conducted with cemiplimab.
Danish: Der er ikke udført farmakokinetiske lægemiddelinteraktionsstudier med cemiplimab.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of cemiplimab (see “Description of selected adverse reactions” below).
Danish: Størstedelen af disse bivirkninger, herunder alvorlige bivirkninger, forsvandt efter initiering af passende medicinsk behandling eller seponering af cemiplimab (se ”Beskrivelse af udvalgte bivirkninger” nedenfor).
English: The effect of hepatic impairment on the exposure of cemiplimab was evaluated by population PK analysis.
Danish: Nedsat leverfunktions effekt på eksponering af cemiplimab blev vurderet ud fra en farmakokinetisk populationsanalyse.
English: Recommended modifications to manage adverse reactions are provided in Table 1.
Danish: Anbefalede justeringer til håndtering af bivirkninger er beskrevet i Tabel 1.
English: Cardiac disorders Myocarditis d
Danish: Hjerte Myocarditis d
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET
English: Concentration data were collected in 548 patients with various solid tumours, including 178 patients with CSCC, who received cemiplimab.
Danish: Koncentrationsdata blev indsamlet fra 548 patienter med forskellige solide tumorer som fik cemiplimab, herunder fra 178 patienter med CSCC.
English: A population PK analysis suggests that the following factors have no clinically significant effect on the exposure of cemiplimab: age, gender, body weight, race, cancer type, albumin level, mild hepatic impairment and renal impairment.
Danish: En farmakokinetisk populationsanalyse viser, at følgende faktorer ikke har nogen klinisk signifikant indvirkning på eksponering for cemiplimab: alder, køn, kropsvægt, etnicitet, cancertype, albuminniveau, let nedsat leverfunktion og nedsat nyrefunktion.
English: • you have diabetes
Danish: • hvis du har sukkersyge (diabetes)
English: Secondary endpoints were duration of response (DOR) by ICR and by investigator assessment (IA), ORR by IA, progression free survival (PFS) by ICR and IA, overall survival (OS), complete response rate (CRR) by ICR, and change in scores in patient reported outcomes on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30).
Danish: Sekundære endepunkter var responsvarighed (DOR) vurderet ved ICR og investigators vurdering (investigator assessment-IA), ORR vurderet ved IA, progressionsfri overlevelse (PSF) vurderet ved ICR og IA, samlet overlevelse (OS), komplet responsrate (CRR) vurderet ved ICR og ændret score i de patientrapporterede resultater i European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with cemiplimab in all subsets of the paediatric population in the treatment of all conditions included in the category of malignant neoplasms, except haematopoietic and lymphoid tissue (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med cemiplimab i alle undergrupper af den pædiatriske population ved behandling af alle tilstande inkluderet i kategorien maligne neoplasmer undtagen i hæmatopoietisk og lymfoidt væv (se pkt.
English: • If you think you may be allergic, or you are not sure, talk to your doctor before you are given LIBTAYO.
Danish: • Hvis du tror, du er allergisk, eller hvis du er tvivl om du er allergisk, skal du tale med lægen, før du får LIBTAYO.
English: Neuropathy peripheral is a composite term that includes neuropathy peripheral and neuritis.
Danish: Perifer neuropati er en sammensat term, der omfatter perifer neuropati og neuritis.
English: • Visually inspect the medicinal product for particulate matter and discoloration prior to administration.
Danish: • Lægemidlet skal inspiceres visuelt for partikler og misfarvning inden administration.
English: For suspected immune-related adverse reactions, patients should be evaluated to confirm an immune-related adverse reaction and to exclude other possible causes.
Danish: Ved mistanke om immunrelaterede bivirkninger skal patienten evalueres for at bekræfte en immunrelateret bivirkning og for at udelukke andre årsager.
English: Store in the original carton in order to protect from light.
Danish: Opbevares i den originale emballage for at beskytte mod lys.
English: For patients with metastatic CSCC without externally visible target lesions, ORR was determined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Danish: Hos patienter med mCSCC uden eksterne, synlige mållæsioner blev ORR bestemt ved hjælp af Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
English: The selected adverse reactions described below are based on safety of cemiplimab in 591 patients in uncontrolled clinical studies.
Danish: De udvalgte bivirkninger beskrevet nedenfor er baseret på data fra 591 patienter i ikke-kontrollerede kliniske studier med cemiplimab.
English: L-proline
Danish: L-prolin
English: • Tell your doctor immediately if you become pregnant while you are being treated with
Danish: • Fortæl det straks til lægen, hvis du bliver gravid, mens du behandles med LIBTAYO.
English: If a woman chooses to be treated with cemiplimab, she should be instructed not to breast-feed while being treated with cemiplimab and for at least 4 months after the last dose.
Danish: Hvis kvinden beslutter, at hun vil behandles med cemiplimab, skal hun informeres om ikke at amme under behandlingen med cemiplimab og i mindst 4 måneder efter den sidste dosis.
English: If you stop receiving LIBTAYO
Danish: Hvis du holder op med at få LIBTAYO
English: • Skin problems
Danish: • Hudproblemer
English: Look out for side effects
Danish: Hold øje med bivirkninger
English: - Grade 4 adverse reaction (excluding endocrinopathies) - Recurrent severe Grade 3 immune-related adverse reaction - Persistent Grade 2 or 3 immune-related adverse reactions lasting 12 weeks or longer (excluding endocrinopathies) - Inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks
Danish: - Grad 4 bivirkning (eksklusive endokrinopatier) - Tilbagevendende svær grad 3 immunrelateret bivirkning - Vedvarende grad 2 eller 3 immunrelaterede bivirkninger, der varer 12 uger eller længere (eksklusive endokrinopatier) - Ikke muligt at reducere kortikosteroid-dosis til 10 mg eller mindre prednison dagligt eller tilsvarende inden for 12 uger
English: Women of childbearing potential should use effective contraception during treatment with cemiplimab and for at least 4 months after the last dose of cemiplimab.
Danish: Fertile kvinder skal anvende effektiv antikonception under behandlingen med cemiplimab og i mindst 4 måneder efter den sidste dosis cemiplimab.
English: Chronic inflammatory demyelinating polyradiculoneuropathy
Danish: Kronisk inflammatorisk demyeliniserende polyradikuloneuropati
English: Partial response (PR) Stable disease (SD) Progressive disease (PD)
Danish: 95 % CI for ORR Komplet respons (CR)b Partiel respons (PR) Stabil sygdom (SD) Progressiv sygdom (PD)
English: Median follow-up was 16.5 months for the mCSCC 3 mg/kg every 2 weeks group, 9.3 months for the laCSCC 3 mg/kg every 2 weeks group and 8.1 months for the mCSCC 350 mg every 3 weeks group.
Danish: Median opfølgningsperiode var 16,5 måneder for gruppen med mCSCC, der fik 3 mg/kg hver anden uge, 9,3 måneder for gruppen med laCSCC, der fik 3 mg/kg hver anden uge og 8,1 måneder for gruppen med mCSCC, der fik 350 mg hver tredje uge.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing foetus resulting in foetal death (see section 5.3).
Danish: Dyreforsøg har påvist, at hæmning af PD-1/PD-L1signalvejen kan medføre en øget risiko for immunmedieret afstødning af fosteret med deraf følgende fosterdød (se pkt.
English: f. Hepatitis is a composite term that includes hepatitis and autoimmune hepatitis.
Danish: f. Hepatitis er en sammensat term, der omfatter hepatitis og autoimmun hepatitis.
English: Overall survival a, c, d
Danish: Samlet overlevelsea, c, d. 12 måneder
English: Patients should be monitored for evidence of suspected severe skin reactions and exclude other causes.
Danish: Patienterne skal monitoreres ved mistanke om alvorlige hudreaktioner, og andre årsager bør udelukkes.
English: Allow the diluted solution to come to room temperature prior to administration.
Danish: Lad den fortyndede opløsning nå stuetemperatur før administration.
English: Thirty-three and 7/10 per cent (33.7%) of patients had received at least 1 prior anti-cancer systemic therapy, 90.2% of patients had received prior cancer related surgery, and 67.9% of patients had received prior radiotherapy.
Danish: 33,7 % af patienterne havde tidligere fået mindst 1 systemisk cancerbehandling, 90,2 % af patienterne havde tidligere fået foretaget cancerrelateret kirurgi, og 67,9 % af patienterne havde tidligere modtaget strålebehandling.
English: • a temporary inflammation of the nerves that cause pain, weakness, and paralysis in the extremities; a condition in which the muscles become weak and tire easily
Danish: • kortvarig nervebetændelse som medfører smerter, svaghed og lammelse i arme og ben; en tilstand hvor musklerne bliver svage og hurtigt bliver trætte
English: LIBTAYO has no or minor influence on your ability to drive and use machines.
Danish: LIBTAYO påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
Danish: I tilfælde af overdosering skal patienten monitoreres tæt for tegn eller symptomer på bivirkninger, og passende symptomatisk behandling påbegyndes.
English: Cemiplimab has no or negligible influence on the ability to drive and use machines.
Danish: Cemiplimab påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Clearance of cemiplimab is linear at doses of 1 mg/kg to 10 mg/kg every two weeks.
Danish: Cemiplimabs clearance er lineær ved doser på 1 mg/kg til 10 mg/kg hver 2. uge.
English: Patients with any of the following were excluded: autoimmune disease that required systemic therapy with immunosuppressant agents within 5 years; history of solid organ transplant; history of pneumonitis within the last 5 years; prior treatment with anti-PD-1/PD-L1 or other immune checkpoint inhibitor therapy; active infection requiring therapy, including known infection with human immunodeficiency virus, or active infection with hepatitis B or hepatitis C virus; chronic lymphocytic leukaemia (CLL); brain metastases or Eastern Cooperative Oncology Group (ECOG) performance score ≥ 2.
Danish: Patienter med noget af følgende blev ekskluderet: autoimmun sygdom, som krævede systemisk behandling med immunosuppressiva inden for de sidste 5 år, organtransplantation i anamnesen, anamnese med pneumonitis inden for de sidste 5 år, tidligere behandling med anti-PD-1/PD-L1 eller anden immunterapi med checkpoint-hæmmere; aktiv, behandlingskrævende infektion, inklusive bekræftet infektion med human immundefektvirus eller aktiv infektion med hepatitis B- eller C-virus, kronisk lymfatisk leukæmi (CLL), hjernemetastaser eller Eastern Cooperative Oncology Group (ECOG)-performance-score på ≥ 2.
English: o A warning message for health care professionals treating the patient at any time, including in conditions of emergency, that the patient is treated with LIBTAYO.
Danish: • Patientkortet skal indeholde følgende hovedelementer o En advarsel til det sundhedspersonale, der til enhver tid behandler patienten, herunder ved akut behandling, om at patienten er i behandling med LIBTAYO.
English: Engagement of PD-1 with its ligands PD-L1 and PD-L2, which are expressed by antigen presenting cells and may be expressed by tumour cells and/or other cells in the tumour microenvironment, results in inhibition of T cell function such as proliferation, cytokine secretion, and cytotoxic activity.
Danish: Interaktionen imellem PD-1 og liganderne PD-L1 og PD-L2, der udtrykkes i antigenpræsenterende celler og muligvis af tumorceller og/eller andre celler i tumors mikromiljø, medfører hæmning af Tcellefunktionen som f.eks. proliferation, cytokinudskillelse og cytotoksisk aktivitet.
English: Marketing Authorisation Holder Regeneron Ireland Designated Activity Company (DAC) Europa House
Danish: Indehaver af markedsføringstilladelsen Regeneron Ireland Designated Activity Company (DAC) Europa House