FrancophonIA/ELRC3.0 huggingface dataset:
English: Cohort 1 included 45 patients (38%) with ECOG performance status of 0, 50 patients (42%) with ECOG performance status of 1 and 24 patients (20%) with ECOG performance status of 2, 35 patients (29%) with no Bajorin risk factors (ECOG performance status ≥ 2 and visceral metastasis), 66 patients (56%) with one Bajorin risk factor and 18 patients (15 %) with two Bajorin risk factors, 84 patients (71%) with impaired renal function (glomerular filtration rate [GFR] < 60 mL/min), and 25 patients (21%) with liver metastasis.
Danish: Kohorte 1 omfattede 45 patienter (38%) med en ECOG-performancestatus på 0, 50 patienter (42%) med en ECOG-performancestatus på 1 og 24 patienter (20%) med en ECOG-performancestatus på 2, 35 patienter (29%) uden Bajorin-risikofaktorer (ECOG-performancestatus ≥2 og viskerale metastaser), 66 patienter (56%) med 1 Bajorin-risikofaktor og 18 patienter (15%) med 2 Bajorin-risikofaktorer, 84 patienter (71%) med nedsat nyrefunktion (glomerulær filtrationshastighed [GFR] <60 ml/min) og 25 patienter (21%) med levermetastaser.
English: Do not co-administer other medicinal products through the same infusion line.
Danish: Tecentriq må ikke administreres sammen med andre lægemidler i samme infusionsslange.
English: No incompatibilities have been observed between Tecentriq and intravenous bags with product-contacting surfaces of polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP).
Danish: Der er ikke set uforligelighed mellem Tecentriq og infusionsposer med kontaktoverflader af polyvinylchlorid (PVC), polyolefin (PO), polyethylen (PE) eller polypropylen (PP).
English: Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Event Version 4.0 (NCI-CTCAE v.4.
Danish: (National Cancer Institute Common Terminology Criteria for Adverse Event Version 4.0)
English: Nausea, diarrhoea, stomatitis, fatigue, pyrexia, mucosal inflammation, decreased appetite, weight decreased, hypertension and proteinuria were reported higher (≥5% difference) in patients receiving atezolizumab in combination with bevacizumab,
Danish: Kvalme, diarré, stomatitis, træthed, pyreksi, slimhindebetændelse, nedsat appetit, vægttab, hypertension og proteinuri blev rapporteret hyppigere (³5% forskel) hos patienter der fik atezolizumab i kombination med bevacizumab, paclitaxel og carboplatin.
English: Details for the significant adverse reactions for atezolizumab when given in combination are presented if clinically relevant differences were noted in comparison to atezolizumab monotherapy.
Danish: Detaljeret information om de signifikante bivirkninger for atezolizumab i kombinationsbehandling er angivet hvis kliniske relevante forskelle er noteret sammenlignet med atezolizumab enkeltstofbehandling.
English: In an exploratory analysis with longer follow up (median: 24.1 months), the median OS for both arms was unchanged relative to the primary analysis, with HR = 0.82 (95% CI: 0.67, 1.01).
Danish: I en eksploratorisk analyse med længere opfølgningstid (median: 24,1 måned), var median samlet overlevelse for begge behandlingsarme uændret i forhold til den primære analyse med hazardratio: 0,82 (95% konfidensinterval: 0,67; 1,01).
English: The bag should be gently inverted to mix the solution in order to avoid foaming.
Danish: For at blande opløsningen, vendes posen forsigtigt for at undgå skumdannelse.
English: Common influenza like illness, chills a
Danish: Influenzalignende sygdom, kulderystelser a
English: Use of atezolizumab in urothelial carcinoma for previously untreated patients who are considered cisplatin ineligible
Danish: Brug af atezolizumab til urotelialt carcinom hos tidligere ubehandlede patienter, hvor behandling med cisplatin ikke vurderes at være velegnet
English: Table 3: Summary of efficacy in all comers (IMvigor211)
Danish: Tabel 3: Opsummering af effekt hos alle grupper (IMvigor211)
English: 472 patients described atezolizumab pharmacokinetics for the dose range: 1 to 20 mg/kg with a linear two-compartment disposition model with first-order elimination.
Danish: En populationsanalyse af 472 patienter beskriver atezolizumabs farmakokinetik for dosisintervallet: 1 til 20 mg/kg med en lineær 2-kompartment dispositionsmodel med førsteordenselimination.
English: Secondary efficacy endpoints included objective response rate (ORR) and duration of response (DOR) per RECIST v1.1.
Danish: Det sekundære effekt-endepunkt inkluderede objektiv responsrate og varighed af respons per RECIST v1.1.
English: The majority of the patients were male (59%) and white (90%).
Danish: Størstedelen af patienterne var mænd (59%) og hvide (90%).
English: Table 12: Summary of efficacy (IMpower133) Key efficacy endpoints
Danish: Table 12: Opsummering af effekt (IMpower133) Vigtigste Effekt-endepunkter
English: Atezolizumab in combination therapy
Danish: Atezolizumab kombinationsbehandling
English: Programmed death-ligand 1 (PD-L1) may be expressed on tumour cells and/or tumour-infiltrating immune cells, and can contribute to the inhibition of the antitumour immune response in the tumour microenvironment.
Danish: Programmeret celledød-ligand 1 (PD-L1) kan være udtrykt på tumorceller (TC) og/eller tumorinfiltrerende immunceller (IC) og kan bidrage til hæmningen af antitumor-immunresponset i tumormikromiljøet.
English: Patients with the following conditions were excluded from clinical trials: a history of autoimmune disease, history of pneumonitis, active brain metastasis, HIV, hepatitis B or hepatitis C infection, significant cardiovascular disease and patients with inadequate hematologic and end-organ function.
Danish: Patienter med følgende tilstande kunne ikke inkluderes i kliniske studier: autoimmun sygdom i anamnesen, tidligere tilfælde af pneumonitis, aktive hjernemetastaser, HIV, hepatitis B eller C, signifikant hjertekar sygdom og patienter med utiltrækkelig hæmatologisk funktion og utilstrækkelig funktion af endeorgan.
English: The data below reflect information for significant adverse reactions for atezolizumab as monotherapy in clinical studies (see section 5.1).
Danish: Nedenstående data afspejler information om signifikante bivirkninger for atezolizumab enkelstofbehandling i kliniske studier (se pkt.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with atezolizumab in all subsets of the paediatric population in the treatment of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms) (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med atezolizumab i alle subgrupper af den pædiatriske population til behandling af maligne neoplasier (bortset fra tumorer i centralnervesystemet samt neoplasier i hæmatopoietisk og lymfoidt væv) (se pkt.
English: + etoposide (100
Danish: + etoposid
English: Mutagenicity studies have not been performed to establish the mutagenic potential of atezolizumab.
Danish: Der er ikke gennemført mutagenicitetsstudier med henblik på at vurdere atezolizumabs mutagene potentiale.
English: Of the 62 patients, two experienced a fatal event.
Danish: Hos 2 ud af de 62 patienter var bivirkningen dødelig.
English: No fertility studies have been conducted with atezolizumab; however assessment of the cynomolgus monkey male and female reproductive organs was included in the chronic toxicity study.
Danish: Der er ikke gennemført fertilitetsstudier med atezolizumab; dog har studiet vedrørende kronisk toksicitet omfattet en vurdering af han- og huncynomolgusabers reproduktive organer.
English: Use of atezolizumab in combination with nab-paclitaxel in metastatic triple negative breast cancer
Danish: Brug af atezolizumab i kombination med nab-paclitaxel ved metastatisk triple-negativ brystkræft
English: Patients should be monitored for symptoms of motor and sensory neuropathy.
Danish: Patienterne bør monitoreres for symptomer på motoriske og sensoriske neuropatier.
English: Patients were randomised (1:1) to receive either atezolizumab or docetaxel.
Danish: Patienterne randomiseredes (1:1) til atezolizumab eller docetaxel.
English: OS was not mature with an event patient ratio of approximately 40%.
Danish: Det er endnu ikke muligt at beregne den samlede overlevelse med en hændelsesfrekvens på ca. 40%.
English: Asymptomatic patients with abnormal thyroid function tests can receive atezolizumab.
Danish: Asymptomatiske patienter med unormale thyroideaværdier kan behandles med atezolizumab.
English: Grade 3 or 4 serum amylase or lipase levels increased (> 2 x ULN) or Grade 2 or 3 pancreatitis
Danish: Grad 3 eller 4 stigninger i serumamylase- eller lipaseniveauer (>2 gange øvre referencegrænse) eller grad 2 eller 3 pancreatitis
English: ^ The Arm C is the comparison group for all hazard ratios * Updated PFS analysis and interim OS analysis at clinical cut-off 22 January 2018 PFS = progression-free survival; RECIST = Response Evaluation Criteria in Solid Tumours v1.1.
Danish: ^ Arm C er sammenligningsgruppen for alle hazardratios * Opdateret analyse af progressionsfri overlevelse og interim analyse af samlet overlevelse ved klinisk cut-off 22. januar 2018 RECIST = Response Evaluation Criteria in Solid Tumours v1.1.
English: The median DOR was not reached in any PD-L1 expression subgroup or in all comers.
Danish: Medianvarighed af respons blev ikke nået i nogen af PDL1- ekspressions-subgrupperne eller i hele gruppen.
English: The median age was 55 years (range: 20-86).
Danish: Medianalderen var 55 år (interval: 20 til 86 år).
English: Each mL contains 60 mg of atezolizumab.
Danish: Hver ml indeholder 60 mg atezolizumab.
English: o Incudes reports of myasthenia gravis.
Danish: o Inkluderer indberetninger om myasthenia gravis p
English: Fifty-nine percent of patients in the nab-paclitaxel and carboplatin arm received any cancer immunotherapy after disease progression, which includes atezolizumab as crossover treatment (41% of all patients), compared to 7.3% of patients in the atezolizumab, nab paclitaxel and carboplatin arm.
Danish: Efter sygdomsprogression fik 59% af patienterne i nab-paclitaxel og carboplatinarmen behandling med en form for immunterapi mod kræft, inklusiv atezolizumab som overkrydsningsbehandling (41% af alle patienterne) sammenlignet med 7,3% af patienterne i atezolizumab, nab-paclitaxel og carboplatinarmen.
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
Danish: I tilfælde af overdosis skal patienten monitoreres tæt for symptomer på bivirkninger og relevant symptombehandling påbegyndes.
English: l Includes reports of neuropathy peripheral, autoimmune neuropathy, peripheral sensory neuropathy, polyneuropathy, herpes zoster, peripheral motor neuropathy, neuralgic amyotrophy, peripheral sensorimotor neuropathy, toxic neuropathy, axonal neuropathy, lumbosacral plexopathy, neuropathic arthropathy, peripheral nerve infection.
Danish: Inkluderer indberetninger om perifer neuropati, autoimmun neuropati, perifer sensorisk neuropati, polyneuropati, herpes zoster, perifer motorisk neuropati, neuralgisk amyotrofi, perifer sensormotorisk neuropati, toksisk neuropati, aksonal neuropati, lumbosakral plexopati, neuropatisk artropati, perifer nervebetændelse.
English: Table 6 - Summary of efficacy in patients with PD-L1 expression ≥1% (IMpassion130) Key efficacy endpoints
Danish: Tabel 6: Opsummering af effect hos patienter med PD-L1-ekspression ≥1% (IMpassion130) Nøgleeffekt-endpunkter
English: A total of 1,202 patients were enrolled and were randomised (1:1:1) to receive one of the treatment regimens described in Table 5.
Danish: Der blev i alt inkluderet 1202 patienter, som var randomiseret (1:1:1) til at få et af behandlingsregimerne beskrevet i tabel 5.
English: Sverige Roche AB
Danish: Roche AB
English: Cohort 2 included patients who received at least one platinum-based chemotherapy regimen for locally advanced or metastatic UC or had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen.
Danish: Kohorte 2 inkluderede patienter, der havde modtaget mindst én platinbaseret kemoterapi for lokalt fremskredent eller metastatisk urotelialt carcinom eller havde oplevet sygdomsprogression inden for 12 måneder efter behandling med platinholdig neoadjuverende eller adjuverende kemoterapi.
English: If you miss a dose of Tecentriq
Danish: Hvis du har sprunget en dosis Tecentriq over
English: A population pharmacokinetic analysis suggests that steady-state is obtained after 6 to 9 weeks (2 to 3 cycles) of repeated dosing.
Danish: En farmakokinetisk populationsanalyse har vist, at steady-state opnås efter gentagen dosering efter 6-9 uger (2-3 serier).
English: At the time of the interim OS analysis, patients had a median follow-up of 19.7 months.
Danish: Ved interimanalysen af den samlede overlevelse havde patienterne en median opfølgningstid på 19,7 måneder.
English: Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway can lead to immune-related rejection of the developing foetus resulting in foetal death.
Danish: Dyrestudier har vist, at hæmning af PD-L1/PD-1-vejen kan medføre immunrelateret afstødning af fostret og føtal død.
English: A total of 287 patients were randomised 1:1 to receive either atezolizumab (1,200 mg by intravenous infusion every 3 weeks until loss of clinical benefit) or docetaxel (75 mg/m2 by intravenous infusion on day 1 of each 3-week cycle until disease progression).
Danish: I alt 287 patienter blev randomiseret i forholdet 1:1 til atezolizumab (1200 mg ved intravenøs infusion hver 3. uge indtil der ikke længere var klinisk gavn) eller docetaxel (75 mg/m2 ved intravenøs infusion på dag 1 i hver 3-ugers cyklus indtil sygdomsprogression).
English: Each vial contains 1,200 mg of atezolizumab (in 20 mL).
Danish: Hvert hætteglas indeholder 1200 mg atezolizumab (i 20 ml).
English: In study IMpower150, age ≥ 65 was associated with a diminished effect of atezolizumab in patients receiving atezolizumab in combination with carboplatin and paclitaxel.
Danish: I studie IMpower150 blev en alder på ≥ 65 år forbundet med formindsket effekt hos patienter, der fik atezolizumab i kombination med carboplatin og paclitaxel.
English: The following side effects have been reported in clinical trials when Tecentriq is given in combination with anticancer medicines:
Danish: Følgende bivirkninger er indberettet i kliniske studier hvor Tecentriq er givet sammen med kemoterapi:
English: Treatment with atezolizumab may be resumed if metabolic control is achieved on insulin replacement therapy.
Danish: Behandling med atezolizumab kan genoptages, hvis der opnås metabolisk kontrol med insulinsubstitutionsbehandling.
English: In study IMpower150, there are no data on the efficacy of atezolizumab in combination with bevacizumab, paclitaxel and carboplatin in EGFR+ patients who have progressed previously on erlotinib+bevacizumab.
Danish: Der foreligger ingen data fra studie IMpower150 om effekten af atezolizumab i kombination med bevacizumab, paclitaxel og carboplatin hos EGFR+ patienter, som har progredieret under tidligere behandling med erlotinib+bevacizumab.
English: No clinical data are available on the possible effects of atezolizumab on fertility.
Danish: Der er ingen tilgængelige kliniske data om hvorvidt atezolizumab påvirker fertiliteten.
English: An analysis was also performed with a median duration of survival follow-up of 21.1 months for
Danish: Der blev også gennemført en analyse af kohorte 2 med en medianvarighed af overlevelsesopfølgning på 21,1 måneder.
English: Approximately 10% of patients had known EGFR mutation, 4% had known ALK rearrangements, 14% had liver metastasis at baseline, and most patients were current or previous smokers (80%).
Danish: Ca. 10% af patienterne havde kendt EGFR-mutation, 4% havde kendt ALK-rearrangement, 14% havde levermetastaser ved baseline, og de fleste patienter var aktive eller tidligere rygere (80%).
English: Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway in murine pregnancy models can lead to immune-related rejection of the developing foetus resulting in foetal death (see section 5.3).
Danish: Dyreforsøg har vist, at PD-L1/PD-1-hæmning i muse-graviditetsmodeller kan medføre immunrelateret afstødelse af fostret under udvikling og føtal død (se pkt.
English: No overall differences in safety were observed between patients ≥ 65 years of age and younger patients receiving atezolizumab monotherapy.
Danish: Der er ikke observeret generelle forskelle i sikkerheden mellem patienter ≥ 65 år og yngre patienter der fik atezolizumab enkeltstofbehandling.
English: SWITZERLAND
Danish: Schweiz
English: Of the 87 patients, one experienced a fatal event.
Danish: Hos én ud af de 87 patienter var bivirkningen dødelig.
English: Based on a population pharmacokinetic analysis, no dose adjustment is required for patients with mild hepatic impairment.
Danish: Baseret på en farmakokinetisk populationsanalyse er dosisjustering ikke nødvendig hos patienter med let nedsat leverfunktion.
English: EU/1/17/1220/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1220/002
English: Table 5: Intravenous treatment regimens (IMpower150) Treatment regimen
Danish: Tabel 5: Intravenøse behandlingsregimer (IMpower150) Behandlingsregime
English: Maintenance (21-day cycles)
Danish: Vedligeholdelse (21-dages cyklus)
English: Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.
Danish: Tecentriq er i kombination med nab-paclitaxel indiceret til behandling af voksne patienter med inoperabel lokalt fremskreden eller metastatisk triplenegativ brystkræft (TNBC), hvor patientens tumorer har en PD-L1-ekspression ≥ 1%, og som ikke tidligere har modtaget kemoterapi mod metastatisk sygdom.
English: Hypophysitis occurred in 0.4% (2/473) of patients who received atezolizumab in combination with nab-paclitaxel and carboplatin.
Danish: Der er set hypofysitis hos 0,4% (2/473) af patienter behandlet med atezolizumab i kombination med nab-paclitaxel og carboplatin.
English: Treatment with atezolizumab must be permanently discontinued for any grade of meningitis or encephalitis.
Danish: Behandling med atezolizumab bør seponeres permanent ved enhver grad af meningitis eller encefalitis.
English: Patients with event (%) Median (months) (95% CI)
Danish: Antal patienter med hændelser (%) Median (måneder) (95% konfidensinterval)
English: Grade 3 or 4: (creatinine level > 3.0 x baseline or > 3.0 x ULN)
Danish: Grad 3 eller 4: (kreatininniveau >3,0 gange baseline eller >3,0 gange øvre referencegrænse)
English: Dose delay or discontinuation (see also sections 4.4 and 4.8) Table 1: Dose modification advice for Tecentriq Immune related adverse reaction
Danish: 4.4 og 4.8) Tabel 1: Anbefalinger vedrørende Tecentriq dosisændringer Immunrelateret bivirkning
English: Cohort 1 included previously untreated patients with locally advanced or metastatic UC who were ineligible or unfit for cisplatin-based chemotherapy or had disease progression at least 12 months after treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen.
Danish: Kohorte 1 inkluderede tidligere ubehandlede patienter med lokalt fremskreden eller metastatisk urotelialt carcinom, der ikke var egnede til cisplatinbaseret kemoterapiregime eller havde sygdomsprogression mindst 12 måneders efter neoadjuverende behandling med platinholdigt lægemiddel eller adjuverende kemoterapiregime.
English: It is used when this cancer has: spread to other parts of the body come back after previous treatment or, if you cannot receive anticancer medicine (a chemotherapy called cisplatin), and your doctor has tested your cancer and found high levels of a specific protein in your body called programmed death-ligand 1 (PD-L1).
Danish: Det anvendes til denne kræftform: når kræften har spredt sig til andre dele af kroppen når kræften er vendt tilbage efter tidligere behandling hvis du ikke kan behandles med cisplatin (en bestemt type af kemoterapi) og din læge har undersøgt din kræft og fundet høje niveauer af et bestemt protein, som kaldes programmeret døds-ligand 1 (PD-L1), i din krop.
English: A total of 902 patients were enrolled and stratified by presence of liver metastases, prior taxane treatment, and by PD-L1 expression status in tumour-infiltrating immune cells (IC) (PD-L1 stained tumour-infiltrating immune cells [IC] <1% of tumour area vs. ≥ 1% of the tumour area) assessed by the VENTANA PD-L1 (SP142) Assay.
Danish: I alt deltog 902 patienter, som blev stratificeret efter forekomsten af levermetastaser, tidligere taxanbehandling og status for PD-L1-ekspression i tumorinfiltrerede immunceller (IC) (PD-L1 farvede tumorinfiltrerede immunceller [IC] <1% af tumorarealet vs. ≥ 1% af the tumorarealet) vurderet ved
English: Table 11: Intravenous treatment regimens (IMpower133) Treatment regimen
Danish: Tabel 11: Intravenøse behandlingsregimer (IMpower133) Behandlingsregime
English: In patients with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section
Danish: Hos patienter med EGFR mutation eller ALK-positiv ikke-småcellet lungekræft, er behandling med Tecentriq i kombination med bevacizumab, paclitaxel og carboplatin kun indiceret efter behandlingssvigt med relevante targeterede lægemidler (se pkt.
English: METHOD OF ADMINISTRATION For intravenous use after dilution.
Danish: ADMINISTRATIONSMETODE Til intravenøst brug efter fortynding
English: EU/1/17/1220/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1220/001
English: In study IMpower150, age ≥ 65 was associated with an increased risk of developing adverse events in patients receiving atezolizumab in combination with bevacizumab, carboplatin and paclitaxel.
Danish: I studie IMpower150 blev en alder på ≥ 65 år forbundet med øget risiko for udvikling af bivirkninger hos patienter, der fik atezolizumab i kombination med bevacizumab, carboplatin og paclitaxel.
English: The recommended dose of Tecentriq is 1,200 mg administered intravenously every three weeks.
Danish: Anbefalet dosis af Tecentriq er 1200 mg administreret intravenøst hver tredje uge.
English: 95% CI
Danish: 95% konfidensinterval
English: To treat extensive-stage SCLC, Tecentriq will be given to you in combination with carboplatin and etoposide.
Danish: For at behandle småcellet lungekræft i udvidet sygdomsstadie vil du få Tecentriq sammen med carboplatin og etoposid.
English: For symptomatic hypothyroidism, atezolizumab should be withheld and thyroid hormone replacement should be initiated as needed.
Danish: Ved symptomatisk hypothyroidisme bør behandling med atezolizumab afbrydes og thyroideahormonsubstitutionsbehandling initieres efter behov.
English: Patients were treated until loss of clinical benefit as assessed by the investigator or unacceptable toxicity.
Danish: Patienterne blev behandlet indtil investigator vurderede, at der ikke længere var klinisk gavn af behandlingen eller uacceptabel toksicitet.
English: Immune-related pancreatitis
Danish: Immunrelateret pancreatitis
English: For ≥ Grade 3 hyperglycaemia (fasting glucose > 250 mg/dL or 13.9 mmol/L), atezolizumab should be withheld.
Danish: Ved ≥grad 3 hyperglykæmi (fastende glucose >250 mg/dl eller 13,9 mmol/l) afbrydes behandling med atezolizumab.
English: Treatment may be resumed when symptoms are controlled by thyroid replacement therapy and TSH levels are decreasing
Danish: Behandlingen kan genoptages, når symptomerne er under kontrol med thyroidsubstitutionsbehandling og TSH-niveauerne falder.
English: Guillain-Barré syndrome led to discontinuation of atezolizumab in 1 patient (< 0.1%).
Danish: Guillain-Barré-syndrom indebar seponering af atezolizumab hos 1 patient (<0,1%).