FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on modelling of dose/exposure efficacy and safety relationships, there are no clinically significant differences in efficacy and safety between a nivolumab dose of 240 mg every 2 weeks or 3 mg/kg every 2 weeks.
Danish: En modellering af forholdet mellem dosis/eksponering i relation til effekt og sikkerhed viser ingen klinisk signifikante forskelle i effekt og sikkerhed mellem en dosis af nivolumab på 240 mg hver 2. uge eller 3 mg/kg hver 2. uge.
English: if you have previously experienced a severe skin adverse reaction on a prior cancer therapy.
Danish: hvis du før har haft en alvorlig hudbivirkning i forbindelse med en tidligere kræftbehandling.
English: See section 4.4 for detailed management guidelines.
Danish: 4.4 for udførlige retningslinjer for behandling.
English: Two patients treated with ipilimumab 10 mg/kg experienced a partial response, one of which was a durable response for more than 1 year.
Danish: To patienter behandlet med ipilimumab 10 mg/kg oplevede partiel respons, hvoraf et var et længerevarende respons på mere end 1 år.
English: (In clinical trials, methylprednisolone 2 mg/kg/day has been used).
Danish: (I kliniske forsøg har man anvendt methylprednisolon 2 mg/kg/dag).
English: In such patients, LFTs must be monitored until normalization.
Danish: Hos disse patienter skal levertallene monitoreres, indtil de igen er normale.
English: Time to resolution ranged from 0.4 to 155.4+ weeks.
Danish: Tid til resolution var 0,4 til 155,4+ uger.
English: NR = not reached
Danish: NR = not reached (ikke opnået)
English: Cmax, Cmin and AUC of ipilimumab were found to be dose proportional within the dose range examined.
Danish: Ipilimumabs Cmax, Cmin og AUC viste sig at være dosisproportionelle inden for det undersøgte dosisinterval.
English: Based on a population PK analysis using available pooled data from 565 patients from 4 phase 2 adult studies (N=521) and 2 paediatric studies (N=44), CL of ipilimumab increased with increasing baseline body weight.
Danish: Baseret på populations-PK-analyse af tilgængelige poolede data fra 565 patienter fra 4 fase 2 studier i voksne (n = 521) og 2 pædiatriske studier (n = 44) viste CL af ipilimumab sig at stige med stigende baseline kropsvægt.
English: Additionally, based on these relationships, there were no clinically significant differences between a nivolumab dose of 480 mg every 4 weeks or 3 mg/kg every 2 weeks in advanced melanoma and RCC.
Danish: Endvidere er der, baseret på disse forhold, ikke fundet klinisk signifikante forskelle mellem en dosis på 480 mg nivolumab hver 4. uge eller 3 mg/kg hver 2. uge i forbindelse med fremskredent melanom og RCC.
English: Ipilimumab was administered every 3 weeks for 4 doses and then every 12 weeks thereafter in the absence of dose limiting toxicity (DLT) and disease progression.
Danish: Ipilimumab blev administreret hver 3. uge i 4 doser og derefter hver 12. uge ved fravær af dosisbegrænsende toksicitet (DLT) og sygdomsprogression.
English: Efficacy results for the intermediate/poor risk patients are shown in Table 12.
Danish: Effektresultater hos mellem- eller højrisikopatienter er vist i tabel 12.
English: No clinically relevant pharmacokinetic drug-drug interaction was observed between ipilimumab and paclitaxel/carboplatin, dacarbazine or its metabolite, 5-aminoimidazole-4-carboxamide (AIC).
Danish: Der blev ikke observeret nogen klinisk relevant farmakokinetisk lægemiddelinteraktion mellem ipilimumab og paclitaxel/carboplatin, dacarbazin eller dets metabolit, 5-aminoimidazol-4-carboxamid (AIC).
English: In patients with melanoma who received ipilimumab, the mean peripheral blood absolute lymphocyte counts (ALC) increased throughout the induction dosing period.
Danish: Hos patienter med melanom, som fik ipilimumab, steg det gennemsnitlige absolutte lymfocyttal i perifert blod (ALC) gennem hele induktionsperioden.
English: Symptoms may also include visual field defects, behavioural changes, electrolyte disturbances, and hypotension.
Danish: Symptomerne kan også omfatte synsfeltsdefekter, adfærdsændringer, elektrolytforstyrrelser og hypotension.
English: Inspect the YERVOY concentrate for particulate matter or discoloration.
Danish: Kontroller YERVOY koncentrat for partikler eller misfarvning.
English: Elevations in LFTs may develop in the absence of clinical symptoms.
Danish: Forhøjede levertal kan opstå uden kliniske symptomer.
English: Number of Subjects at Risk
Danish: Antal forsøgspersoner i risikogruppe
English: Table 11: Objective response (CA209067)
Danish: Tabel 11: Objektiv respons (CA209067)
English: The experience from clinical trials on the management of corticosteroid-refractory diarrhoea or colitis is limited.
Danish: Erfaringen fra kliniske forsøg vedrørende behandling af kortikosteroid-refraktær diarre eller colitis er begrænset.
English: A total of 77 patients had a history of previously treated brain metastases.
Danish: I alt 77 patienter havde tidligere fået behandling for hjernemetastaser.
English: Proportion ≥12 months in duration
Danish: Andel ≥12 måneders varighed
English: If immunosuppression with corticosteroids is used to treat an adverse reaction that occurs as a consequence of combination therapy, a taper of at least 1 month duration should be initiated upon improvement.
Danish: Hvis immunsuppression med kortikosteroider anvendes til behandling af en bivirkning, der er opstået som følge af en kombinationsbehandling, skal nedtrapning over mindst 1 måned initieres, når der er opnået bedring.
English: 10 months
Danish: 10 måneder
English: How to use YERVOY 4.
Danish: Sådan skal du bruge YERVOY 4.
English: Check with your doctor or nurse before you are given YERVOY if you have an autoimmune disease (a condition where the body attacks its own cells); if you have, or have ever had, chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C (HCV); if you have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS).
Danish: Tal med lægen eller sygeplejersken, inden du får YERVOY hvis du har en autoimmun sygdom (en tilstand hvor kroppen angriber sine egne celler); hvis du har eller har haft en kronisk virusinfektion i leveren, herunder hepatitis B (HBV) eller hepatitis C (HCV);
English: No controlled studies have been conducted to evaluate the pharmacokinetics of ipilimumab in the paediatric population or in patients with hepatic or renal impairment.
Danish: Der er ikke udført kontrollerede studier for at vurdere ipilimumabs farmakokinetik i den pædiatriske population eller hos patienter med nedsat lever‑ eller nyrefunktion.
English: Infliximab must not be used if gastrointestinal perforation or sepsis is suspected (see the Summary of Product Characteristics for infliximab).
Danish: Infliximab må ikke anvendes ved mistanke om gastrointestinal perforation eller sepsis (se produktresumeet for infliximab).
English: a. Summary of the safety profile
Danish: a. Sammendrag af sikkerhedsprofilen
English: Use of ipilimumab in combination with nivolumab in melanoma patients with rapidly progressing disease.
Danish: Brug af ipilimumab i kombination med nivolumab hos patienter med melanom med hurtigt progredierende sygdom.
English: Assessment of tumour response to ipilimumab was conducted at approximately Week 12, after completion of induction therapy.
Danish: Vurdering af tumorresponset på ipilimumab blev foretaget omkring uge 12 efter afslutning af induktionsbehandlingen.
English: (95% CI) Difference in ORR (95% CI)d p-valuee,f
Danish: (95 % CI) Forskel i ORR (95 % CI)d p-værdie, f
English: Based on an exposure-response analysis in 497 patients with advanced melanoma, OS was independent of prior systemic anti-cancer therapy and increased with higher ipilimumab Cminss plasma concentrations.
Danish: Baseret på en analyse af eksponeringsrespons hos 497 patienter med fremskredent melanom var OS uafhængig af tidligere systemisk kræftbehandling og øgedes i takt med højere Cminss ipilimumab-plasmakoncentrationer.
English: It is recommended to continue treatment with YERVOY in combination with nivolumab for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
Danish: Det anbefales at fortsætte behandlingen med YERVOY i kombination med nivolumab hos klinisk stabile patienter, der indledningsvist udviser tegn på sygdomsprogression, indtil sygdomsprogression er bekræftet.
English: Median OS in the subgroup with brain metastases at baseline was 5.67 months at the recommended dose of 3 mg/kg.
Danish: Median OS i subgruppen med metastaser i hjernen ved benhandlingsstart var 5,67 måneder ved den anbefalede dosis på 3 mg/kg.
English: Unexplained motor neuropathy, muscle weakness, or sensory neuropathy lasting > 4 days must be evaluated, and non-inflammatory causes such as disease progression, infections, metabolic syndromes and concomitant medication should be excluded.
Danish: Uforklarlig motorisk neuropati, nedsat muskelkraft eller sensorisk neuropati, der varer > 4 dage skal evalueres, og ikke-inflammatoriske årsager såsom sygdomsprogression, infektioner, metaboliske syndromer og samtidig medicinering bør udelukkes.
English: 50 mg/ml (5%) glucose solution for injection
Danish: 50 mg/ml (5 %) glucose injektionsvæske
English: Ipilimumab has been shown to be present at very low levels in milk from cynomolgus monkeys treated during pregnancy.
Danish: Ipilimumab er vist at være til stede i meget små mængder i mælken hos cynomolgusaber, der blev behandlet i drægtighedsperioden.
English: Recommended treatment modifications for YERVOY in combination with nivolumab or administration of the second phase of treatment (nivolumab monotherapy) following combination treatment
Danish: Anbefalede modifikationer for YERVOY i kombination med nivolumab eller administration af anden fase af behandlingen (nivolumab monoterapi) efterfulgt af kombinationsbehandling
English: You should not be given YERVOY if you are allergic to ipilimumab or any of the other ingredients of this medicine (listed in Section 6 "Contents of the pack and other information").
Danish: Brug ikke YERVOY hvis du er allergisk over for ipilimumab eller et af de øvrige indholdsstoffer i YERVOY (angivet i afsnit 6 "Pakningsstørrelser og yderligere oplysninger").
English: Both nivolumab-containing arms demonstrated greater objective response rates than ipilimumab regardless of PD-L1 expression levels.
Danish: Begge nivolumab-arme viste større objektive responsrater end ipilimumab uanset PDL1ekspressionsniveauer.
English: If there are any signs of adrenal crisis such as severe dehydration, hypotension, or shock, immediate administration of intravenous corticosteroids with mineralocorticoid activity is recommended, and the patient must be evaluated for presence of sepsis or infections.
Danish: Hvis der er tegn på akut binyrebarkinsufficiens, som f.eks. svær dehydrering, hypotension eller shock, anbefales øjeblikkelig intravenøs administration af kortikosteroider med mineralkortikoid aktivitet, og patienten skal undersøges for sepsis eller infektioner.
English: a. Summary of safety profile
Danish: a. Sammendrag af sikkerhedsprofil
English: Patients with apparent tumour burden increase before completion of the induction period were continued on induction therapy as tolerated if they had adequate performance status.
Danish: Patienter med tydeligt øget tumorbyrde inden gennemførelse af induktionsbehandlingen, fik forlænget induktionsbehandling, hvis det blev tolereret og hvis de havde en passende performance status.
English: Clinical experience with ipilimumab-associated endocrinopathy is limited.
Danish: Den kliniske erfaring med ipilimumab-associeret endokrinopati er begrænset.
English: Increases in AST and ALT of any severity were reported in 1% and 2% of patients, respectively.
Danish: Forhøjet ASAT og ALAT uanset grad blev rapporteret hos henholdsvis 1 % og 2 % af patienterne.
English: Thereafter, nivolumab will be given as an infusion over a period of 30 or 60 minutes, every 2 weeks or 4 weeks, depending on the dose you are receiving (single-agent phase).
Danish: Herefter vil du få nivolumab som en infusion over en periode på 30 eller 60 minutter hver 2. eller 4. uge, alt afhængigt af den dosis, du modtager (enkeltstoffasen).
English: Both nivolumab-containing arms demonstrated a significant PFS and OS benefit and greater ORR compared with ipilimumab alone.
Danish: Begge nivolumab-arme viste en signifikant PFS og OS-fordel og større ORR sammenlignet med ipilimumab alene.
English: Less than 2% of patients with advanced melanoma who received ipilimumab in Phase 2 and 3 clinical trials developed antibodies against ipilimumab.
Danish: Færre end 2 % af patienterne med fremskredent melanom, som fik ipilimumab i fase 2 og 3 kliniske forsøg, udviklede antistoffer mod ipilimumab.
English: Any other adverse reactions that are demonstrated or suspected to be immune-related should be graded according to CTCAE.
Danish: Alle andre bivirkninger, som er vist eller mistænkes for at være immunrelaterede, bør klassificeres i henhold til CTCAE.
English: No patients with pre-existing severe hepatic impairment were identified in clinical studies.
Danish: Der blev ikke identificeret nogen patienter med eksisterende alvorligt nedsat leverfunktion i kliniske studier.
English: Data outside the 9 completed clinical trials in melanoma were included in frequency determinations.
Danish: Data fra andre end de 9 afsluttede kliniske melanomforsøg blev inkluderet i hyppighedsbestemmelsen.
English: Immune-related adverse reaction leading to permanent discontinuation Pneumonitis
Danish: Immunrelateret bivirkning, der førte til permanent seponering Pneumonitis
English: Contrada Fontana del Ceraso 03012 Anagni (FR) Italy
Danish: Contrada Fontana del Ceraso 03012 Anagni (FR)
English: Do not use if unusual amount of particles and signs of discoloration are present.
Danish: YERVOY må ikke anvendes, hvis der er usædvanligt mange partikler og tegn på misfarvning.
English: If dosing is resumed after a delay, either the combination treatment or nivolumab monotherapy could be resumed based on the evaluation of the individual patient.
Danish: Hvis dosering genoptages efter at have været udsat, kan enten kombinationsbehandling eller nivolumab-monoterapi genoptages baseret på en vurdering af den enkelte patient.
English: In study CA184070, no immune-related adverse reactions (irAR) ≥Grade 3 were reported for the single patient 12 years of age and older who was treated with ipilimumab 3 mg/kg.
Danish: I studie CA184070 blev ingen immunrelaterede bivirkninger (irAR) ≥Grad 3 rapporteret for den enkelte patient på 12 år eller derover, som blev behandlet med ipilimumab 3 mg/kg.
English: However, significant exposure of ipilimumab to the infant through breast milk is not expected and no effects on the breast-fed infant are anticipated.
Danish: Det forventes dog ikke, at spædbarnet eksponeres for ipilimumab i nogen betydelig grad gennem mælken, og der forventes ingen påvirkning af det ammede spædbarn.
English: Rare cases of SJS and TEN, some of them with fatal outcome, have been observed.
Danish: Der er observeret sjældne tilfælde af SJS og TEN, hvoraf nogle havde dødelig udgang.
English: Post-marketing cases of cytomegalovirus (CMV) infection/reactivation have been reported in patients with corticosteroid-refractory immune-related colitis.
Danish: Efter markedsføring er der rapporteret om tilfælde af cytomegalovirus (CMV)-infektion/reaktivering hos patienter med kortikosteroid-refraktær immunrelateret colitis.
English: Ipilimumab is associated with inflammatory adverse reactions resulting from increased or excessive immune activity (immune-related adverse reactions), likely to be related to its mechanism of action.
Danish: Ipilimumab er associeret med inflammatoriske bivirkninger forårsaget af øget eller overdreven immunaktivitet (immunrelaterede bivirkninger), hvilket sandsynligvis er relateret til dets virkningsmekanisme.
English: No new adverse drug reactions were reported in adolescents 12 years of age and older.
Danish: Ingen nye bivirkninger blev rapporteret hos unge på 12 år og derover.
English: Median and estimated rates of OS at 1 year and 2 years are presented in Table 8.
Danish: Mediane og estimerede rater for OS efter 1 år og 2 år er vist i Tabel 8.
English: Upon repeated dosing of ipilimumab administered every 3 weeks, CL was found to be time-invariant, and minimal systemic accumulation was observed as evident by an accumulation index 1.5 fold or less.
Danish: Efter gentagen dosering af ipilimumab hver 3. uge var CL tidsinvariant, og minimal systemisk akkumulering blev observeret og tydeliggjort ved et akkumuleringsindeks på 1,5 gange eller mindre.
English: Other organ systemsb: (e.g. nephritis, pneumonitis, pancreatitis, non-infectious myocarditis)
Danish: Andre organsystemerb: (f.eks. nefritis, pneumonitis, pancreatitis, ikke-infektiøs myokarditis)
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om YERVOY findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Ipilimumab in combination with nivolumab should not be resumed while the patient is receiving immunosuppressive doses of corticosteroids or other immunosuppressive therapy.
Danish: Ipilimumab i kombination med nivolumab bør ikke genoptages, mens patienten får immunsuppressive doser af kortikosteroid eller anden immunsuppressiv behandling.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC11.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, monoklonale antistoffer, ATC-kode: L01XC11.
English: The safety of re-initiating ipilimumab in combination with nivolumab therapy in patients previously experiencing immune-related myocarditis is not known.
Danish: Sikkerheden ved at genoptage behandlingen med ipilimumab i kombination med nivolumab hos patienter, der tidligere har haft immunrelateret myocarditis, kendes ikke.
English: Preparing the infusion: Take care to ensure aseptic handling when you prepare the infusion.
Danish: Klargøring af infusion: Man skal sørge for aseptisk håndtering, mens infusionen forberedes.
English: Guidelines for permanent discontinuation or withholding of doses are described in Tables 3A and 3B for YERVOY as monotherapy, and in Table 3C for YERVOY in combination with nivolumab or administration of the second phase of treatment (nivolumab monotherapy) following combination treatment.
Danish: Retningslinjer for permanent seponering eller udsættelse af doser fremgår af Tabel 3A og 3B for YERVOY som monoterapi og af Tabel 3C for YERVOY i kombination med nivolumab eller administration af anden fase af behandlingen (nivolumab som monoterapi) efterfulgt af kombinationsbehandling.
English: CA184004/ 022Pooled
Danish: CA184004/ 022Poolet
English: Overall Survival (proportion)
Danish: Samlet overlevelse (andel)
English: Pentetic acid (diethylenetriaminepentaacetic acid) Polysorbate 80
Danish: Pentetatsyre (diethylentriaminpentetatsyre) Polysorbat 80
English: Additionally, for patients who experienced an event, Table 6 presents the percentage of patients who required high-dose corticosteroids (at least 40 mg daily prednisone equivalents).
Danish: Blandt de patienter, der fik en bivirkning, viser Tabel 6 desuden procentdelen af patienter, der fik brug for højdosis-kortikosteroider (mindst ækvivalent med 40 mg prednison dagligt).
English: • Information that ipilimumab can cause serious side effects in many parts of the body that can lead to death and require early intervention, as outlined in the guidelines for the management of immune-related adverse reactions in section 4.4 of the SmPC.
Danish: • Information om, at ipilimumab kan forårsage alvorlige bivirkninger mange steder i kroppen, som kan medføre død og derfor kræver tidlig intervention, som angivet i retningslinjerne for behandling af immunrelaterede bivirkninger i pkt.
English: Evaluation of laboratory results to assess endocrine function may be performed before corticosteroid therapy is initiated.
Danish: En vurdering af laboratorieresultater som led i undersøgelse af den endokrine funktion bør udføres, inden behandlingen med kortikosteroider indledes.
English: While most immune-related adverse reactions occurred during the induction period, onset months after the last dose of ipilimumab has also been reported.
Danish: Mens de fleste immunrelaterede bivirkninger opstod i induktionsperioden, er der også rapporter om sent opståede bivirkninger måneder efter den sidste ipilimumab‑dosis.
English: CA184332 and CA184338
Danish: CA184332 og CA184338
English: Table 3B
Danish: Tabel 3B
English: Studies to evaluate the effect of ipilimumab on fertility have not been performed.
Danish: Der er ikke udført studier til vurdering af ipilimumabs virkning på fertilitet.
English: In clinical trials, mycophenolate mofetil was used in patients without response to corticosteroid therapy, or who had an LFT elevation during corticosteroid tapering that was not responsive to an increase in the dose of corticosteroids (see the Summary of Product Characteristics for mycophenolate mofetil).
Danish: I kliniske forsøg blev mycophenolatmofetil anvendt til patienter, der ikke responderede på kortikosteroid‑behandling, eller som havde forhøjede levertal under kortikosteroidnedtrapningen, og som ikke responderede på en øget dosis kortikosteroid (se produktresumeet for mycophenolatmofetil).
English: YERVOY in combination with nivolumab may cause changes in the results of tests carried out by your doctor.
Danish: YERVOY i kombination med nivolumab kan ændre resultaterne af de tests lægen har udført.
English: Treatment with YERVOY in combination with nivolumab, should be continued for the four doses of combination therapy as long as clinical benefit is observed or until treatment is no longer tolerated by the patient.
Danish: Behandling med YERVOY i kombination med nivolumab bør fortsættes for de fire doser i kombinationsterapi, så længe der observeres en klinisk gavnlig effekt, eller indtil patienten ikke længere tolererer behandlingen.
English: It is currently unknown if the corticosteroid treatment reverses the gland dysfunction.
Danish: Det vides endnu ikke, om kortikosteroid-behandling ophæver dysfynktionen i glandlen.
English: Recommended doses and infusion times for intravenous administration of ipilimumab in combination with nivolumab
Danish: Anbefalede doser og infusionstider for intravenøs administration af ipilimumab og nivolumab i kombination
English: No Grade 4 or 5 cases were reported in this study.
Danish: Ingen grad 4 eller 5 tilfælde blev rapporteret i dette studie.
English: Rates of immune-related adverse reactions in HLA-A2*0201 positive patients who received ipilimumab in MDX010-20 were similar to those observed in the overall clinical program.
Danish: Hyppigheden af immunrelaterede bivirkninger hos HLA-A2*0201‑positive patienter, som fik ipilimumab i MDX010-20, var den samme som den, der blev observeret i det samlede kliniske program.
English: A Phase 3, double-blind study enrolled patients with advanced (unresectable or metastatic) melanoma who had previously been treated with regimens containing one or more of the following: IL-2, dacarbazine, temozolomide, fotemustine, or carboplatin.
Danish: I et fase 3, dobbeltblindet studie indgik patienter med fremskredent (inoperabelt eller metastatisk) melanom, som tidligere var blevet behandlet med et regime, der indeholdt et eller flere af følgende: IL-2, dacarbazin, temozolomid, fotemustin eller carboplatin.
English: Ipilimumab was administered every 3 weeks for 4 doses.
Danish: Ipilimumab blev administreret hver 3. uge i 4 doser.
English: One female infant had unilateral renal agenesis of the left kidney and ureter, and one male infant had an imperforate urethra with associated urinary obstruction and subcutaneous scrotal edema.
Danish: En nyfødt hunabe havde unilateral renal agenesi i venstre nyre og ureter, og en nyfødt hanabe havde urethra‑atresi med urinvejsobstruktion og subkutant skrotalt ødem.
English: NCI-CTCAE v4 Gradea
Danish: NCI-CTCAE v4 Grada