FrancophonIA/ELRC3.0 huggingface dataset:
English: Fatal cardiac arrest, life-threatening ventricular arrhythmias, and myocardial infarction may result from the ischaemia induced by pharmacologic stress agents like regadenoson.
Danish: Myokardieiskæmi induceret af midler til farmakologisk stress, såsom eregadenoson, kan resultere i fatalt hjertestop, livstruende ventrikulære arytmier og myokardieinfarkt.
English: • wheezing
Danish: • rødmen
English: Malaise, asthenia
Danish: • opkastning, kvalme
English: Bronchospasm, Respiratory arrest Gastrointestinal disorders:
Danish: Bronkospasme, respirationssvigt
English: Pain at injection site, general body pain
Danish: Utilpashed, asteni Ikke almindelig Smerter på injektionsstedet, generelle legemssmerter
English: • 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection should be administered immediately after the injection of Rapiscan.
Danish: • 5 ml natriumchlorid 9 mg/ml (0,9%) injektionsvæske skal indgives umiddelbart efter injektionen af Rapiscan.
English: Cardiac disorders:
Danish: Mave-tarm-kanalen:
English: 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection should be administered immediately after the injection of Rapiscan.
Danish: 5 ml natriumchlorid 9 mg/ml (0,9%) injektionsvæske skal indgives umiddelbart efter injektionen af Rapiscan.
English: • 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection should be administered immediately after the injection of Rapiscan.
Danish: • 10 ml natriumchlorid 9 mg/ml (0,9%) injektionsvæske, opløsning skal indgives umiddelbart efter injektionen af Rapiscan.
English: Warnings related to excipients
Danish: Advarsler angående hjælpestofferne
English: • blurred vision, eye pain
Danish: • sløret syn, øjensmerter
English: 10 mL of sodium chloride 9 mg/ml (0.9%) solution for injection should be administered immediately after the injection of Rapiscan.
Danish: 10 ml natriumchlorid 9 mg/ml (0,9%) injektionsvæske, opløsning skal indgives umiddelbart efter injektionen af Rapiscan.
English: Disodium edetate
Danish: Nedsat nyrefunktion
English: • shortness of breath
Danish: • hivende vejrtrækning
English: Musculoskeletal and connective tissue disorders: Common
Danish: Ikke almindelig Erytem Knogler, led, muskler og bindevæv: Almindelig
English: Immune system disorders: Uncommon
Danish: Immunsystemet:
English: Anxiety, insomnia
Danish: Psykiske forstyrrelser: Ikke almindelig Angst, søvnløshed
English: Immediate Packaging
Danish: (Særnavn) Navn Styrke Lægemiddelform Administration Emballage
English: • Problems in other parts of the body.
Danish: • Problemer i andre dele af kroppen.
English: The study should be conducted according to an agreed protocol.
Danish: Studiet skal udføres i henhold til en aftalt protokol.
English: • The infusion will last about 30 minutes.
Danish: • Infusionen tager ca. 30 minutter.
English: ATC code: not yet assigned
Danish: ATC-kode: endnu ikke tildelt
English: Date of first authorisation: 28 June 2019
Danish: Dato for første markedsføringstilladelse: 28. juni 2019
English: You may have more than one side effect at the same time.
Danish: Du kan få mere end en bivirkning på samme tid.
English: These serious side effects include:
Danish: De alvorlige bivirkninger omfatter:
English: Treatment may be continued until disease progression or unacceptable toxicity.
Danish: Behandlingen kan fortsætte indtil sygdomsprogression eller uacceptabel toksicitet.
English: Inflammation may cause serious damage to your body.
Danish: Inflammation kan forårsage alvorlige skader i din krop.
English: Overall survival does not require central review.
Danish: Samlet overlevelse kræver ikke central vurdering.
English: The event was Grade 3 hypophysitis.
Danish: Hændelsen var grad 3 hypofysitis.
English: Additional intervention
Danish: Yderligere intervention
English: • you have an autoimmune disease (a condition where the body attacks its own cells)
Danish: • hvis du har en autoimmun sygdom (en tilstand, hvor kroppen angriber sine egne celler)
English: This leaflet was last revised in June 2019.
Danish: Denne indlægsseddel blev senest ændret juni 2019.
English: It is very important that you do not miss a dose of this medicine.
Danish: Det er meget vigtigt, at du ikke springer en dosis med dette lægemiddel over.
English: If you feel tired, do not drive or use machines until you feel better.
Danish: Hvis du føler dig træt, må du ikke føre motorkøretøj eller betjene maskiner, før du får det bedre.
English: Efficacy and PD-L1 status
Danish: Virkning og PD-L1-status
English: The events were Grade 3 or less unless stated otherwise:
Danish: Hændelserne var grad 3 eller derunder medmindre andet er anført:
English: 31st October
Danish: 31. oktober
English: One of the 3 patients was treated with systemic corticosteroids.
Danish: En af de 3 patienter blev behandlet med systemisk kortikosteroid.
English: Thyroid disorders can occur at any time during the treatment.
Danish: Thyroideasygdomme kan opstå på ethvert tidspunkt i løbet af behandlingen.
English: • LIBTAYO is usually given every 3 weeks.
Danish: • LIBTAYO gives sædvanligvis hver 3. uge.
English: Patients excluded from clinical studies
Danish: Patienter udelukket fra kliniske studier
English: • LIBTAYO can harm your unborn baby.
Danish: • LIBTAYO kan skade dit ufødte barn.
English: Unopened vial 30 months
Danish: Uåbnet hætteglas 30 måneder
English: • It is important that you keep the Patient Alert Card with you during treatment.
Danish: • Det er vigtigt, at du har patientkortet med dig under behandlingen.
English: • you have had an organ transplant
Danish: • hvis du har gennemgået en organtransplantation
English: These animal species have similar maternal-foetal interface to that in humans.
Danish: Disse dyrearter har lignende maternale-føtale barriere som hos mennesker.
English: Patients that had active infections or that were immunocompromised were not included in the main study.
Danish: Patienter med aktive infektioner, eller som var immunkompromitterede, blev ikke inkluderet i hovedstudiet.
English: This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Danish: Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14-a(4) i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at få dette lægemiddel, da den indeholder vigtige oplysninger.
English: LIBTAYO can cause some serious side effects that you need to tell your doctor about immediately.
Danish: LIBTAYO kan give alvorlige bivirkninger, som du straks skal fortælle din læge om.
English: If diluted solution is not administered immediately, it may be stored temporarily either:
Danish: Hvis den fortyndede opløsning ikke anvendes straks, kan den opbevares midlertidigt enten:
English: Conditional approval
Danish: Betinget godkendelse
English: Time to response Median (months) range (min:max)
Danish: Tid til respons Median (måneder) interval (min:max)
English: CI: confidence interval; ICR: Independent Central Review; NR: Not Reached; +: Denotes ongoing at last assessment a.
Danish: CI: konfidensinterval; ICR: Independent Central Review; NR: ikke nået; +: Angiver igangværende ved seneste vurdering a.
English: Steady-state exposure is achieved after approximately 4 months of treatment.
Danish: Steady state eksponering nås ca. 4 måneder efter behandlingen.
English: Your doctor will decide how much LIBTAYO you will receive and how many treatments you will need.
Danish: Lægen beslutter, hvor meget LIBTAYO du skal have og hvor mange behandlinger, du har brug for.
English: o The importance of not attempting to self-treat any symptoms without consulting their healthcare professional first.
Danish: o Vigtigheden af ikke selv at behandle eventuelle symptomer uden først at tale med sundhedspersonalet.
English: • you are allergic to cemiplimab or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for cemiplimab eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Danish: Hyppigheden er defineret 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 tilgængelig data).
English: In the absence of data, cemiplimab should be used with caution in these populations after careful evaluation of the balance of benefits and risks for the patient.
Danish: På grund af manglende data bør cemiplimab anvendes med forsigtighed til disse populationer efter nøje vurdering af fordele og risici for patienten.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal handelsnavnet og batchnummeret på det administrerede præparat registreres tydeligt.
English: All patients recovered from the infusion-related reaction.
Danish: Alle patienter restituerede fra den infusionsrelaterede reaktion.
English: No dose reductions are recommended.
Danish: Dosisreduktion anbefales ikke.
English: It is important that you keep this Patient Alert Card and show it to your partner or caregivers.
Danish: Det er vigtigt, at du gemmer dit patientkort og viser det til din partner eller andre støttepersoner.
English: As with all therapeutic proteins, there is a potential for immunogenicity with cemiplimab.
Danish: Som med alle terapeutiske proteiner er der mulighed for immunogenicitet med cemiplimab.
English: Grades 1-5 (Frequency category)
Danish: Grad 1-5 (Hyppighedskategori)
English: The recommended dose of LIBTAYO is 350 mg.
Danish: Den anbefalede dosis LIBTAYO er 350 mg.
English: Seek urgent medical attention if you have any of the following signs or symptoms, or if they get worse:
Danish: Søg øjeblikkeligt lægehjælp, hvis du får et eller flere af følgende symptomer, eller hvis de forværres:
English: 12 months
Danish: 12 måneder
English: Do not stop treatment of LIBTAYO unless you have discussed this with your doctor.
Danish: Du må ikke stoppe behandlingen med LIBTAYO, medmindre du har aftalt det med lægen.
English: Cemiplimab is expected to degrade to small peptides and individual amino acids.
Danish: Cemiplimab forventes at blive nedbrudt til små peptider og individuelle aminosyrer.
English: • Talk to your doctor about the contraception methods that you must use during this time.
Danish: • Tal med lægen om hvilken type prævention, du skal bruge i den periode.
English: Your doctor may give you other medicines in order to stop more severe reactions and reduce your symptoms.
Danish: Din læge vil muligvis give dig anden medicin for at stoppe de mere alvorlige bivirkninger og for at mildne dine symptomer.
English: Based on Kaplan Meier estimates d.
Danish: Baseret på Kaplan-Meier estimat d.
English: Treatment must be initiated and supervised by physicians experienced in the treatment of cancer.
Danish: Behandlingen skal initieres og overvåges af en læge med erfaring i cancerbehandling.
English: Clinical activity was observed regardless of tumour PD-L1 expression status.
Danish: Klinisk aktivitet blev observeret uanset tumor PD-L1-ekspressionsstatus.
English: Children and adolescents LIBTAYO should not be used in children and adolescents below 18 years of age.
Danish: Børn og unge LIBTAYO må ikke anvendes til børn og unge under 18 år.
English: Specific metabolism studies were not conducted because cemiplimab is a protein.
Danish: Der er ikke udført specifikke metaboliseringsstudier, eftersom cemiplimab er et protein.
English: Absorption Cemiplimab is administered via the intravenous route and hence is completely bioavailable.
Danish: Absorption Cemiplimab administreres intravenøst, og er derfor fuldstændig biotilgængeligt.
English: The within dosing interval half-life at steady state is 19.4 days.
Danish: Halveringstiden inden for doseringsintervallet ved steady state er 19,4 dage.
English: o A reminder that all known or suspected adverse drug reactions (ADRs) can also be reported to local regulatory authorities.
Danish: o En påmindelse om at alle kendte eller formodede bivirkninger også kan rapporteres til de lokale myndigheder.
English: Your doctor will discuss these with you and will explain the risks and benefits of your treatment.
Danish: Lægen vil tale med dig om disse bivirkninger og forklare dig om risikoen og fordelen ved behandlingen.
English: Recommended treatment modifications
Danish: Anbefalede behandlingsjusteringer
English: a Toxicity should be graded with the current version of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Danish: Toksicitet er klassificeret i henhold til gældende version af National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
English: These medicines may interfere with the effect of LIBTAYO.
Danish: Disse lægemidler kan påvirke virkningen af LIBTAYO.
English: Cemiplimab is primarily distributed in the vascular system with a volume of distribution at steady-state (Vss) is 5.2 l.
Danish: Cemiplimab fordeles primært i det vaskulære system med et fordelingsvolumen ved steady state (Vss) på 5,2 l.
English: Regeneron Ireland DAC Europa House, Harcourt Centre Harcourt Street, Dublin 2, Ireland
Danish: Regeneron Ireland DAC Europa House, Harcourt Centre Harcourt Street, Dublin 2, Irland
English: It is known that antibodies (including IgG4) are secreted in human milk; a risk to the breast-feeding newborns/infants cannot be excluded.
Danish: Det er kendt, at antistoffer (inklusiv IgG4) udskilles i modermælk, og en risiko for den ammede nyfødte/spædbarnet kan ikke udelukkes.
English: There are no available data on the use of cemiplimab in pregnant women.
Danish: Der foreligger ingen data om anvendelsen af cemiplimab til gravide kvinder.
English: Guillain-Barre syndrome
Danish: Guillain-Barré syndrom
English: The information in this Package Leaflet can be found in the Patient Alert Card you have been given by your doctor.
Danish: Du kan også finde oplysninger fra denne indlægsseddel på det patientkort, du har fået af din læge.
English: • bruises on the skin or bleeding.
Danish: • blå mærker på huden eller blødning.
English: No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Danish: Der blev ikke observeret nogen overordnede forskelle mellem disse personer og yngre patienter, hvad angår sikkerhed eller virkning.
English: See ‘Possible side effects' section in section 4.
Danish: Se ”Bivirkninger” i afsnit 4.
English: 31st March
Danish: 31. marts
English: Call your doctor as soon as possible to make another appointment.
Danish: Kontakt straks lægen for at få en ny aftale.
English: The total clearance appears to decrease by approximately 35% over time, resulting in a steady state clearance (CLss) of 0.21 l/day; the decrease in CL is not considered clinically relevant.
Danish: Total clearance synes at falde med ca. 35 % over tid, hvilket resulterer i clearance ved steady state (CLss) på 0,21 l/dag; fald i clearance anses ikke som klinisk relevant.
English: The relationship between PD-L1 status and efficacy was analysed post-hoc in patients with available tissue samples.
Danish: Forholdet mellem PD-L1status og virkning blev analyseret post-hoc hos patienter med tilgængelige vævsprøver.
English: Each carton contains 1 vial.
Danish: Hver karton indeholder 1 hætteglas.
English: These immune-related reactions may involve any organ system.
Danish: Disse immunrelaterede bivirkninger kan omfatte alle organsystemer.
English: No neutralizing antibodies have been observed.
Danish: Der blev ikke observeret neutraliserende antistoffer.
English: LIBTAYO acts on your immune system and may cause inflammation in parts of your body (see the conditions listed in ‘Look out for side effects' in section 2).
Danish: LIBTAYO virker på dit immunsystem og kan forårsage inflammation (betændelseslignende tilstand) i dele af din krop (se de beskrevne tilstande i ”Hold øje med bivirkninger” i afsnit 2).
English: Efficacy results - Study 1540 - metastatic CSCC by dosing group, locally advanced CSCC
Danish: Effektresultater - Studie 1540 - metastatisk CSCC efter doseringsgrupper, lokalt avanceret CSCC
English: This is because stopping your treatment may stop the effect of the medicine.
Danish: Hvis du stopper behandlingen, kan virkningen af medicinen ophøre.
English: In particular, tell your doctor if you are taking or have ever taken any of the following medicines:
Danish: Det er især vigtigt, at du fortæller lægen, hvis du tager eller har taget en eller flere af følgende lægemidler:
English: Grade 3 clinical signs or symptoms of an immune-related adverse reaction not described above
Danish: Grad 3 kliniske tegn eller symptomer på en immunrelateret bivirkning, der ikke er beskrevet ovenfor
English: LIBTAYO does not contain a preservative.
Danish: LIBTAYO indeholder ikke konserveringsmiddel.
English: As reported in the literature, PD-1 / PD-L1 signalling pathway plays a role in sustaining pregnancy by maintaining immunological tolerance and studies have shown that PD-1 receptor blockade results in early termination of pregnancy.
Danish: Som rapporteret i litteraturen spiller PD-1 / PD-L1-signalvejen en rolle i opretholdelse af graviditeten ved at bevare immunologisk tolerance, og studier har vist, at PD-1 receptorblokade medfører præmatur afbrydelse af graviditeten.
English: LIBTAYO works by helping your immune system fight your cancer.
Danish: LIBTAYO virker ved at hjælpe immunsystemet med at bekæmpe kræften.
English: • It is not known if LIBTAYO passes into your breast milk.
Danish: • Det vides ikke, om LIBTAYO passerer over i modermælken.
English: Some inflammatory conditions may also lead to death and need treatment, or you may need to stop treatment with LIBTAYO.
Danish: Nogle inflammationstilstande kan være dødelige og kræve behandling eller kan gøre det nødvendigt at stoppe behandlingen med LIBTAYO.
English: In Groups 1, 2, and 3, median durations of follow-up were 16.5, 9.3, and 8.1 months, respectively.
Danish: I gruppe 1, 2 og 3 var median varighed af opfølgningsperioden henholdsvis 16,5, 9,3 og 8,1 måneder.
English: • Central nervous system problems (such as meningitis)
Danish: • Problemer med centralnervesystemet (f.eks. meningitis)
English: The final concentration of the diluted solution should be between 1 mg/ml to 20 mg/ml.
Danish: Den færdige koncentration i den fortyndede opløsning bør være mellem 1 mg/ml til 20 mg/ml.
English: ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal.
Danish: Permanent seponering ALAT: alaninaminotransferase; ASAT: aspartataminotransferase; ULN: Øvre grænse for normal.
English: The safety and efficacy of LIBTAYO in children and adolescents below the age of 18 years have not been established.
Danish: LIBTAYOs sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Cemiplimab clearance after the first dose is approximately 0.33 l/day.
Danish: Cemiplimabs clearance efter den første dosis er ca. 0,33 l/dag.
English: Only includes patients with complete healing of prior cutaneous involvement; locally advanced CSCC patients in Study 1540 required biopsy to confirm complete response.
Danish: Omfatter kun patienter med komplet heling af tidligere påvirkede hudområde; hos patienter med lokalt avanceret CSCC i Studie 1540 krævedes biopsi for at bekræfte komplet respons.
English: Human IgG4 is known to cross the placental barrier and cemiplimab is an IgG4; therefore, cemiplimab has the potential to be transmitted from the mother to the developing foetus.
Danish: Humant IgG4 er kendt for at passere placentabarrieren, og cemiplimab er et IgG4; cemiplimab har derfor potentiale til at blive overført fra moderen til fosteret.
English: Nervous system disorders: Meningitis a
Danish: Nervesystemet: meningitis a
English: Patients should be monitored for signs and symptoms of pneumonitis.
Danish: Patienterne bør monitoreres for tegn og symptomer på pneumonitis.
English: However, once you are treated with LIBTAYO, your doctor may give you corticosteroids to reduce the side effects that you may have with LIBTAYO.
Danish: Når du er i behandling med LIBTAYO, kan lægen imidlertid godt give dig kortikosteroider for at mildne de bivirkninger, du kan få af LIBTAYO.
English: The physician will provide the Patient Alert Card to each patient.
Danish: Lægen skal udlevere et patientkort til alle patienter.
English: Results are presented from 193 patients in Study 1540.
Danish: Resultaterne for 193 patienter i Studie 1540 vises i nedenstående.
English: After opening Once opened, the medicinal product should be diluted and infused immediately.
Danish: Efter åbning Lægemidlet bør fortyndes og infunderes umiddelbart efter åbning.
English: The primary endpoint of Study 1540 was confirmed objective response rate (ORR), as assessed by independent central review (ICR).
Danish: Det primære endepunkt i Studie 1540 var bekræftet objektiv responsrate (ORR), som blev vurderet ved en uafhængig central vurdering (independent central review-ICR).
English: Cemiplimab is not recommended during pregnancy and in women of childbearing potential not using effective contraception unless the clinical benefit outweighs the potential risk.
Danish: Cemiplimab bør ikke anvendes under graviditet og til fertile kvinder, som ikke anvender effektiv antikonception, medmindre den kliniske fordel opvejer den potentielle risiko.
English: Of these 193 patients, 115 had mCSCC and 78 had laCSCC.
Danish: Af de 193 patienter havde 115 patienter mCSCC, og 78 patienter havde laCSCC.
English: Overall in Studies 1423 and 1540, PD-L1 IHC results were available for 75 advanced CSCC patients.
Danish: I Studie 1423 og 1540 var PD-L1 IHC-resultater samlet set tilgængelige for 75 patienter med avanceret CSCC.
English: • LIBTAYO is given as a drip into a vein (intravenous infusion).
Danish: • LIBTAYO gives som et drop i en vene (intravenøs infusion).
English: a. Type 1 diabetes mellitus is a composite term that includes diabetes mellitus, diabetic ketoacidosis and type 1 diabetes mellitus.
Danish: a. Type 1-diabetes mellitus er en sammensat term, der omfatter diabetes mellitus, diabetisk ketoacidose og type 1-diabetes mellitus.
English: Patients with DOR ≥ 6 months, % 93.1%
Danish: Patienter med DOR ≥ 6 måneder, %
English: L-histidine monohydrochloride monohydrate Sucrose
Danish: L-histidinmonohydrochloridmonohydrat Saccharose
English: Grade 4 or confirmed SJS or TEN
Danish: Grad 4 eller bekræftet SJS eller TEN
English: Cemiplimab is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture.
Danish: Cemiplimab er fremstillet ved rekombinant DNA-teknologi i cellesuspensionskultur med ovarieceller fra kinesiske hamstre (CHO).
English: Arthritis j
Danish: Artritis j
English: Grade 3 or 4 (excluding endocrinopathies) or recurrent Grade 2
Danish: Grad 3 eller 4 (eksklusive endokrinopatier) eller tilbagevendende grad 2
English: Confirmed objective response rate (ORR)
Danish: Bekræftet objektiv responsrate (ORR) a
English: If patients with locally advanced disease showed sufficient response to treatment, surgery with curative intent was permitted.
Danish: Hos patienter med lokalt avanceret sygdom, der havde tilstrækkeligt behandlingsrespons, var kurativ kirurgi tilladt.
English: Data cut-off was Sep 20, 2018 for Groups 1 and 3 patients, and Oct 10, 2018 for Group 2 patients.
Danish: Tidspunktet for data cut-off var 20. september 2018 for patienter i gruppe 1 og 3 og 10. oktober 2018 for patienter i gruppe 2.