FrancophonIA/ELRC3.0 huggingface dataset:
English: As the subgroups analysis includes only small numbers of patients, no definitive conclusions can be drawn from these data.
Danish: Eftersom subgruppeanalyserne kun inkluderede et lille antal patienter, kan der ikke drages nogle definitive konklusioner på baggrund af disse data.
English: In clinical trials, patients received up to 20 mg/kg without apparent toxic effects.
Danish: I kliniske forsøg fik patienter op til 20 mg/kg uden nogen åbenlys toksisk effekt.
English: These medicines may interfere with the effect of YERVOY.
Danish: Disse typer medicin kan påvirke YERVOYs virkning.
English: The development or maintenance of clinical activity following ipilimumab treatment was similar with or without the use of systemic corticosteroids.
Danish: Udviklingen eller vedligeholdelse af klinisk aktivitet efter ipilimumab‑behandling var den samme med eller uden brug af systemiske kortikosteroider.
English: No statistically significant difference in progression free survival (PFS) was observed between the 10 mg/kg and the 3 mg/kg groups.
Danish: Ingen statistisk signifikant forskel i progressionsfri overlevelse (PFS) blev observeret mellem grupperne, der fik 10 mg/kg og 3 mg/kg.
English: This study included patients regardless of their tumour PD-L1 status.
Danish: Studiet inkluderede patienter uagtet deres PD-L1 tumorstatus.
English: Sensory neuropathy may also occur.
Danish: Der kan også forekomme sensorisk neuropati.
English: An updated OS analysis was performed when all patients had a minimum follow-up of 24 months (see figure 7).
Danish: En opdateret analyse af OS blev foretaget da alle patienter havde en opfølgningsperiode på minimum 24 måneder (se Figur 7).
English: Ipilimumab has been administered to approximately 10,000 patients in a clinical program evaluating its use with various doses and tumour types.
Danish: Ipilimumab er blevet administreret til omkring 10.000 patienter i et klinisk program, der evaluerede brugen af YERVOY ved forskellige doser og tumortyper.
English: Overall survival Events
Danish: Samlet overlevelse Hændelser
English: Significant systemic exposure of the infant is not expected and no effects on the breast-fed newborn/infant are anticipated.
Danish: Der forventes ikke nogen signifikant systemisk eksponering af barnet, ligesom der ikke forventes nogen påvirkning af ammede nyfødte/spædbørn.
English: If you stop using YERVOY
Danish: Hvis du holder op med at bruge YERVOY
English: More than one vial may be necessary to obtain the required dose.
Danish: Det kan være nødvendigt at anvende mere end et hætteglas for at opnå den nødvendige dosis.
English: Symptomatic treatment (e.g. loperamide, fluid replacement) and close monitoring are advised.
Danish: Symptomatisk behandling (f.eks. loperamid, væsketilskud) og tæt monitorering tilrådes.
English: No differences in the spectrum of irARs reported in adults and the paediatric population were evident.
Danish: Ingen forskelle i spektret af irAR'er rapporteret hos børn og voksne var evidente.
English: Attribution to ipilimumab reported as Possible, Probable, Definite, or Missing for CA184178 and Adult Safety Pool, and Related or Missing for CA184070.
Danish: Sammenhæng med ipilimumab blev rapporteret som Mulig, Sandsynlig, Definitiv eller Manglende for CA184178 og Voksen Sikkerhedspool, og som Relateret eller Manglende for CA184070.
English: Additionally, developmental external or visceral abnormalities were identified in the urogenital system of 2 infants exposed in utero to ipilimumab.
Danish: Derudover blev der identificeret eksterne eller viscerale udviklingsmæssige anomalier i det urogenitale system hos 2 nyfødte, der blev eksponeret for ipilimumab in utero.
English: The adverse reaction mostly responded well to treatment with corticosteroids.
Danish: Bivirkningen responderede i de fleste tilfælde godt på behandling med kortikosteroider.
English: • Follow-up of patients due to late onset (months after treatment) of irARs
Danish: • Follow-up af patienter på grund af sene (måneder efter behandlingen) bivirkninger.
English: At the recommended dose of 3 mg/kg median OS was similar in the subgroup of females ≥ 50 years of age compared to the overall population: (11.40 vs 11.53 months).
Danish: Ved den anbefalede dosis på 3 mg/kg var median OS i subgruppen af kvinder ≥ 50 år sammenlignelig med den samlede population: (11,40 sammenlignet med 11,53 måneder).
English: A summary of adverse events in adolescents 12 years of age and older, as well as adults, is presented in Table 7.
Danish: Et sammendrag af bivirkninger hos unge på 12 år og derover, såvel som hos voksne, er vist i Tabel 7.
English: In study CA184178, no new or unexpected irARs were observed, and the observed irARs were similar in frequency, intensity and organ site to what has been reported in adult studies.
Danish: I studie CA184178 blev ingen nye eller uventede irAR'er observeret, og de observerede irAR'er var tilsvarende i frekvens, intensitet og organklasse til det, der er rapporteret i studier hos voksne.
English: Patients with cardiac or cardio-pulmonary symptoms should be assessed for potential myocarditis.
Danish: Patienter med hjerte- eller hjertelunge-symptomer skal vurderes for potentiel myocarditis.
English: The recommended infusion period is 30 or 90 minutes, depending on the dose.
Danish: Den anbefalede infusionsperiode er 30 eller 90 minutter, afhængigt af dosen.
English: Treatment should be continued in the presence of hormone replacement therapya as long as no symptoms are present
Danish: Behandlingen bør fortsættes under hormonsubstitutionsbehandlinga så længe, der ikke er symptomer
English: Be aware of important symptoms of inflammation YERVOY acts on your immune system and may cause inflammation in parts of your body.
Danish: Vær opmærksom på vigtige symptomer på inflammation (betændelseslignende tilstand) YERVOY virker på dit immunsystem og kan forårsage inflammation i dele af din krop.
English: In the two observational studies, 12.1% and 33.1% of the patients had brain metastases at the time of advanced melanoma diagnosis.
Danish: I de to observationsstudier havde 12,1 % og 33,1 % af patienterne hjernemetastaser, da diagnosen fremskredent melanom blev stillet.
English: - inflammation of the eyes.
Danish: - øjenbetændelse.
English: As YERVOY may be given in combination with nivolumab, it is important that you also read the package leaflet for this medicine.
Danish: Da YERVOY kan gives i kombination med nivolumab, er det vigtigt, at du også læser indlægssedlen for dette lægemiddel.
English: Most patients were male (58%) and white (92%).
Danish: De fleste patienter var af hankøn (58 %) og hvide (92 %).
English: Patients should receive the entire induction regimen (4 doses) as tolerated, regardless of the appearance of new lesions or growth of existing lesions.
Danish: Patienten bør få hele induktionsbehandlingen (4 doser) afhængig af tolerance, uanset eventuel opståen af nye læsioner eller vækst af allerede eksisterende læsioner.
English: Progression Free Survival per Investigator (Months)
Danish: Progressionsfri overlevelse i henhold til investigator (måneder)
English: Do not store any unused portion of the infusion solution for reuse.
Danish: Opbevar ikke nogen rester af den ikke anvendte infusionsopløsning til senere brug.
English: YERVOY is not recommended during pregnancy or in women of childbearing potential not using effective contraception, unless the clinical benefit outweighs the potential risk.
Danish: YERVOY bør ikke anvendes under graviditeten eller til kvinder i den fertile alder, som ikke anvender sikker kontraception, medmindre den kliniske fordel opvejer den potentielle risiko.
English: Median OS and estimated 1-year, 2-year, 3-year and 4-year survival rates are presented in Table 9.
Danish: Median OS og estimerede overlevelsesrater efter 1 år, 2 år, 3 år og 4 år er vist i Tabel 9.
English: Abbreviations: SAEs = serious adverse events; AEs = adverse events; irAEs = immune-related adverse events
Danish: Forkortelser: SAE'er = Alvorlige bivirkninger; AE'er = bivirkninger; irAE'er = immunrelaterede bivirkninger
English: Until administration of all 4 doses or 16 weeks from first dose, whichever occurs earlier.
Danish: Indtil administration af alle 4 doser eller 16 uger efter første dosis afhængigt af, hvad der indtræder først.
English: 14 months
Danish: 14 måneder
English: Very rare (may affect up to 1 in 10,000 people) Serious, potential life-threatening allergic reaction
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 personer) Alvorlig, muligvis livstruende allergisk reaktion
English: • Patient Information Brochures including Alert Cards
Danish: • Informationsbrochure til patienter inklusive patient-informationskort
English: • Information that ipilimumab can cause serious side effects in many parts of the body that can lead to death and need to be addressed immediately
Danish: • Information om, at ipilimumab kan forårsage alvorlige bivirkninger mange steder i kroppen, som kan medføre død og derfor skal behandles straks.
English: Adrenal crisis as a cause of the patient's symptoms must be excluded.
Danish: Akut binyrebarkinsufficiens som årsag til patientens symptomer skal udelukkes.
English: The final OS analysis occurred when all patients had a minimum follow-up of 28 months.
Danish: Den endelige analyse af OS blev foretaget da alle patienter havde haft en opfølgningsperiode på minimum 28 måneder.
English: These medicines may increase the likelihood of bleeding in the stomach or intestine, which is a sideeffect of YERVOY.
Danish: Denne type medicin kan øge risikoen for blødning i maven eller tarmene, som er en bivirkning ved YERVOY.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from available post-marketing data).
Danish: Hyppigheden er defineret som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data efter markedsføring).
English: Overall, no apparent association was observed between antibody development and adverse reactions.
Danish: Samlet set blev der ikke observeret nogen åbenlys forbindelse mellem antistofudvikling og bivirkninger.
English: The effects of ipilimumab on prenatal and postnatal development were investigated in a study in cynomolgus monkeys.
Danish: Effekten af ipilimumab på prænatal og postnatal udvikling blev undersøgt i et studie med cynomolgusaber.
English: Beginning in the third trimester, both ipilimumab groups experienced higher incidences of abortion, stillbirth, premature delivery (with corresponding lower birth weight), and infant mortality relative to control animals; these findings were dose-dependent.
Danish: I begyndelsen af tredje trimester havde begge ipilimumab‑grupper en højere forekomst af aborter, dødfødsler, præmature fødsler (med tilsvarende lavere fødselsvægt) og spædbørnsdødelighed i forhold til kontroldyrene; disse fund var dosisafhængige.
English: There are no data on the use of ipilimumab in pregnant women.
Danish: Der foreligger utilstrækkelige data fra anvendelse af ipilimumab til gravide kvinder.
English: CTLA-4 blockade can also reduce T-regulatory cell function, which may contribute to an anti-tumour immune response.
Danish: Blokering af CTLA-4 kan også reducere funktionen af regulatoriske T-celler, hvilket kan bidrage til et anti-tumor-immunrespons.
English: Bristol-Myers Squibb Company 6000 Thompson Road East Syracuse, New York 13057 United States
Danish: Bristol‑Myers Squibb Company 6000 Thompson Road East Syracuse, New York 13057 USA
English: Additional treatment with ipilimumab (re-treatment) was offered to those who developed PD after initial clinical response (PR or CR) or after SD (per the modified WHO criteria) > 3 months from the first tumour assessment.
Danish: Yderligere behandling med ipilimumab (genbehandling) blev tilbudt de patienter, som udviklede PD efter initialt klinisk respons (PR eller CR) eller efter SD (ifølge modificerede WHO kriterier) > 3 måneder fra den første tumorvurdering.
English: Grade 3 or 4 motor or sensory neuropathy
Danish: Grad 3 eller 4 motorisk eller sensorisk neuropati
English: Feeling tired or weak is a very common side effect of YERVOY.
Danish: Træthed og svaghedsfølelse er en meget almindelig bivirkning ved YERVOY.
English: You will be treated with YERVOY once every 3 weeks, for a total of 4 doses.
Danish: Du vil blive behandlet med YERVOY en gang hver 3. uge med i alt 4 doser.
English: Ipilimumab steady-state was reached by the third dose.
Danish: Steady-state for ipilimumab blev nået ved den tredje dosis.
English: YERVOY is for intravenous use.
Danish: YERVOY er til intravenøs anvendelse.
English: Ipilimumab should be avoided in patients with severe active autoimmune disease where further immune activation is potentially imminently life threatening.
Danish: Ipilimumab bør undgås hos patienter med alvorlig aktiv autoimmun sygdom, hvor yderligere immunaktivering er potentielt livstruende.
English: The estimated geometric mean CL is 8.72 mL/h in adolescent patients aged ≥12 to <18 years.
Danish: Det estimerede geometriske gennemsnit af CL er 8,72 ml/time for unge patienter i alderen ≥ 12 til < 18 år.
English: YERVOY contains the active substance ipilimumab, a protein which helps your immune system to attack and destroy cancer cells by your immune cells.
Danish: YERVOY indeholder det aktive stof ipilimumab, som er et protein, der hjælper immunsystemet med at angribe og ødelægge kræftceller.
English: • Reminder to distribute the Patient Information Brochure, and to educate patients/caregivers about symptoms of irARs and of the need to report them immediately to the physician.
Danish: • En påmindelse om at udlevere informationsbrochuren til patienterne og oplyse patienter/plejere om symptomerne på immunrelaterede bivirkninger og nødvendigheden af straks at rapportere dem til lægen.
English: A decrease in the weight of the thyroid and testes was seen in one study without accompanying histopathologic findings; the clinical relevance of this finding is unknown.
Danish: Der er observeret nedsat vægt af skjoldbruskkirtlen og testis i et studie uden ledsagende histopatologiske fund; den kliniske relevans af disse fund er ukendt.
English: Management recommendations for diarrhoea or colitis are based on severity of symptoms (per NCI-CTCAE v4 severity grading classification).
Danish: Anbefalinger for behandling af diarre eller colitis er baseret på symptomernes sværhedsgrad (ifølge NCI-CTCAE v4 graduering af sværhedsgrad).
English: In addition, any signs or symptoms of immune-related adverse reactions, including diarrhoea and colitis, must be assessed during treatment with YERVOY (see Tables 3A, 3B, and section 4.4).
Danish: Derudover skal alle tegn eller symptomer på immunrelaterede bivirkninger, herunder diarre og colitis, vurderes under behandling med YERVOY (se Tabel 3A, 3B og pkt.
English: (HR 0.89 with a 95% CI of 0.76, 1.04 and log-rank test P-value = 0.1548).
Danish: (HR 0,89 med et 95 % CI på 0,76; 1,04 og log-rank test P-værdi = 0,1548).
English: To dilute the YERVOY concentrate, you can use either:
Danish: Til fortynding af YERVOY koncentrat kan der anvendes enten:
English: Based on the simulation in adults and paediatrics, comparable exposure is achieved in adults and paediatrics at the recommended dose of 3 mg/kg every 3 weeks.
Danish: Baseret på en simulering i voksne og pædiatriske patienter blev sammenlignelig eksponering opnået hos voksne og pædiatriske patienter ved den anbefalede dosis på 3 mg/kg hver 3. uge.
English: • Obligation to conduct post-authorisation measure
Danish: • Forpligtelse til at gennemføre foranstaltning efter udstedelse af markedsføringstilladelse
English: Use an infusion set and an in-line, sterile, non-pyrogenic, low protein binding filter (pore size of 0.2 μm to 1.2 μm).
Danish: Der skal anvendes et infusionssæt og et in-line, sterilt, ikke-pyrogent, minimalt proteinbindende filter (porrestørrelse 0,2 μm til 1,2 μm).
English: Also tell your doctor if you are taking or have recently taken any other medicines.
Danish: Fortæl også altid lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig.
English: Hepatic:
Danish: Hepatisk:
English: Secondary efficacy endpoints of best overall response rate (BORR), stable disease (SD), disease control rate (DCR), and progression free survival (PFS) were based on mWHO criteria and determined by the investigator's assessment.
Danish: De sekundære effektendepunkter, bedste overordnede responsrate (BORR), stabil sygdom (SD), sygdomskontrolrate (DCR) og progressionsfri overlevelse (PFS), blev baseret på WHOs kriterier og afgjort efter investigators vurdering.
English: Clinical trials excluded patients with ECOG performance status > 1 and mucosal melanoma.
Danish: I kliniske forsøg blev patienter med ECOG performance status >1 og mucosalt melanom ekskluderet.
English: • The importance of carrying the detachable wallet-sized Patient Alert Card at all times to show it at all medical visits to healthcare professionals other than the prescriber (e.g. emergency healthcare professionals).
Danish: • Vigtigheden af altid at have det løse patient-informationskort på sig for at kunne vise det ved alle besøg hos andre læger end den ordinerende (f.eks. sundhedspersonalet på skadestuen).
English: Exposures in adolescents are comparable with those in adults receiving the same mg/kg dose.
Danish: Eksponering hos unge er sammenlignelig med den hos voksne ved den samme dosis i mg/kg.
English: However, once you are treated with YERVOY, your doctor may give you corticosteroids to reduce the side-effects that you may have with YERVOY.
Danish: Når du er i behandling med YERVOY, kan lægen imidlertid godt give dig kortikosteroider for at nedsætte de bivirkninger, du kan få af YERVOY.
English: Hypersensitivity/Infusion Reaction a at least 40 mg daily prednisone equivalents b frequency is based on the number of patients who experienced the immune-related adverse reaction
Danish: Overfølsomhed/infusionsreaktion a ækvivalent med mindst 40 mg prednison dagligt b hyppigheden er baseret på det antal patienter, der fik den immunrelaterede bivirkning
English: What you need to know before you use YERVOY 3.
Danish: Det skal du vide, før du begynder at bruge YERVOY 3.
English: - problems with your heart such as a change in the rhythm or rate of the heartbeat or an abnormal heart rythm.
Danish: - problemer med hjertet som f.eks. ændringer i rytmen eller hastigheden af hjerteslag eller en unormal hjerterytme.
English: Rare cases of toxic epidermal necrolysis (TEN) (including Steven Johnson Syndrome) have been observed, some with fatal outcome.
Danish: Sjældne tilfælde af toksisk epidermal nekrolyse (TEN) (inklusive Stevens-Johnsons syndrom) er blevet observeret, nogle med dødelig udgang.
English: SN: <NN:>
Danish: <NN:>
English: Table 3A
Danish: Tabel 3A
English: Two (25.0%) of 8 patients treated with 5 mg/kg and 1 (11.1%) of 9 patients treated with 10 mg/kg reported Grade 3-4 events.
Danish: To (25,0 %) af 8 patienter behandlet med 5 mg/kg og 1 (11,1 %) af 9 patienter behandlet med 10 mg/kg rapporterede Grad 3-4 hændelser.
English: Ipilimumab with nivolumab was continued beyond progression in 29% of patients.
Danish: Ipilimumab med nivolumab-behandling blev fortsat efter progression hos 29 % af patienterne.
English: The maximum tolerated dose of ipilimumab has not been determined.
Danish: Den maksimalt tolererede ipilimumab‑dosis er ikke blevet fastlagt.
English: Decision whether to withhold a dose should be based on severity.
Danish: Beslutningen om at udsætte en dosis bør være baseret på sværhedsgrad.
English: The Kaplan-Meier curves for OS (with a minimum follow-up of 24 months) in intermediate/poor risk patients are shown in Figure 7.
Danish: Kaplan-Meier-kurverne for OS (med en minimum opfølgningsperiode på 24 måneder) hos mellemeller højrisikopatienter er vist i Figur 7.
English: Immune-mediated adverse reactions were observed infrequently (~3%) and included colitis (which resulted in a single fatality), dermatitis, and infusion reaction (possibly due to acute cytokine release resulting from a rapid injection rate).
Danish: Immunmedierede bivirkninger blev sjældent observeret (~3 %) og omfattede colitis (som medførte et enkelt dødsfald), dermatitis og infusionsreaktion (muligvis på grund af akut cytokin frigivelse, som skyldes en hurtig injektionshastighed).
English: YERVOY can be used for intravenous administration either: without dilution, after transfer to an infusion container using an appropriate sterile syringe; or after diluting to up to 5 times the original volume of concentrate (up to 4 parts of diluent to 1 part of concentrate).
Danish: YERVOY kan anvendes til intravenøs administration enten: ufortyndet, efter overførsel til en infusionsbeholder ved brug af en passende steril sprøjte; eller efter fortynding til op til 5 gange den oprindelige mængde koncentrat (op til 4 dele opløsningsvæske til 1 del koncentrat).
English: ORRs were higher for the combination of nivolumab and ipilimumab relative to nivolumab monotherapy across tumour PD-L1 expression levels (Table 11) after 28 months of follow-up, with a best overall response of complete response correlating to an improved survival rate.
Danish: ORR var højere med kombinationen af nivolumab og ipilimumab i forhold til nivolumab-monoterapi på tværs af PD-L1-tumorekspressionsniveauer (Tabel 11) efter en opfølgningsperiode på 28 måneder, hvor det bedste samlede respons i form af komplet respons var korreleret til en forbedret overlevelsesrate.
English: Clear to slightly opalescent, colourless to pale yellow liquid that may contain light (few) particulates and has a pH of 7.0 and an osmolarity of 260-300 mOsm/kg.
Danish: Klar til let opaliserende, farveløs til lysegul væske, der kan indeholde lyse (få) partikler og har en pH på 7,0 og en osmolaritet på 260-300 mOsm/kg.
English: Animal reproduction studies have shown reproductive toxicity (see section 5.3).
Danish: Reproduktionsstudier hos dyr har påvist reproduktionstoksicitet (se pkt.
English: Table 3C:
Danish: Tabel 3C:
English: The use of anticoagulants is known to increase the risk of gastrointestinal haemorrhage.
Danish: Brugen af antikoagulantia vides at øge risikoen for gastrointestinal blødning.
English: YERVOY may cause changes in the results of tests carried out by your doctor.
Danish: YERVOY kan ændre resultaterne af de tests lægen har udført.
English: Key elements for the Patient Information Brochure and Alert Card:
Danish: Væsentlige punkter i informationsbrochuren til patienterne og i patient-informationskortet:
English: Severe or life-threatening adverse reactions
Danish: Svære eller livstruende bivirkninger
English: Proportion ≥24 months in duration
Danish: Andel ≥24 måneders varighed
English: Cytotoxic T-lymphocyte antigen-4 (CTLA-4) is a key regulator of T-cell activity.
Danish: Cytotoksisk T-lymfocyt-antigen-4 (CTLA-4) er en hovedregulator af T-celleaktivitet.
English: • Importance of evaluating liver function tests (LFTs), TSH and signs/symptoms of irARs before each treatment.
Danish: • Vigtigheden af at evaluere leverfunktionstest, TSH og tegn/symptomer på immunrelaterede bivirkninger før hver behandling.
English: Patients should be monitored continuously (at least up to 5 months after the last dose) as an adverse reaction with ipilimumab in combination with nivolumab may occur at any time during or after discontinuation of therapy.
Danish: Patienterne bør monitoreres løbende (som minimum i op til 5 måneder efter den sidste dosis), da bivirkninger ved ipilimumab i kombination med nivolumab kan opstå på et hvilket tidspunkt under eller efter seponering af behandlingen.