natgillin/translations-raw huggingface dataset:
Anbefalet dosis af Tecentriq er 840 mg administreret som intravenøs infusion efterfulgt af 100 mg/m2 nab-paclitaxel.
Tecentriq in combination with nab-paclitaxel in 1L mTNBC The recommended dose of Tecentriq is 840 mg administered by intravenous infusion, followed by 100 mg/m2 nab-paclitaxel.
Grad 2 eller 3 diarré (≥4 gange så mange afføringer/dag i forhold til baseline)
Grade 2 or 3 Diarrhoea (increase of ≥ 4
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Tecentriq 1200 mg koncentrat til infusionsvæske, opløsning.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Tecentriq 1,200 mg concentrate for solution for infusion atezolizumab
Medianvarighed var 24 dage (interval: 3 dage til 12,0+ måneder; + angiver en censureret værdi).
The median duration was 24 days (range 3 days to 12.0+ months; + denotes a censored value).
Behandling med atezolizumab indtil ophør af klinisk effekt var tilladt og defineret ved følgende kriterier: · Ingen symptomer (inklusiv forværring af laboratorieværdier [f.eks. ny eller forværret hypercalcæmi]) på utvetydig tegn på sygdom · Ingen forværring af ECOG-performancestatus · Ingen tumorprogression ved kritiske anatomiske placeringer (fx leptomeningeal sygdom), der ikke umiddelbart kan behandles og stabiliseres ved hjælp af protokoltilladte medicinske interventioner inden dosering gentages · Evidens for klinisk effekt, efter investigators vurdering
• Absence of tumour progression at critical anatomical sites (e.g., leptomeningeal disease) that cannot be readily managed and stabilised by protocol-allowed medical interventions prior to repeat dosing
LÆGEMIDLETS NAVN Tecentriq 840 mg koncentrat til infusionsvæske, opløsning.
NAME OF THE MEDICINAL PRODUCT Tecentriq 840 mg concentrate for solution for infusion.
LÆGEMIDLETS NAVN Tecentriq 1200 mg koncentrat til infusionsvæske, opløsning.
NAME OF THE MEDICINAL PRODUCT Tecentriq 1,200 mg concentrate for solution for infusion.
Ved symptomatisk binyrebarkinsufficiens bør behandling med atezolizumab afbrydes, og behandling med intravenøst kortikosteroid (1 til 2 mg/kg/dag methylprednisolon, eller ækvivalent produkt), igangsættes.
For symptomatic adrenal insufficiency, atezolizumab should be withheld and treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started.
POPLAR (GO28753): Randomiseret fase II-studie med patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft, tidligere behandlet med kemoterapi
POPLAR (GO28753): Randomised phase II trial in locally advanced or metastatic NSCLC patients previously treated with chemotherapy
Patienter med småcellet lungekræft i udvidet sygdomsstadie blev behandlet med atezolizumab indtil sygdomsprogression.
Patients with ES-SCLC were treated with atezolizumab until disease progression.
Der sås en forbedring i samlet overlevelse i atezolizumab-gruppen sammenlignet med docetaxel, både hos patienter med ikke-planocellulær ikke-småcellet lungekræft (hazardratio 0,73; 95% konfidensinterval: 0,60; 0,89; median samlet overlevelse 15,6 versus 11,2 måneder for henholdsvis atezolizumab og docetaxel) og patienter med planocellulær ikke-småcellet lungekræft (hazardratio 0,73; 95% konfidensinterval: 0,54; 0,98; median samlet overlevelse 8,9 versus 7,7 måneder for henholdsvis atezolizumab og docetaxel).
NSCLC patients (hazard ratio [HR] of 0.73, 95% CI: 0.60, 0.89; median OS of 15.6 vs. 11.2 months for atezolizumab and docetaxel, respectively) and squamous NSCLC patients (HR of 0.73, 95% CI: 0.54, 0.98; median OS of 8.9 vs. 7.7 months for atezolizumab and docetaxel, respectively).
Ved grad 2 diarré eller colitis påbegyndes behandling med 1 til 2 mg/kg/dag prednison eller ækvivalent produkt, hvis symptomerne vedvarer i >5 dage eller ved recidiv.
For Grade 2 diarrhoea or colitis, if symptoms persist > 5 days or recur, treatment with 1 to 2 mg/kg/day prednisone or equivalent should be started.
Der er set hyperthyroidisme hos 0,9% (30/3.178)) af de patienter, der har fået atezolizumab enkeltstofbehandling.
Hyperthyroidism occurred in 0.9% (30/3,178) of patients who received atezolizumab monotherapy.
Hvis nabpaclitaxel blev seponeret på grund af uacceptabel toksicitet, kunne behandling med atezolizumab fortsættes.
Treatment with atezolizumab could be continued when nab-paclitaxel was stopped due to unacceptable toxicity.
Der er gennemført et åbent, randomiseret, fase III-studie, GO29537 (IMpower130) for at evaluere effekt og sikkerhed af atezolizumab i kombination med nab-paclitaxel og carboplatin, hos kemoterapinaive patienter med metastatisk ikke-planocellulært ikke-småcellet lungekræft, der ikke tidligere er behandlet med kemoterapi.
A phase III, open-label, randomised study, GO29537 (IMpower130), was conducted to evaluate the efficacy and safety of atezolizumab in combination with nab-paclitaxel and carboplatin, in chemotherapy-naïve patients with metastatic non-squamous NSCLC.
Når symptomerne forbedres igangsættes behandling med 1 til 2 mg/kg/dag prednison, eller ækvivalent produkt.
Once symptoms improve, treatment with 1 to 2 mg/kg/day of prednisone or equivalent should follow.
Investigator-vurderet objektiv responsrate (RECIST v1.1)**^
Investigator-assessed DOR (RECIST 1.1)** ^
Ikke almindelig Myositisy Nyrer og urinveje Almindelig
Uncommon myositisy Renal and urinary disorders Common proteinuriaz
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Tecentriq 840 mg koncentrat til infusionsvæske, opløsning.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Tecentriq 840 mg concentrate for solution for infusion atezolizumab
Et åbent, multicenter, internationalt, randomiseret, fase III-studie, IMpower150, blev gennemført for at evaluere virkning og sikkerhed af atezolizumab i kombination med paclitaxel and carboplatin, med eller uden bevacizumab, hos kemoterapinaive patienter med metastatisk ikke-planocellurlær ikkesmåcellet lungekræft.
A phase III, open-label, multicenter, international, randomised study, IMpower150, was conducted to evaluate the efficacy and safety of atezolizumab in combination with paclitaxel and carboplatin, with or without bevacizumab, in chemotherapy-naïve patients with metastatic non-squamous NSCLC.
Immunrelateret meningoencefalitis
Immune-related meningoencephalitis
Der er set myasthenia gravis hos <0,1% (1/3.178) af patienterne der fik atezolizumab enkeltstofbehandling.
Myasthenia gravis occurred in < 0.1% (1/3,178) of patients who received atezolizumab monotherapy.
Myocarditisp Vaskulære sygdomme Almindelig
Hepatobiliary disorders Common
Hos patienterne med levermetastaser sås der ikke forbedret progressionsfri overlevelse eller samlet overlevelse med atezolizumab, nab-paclitaxel og carboplatin sammenlignet med nab-paclitaxel og carboplatin (hazardratio: 0,93; 95% konfidensinterval: 0,59; 1,47 for progressionsfri overlevelse og hazardratio:1,04; 95% konfidensinterval: 0,63; 1,72 for samlet overlevelse).
Patients with liver metastases did not show improved PFS or OS with atezolizumab, nab-paclitaxel and carboplatin, compared to nab-paclitaxel and carboplatin (HR of 0.93, 95% CI: 0.59, 1.47 for PFS and HR of 1.04,
Beskrivelse af hovedsymptomerne af de efterfølgende sikkerhedsmæssige aspekter og påmindelse om, at kontakte den behandlende læge omgående hvis symptomerne fremkommer, er vedvarende eller forværres:
• Description of the main signs and symptoms of the following safety concerns and reminder of the importance of notifying their treating physician immediately if symptoms occur, persist or worsen: Immune-Related Hepatitis Immune-Related Pneumonitis Immune-Related Colitis Immune-Related Pancreatitis
Den bekræftede objektiv responsrate, vurderet af et uafhængigt bedømmelsespanel ved hjælp af RECIST v1.1, var 28,0% (95% konfidensinterval: 19,5; 37,9) hos patienter med PD-L1ekspression ≥5%, 19,3% (95% konfidensinterval: 14,2; 25,4) hos patienter med PD-L1-ekspression ≥1% og 15,8% (95% konfidensinterval: 11,9; 20,4) i ITT-populationen.
The confirmed ORRs per IRF-RECIST v1.1 were 28.0% (95% CI: 19.5, 37.9) in patients with PD-L1 expression ≥ 5%, 19.3% (95% CI: 14.2, 25.4) in patients with PD-L1 expression ≥ 1%, and 15.8% (95% CI: 11.9, 20.4) in all comers.
OAK (GO28915): Randomiseret fase III-studie med patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft, tidligere behandlet med kemoterapi
OAK (GO28915): Randomised phase III trial in locally advanced or metastatic NSCLC patients previously treated with chemotherapy
Der er ikke gennemført studier med atezolizumab specifikt hos patienter med nedsat leverfunktion.
No dedicated studies of atezolizumab have been conducted in patients with renal impairment.
ECOG-status ved baseline var 0 (35%) eller 1 (65%).
Baseline ECOG performance status was 0 (35%) or 1 (65%).
Figur 8: Kaplan-Meier-kurver for progressionsfri overlevelse (IMpower130)
Figure 8: Kaplan-Meier curves for progression free survival (IMpower130)
Denne påvirkning var reversibel (se pkt.
This leaflet was last revised in {MM/YYYY}.
Der er konstateret hypothyroidisme hos 5,2% (164/3.178) af de patienter, der har fået atezolizumab enkeltstofbehandling.
Hypothyroidism occurred in 5.2% (164/3,178) of patients who received atezolizumab monotherapy.
Tecentriq kombinationsbehandling
Tecentriq in combination therapy
ECOG-status ved baseline var 0 (43%) eller 1 (57%).
Baseline ECOG performance status was 0 (43%) or 1 (57%).
De eksploratoriske resultater for samlet overlevelse og progressionsfri overlevelse fordelt på PD-L1-eskpression er vist i henholdsvis figur 7 og 9.
and PFS by PD-L1 expression are summarised in Figures 7 and 9, respectively.
· Spørg lægen eller sundhedspersonalet, hvis der er mere, du vil vide.
• If you have any further questions, ask your doctor or nurse.
Ved infusionsrelaterede reaktioner af grad 1 eller 2, skal infusionshastigheden nedsættes eller behandlingen afbrydes.
The rate of infusion should be reduced or treatment should be interrupted in patients with Grade 1 or 2 infusion-related reactions.
Afbryd behandling med Tecentriq
Permanently discontinue Tecentriq
Median progressionsfri overlevelse var 2,2 måneder i atezolizumab og nab-paclitaxel-armen (n=15) sammenlignet med 5,6 måneder i placebo og nabpaclitaxel-armen (n=11).
There was no evidence of efficacy in patients with asymptomatic brain metastases at baseline, although the number of patients treated was small; the median PFS was 2.2 months in the atezolizumab plus nab-paclitaxel arm (n=15) compared to 5.6 months in the placebo plus nabpaclitaxel arm (n=11) (HR 1.40; 95% CI 0.57, 3.44).
Perifer neuropatil, svimmelhed, hovedpine
Nervous system disorders Very Common peripheral neuropathyl , dizziness, headache
Behandling med atezolizumab bør afbrydes ved grad 2 pneumonitis, og behandling igangsættes med 1-2 mg/kg/dag prednison eller ækvivalent produkt.
Treatment with atezolizumab should be withheld for Grade 2 pneumonitis, and 1 to 2 mg/kg/day prednisone or equivalent should be started.
Grad 4 eller grad 3 af recidiverende myositis
Withhold Tecentriq Grade 4 or grade 3 recurrent myositis Permanently discontinue Tecentriq
Patienter blev ekskluderede fra studiet, hvis de havde; autoimmun sygdom i anamnesen, fået administreret levende, svækket vaccine inden for 28 dage inden randomisering, fået administreret immunstimulerende midler inden for 4 uger eller systemiske immunsupprimerende midler inden for 2 uger inden randomisering eller aktive eller ubehandlede CNS-metastaser.
Patients were excluded if they had a history of autoimmune disease, administration of live, attenuated vaccine within 28 days prior to randomisation, administration of immunostimulatory agents within 4 weeks or systemic immunosuppressive medications within 2 weeks prior to randomisation, and active or untreated CNS metastases.
Følgende patienter blev ekskluderet fra studiet: Autoimmun sygdom i anamnesen, administration af levende, svækket vaccine inden for 28 dage inden inklusion, administration af systemisk immunstimulerende midler inden for 4 uger eller systemisk immunsupprimerende midler inden for 2 uger inden inklusion, aktiv eller ubehandlede hjernemetastaser og tydelig tumorinfiltration i de store thorakale kar eller tydelig kavitation af lunge læsioner, set ved billeddannelse.
Patients were excluded if they had history of autoimmune disease, administration of a live, attenuated vaccine within 28 days prior to randomisation, administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medicinal product within 2 weeks prior to randomisation, active or untreated CNS metastases, clear tumour infiltration into the thoracic great vessels or clear cavitation of pulmonary lesions, as seen on imaging.
Medianvarighed var 1,4 måneder (interval: 0 dage til 21,2+ måneder; + angiver censureret værdi).
The median duration was 1.4 months (range 0 day to 21.2+ months; + denotes a censored value).
Stratificeret hazardratio konfidensinterval) p-værdi
Stratified hazard ratio
Et åbent, internationalt, randomiseret, fase III multicenter-studie, OAK, blev gennemført for at evaluere virkning og sikkerhed af atezolizumab sammenlignet med docetaxel hos patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft, som oplever progression under eller efter en platinholdig behandling.
A phase III, open-label, multi-center, international, randomised study, OAK, was conducted to evaluate the efficacy and safety of atezolizumab compared with docetaxel in patients with locally advanced or metastatic NSCLC who progressed during or following a platinum-containing regimen.
Der er konstateret diabetes mellitus hos 0,3% (11/3.178) af de patienter, der har fået atezolizumab enkeltstofbehandling.
Diabetes mellitus occurred in 0.3% (11/3,178) of patients who received atezolizumab monotherapy.
Der er en risiko for, at det kan skade det ufødte barn.
This is because the effect of Tecentriq in pregnant women is not known - it is possible that it could harm your unborn baby.
Figur 12: Kaplan-Meier-kurve for samlet overlevelse (IMpower133)
Figure 12: Kaplan-Meier curve for overall survival (IMpower133)
Sekundære og eksploratoriske endepunkter Investigatorvurderet progressionfri overlevelse (RECIST v1.1)
Secondary and exploratory endpoints Investigator-assessed PFS (RECIST v1.1)
Pneumonitis med behov for brug af kortikosteroider sås hos 1,6% (51/3.178) af de patienter, der fik atezolizumab.
Pneumonitis requiring the use of corticosteroids occurred in 1.6% (51/3,178) of patients receiving atezolizumab monotherapy.
Tumoranalyser blev udført hver 6. uge i de første 48 uger efter 1. serie, dag 1 og herefter hver 9. uge.
Tumour assessments were conducted every 6 weeks for the first 48 weeks following Cycle 1, Day 1 and then every 9 weeks thereafter.
PD-L1 test for patienter med urotelialt carcinom eller triplenegativ brystkræft
PD-L1 testing for patients with UC or TNBC
Behandling med atezolizumab kan genoptages hvis serum-amylase og -lipase er forbedret til ≤ grad 1 inden for 12 uger, eller symptomerne på pancreatitis er forsvundet, og kortikosteroiddosis er reduceret til ≤10 mg/dag prednison eller ækvivalent produkt.
Treatment with atezolizumab may be resumed when serum amylase and lipase levels improve to ≤ Grade 1 within 12 weeks, or symptoms of pancreatitis have resolved, and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day.
Mave-tarm-kanalen Meget almindelig Kvalme, opkastning, diarrér
Gastrointestinal disorders Very common nausea, vomiting, diarrhoear nausea, diarrhoear, constipation, vomiting
Medianvarighed var 2,1 måneder (interval: 0 dage til 22,0+ måneder; + angiver en censureret værdi).
The median duration was 2.1 months (range 0 day to 22.0+ months; + denotes a censored value).
Nab-paclitaxel administeres på dag 1, 8 og 15 af hver serie c Nab-paclitaxel og carboplatin administeres indtil 4 - 6 serier er afsluttede, eller progressiv sygdom eller uacceptabel toksicitet, hvad end der forekommer først
Nab-paclitaxel and carboplatin are administered until completion of 4-6 cycles, or progressive disease or unacceptable toxicity whichever occurs first
6-månder samlet overlevelse(%) 12-måneder samlet overlevelse (%) Investigatorvurderet overordnet bedste respons3* (RECIST 1.1)
Investigator-assessed Overall Best Response3* (RECIST 1.1)
Kaplan-Meierkurver for samlet overlevelse og progressionsfri overlevelse vises i figur 12 og 13.
Kaplan-Meier curves for OS and PFS are presented in Figures 12 and 13.
** Baseret på den stratificerede log-rank-test *** Baseret på Kaplan-Meier estimater
ǂStratified by PD-L1 expression in tumour infiltrating immune cells, the number of prior chemotherapy regimens, and histology ** Based on the stratified log-rank test *** Based on Kaplan-Meier estimates
Tecentriq i kombination med nab-paclitaxel og carboplatin I induktionsfasen er den anbefalede dosis 1.200 mg Tecentriq administreret som intravenøs infusion efterfulgt af nab-paclitaxel og carboplatin hver 3. uge i fire eller seks serier.
During the induction phase, the recommended dose of Tecentriq is 1,200 mg administered by intravenous infusion, followed by nab-paclitaxel and carboplatin every three weeks for four or six cycles.
Det skal du vide, før du begynder at bruge Tecentriq Sådan skal du bruge Tecentriq Bivirkninger
What Tecentriq is and what it is used for What you need to know before you are given Tecentriq How Tecentriq is given
Der er konstateret hepatitis hos 2,0% (62/3.178) af de patienter, der har fået atezolizumab enkeltstofbehandling.
Hepatitis occurred in 2.0% (62/3,178) of patients who received atezolizumab monotherapy.
Behandling med atezolizumab skal seponeres permanent ved grad 3 eller 4 nefritis.
Treatment with atezolizumab must be permanently discontinued for Grade 3 or 4 nephritis.
Bekræftet objektiv responsrate var ifølge investigatorvurderet mRECIST 29,0% (95% konfidensinterval: 20,4; 38,9) hos patienter med PD-L1-ekspression ≥5%, 23,7% (95% konfidensinterval: 18,1; 30,1) hos patienter med PD-L1ekspression ≥1% og 19,7% (95% konfidensinterval: 15,4; 24,6) i ITT-populationen.
The confirmed ORR per investigator-assessed mRECIST was 29.0% (95% CI: 20.4, 38.9) in patients with PD-L1 expression ≥ 5%, 23.7% (95% CI: 18.1, 30.1) in patients with PD-L1 expression ≥ 1%, and 19.7% (95% CI: 15.4, 24.6) in all comers.
Influenzalignende sygdom,
• flu-like illness
Sekundære endepunkter Investigatorvurderet progressionsfri overlevelse (RECIST v1.1)*
Secondary Endpoints Investigator-assessed PFS (RECIST v1.1)*
IMpower150 (GO29436): Randomiseret, fase III-studie i kombination med paclitaxel og carboplatin, med eller uden bevacizumab, hos kemoterapinaive patienter med metastatisk ikke-planocellulær ikkesmåcellet lungekræft.
IMpower150 (GO29436): Randomised phase III trial in chemotherapy-naïve patients with metastatic non-squamous NSCLC, in combination with paclitaxel and carboplatin with or without bevacizumab
Der er set hypofysitis hos <0,1% (2/3.178) af patienterne behandlet med atezolizumab enkeltstofbehandling.
Hypophysitis Hypophysitis occurred in < 0.1% (2/3,178) of patients who received atezolizumab monotherapy.
I dette studie ekskluderedes patienter med autoimmun sygdom i anamnesen, aktive eller kortikosteroidafhængige hjernemetastaser, administration af levende, svækket vaccine inden for 28 dage inden inklusion, administration af systemiske immunstimulerende midler inden for 4 uger eller systemisk immunsupprimerende lægemiddel inden for 2 uger inden inklusion.
This study excluded patients who had a history of autoimmune disease, active or corticosteroid-dependent brain metastases, administration of a live, attenuated vaccine within 28 days prior to enrolment, administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medicinal product within 2 weeks prior to enrolment.
12-måneders progressionsfri overlevelse (%) Investigatorvurderet progressionsfri overlevelse (RECIST v1.1) - opdateret eksploratorisk analyse4
Investigator-assessed PFS (RECIST v1.1) - Updated exploratory analysis4
Antal med delvist respons (%) 95% konfidensinterval
No. of partial response (%) 95% CI
Førstelinjebehandling af småcellet lungekræft i udvidet sygdomsstadie Tecentriq i kombination med carboplatin og etoposid I induktionsfasen er den anbefalede dosis 1.200 mg Tecentriq administreret som intravenøs infusion efterfulgt af carboplatin og derefter etoposid administreret som intravenøs infusion på dag 1.
During the induction phase, the recommended dose of Tecentriq is 1,200 mg administered by intravenous infusion followed by carboplatin, and then etoposide administered by intravenous infusion on day 1.
Figur 6: Kaplan-Meier-kurver for samlet overlevelse (IMpower130)
Figure 6: Kaplan-Meier curves for overall survival (IMpower130)
Til den anbefalede dosis på 1680 mg: Træk 28 ml Tecentriq koncentrat fra to Tecentriq 840 mg hætteglas, som fortyndes i en 250 ml polyvinylchlorid (PVC), polyolefin (PO), polyethylen (PE) eller eller polypropylen (PP) infusionspose indeholdende natriumchlorid 9 mg/ml (0,9%) injektionsvæske, opløsning.
For the recommended dose of 1680 mg: twenty-eight mL of Tecentriq concentrate should be withdrawn from two vials of Tecentriq 840 mg and diluted into a 250 mL polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP) infusion bag containing sodium chloride
Den anbefalede dosis er enten: · 840 milligram (mg) hver 2. uge, eller · 1680 milligram (mg) hver 4. uge.
• 1,680 milligrams (mg) every four weeks.
F. Hoffmann-La Roche AG Grenzacherstrasse 124 4070 Basel
Grenzacherstrasse 124
Tecentriq anvendes sammen med kemoterapi, kaldet nab-paclitaxel: hvis din læge tester din kræft og finder høje niveauer af et bestemt protein, kaldet programmeret døds-ligand 1 (PD-L1), i din krop.
Tecentriq is used in combination with anticancer medicine (chemotherapy called nab-paclitaxel): if your doctor tested your cancer and found high levels of a specific protein in your body called program death ligand (PD-L1) when the cancer has spread to other parts of the body and has not been treated with anticancer medicines (chemotherapy) or else when the cancer has come back in the breast after previous treatment.
Stratificeretǂ hazardratio (95%
95% CI Stratifiedǂ hazard ratio (95% CI)
Anæmi, trombocytopenic, neutropenid, leukopenie
Blood and lymphatic system disorders Very common anaemia, thrombocytopeniac, neutropeniad, leukopeniae
Antal med fuldstændigt respons (%) 95% konfidensinterval
No. of complete response (%) 95% CI
Prognostiske risikofaktorer inkluderede tid siden tidligere kemobehandling <3 måneder, ECOG-performancestatus >0 og hæmoglobin <10 g/dl.
ECOG performance status > 0 and haemoglobin < 10 g/dL.
Hepatitis med behov for brug af kortikosteroider sås hos 0,6% (18/3.178) af de patienter, der fik atezolizumab enkeltstofbehandling.
Hepatitis requiring the use of corticosteroids occurred in 0.6% (18/3,178) of patients receiving atezolizumab monotherapy.
Colitis med behov for brug af kortikosteroider sås hos 0,6% (19/3.178) af de patienter, der fik atezolizumab enkeltstofbehandling.
Colitis requiring the use of corticosteroids occurred in 0.6% (19/3,178) of patients receiving atezolizumab monotherapy.
Der er observeret nefritis i kliniske studier med atezolizumab (se pkt.
Nephritis has been observed in clinical trials with atezolizumab (see section 4.8).
Nefritisaa
Nephritis
Beskrivelse af kliniske forsøg med Tecentriq kan findes under punk 5.1 i produkresuméet for Tecentriq 1200 mg koncentrat til infusionsvæske, opløsning.
For the description of Tecentriq trials, refer to the Tecentriq 1,200 mg concentrate for solution for infusion Summary of Product Characteristics (SmPC) section 5.1.