FrancophonIA/ELRC3.0 huggingface dataset:
English: • Flu-like illness (includes feeling of fever, muscle aches)
Danish: • Influenzalignende sygdom (herunder feberfornemmelser, muskelsmerter)
English: Blood creatinine increased, amylase increased, lipase increased, gamma-glutamyltransferase increased, blood alkaline phosphatase increased, blood creatine phosphokinase increased, blood thyroid stimulating hormone decreased, transaminases increased
Danish: Forhøjet kreatinin i blodet, forhøjet amylase, forhøjet lipase, forhøjet gamma-glutamyltransferase, forhøjet basisk phosphatase i blodet, forhøjet kreatinphosphokinase i blodet, nedsat tyroideastimulerende hormon i blodet, forhøjede transaminaser
English: 12-month PFS rate by K-M, (95% CI)** 52.4% (47.4, 57.2) 18-month PFS rate by K-M, (95% CI)** 43.9% (38.8, 49.0)
Danish: 12-måneders PFS-rate ved K-M, (95 % CI)** 52,4% (47,4; 57,2) 18-måneders PFS-rate ved K-M, (95 % CI)** 43,9% (38,8; 49,0)
English: The median time to onset of Type 1 diabetes mellitus was 1.9 months (range: 1.1 months to 7.3 months).
Danish: Mediantiden til type 1 diabetes mellitus opstod var 1,9 måneder (interval: 1,1 måneder til 7,3 måneder).
English: AST or ALT greater than 5 times ULN or total bilirubin greater than 3 times ULN
Danish: ASAT eller ALAT over 5 gange ULN eller totalt bilirubin over 3 gange ULN
English: Objective response rate (ORR)
Danish: Objektiv responsrate (ORR)
English: In order to confirm the efficacy for chemotherapy-naïve treated patients, the MAH should submit the final results of study EMR 100070-003 - Part B.
Danish: For at bekræfte virkningen hos kemoterapi-naive patienter, der behandles, skal indehaveren af markedsføringstilladelsen indsende de endelige resultater af studiet EMR100070-003 - del B.
English: Tumour samples were evaluated for PD-L1 tumour cell expression, and for Merkel cell polyomavirus (MCV) using an investigational immunohistochemistry (IHC) assay.
Danish: Tumorprøver blev undersøgt for PD-L1-ekspression på tumorceller og for Merkelcelle-polyomavirus (MCV) med en eksperimentel immunhistokemisk test (IHC).
English: Figure 4: Forest plot of progression-free survival based on BICR assessment in patients irrespective of PD-L1 expression
Danish: Figur 4: Forest-afbildning af progressionsfri overlevelse baseret på BICR-vurdering hos patienter uanset ekspression af PD-L1
English: If you stop receiving Bavencio
Danish: Hvis du holder op med at få Bavencio
English: The following side effects have been reported in clinical trials with avelumab in combination with axitinib:
Danish: De følgende bivirkninger er blevet indberettet i de kliniske studier med avelumab i kombination med axitinib:
English: There are insufficient data in patients with moderate or severe hepatic impairment for dosing recommendations.
Danish: Der er ikke tilstrækkelige data for patienter med moderat eller svært nedsat leverfunktion til doseringsanbefalinger.
English: Weight decreased, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased
Danish: Meget almindelig Vægttab, forhøjet alaninaminotransferase (ALAT), forhøjet aspartataminotransferase (ASAT)
English: Objective response rate (ORR) n (%) (95% CI)
Danish: Objektiv responsrate (ORR) n (%) (95% CI)
English: Type 1 diabetes mellitus Avelumab can cause Type 1 diabetes mellitus, including diabetic ketoacidosis (see section 4.8).
Danish: Type 1 diabetes mellitus Avelumab kan forårsage type 1 diabetes mellitus, herunder diabetisk ketoacidose (se pkt.
English: • Decrease in the number of red blood cells
Danish: • Nedsat antal røde blodlegemer
English: Other medicines and Bavencio
Danish: Brug af anden medicin sammen med Bavencio
English: Other clinically important immune-related adverse reactions were reported in less than 1% of patients: myositis, hypopituitarism, uveitis, and Guillain-Barré syndrome (see section 4.8).
Danish: Andre klinisk vigtige immunrelaterede bivirkninger blev rapporteret hos under 1 % af patienterne: myositis, hypopituitarisme, uveitis, og Guillain-Barrés syndrom (se pkt.
English: Initiate treatment with insulin for Type 1 diabetes mellitus.
Danish: Behandling med insulin påbegyndes ved type 1 diabetes mellitus.
English: In this patient population, the most common adverse reactions were diarrhoea (62.8%), hypertension (49.3%), fatigue (42.9%), nausea (33.5%), dysphonia (32.7%), decreased appetite (26.0%), hypothyroidism (25.2%), cough (23.7%), headache (21.3%), dyspnoea (20.9%), and arthralgia
Danish: Hos denne patientpopulation var de mest almindelige bivirkninger diarré (62,8 %), hypertension (49,3 %), træthed (42,9 %), kvalme (33,5 %), dysfoni (32,7 %), nedsat appetit (26,0 %), hypotyroidisme (25,2 %), hoste (23,7 %), hovedpine (21,3 %), dyspnø (20,9 %) og artralgi (20,9 %).
English: Clear, colourless to slightly yellow solution.
Danish: Klar, farveløs til let gullig opløsning.
English: Elderly No dose adjustment is needed for elderly patients (≥ 65 years) (see sections 5.1 and 5.2).
Danish: Ældre Dosisjustering er ikke nødvendig for ældre patienter (≥ 65 år) (se pkt.
English: Twenty-eight (90.3%) of the 31 patients received high dose corticosteroids for a median of 2.4 weeks (range: 1 day to 10.2 months).
Danish: 28 (90,3 %) ud af 31 patienter fik højdosis kortikosteroider i en median periode på 2,4 uger (interval: 1 dag til 10,2 måneder).
English: Infusion-related reactions, which might be severe, have been reported in patients receiving avelumab (see section 4.8).
Danish: Infusionsrelaterede reaktioner, som kan være svære, er blevet rapporteret hos patienter, der fik avelumab (se pkt.
English: Avelumab is a human immunoglobulin G1 (IgG1) monoclonal antibody directed against programmed death ligand 1 (PD-L1).
Danish: Avelumab er et humant immunoglobulin G1 (IgG1) monoklonalt antistof rettet mod liganden for programmeret celledød 1 (PD-L1).
English: Product-Limit Survival Estimate (N=116)
Danish: Produktgrænse overlevelsesestimat (N = 116)
English: Excipients: Mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injections.
Danish: Hjælpestoffer: Mannitol, koncentreret eddikesyre, polysorbat 20, natriumhydroxid, vand til injektionsvæsker.
English: Colitis*, autoimmune colitis*, enterocolitis*, ileus
Danish: Ikke almindelig Colitis*, autoimmun colitis*, enterocolitis*, ileus Sjælden
English: • inflammation of your intestines (colitis), diarrhoea (watery, loose or soft stools) or more bowel movements than usual;
Danish: • tarmbetændelse (colitis), diarré (vandig, løs eller blød afføring) eller flere afføringer end normalt,
English: Adrenal insufficiency resolved in 1 patient with corticoid treatment at the time of data cut-off.
Danish: Binyreinsufficiens gik væk hos 1 patient efter kortikoidbehandling på tidspunktet for data cut-off.
English: Hepatitis, hepatotoxicity, immune-mediated hepatitis, liver disorder
Danish: Hepatitis, hepatotoksicitet, immunmedieret hepatitis, leversygdom
English: The management guidelines for these adverse reactions are described in section 4.4.
Danish: Retningslinjerne for behandling af disse bivirkninger er beskrevet i pkt.
English: • Recurrent Grade 3 immune-related adverse reaction
Danish: • Tilbagevendende grad 3 immunrelateret bivirkning
English: Preparation and administration An aseptic technique for the preparation of the solution for infusion should be used.
Danish: Forberedelse og administration Anvend aseptisk teknik for at forberede infusionsvæsken, opløsningen.
English: Complete response (CR)** n (%) Partial response (PR)** n (%)
Danish: Komplet respons (complete response, CR)** n (%) Partielt respons (partial response, PR)** n (%)
English: • Signs of type 1 diabetes may include feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, and feeling tired.
Danish: • Tegn på type 1 diabetes kan omfatte en større sult- eller tørstfølelse end normalt, et hyppigere vandladningsbehov, vægttab og træthedsfølelse.
English: Hepatotoxicity occurred in patients treated with avelumab in combination with axitinib with higher than expected frequencies of Grade 3 and Grade 4 ALT and AST elevation compared to avelumab alone (see section 4.8).
Danish: Der opstod hepatotoksicitet hos patienter i behandling med avelumab i kombination med axitinib med højere end forventede hyppigheder af grad 3 og grad 4 ALAT- og ASAT-forhøjelser, sammenlignet med avelumab alene (se pkt.
English: Avelumab pharmacokinetics (PK) was assessed using a population PK approach for avelumab as monotherapy and avelumab in combination with axitinib.
Danish: Farmakokinetikken for avelumab blev vurderet ved brug af en population til at undersøge farmakokinetikken for avelumab som monoterapi, og avelumab i kombination med axitinib.
English: Positive (n=19) Negative (n=55)
Danish: Positiv (n = 19) Negativ (n = 55)
English: If you are breast-feeding, tell your doctor.
Danish: Hvis du ammer, skal du fortælle det til lægen.
English: Positive (n=58) Negative (n=16)
Danish: Positiv (n = 58) Negativ (n = 16)
English: No clinically important differences in the clearance of avelumab were found between patients with mild hepatic impairment (bilirubin ≤ ULN and AST > ULN or bilirubin between 1 and 1.5 times ULN, n=217) and normal hepatic function (bilirubin and AST ≤ ULN, n=1,388) in a population PK analysis.
Danish: Der blev ikke fundet nogen klinisk vigtige forskelle i clearance af avelumab mellem patienter med let nedsat leverfunktion (bilirubin ≤ ULN og ASAT > ULN eller bilirubin fra 1 til 1,5 gange ULN, n = 217) og normal leverfunktion (bilirubin og ASAT ≤ ULN, n = 1.388) i en populationsfarmakokinetisk analyse.
English: Avelumab should be withheld in the event of suspected immune-related myocarditis.
Danish: Avelumab bør tilbageholdes i tilfælde af formodet immunrelateret myokarditis.
English: No interaction studies have been conducted with avelumab.
Danish: Der er ikke udført interaktionsstudier med avelumab.
English: However, in murine models of pregnancy, blockade of PD-L1 signalling has been shown to disrupt tolerance to the foetus and to result in an increased foetal loss (see section 5.3).
Danish: I murine(mus) drægtighedsmodeller har blokeringen af PD-L1-signalering vist forstyrrelse i tolerancen over for fosteret, og medført et øget fostertab (se pkt.
English: Handling instructions
Danish: Håndteringsanvisninger
English: Concentrate for solution for infusion (sterile concentrate).
Danish: Koncentrat til infusionsvæske, opløsning (koncentrat, sterilt).
English: Table 6 summarises the subsequent interim analysis of efficacy endpoints including an estimate of the 6-month rates by Kaplan-Meier for DOR and PFS, in patients receiving avelumab at the recommended dose for study EMR100070-003, Part B.
Danish: Tabel 6 opsummerer den efterfølgende interimanalyse af effektendepunkter, herunder et estimat af hyppighederne for DOR og PSF efter 6 måneder ved Kaplan-Meier, hos patienter, der fik avelumab ved den anbefalede dosis for studie EMR100070-003, del B.
English: In this patient population, the most common adverse reactions with avelumab were fatigue (32.4%), nausea (25.1%), diarrhoea (18.9%), decreased appetite (18.4%), constipation (18.4%), infusion-related reactions (17.1%), weight decreased (16.6%), and vomiting (16.2%).
Danish: Hos denne patientpopulation var de mest almindelige bivirkninger med avelumab træthed (32,4 %), kvalme (25,1 %), diarré (18,9 %), nedsat appetit (18,4 %), obstipation (18,4 %), infusionsrelaterede reaktioner (17,1 %), vægttab (16,6 %) og opkastning (16,2 %).
English: Immune-related nephritis and renal dysfunction Avelumab can cause immune-related nephritis (see section 4.8).
Danish: Immunrelateret nefritis og nyredysfunktion Avelumab kan forårsage immunrelateret nefritis (se pkt.
English: Animal reproduction studies have not been conducted with avelumab.
Danish: Der er ikke udført reproduktionsstudier hos dyr med avelumab.
English: Immune-related hepatitis
Danish: Immunrelateret hepatitis
English: Avelumab has not been studied in patients with moderate hepatic impairment (bilirubin between 1.5 and 3 times ULN) or severe hepatic impairment (bilirubin > 3 times ULN).
Danish: Avelumab er ikke blevet undersøgt hos patienter med moderat nedsat leverfunktion (bilirubin fra 1,5 til 3 gange ULN) eller svært nedsat leverfunktion (bilirubin > 3 gange ULN).
English: After opening
Danish: efter fortynding
English: Common (may affect up to 1 in 10 people)
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer)
English: For Grade 3 or Grade 4 infusion-related reactions, the infusion should be stopped and avelumab should be permanently discontinued (see section 4.2).
Danish: Ved infusionsrelaterede reaktioner af grad 3 eller grad 4 skal infusionen stoppes, og avelumab skal seponeres permanent (se pkt.
English: Minimum, maximum (months) ≥ 3 months by K-M, (95% CI) ≥ 6 months by K-M, (95% CI) ≥ 12 months by K-M, (95% CI)
Danish: Minimum, maksimum (måneder) ≥ 3 måneder ved K-M, (95 % CI) ≥ 6 måneder ved K-M, (95 % CI) ≥ 12 måneder ved K-M, (95 % CI)
English: Thyroid disorders resolved in 15 (12.4%) of the 121 patients at the time of data cut-off.
Danish: Tyreoideasygdommene gik væk hos 15 (12,4 %) af de 121 patienter på tidspunktet for data cut-off.
English: • Recommendation to consult the package leaflet
Danish: • Anbefaling om at se indlægssedlen
English: Figure 2: Kaplan-Meier estimates of progression-free survival (PFS) per RECIST v1.1, IERC (Part B, N=116)
Danish: Figur 2: Kaplan-Meier-estimater for progressionsfri overlevelse (PFS) pr. RECIST v1.1, IERC (del B, N=116)
English: • Decrease in the number of a type of white blood cells (lymphocytes)
Danish: • Nedsat antal af en type af hvide blodlegemer (lymfocytter)
English: Patients should be monitored for clinical signs and symptoms of endocrinopathies.
Danish: Patienterne skal overvåges for kliniske tegn og symptomer på endokrinopatier.
English: The required volume of Bavencio should be withdrawn from the vial(s) and be transferred to the infusion bag.
Danish: Det rette volumen Bavencio skal trækkes up af hætteglasset/hætteglassene, og overføres til infusionsposen.
English: Do not freeze or shake the diluted solution.
Danish: Den fortyndede opløsning må ikke nedfryses eller omrystes.
English: Immune-related myocarditis
Danish: Immunrelateret myokarditis
English: • Signs of liver problems, including inflammation of the liver (hepatitis) may include yellowing of your skin (jaundice) or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea coloured), bleeding or bruising more easily than normal, feeling less hungry than usual, tiredness or abnormal liver function tests.
Danish: • Tegn på leverproblemer, herunder leverbetændelse (hepatitis) kan omfatte gulfarvning af huden (gulsot) eller det hvide i øjnene, svær kvalme eller opkastning, smerter i højre side af maveområdet (abdomen), døsighed, mørk urin (tefarvet), større tendens til blødning eller blå mærker end normalt, mindre sultfølelse end normalt, træthed eller unormale leverfunktionsprøver.
English: Figure 3: Kaplan-Meier estimates for progression-free survival based on BICR assessment in patients irrespective of PD-L1 expression
Danish: Figur 3: Kaplan-Meier-estimater for progressionsfri overlevelse baseret på BICR-bedømmelsen hos patienter uanset ekspression af PD-L1
English: Fertility studies have not been conducted with avelumab.
Danish: Der er ikke udført fertilitetsstudier med avelumab.
English: Immune-related thyroid disorders, immune-related adrenal insufficiency, and Type 1 diabetes mellitus have been reported in patients receiving avelumab (see section 4.8).
Danish: Immunrelaterede tyreoideasygdomme, immunrelateret binyreinsufficiens og type 1 diabetes mellitus er blevet rapporteret hos patienter, der fik avelumab (se pkt.
English: Adverse reactions Infections and infestations
Danish: Bivirkninger Infektioner og parasitære sygdomme
English: SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Danish: SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER BETINGEDE VILKÅR
English: Assessment of tumour status was performed at baseline, after randomisation at 6 weeks, then every 6 weeks thereafter up to 18 months after randomisation, and every 12 weeks thereafter until documented confirmed disease progression by BICR.
Danish: Vurderingen af tumorstatus blev udført ved baseline, efter randomisering efter 6 uger, derefter hver 6. uge op til 18 måneder efter
English: For suspected immune-related adverse reactions, adequate evaluation should be performed to confirm aetiology or exclude other causes.
Danish: Der skal udføres en tilstrækkelig evaluering af formodede, immunrelaterede bivirkninger for at bekræfte ætiologien eller udelukke andre årsager.
English: Immune-related hepatitis resolved in 27 (87.1%) of the 31 patients at the time of data cut-off.
Danish: Immunrelateret hepatitis gik væk hos 27 (87,1 %) af de 31 patienter på tidspunktet for data cut-off.
English: Adrenal insufficiency*, hyperthyroidism*, thyroiditis*, autoimmune thyroiditis*, adrenocortical insufficiency acute*, autoimmune hypothyroidism*, hypopituitarism*
Danish: Ikke almindelig Binyreinsufficiens*, hypertyroidisme*, tyroiditis*, autoimmun tyroiditis*, akut binyrebarkinsufficiens*, autoimmun hypotyroidisme*, hypopituitarisme*
English: Adverse reactions Blood and lymphatic system disorders
Danish: Bivirkninger Blod og lymfesystem
English: • Patient Information brochure
Danish: • Patientinformationskort
English: Pancreatitis*
Danish: Pankreatitis*
English: For information on the posology of axitinib, please refer to the axitinib product information.
Danish: For oplysninger om doseringen af axitinib henvises til produktinformationen for axitinib.
English: • Signs of inflammation of the lungs (pneumonitis) may be breathing difficulties or cough.
Danish: • Tegn på betændelse i lungerne (pneumonitis) kan være vejrtrækningsbesvær eller hoste.
English: Two fatal cases have been reported in patients receiving avelumab in combination with axitinib (see section 4.8).
Danish: To tilfælde med dødelig udgang er blevet rapporteret hos patienter, der fik avelumab i kombination med axitinib (se pkt.
English: Merkel cell carcinoma
Danish: Merkelcelle-karcinom
English: In patients treated with avelumab in combination with axitinib, 24.7% (121/489) of patients developed immune-related thyroid disorders, including 111 (22.7%) patients with hypothyroidism, 17 (3.5%) with hyperthyroidism, and 7 (1.4%) with thyroiditis.
Danish: Hos patienter behandlet med avelumab i kombination med axitinib udviklede 24,7 % (121/489) af patienterne immunrelaterede tyreoideasygdomme, herunder 111 (22,7 %) patienter med hypotyroidisme, 17 (3,5 %) med hypertyroidisme og 7 (1,4 %) med tyroiditis.
English: Median PFS, months (95% CI) 3-month PFS rate by K-M, (95% CI) 6-month PFS rate by K-M, (95% CI) 12-month PFS rate by K-M, (95% CI) CI: Confidence interval; RECIST: Response Evaluation Criteria in Solid Tumours; IERC: Independent Endpoint Review Committee; K-M: Kaplan-Meier * Efficacy data with a minimum follow-up of 7 months (cut-off date 14 September 2018) ** CR or PR was confirmed at a subsequent tumour assessment a Based on number of patients with confirmed response (CR or PR)
Danish: Median PFS, måneder (95 % CI) 3 måneders PFS-rate ved K-M, (95 % CI) 6 måneders PFS-rate ved K-M, (95 % CI) 12 måneders PFS-rate ved K-M, (95 % CI) CI: Konfidensinterval; RECIST: Response Evaluation Criteria in Solid Tumours; IERC: Independent Endpoint Review Committee; K-M: Kaplan-Meier * Effektdata med en minimumsopfølgning på 7 måneder (cut-off-dato 14. september 2018) ** CR eller PR blev bekræftet ved en efterfølgende tumorvurdering a Baseret på antallet af patienter med et bekræftet respons (CR eller PR)
English: Confirmed myocarditis
Danish: Bekræftet myokarditis
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer)
English: • Signs of infusion-related reactions such as shortness of breath or wheezing, chills or shaking,
Danish: • Tegn på infusionsrelaterede reaktioner, såsom stakåndethed eller hvæsende vejrtrækning,
English: Efficacy endpoints (Part A) (per RECIST v1.1, IERC)
Danish: Endepunkter for effekt (del A) (pr. RECIST v1.1, IERC)
English: Table 2: Adverse reactions in patients treated with avelumab as monotherapy in clinical study EMR100070-003 and adverse reactions from a phase I study (EMR100070-001) in solid tumours
Danish: Tabel 2: Bivirkninger hos patienter i behandling med avelumab som monoterapi i klinisk studie EMR100070-003 og bivirkninger fra et fase I-studie (EMR100070-001) af solide tumorer
English: Adrenal insufficiency resolved in 4 (44.4%) of the 9 patients at the time of data cut-off.
Danish: Binyreinsufficiens gik over hos 4 (44,4 %) af de 9 patienter på tidspunktet for data cut-off.
English: • Signs of inflammation of the heart (myocarditis) may include trouble breathing, dizziness or fainting, fever, chest pain and chest tightness or flu like symptoms.
Danish: • Tegn på betændelse i hjertet (myokarditis) kan omfatte vejrtrækningsbesvær, svimmelhed eller besvimelse, feber, brystsmerter og trykken for brystet eller influenzalignende symptomer.
English: Blockade of PD-L1 signalling has been shown in murine models of pregnancy to disrupt tolerance to the foetus and to result in an increase in foetal loss.
Danish: Hvis PD-L1-signallering blokeres, har det vist sig at forstyrre tolerancen over for fosteret i murine drægtighedsmodeller og at føre til et øget fostertab.
English: Median PFS, months (95% CI) 6-month PFS rate by K-M, (95% CI) 12-month PFS rate by K-M, (95% CI) 24-month PFS rate by K-M, (95% CI) 36-month PFS rate by K-M, (95% CI) CI: Confidence interval; RECIST: Response Evaluation Criteria in Solid Tumours; IERC: Independent Endpoint Review Committee; K-M: Kaplan-Meier; +denotes a censored value * Efficacy data with a minimum follow-up of 36 months (cut-off date 14 September 2018) ** CR or PR was confirmed at a subsequent tumour assessment a Based on number of patients with confirmed response (CR or PR)
Danish: Median PFS, måneder (95 % CI) 6 måneders PFS-rate ved K-M, (95 % CI) 12 måneders PFS-rate ved K-M, (95 % CI) 24 måneders PFS-rate ved K-M, (95 % CI) 36 måneders PFS-rate ved K-M, (95 % CI) CI: Konfidensinterval, RECIST: Response Evaluation Criteria in Solid Tumours, IERC: Independent Endpoint Review Committee; K-M: Kaplan-Meier; + angiver en censureret værdi * Data for virkning med en minimumsopfølgning på 36 måneder (cut-off-dato 14. september 2018) ** CR eller PR blev bekræftet ved en efterfølgende tumorvurdering a Baseret på antallet af patienter med et bekræftet respons (CR eller PR)
English: Oedema peripheral, influenza like illness
Danish: Perifert ødem, influenzalignende sygdom
English: Fatigue, pyrexia, oedema peripheral
Danish: Meget almindelig Træthed, pyreksi, perifert ødem Almindelig
English: Autoimmune hepatitis*, acute hepatic failure*, hepatic failure*, hepatitis*
Danish: Ikke almindelig Autoimmun hepatitis*, akut leversvigt*, leversvigt*, hepatitis*
English: Immune-related pneumonitis
Danish: Immunrelateret pneumonitis
English: Patients should be monitored for changes in liver function and symptoms of immune-related hepatitis and causes other than immune-related hepatitis should be ruled out.
Danish: Patienterne skal overvåges for ændring af leverfunktionen og symptomer på immunrelateret hepatitis, og andre årsager end immunrelateret hepatitis skal udelukkes.
English: Patients should be monitored for signs and symptoms of immune-related myocarditis.
Danish: Patienterne skal overvåges for tegn og symptomer på immunrelateret myokarditis.
English: • Feeling less hungry, weight loss
Danish: • Mindre sultfølelse, vægttab
English: It is administered over 60 minutes as an intravenous infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or add-on filter.
Danish: Det skal administreres i løbet af 60 minutter som en intravenøs infusion med et sterilt, ikke-pyrogent, lavproteinbindende 0,2 mikrometer in-line- eller add-on-filter.
English: Grade 2 infusion-related reaction
Danish: Grad 2 infusionsrelateret reaktion