FrancophonIA/ELRC3.0 huggingface dataset:
English: Severe adverse reactions in the endocrine glands, such as hypophysitis and thyroiditis that are not adequately controlled with hormone replacement therapy or high-dose immunosuppressive therapy
Danish: Alvorlige bivirkninger i de endokrine kirtler, som f.eks. hypophysitis og tyroiditis, som ikke er tilstrækkeligt kontrolleret med hormonsubstitutionsbehandling eller højdosis immunosuppressiv behandling
English: Patients should be monitored for clinical signs and symptoms of endocrinopathies and for hyperglycaemia and changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation).
Danish: Patienterne skal monitoreres for kliniske tegn og symptomer på endokrinopatier, hyperglykæmi og ændringer i thyroideafunktionen (i begyndelsen af behandlingen, regelmæssigt under behandlingen og som indiceret baseret på klinisk evaluering).
English: A rare disease in which our immune system makes too many of otherwise normal infection fighting cells called histiocytes and lymphocytes.
Danish: En sjælden sygdom hvor vores immunforsvar laver for mange, ellers normale, infektions-bekæmpende celler kaldet histiocytter og lymfocytter.
English: Other side effects that have been reported (frequency not known) include:  a type of skin blistering disease (called pemphigoid)  a condition where the immune system makes too many infection-fighting cells called histiocytes and lymphocytes that may cause various symptoms (called histiocytosis haematophagic)
Danish: Andre rapporterede bivirkninger (frekvens ikke kendt) inkluderer:  en type sygdom med blæredannelse på huden (kaldet pemphigoid) en tilstand hvor immunsystemet laver for mange infektions-bekæmpende celler kaldet histiocytter og lymfocytter, der kan forårsage forskellige symptomer (kaldet hæmatofagisk histiocytose)
English: The following side effects have been reported in patients receiving 3 mg/kg ipilimumab alone:
Danish: Følgende bivirkninger er blevet rapporteret hos patienter, der har fået 3 mg/kg ipilimumab alene:
English: Cases of myotoxicity (myositis, myocarditis, and rhabdomyolysis), some with fatal outcome, have been reported with ipilimumab in combination with nivolumab.
Danish: Tilfælde af myotoksicitet (myositis, myocarditis og rhabdomyolyse), herunder tilfælde med dødelig udgang, er rapporteret med ipilimumab i kombination med nivolumab.
English: Ipilimumab is a fully human anti-CTLA-4 monoclonal antibody (IgG1κ) produced in Chinese hamster ovary cells by recombinant DNA technology.
Danish: Ipilimumab er et fuldt humant anti-CTLA-4 monoklonalt antistof (IgG1κ) fremstillet ved rekombinant DNA-teknologi i ovarieceller fra kinesiske hamstre.
English: When YERVOY is given alone for the treatment of skin cancer, YERVOY will be given to you as an infusion (a drip) into a vein (intravenously) over a period of 90 minutes.
Danish: Når YERVOY gives alene til behandling af hudkræft, vil du få YERVOY som en intravenøs infusion (som drop) i en vene over en periode på 90 minutter.
English: Table 6 presents the percentage of patients with immune-related adverse reactions who were permanently discontinued from treatment with ipilimumab in combination with nivolumab.
Danish: Tabel 6 viser procentdelen af de patienter med immunrelaterede bivirkninger, der permanent fik seponeret behandlingen med ipilimumab i kombination med nivolumab.
English: Stable disease was achieved in two patients at the ipilimumab 5mg/kg dose, one with a duration of > 22 months.
Danish: Stabil sygdom blev opnået hos to patienter på ipilimumab 5 mg/kg dosis; en med en varighed på >22 måneder.
English: Life threatening skin rash (including Stevens-Johnson syndrome or toxic epidermal necrolysis) or severe widespread pruritus interfering with activities of daily living or requiring medical intervention
Danish: Livstruende hududslæt (herunder Stevens-Johnson syndrom eller toksisk epidermal nekrolyse) eller svær, udbredt pruritus, der påvirker daglige aktiviteter eller kræver medicinsk behandling
English: Patients received ipilimumab every 3 weeks for 4 doses as tolerated (induction therapy).
Danish: Patienterne fik ipilimumab hver 3. uge op til 4 doser hvis tolereret (induktionsbehandling).
English: Subsequent systemic therapy was received by 31.8%, 44.3%, and 62.2% of patients in the combination, nivolumab monotherapy, and ipilimumab arms, respectively.
Danish: Efterfølgende systemisk behandling blev modtaget af 31,8 %, 44,3 % og 62,2 % af patienterne i henholdsvis kombinationsarmen, nivolumab-armen og ipilimumab-armene.
English: Elevations in LFTs during taper may be managed with an increase in the dose of corticosteroid and a slower taper.
Danish: Forhøjede levertal under nedtrapningen kan behandles med en øget dosis kortikosteroid og en langsommere nedtrapning.
English: Pregnant monkeys received ipilimumab every 3 weeks from the onset of organogenesis in the first trimester through delivery, at exposure (AUC) levels either similar to or higher than those associated with the clinical dose of 3 mg/kg of ipilimumab.
Danish: Drægtige aber fik ipilimumab hver 3. uge fra starten af organogenesen i første trimester til fødslen ved eksponeringsniveauer (AUC), der enten svarede til eller var højere end eksponeringen ved den kliniske dosis på 3 mg/kg ipilimumab.
English: The majority of patients were male (73%) and white (87%), and 31% and 69% of patients had a baseline KPS of 70 to 80% and 90 to 100%, respectively.
Danish: Størstedelen af patienterne var mænd (73 %) og kaukasiere (87 %), og 31 % og 69 % af patienterne havde en KPS ved baseline på henholdsvis 70 til 80 % og 90 til 100 %.
English: Myasthenia gravis-like symptoms have also been reported in < 1% of patients who received higher doses of ipilimumab in clinical trials.
Danish: Myasthenia gravis-lignende symptomer er også rapporteret hos <1 % af de patienter, som fik højere doser af ipilimumab i kliniske forsøg.
English: For patients with moderate (Grade 2) neuropathy (motor with or without sensory) likely related to ipilimumab, the scheduled dose should be withheld.
Danish: Hos patienter med moderat (Grad 2) neuropati (motorisk med eller uden sensorisk komponent), der sandsynligvis er relateret til ipilimumab, bør den planlagte dosis udsættes.
English: In some cases, addition of other immunosuppressive therapy may be considered (see section 4.4).
Danish: I visse tilfælde kan samtidig behandling med anden immunsuppressiv behandling overvejes (se pkt.
English: If a patient develops signs and symptoms of myotoxicity, close monitoring should be implemented, and the patient referred to a specialist for assessment and treatment without delay.
Danish: Hvis en patient udvikler tegn og symptomer på myotoksicitet, skal patienten nøje overvåges og straks henvises til en specialist for vurdering og behandling.
English: Skin: Moderate to severe (Grade 3)b skin rash or (Grade 2)
Danish: Hud: Moderat til svær (Grad 3)b hududslæt eller (Grad 2)
English: The use of systemic corticosteroids after starting ipilimumab treatment does not appear to impair the efficacy of ipilimumab.
Danish: Brugen af systemiske kortikosteroider efter initiering af ipilimumab‑behandling synes ikke at nedsætte effekten af ipilimumab.
English: YERVOY in combination with nivolumab should be permanently discontinued for:
Danish: YERVOY i kombination med nivolumab skal seponeres permanent ved:
English: Tell your doctor immediately if you get any of these side effects.
Danish: Fortæl det straks til lægen, hvis du får et eller flere af disse bivirkninger.
English: In addition, the following uncommon (may affect up to 1 in 100 people) side effects have been reported in patients who received doses other than 3mg/kg of YERVOY in clinical trials:
Danish: Derudover er følgende ikke almindelige (kan forekomme hos færre end 1 ud af 100 personer) bivirkninger blevet rapporteret hos patienter, som i kliniske forsøg fik andre doser end 3 mg/kg YERVOY:
English: CA184004/007 Pooled
Danish: CA184004/007 Poolet
English: Talk to your doctor if you are not sure.
Danish: Tal med lægen, hvis der er noget, du er i tvivl om.
English: It is unknown whether ipilimumab is secreted in human milk.
Danish: Det er ukendt, om ipilimumab udskilles i human mælk.
English: Each ml of this medicinal product contains 0.1 mmol (or 2.30 mg) sodium.
Danish: En ml af dette lægemiddel indeholder 0,1 mmol (eller 2,30 mg) natrium.
English: Ipilimumab may selectively deplete T-regulatory cells at the tumour site, leading to an increase in the intratumoral T-effector/ T-regulatory cell ratio which drives tumour cell death.
Danish: Ipilimumab kan selektivt ødelægge regulatoriske T-celler på tumorstedet, hvilket medfører en stigning i forholdet mellem intratumorale effektor/regulatoriske T-celler, hvilket resulterer i tumorcelledød.
English: Assessments of tumour response should be conducted only after completion of induction therapy.
Danish: Vurdering af tumorrespons bør først foretages efter afslutning af induktionsbehandlingen.
English: ORR (95% CI) by tumour PD-L1 expression n=210
Danish: ORR (95 % CI) i forhold til PD-L1-tumorekspression n=210
English: Among 131 patients who discontinued the combination due to adverse reaction after 28 months of follow-up, the ORR was 71% (93/131) with 20% (26/131) achieving a complete response and median OS was not reached.
Danish: Blandt de 131 patienter, hvor kombinationen blev seponeret på grund af bivirkninger efter en opfølgningsperiode på 28 måneder, var ORR 71 % (93/131), hvoraf 20 % (26/131) opnåede komplet respons, og median OS var ikke blevet nået.
English: NA = not assessed For adults, deaths reported in this table are within 70 days of the last dose, regardless of relationship.
Danish: I denne tabel er dødsfald for voksne rapporteret indenfor 70 dage efter sidste dosis, uanset sammenhæng.
English: Unless an alternate etiology has been identified, diarrhoea, increased stool frequency, bloody stool, LFT elevations, rash and endocrinopathy must be considered inflammatory and ipilimumab-related.
Danish: Medmindre der er identificeret en alternativ ætiologi, skal diarre, hyppigere afføring, blod i afføringen, forhøjelse af levertallene, udslæt og endokrinopati betragtes som inflammatoriske og relaterede til ipilimumab.
English: However, patients with brain metastases were included in this study, if they were free of neurologic symptoms related to metastatic brain lesions and if they did not require or receive systemic corticosteroid therapy in the 10 days prior to beginning ipilimumab therapy (see section 5.1).
Danish: Imidlertid blev patienter med metastaser i hjernen inkluderet i dette forsøg, hvis de var fri for neurologiske symptomer relateret til de metastatiske hjernelæsioner, og hvis de ikke havde behov for eller havde fået systemisk behandling med kortikosteroider i 10 dage inden påbegyndelse af behandling med ipilimumab (se pkt.
English: The frequency of severe (Grade 3 or 4) hypopituitarism was reported in 3% of patients.
Danish: Svær (Grad 3 eller 4) hypopituitarisme blev rapporteret hos 3 % af patienterne.
English: A mean increase in the percent of central memory (CCR7+ CD45RA-) CD4+ and CD8+ T cells and a smaller, but significant, mean increase in the percent of effector memory (CCR7- CD45RA-) CD8+ T cells also was observed after treatment with ipilimumab.
Danish: Der blev også observeret en gennemsnitlig procentstigning i antallet af centrale hukommelses (CCR7+ CD45RA-) CD4+ og CD8+ T‑celler og en mindre, men signifikant gennemsnitlig procentstigning i antallet af effektor hukommelses (CCR7- CD45RA-) CD8+ T-celler efter behandling med ipilimumab.
English: - inflammation of the intestines (colitis) which can worsen to bleedings or bowel perforation.
Danish: - betændelse i tarmene (colitis) som kan forværres med blødning eller perforering af tarmen.
English: In clinical trials, immune-related colitis was associated with evidence of mucosal inflammation, with or without ulcerations, and lymphocytic and neutrophilic infiltration.
Danish: I kliniske forsøg var immunrelateret colitis associeret med tegn på slimhindeinflammation, med eller uden ulceration samt infiltration af lymfocytter og neutrofile granulocytter.
English: Patients should be monitored for diarrhoea and additional symptoms of colitis, such as abdominal pain and mucus or blood in stool.
Danish: Patienterne bør monitoreres for diarré og yderligere symptomer på colitis, f.eks. abdominalsmerter og slim eller blod i afføringen.
English: Additional adverse reactions not listed in Table 4 have been reported in patients who received other doses (either < or > 3 mg/kg) of ipilimumab in clinical trials of melanoma.
Danish: Yderligere bivirkninger, der ikke er anført i Tabel 4, er rapporteret hos patienter, der fik andre doser (enten < eller > 3 mg/kg) af ipilimumab i kliniske forsøg med melanom.
English: The Kaplan-Meier OS curve revealed a plateau beginning around year 3 (OS rate = 21% [95% CI: 17-24]) that extended up to 10 years in some patients (see Figure 1).
Danish: Kaplan-Meier kurven over OS viste et plateau, som begynder ved år 3 (OSr-ate = 21 % [95 % CI: 17-24]) og, som hos nogle patienter varer i op til 10 år (se figur 1).
English: Subsequent immunotherapy (including anti-PD1 therapy, anti-CTLA-4 antibody, or other immunotherapy) was received by 14.6%, 29.1%, and 44.1% of patients in the combination, nivolumab monotherapy, and ipilimumab arms, respectively.
Danish: Efterfølgende immunterapi (inklusive anti-PD1-terapi, anti-CTLA-4 antistof eller anden immunterapi) blev givet til 14,6 %, 29,1 % og 44,1 % af patienterne i henholdsvis kombinationsarmen, nivolumab-armen og ipilimumab-armen.
English: - Inflammation of the muscles such as myocarditis (inflammation of the heart muscle), myositis (inflammation of the muscles) and rhabdomyolysis (stiffness in muscles and joints, muscle spasm).
Danish: - betændelseslignende reaktion i musklerne såsom myocarditis (inflammation i hjertemusklen), myositis (inflammation i musklerne) og rhabdomyolyse (stivhed i muskler og led, muskelkramper).
English: Fatal Guillain-Barré syndrome has been reported in clinical trials.
Danish: Der er rapporteret om dødelig Guillain-Barré syndrom i kliniske forsøg.
English: Patients on controlled sodium diet
Danish: Patienter på kontrolleret saltfattig diæt
English: Sodium hydroxide (for pH-adjustment)
Danish: Natriumhydroxid (til pH-justering)
English: Studies to evaluate the mutagenic and carcinogenic potential of ipilimumab have not been performed.
Danish: Der er ikke foretaget studier for at evaluere ipilimumabs mutagene og karcinogene potentiale.
English: Patients with severe (Grade 3 or 4) endocrinopathy controlled with hormone replacement therapy may remain on therapy.
Danish: Patienter med svær (Grad 3 eller 4) endokrinopati, som kontrolleres med hormonsubstitutionsbehandling, kan eventuelt fortsætte med behandlingen.
English: Permanently discontinue treatment (see section 4.4)
Danish: Behandlingen seponeres permanent (se pkt.
English: Treatment was continued as long as clinical benefit was observed or until treatment was no longer tolerated.
Danish: Behandlingen fortsatte så længe, der kunne observeres klinisk fordel, eller indtil patienten ikke længere tålte behandlingen.
English: It is available in packs containing either 1 glass vial of 10 ml or 1 glass vial of 40 ml.
Danish: Den fås i æsker med enten 1 hætteglas a 10 ml eller 1 hætteglas a 40 ml.
English: With protocol-specified management guidelines, time to resolution ranged from 0.7 to 2 weeks.
Danish: Med protokolspecificerede retningslinjer for behandling indtrådte remission/ophør efter 0,7 til 2 uger.
English: Any other organ system adverse reactions that are considered immune-related should be graded according to CTCAE.
Danish: Alle andre bivirkninger i organsystemet, der anses for at være immunrelaterede, bør klassificeres i henhold til CTCAE.
English: In peripheral blood of patients with melanoma, a mean increase in the percent of activated HLA-DR+ CD4+ and CD8+ T cells was observed after treatment with ipilimumab, consistent with its mechanism of action.
Danish: I perifert blod fra patienter med melanom blev der observeret en gennemsnitlig procentstigning i antallet af aktiverede HLA-DR+ CD4+ and CD8+ T‑celler efter behandling med ipilimumab, svarende til dets virkningsmekanisme.
English: For ipilimumab-related uveitis, iritis, serous retinal detachment or episcleritis, topical corticosteroid eye drops should be considered as medically indicated.
Danish: Til behandling af ipilimumab-relateret uveitis, iritis, serøs nethindeløsning eller episcleritis bør kortikosteroid‑øjendråber overvejes, hvis medicinsk indiceret.
English: Rare proctitisd
Danish: Sjælden proktitd
English: STEP 1 Allow the appropriate number of vials of YERVOY to stand at room temperature for approximately 5 minutes.
Danish: TRIN 1 Lad det passende antal hætteglas med YERVOY stå ved stuetemperatur i ca. 5 minutter.
English: 1-year OS (%) (95% CI) BORR (%) (95% CI) SD (n/N)a
Danish: 1-års OS (%) (95 % CI) BORR (%) (95 % CI) SD (n/N)a
English: Disposal:
Danish: Destruktion:
English: Transfer the concentrate into a sterile, evacuated glass bottle or IV bag (PVC or non-PVC).
Danish: Overfør koncentratet til en steril, tom glasflaske eller IV pose (PVC eller non-PVC).
English: Allow the appropriate number of vials of YERVOY to stand at room temperature for approximately 5 minutes.
Danish: Lad det passende antal hætteglas med YERVOY stå ved stuetemperatur i ca. 5 minutter.
English: The potential risk of treatment to the developing foetus is unknown.
Danish: Den potentielle risiko for fostret er ukendt.
English: Physicians should consider the delayed onset of ipilimumab in combination with nivolumab effect before initiating treatment in patients with rapidly progressing disease (see section 5.1).
Danish: Lægen skal tage hensyn til den forsinkede virkning af ipilimumab i kombination med nivolumab, før behandling initieres hos patienter med hurtigt progredierende sygdom (se pkt.
English: When YERVOY is given following prior vemurafenib there may be an increased risk of skin side-effects.
Danish: Når YERVOY gives efter vemurafenib kan der være øget risiko for hudbivirkninger.
English: There are no data on the use of ipilimumab in combination with nivolumab in patients with only a non clear-cell histology in first line RCC.
Danish: Der foreligger ingen data fra anvendelse af ipilimumab i kombination med nivolumab hos førstelinje RCC-patienter med kun en non-clear cell-histologi.
English: Severe symptoms (abdominal pain, severe diarrhoea or significant change in the number of stools, blood in stool, gastrointestinal haemorrhage, gastrointestinal perforation)
Danish: Svære symptomer (mavesmerter, kraftig diarre eller signifikant ændring i hyppigheden af afføring, blod i afføringen, gastrointestinal blødning, gastrointestinal perforation)
English: Hazard ratioa 99.1% CI p-valueb,h Median (95% CI) Confirmed objective response (BICR)
Danish: 99,1 % CI p-værdib, h Median (95 % CI) Bekræftet objektivt respons (BICR)
English: OS results from this follow-up analysis are shown in Figure 5 (all randomised), Figure 6 (at the tumour PD-L1 1% cut off), and Table 10 (at the tumour PD-L1 5% cut off).
Danish: OSresultater fra denne opfølgende analyse er vist i Figur 5 (hele den randomiserede population), Figur 6 (ved tumor-PD-L1 1 % cut-off) og Tabel 10 (ved tumor-PD-L1 5 % cut-off).
English: Patients should be monitored for signs and symptoms of pneumonitis such as radiographic changes (e.g., focal ground glass opacities, patchy filtrates), dyspnoea, and hypoxia.
Danish: Patienterne skal monitoreres for tegn og symptomer på pneumonitis, f.eks. radiografiske ændringer (f.eks. små fokale matglasforandringer (ground glass opacities), pletvis infiltration), dyspnø og hypoksi.
English: - inflammation of hormone producing glands (especially the pituitary, adrenal and thyroid glands) that may affect how these glands work.
Danish: - betændelse i de hormonproducerende kirtler (især i hypofysen, binyrerne og skjoldbruskkirtlen) som kan påvirke måden, hvorpå disse kirtler virker.
English: CR+PR+SD) was 75% (6/8 patients) and 0%, respectively.
Danish: Disease Control Rate (DCR) (defineret som CR+PR+SD) var henholdsvis 75 % (6/8 patienter) og 0 %.
English: - inflammation of the nerves that can lead to paralysis.
Danish: - nervebetændelse som kan medføre lammelser.
English: Patients with ocular melanoma were not included in the CA184-169 clinical trial.
Danish: Patienter med okulært melanom blev ikke inkluderet i det kliniske forsøg CA184-169.
English: Patients with mild or moderate infusion reaction may receive ipilimumab or ipilimumab in combination with nivolumab with close monitoring and use of premedication according to local treatment guidelines for prophylaxis of infusion reactions.
Danish: Patienter, der oplever lette eller moderate infusionsreaktioner, kan få ipilimumab eller ipilimumab i kombination med nivolumab under nøje overvågning og med anvendelse af præmedicinering i henhold til gældende lokale retningslinjer for profylakse mod infusionsreaktioner.
English: Patients must be monitored for gastrointestinal signs and symptoms that may be indicative of immune-related colitis or gastrointestinal perforation.
Danish: Patienten skal monitoreres for gastrointestinale tegn og symptomer, der kan indikere immunrelateret colitis eller gastrointestinal perforation.
English: The primary efficacy population included those intermediate/poor risk patients with at least 1 or more of 6 prognostic risk factors as per the International Metastatic RCC Database Consortium (IMDC) criteria (less than one year from time of initial renal cell carcinoma diagnosis to randomisation, Karnofsky performance status <80%, haemoglobin less than the lower limit of normal, corrected calcium of greater than 10 mg/dL, platelet count greater than the upper limit of normal, and absolute neutrophil count greater than the upper limit of normal).
Danish: Den primære effektpopulation inkluderede de mellem- eller højrisikopatienter med mindst 1 eller flere af de 6 prognostiske risikofaktorer i International Metastatic RCC Database Consortium (IMDC) (mindre end et år fra diagnosetidspunktet for renalcellekarcinom til randomisering, Karnofsky Performance Status (KPS) < 80 %, hæmoglobin mindre end den nedre normalgrænse, korrigeret calcium højere end 10 mg/dl, blodpladetal højere end den øvre normalgrænse og absolut neutrofiltal højere end den øvre normalgrænse).
English: There were no reports of severe or very severe (Grade 3 or 4) adrenal insufficiency, hyperthyroidism, or hypothyroidism.
Danish: Der var ingen rapporter om svær eller meget svær (Grad 3 eller 4) binyrebarkinsufficiens, hypertyroidisme eller hypotyroidisme.
English: Caution should be used when ipilimumab is administered following prior vemurafenib.
Danish: Forsigtighed skal udvises når ipilimumab administreres efter forudgående behandling med vemurafenib.
English: Blood and lymphatic system disorders Common eosinophilia
Danish: Blod og lymfesystem Almindelig eosinofili
English: The majority (71-73%) of patients had M1c stage disease and 37-40% of patients had an elevated lactate dehydrogenase (LDH) at baseline.
Danish: Hovedparten (71-73 %) af patienterne havde sygdom på M1c‑stadiet, og 37-40 % af patienterne havde forhøjet lactatdehydrogenase (LD) ved behandlingsstart.
English: Hepatic transaminase and bilirubin must be evaluated before each dose of ipilimumab, as early laboratory changes may be indicative of emerging immune-related hepatitis (see section 4.2).
Danish: Leveraminotransferaser og bilirubin skal vurderes, inden hver ipilimumab‑dosis indgives, da tidlige laboratorieændringer kan være tegn på nyopstået immunrelateret hepatitis (se pkt.
English: If symptoms or signs of SJS or TEN appear, treatment with ipilimumab in combination with nivolumab should be discontinued and the patient referred to a specialised unit for assessment and treatment.
Danish: Hvis der opstår symptomer eller tegn på SJS eller TEN, skal behandling med ipilimumab i kombination med nivolumab seponeres og patienten henvises til en specialafdeling til vurdering og behandling.