FrancophonIA/ELRC3.0 huggingface dataset:
English: While the analysis in patients with PD-L1 positive tumours was a co-primary endpoint, pre-defined subgroup analyses were performed in patients whose tumours were PD-L1 negative, BRAF mutation positive or negative.
Danish: Selvom analysen hos patienter med PD-L1-positive tumorer var et co-primært endepunkt, blev der udført prædefinerede subgruppeanalyser hos patienter, hvis tumorer var PD-L1-negative, positive eller negative for BRAF-mutation.
English: People get KEYTRUDA when their cancer has spread or cannot be taken out by surgery.
Danish: Keytruda gives til patienter, når deres kræft har spredt sig eller ikke kan fjernes ved en operation.
English: Eighty-eight percent had M1 disease and 12% had M0 disease.
Danish: 88% havde M1-sygdom, og 12% havde M0-sygdom.
English: KEYTRUDA must be administered by intravenous infusion over 30 minutes.
Danish: KEYTRUDA skal administreres som intravenøs infusion over 30 minutter.
English: Pembrolizumab may have a minor influence on the ability to drive and use machines.
Danish: Pembrolizumab kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Upon improvement to Grade ≤ 1, corticosteroid taper should be initiated and continued over at least 1 month.
Danish: Ved bedring til grad ≤ 1 påbegyndes langsom udtrapning af kortikosteroider over en periode på mindst 1 måned.
English: The primary efficacy outcome measures were investigator-assessed recurrence-free survival (RFS) in the whole population and in the population with PD-L1 positive tumours, where RFS was defined as the time between the date of randomisation and the date of first recurrence (local, regional, or distant metastasis) or death, whichever occurs first.
Danish: Det primære resultatmål var investigator-vurderet recidivfri overlevelse (RFS) i hele populationen og i populationen med PD-L1-positive tumorer, hvor RFS blev defineret som tiden mellem datoen for randomisering og datoen for første recidiv (lokale, regionale eller fjernmetastaser) eller død, afhængigt af, hvad der indtræffer først.
English: Women of childbearing potential should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen med pembrolizumab og i mindst 4 måneder efter den sidste pembrolizumab-dosis.
English: Factors associated with early deaths were fast progressive disease on prior platinum therapy and liver metastases.
Danish: Faktorer associeret med tidlig død var hurtig progressiv sygdom efter tidligere platinbehandling og levermetastaser.
English: Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of pembrolizumab (see “Description of selected adverse reactions” below).
Danish: De fleste af disse, herunder alvorlige bivirkninger, gik over efter initiering af passende medicinsk behandling eller pausering af behandlingen af pembrolizumab (se “Beskrivelse af udvalgte bivirkninger” nedenfor).
English: The effects of various covariates on the pharmacokinetics of pembrolizumab were assessed in population pharmacokinetic analyses.
Danish: Indvirkningen af forskellige kovariater på pembrolizumabs farmakokinetik blev vurderet i farmakokinetiske populationsanalyser.
English: However, once you are treated with KEYTRUDA, your doctor may give you corticosteroids to reduce the side-effects that you may have with KEYTRUDA.
Danish: Når du er i behandling med Keytruda, kan lægen imidlertid godt give dig kortikosteroider for at mildne de bivirkninger, du kan få af Keytruda.
English: Your doctor will monitor you for signs and symptoms, which may include skin rash, liver inflammation, abdominal pain, or diarrhoea.
Danish: Lægen vil overvåge dig for tegn og symptomer, som kan inkludere hududslæt, leverbetændelse, mavesmerter eller diarré.
English: Until further data become available, careful consideration to the potential benefits of HSCT and the possible increased risk of transplant-related complications should be made case by case (see section 4.8).
Danish: Indtil yderligere data bliver tilgængelige, skal de potentielle fordele ved HSCT og den potentielt øgede risiko for transplantationsrelaterede komplikationer vurderes nøje for hver enkelt patient (se pkt.
English: Sub-population analyses
Danish: Analyser af subgrupper
English: KEYTRUDA in combination with axitinib in RCC
Danish: KEYTRUDA i kombination med axitinib ved RCC
English: Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen eller etiketten på hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: uveitis (iritis and iridocyclitis) k. myocarditis (autoimmune myocarditis) l.
Danish: uveitis (iritis og iridocyklitis) k. myokarditis (autoimmun myokarditis) l.
English: 2Q 2020
Danish: 2. kvartal 2020
English: It is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
Danish: Det anbefales at fortsætte behandlingen hos klinisk stabile patienter med initiale tegn på sygdomsprogression, indtil sygdomsprogression er bekræftet.
English: Administer the infusion solution intravenously over 30 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 to 5 µm in-line or add-on filter.
Danish: Administrer infusionsvæsken intravenøst over en periode på 30 minutter med et infusionssæt med et in-line eller add-on sterilt, ikke-pyrogent, minimalt proteinbindende filter (porestørrelse 0,2 til 5 µm).
English: Grade 2 with creatinine > 1.5 to ≤ 3 times upper limit of normal (ULN)
Danish: Grad 2 med kreatinin > 1,5 til ≤ 3 gange øvre normale grænseværdi (ULN)
English: Schering-Plough Labo NV Industriepark 30, Heist-op-den-Berg B-2220, Belgium
Danish: Schering-Plough Labo NV Industriepark 30, Heist-op-den-Berg B-2220, Belgien
English: Complete response Partial response p-Value
Danish: Komplet respons Partielt respons p-værdi
English: No dose adjustment is necessary in patients ≥ 65 years (see section 5.1).
Danish: Dosisjustering er ikke nødvendig hos patienter ≥ 65 år (se pkt.
English: These results indicate a potential risk, based on its mechanism of action, that administration of pembrolizumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth.
Danish: Med udgangspunkt i pembrolizumabs virkningsmekanisme viser disse resultater en potentiel risiko for, at administration af pembrolizumab under graviditet kan medføre fosterskader, herunder en øget forekomst af abort eller dødfødsel.
English: The MAH shall ensure that in each Member State where KEYTRUDA is marketed, all healthcare professionals and patients/caregivers who are expected to prescribe and use KEYTRUDA have access to/are provided with the patient educational material.
Danish: I alle medlemslande, hvor KEYTRUDA markedsføres, skal indehaveren af markedsføringstilladelsen sikre, at alle sundhedspersoner og patienter/omsorgsgivere, der forventes at ordinere og anvende KEYTRUDA, er forsynet med/får udleveret uddannelsesmateriale til patienter.
English: Table 12 summarizes key efficacy measures for the entire intent to treat (ITT) population.
Danish: I tabel 12 opsummeres de vigtigste effektresultater for hele intent to treat (ITT)populationen.
English: The patient will be provided with the Patient Alert Card with each prescription.
Danish: Patienten skal have udleveret patientinformationskortet ved hver ordination.
English: Uncommon uveitis uveitis
Danish: Ikke almindelig uveitis uveitis
English: Over 15 weeks of follow-up, patients treated with pembrolizumab had stable global health status/QoL, while those treated with investigator's choice chemotherapy had a decline in global health status/QoL.
Danish: I løbet af 15 ugers opfølgning opnåede patienter, der var blevet behandlet med pembrolizumab, en stabil global helbredstilstand/QoL, hvorimod de der var blevet behandlet med investigators valg af kemoterapi fik en nedgang i global helbredstilstand/QoL.
English: (see Table 22).
Danish: -analysen (se tabel 22).
English: Of these patients, 55% had no recurrence of ALT > 3 times ULN, and of those patients with recurrence of ALT > 3 times ULN, all recovered.
Danish: 55% af disse patienter havde ingen recidiv af ALAT > 3 gange ULN, og bedring forekom hos alle patienter med recidiv af ALAT > 3 gange ULN.
English: • Slowly swirl the vial to allow reconstitution of the lyophilised powder.
Danish: • Hvirvl langsomt hætteglasset rundt således, at det frysetørrede pulver bliver opløst.
English: Patients should be monitored for hyperglycaemia or other signs and symptoms of diabetes.
Danish: Patienterne skal monitoreres for hyperglykæmi eller andre tegn og symptomer på diabetes.
English: Disease subtypes were 97% nodular sclerosis and 3% mixed cellularity.
Danish: Sygdomsundergrupperne var 97% nodulær sklerose og 3% blandet cellularitet.
English: For suspected immune-related adverse reactions, adequate evaluation to confirm aetiology or exclude other causes should be ensured.
Danish: Ved mistanke om immunrelaterede bivirkninger skal det sikres, at der foretages tilstrækkelig udredning for at bekræfte ætiologi eller udelukke andre årsager.
English: Dose escalation of axitinib to 10 mg twice daily was permitted using the same criteria.
Danish: Det var tilladt at øge dosis af axitinib til 10 mg to gange dagligt ud fra de samme kriterier.
English: Five study subjects were ineligible to ASCT due to reasons other than failure to salvage chemotherapy.
Danish: 5 forsøgspersoner var uegnede til ASCT af andre årsager end behandlingssvigt efter salvage-kemoterapi.
English: OS and PFS benefits were observed regardless of PD-L1 expression level.
Danish: OS- og PFS-fordel sås uanset PD-L1-ekspressionsniveau.
English: Patients should be monitored for signs and symptoms of pneumonitis.
Danish: Patienterne skal monitoreres for tegn og symptomer på pneumonitis.
English: The frequencies included below and in Table 2 are based on all reported adverse drug reactions, regardless of the investigator assessment of causality.
Danish: Hyppighederne, som er inkluderet nedenfor og i tabel 2, er baseret på alle rapporterede bivirkninger, uden hensyn til investigators vurdering af kausalitet.
English: KEYTRUDA will be given to you in a hospital or clinic under the supervision of a doctor experienced in cancer treatment.
Danish: Du får Keytruda på et hospital under tilsyn af en læge med erfaring i behandling af kræft.
English: Adverse reactions known to occur with pembrolizumab or chemotherapies given alone may occur during treatment with these medicinal products in combination, even if these reactions were not reported in clinical trials with combination therapy.
Danish: Bivirkninger, der vides at forekomme ved behandling med pembrolizumab eller ved kemoterapi givet alene, kan forekomme under behandlingen med disse lægemidler i kombination, selvom disse bivirkninger ikke blev rapporteret i kliniske studier med kombinationsbehandling.
English: The Kaplan-Meier curve for OS for the TPS ≥ 50% population is shown in Figure 15.
Danish: Kaplan-Meier-kurver for OS for populationen med TPS ≥ 50% er vist i figur 15.
English: Secondary efficacy outcome measures were duration of response, PFS, and OS. Table 21 summarises the key efficacy measures for the study population at the final analysis based on a median follow-up time of 11.4 months (range: 0.1, 41.2 months) for all patients.
Danish: De sekundære resultatmål var responsvarighed, PFS og OS. I tabel 21 opsummeres de centrale effektresultater for studiepopulationen ved den endelige analyse på basis af en median opfølgningstid på 11,4 måneder (interval: 0,1; 41,2 måneder) for alle patienter.
English: Other medicines and KEYTRUDA Tell your doctor - If you are taking other medicines that make your immune system weak.
Danish: Brug af anden medicin sammen med Keytruda Fortæl det altid til lægen, - hvis du tager anden medicin, som svækker dit immunsystem.
English: Standard Treatment
Danish: Standardbehandling
English: The European Medicines Agency has deferred the obligation to submit the results of studies with pembrolizumab in one or more subsets of the paediatric population in treatment of Hodgkin lymphoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med pembrolizumab i en eller flere undergrupper af den pædiatriske population ved behandling af Hodgkins lymfom (se pkt.
English: Assessment of tumour status was performed every 9 weeks.
Danish: Tumorstatus blev vurderet hver 9. uge.
English: Table 17 summarises key efficacy measures for the entire population (TPS  1%) and for the patients with TPS  50%, and Figure 11 shows the Kaplan-Meier curve for OS (TPS  1%), based on a final analysis with median follow up of 42.6 months.
Danish: I tabel 17 opsummeres de centrale effektresultater for hele populationen (TPS  1%) og for patienter med TPS  50%, og figur 11 viser Kaplan-Meier-kurverne for OS (TPS  1%) baseret på en endelig analyse med en median opfølgningstid på 42,6 måneder.
English: Thirty-one percent had an ECOG Performance Status of 1, 69% had ECOG Performance Status of 0 and 32% had elevated LDH.
Danish: 31% havde ECOG-performance-status på 1, 69% havde ECOG-performance-status på 0 og 32% havde forhøjet LDH.
English: Disease subtypes were 80% nodular sclerosis, 11% mixed cellularity, 4% lymphocyte-rich and 2% lymphocyte-depleted.
Danish: Sygdomsundergrupperne var 80% nodulær sklerose, 11% blandet cellularitet, 4% lymfocytrig og 2% lymfocytfattig.
English: 2Q 2020 2Q 2019 4Q 2021 4Q 2024
Danish: kvartal 2020 2. kvartal 2019 4. kvartal 2021 4. kvartal 2024
English: Consistent with a limited extravascular distribution, the volume of distribution of pembrolizumab at steady state is small (~6.0 L; CV: 20%).
Danish: I overensstemmelse med en begrænset ekstravaskulær fordeling er det gennemsnitlige fordelingsvolumen for pembrolizumab ved steady state lille (~6,0 liter; variationskoefficient (CV) 20%).
English: Standard Treatment:
Danish: Standardbehandling:
English: Patients should be monitored for signs and symptoms of colitis, and other causes excluded.
Danish: Patienterne skal monitoreres for tegn og symptomer på colitis, og andre årsager skal udelukkes.
English: Severe skin reactions resolved in 64 patients.
Danish: Alvorlige hudreaktioner gik over hos 64 patienter.
English: The prescriber must discuss the risks of KEYTRUDA therapy with the patient.
Danish: Lægen skal drøfte risiciene ved KEYTRUDA-behandlingen med patienten.
English: Table 27 summarises the key efficacy measures for the TPS ≥ 50% population.
Danish: I tabel 27 opsummeres de centrale effektresultater for populationen med TPS ≥ 50%.
English: BRAF mutations were reported in 20 (39%) patients.
Danish: BRAF-mutation blev rapporteret hos 20 (39%) patienter.
English: Most immune-related adverse reactions occurring during treatment with pembrolizumab were reversible and managed with interruptions of pembrolizumab, administration of corticosteroids and/or supportive care.
Danish: De fleste immunrelaterede bivirkninger, der forekom under behandlingen med pembrolizumab, var reversible og blev håndteret ved hjælp af afbrydelse af behandlingen med pembrolizumab, behandling med kortikosteroider og/eller understøttende pleje.
English: Uncommon pancreatitis pancreatitis pancreatitis
Danish: Ikke almindelig pankreatitis pankreatitis pankreatitis
English: The following factors had no clinically important effect on the clearance of pembrolizumab: age (range 15-94 years), gender, race, mild or moderate renal impairment, mild hepatic impairment and tumour burden.
Danish: Følgende faktorer havde ingen klinisk betydningsfuld indvirkning på pembrolizumabs clearance: alder (interval: 15-94 år), køn, race, let eller moderat nedsat nyrefunktion, let nedsat leverfunktion og tumorbyrde.
English: Secondary efficacy outcome measures were duration of response, PFS and OS.
Danish: Sekundære resultatmål var responsvarighed, PFS og OS.
English: Non-squamous patients could receive pemetrexed maintenance).
Danish: Patienter med ikke-planocellulært karcinom kunne få vedligeholdelsesbehandling med pemetrexed).
English: The frequencies are based on all reported adverse drug reactions, regardless of the investigator assessment of causality.
Danish: Hyppighederne er baseret på alle rapporterede bivirkninger, uden hensyn til investigators vurdering af kausalitet.
English: In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
Danish: I tilfælde af overdosering skal patienten monitoreres tæt for tegn og symptomer på bivirkninger, og passende symptomatisk behandling iværksættes.
English: Use of pembrolizumab for adjuvant treatment of patients with melanoma A trend toward increased frequency of severe and serious adverse reactions in patients ≥ 75 years was observed.
Danish: Brug af pembrolizumab til adjuverende behandling af melanom-patienter En tendens til øget hyppighed af svære og alvorlige bivirkninger hos patienter ≥ 75 år blev observeret.
English: Not reached (2.7, 13.8+)
Danish: Ikke nået (2,7; 13,8+)
English: Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed.
Danish: Klinisk stabile patienter med initial evidens på sygdomsprogression fik lov til at forblive i behandling, indtil sygdomsprogression var blevet bekræftet.
English: The initial analysis resulted in a HR for OS of 0.82 (95% CI: 0.67, 1.01) with a one-sided p-value of 0.0316.
Danish: Den initiale analyse resulterede i en HR for OS på 0,82 (95% CI: 0,67; 1,01) med ensidet p-værdi på 0,0316.
English: KEYNOTE-087 and KEYNOTE-013: Open-label studies in patients with relapsed or refractory classical Hodgkin lymphoma (cHL)
Danish: KEYNOTE-087 og KEYNOTE-013: Åbne studier med patienter med recidiverende eller refraktært klassisk Hodgkins lymfom (cHL)
English: The use of systemic corticosteroids or immunosuppressants before starting pembrolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of pembrolizumab.
Danish: Systemiske kortikosteroider og immunsuppressiva bør undgås før initiering af behandling med pembrolizumab på grund af deres potentielle interferens med pembrolizumabs farmakodynamiske aktivitet og virkning.
English: Steady-state concentrations of pembrolizumab were reached by 16 weeks of repeated dosing with an every 3 week regimen and the systemic accumulation was 2.1-fold.
Danish: Steady state-koncentrationer af pembrolizumab blev nået efter 16 uger med gentagen dosering med et regime med administration hver 3. uge, og den systemiske akkumulering var cirka 2,1 gange.
English: Patients should be monitored for signs and symptoms of adrenal insufficiency and hypophysitis (including hypopituitarism) and other causes excluded.
Danish: Patienterne skal monitoreres for tegn og symptomer på binyrebarkinsufficiens og hypofysitis (inklusive hypofyseinsufficiens (hypopituitarisme), og andre årsager skal udelukkes.
English: Based on stratified Log rank test
Danish: Baseret på stratificeret log rank-test
English: Immune-related adverse reactions have also occurred after the last dose of pembrolizumab.
Danish: Immunrelaterede bivirkninger er også observeret efter den sidste dosis af pembrolizumab.
English: Patients with an ECOG performance status of 2 had to have a hemoglobin ≥ 10 g/dL, could not have liver metastases, and must have received the last dose of their last prior chemotherapy regimen ≥ 3 months prior to enrollment.
Danish: Patienter med ECOG-performance-status på 2 skulle have et hæmoglobinniveau på ≥ 10 g/dl, måtte ikke have levermetastaser og måtte have fået den sidste dosis af det seneste tidligere kemoterapiregime ≥ 3 måneder før inklusion.
English: Rechallenge with a single medicine or sequential rechallenge with both medicines after recovery may be considered.
Danish: Genoptagelse af behandling (rechallenge) med et enkelt lægemiddel eller sekventiel genoptagelse af behandlingen (sequential rechallenge) med begge lægemidler efter bedring kan overvejes.
English: For the adjuvant treatment of melanoma, KEYTRUDA should be administered until disease recurrence, unacceptable toxicity, or for a duration of up to one year.
Danish: Ved adjuverende behandling af melanom skal KEYTRUDA administreres indtil sygdomsrecidiv, uacceptabel toksicitet eller i en periode på op til 1 år.
English: Grade 4 or confirmed SJS or TEN Permanently discontinue
Danish: Grad 4 eller bekræftet SJS eller TEN Seponer behandlingen permanent
English: * Cetuximab, platinum, and 5-FU
Danish: * Cetuximab, platinbaseret behandling og 5-FU
English: Adverse reactions observed in clinical studies of pembrolizumab as monotherapy or in combination with chemotherapy or other anti-tumour medicines or reported from post-marketing use of pembrolizumab are listed in Table 2.
Danish: De bivirkninger, der blev observeret i kliniske studier med pembrolizumab som monoterapi eller i kombination med kemoterapi eller andre anti-tumor lægemidler eller rapporteret i forbindelse med brug af pembrolizumab efter markedsføring, er opført i tabel 2.
English: These studies enrolled patients who failed ASCT and BV, who were ineligible for ASCT because they were unable to achieve a complete or partial remission to salvage chemotherapy and failed BV, or who failed ASCT and did not receive BV.
Danish: Disse studier indrullerede patienter, som havde oplevet svigt af ASCT og svigt af behandling med BV; som var uegnede til ASCT, da de ikke var i stand til at opnå komplet eller partiel remission efter salvage-kemoterapi og havde oplevet svigt af behandling med BV; eller som havde oplevet svigt af ASCT og ikke havde fået BV.
English: Since pembrolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected.
Danish: Eftersom pembrolizumab elimineres fra kredsløbet via nedbrydning (katabolisme) forventes ingen metaboliske lægemiddelinteraktioner.
English: • Genomic analyses using whole exome sequencing and/or RNAseq (e.g.
Danish: • Genomanalyser med fuld exomsekventering og/eller RNAseq (f.eks. Nanostring RNA-gensignatur)
English: Patients who experienced GVHD after their transplant procedure may be at an increased risk for GVHD after treatment with pembrolizumab.
Danish: Patienter, der udviklede GVHD efter deres transplantation, kan have øget risiko for GVHD efter behandling med pembrolizumab.
English: The most common tumour types by histology were Hodgkin lymphoma (11.7%), glioblastoma multiforme (9.1%), neuroblastoma (6.5%), osteosarcoma (6.5%) and melanoma (5.2%).
Danish: De hyppigste tumortyper ud fra histologi var Hodgkins lymfom (11,7%), glioblastom multiforme (9,1%), neuroblastom (6,5%), osteosarkom (6,5%) og melanom (5,2%).
English: Hypothyroidism is more frequently reported in patients with HNSCC with prior radiation therapy.
Danish: Hypotyroidisme er rapporteret oftere hos patienter med HNSCC, som tidligere havde fået strålebehandling.
English: Patients who received prior therapy for melanoma other than surgery or interferon for thick primary melanomas without evidence of lymph node involvement were ineligible.
Danish: Patienter, som havde modtaget anden forudgående behandling for melanom end kirurgisk indgreb eller interferon for tykke primære melanomer uden tegn på lymfeknudeinvolvering, var uegnede til studiet.
English: Combination with chemotherapy
Danish: Kombination med kemoterapi
English: Human immunoglobulins G4 (IgG4) are known to cross the placental barrier; therefore, being an IgG4, pembrolizumab has the potential to be transmitted from the mother to the developing foetus.
Danish: Det er vist, at humant immunglobulin G4 (IgG4) kan passere placentabarrieren, og da pembrolizumab er et IgG4, kan pembrolizumab derfor potentielt overføres fra moderen til fosteret.
English: BRAF mutation positive
Danish: Positiv for BRAF-mutation