natgillin/translations-raw huggingface dataset:
Det kan være nødvendigt at anvende mere end et hætteglas OPDIVO for at opnå den nødvendige dosis. 
More than one vial of OPDIVO may be necessary to obtain the required dose.
Median-OSa (måneder) 
Median OSa (months)
Patienten skal monitoreres for kliniske tegn og symptomer på endokrinopatier, hyperglykæmi og ændringer i thyroideafunktionen (i begyndelsen af behandlingen, regelmæssigt under behandlingen og som indiceret baseret på klinisk evaluering). 
Patients should be monitored for clinical signs and symptoms of endocrinopathies and for hyperglycaemia and changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation).
En farmakokinetisk populationsanalyse tydede ikke på nogen forskel i nivolumabs CL på basis af alder, køn, race, type af solid tumor, tumorstørrelse og nedsat leverfunktion. 
A population PK analysis suggested no difference in CL of nivolumab based on age, gender, race, solid tumour type, tumour size, and hepatic impairment.
Kardielle og pulmonale bivirkninger, herunder lungeemboli, er også rapporteret med kombinationsbehandling. 
Cardiac and pulmonary adverse events including pulmonary embolism have also been reported with combination therapy.
Den overordnede sikkerhedsprofil for nivolumab 3 mg/kg til adjuverende behandling af melanom (n = 452) var i overensstemmelse med den, der er etableret på tværs af tumortyper for nivolumabmonoterapi. 
The overall safety profile of nivolumab 3 mg/kg for the adjuvant treatment of melanoma (n = 452) was consistent with that established across tumour types for nivolumab monotherapy.
Overfølsomhed/infusionsreaktion 
Hypersensitivity/Infusion Reaction
Tabel 7 viser procentdelen af immunrelatererede bivirkninger, hvor behandling blev seponeret permanent ud fra dosisregime. 
Table 7 presents the percentage for immune-related adverse reactions who were permanently discontinued from treatment by dosing regimen.
Effektparametrene omfattede investigatorvurderet ORR, retrospektivt evalueret af en IRRC, og responsvarighed. 
Efficacy assessments included investigator-assessed ORR, retrospectively evaluated by an IRRC, and duration of response.
Hvis du holder op med at få OPDIVO 
If you stop using OPDIVO
Det uåbnede hætteglas kan opbevares ved stuetemperaturer på op til 25°C og rumbelysning i op til 48 timer. 
The unopened vial can be stored at controlled room temperature up to 25°C with room light for up to 48 hours.
Sådan skal du bruge OPDIVO 4. 
How to use OPDIVO 4.
Kontroller OPDIVO-koncentratet for partikler eller misfarvning. 
Inspect the OPDIVO concentrate for particulate matter or discoloration.
Hyppigheden af kardielle bivirkninger var lavere i nivolumabgruppen end i dacarbazingruppen i populationen med metastatisk melanom uden tidligere behandling. 
The frequency of cardiac adverse events was lower in the nivolumab group than in the dacarbazine group in the metastatic melanoma without prior treatment population.
Der er rapporteret om infektion med/reaktivering af cytomegalovirus (CMV) hos patienter med kortikosteroid-refraktær immunrelateret colitis. 
Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immunerelated colitis.
Nivolumabs CL hos patienter med klassisk HL var cirka 32 % lavere i forhold til NSCLC. 
Nivolumab CL in cHL patients was approximately 32% lower relative to NSCLC.
Fordelene ved behandling med nivolumab skal afvejes mod risikoen for mulig organafstødning hos disse patienter. 
The benefit of treatment with nivolumab versus the risk of possible organ rejection should be considered in these patients.
ORR (95 % CI) i forhold til PD-L1-tumorekspression n = 210 
ORR (95% CI) by tumour PD-L1 expression n=210
Medianalderen var 60 år (23-88). 
The median age was 60 years (range: 23-88).
Sikkerheden ved at genoptage behandlingen med nivolumab eller nivolumab i kombination med ipilimumab hos patienter, der tidligere har haft immunrelateret myocarditis, kendes ikke. 
The safety of re-initiating nivolumab or nivolumab in combination with ipilimumab therapy in patients previously experiencing immune-related myocarditis is not known.
OPDIVO eller OPDIVO i kombination med ipilimumab skal seponeres permanent ved: 
OPDIVO or OPDIVO in combination with ipilimumab should be permanently discontinued for:
Det omfatter 243 patienter der har ASCT: Kohorte A omfattede 63 (26 %) patienter som var brentuximab vedotin-naive; Kohorte B omfattede 80 (33 %) patienter, som havde fået brentuximab vedotin efter ASCT-svigt; og Kohorte C omfattede 100 (41 %) patienter som havde fået brentuximab vedotin før og/eller efter ACST hvoraf 33 (14 %) patienter kun fik brentuximab vedotin før ACST. 
It includes 243 patients who had ASCT; Cohort A included 63 (26%) patients who were brentuximab vedotin naïve; Cohort B included 80 (33%) patients who had received brentuximab vedotin after ASCT failure; and Cohort C included 100 (41%) patients who had received brentuximab vedotin before and/or after ASCT out of which 33 (14%) patients received brentuximab vedotin only prior to ASCT.
Problemer med hjertet som f.eks. ændringer i rytmen eller hastigheden af hjerteslag eller en unormal hjerterytme. 
Problems with your heart such as a change in the rhythm or rate of the heartbeat or an abnormal heart rhythm.
Ikke kendt aseptisk meningitish 
Not known aseptic meningitish
Kroniske sygdomme forbundet med ophobning af betændelsesceller i forskellige organer og væv, oftest i lungerne (sarkoidose) 
Chronic diseases associated with a build-up of inflammatory cells in various organs and tissues, most commonly the lungs (sarcoidosis)
Mediantiden fra initial diagnosticering til randomisering var 2,6 år i både nivolumab-gruppen og everolimus-gruppen. 
The median duration of time from initial diagnosis to randomisation was 2.6 years in both the nivolumab and everolimus groups.
Tabel 9: Bedste samlet respons, tid til respons og responsvarighed (CA209037) 
Table 9: Best overall response, time and duration of response (CA209037)
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med nivolumab i alle undergrupper af den pædiatriske population ved behandling af maligne solide tumorer, maligne neoplasmer i lymfevæv og maligne neoplasmer i centralnervesystemet (se pkt. 
The European Medicines Agency has deferred the obligation to submit the results of studies with nivolumab in all subsets of the paediatric population in the treatment of malignant solid tumours, malignant neoplasms of lymphoid tissue and malignant neoplasms of the central nervous system (see section 4.2 for information on paediatric use).
Grad 2 myocarditis 
Grade 2 myocarditis
Hvis en patient udvikler symptomer på myotoksicitet, skal patienten nøje overvåges og straks henvises til en specialist for vurdering og behandling. 
If a patient develops signs and symptoms of myotoxicity, close monitoring should be implemented, and the patient referred to a specialist for assessment and treatment without delay.
Volumen (ml) af OPDIVO-koncentrat til klargøring af dosis = den totale dosis i mg, divideret med 10 (styrken af OPDIVO-koncentratet er 10 mg/ml). 
The volume of OPDIVO concentrate to prepare the dose (mL) = the total dose in mg, divided by 10 (the OPDIVO concentrate strength is 10 mg/mL).
Patienterne skulle have ECOG-performance-score 0 eller 1. 
Patients were to have ECOG performance status score of 0 or 1.
Det skal du vide, før du begynder at bruge OPDIVO 3. 
What you need to know before you use OPDIVO 3.
PD-1s interaktion med liganderne PD-L1 og PD-L2, der udtrykkes i antigenpræsenterende celler og muligvis af tumorer eller andre celler i tumors mikromiljø, medfører hæmning af T-celleproliferation og cytokinudskillelse. 
Engagement of PD-1 with the ligands PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumours or other cells in the tumour microenvironment, results in inhibition of T-cell proliferation and cytokine secretion.
Begge nivolumab-arme viste større objektive responsrater end ipilimumab uanset PDL1-ekspressionsniveau. 
Both nivolumab-containing arms demonstrated greater objective response rates than ipilimumab regardless of PD-L1 expression levels.
P-værdi er udledt af en log-rank-test stratificeret efter tidligere cetuximab-behandling; grænsen for det tilsvarende O'Brien-Fleming-signifikansniveau for effekt er 0,0227. 
P-value is derived from a log-rank test stratified by prior cetuximab; the corresponding O'Brien-Fleming efficacy boundary significance level is 0.0227.
Ikke almindelig intestinal perforationa, gastritis, duodenitis gastritis 
Uncommon intestinal perforationa, gastritis, duodenitis gastritis
Lægen skal tage hensyn til nivolumabs forsinkede virkning, før behandling initieres hos patienter med dårlige prognostiske udsigter og/eller aggressiv sygdom. 
Physicians should consider the delayed onset of nivolumab effect before initiating treatment in patients with poorer prognostic features and/or aggressive disease.
Immunrelateret myocarditis 
Immune-related myocarditis
Immunrelateret bivirkning, der krævede behandling med højdosis-kortikosteroidera,b 
Immune-related adverse reaction requiring high-dose corticosteroidsa,b
Grad 2 forhøjelse af aspartataminotransferase (ASAT), alaninaminotransferase (ALAT) eller total-bilirubin 
Grade 2 elevation in aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin
Nivolumab i kombination med ipilimumab: 
Nivolumab in combination with ipilimumab:
Der blev ikke rapporteret om nogen generel forskel på sikkerheden mellem ældre (≥ 65 år) og yngre patienter (< 65 år). 
No overall differences in safety were reported between elderly (≥ 65 years) and younger patients (< 65 years).
Data fra den længere opfølgningsperiode fra kohorte B (minimum 20,5 måneder) og effekt i kohorte C fra CA209205 er vist i nedenstående tabel 22. 
Longer follow-up data from Cohort B (minimum 20.5 months) and efficacy of Cohort C from CA209205 are presented below in Table 22.
240 mg hver 2. uge over 30 minutter 
240 mg every 2 weeks over 30 minutes
Behandling med OPDIVO, enten som monoterapi eller i kombination med ipilimumab, bør fortsættes, så længe der observeres en klinisk gavnlig effekt, eller indtil patienten ikke længere tolererer behandlingen. 
Treatment with OPDIVO, either as a monotherapy or in combination with ipilimumab, should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient.
Af de 306 tidligere behandlede patienter, der deltog i studiet, havde 107 melanom og fik nivolumab i en dosis på 0,1 mg/kg, 0,3 mg/kg, 1 mg/kg, 3 mg/kg eller 10 mg/kg i højst 2 år. 
Of the 306 previously treated patients enrolled in the study, 107 had melanoma and received nivolumab at a dose of 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, or 10 mg/kg for a maximum of 2 years.
Det skal besluttes, om amning skal ophøre eller behandling med nivolumab seponeres, idet der tages hensyn til fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen. 
A decision must be made whether to discontinue breast-feeding or to discontinue from nivolumab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
PD-L1-ekspression nivolumab investigators valg OS i forhold til PD-L1-tumorekspression Antal hændelser (antal patienter) 
PD-L1 Expression nivolumab investigator's choice OS by tumour PD-L1 expression Number of events (number of patients)
Af de 811 behandlede patienter havde 103 (13 %) en ECOG-performance-score på 2, 686 (85 %) var < 75 år, og 125 (15 %) var ≥ 75 år. 
Of the 811 treated patients, 103 (13%) had an ECOG performance score of 2, 686 (85%) were < 75 years old and 125 (15%) were ≥ 75 years old.
Det er meget vigtigt, at du overholder alle dine aftaler om behandling med OPDIVO. 
It is very important for you to keep all your appointments to receive OPDIVO.
Der blev ikke rapporteret nogen generelle forskelle i sikkerhed og virkning mellem ældre (≥ 65 år) og yngre patienter (< 65 år). 
No overall differences in safety or efficacy were reported between elderly (≥ 65 years) and younger patients (< 65 years).
År fra seneste transplantation til første dosis af studiebehandlingen, median (min-maks) a 18/80 (22,5 %) af patienterne i CA209205 kohorte B udviste B-symptomer ved baseline. 
Years from most recent transplant to first dose of study therapy, median (min-max) a 18/80 (22.5%) of the patients in CA209205 Cohort B presented B-Symptoms at baseline.
Tabel 17 opsummerer resultaterne for ORR og OS i forhold til PD-L1-tumorekspression. 
Table 17 summarises results of ORR and OS by tumour PD-L1 expression.
Afstødning af et transplanteret fast organ 
Solid organ transplant rejection
Sandsynlighed for overlevelse 
Probability of Survival
Behandling med nivolumab eller nivolumab i kombination med ipilimumab bør ikke genoptages, mens patienten får immunsuppressive doser af kortikosteroid eller anden immunsuppressiv behandling. 
Nivolumab or nivolumab in combination with ipilimumab should not be resumed while the patient is receiving immunosuppressive doses of corticosteroids or other immunosuppressive therapy.
Hvis OPDIVO ikke anvendes straks, kan den opbevares i køleskab (2°C-8°C) og beskyttet mod lys i op til 24 timer [højst 8 timer ud af de 24 timer ved stuetemperatur (20°C-25°C) og dagslys]. 
If not used immediately, the solution may be stored under refrigeration conditions (2°C-8°C) and protected from light for up to 24 hours [a maximum of 8 hours of the total 24 hours can be at room temperature (20°C-25°C) and room light].
Nivolumabs CL ved baseline hos patienter behandlet for adjuverende melanom var cirka 40 % lavere, og CL ved steady state var cirka 20 % lavere i forhold til fremskredent melanom. 
Nivolumab baseline CL in adjuvant melanoma patients was approximately 40% lower and steady state CL approximately 20 % lower relative to advanced melanoma.
Et hætteglas indeholder enten 40 mg (i 4 ml), 100 mg (i 10 ml) eller 240 mg (i 24 ml) nivolumab. 
Each vial contains either 40 mg (in 4 mL), 100 mg (in 10 mL) or 240 mg (in 24 mL) of nivolumab.
Vogt-Koyanagi-Harada syndromh 
Vogt-Koyanagi-Harada syndromeh Cardiac disorders
Medianresponsvarighed var 13,2 måneder (95 % CI: 8.2; NE) 
Median duration of response was 13.2 months (95% CI: 8.2, NE)
Følgende bivirkninger er blevet rapporteret med nivolumab i kombination med ipilimumab: 
The following side effects have been reported with nivolumab in combination with ipilimumab:
EU/1/15/1014/001 40 mg hætteglas EU/1/15/1014/002 100 mg hætteglas EU/1/15/1014/003 240 mg hætteglas 
EU/1/15/1014/001 40 mg vial EU/1/15/1014/002 100 mg vial EU/1/15/1014/003 240 mg vial
Der er rapporteret dødelige tilfælde i afsluttede eller igangværende kliniske studier. 
Fatal cases have been reported in completed or ongoing clinical studies b
Der foreligger ingen data fra anvendelse af nivolumab i kombination med ipilimumab hos førstelinje RCC-patienter med kun en non-clear cell-histologi. 
There are no data on the use of nivolumab in combination with ipilimumab in patients with only a non clear-cell histology in first line RCC.
Ikke almindelig metabolisk acidose 
Uncommon metabolic acidosis
Åndenød (dyspnø) 
Shortness of breath (dyspnoea)
Ikke tilgængeligb 
Not Availableb
Studiet inkluderede patienter (18 år eller ældre) med tidligere ubehandlet, fremskredent eller metastatisk renalcellekarcinom med en clear cell-komponent. 
The study included patients (18 years or older) with previously untreated, advanced or metastatic renal cell carcinoma with a clear-cell component.
Baseline-karakteristika var velbalancerede grupperne imellem undtagen andelen af patienter, som havde hjernemetastaser i anamnesen (19 % og 13 % i henholdsvis nivolumabgruppen og kemoterapigruppen) og patienter med LDH ved baseline, som var højere end ULN (henholdsvis 51 % og 35 %). 
Baseline characteristics were balanced between groups except for the proportions of patients who had a history of brain metastasis (19% and 13% in the nivolumab group and chemotherapy group, respectively) and patients with LDH greater than ULN at baseline (51% and 35%, respectively).
Primær analyse Minimum opfølgning: 10,6 måneder 
Primary analysis Minimum follow-up: 10.6 months
Efterfølgende systemisk behandling blev modtaget af 31,8 %, 44,3 % og 62,2 % af patienterne i henholdsvis kombinations-armen, nivolumab-armen og ipilimumab-armen. 
Subsequent systemic therapy was received by 31.8%, 44.3%, and 62.2% of patients in the combination, nivolumab monotherapy, and ipilimumab arms, respectively.
Ikke almindelig bronkitis bronkitis, aseptisk meningitis 
Uncommon bronchitis bronchitis, aseptic meningitis
Resolution forekom hos 64 patienter (45,4 %). 
Resolution occurred in 64 patients (45.4%).
Ikke nået (1,9+, 12,0+) 
Not Reached (1.9+, 12.0+)
Vævsprøver fra tumor før studiet blev systematisk indsamlet før randomisering for at kunne udføre forudplanlagte analyser af virkning i forhold til PD-L1-tumorekspression. 
Pre-study tumour tissue specimens were systematically collected prior to randomisation in order to conduct pre-planned analyses of efficacy according to tumour PD-L1 expression.
Kombineret nivolumab (anti-PD-1) og ipilimumab (anti-CTLA-4) medieret hæmning resulterer i forbedret anti-tumorrespons ved metastatisk melanom. 
Combined nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) mediated inhibition results in improved anti-tumour responses in metastatic melanoma.
99,79 % CI 95 % CI p-værdi 
99.79% CI 95% CI
• patienter der tidligere har modtaget behandling for melanom (bortset fra patienter der har modtaget kirurgiske indgreb, adjuverende strålebehandling efter neurokirurgisk resektion for læsioner i centralnervesystemet, og tidligere adjuverende interferon færdigbehandlet ≥ 6 måneder inden randomisering), 
• patients with prior therapy for melanoma (except patients with surgery, adjuvant radiotherapy after neurosurgical resection for lesions of the central nervous system, and prior adjuvant interferon completed ≥ 6 months prior to randomisation),
Tilfælde af myotoksicitet (myositis, myocarditis og rabdomyolyse), herunder tilfælde med dødelig udgang, er rapporteret med nivolumab og nivolumab i kombination med ipilimumab. 
Cases of myotoxicity (myositis, myocarditis, and rhabdomyolysis), some with fatal outcome, have been reported with nivolumab or nivolumab in combination with ipilimumab.
Studiet inkluderede voksne patienter med bekræftet, inoperabelt stadie III eller IV melanom. 
The study included adult patients with confirmed unresectable Stage III or Stage IV melanoma.
I en post-hoc-analyse af de 80 patienter i CA209205 kohorte B, havde 37 ikke noget respons på forudgående behandling med brentuximab vedotin. 
In a post-hoc analysis of the 80 patients in CA209205 Cohort B, 37 had no response to prior brentuximab vedotin treatment.
PD-L1-ekspression nivolumab docetaxel ORR i forhold til PD-L1-tumorekspression Minimum opfølgning: 13,2 måneder 
PD-L1 Expression nivolumab docetaxel ORR by tumour PD-L1 expression Minimum follow-up: 13.2 months
Permanent seponering af behandlingen var nødvendig hos en større andel af de patienter, der fik nivolumab i kombination med ipilimumab, end hos de patienter, der fik nivolumab-monoterapi. 
Permanent discontinuation of treatment was required in a greater proportion of patients receiving nivolumab in combination with ipilimumab than in those receiving nivolumab monotherapy.
Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) Bronkitis 
Uncommon (may affect up to 1 in 100 people) Bronchitis
Patienter, der oplever lette eller moderate infusionsreaktioner, kan få nivolumab eller nivolumab i kombination med ipilimumab under nøje overvågning og med anvendelse af præmedicinering i henhold til gældende retningslinjer for profylakse mod infusionsreaktioner. 
Patients with mild or moderate infusion reaction may receive nivolumab or nivolumab in combination with ipilimumab with close monitoring and use of premedication according to local treatment guidelines for prophylaxis of infusion reactions.
Effekt i forhold til BRAF-status: Objektivt repons på nivolumab (i henhold til definitionen på de to primære endepunkter) blev observeret hos patienter med eller uden BRAF mutationspositivt melanom. 
Efficacy by BRAF status: Objective responses to nivolumab (according to the definition of the coprimary endpoint) were observed in patients with or without BRAF mutation-positive melanoma.
OPDIVO-infusion administreres intravenøst over en periode på 30 eller 60 minutter alt afhængig af dosis. 
Administer the OPDIVO infusion intravenously over a period of 30 or 60 minutes depending on the dose.
Hvis OPDIVO ikke anvendes straks, er der påvist kemisk og fysisk stabilitet under anvendelse i 24 timer ved 2°C-8°C og beskyttet mod lys og i højst 8 timer ved 20°-25°C og dagslys (de 8 timer af de i alt 24 timer er inklusive administrationsperioden). 
If not used immediately, chemical and physical in-use stability of OPDIVO has been demonstrated for 24 hours at 2ºC to 8ºC protected from light and a maximum of 8 hours at 20°C-25°C and room light (this 8-hour period of the total 24 hours should be inclusive of the product administration period).
Derudover udelukkede CA209037 patienter, som havde haft en grad 4 bivirkning, der var relateret til anti-CTLA-4-behandling (se pkt. 
In addition, CA209037 excluded patients who have had a Grade 4 adverse reaction that was related to anti-CTLA-4 therapy (see section 5.1).
95 % CI: 1,4; 17,9 OS i forhold til PD-L1-tumorekspression Minimum opfølgning: 13,2 måneder Antal hændelser (antal patienter) 
95% CI: 1.4, 17.9 OS by tumour PD-L1 expression Minimum follow-up: 13.2 months Number of events (number of patients)
De fleste immunrelaterede bivirkninger forbedredes eller forsvandt med passende behandling, herunder kortikosteroidbehandling og behandlingsmodifikationer (se pkt. 
Most immune-related adverse reactions improved or resolved with appropriate management, including initiation of corticosteroids and treatment modifications (see section 4.2).
Tabel 22: Opdaterede effektresultater hos patienter med recidiverende/refraktær klassisk Hodgkins lymfom fra den længere opfølgningsperiode i studie CA209205 
Table 22: Updated efficacy results in patients with relapsed/refractory classical Hodgkin lymphoma from longer follow up of study CA209205
Yderligere data fra 100 patienter fra CA209205 kohorte C, som fik brentuximab før og/eller efter ASCT er også vist. 
Additional data from 100 patients from CA209205 Cohort C who received brentuximab before and/or after ASCT are also presented.
Urothelialt karcinom 
Urothelial Carcinoma
Virkningsundersøgelse efter tilladelse til markedsføring (PAES): Indehaveren af markedsføringstilladelsen skal indsende addendummet for den endelige CA209205 CSR med rapportering af OS-data og data fra seponeringsskemaet i Kohorte C. 
Post authorisation efficacy study (PAES): The MAH should submit the addendum to the CA209205 Final CSR reporting the OS data and data from the discontinuation schedule in Cohort C.
Forhøjet syreindhold i blodet 
Increased acid levels in the blood
Hvis der opstår symptomer eller tegn på SJS eller TEN, skal behandling med nivolumab eller nivolumab i kombination med ipilimumab seponeres og patienten henvises til en specialafdeling til vurdering og behandling. 
If symptoms or signs of SJS or TEN appear, treatment with nivolumab or nivolumab in combination with ipilimumab should be discontinued and the patient referred to a specialised unit for assessment and treatment.
I nivolumab-gruppen var der to patienter med CR og syv patienter med PR, der havde PD-L1tumorekspression < 1 %. 
In the nivolumab group there were two patients with CRs and seven patients with PRs who had tumour PD-L1 expression < 1%.