natgillin/translations-raw huggingface dataset:
Dato for første markedsføringstilladelse: 28. juni 2019 
Date of first authorisation: 28 June 2019
Du kan få mere end en bivirkning på samme tid. 
You may have more than one side effect at the same time.
De alvorlige bivirkninger omfatter: 
These serious side effects include:
Behandlingen kan fortsætte indtil sygdomsprogression eller uacceptabel toksicitet. 
Treatment may be continued until disease progression or unacceptable toxicity.
Inflammation kan forårsage alvorlige skader i din krop. 
Inflammation may cause serious damage to your body.
Samlet overlevelse kræver ikke central vurdering. 
Overall survival does not require central review.
Hændelsen var grad 3 hypofysitis. 
The event was Grade 3 hypophysitis.
Yderligere intervention 
Additional intervention
• hvis du har en autoimmun sygdom (en tilstand, hvor kroppen angriber sine egne celler) 
• you have an autoimmune disease (a condition where the body attacks its own cells)
Denne indlægsseddel blev senest ændret juni 2019. 
This leaflet was last revised in June 2019.
Det er meget vigtigt, at du ikke springer en dosis med dette lægemiddel over. 
It is very important that you do not miss a dose of this medicine.
Hvis du føler dig træt, må du ikke føre motorkøretøj eller betjene maskiner, før du får det bedre. 
If you feel tired, do not drive or use machines until you feel better.
Virkning og PD-L1-status 
Efficacy and PD-L1 status
Hændelserne var grad 3 eller derunder medmindre andet er anført: 
The events were Grade 3 or less unless stated otherwise:
31. oktober 
31st October
En af de 3 patienter blev behandlet med systemisk kortikosteroid. 
One of the 3 patients was treated with systemic corticosteroids.
Thyroideasygdomme kan opstå på ethvert tidspunkt i løbet af behandlingen. 
Thyroid disorders can occur at any time during the treatment.
• LIBTAYO gives sædvanligvis hver 3. uge. 
• LIBTAYO is usually given every 3 weeks.
Patienter udelukket fra kliniske studier 
Patients excluded from clinical studies
• LIBTAYO kan skade dit ufødte barn. 
• LIBTAYO can harm your unborn baby.
Uåbnet hætteglas 30 måneder 
Unopened vial 30 months
• Det er vigtigt, at du har patientkortet med dig under behandlingen. 
• It is important that you keep the Patient Alert Card with you during treatment.
• hvis du har gennemgået en organtransplantation 
• you have had an organ transplant
Disse dyrearter har lignende maternale-føtale barriere som hos mennesker. 
These animal species have similar maternal-foetal interface to that in humans.
Patienter med aktive infektioner, eller som var immunkompromitterede, blev ikke inkluderet i hovedstudiet. 
Patients that had active infections or that were immunocompromised were not included in the main study.
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: 
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:
Læs denne indlægsseddel grundigt, inden du begynder at få dette lægemiddel, da den indeholder vigtige oplysninger. 
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
LIBTAYO kan give alvorlige bivirkninger, som du straks skal fortælle din læge om. 
LIBTAYO can cause some serious side effects that you need to tell your doctor about immediately.
Hvis den fortyndede opløsning ikke anvendes straks, kan den opbevares midlertidigt enten: 
If diluted solution is not administered immediately, it may be stored temporarily either:
Betinget godkendelse 
Conditional approval
Tid til respons Median (måneder) interval (min:max) 
Time to response Median (months) range (min:max)
CI: konfidensinterval; ICR: Independent Central Review; NR: ikke nået; +: Angiver igangværende ved seneste vurdering a. 
CI: confidence interval; ICR: Independent Central Review; NR: Not Reached; +: Denotes ongoing at last assessment a.
Steady state eksponering nås ca. 4 måneder efter behandlingen. 
Steady-state exposure is achieved after approximately 4 months of treatment.
Lægen beslutter, hvor meget LIBTAYO du skal have og hvor mange behandlinger, du har brug for. 
Your doctor will decide how much LIBTAYO you will receive and how many treatments you will need.
o Vigtigheden af ikke selv at behandle eventuelle symptomer uden først at tale med sundhedspersonalet. 
o The importance of not attempting to self-treat any symptoms without consulting their healthcare professional first.
• hvis du er allergisk over for cemiplimab eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6). 
• you are allergic to cemiplimab or any of the other ingredients of this medicine (listed in section 6).
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). 
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).
På grund af manglende data bør cemiplimab anvendes med forsigtighed til disse populationer efter nøje vurdering af fordele og risici for patienten. 
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.
For at forbedre sporbarheden af biologiske lægemidler skal handelsnavnet og batchnummeret på det administrerede præparat registreres tydeligt. 
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Alle patienter restituerede fra den infusionsrelaterede reaktion. 
All patients recovered from the infusion-related reaction.
Dosisreduktion anbefales ikke. 
No dose reductions are recommended.
Det er vigtigt, at du gemmer dit patientkort og viser det til din partner eller andre støttepersoner. 
It is important that you keep this Patient Alert Card and show it to your partner or caregivers.
Som med alle terapeutiske proteiner er der mulighed for immunogenicitet med cemiplimab. 
As with all therapeutic proteins, there is a potential for immunogenicity with cemiplimab.
Grad 1-5 (Hyppighedskategori) 
Grades 1-5 (Frequency category)
Den anbefalede dosis LIBTAYO er 350 mg. 
The recommended dose of LIBTAYO is 350 mg.
Søg øjeblikkeligt lægehjælp, hvis du får et eller flere af følgende symptomer, eller hvis de forværres: 
Seek urgent medical attention if you have any of the following signs or symptoms, or if they get worse:
Du må ikke stoppe behandlingen med LIBTAYO, medmindre du har aftalt det med lægen. 
Do not stop treatment of LIBTAYO unless you have discussed this with your doctor.
Cemiplimab forventes at blive nedbrudt til små peptider og individuelle aminosyrer. 
Cemiplimab is expected to degrade to small peptides and individual amino acids.
• Tal med lægen om hvilken type prævention, du skal bruge i den periode. 
• Talk to your doctor about the contraception methods that you must use during this time.
Din læge vil muligvis give dig anden medicin for at stoppe de mere alvorlige bivirkninger og for at mildne dine symptomer. 
Your doctor may give you other medicines in order to stop more severe reactions and reduce your symptoms.
Baseret på Kaplan-Meier estimat d. 
Based on Kaplan Meier estimates d.
Behandlingen skal initieres og overvåges af en læge med erfaring i cancerbehandling. 
Treatment must be initiated and supervised by physicians experienced in the treatment of cancer.
Klinisk aktivitet blev observeret uanset tumor PD-L1-ekspressionsstatus. 
Clinical activity was observed regardless of tumour PD-L1 expression status.
Børn og unge LIBTAYO må ikke anvendes til børn og unge under 18 år. 
Children and adolescents LIBTAYO should not be used in children and adolescents below 18 years of age.
Der er ikke udført specifikke metaboliseringsstudier, eftersom cemiplimab er et protein. 
Specific metabolism studies were not conducted because cemiplimab is a protein.
Absorption Cemiplimab administreres intravenøst, og er derfor fuldstændig biotilgængeligt. 
Absorption Cemiplimab is administered via the intravenous route and hence is completely bioavailable.
Halveringstiden inden for doseringsintervallet ved steady state er 19,4 dage. 
The within dosing interval half-life at steady state is 19.4 days.
o En påmindelse om at alle kendte eller formodede bivirkninger også kan rapporteres til de lokale myndigheder. 
o A reminder that all known or suspected adverse drug reactions (ADRs) can also be reported to local regulatory authorities.
Lægen vil tale med dig om disse bivirkninger og forklare dig om risikoen og fordelen ved behandlingen. 
Your doctor will discuss these with you and will explain the risks and benefits of your treatment.
Anbefalede behandlingsjusteringer 
Recommended treatment modifications
Toksicitet er klassificeret i henhold til gældende version af National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). 
a Toxicity should be graded with the current version of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Disse lægemidler kan påvirke virkningen af LIBTAYO. 
These medicines may interfere with the effect of LIBTAYO.
Cemiplimab fordeles primært i det vaskulære system med et fordelingsvolumen ved steady state (Vss) på 5,2 l. 
Cemiplimab is primarily distributed in the vascular system with a volume of distribution at steady-state (Vss) is 5.2 l.
Regeneron Ireland DAC Europa House, Harcourt Centre Harcourt Street, Dublin 2, Irland 
Regeneron Ireland DAC Europa House, Harcourt Centre Harcourt Street, Dublin 2, Ireland
Det er kendt, at antistoffer (inklusiv IgG4) udskilles i modermælk, og en risiko for den ammede nyfødte/spædbarnet kan ikke udelukkes. 
It is known that antibodies (including IgG4) are secreted in human milk; a risk to the breast-feeding newborns/infants cannot be excluded.
Der foreligger ingen data om anvendelsen af cemiplimab til gravide kvinder. 
There are no available data on the use of cemiplimab in pregnant women.
Guillain-Barré syndrom 
Guillain-Barre syndrome
Du kan også finde oplysninger fra denne indlægsseddel på det patientkort, du har fået af din læge. 
The information in this Package Leaflet can be found in the Patient Alert Card you have been given by your doctor.
• blå mærker på huden eller blødning. 
• bruises on the skin or bleeding.
Der blev ikke observeret nogen overordnede forskelle mellem disse personer og yngre patienter, hvad angår sikkerhed eller virkning. 
No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Se ”Bivirkninger” i afsnit 4. 
See ‘Possible side effects' section in section 4.
31. marts 
31st March
Kontakt straks lægen for at få en ny aftale. 
Call your doctor as soon as possible to make another appointment.
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. 
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.
Forholdet mellem PD-L1status og virkning blev analyseret post-hoc hos patienter med tilgængelige vævsprøver. 
The relationship between PD-L1 status and efficacy was analysed post-hoc in patients with available tissue samples.
Hver karton indeholder 1 hætteglas. 
Each carton contains 1 vial.
Disse immunrelaterede bivirkninger kan omfatte alle organsystemer. 
These immune-related reactions may involve any organ system.
Der blev ikke observeret neutraliserende antistoffer. 
No neutralizing antibodies have been observed.
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). 
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).
Effektresultater - Studie 1540 - metastatisk CSCC efter doseringsgrupper, lokalt avanceret CSCC 
Efficacy results - Study 1540 - metastatic CSCC by dosing group, locally advanced CSCC
Hvis du stopper behandlingen, kan virkningen af medicinen ophøre. 
This is because stopping your treatment may stop the effect of the medicine.
Det er især vigtigt, at du fortæller lægen, hvis du tager eller har taget en eller flere af følgende lægemidler: 
In particular, tell your doctor if you are taking or have ever taken any of the following medicines:
Grad 3 kliniske tegn eller symptomer på en immunrelateret bivirkning, der ikke er beskrevet ovenfor 
Grade 3 clinical signs or symptoms of an immune-related adverse reaction not described above
LIBTAYO indeholder ikke konserveringsmiddel. 
LIBTAYO does not contain a preservative.
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. 
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.
LIBTAYO virker ved at hjælpe immunsystemet med at bekæmpe kræften. 
LIBTAYO works by helping your immune system fight your cancer.
• Det vides ikke, om LIBTAYO passerer over i modermælken. 
• It is not known if LIBTAYO passes into your breast milk.
Nogle inflammationstilstande kan være dødelige og kræve behandling eller kan gøre det nødvendigt at stoppe behandlingen med LIBTAYO. 
Some inflammatory conditions may also lead to death and need treatment, or you may need to stop treatment with LIBTAYO.
I gruppe 1, 2 og 3 var median varighed af opfølgningsperioden henholdsvis 16,5, 9,3 og 8,1 måneder. 
In Groups 1, 2, and 3, median durations of follow-up were 16.5, 9.3, and 8.1 months, respectively.
• Problemer med centralnervesystemet (f.eks. meningitis) 
• Central nervous system problems (such as meningitis)
Den færdige koncentration i den fortyndede opløsning bør være mellem 1 mg/ml til 20 mg/ml. 
The final concentration of the diluted solution should be between 1 mg/ml to 20 mg/ml.
Permanent seponering ALAT: alaninaminotransferase; ASAT: aspartataminotransferase; ULN: Øvre grænse for normal. 
ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal.
LIBTAYOs sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt. 
The safety and efficacy of LIBTAYO in children and adolescents below the age of 18 years have not been established.
Cemiplimabs clearance efter den første dosis er ca. 0,33 l/dag. 
Cemiplimab clearance after the first dose is approximately 0.33 l/day.
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. 
Only includes patients with complete healing of prior cutaneous involvement; locally advanced CSCC patients in Study 1540 required biopsy to confirm complete response.
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. 
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.
Nervesystemet: meningitis a 
Nervous system disorders: Meningitis a
Patienterne bør monitoreres for tegn og symptomer på pneumonitis. 
Patients should be monitored for signs and symptoms of pneumonitis.
Når du er i behandling med LIBTAYO, kan lægen imidlertid godt give dig kortikosteroider for at mildne de bivirkninger, du kan få af LIBTAYO. 
However, once you are treated with LIBTAYO, your doctor may give you corticosteroids to reduce the side effects that you may have with LIBTAYO.
Lægen skal udlevere et patientkort til alle patienter. 
The physician will provide the Patient Alert Card to each patient.
Resultaterne for 193 patienter i Studie 1540 vises i nedenstående. 
Results are presented from 193 patients in Study 1540.
Efter åbning Lægemidlet bør fortyndes og infunderes umiddelbart efter åbning. 
After opening Once opened, the medicinal product should be diluted and infused immediately.
Det primære endepunkt i Studie 1540 var bekræftet objektiv responsrate (ORR), som blev vurderet ved en uafhængig central vurdering (independent central review-ICR). 
The primary endpoint of Study 1540 was confirmed objective response rate (ORR), as assessed by independent central review (ICR).
Cemiplimab bør ikke anvendes under graviditet og til fertile kvinder, som ikke anvender effektiv antikonception, medmindre den kliniske fordel opvejer den potentielle risiko. 
Cemiplimab is not recommended during pregnancy and in women of childbearing potential not using effective contraception unless the clinical benefit outweighs the potential risk.
Af de 193 patienter havde 115 patienter mCSCC, og 78 patienter havde laCSCC. 
Of these 193 patients, 115 had mCSCC and 78 had laCSCC.
I Studie 1423 og 1540 var PD-L1 IHC-resultater samlet set tilgængelige for 75 patienter med avanceret CSCC. 
Overall in Studies 1423 and 1540, PD-L1 IHC results were available for 75 advanced CSCC patients.
• LIBTAYO gives som et drop i en vene (intravenøs infusion). 
• LIBTAYO is given as a drip into a vein (intravenous infusion).
a. Type 1-diabetes mellitus er en sammensat term, der omfatter diabetes mellitus, diabetisk ketoacidose og type 1-diabetes mellitus. 
a. Type 1 diabetes mellitus is a composite term that includes diabetes mellitus, diabetic ketoacidosis and type 1 diabetes mellitus.
Patienter med DOR ≥ 6 måneder, % 
Patients with DOR ≥ 6 months, % 93.1%
L-histidinmonohydrochloridmonohydrat Saccharose 
L-histidine monohydrochloride monohydrate Sucrose
Grad 4 eller bekræftet SJS eller TEN 
Grade 4 or confirmed SJS or TEN
Cemiplimab er fremstillet ved rekombinant DNA-teknologi i cellesuspensionskultur med ovarieceller fra kinesiske hamstre (CHO). 
Cemiplimab is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture.
Artritis j 
Arthritis j
Grad 3 eller 4 (eksklusive endokrinopatier) eller tilbagevendende grad 2 
Grade 3 or 4 (excluding endocrinopathies) or recurrent Grade 2
Bekræftet objektiv responsrate (ORR) a 
Confirmed objective response rate (ORR)
Hos patienter med lokalt avanceret sygdom, der havde tilstrækkeligt behandlingsrespons, var kurativ kirurgi tilladt. 
If patients with locally advanced disease showed sufficient response to treatment, surgery with curative intent was permitted.
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. 
Data cut-off was Sep 20, 2018 for Groups 1 and 3 patients, and Oct 10, 2018 for Group 2 patients.
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. 
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.
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. 
Clear to slightly opalescent, colourless to pale yellow solution with a pH of 6.0 and osmolality between 300 and 360 mmol/kg.
d. Myocarditis er en sammensat term, der omfatter autoimmun myocarditis og myocarditis. 
d. Myocarditis is a composite term that includes autoimmune myocarditis and myocarditis.
Der foreligger ingen kliniske data om cemiplimabs mulige påvirkning af fertilitet. 
No clinical data are available on the possible effects of cemiplimab on fertility.
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. 
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.
Effektresultater for Studie 1540 er vist i tabel 3. 
Efficacy results for Study 1540 are presented in Table 3.
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. 
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.
Der blev ikke påvist klinisk betydningsfulde forskelle i eksponering for cemiplimab mellem patienter med nedsat nyrefunktion og patienter med normal nyrefunktion. 
No clinically important differences in the exposure of cemiplimab were found between patients with renal impairment and patients with normal renal function.
Blandt patienterne med mCSCC havde 76,5 % fjernmetastaser, og 22,6 % havde kun lymfemetastaser. 
Among patients with mCSCC, 76.5% had distant metastases, and 22.6% had only nodal metastases.
Der sås ingen tegn på ændringer i den farmakokinetiske profil eller i sikkerhedsprofilen med udvikling af anti-cemiplimab-antistof. 
There was no evidence of an altered pharmacokinetic or safety profile with anti-cemiplimab antibody development.
Indehaveren af markedsføringstilladelsen skal undersøge biomarkører for at bekræfte, at PD-L1-ekspression ikke er en prædiktiv faktor for virkning. 
The MAH should investigate biomarkers in order to confirm that PD-L1 expression is not predictive of efficacy.
Hvis du har glemt en behandling 
If you miss an appointment
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]. 
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].
Hyperthyreoidisme bør håndteres i henhold til medicinsk standardpraksis (se pkt. 
Hyperthyroidism should be managed according to standard medical practice (see section 4.2).
Klargøring og administration 
Preparation and administration
Initiér behandling med antihyperglykæmika som klinisk indiceret 
Initiate treatment with anti-hyperglycaemics as clinically indicated
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). 
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).
Observeret med LIBTAYO eller med andre monoklonale anti-PD-1-/anti-PD-L1-antistoffer 
b Observed with LIBTAYO or with other anti-PD-1/PD-L1 monoclonal antibodies
• diarré (løs afføring). 
• diarrhoea (loose stools).
Der er ikke behov for dosisjustering til ældre patienter. 
No dose adjustment is recommended for elderly patients.
Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler end dem, der er anført under pkt. 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.