FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on population PK and exposure-response analyses age (21-89 years), region, ethnicity, renal impairment, mild hepatic impairment, level of PD-L1 expression, or ECOG performance status have no effect on atezolizumab pharmacokinetics.
Danish: Baseret på en responsanalyse af populationsfarmakokinetik og eksponering, påvirkede alder (21-89 år), region, etnicitet, nedsat nyrefunktion, let nedsat leverfunktion, niveau af PD-L1-ekspression eller ECOG-performancestatus ikke atezolizumabs farmakokinetik.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, monoklonale antistoffer.
English: Neutropenia and peripheral neuropathies occurring during treatment with atezolizumab and nabpaclitaxel may be reversible with interruptions of atezolizumab and/or nab-paclitaxel.
Danish: Neutropeni og perifere neuropatier, der opstår under behandling med atezolizumab og nab-paclitaxel, kan være reversible, hvis der er afbrydelser i behandlingen med atezolizumab og/eller nab-paclitaxel.
English: Grade 4 or any grade of recurrent pancreatitis
Danish: Grad 4 eller enhver grad af recidiverende pancreatitis
English: Atezolizumab is an Fc-engineered, humanised immunoglobulin G1 (IgG1) monoclonal antibody that directly binds to PD-L1 and provides a dual blockade of the PD-1 and B7.1 receptors, releasing PD-L1/PD-1 mediated inhibition of the immune response, including reactivating the antitumour immune response without inducing antibody-dependent cellular cytotoxicity.
Danish: Atezolizumab er et Fc-designet, humaniseret immunoglobulin G1 (IgG1) monoklonalt antistof, der direkte binder sig til PD-L1 og blokerer både PD-1- og B7.1-receptorer, hvilket frigør PD-L1/PD-1medieret hæmning af immunresponset, inklusiv reaktivering af antitumor-immunresponset uden at inducere antistofafhængig cellulær cytotoksicitet.
English: There is no information on overdose with atezolizumab.
Danish: Der foreligger ingen information vedrørende overdosering med atezolizumab.
English: No clinically important difference was observed in the pharmacokinetics of atezolizumab among patients < 65 years (n=274), patients between 65−75 years (n=152) and patients > 75 years (n=46) (see section 4.2).
Danish: Der er ikke observeret klinisk betydningsfuld forskel i atezolizumabs farmakokinetik blandt patienter <65 år (n=274), patienter i aldersgruppen 65-75 år (n=152) og patienter >75 år (n=46) (se pkt.
English: Most immune-related adverse reactions occurring during treatment with atezolizumab were reversible with interruptions of atezolizumab and initiation of corticosteroids and/or supportive care.
Danish: De fleste immunrelaterede bivirkninger opstået under behandling med atezolizumab var reversible når behandling med atezolizumab blev afbrudt og behandling med kortikosteroider og/eller understøttende behandling blev initieret.
English: Myocarditis occurred in < 0.1% (2/8,000) of patients across all atezolizumab clinical trials in multiple tumour types and treatment combinations.
Danish: Der er set myocarditis hos < 0,1% (2/8.000) af patienterne på tværs af alle kliniske studier med atezolizumab og i forbindelse med flere forskellige tumortyper og kombinationsbehandlinger.
English: Randomisation was stratified by sex, ECOG performance status, and presence of brain metastases.
Danish: Randomiseringen blev stratificeret efter køn, ECOGperformancestatus og tilstedeværelsen af hjernemetastaser.
English: Reminder to distribute the patient alert card to all patients receiving treatment with Tecentriq and to advise them to show it to any healthcare professional who may treat them.
Danish: Påmindelse om at aflevere patientkortet til alle patienter, som får Tecentriq-behandling og vejlede dem i, at vise kortet til alle sundhedspersoner, som behandler dem.
English: For Cohort 2, median DOR was not reached in any PD-L1 expression subgroup or in all comers, however was reached in patients with PD-L1 expression < 1% (13.3 months; 95% CI 4.2, NE).
Danish: Medianvarighed af respons blev ikke nået i kohorte 2 for nogen af PD-L1-ekspressionssubgrupperne eller i ITT-populationen, men blev dog nået blandt patienter med PD-L1-ekspression <1% (13,3 måneder; 95% konfidensinterval 4,2; NE).
English: The recommended dose is 1,200 milligrams (mg) every three weeks.
Danish: Den anbefalede dosis er 1200 milligram (mg) hver 3. uge.
English: Bladder was the primary tumour site for 71.1% of patients and 25.4% of patients had upper tract urothelial carcinoma.
Danish: Blæren var primær tumorplacering for 71,1% patienterne; og 25,4% af patienterne havde urotelialt carcinom i øvre urinveje.
English: Tecentriq is given as a drip into a vein (an intravenous infusion).
Danish: Tecentriq gives i et drop i en vene (intravenøs infusion).
English: • Periodic safety update reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Patients with event (%)
Danish: Antal patienter med hændelser (%)
English: At the time of the primary analysis, patients had a median survival follow up time of 13.9 months.
Danish: Ved den primære analyse havde patienterne en median overlevelses opfølgningstid på 13,9 måneder.
English: Grade 3 or 4 hyperglycaemia (fasting glucose > 250 mg/dL or 13.9 mmol/L)
Danish: Grad 3 eller 4 hyperglykæmi (fastende glucose >250 mg/dl eller 13,9 mmol/l)
English: Carcinogenicity studies have not been performed to establish the carcinogenic potential of atezolizumab.
Danish: Der er ikke gennemført carcinogenicitetsstudier med henblik på at vurdere atezolizumabs carcinogene potentiale.
English: Pack of one vial.
Danish: Pakninger med 1 hætteglas.
English: If you notice any of the side effects above or if they get worse, tell your doctor straight away.
Danish: Hvis du oplever én eller flere af ovenstående bivirkninger eller de forværres, skal du straks kontakte lægen.
English: From the PD-L1+/BRCA1/2 mutant subgroup, 19 patients received atezolizumab plus nabpaclitaxel and 26 placebo plus nab-paclitaxel.
Danish: I PD-L1+/BRCA1/2-mutation subgruppen fik 19 patiener atezolizumab og nab-paclitaxel og 26 patienter placebo og nab-paclitaxel.
English: PD-L1 expression of ≥ 1% in IC
Danish: PD-L1ekspression ≥1% i IC
English: No. of confirmed responders (%)
Danish: Antal bekræftede respondere (%)
English: Rare myasthenic syndrome o
Danish: Myastenisk syndrom o
English: If you notice any of the symptoms above, tell your doctor straight away.
Danish: Hvis du oplever et eller flere af ovennævnte symptomer, skal du straks kontakte lægen.
English: Patients were randomised (1:1) to receive either atezolizumab or chemotherapy.
Danish: Patienterne blev randomiseret (1:1) til atezolizumab eller kemoterapi.
English: Dose reductions of Tecentriq are not recommended.
Danish: Dosisreduktion af Tecentriq frarådes.
English: Tecentriq works by attaching to a specific protein in your body called programmed death-ligand 1 (PD-L1).
Danish: Tecentriq virker ved at hæfte sig fast på et bestemt protein, programmeret døds-ligand 1 (PD-L1), i kroppen.
English: It is not known if Tecentriq gets into breast milk.
Danish: Det vides ikke om Tecentriq udskilles i brystmælken.
English: Treatment beyond disease progression may be considered at the discretion of the physician (see section 5.1).
Danish: Behandling efter sygdomsprogression kan overvejes efter lægens vurdering (se pkt.
English: m Includes reports of Guillain-Barré syndrome and demyelinating polyneuropathy.
Danish: m Inkluderer indberetninger om Guillain-Barré-syndrom, demyeliserende polyneuropati.
English: Treatment with atezolizumab must be permanently discontinued for Grade 4 (life threatening; urgent intervention indicated) diarrhoea or colitis.
Danish: Behandling med atezolizumab skal seponeres permanent ved grad 4 (livstruende; akut intervention indiceret) diarré eller colitis.
English: • The diluted solution should not be kept more than 24 hours at 2 °C to 8 °C or 8 hours at ambient temperature (≤ 25 °C), unless dilution has taken place in controlled and validated aseptic conditions.
Danish: · Den fortyndede opløsning må ikke opbevares længere end 24 timer ved 2°C til 8°C eller 8 timer ved stuetemperatur (≤ 25 °C), medmindre fortyndingen har fundet sted under kontrollerede og validerede aseptiske betingelser.
English: The pharmacokinetic properties of atezolizumab 840 mg administered every 2 weeks and atezolizumab 1,200 mg administered every 3 weeks are comparable.
Danish: De farmakokinetiske egenskaber for atezolizumab 840 mg administreret hver 2. uge og atezolizumab 1200 mg administreret hver 3. uge er sammenlignlige.
English: Includes reports of encephalitis, meningitis, photophobia.
Danish: Inkluderer indberetninger om encefalitis, meningitis, fotofobi.
English: The maximum systemic accumulation ratio across dosing regimens is 3.3.
Danish: Den maksimale systemiske akkumulationsratio på tværs af doseringsregimer er
English: Across multiple phase III studies, 13.1 % to 36.4% of patients developed treatment-emergent anti-drug antibodies (ADAs).
Danish: På tværs af flere fase III-studier udviklede 13,1% til 36,4% af patienterne behandlingrelaterede antilægemiddel-antistoffer (ADAs).
English: AST increased, ALT increased, hepatitisv
Danish: ASAT-stigninger, ALATstigninger, hepatitisv
English: Atezolizumab must be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for any Grade 4 immune-related adverse reactions, except for endocrinopathies that are controlled with replacement hormones (see sections 4.2 and 4.8).
Danish: Atezolizumab skal seponeres permanent ved enhver grad 3 immunrelateret bivirkning, der recidiverer og enhver grad 4 immunrelateret bivirkning, bortset fra endokrinopati, der kan kontrolleres med hormonsubstitution (se pkt.
English: NE (11.1, NE)
Danish: NE (11,1; NE) NE (NE)
English: The majority of patients were white (72.1%), 53.9% of patients within the chemotherapy arm received vinflunine, 71.4% of patients had at least one poor prognostic risk factor and 28.8% had liver metastases at baseline.
Danish: Størstedelen af patienterne var af kaukasisk etnicitet (72,1%), 53,9% af patienterne i kemoterapiarmen fik vinflunin, 71,4% af patienterne havde mindst én prognostisk risikofaktor og 28,8% havde levermetastaser ved baseline.
English: All prescribers of Tecentriq must be familiar with the Physician Information and Management Guidelines.
Danish: Alle læger, der ordinerer Tecentriq bør være bekendt med «Information til lægen» og «Retningslinjer for behandling».
English: Exposure to atezolizumab increased dose proportionally over the dose range 1 mg/kg to 20 mg/kg including the fixed dose 1,200 mg administered every 3 weeks.
Danish: Eksponeringen af atezolizumab øgedes proportionelt over dosisintervallet 1 mg/kg til 20 mg/kg, herunder ved den faste dosis på 1200 mg, administreret hver 3. uge.
English: Atezolizumab spares the PD-L2/PD-1 interaction allowing PD-L2/PD-1 mediated inhibitory signals to persist.
Danish: Atezolizumab bevarer PD-L2/PD-1-interaktion og muliggør fortsat PD-L2/PD-1-medieret hæmning.
English: A total of 403 patients were enrolled and randomised (1:1) to receive one of the treatment regimens described in Table 11.
Danish: Der blev i alt inkluderet 403 patienter, som var randomiserede (1:1) til at få et af behandlingsregimerne beskrevet i tabel 11.
English: For all treated patients, the median duration of treatment was 2.8 months for the atezolizumab arm, 2.1 months for the vinflunine and paclitaxel arms and 1.6 months for the docetaxel arm.
Danish: For alle behandlede patienter var medianvarighed af behandling 2,8 måneder i atezolizumabarmen, 2,1 måneder i vinflunin- og paclitaxelarmen og 1,6 måneder i docetaxelarmen.
English: PD-L1 expression of ≥ 5% in IC
Danish: PD-L1ekspression ≥5% i IC
English: s Includes reports of colitis, autoimmune colitis, colitis ischaemic, colitis microscopic, colitis ulcerative.
Danish: s Inkluderer indberetninger om colitis, autoimmun colitis, iskæmisk colitis, mikroskopisk colitis, colitis ulcerosa.
English: Once symptoms improve, treatment with
Danish: Hvis symptomerne forbedres til
English: • The Guide for healthcare professionals shall contain the following key elements: Relevant information (e.g. seriousness, severity, frequency, time to onset, reversibility as applicable) of the following safety concerns associated with the use of Tecentriq: - Immune-Related Hepatitis - Immune-Related Pneumonitis - Immune-Related Colitis - Immune-Related Pancreatitis - Immune-Related Endocrinopathies (Type 1 Diabetes Mellitus, Hypothyroidism,
Danish: · Produktresumé · Vejledning for sundhedspersonalet · Vejledning for sundhedspersonalet skal indeholde følgende hovedelementer: Relevant information (såsom alvorligheden, sværhedsgraden, hyppigheden, tiden til fremkomst, reversibiliteten, hvis relevant) af de efterfølgende sikkerhedsmæssige aspekter som er associeret ved anvendelse af Tecentriq: - Immunrelateret hepatitis - Immunrelateret pneumonitis - Immunrelateret colitis - Immunrelateret pancreatitis - Immunrelaterede endokrinopatier (type 1 diabetes mellitus, hypothyroidisme,
English: The key results from this analysis as well as from the updated PFS analysis in the ITT population are summarised in Tables 6 and 7.
Danish: Nøgleresultaterne, fra denne analyse og ligeledes analysen af opdateret progressionsfri overlevelse for ITT-populationen, vises i tabel 6 og 7.
English: h Includes reports of hyperthyroidism, Basedow's disease, endocrine ophthalmopathy, exophthalmos.
Danish: h Inkluderer indberetninger om hyperthyroidisme, Basedows sygdom, endokrin oftalmopati, eksoftalmus.
English: The iDMC did not recommend any change of therapy for patients who had already been randomized to and were receiving treatment in the monotherapy arm. No other changes were recommended.
Danish: Den uafhængige dataovervågningskomité (iDMC) anbefalede ikke nogen ændring i behandlingen til patienter, der allerede var randomiseret til og fik behandling i monoterapiarmen.
English: Tecentriq is for intravenous use.
Danish: Tecentriq anvendes intravenøst.
English: Other clinically significant adverse events which were observed more frequently in the atezolizumab, bevacizumab, paclitaxel, and carboplatin arm were epistaxis, haemoptysis, cerebrovascular accident, including fatal events.
Danish: Andre klinisk signifikante birvirkninger, som blev rapporteret hyppigere i armen med atezolizumab, bevacizumab, paclitaxel og carboplatin var epitaxis, hæmoptyse, cerebrovaskulær hændelse, herunder dødelige hændelser.
English: A population pharmacokinetic analysis suggests that steady-state is obtained after 6 to 9 weeks after multiple doses.
Danish: En farmakokinetisk populationsanalyse har vist, at steady-state opnås efter flere doser efter 6-9 uger.
English: If you stop receiving Tecentriq
Danish: Hvis du holder op med at bruge Tecentriq
English: Myasthenic syndrome
Danish: Myastenisk syndrom
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C or 8 hours at ambient temperature (≤ 25 °C), unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis den ikke anvendes straks, er opbevaringstid og -forhold brugerens ansvar og ville normalt ikke være længere end 24 timer ved 2 °C til 8 °C eller i 8 timer ved stuetemperatur (≤25°C), medmindre fortyndingen har fundet sted under kontrollerede og validerede aseptiske betingelser.
English: You can also report side effects directly via the national reporting system listed in
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i
English: Hepatic impairment was defined by the National Cancer Institute (NCI) criteria of hepatic dysfunction (see section 4.2).
Danish: Nedsat leverfunktion er defineret ud fra NCI's (National Cancer Institute) kriterier for nedsat leverfunktion (se pkt.
English: However, systemic corticosteroids or other immunosuppressants can be used to treat immune-related adverse reactions after starting atezolizumab (see section 4.4).
Danish: Systemiske kortikosteroider eller andre immunsupprimerende midler kan dog anvendes til at behandle immunrelaterede bivirkninger efter påbegyndelse af atezolizumab (se pkt.
English: The educational programme is aimed at increasing awareness and providing information concerning the signs and symptoms of certain important identified risks of atezolizumab, including immunerelated pneumonitis, hepatitis, colitis, hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, neuropathies, meningoencephalitis, pancreatitis, and infusion related reactions, and how to manage them.
Danish: Uddannelsesmaterialets formål er, at øge bevidstheden om, samt at give information om symptomer af bestemte vigtige risici ved atezolizumab, som er blevet identificeret, herunder immunrelateret pneumonitis, hepatitis, colitis, hypothyroidisme, hyperthyroidisme, type 1 diabetes mellitus, neuropatier, meningoencefalitis, pancreatitis og infusionsrelaterede reaktioner, samt håndtering af disse.
English: Women of childbearing potential have to use effective contraception during and for 5 months after treatment with atezolizumab.
Danish: Fertile kvinder skal bruge sikker prævention under behandling og i 5 måneder efter behandling med atezolizumab.
English: Common pneumonitisq, hypoxia, nasal congestion, nasopharyngitis dysphonia
Danish: Pneumonitisq, hypoksi, nasal congestion, nasofaryngitis
English: Figure 3 summarises the results of OS in the ITT and PD-L1 subgroups.
Danish: Figur 3 viser resultaterne af den samlede overlevelse i ITT samt i PD-L1-subgrupperne.
English: • The active substance is atezolizumab.
Danish: · Det aktive indholdsstof er atezolizumab.
English: Grade 4 or recurrent Grade 3
Danish: Grad 4 eller gentagen grad 3
English: Chemical and physical in-use stability has been demonstrated for up to 24 hours at ≤ 30 °C and for up to 30 days at 2 °C to 8 °C from the time of preparation.
Danish: Der er påvist kemisk og fysisk brugsholdbarhed i op til 24 timer ved ≤ 30 °C og i op til 30 dage ved 2 °C til 8 °C efter fortynding.
English: For each 28-day cycle, Tecentriq is administered on days 1 and 15, and nab-paclitaxel is administered on days 1, 8, and 15.
Danish: For hver behandlingsserie på 28 dage, administreres Tecentriq på dag 1 og 15, og nab-paclitaxel administreres på dag 1, 8 og 15.
English: Triple-negative breast cancer
Danish: Triplenegativ brystkræft
English: The key results are summarised in Table 9 and Kaplan-Meier curves for OS and PFS are presented in Figures 6 and 8, respectively.
Danish: Nøgleresultaterne er vist i tabel 9, og Kaplan-Meier-kurver for samlet overlevelse og progressionsfri overlevelse er vist i henholdsvis figur 6 og 8.
English: Patients had a median survival follow up time of 18.6 months and showed improved OS and PFS with atezolizumab, nab-paclitaxel and carboplatin as compared to the control.
Danish: Patienterne havde en median overlevelsesopfølgningstid på 18,6 måneder, og der sås forbedret samlet overlevelse og progressionsfri overlevelse med atezolizumab, nab-paclitaxel og carboplatin sammenlignet med kontrolarmen.
English: Includes reports of diarrhoea, defaecation urgency, frequent bowel movements, gastrointestinal hypermotility.
Danish: Inkluderer indberetninger om diarré, defækationstrang, hyppig afføring, gastrointestinal hypermotilitet.
English: The Adverse Drug Reactions (ADRs) are listed by MedDRA system organ class (SOC) and categories of frequency in Table 2 for atezolizumab given as monotherapy or as combination therapy.
Danish: Bivirkninger er angivet efter MedDRAs systemorganklasse (SOC) og hyppighed i tabel 2 for atezolizumab som enkeltstofbehandling eller kombinationsbehandling.
English: Patients were randomised to receive atezolizumab 840 mg or placebo by intravenous infusions on days 1 and 15 of every 28-day cycle, plus nab-paclitaxel (100 mg/m2) administered via intravenous infusion on days 1, 8 and 15 of every 28-day cycle.
Danish: Patienter blev randomiseret til at få atezolizumab 840 mg eller placebo administreret ved intravenøs infusion på dag 1 og 15 for hver serie af 28 dage, samt nab-paclitaxel (100 mg/m2) administreret ved intravenøs infusion på dag 1, 8 og 15 for hver serie af 28 dage.
English: Description of the signs and symptoms of immune-related adverse reactions.
Danish: Beskrivelse af symptomer af immunrelaterede bivirkninger.
English: ǂ Stratified by chemotherapy (vinflunine vs. taxane), status on IC (< 5% vs. ≥ 5%), number of prognostic risk factors (0 vs. 1-3), and liver metastases (yes vs. no).
Danish: ǂStratificeret efter kemoterapi (vinflunin vs. taxan), IC-status (<5% vs. ≥5%), antal prognostiske risikofaktorer (0 vs. 1-3) og levermetastaser (ja vs. nej).
English: * Exploratory OS final analysis at clinical cut-off 24 January 2019 ** PFS, ORR and DOR analyses at clinical cut-off 24 April 2018 *** For descriptive purposes only ^ Confirmed ORR and DoR are exploratory endpoints
Danish: * Endelig eksploratorisk analyse af samlet overlevelse ved klinisk cut-off den 24. januar 2019 ** Analyse af progressionsfri overlevelse, objektiv responsrate og varighed af respons ved klinisk cut-off den 24. april 2018 *** Kun til beskrivende formål ^ Konfirmeret objektiv responsrate og varighed af respons er eksploratoriske endepunkter
English: Immune system disorders Common infusion-related reactionf Endocrine disorders Very common hypothyroidismg
Danish: Infusionsrelateret reaktionf Det endokrine system Meget almindelig
English: Based on the stratified log-rank test For informational purposes; in the ITT population, comparisons between Arm B and Arm C as well as between Arm A and Arm C were not formally tested yet as per the pre-specified analysis hierarchy Overall best response for complete response and partial response ‡ Stratified by sex, presence of liver metastases and PD-L1 tumour expression on TC and IC
Danish: Til orientering; i ITT-populationen, blev sammenligninger mellem arm B and arm C og ligeledes mellem arm A og arm C endnu ikke formelt testet i overensstemmelse med det præ-specificerede analysehierarki Overordnet bedste respons for fuldstændigt respons and delvist respons ‡ Stratificeret efter køn, tilstedeværelsen af levermetastaser, og PD-L1-ekspression på TC og IC
English: Myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome and Meningoencephalitis
Danish: Myasthenisyndrom/myasthenia gravis, Guillain-Barré syndrome og meningoencefalitis
English: Patients receiving treatment regimen B were able to crossover and receive atezolizumab monotherapy following disease progression.
Danish: Patienterne, der fik behandlingsregime B, fik mulighed for at skifte over til atezolizumab enkeltstofbehandling efter sygdomsprogression.
English: An updated analysis was performed with a median duration of survival follow-up of 17.2 months for Cohort 1 and is summarised in Table 4.
Danish: Der er gennemført en opdateret analyse med en median varighed af overlevelsesopfølgning på 17,2 måneder for kohorte 1.
English: Tecentriq has not been studied in patients with moderate or severe hepatic impairment (see section 5.2).
Danish: Tecentriq er ikke undersøgt hos patienter med moderat eller svært nedsat leverfunktion (se pkt.