FrancophonIA/ELRC3.0 huggingface dataset:
English: • The importance of not attempting to self-treat any symptoms without consulting their healthcare professional first
Danish: • Vigtigheden af ikke selv at behandle eventuelle symptomer uden først at tale med en sundhedsperson
English: Based on available safety data in cHL and other tumour types, these differences are not clinically meaningful.
Danish: Baseret på tilgængelige sikkerhedsdata for cHL og andre tumortyper er disse forskelle ikke klinisk relevante.
English: • Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
Danish: • Parenterale lægemidler skal inspiceres visuelt for partikler og misfarvning inden administration.
English: When assessing the PD-L1 status of the tumour, it is important that a well-validated and robust methodology is chosen to minimise false negative or false positive determinations.
Danish: Ved vurdering af PD-L1-status af tumoren er det vigtigt, at der vælges en valideret og robust metode for at minimere forekomsten af falsk negative eller falsk positive resultater.
English: The reconstituted or diluted solution must not be frozen.
Danish: Den rekonstituerede eller fortyndede opløsning må ikke nedfryses.
English: Based on severity and type of reaction (Grade 2 or Grade 3)
Danish: Baseret på sværhedsgrad og type af bivirkning (grad 2 eller grad 3)
English: When you get KEYTRUDA, you can have some serious side effects.
Danish: Når du får Keytruda, kan du få nogle alvorlige bivirkninger.
English: Patients excluded from clinical trials
Danish: Patienter, der blev ekskluderet fra kliniske studier
English: Feeling tired or weak is a very common side effect of KEYTRUDA.
Danish: Træthed eller svaghedsfølelse er en meget almindelig bivirkning ved Keytruda.
English: meningitis aseptic (meningitis, meningitis non-infective)
Danish: aseptisk meningitis (meningitis, non-infektiøs meningitis)
English: Assessment of PD-L1 status
Danish: Vurdering af PD-L1-status
English: - It is very important that you do not miss a dose of this medicine.
Danish: - Det er meget vigtigt, at du ikke springer en infusion med dette lægemiddel over.
English: Each carton contains one vial.
Danish: Hver karton indeholder et hætteglas.
English: Hyperthyroidism may be managed symptomatically.
Danish: Hypertyroidisme kan behandles symptomatisk.
English: Both studies included patients regardless of PD-L1 expression.
Danish: Begge studier inkluderede patienter uanset PD-L1-ekspression.
English: The patient educational material should contain:
Danish: Uddannelsesmaterialet til patienter skal indeholde:
English: Hepatitis resolved in 36 patients.
Danish: Hepatitis gik over hos 36 patienter.
English: White to off-white lyophilised powder.
Danish: Hvidt til offwhite frysetørret pulver.
English: The geometric mean value (CV%) for the terminal half-life is 22 days (32%) at steady-state.
Danish: Den geometriske gennemsnitsværdi (CV%) for den terminale halveringstid er 22 dage (32%) ved steady state.
English: Pregnancy - You must not use KEYTRUDA if you are pregnant unless your doctor specifically recommends it. - If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor.
Danish: Graviditet - Du må ikke få Keytruda, hvis du er gravid, medmindre lægen specifikt anbefaler det. - Fortæl det til lægen, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: Based on Kaplan-Meier estimation
Danish: Baseret på Kaplan-Meier-estimering
English: BRAF mutations were reported in 13% of the study population.
Danish: BRAFmutation blev rapporteret hos 13% af studiepopulationen.
English: The same scoring system was used for metastatic melanoma (MEL score).
Danish: Der blev anvendt det samme scoringssystem ved metastatisk melanom (MEL-score).
English: Table 1: Recommended treatment modifications for KEYTRUDA
Danish: Tabel 1: Anbefalede ændringer i KEYTRUDA-behandling
English: Warnings and precautions Talk to your doctor or nurse before receiving KEYTRUDA.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller sygeplejersken, før du får Keytruda.
English: Patients must have undergone lymph node dissection, and if indicated, radiotherapy within 13 weeks prior to starting treatment.
Danish: Patienterne skal have fået foretaget lymfeknude-dissektion, og hvis det er indiceret, strålebehandling inden for 13 uger før påbegyndelse af behandlingen.
English: Do not drive or use machines after you have been given KEYTRUDA unless you are sure you are feeling well.
Danish: Kør ikke bil og arbejd ikke med maskiner, hvis du har fået Keytruda, medmindre du er sikker på, at du har det godt.
English: Exclusion criteria were similar to those of KEYNOTE-002.
Danish: Eksklusionskriterierne var de samme som i KEYNOTE-002.
English: The median OS was 8.4 months for pembrolizumab compared to 7.1 months for standard treatment.
Danish: Den mediane OS var 8,4 måneder for pembrolizumab sammenlignet med 7,1 måneder for standardbehandling.
English: - If you are taking, have recently taken or might take any other medicines.
Danish: - hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: Do not stop treatment with KEYTRUDA unless you have discussed this with your doctor.
Danish: Du må ikke stoppe behandlingen med Keytruda, medmindre du har aftalt det med lægen.
English: The Patient Information Brochure and Patient Alert Card shall contain the following key elements:
Danish: Patientinformationsbrochuren og patientinformationskortet skal indeholde følgende væsentlige punkter:
English: Treatment modification
Danish: Ændring af behandling
English: Efficacy and safety data from patients ≥ 75 years are limited.
Danish: Data vedrørende sikkerhed og virkning hos patienter ≥ 75 år er begrænsede.
English: • Data on RNA and proteomic serum profiling
Danish: • Data om RNA og proteomisk profilering af serum2.
English: The relationship between body weight and clearance supports the use of either fixed dose or body weight-based dosing to provide adequate and similar control of exposure.
Danish: Forholdet mellem kropsvægt og clearance understøtter dosering med enten fast dosis eller dosis baseret på kropsvægt til at give tilstrækkelig og sammenlignelig eksponeringskontrol.
English: The educational programme is aimed at increasing the awareness of patients and/or their caregivers on the signs and symptoms relevant to the early recognition/identification of the potential immunerelated adverse reactions (irARs).
Danish: Formålet med uddannelsesprogrammet er at øge patienternes og/eller omsorgsgivernes bevidsthed om tegn og symptomer, der er relevante for tidlig erkendelse/identifikation af potentielle immunrelaterede bivirkninger.
English: Uncommon type 1 diabetes mellitus type 1 diabetes mellitus type 1 diabetes mellitus
Danish: Ikke almindelig type 1-diabetes mellitus type 1-diabetes mellitus type 1-diabetes mellitus
English: Progression-Free Survival (%)
Danish: Progressionsfri overlevelse (%)
English: These medicines may interfere with the effect of KEYTRUDA.
Danish: Disse typer medicin kan påvirke virkningen af Keytruda.
English: Prior to launch of KEYTRUDA in each Member State the MAH must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Forud for lancering af KEYTRUDA i hvert enkelt medlemsland skal indehaveren af markedsføringstilladelsen aftale indholdet og udformningen af uddannelsesprogrammet for KEYTRUDA, herunder en kommunikationsplan, distributionsmåde og andre aspekter af programmet, med den relevante nationale myndighed.
English: Note: toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4).
Danish: Seponer behandlingen permanent Bemærk: Toksicitetsgrader er angivet i overensstemmelse med National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4).
English: For patients who completed 24 months of therapy or had a complete response, treatment with pembrolizumab could be reinitiated for disease progression and administered for up to 1 additional year.
Danish: Hos patienter, der gennemførte 24 måneders behandling eller som havde komplet respons, kunne behandlingen med pembrolizumab genoptages ved sygdomsprogression og blive administreret i op til yderligere 1 år.
English: Long-term hormone replacement therapy may be necessary in cases of immune-related endocrinopathies.
Danish: Langtidsbehandling med hormonsubstitution kan være nødvendig ved immunrelaterede endokrinopatier.
English: Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered.
Danish: På basis af begrænsede data fra kliniske studier med patienter, hvis immunrelaterede bivirkninger ikke kunne kontrolleres med kortikosteroider, kan det overvejes at administrere andre systemiske immunsuppressiva.
English: The safety profile in these paediatric patients was generally similar to that seen in adults treated with pembrolizumab.
Danish: Sikkerhedsprofilen hos disse pædiatriske patienter var generelt sammenlignelig med sikkerhedsprofilen hos voksne, der blev behandlet med pembrolizumab.
English: Atypical responses (i.e., an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed.
Danish: Atypisk respons (pseudoprogression) er observeret (initial forbigående stigning i tumorstørrelse eller små nye læsioner inden for de første få måneder efterfulgt af tumorregression).
English: Chemotherapy OS by PD-L1 Expression Number of Events (number of patients)*
Danish: Kemoterapi OS ved PD-L1-ekspression Antal hændelser (antal patienter)*
English: In the absence of these data, pembrolizumab should be used with caution in this population after careful consideration of the potential risk-benefit on an individual basis.
Danish: I mangel af disse data bør pembrolizumab anvendes med forsigtighed hos denne population efter nøje overvejelse af det potentielle benefit/risk-forhold på individuel basis.
English: Based on method by Miettinen and Nurminen
Danish: Baseret på Miettinen og Nurminen-metoden
English: In addition, no safety and efficacy data are available in frailer patients (e.g., ECOG performance status 3) considered not eligible for chemotherapy.
Danish: Derudover findes der ingen data vedrørende sikkerhed og virkning hos svagere patienter (f.eks. ECOG-performance-status 3), der ikke anses for egnede til behandling med kemoterapi.
English: Therapy must be initiated and supervised by specialist physicians experienced in the treatment of cancer.
Danish: Behandlingen skal initieres og superviseres af læger med erfaring i behandling af cancer.
English: *Adverse reaction frequencies presented in Table 2 may not be fully attributable to pembrolizumab alone but may contain contributions from the underlying disease or from other medicinal products used in a combination.
Danish: *Bivirkningshyppighederne, som er angivet i tabel 2, kan muligvis ikke udelukkende henføres til pembrolizumab alene, men kan måske også indeholde bidrag fra den underliggende sygdom eller fra andre lægemidler, som anvendes i kombination.
English: Chemistry and haematology laboratory tests were performed at each cycle.
Danish: Kemiske og hæmatologiske laboratorietests blev udført ved hver behandlingsserie.
English: The primary efficacy outcome was OS in the ITT population.
Danish: Det primære resultatmål var OS i ITT-populationen.
English: • The importance of carrying the Patient Alert Card at all times and 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 patientinformationskortet på sig og at vise det ved alle besøg hos andre læger (f.eks. sundhedspersoner på skadestue) end den ordinerende læge.
English: There are no notable differences in median Cmax between cHL and other tumour types.
Danish: Der er ingen væsentlig forskel i median Cmax mellem cHL og andre tumortyper.
English: OS results are reported from the final analysis at a median follow-up of 25 months.
Danish: OS-resultater er rapporteret fra den endelige analyse med en median opfølgningstid på 25 måneder.
English: Randomisation was stratified by risk categories (favourable versus intermediate versus poor) and geographic region (North America versus Western Europe versus “Rest of the World”).
Danish: Randomiseringen blev stratificeret ud fra risikokategorier (lav risiko versus middel risiko versus høj risiko) og geografisk område (Nordamerika versus Vesteuropa versus “resten af verden”).
English: Common hypertension hypertension
Danish: Almindelig hypertension hypertension
English: The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy.
Danish: Det menes, at PD-1/PD-L1signalvejen er involveret i at opretholde tolerancen over for fostret under graviditeten.
English: KEYTRUDA may be given in combination with other anti-cancer medicines.
Danish: Keytruda kan gives i kombination med anden kræftmedicin.
English: Manufacturer Schering-Plough Labo NV Industriepark 30
Danish: Schering-Plough Labo NV Industriepark 30
English: • Description of the main signs or symptoms of the irARs and the importance of notifying their treating physician immediately if symptoms occur
Danish: • Beskrivelse af de vigtigste tegn eller symptomer på immunrelaterede bivirkninger og vigtigheden af straks at fortælle det til den behandlende læge, hvis symptomer opstår
English: It also contains prompts to enter contact details of the physician and to alert other physicians that the patient is treated with KEYTRUDA.
Danish: Det indeholder også en opfordring om at påføre lægens kontaktoplysninger og om at informere andre læger om, at patienten er i behandling med KEYTRUDA
English: Patient-reported outcomes (PROs) were assessed using EORTC QLQ-C30.
Danish: Patient-rapporterede oplysninger (PRO) blev vurderet i henhold til EORTC QLQ-C30.
English: Fifty-nine percent of the patients with increased ALT received systemic corticosteroids.
Danish: 59% af patienterne med forhøjet ALAT fik systemiske kortikosteroider.
English: Patients must have received first line platinum-containing regimen for locally advanced/metastatic disease or as neoadjuvant/adjuvant treatment, with recurrence/progression ≤ 12 months following completion of therapy.
Danish: Patienterne skal have fået et first line platinbaseret regime for lokalt fremskredent/metastatisk sygdom eller som neoadjuvant/adjuvant behandling med tilbagevenden/progression ≤ 12 måneder efter afsluttet behandling.
English: Efficacy results are summarized in Table 18.
Danish: Effektresultaterne opsummeres i tabel 18.
English: Your doctor may withhold the next dose of KEYTRUDA or stop your treatment with KEYTRUDA.
Danish: Din læge vil muligvis udsætte den næste dosis af Keytruda eller helt stoppe din behandling med Keytruda.
English: Efficacy results for OS were consistent regardless of the age of tumour specimen (new vs. archival) based on an intergroup comparison.
Danish: Effektresultaterne for OS var konsistente uanset tumorprøvens alder (nyt væv versus arkivvæv) baseret på en sammenligning mellem grupperne.
English: Uncommon epilepsy epilepsy myasthenic syndrome
Danish: Ikke almindelig epilepsi epilepsi myastenisk syndrom
English: The safety of re-initiating pembrolizumab therapy in patients previously experiencing immune-related myocarditis is not known.
Danish: Sikkerheden ved re-initiering af behandling med pembrolizumab hos patienter, der tidligere har oplevet immunrelateret myokarditis, er ikke kendt.
English: • IHC staining for PD-L2
Danish: • IHC-farvning for PD-L2
English: Control:
Danish: Kontrol:
English: pruritus (urticaria, urticaria papular, pruritus generalised and pruritus genital)
Danish: pruritus (urticaria, papuløs urticaria, generaliseret pruritus og genital pruritus)
English: 11.3 (10.8, Not reached)
Danish: 11,3 (10,8; Ikke nået)
English: 28.0 (14, not available)
Danish: 28,0 (14, foreligger ikke)
English: There are no data on the use of pembrolizumab in pregnant women.
Danish: Der er ingen data fra anvendelse af pembrolizumab til gravide kvinder.
English: Guillain-Barré syndrome g,
Danish: Sjælden Guillain-Barrés syndrom g,
English: Patients treated with KEYTRUDA must be given the Patient Alert Card and be informed about the risks of KEYTRUDA (see also package leaflet).
Danish: Patienter, som bliver behandlet med KEYTRUDA, skal have udleveret et patientinformationskort og informeres om risiciene ved KEYTRUDA (se også indlægssedlen).
English: • KEYTRUDA is for single use only.
Danish: • KEYTRUDA er kun til engangsbrug.
English: Pembrolizumab should not be used during pregnancy unless the clinical condition of the woman requires treatment with pembrolizumab.
Danish: Pembrolizumab bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver behandling med pembrolizumab.
English: Uncommon tenosynovitis tenosynovitis
Danish: Ikke almindelig tenosynovitis tenosynovitis
English: KEYTRUDA must not be administered as an intravenous push or bolus injection.
Danish: KEYTRUDA må ikke administreres som intravenøs push- eller bolus-injektion.
English: - If you are a woman who could become pregnant, you must use adequate birth control while you are being treated with KEYTRUDA and for at least 4 months after your last dose.
Danish: - Hvis du er en kvinde i den fødedygtige alder, skal du anvende sikker prævention, mens du bliver behandlet med Keytruda og i mindst 4 måneder efter din sidste dosis.
English: Pembrolizumab is administered via the intravenous route and therefore is immediately and completely bioavailable.
Danish: Absorption Pembrolizumab administreres intravenøst, og biotilgængeligheden er derfor øjeblikkelig og fuldstændig.
English: No findings of toxicological significance were observed and the no observed adverse effect level (NOAEL) in both studies was ≥ 200 mg/kg, which produced exposure multiples of 19 and 94 times the exposure in humans at doses of 10 and 2 mg/kg, respectively.
Danish: Der blev ikke observeret fund af toksikologisk betydning, og NOAEL-værdien (No Observed Adverse Effect Level) i begge studier var ≥ 200 mg/kg, hvilket gav multiple eksponeringer på 19 og 94 gange eksponeringen hos mennesker ved doser på henholdsvis 10 og 2 mg/kg.
English: For signs or symptoms of SJS or TEN, pembrolizumab should be withheld and the patient should be referred to a specialised unit for assessment and treatment.
Danish: Hvis der opstår tegn eller symptomer på SJS eller TEN, skal behandling med pembrolizumab pauseres, og patienten henvises til en specialafdeling til vurdering og behandling.
English: Secondary efficacy outcome measures were disease control rate (DCR; including complete response, partial response and stable disease), response duration, PFS and OS. Tumour response was assessed at 12-week intervals.
Danish: De sekundære resultatmål var sygdomskontrolrate (DCR, herunder komplet respons, partielt respons og stabil sygdom), responsvarighed, PFS og OS. Tumorrespons blev vurderet hver 12. uge.
English: • Patient Information Brochure
Danish: • Patientinformationsbrochure
English: Methotrexate, docetaxel, or cetuximab
Danish: Methotrexat, docetaxel eller cetuximab
English: % ongoing at 12 months
Danish: % igangværende i måned 12
English: Complete Response Partial Response
Danish: Komplet respons Partielt respons
English: • sunitinib 50 mg orally, once daily for 4 weeks and then off treatment for 2 weeks.
Danish: • sunitinib 50 mg oralt, en gang dagligt i 4 uger og herefter stop af behandling i 2 uger.
English: When administering KEYTRUDA as part of a combination with intravenous chemotherapy, KEYTRUDA should be administered first.
Danish: Når KEYTRUDA administreres som del af en kombinationsbehandling med intravenøs kemoterapi, skal KEYTRUDA administreres først.
English: TPS 1 to 49%
Danish: TPS 1 til 49%
English: Treatment with pembrolizumab may increase the risk of rejection in solid organ transplant recipients.
Danish: Behandling med pembrolizumab kan øge risikoen for afstødning hos modtagere af transplanterede solide organer.
English: Combination with axitinib
Danish: Kombination med axitinib
English: Axitinib could be interrupted or reduced to 3 mg twice daily and subsequently to 2 mg twice daily to manage toxicity.
Danish: Axitinib kunne pauseres eller reduceres til 3 mg to gange dagligt og efterfølgende til 2 mg to gange dagligt med henblik på at behandle toksicitet.
English: PFS and ORR results are reported from an interim analysis at a median follow-up of 11 months.
Danish: PFS- og ORR-resultater er rapporteret fra en interimanalyse med en median opfølgningstid på 11 måneder.
English: Liver enzymes should be monitored before initiation of and periodically throughout treatment.
Danish: Leverenzymer skal monitoreres før initiering af behandlingen og med jævne mellemrum under behandlingen.
English: Corticosteroid therapy may be considered.
Danish: Behandling med kortikosteroider kan overvejes.
English: In patients with solid tumours and other lymphomas, the ORR was 5.9%, no patient had a complete response and 8 patients (5.9%) had a partial response.
Danish: Hos patienter med solide tumorer og andre lymfomer var ORR 5,9%, ingen patienter havde komplet respons og 8 patienter (5,9%) havde partielt respons.
English: If you miss an appointment to get KEYTRUDA - Call your doctor right away to reschedule your appointment.
Danish: Hvis du glemmer en aftale om at få behandling med Keytruda - Kontakt straks lægen for at lave en ny aftale.
English: Physicians should consider the delayed onset of pembrolizumab effect before initiating treatment in patients with poorer prognostic features and/or aggressive disease.
Danish: Lægen bør overveje pembrolizumabs forsinkede indsættelse af virkning, før behandling initieres hos patienter med dårligere prognoser og/eller aggressiv sygdom.
English: Based upon a standard query including bradyarrhythmias and tachyarrhythmias.
Danish: Baseret på en standardforespørgsel inklusive bradyarytmier og takyarytmier.
English: Pembrolizumab was administered prior to chemotherapy on Day 1.
Danish: Pembrolizumab blev administreret før kemoterapi på dag 1.
English: - Do not breast-feed while taking KEYTRUDA.
Danish: - Du må ikke amme, mens du får Keytruda.
English: Not reached (0.0+, 45.6+)
Danish: Ikke nået (0,0+; 45,6+)
English: As expected for an antibody, pembrolizumab does not bind to plasma proteins in a specific manner.
Danish: Som forventet for et antistof binder pembrolizumab ikke specifikt til plasmaproteiner.
English: BRAF mutations were reported in 302 (36%) patients.
Danish: BRAF-mutation blev rapporteret hos 302 (36%) patienter.
English: PD-L1 status in melanoma
Danish: PD-L1-status ved melanom
English: Of the 154 patients, 134 were enrolled with solid tumours, 18 with Hodgkin lymphoma, and 2 with other lymphomas.
Danish: Ud af 154 patienter blev 134 inkluderet med solide tumorer, 18 med Hodgkins lymfom og 2 med andre lymfomer.
English: Randomisation to the chemotherapy and the chemotherapy-pembrolizumab arms remains open.
Danish: Randomisering til kemoterapi- og kemoterapi-pembrolizumab-armene forbliver åben.
English: BRAF mutation status in melanoma
Danish: BRAF-mutationstatus ved melanom
English: Prior therapy included platinum-doublet regimen (100%); patients received one (69%) or two or more (29%) treatment lines.
Danish: Forudgående behandling inkluderede platinbaseret dublet-regime (100%); patienterne havde fået en (69%) eller to eller flere (29%) behandlingslinjer.
English: After careful consideration of the potential increased risk, pembrolizumab may be used with appropriate medical management in these patients.
Danish: Efter nøje overvejelse af den potentielt øgede risiko kan pembrolizumab anvendes til disse patienter med passende klinisk håndtering.