natgillin/translations-raw huggingface dataset:
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. 
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.
I tabel 12 opsummeres de vigtigste effektresultater for hele intent to treat (ITT)populationen. 
Table 12 summarizes key efficacy measures for the entire intent to treat (ITT) population.
Patienten skal have udleveret patientinformationskortet ved hver ordination. 
The patient will be provided with the Patient Alert Card with each prescription.
Ikke almindelig uveitis uveitis 
Uncommon uveitis uveitis
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. 
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.
-analysen (se tabel 22). 
(see Table 22).
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. 
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.
• Hvirvl langsomt hætteglasset rundt således, at det frysetørrede pulver bliver opløst. 
• Slowly swirl the vial to allow reconstitution of the lyophilised powder.
Patienterne skal monitoreres for hyperglykæmi eller andre tegn og symptomer på diabetes. 
Patients should be monitored for hyperglycaemia or other signs and symptoms of diabetes.
Sygdomsundergrupperne var 97% nodulær sklerose og 3% blandet cellularitet. 
Disease subtypes were 97% nodular sclerosis and 3% mixed cellularity.
Ved mistanke om immunrelaterede bivirkninger skal det sikres, at der foretages tilstrækkelig udredning for at bekræfte ætiologi eller udelukke andre årsager. 
For suspected immune-related adverse reactions, adequate evaluation to confirm aetiology or exclude other causes should be ensured.
Det var tilladt at øge dosis af axitinib til 10 mg to gange dagligt ud fra de samme kriterier. 
Dose escalation of axitinib to 10 mg twice daily was permitted using the same criteria.
5 forsøgspersoner var uegnede til ASCT af andre årsager end behandlingssvigt efter salvage-kemoterapi. 
Five study subjects were ineligible to ASCT due to reasons other than failure to salvage chemotherapy.
OS- og PFS-fordel sås uanset PD-L1-ekspressionsniveau. 
OS and PFS benefits were observed regardless of PD-L1 expression level.
Patienterne skal monitoreres for tegn og symptomer på pneumonitis. 
Patients should be monitored for signs and symptoms of pneumonitis.
Hyppighederne, som er inkluderet nedenfor og i tabel 2, er baseret på alle rapporterede bivirkninger, uden hensyn til investigators vurdering af kausalitet. 
The frequencies included below and in Table 2 are based on all reported adverse drug reactions, regardless of the investigator assessment of causality.
Du får Keytruda på et hospital under tilsyn af en læge med erfaring i behandling af kræft. 
KEYTRUDA will be given to you in a hospital or clinic under the supervision of a doctor experienced in cancer treatment.
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. 
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.
Kaplan-Meier-kurver for OS for populationen med TPS ≥ 50% er vist i figur 15. 
The Kaplan-Meier curve for OS for the TPS ≥ 50% population is shown in Figure 15.
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. 
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.
Brug af anden medicin sammen med Keytruda Fortæl det altid til lægen, - hvis du tager anden medicin, som svækker dit immunsystem. 
Other medicines and KEYTRUDA Tell your doctor - If you are taking other medicines that make your immune system weak.
Standardbehandling 
Standard Treatment
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. 
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).
Tumorstatus blev vurderet hver 9. uge. 
Assessment of tumour status was performed every 9 weeks.
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. 
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.
31% havde ECOG-performance-status på 1, 69% havde ECOG-performance-status på 0 og 32% havde forhøjet LDH. 
Thirty-one percent had an ECOG Performance Status of 1, 69% had ECOG Performance Status of 0 and 32% had elevated LDH.
Sygdomsundergrupperne var 80% nodulær sklerose, 11% blandet cellularitet, 4% lymfocytrig og 2% lymfocytfattig. 
Disease subtypes were 80% nodular sclerosis, 11% mixed cellularity, 4% lymphocyte-rich and 2% lymphocyte-depleted.
kvartal 2020 2. kvartal 2019 4. kvartal 2021 4. kvartal 2024 
2Q 2020 2Q 2019 4Q 2021 4Q 2024
I overensstemmelse med en begrænset ekstravaskulær fordeling er det gennemsnitlige fordelingsvolumen for pembrolizumab ved steady state lille (~6,0 liter; variationskoefficient (CV) 20%). 
Consistent with a limited extravascular distribution, the volume of distribution of pembrolizumab at steady state is small (~6.0 L; CV: 20%).
Standardbehandling: 
Standard Treatment:
Patienterne skal monitoreres for tegn og symptomer på colitis, og andre årsager skal udelukkes. 
Patients should be monitored for signs and symptoms of colitis, and other causes excluded.
Alvorlige hudreaktioner gik over hos 64 patienter. 
Severe skin reactions resolved in 64 patients.
Lægen skal drøfte risiciene ved KEYTRUDA-behandlingen med patienten. 
The prescriber must discuss the risks of KEYTRUDA therapy with the patient.
I tabel 27 opsummeres de centrale effektresultater for populationen med TPS ≥ 50%. 
Table 27 summarises the key efficacy measures for the TPS ≥ 50% population.
BRAF-mutation blev rapporteret hos 20 (39%) patienter. 
BRAF mutations were reported in 20 (39%) patients.
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. 
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.
Ikke almindelig pankreatitis pankreatitis pankreatitis 
Uncommon pancreatitis pancreatitis pancreatitis
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. 
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.
Sekundære resultatmål var responsvarighed, PFS og OS. 
Secondary efficacy outcome measures were duration of response, PFS and OS.
Patienter med ikke-planocellulært karcinom kunne få vedligeholdelsesbehandling med pemetrexed). 
Non-squamous patients could receive pemetrexed maintenance).
Hyppighederne er baseret på alle rapporterede bivirkninger, uden hensyn til investigators vurdering af kausalitet. 
The frequencies are based on all reported adverse drug reactions, regardless of the investigator assessment of causality.
I tilfælde af overdosering skal patienten monitoreres tæt for tegn og symptomer på bivirkninger, og passende symptomatisk behandling iværksættes. 
In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
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. 
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.
Ikke nået (2,7; 13,8+) 
Not reached (2.7, 13.8+)
Klinisk stabile patienter med initial evidens på sygdomsprogression fik lov til at forblive i behandling, indtil sygdomsprogression var blevet bekræftet. 
Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed.
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. 
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.
KEYNOTE-087 og KEYNOTE-013: Åbne studier med patienter med recidiverende eller refraktært klassisk Hodgkins lymfom (cHL) 
KEYNOTE-087 and KEYNOTE-013: Open-label studies in patients with relapsed or refractory classical Hodgkin lymphoma (cHL)
Systemiske kortikosteroider og immunsuppressiva bør undgås før initiering af behandling med pembrolizumab på grund af deres potentielle interferens med pembrolizumabs farmakodynamiske aktivitet og virkning. 
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.
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. 
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.
Patienterne skal monitoreres for tegn og symptomer på binyrebarkinsufficiens og hypofysitis (inklusive hypofyseinsufficiens (hypopituitarisme), og andre årsager skal udelukkes. 
Patients should be monitored for signs and symptoms of adrenal insufficiency and hypophysitis (including hypopituitarism) and other causes excluded.
Baseret på stratificeret log rank-test 
Based on stratified Log rank test
Immunrelaterede bivirkninger er også observeret efter den sidste dosis af pembrolizumab. 
Immune-related adverse reactions have also occurred after the last dose of pembrolizumab.
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. 
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.
Genoptagelse af behandling (rechallenge) med et enkelt lægemiddel eller sekventiel genoptagelse af behandlingen (sequential rechallenge) med begge lægemidler efter bedring kan overvejes. 
Rechallenge with a single medicine or sequential rechallenge with both medicines after recovery may be considered.
Ved adjuverende behandling af melanom skal KEYTRUDA administreres indtil sygdomsrecidiv, uacceptabel toksicitet eller i en periode på op til 1 år. 
For the adjuvant treatment of melanoma, KEYTRUDA should be administered until disease recurrence, unacceptable toxicity, or for a duration of up to one year.
Grad 4 eller bekræftet SJS eller TEN Seponer behandlingen permanent 
Grade 4 or confirmed SJS or TEN Permanently discontinue
* Cetuximab, platinbaseret behandling og 5-FU 
* Cetuximab, platinum, and 5-FU
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. 
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.
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. 
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.
Eftersom pembrolizumab elimineres fra kredsløbet via nedbrydning (katabolisme) forventes ingen metaboliske lægemiddelinteraktioner. 
Since pembrolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected.
• Genomanalyser med fuld exomsekventering og/eller RNAseq (f.eks. Nanostring RNA-gensignatur) 
• Genomic analyses using whole exome sequencing and/or RNAseq (e.g.
Patienter, der udviklede GVHD efter deres transplantation, kan have øget risiko for GVHD efter behandling med pembrolizumab. 
Patients who experienced GVHD after their transplant procedure may be at an increased risk for GVHD after treatment with pembrolizumab.
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%). 
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%).
Hypotyroidisme er rapporteret oftere hos patienter med HNSCC, som tidligere havde fået strålebehandling. 
Hypothyroidism is more frequently reported in patients with HNSCC with prior radiation therapy.
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. 
Patients who received prior therapy for melanoma other than surgery or interferon for thick primary melanomas without evidence of lymph node involvement were ineligible.
Kombination med kemoterapi 
Combination with chemotherapy
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. 
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.
Positiv for BRAF-mutation 
BRAF mutation positive
I alt 67 patienter i placebo plus kemoterapiarmen krydsede over til pembrolizumab som monoterapi på tidspunktet for sygdomsprogression, og yderligere 18 patienter fik en checkpoint-hæmmer som efterfølgende behandling. 
A total of 67 patients in the placebo plus chemotherapy arm crossed over to receive monotherapy pembrolizumab at the time of disease progression and 18 additional patients received a checkpoint inhibitor as subsequent therapy.
Patienter med aktiv, ikke-infektiøs pneumonitis, allogen transplantation inden for de seneste 5 år (eller > 5 år, men med GVHD), aktiv autoimmun sygdom eller en lidelse, som nødvendiggjorde behandling med immunsuppressiva, var uegnede til at deltage i begge 
Patients with active, non-infectious pneumonitis, an allogeneic transplant within the past 5 years (or > 5 years but with GVHD), active autoimmune disease or a medical condition that required immunosuppression were ineligible for either trial.
Binyrebarkinsufficiens Symptomatisk hypofysitis Type 1-diabetes associeret med hyperglykæmi grad ≥ 3 (glucose > 250 mg/dl eller > 13,9 mmol/l) eller associeret med ketoacidose Hypertyroidisme grad ≥ 3 
Adrenal insufficiency Symptomatic hypophysitis Type 1 diabetes associated with Grade ≥ 3 hyperglycaemia (glucose > 250 mg/dL or > 13.9 mmol/L) or associated with ketoacidosis Hyperthyroidism Grade ≥ 3
I populationen med Hodgkins lymfom var ORR 50,0%, 2 patienter (11,1%) havde komplet respons og 7 patienter (38,9%) havde partielt respons. 
In the Hodgkin lymphoma population, the ORR was 50.0%, 2 patients (11.1%) had a complete response and 7 patients (38.9%) had a partial response.
Alt i alt blev 20 cHL-patienter ≥ 65 år behandlet med pembrolizumab i studierne KEYNOTE-087 og KEYNOTE-013. 
Overall, 20 cHL patients ≥ 65 years were treated with pembrolizumab in studies KEYNOTE-087 and KEYNOTE-013.
Eksponeringen for pembrolizumab udtrykt ved peak-koncentration (Cmax) eller areal under kurven for plasmakoncentration over tid (AUC) steg dosisproportionalt inden for det terapeutiske dosisinterval. 
Exposure to pembrolizumab as expressed by peak concentration (Cmax) or area under the plasma concentration time curve (AUC) increased dose proportionally within the dose range for efficacy.
35% havde PD-L1tumorekspression TPS < 1% [negativ]; 19% var østasiatere og 60% fik paclitaxel. 
Thirty-five percent had tumour PD-L1 expression TPS < 1% [negative]; 19% were East Asian; and 60% received paclitaxel.
I EORTC QLQC30 global helbredstilstand/QoL sås en forlængelse af tiden til forværring hos patienter, der var blevet behandlet med pembrolizumab sammenlignet med investigators valg af kemoterapi (HR 0,70; 95% CI 0,55-0,90). 
A prolonged time to deterioration in EORTC QLQ-C30 global health status/QoL was observed for patients treated with pembrolizumab compared to investigator's choice chemotherapy (HR 0.70; 95% CI 0.55-0.90).
Patienter med aktive infektioner blev ekskluderet fra kliniske studier, og det var en forudsætning, at infektionen blev behandlet, inden de kunne få pembrolizumab. 
Patients with active infections were excluded from clinical trials and were required to have their infection treated prior to receiving pembrolizumab.
Pembrolizumab er et humaniseret monoklonalt anti-programmed cell death-1 (PD-1)-antistof (IgG4/kappa-isotype med en stabiliserende forandring af sekvensen i Fc-regionen), som er fremstillet ved rekombinant dna-teknologi i ovarieceller fra kinesiske hamstre. 
Pembrolizumab is a humanised monoclonal anti-programmed cell death-1 (PD-1) antibody (IgG4/kappa isotype with a stabilising sequence alteration in the Fc region) produced in Chinese hamster ovary cells by recombinant DNA technology.
Data fra patienter ≥ 65 år med cHL er for begrænsede til at kunne drage konklusioner (se pkt. 
Data from patients ≥ 65 years are too limited to draw conclusions on cHL population (see section 5.1).
Hypotyroidisme kan substitutionsbehandles uden afbrydelse af behandlingen og uden kortikosteroider. 
Hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids.
Det er ukendt, om pembrolizumab udskilles i human mælk. 
It is unknown whether pembrolizumab is secreted in human milk.
PD-L1-ekspression Pembrolizumab 
PD-L1 Expression Pembrolizumab
Det kan overvejes at udføre hyppigere monitorering af leverenzymer i forhold til, når lægemidlerne anvendes som monoterapi. 
More frequent monitoring of liver enzymes as compared to when the medicines are used in monotherapy may be considered.
De 23 patienter havde en median opfølgningstid fra efterfølgende allogen HSCT på 5,1 måneder (interval: 0-26,2 måneder). 
The 23 patients had a median follow-up from subsequent allogeneic HSCT of 5.1 months (range: 0-26.2 months).
Respons: Bedste objektive respons, der er bekræftet komplet eller partielt respons Baseret på Miettinen og Nurminen-metoden stratificeret ud fra ECOG (0 versus 1), HPV-status (positiv versus negativ) og PD-L1-status (markant positiv versus ikke markant positiv) 
Response: Best objective response as confirmed complete response or partial response Based on Miettinen and Nurminen method stratified by ECOG (0 vs. 1), HPV status (positive vs. negative) and PD-L1 status (strongly positive vs. not strongly positive)
I tabel 29 opsummeres effektresultater ud fra IMDC-risikokategori fra den præspecificerede interimanalyse. 
Table 29 summarises the efficacy measures by IMDC risk category from the pre-specified interim analysis.
Der sås ingen tegn på ændret farmakokinetisk profil eller sikkerhedsprofil i forbindelse med anti-pembrolizumab binding eller dannelse af neutraliserende antistoffer mod pembrolizumab. 
There was no evidence of an altered pharmacokinetic or safety profile with anti-pembrolizumab binding or neutralising antibody development.
De primære resultatmål var progressionsfri overlevelse (PFS, baseret på IRO-vurdering [Integrated Radiology and Oncology Assessment] i henhold til RECIST version 1.1 [Response Evaluation Criteria in Solid Tumors]) og samlet overlevelse (OS). 
The primary efficacy outcome measures were progression free survival (PFS; as assessed by Integrated Radiology and Oncology Assessment [IRO] review using Response Evaluation Criteria in Solid Tumours [RECIST], version 1.1) and overall survival (OS).
Forsøgspersoner, hvis tumorer udtrykker PD-L1 CPS < 10 og som allerede er indrulleret i armen med pembrolizumab som monoterapi, kan fortsætte behandlingen. 
Subjects whose tumours express PD-L1 CPS < 10 already enrolled into the pembrolizumab monotherapy arm can continue treatment.
Patienter, hvor aktive infektioner indtrådte under behandlingen med pembrolizumab, blev behandlet med passende medicinsk behandling. 
Patients with active infections occurring during treatment with pembrolizumab were managed with appropriate medical therapy.
KEYTRUDAs sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt. 
The safety and efficacy of KEYTRUDA in children below 18 years of age have not yet been established.
21% havde tidligere fået 2 systemiske regimer til behandling af metastaser. 
Twenty-one percent had received 2 prior systemic regimens in the metastatic setting.
• en bestemt type lungekræft kaldet ikke-småcellet lungekræft 
• a kind of lung cancer called non-small cell lung cancer
Hvis du holder op med at få Keytruda 
If you stop receiving KEYTRUDA
Pneumonitis forekom hyppigere hos patienter, der tidligere havde fået torakal strålebehandling (8,1%) end hos patienter, der ikke tidligere havde fået torakal strålebehandling (3,4%). 
Pneumonitis occurred more frequently in patients with a history of prior thoracic radiation (8.1%) than in patients who did not receive prior thoracic radiation (3.4%).