natgillin/translations-raw huggingface dataset:
Varighed af respons (duration of response, DOR) 
Duration of response (DOR)
Tabel 3: Bivirkninger hos patienter i behandling med avelumab i kombination med axitinib i klinisk studie B9991002 og B9991003 
Table 3: Adverse reactions in patients treated with avelumab in combination with axitinib in clinical studies B9991002 and B9991003
I tilfælde af tilbagevendende grad 1 eller grad 2 infusionsrelateret reaktion, kan patienten fortsætte med at få avelumab under nøje overvågning, efter passende modifikation af infusionshastigheden og præmedicinering med paracetamol og antihistamin (se pkt. 
In case of recurrence of Grade 1 or Grade 2 infusion-related reaction, the patient may continue to receive avelumab under close monitoring, after appropriate infusion rate modification and premedication with paracetamol and antihistamine (see section 4.2).
Avelumabs virkning og sikkerhed i kombination med axitinib blev vist i studie B9991003, et randomiseret, åbent multicenterstudie af avelumab i kombination med axitinib hos 886 patienter med ubehandlet fremskredent eller metastatisk RCC med en clear cell-komponent. 
The efficacy and safety of avelumab in combination with axitinib was demonstrated in study B9991003, a randomised, multicentre, open-label study of avelumab in combination with axitinib in 886 patients with untreated advanced or metastatic RCC with a clear-cell component.
• Avelumab 10 mg/kg intravenøs infusion hver 2. uge i kombination med axitinib 5 mg to gange dagligt oralt (N = 442). 
• Avelumab 10 mg/kg intravenous infusion every 2 weeks in combination with axitinib 5 mg twice daily orally (N=442).
Bavencio er kompatibelt med infusionsposer af polyethylen, polypropylen og ethylen-vinylacetat, glasflasker, infusionssæt af polyvinylchlorid og in-line-filtre med polyethersulfonmembraner med en porestørrelse på 0,2 mikrometer. 
Bavencio is compatible with polyethylene, polypropylene, and ethylene vinyl acetate infusion bags, glass bottles, polyvinyl chloride infusion sets and in-line filters with polyethersulfone membranes with pore sizes of 0.2 micrometre.
Avelumab er hyppigst forbundet med immunrelaterede bivirkninger. 
Avelumab is most frequently associated with immune-related adverse reactions.
• Tørhed i munden 
• Dryness in the mouth
I begge studier blev avelumab administreret med 10 mg/kg hver 2. uge. 
In both studies, avelumab was administered at 10 mg/kg every 2 weeks.
• Kuldefølelse 
• Feeling cold
Median, måneder (interval) 
Median, months (range)
Del A var et enkelarmet multicenter studie, hvor patienterne var diagnostiseret med histologisk bekræftet metastatisk MCC og sygdomsprogression under eller efter kemoterapi mod metastatisk sygdom, hvor den forventede levetid var over 3 måneder. 
Part A was a single-arm, multi-centre study conducted in patients with histologically confirmed metastatic MCC, whose disease had progressed on or after chemotherapy administered for distant metastatic disease, with a life expectancy of more than 3 months.
Betændelsen kan forårsage alvorlige skader på kroppen, og nogle betændelsestilstande kan være livstruende og kræve behandling, eller det kan være nødvendigt at stoppe behandlingen med Bavencio. 
Inflammation may cause serious damage to your body and some inflammatory conditions may lead to death and need treatment or withdrawal of Bavencio.
Hos symptomatiske patienter skal der udføres en gastroenterologikonsultation og laboratorieundersøgelser (herunder billeddannelse) for at sikre, at de relevante behandlinger pågyndes på et tidligt stadie. 
In symptomatic patients, obtain gastroenterology consultation and laboratory investigations (including imaging) to ensure the initiation of appropriate measures at an early stage.
Ammende kvinder bør rådes til ikke at amme under behandlingen, og i mindst 1 måned efter den sidste dosis, på grund af risikoen for alvorlige bivirkninger hos ammede spædbørn. 
Breast-feeding women should be advised not to breast-feed during treatment and for at least 1 month after the last dose due to the potential for serious adverse reactions in breast-fed infants.
Når avelumab 10 mg/kg blev administreret i kombination med axitinib 5 mg, var de tilhørende eksponeringer for avelumab og axitinib uændrede, sammenlignet med enkeltstofferne. 
When avelumab 10 mg/kg was administered in combination with axitinib 5 mg, the respective exposures of avelumab and axitinib were unchanged compared to the single agents.
I kliniske studier havde 98,6 % (433/439) af patienterne med infusionsrelaterede reaktioner en første infusionsrelateret reaktion i løbet af de første 4 infusioner, hvoraf 2,7 % (12/439) var grad ≥ 3. 
In clinical trials, 98.6% (433/439) of patients with infusion-related reactions had a first infusion-related reaction during the first 4 infusions of which 2.7% (12/439) were Grade ≥ 3.
Aspartataminotransferase (ASAT) eller alaninaminotransferase (ALAT) over 3 og op til 5 gange den øvre normalgrænse (upper limit of normal, ULN) eller totalt bilirubin over 1,5 og op til 3 gange ULN 
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 and up to 5 times upper limit of normal (ULN) or total bilirubin greater than 1.5 and up to 3 times ULN
• infusionsrelaterede reaktioner, 
• infusion-related reactions;
Kortikosteroider bør overvejes for grad ≥ 2 hændelser (se pkt. 
Corticosteroids should be considered for Grade ≥ 2 events (see section 4.2).
Avelumab er ikke blevet undersøgt hos patienter med svært nedsat nyrefunktion (GFR 15-29 ml/min). 
Avelumab has not been studied in patients with severe renal impairment (GFR 15 to 29 mL/min).
• problemer med nyrerne, 
• problems with your kidneys;
Avelumab påvirker i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner. 
Avelumab has negligible influence on the ability to drive and use machines.
Afbryd, indtil bivirkningerne bedres til grad 0-1 
Withhold until adverse reactions recover to Grade 0-1
10 ml koncentrat i et hætteglas (type I-glas) med en prop af halobutylgummi og en aluminiumsforsegling forsynet med et aftageligt plasticlåg. 
10 mL of concentrate in a vial (Type I glass) with a halobutyl rubber stopper and an aluminium seal fitted with a removable plastic cap.
Tabel 7: Virkningsresultater fra studie B9991003 hos patienter uanset ekspression af PD-L1 Effekt endepunkter (Baseret på BICR-bedømmelse) 
Table 7: Efficacy results from study B9991003 in patients irrespective of PD-L1 expression Efficacy endpoints (Based on BICR assessment)
Avelumab binder sig til PD-L1 og blokerer påvirkningen mellem PD-L1 og receptorer for programmeret celledød 1 (PD-1) og B7.1. 
Avelumab binds PD-L1 and blocks the interaction between PD-L1 and the programmed death 1 (PD-1) and B7.1 receptors.
Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri. 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
• problemer på grund af betændelse i lungerne (pneumonitis), 
• problems due to inflammation of your lungs (pneumonitis);
Der blev observeret perivaskulær mononuklær celle-infiltration i hjernen og rygsøjlen hos aber, der blev behandlet med avelumab ved ≥ 20 mg/kg i 3 måneder. 
Perivascular mononuclear cell cuffing was observed in the brain and spinal cord of monkeys treated with avelumab at ≥ 20 mg/kg for 3 months.
Disse resultater indikerer en mulig risiko for, at administration af avelumab under graviditet kunne forårsage fosterskade, herunder en øget hyppighed for abort eller dødfødsel. 
These results indicate a potential risk that administration of avelumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth.
Selvom der ikke er udført studier for at evaluere virkningen på fertilitet, var der ingen bemærkelsesværdig virkning i kønsorganerne hos hunaber, baseret på 1-måneds og 3-måneders toksicitetsstudier med gentagne doser (se pkt. 
Although studies to evaluate the effect of avelumab on fertility have not been conducted, there were no notable effects in the female reproductive organs in monkeys based on 1-month and 3-month repeat-dose toxicity studies (see section 5.3).
For renalcellekræft skal Bavencio anvendes i kombination med axitinib. 
For renal cell cancer, Bavencio is to be used in combination with axitinib.
Hvis du glemmer en dosis Bavencio 
If you miss a dose of Bavencio
• Renalcellekarcinom (RCC), en type nyrekræft, når det er fremskredent (har spredt sig videre end nyrerne eller til andre dele af kroppen). 
• Renal cell carcinoma (RCC), a type of kidney cancer, when it is advanced (has spread beyond the kidney or to other parts of the body).
Hvis du er en kvinde, som kan blive gravid, skal du bruge sikker prævention, mens du behandles med Bavencio, og i mindst 1 måned efter din sidste dosis. 
If you are a woman who could become pregnant, you must use effective contraceptives while you are being treated with Bavencio and for at least 1 month after your last dose.
Andre immunrelaterede bivirkninger (herunder myositis, hypopituitarisme, uveitis, Guillain-Barrés syndrom) 
Other immune-related adverse reactions (including myositis, hypopituitarism, uveitis, Guillain-Barré syndrome)
Blandt de 73 patienter, hvor enten avelumab (59 %) eller axitinib (85 %) blev genstartet som monoterapi eller med begge (55 %) oplevede 66 % ingen tilbagevending til ALT ≥ 3 gange ULN. 
Among the 73 patients who were rechallenged with either avelumab (59%) or axitinib (85%) monotherapy or with both (55%), 66% had no recurrence of ALT ≥ 3 times ULN.
Baseret på en farmakokinetisk populationsanalyse for avelumab som monoterapi og i kombination med axitinib er der ingen forventede klinisk betydningfulde forskelle i eksponering for avelumab mellem administration hver 2. uge med 800 mg eller 10 mg/kg. 
Based on a population PK analysis for avelumab as monotherapy and in combination with axitinib, there are no expected clinically meaningful differences in exposure of avelumab between settings administered every 2 weeks at 800 mg or 10 mg/kg.
Disse resultater indikerer en mulig risiko, baseret på virkningsmekanismen, for at administration af avelumab under graviditet kan medføre fosterskade, herunder en øget hyppighed af aborter eller dødfødsler. 
These results indicate a potential risk, based on its mechanism of action, that administration of avelumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth.
Brug ikke lægemidlet efter den udløbsdato, der står på hætteglassets etiket og æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Bivirkninger rapporteret for 88 patienter med metastatisk MCC samt for 1.650 patienter i et fase I-studie af solide tumorer vises i tabel 2. 
Adverse reactions reported for 88 patients with metastatic MCC and for 1,650 patients in a phase I study in solid tumours are presented in Table 2.
Før du får Bavencio 
Before you receive Bavencio
Spørg lægen, hvis du har spørgsmål om axitinib. 
If you have any questions about axitinib, ask your doctor.
En populationsfarmakokinetisk analyse tydede ikke på nogen forskel i den totale systemiske clearance af avelumab, baseret på alder, køn, race, PD-L1-status, tumorbyrde, nedsat nyrefunktion og let til moderat nedsat leverfunktion. 
A population pharmacokinetic analysis suggested no difference in the total systemic clearance of avelumab based on age, gender, race, PD-L1 status, tumour burden, renal impairment and mild or moderate hepatic impairment.
Den anbefalede dosis af Bavencio i kombination med axitinib er 800 mg, administreret intravenøst over 60 minutter hver 2. uge, og axitinib 5 mg der tages oralt to gange dagligt (med 12 timers mellemrum) sammen med eller uden mad indtil sygdomsprogression eller uacceptabel toksicitet. 
The recommended dose of Bavencio in combination with axitinib is 800 mg administered intravenously over 60 minutes every 2 weeks and axitinib 5 mg orally taken twice daily (12 hours apart) with or without food until disease progression or unacceptable toxicity.
Patienterne fik en median på 7 doser avelumab (interval: 1 dosis til 95 doser), og den mediane behandlingsvarighed var 17 uger (interval: 2 uger til 208 uger). 
Patients received a median of 7 doses of avelumab (range: 1 dose to 95 doses), and the median duration of treatment was 17 weeks (range: 2 weeks to 208 weeks).
(ORR) var 62,1 % (95 % CI: 42,3; 79,3) hvor der for 4 (14 %) af patienterne blev rapporteret om et komplet respons, og 14 (48 %) havde et partielt respons. 
The objective response rate (ORR) was 62.1% (95% CI: 42.3, 79.3) with 4 (14%) of patients reported to have a complete response and 14 (48%) to have a partial response.
Patienterne skal overvåges for hyperglykæmi eller andre tegn og symptomer på diabetes. 
Patients should be monitored for hyperglycaemia or other signs and symptoms of diabetes.
Samlet blev det rapporteret, at 52 (59 %) af patienterne havde fået 1 tidligere behandling mod MCC, 26 (30 %) havde fået 2 tidligere behandlinger, og 10 (11 %) havde fået 3 eller flere tidligere behandlinger. 
Overall, 52 (59%) patients were reported to have had 1 prior anti-cancer therapy for MCC, 26 (30%) with 2 prior therapies, and 10 (11%) with 3 or more prior therapies.
• Hætteglasset skal inspiceres visuelt for partikler og misfarvning. 
• The vial should be visually inspected for particulate matter and discoloration.
Det primære endepunkt for effekt for del A var det bekræftede bedste samlede respons (best overall response, BOR); sekundære endepunkter for effekt omfattede varigheden af responset (duration of response, DOR) og progressionsfri overlevelse (progression free survival, PFS). 
For Part A, the major efficacy outcome measure was confirmed best overall response (BOR); secondary efficacy outcome measures included duration of response (DOR), and progression-free survival (PFS).
• Beskrivelse af de vigtigste tegn og symptomer på de følgende sikkerhedsovervejelser, og en påmindelse om vigtigheden af straks at informere den behandlende læge, hvis symptomerne opstår, varer ved eller forværres: o Immunrelateret pneumonitis o Immunrelateret hepatitis o Immunrelateret colitis o Immunrelateret pankreatitis o Immunrelateret myokarditis o Immunrelaterede endokrinopatier (diabetes mellitus, tyreoideasygdomme, binyreinsufficiens) o Immunrelateret nefritis og nyredysfunktion o Andre immunrelaterede bivirkninger, herunder myositis, hypopituitarisme, uveitis og Guillain-Barrés syndrom) o Infusionsrelaterede reaktioner 
• Description of the main signs and symptoms of the following safety concerns and reminder of the importance of notifying their treating physician immediately if symptoms occur, persist or worsen: o Immune-Related Pneumonitis o Immune-Related Hepatitis o Immune-Related Colitis o Immune-Related Pancreatitis o Immune-Related Myocarditis o Immune-Related Endocrinopathies (diabetes mellitus, thyroid disorders, adrenal insufficiency) o Immune-related nephritis and renal dysfunction o Other immune-related adverse reactions including myositis, hypopituitarism, uveitis and Guillain-Barre Syndrome o Infusion-Related Reactions
Ubrugte dele af koncentratet eller af den fortyndede infusionsopløsning må ikke opbevares til genbrug. 
Do not store any unused portion of the concentrate or of the diluted infusion solution for reuse.
• leverbetændelse (hepatitis) eller andre leverproblemer, 
• inflammation of your liver (hepatitis) or other liver problems;
Bavencio er indiceret som monoterapi ved behandling af voksne patienter med metastatisk Merkelcelle karcinom (MCC). 
Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).
Den anbefalede dosis af Bavencio som monoterapi er 800 mg, administreret intravenøst over 60 minutter hver 2. uge. 
The recommended dose of Bavencio as monotherapy is 800 mg administered intravenously over 60 minutes every 2 weeks.
• Forhøjet antal af en type hvide blodlegemer (eosinofiler) 
• Increase in the number of a type of white blood cells (eosinophils)
Ud af de 1.738 patienter, der blev behandlet med avelumab 10 mg/kg som en intravenøs infusion hver 2. uge, kunne 1.627 evalueres for, om der opstod antidrug-antistoffer (anti-drug antibodies, ADA) under behandlingen, og 96 (5,9 %) blev testet positiv. 
Of 1,738 patients treated with avelumab 10 mg/kg as an intravenous infusion every 2 weeks, 1,627 were evaluable for treatment-emergent anti-drug antibodies (ADA) and 96 (5.9%) tested positive.
Der blev ikke fundet nogen klinisk vigtige forskelle i clearance af avelumab mellem patienter med let (glomerulær filtrationsrate (GFR) 60 til 89 ml/min, Cockcroft-Gault kreatininclearance (CrCL), n = 623), moderat (GFR 30 til 59 ml/min, n = 320) og patienter med normal (GFR ≥ 90 ml/min, n = 671) nyrefunktion. 
No clinically important differences in the clearance of avelumab were found between patients with mild (glomerular filtration rate (GFR) 60 to 89 mL/min, Cockcroft-Gault Creatinine Clearance (CrCL); n=623), moderate (GFR 30 to 59 mL/min, n=320) and patients with normal (GFR ≥ 90 mL/min, n=671) renal function.
Autoimmun colitis, autoimmun pankreatitis, enterocolitis, ileus, nekrotiserende pankreatitis 
Autoimmune colitis, autoimmune pancreatitis, enterocolitis, ileus, pancreatitis necrotizing
Seponer permanent 
Permanently discontinue
Øvrige indholdsstoffer: Mannitol, koncentreret eddikesyre, polysorbat 20, natriumhydroxid, vand til injektionsvæsker (se punkt 2 ”Bavencio har et lavt natriumindhold”). 
The other ingredients are mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injections (see section 2 “Bavencio has a low sodium content”).
Median i måneder (95 % CI) 
Median in months (95% CI)
Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) 
Very common (may affect more than 1 in 10 people)
• betændelse i musklerne (myositis). 
• inflammation of your muscles (myositis).
Kontakt lægen, før du får Bavencio: 
Talk to your doctor before receiving Bavencio:
Bavencio er et klart, farveløst til let gulligt koncentrat til infusionsvæske, opløsning (koncentrat, sterilt). 
Bavencio is a clear, colourless to slightly yellow concentrate for solution for infusion (sterile concentrate).
Data for immunrelaterede bivirkninger for avelumab som monoterapi er baseret på 1.650 patienter i fase I-studiet EMR100070-001 af solide tumorer, og 88 patienter i studie EMR100070-003, og for avelumab i kombination med axitinib er baseret på 489 patienter i studie B9991002 og B9991003 (se pkt. 
Data for immune-related adverse reactions for avelumab as a monotherapy are based on 1,650 patients in the phase I study EMR100070-001 in solid tumours and 88 patients in study EMR100070-003, and for avelumab in combination with axitinib are based on 489 patients in study B9991002 and B9991003 (see section 5.1).
Avelumab bør genoptages, når den immunrelaterede bivirkning falder til grad 1 eller derunder, efter en nedtrapning af kortikosteroider. 
Avelumab should be resumed when the immune-related adverse reaction returns to Grade 1 or less following corticosteroid taper.
Hvis opløsningen er afkølet, skal den fortyndede opløsning i de intravenøse poser have stuetemperatur før brug. 
If refrigerated, allow the diluted solution in the intravenous bags to come to room temperature prior to use.
Alle 31 patienter med immunrelateret hepatitis blev behandlet for hepatitis, herunder 30 (96,8 %) patienter behandlet med kortikosteroider, og 1 patient med et non-steroidt immunosuppressivum. 
All 31 patients with immune-related hepatitis were treated for hepatitis including 30 (96.8%) patients treated with corticosteroids and 1 patient with a non-steroidal immunosuppressant.
Fra et mikrobiologisk synspunkt bør den fortyndede opløsning infunderes straks, medmindre fortyndingsmetoden udelukker risikoen for mikrobiel kontaminering. 
From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the diluted solution should be infused immediately.
Median, måneder (95 % CI) 
Median, months (95% CI)
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Bavencio i alle undergrupper af den pædiatriske population ved behandling af Merkelcellekarcinom og renalcellekarcinom (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with Bavencio in all subsets of the paediatric population for the treatment of Merkel cell carcinoma and renal cell carcinoma (see section 4.2 for information on paediatric use).
Komplet respons (CR) n (%) Partielt respons (PR) n (%) 
Complete response (CR) n (%) Partial response (PR) n (%)
Nefritis og renaldysfunktion 
Nephritis and renal dysfunction
Alvorlige bivirkninger var immunrelaterede bivirkninger og infusionsrelateret reaktion (se pkt. 
Serious adverse reactions were immune-related adverse reactions and infusion-related reaction (see section 4.4).
Så meget Bavencio vil du modtage 
How much Bavencio you will receive
Resultater (N=116) 
Results (N=116)
Lymfopeni, eosinofili 
Lymphopenia, eosinophilia
Efter del B havde inkluderet alle, blev der udført en efterfølgende interimanalyse med 116 patienter, som fik mindst én dosis af avelumab og med mindst 7 måneders opfølgning på tidspunktet for dataafskæringen (cut-off-dato 14. september 2018). 
After Part B was fully enrolled, a subsequent interim analysis was conducted with 116 patients who received at least one dose of avelumab and with at least 7 months of follow-up at the time of the data cut-off (cut-off date 14 September 2018).
Hyppighederne defineres 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). 
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).
Bavencio indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, og derfor er det i det væsentlige natriumfrit. 
Bavencio contains less than 1 mmol sodium (23 mg) in each dose and therefore is essentially sodium-free.
Analysen af progressionsfri overlevelse (PFS) var baseret på 39 patienter, som fik mindst én dosis af avelumab med en median PFS på 9,1 måneder (95 % CI: 1,9 kunne ikke estimeres) og en estimeret PFS-rate efter 3 måneder ved Kaplan-Meier på 67 % (95% CI: 48; 80). 
Analysis of progression-free survival (PFS) was based on 39 patients who received at least one dose of avelumab, with median PFS of 9.1 months (95% CI: 1.9, not estimable) and estimated 3-month PFS rate by Kaplan-Meier of 67% (95% CI: 48, 80).
Hypotyroidisme skal behandles med erstatningsbehandling med et antityreoidea lægemiddel, efter behov. 
Hypothyroidism should be managed with replacement therapy and hyperthyroidism with anti-thyroid medicinal product, as needed.
Patienterne skal overvåges for tegn og symptomer på infusionsrelaterede reaktioner, herunder pyreksi, kulderystelser, rødme, hypotension, dyspnø, hvæsende vejrtrækning, rygsmerter, abdominalsmerter og urticaria. 
Patients should be monitored for signs and symptoms of infusion-related reactions including pyrexia, chills, flushing, hypotension, dyspnoea, wheezing, back pain, abdominal pain, and urticaria.
Positiv (n = 46) 
Positive (n=46)
• Brochure med patientinformation 
• Patient Information Brochure
Bavencio i kombination med axitinib er indiceret som førstevalgsbehandling af voksne patienter med fremskredent renalcellekarcinom (RCC) (se pkt. 
Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) (see section 5.1).
Godkendelse under betingede omstændigheder 
Conditional approval
Nedsat leverfunktion blev defineret i henhold til kriterierne for leverdysfunktion fra National Cancer Institute (NCI). 
Hepatic impairment was defined by National Cancer Institute (NCI) criteria of hepatic dysfunction.