FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary analysis was performed when all patients had at least 24 weeks of follow-up.
Slovenian: Primarna analiza je bila izvedena, ko so vse bolnike spremljali vsaj 24 tednov.
English: It belongs to a group of medicines called monoclonal antibodies.
Slovenian: Spada v skupino zdravil, imenovanih monoklonska protitelesa.
English: • have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome
Slovenian: • imate okužbo z virusom humane imunske pomanjkljivosti (HIV) ali sindrom pridobljene imunske pomanjkljivosti (AIDS),
English: No dose adjustments are recommended.
Slovenian: Drugih sprememb niso priporočili.
English: (10.0, NE)
Slovenian: (10,0; NO)
English: Atezolizumab is a monoclonal antibody and is expected to be present in the first milk and at low levels afterwards.
Slovenian: Atezolizumab je monoklonsko protitelo in pričakovano je, da je prisoten v prvem mleku ter v majhni koncentraciji pozneje.
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.
Slovenian: Ključni rezultati te analize kot tudi posodobljene analize PFS v populaciji ITT so povzeti v preglednicah 6 in 7.
English: The recommended dose is either:
Slovenian: Priporočeni odmerek je:
English: The MAH shall ensure that in each Member State where Tecentriq is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use Tecentriq have access to/are provided with the following educational package:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo Tecentriq trži, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo predpisovali ali uporabljali zdravilo Tecentriq, imeli dostop ali prejeli naslednji paket izobraževanih gradiv:
English: The recommended dose of Tecentriq is:
Slovenian: Priporočeni odmerek zdravila Tecentriq je:
English: Seven (0.2%) patients required the use of corticosteroids.
Slovenian: Pri 7 (0,2 %) bolnikih je bilo treba uporabiti kortikosteroide.
English: ** Based on Kaplan-Meier estimate
Slovenian: ** Na osnovi Kaplan-Meierjeve ocene.
English: Due to increased haematologic toxicities observed in Asian patients in IMpower150, it is recommended that the starting dose of paclitaxel should be 175 mg/m2 every three weeks.
Slovenian: Zaradi povečane hematološke toksičnosti, ki so jo opazili pri azijskih bolnikih v študiji IMpower150, je priporočljivo, da je začetni odmerek paklitaksela 175 mg/m na tri tedne.
English: Further details on serious adverse reactions are provided in Section 4.4 Warnings & Precautions.
Slovenian: Nadaljnje podrobnosti o resnih neželenih učinkih so navedene v poglavju 4.4 Posebna opozorila in previdnostni ukrepi.
English: Patients experiencing fatigue should be advised not to drive and use machines until symptoms abate (see section 4.8).
Slovenian: Bolnikom, ki se jim pojavi utrujenost, je treba naročiti, naj ne vozijo in ne upravljajo strojev, dokler simptomi ne izzvenijo (glejte poglavje 4.8).
English: Seventy-five percent of patients received only one prior platinum-based therapeutic regimen.
Slovenian: 75 % bolnikov je prejelo le eno predhodno terapevtsko shemo na osnovi platine.
English: No data are available to allow conclusions to be drawn on possible effects of neutralising antibodies.
Slovenian: Podatkov, ki bi omogočili sklepanje na morebitne učinke nevtralizirajočih protiteles, ni na voljo.
English: • Store in a refrigerator (2 °C - 8 °C).
Slovenian: • Shranjujte v hladilniku (2 °C do 8 °C).
English: The time to onset was 1.2 months.
Slovenian: Čas do pojava je bil 1,2 meseca.
English: Patients who met established criteria and who agreed to be treated beyond disease progression had tumour assessments conducted every 6 weeks until treatment discontinuation.
Slovenian: Bolnikom, ki so izpolnjevali postavljena merila in so soglašali z zdravljenjem po napredovanju bolezni, so oceno tumorja opravili vsakih 6 tednov do prenehanja zdravljenja.
English: The primary analysis of Cohort 2 was performed when all patients had at least 24 weeks of follow-up.
Slovenian: Primarna analiza 2. kohorte je bila izvedena, ko so vse bolnike spremljali vsaj 24 tednov.
English: • Absence of symptoms and signs (including worsening of laboratory values [e.g., new or worsening hypercalcaemia]) indicating unequivocal progression of disease
Slovenian: • odsotnost simptomov in znakov (vključno s poslabšanjem laboratorijskih vrednosti [npr. novonastalo hiperkalciemijo ali poslabšanjem hiperkalciemije]), ki nedvomno kažejo napredovanje bolezni;
English: These results indicate a potential risk, based on its mechanism of action, that administration of atezolizumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth.
Slovenian: Ti rezultati kažejo možno tveganje, da bi uporaba atezolizumaba med nosečnostjo zaradi njegovega mehanizma delovanja lahko povzročila okvaro ploda, vključno z večjimi deleži splavov ali mrtvorojenosti.
English: This is because the effect of Tecentriq in pregnant women is not known - it is possible that it could harm your unborn baby.
Slovenian: Vpliv zdravila Tecentriq pri nosečnicah namreč ni znan in zdravilo bi morda lahko škodovalo vašemu nerojenemu otroku.
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
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Among 107 Arm B patients who had a response status of stable disease, partial response, or complete response after induction therapy, 40 received pemetrexed switch maintenance therapy.
Slovenian: Od 107 bolnikov v skupini B, ki so po uvodnem zdravljenju dosegli odziv stabilne bolezni, delnega odgovora ali popolnega odgovora, jih je 40 nadaljevalo vzdrževalno zdravljenje zamenjano s pemetreksedom.
English: For suspected immune-related adverse reactions, thorough evaluation to confirm aetiology or exclude other causes should be performed.
Slovenian: Pri sumu na imunsko pogojene neželene učinke je treba opraviti temeljito oceno za potrditev etiologije oziroma izključitev drugih vzrokov.
English: Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with systemic corticosteroid use, administration of other systemic immunosuppressants may be considered.
Slovenian: Na podlagi majhnega števila podatkov iz kliničnih študij pri bolnikih, katerih imunsko pogojenih neželenih učinkov ni mogoče nadzorovati s sistemskim zdravljenjem s kortikosteroidi, se lahko razmisli o uvedbi drugih sistemskih imunosupresivov.
English: This protein suppresses the body's immune (defense) system, thereby protecting cancer cells from being attacked by the immune cells.
Slovenian: Ta beljakovina zavira imunski (obrambni) sistem telesa, s čimer ščiti rakave celice pred napadom imunskih celic.
English: • numbness or paralysis, which may be signs of Guillain-Barré syndrome
Slovenian: • omrtvičenost ali paraliza, ki sta lahko znaka t. i. Guillain-Barréjevega sindroma
English: • If you do not have an infusion reaction during the first infusion, the next infusions will be given to you over a period of 30 minutes.
Slovenian: • Če med prvo infuzijo ne boste imeli reakcije na infundiranje, boste naslednje infuzije prejeli v
English: How long treatment lasts
Slovenian: Kako dolgo traja zdravljenje
English: There are no data from the use of atezolizumab in pregnant women.
Slovenian: Podatkov o uporabi atezolizumaba pri nosečnicah ni.
English: OS was not mature with an event patient ratio of approximately 40%.
Slovenian: Celokupno preživetje ni bilo dozorelo; razmerje bolnikov z dogodki je bilo približno 40 %.
English: Patients received treatment until radiographic disease progression per RECIST v1.1, or unacceptable toxicity.
Slovenian: Bolniki so zdravljenje prejemali do radiografskega napredovanja po merilih RECIST v1.1 ali do nesprejemljivih toksičnih učinkov.
English: As a consequence, no formal tests of statistical significance could be performed for OS in the IC1/2/3 or all comer populations, and results of those analyses would be considered exploratory.
Slovenian: Posledično niso mogli izvesti formalnih testov statistične značilnosti za celokupno preživetje v populacijah IC1/2/3 in neselekcioniranih bolnikov, te rezultate smatramo kot raziskovalne.
English: Your doctor will keep giving you Tecentriq until you no longer benefit from it.
Slovenian: Zdravnik vam bo zdravilo Tecentriq dajal, vse dokler vam bo koristilo.
English: In the IMpassion130 study, of the 614 patients tested, 89 (15%) carried pathogenic BRCA1/2 mutations.
Slovenian: V študiji IMpassion130 je imelo od 614 testiranih bolnikov 89 (15 %) patogene mutacije BRCA1/2.
English: Polska Roche Polska Sp.z o.o.
Slovenian: Roche Polska Sp.z o.o.
English: Reminder to educate patients/caregivers about the symptoms of immune-related adverse reactions and of the need to report them immediately to the physician.
Slovenian: Opomnik za izobraževanje bolnikov/skrbnikov o simptomih imunsko pogojenih neželenih učinkov in o nujnosti njihovega takojšnjega poročanja zdravniku.
English: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin should be monitored prior to initiation of treatment, periodically during treatment with atezolizumab and as indicated based on clinical evaluation.
Slovenian: Vrednosti aspartat-aminotransferaze (AST), alanin-aminotransferaze (ALT) in bilirubina je treba spremljati pred začetkom zdravljenja z atezolizumabom, redno med zdravljenjem in kot je potrebno glede na klinično oceno.
English: * An analysis of OS in the all comer population was performed based on the stratified log-rank test and the result is provided for descriptive purposes only (p = 0.0378); according to the pre-specified analysis hierarchy, the p-value for the OS analysis in the all comer population cannot be considered statistically significant.
Slovenian: * Analizo celokupnega preživetja v populaciji neselekcioniranih bolnikov so izvedli na osnovi stratificiranega testa log-rang; rezultat je predviden le za opisne namene (p = 0,0378); v skladu s predhodno določeno hierarhijo analiz, p-vrednosti za analizo celokupnega preživetja v populaciji neselekcioniranih bolnikov ne moremo smatrati za statistično značilno.
English: • pain in the muscles and bones
Slovenian: • bolečine v mišicah in kosteh
English: Unstratified HR for other exploratory subgroups.
Slovenian: Nestratificirano razmerje ogroženosti za druge raziskovalne podskupine.
English: Patient demographics and baseline tumour disease in patients with PD-L1 expression ≥1% were generally representative of the broader study population.
Slovenian: Demografija in izhodiščna tumorska bolezen pri bolnikih z izražanjem PD-L1 ≥ 1 % sta bili na splošno reprezentativni za širšo raziskovano populacijo.
English: Tecentriq is used to treat adults with:
Slovenian: Tecentriq uporabljamo za zdravljenje odraslih z:
English: Based on the stratified log-rank test.
Slovenian: na osnovi stratificiranega testa log-rang
English: By attaching to the protein, Tecentriq helps your immune system to fight your cancer.
Slovenian: Z vezavo na to beljakovino zdravilo Tecentriq vašemu imunskemu sistemu pomaga premagovati raka.
English: A population pharmacokinetic analysis indicates that the clearance of atezolizumab is 0.200 L/day and the typical terminal elimination half-life is 27 days.
Slovenian: Populacijska farmakokinetična analiza kaže, da je očistek atezolizumaba 0,200 l/dan in da je tipični končni razpolovni čas izločanja 27 dni.
English: Do not stop treatment with Tecentriq unless you have discussed this with your doctor.
Slovenian: Ne prenehajte zdravljenja z zdravilom Tecentriq, ne da bi se o tem posvetovali z zdravnikom.
English: • allergic reaction (infusion-related reaction, hypersensitivity or anaphylaxis)
Slovenian: • alergijska reakcija (z infundiranjem povezana reakcija, preobčutljivost ali anafilaksija)
English: Treatment beyond disease progression was permitted at the discretion of the physician.
Slovenian: Zdravljenje po napredovanju bolezni je bilo dovoljeno po presoji zdravnika.
English: Patients, including those with EGFR mutations or ALK rearrangements, were enrolled and were randomised in a 2:1 ratio to receive one of the treatment regimens described in Table 8.
Slovenian: Bolnike, vključno s tistimi, ki so imeli mutacije EGFR ali preureditve ALK, so vključili in jih v razmerju 2:1 randomizirali na prejemanje ene od shem zdravljenja, opisanih v preglednici 8.
English: • Information that atezolizumab can cause serious side effects during or after treatment, that need to be treated right away
Slovenian: • Informacije, da lahko atezolizumab med zdravljenjem ali po njem povzroči resne neželene učinke, ki jih je treba zdraviti takoj.
English: Women of childbearing potential have to use effective contraception during and for 5 months after treatment with atezolizumab.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem in še 5 mesecev po zdravljenju z atezolizumabom uporabljati učinkovito kontracepcijsko zaščito.
English: Body weight, gender, positive ADA status, albumin levels and tumour burden have a statistically significant, but not clinically relevant effect on atezolizumab pharmacokinetics.
Slovenian: Telesna masa, spol, pozitivno stanje ADA, koncentracija albumina in tumorsko breme imajo statistično značilen učinek na farmakokinetiko atezolizumaba, ki pa ni klinično pomemben.
English: For instructions on dilution and handling of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila o razredčenju in ravnanju z zdravilom pred dajanjem glejte poglavje 6.6.
English: At the time of the updated OS analysis, an exploratory PFS analysis was performed as presented in Table 6.
Slovenian: V času posodobljene analize OS je bila izvedena eksploratorna analiza PFS, ki je predstavljena v preglednici 6.
English: Tecentriq has minor influence on your ability to drive and use machines.
Slovenian: Zdravilo Tecentriq ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: The use of systemic corticosteroids or immunosuppressants before starting atezolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of atezolizumab.
Slovenian: Uporabi sistemskih kortikosteroidov ali imunosupresivov se je pred uvedbo atezolizumaba treba izogibati, ker lahko vplivajo na farmakodinamično aktivnost in učinkovitost atezolizumaba.
English: Patients with EGFR mutations or ALK rearrangements should have been previously treated with tyrosine kinase inhibitors.
Slovenian: Bolniki z mutacijami EGFR ali preureditvami ALK so morali biti predhodno zdravljeni z zaviralci tirozin kinaze.
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).
Slovenian: Atezolizumab je treba trajno prenehati uporabljati pri vseh imunsko pogojenih neželenih učinkih 3. stopnje, ki se ponovijo, in pri vseh imunsko pogojenih neželenih učinkih 4. stopnje, z izjemo endokrinopatij, ki jih je mogoče nadzorovati z nadomestnimi hormoni (glejte poglavji 4.2 in 4.8).
English: Patients should be monitored for changes in renal function.
Slovenian: Bolnike je treba nadzorovati glede sprememb v delovanju ledvic.
English: • feeling very tired (fatigue)
Slovenian: • občutek hude utrujenosti (izčrpanost)
English: The majority of patients had a baseline ECOG performance status of 1 (59%) and PDL1 expression <1% (approximately 52%).
Slovenian: Večina bolnikov je imela izhodiščno stanje zmogljivosti po ECOG 1 (59 %) in izražanje PD-L1 < 1 % (približno 52 %).
English: • low number of red blood cells, which can cause tiredness and shortness of breath
Slovenian: • majhno število rdečih krvnih celic, ki lahko povzroči utrujenost in težko dihanje
English: The time to deterioration in other lung cancer symptoms (i.e. cough, dyspnoea, and arm/shoulder pain) as measured by the EORTC QLQ-LC13 was similar between atezolizumab and docetaxel.
Slovenian: Čas do poslabšanja drugih simptomov raka pljuč (tj. kašlja, dispneje in bolečin v roki/rami), merjenih z EORTC QLQ-LC13, je bil z atezolizumabom in docetakselom podoben.
English: What you need to know before you are given Tecentriq
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Tecentriq
English: • prepared in a laminar flow hood or biological safety cabinet using standard precautions for the safe handling of intravenous agents.
Slovenian: • Priprava mora potekati v komori z laminarnim pretokom zraka ali v varnostni komori za pripravo bioloških zdravil; upoštevati je treba standardne previdnostne ukrepe za varno ravnanje z intravenskimi zdravili.
English: • 840 milligrams (mg) every two weeks, or
Slovenian: • 840 miligramov (mg) na dva tedna ali
English: Tecentriq must be initiated and supervised by physicians experienced in the treatment of cancer.
Slovenian: Zdravilo Tecentriq morajo uvesti in nadzorovati zdravniki z izkušnjami pri zdravljenju raka.
English: Your first infusion will be given over 60 minutes.
Slovenian: Prva infuzija, ki jo boste dobili, bo trajala 60 minut.
English: 14.1 (9.2, NE) 15.9 (10.4, NE)
Slovenian: 12,3 (6,0; NO) 14,1 (9,2; NO) 15,9 (10,4; NO)
English: Median duration of PFS (months)
Slovenian: Mediano trajanje PFS (meseci)
English: Based on exploratory analysis and acknowledging the small sample size, the presence of BRCA1/2 mutation does not seem to impact the PFS clinical benefit of atezolizumab and nab-paclitaxel.
Slovenian: Na podlagi eksploratorne analize in upoštevanja majhne velikosti vzorca se zdi, da prisotnost mutacije BRCA1/2 nima vpliva na klinično korist atezolizumaba in nabpaklitaksela v smislu PFS.
English: Most patients were women (99.6%), 67.5% were white and 17.8% Asian.
Slovenian: Večina vključenih je bila žensk (99,6 %), 67,5 % je bilo belk in 17,8 % Azijk.
English: The initial dose of Tecentriq must be administered over 60 minutes.
Slovenian: Začetni odmerek zdravila Tecentriq je treba dati v 60 minutah.
English: The effect of age on the pharmacokinetics of atezolizumab was assessed in a population pharmacokinetic analysis.
Slovenian: Vpliv starosti na farmakokinetiko atezolizumaba so ocenili v populacijski farmakokinetični analizi.
English: Deutschland Roche Pharma AG
Slovenian: Roche Pharma AG
English: The demographics and baseline disease characteristics of the study population defined as ITT-WT (n=679) were well balanced between the treatment arms.
Slovenian: Demografske značilnosti in izhodiščne značilnosti bolezni v študijski populaciji, opredeljeni kot populacija ITT-divji tip (n = 679), so bile med terapevtskima skupinama dobro uravnotežene.
English: Per final analysis for PFS, ORR, DOR and first interim analysis for OS at clinical cut off 17th April 2018
Slovenian: 3. po končni analizi PFS, ORR, DOR in prvi vmesni analizi OS na klinični presečni datum 17. april 2018;
English: PFS, ORR and DOR results of IMpassion130 for patients with PD-L1 expression ≥ 1% at the time of the final analysis for PFS with a median survival follow up of 13 months are summarized in Table 6 with Kaplan-Meier curves for PFS in Figure 4.
Slovenian: Rezultati PFS, ORR in DOR v preskušanju IMpassion130 pri bolnikih z izražanjem PD-L1 ≥ 1 % v času končne analize PFS z medianim spremljanjem preživetja 13 mesecev so povzeti v preglednici 6 in s Kaplan-Meierjevima krivuljama za PFS na sliki 4.
English: Prior to launch of Tecentriq in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media,
Slovenian: Pred prihodom zdravila Tecentriq na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega programa, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi ostalimi vidiki programa.
English: No dose reduction of atezolizumab was allowed.
Slovenian: Zmanjšanje odmerka atezolizumaba ni bilo dovoljeno.
English: • Evidence of clinical benefit as assessed by the investigator
Slovenian: • dokazi o klinični koristi po oceni raziskovalca.
English: România Roche România S.R.L.
Slovenian: Roche România S.R.L.
English: 51% of patients' tumours had PD-L1 expression of ≥ 1% TC or ≥ 1% IC and 49% of patients' tumours had PD-L1 expression of < 1% TC and < 1% IC.
Slovenian: 51 % tumorjev bolnikov je izražalo PD-L1 na ≥ 1 % TC ali ≥ 1% IC in 49 % tumorjev bolnikov je izražalo PD-L1 na < 1 % TC in < 1 % IC.
English: NE (11.1, NE)
Slovenian: NO (11,1; NO)
English: Median duration of treatment was 15.0 weeks and median duration of survival follow-up was 8.5 months in all comers.
Slovenian: Mediano trajanje zdravljenja je bilo 15,0 tednov; mediano trajanje spremljanja preživetja je bilo 8,5 meseca pri neselekcioniranih bolnikih.
English: Adverse reactions known to occur with atezolizumab or chemotherapies given alone may occur during treatment with these medicinal products in combination, even if these reactions were not reported in clinical trials with combination therapy.
Slovenian: Znani neželeni učinki samostojnega zdravljenja z atezolizumabom ali kemoterapijami se lahko pojavijo pri kombiniranem zdravljenju s temi zdravili, čeprav o njih v kliničnih preskušanjih s kombiniranim zdravljenjem niso poročali.
English: Median OS for all patient subgroups (PD-L1 expression ≥ 5 % and ≥ 1 %) and in all comers was 10.6 months.
Slovenian: Mediano celokupno preživetje za vse podskupine bolnikov (izražanje PD-L1 ≥ 5 % in ≥ 1 %) in za neselekcionirane bolnike je bilo 10,6 meseca.
English: Other medicines and Tecentriq
Slovenian: Druga zdravila in zdravilo Tecentriq
English: No data are available in patients with either moderate or severe hepatic impairment.
Slovenian: Podatkov o bolnikih z zmerno ali hudo okvaro jeter ni na voljo.
English: Please also refer to the full prescribing information for the combination products (see also section 5.1).
Slovenian: Glejte tudi celotne informacije za predpisovanje zdravil, ki se uporabljajo v kombinaciji (glejte tudi poglavje 5.1).
English: The time to deterioration (a sustained ≥ 10-point decline from baseline score) of patient-reported global health status/health-related quality of life as measured by the EORTC QLQ-C30 was similar in each treatment group indicating that all patients maintained their baseline HRQoL for a comparable duration of time.
Slovenian: Čas do poslabšanja (trajno zmanjšanje ≥ 10 točk glede na izhodiščno vrednost) celotnega zdravstvenega stanja/zdravstvene kakovosti življenja po navedbi bolnikov, merjen z EORTC QLQC30, je bil v obeh zdravljenih skupinah podoben, kar kaže, da so vsi bolniki ohranili izhodiščno zdravstveno kakovost življenja v primerljivem časovnem obdobju.
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.
Slovenian: Večina bolnikov je bila belcev (72,1 %), 53,9 % bolnikov v skupini s kemoterapijo je prejemalo vinflunin, 71,4 % bolnikov je imelo vsaj eno slab napovedni dejavnik tveganja in 28,8 % jih je ob začetku zdravljenja imelo zasevke v jetrih.
English: The maximum systemic accumulation ratio across dosing regimens is 3.3.
Slovenian: Maksimalni delež sistemskega kopičenja obeh režimov odmerjanja je bil 3,3.
English: There were no effects on the male reproductive organs.
Slovenian: Vplivov na reproduktivne organe samcev ni bilo.
English: Dose reductions of Tecentriq are not recommended.
Slovenian: Odmerkov zdravila Tecentriq ni priporočljivo zmanjševati.