FrancophonIA/ELRC3.0 huggingface dataset:
English: Tecentriq has not been studied in patients with moderate or severe hepatic impairment (see section 5.2).
Slovenian: Zdravila Tecentriq pri bolnikih z zmerno ali hudo okvaro jeter niso preskušali (glejte poglavje 5.2).
English: OS interim analysis*
Slovenian: Vmesna analiza OS*
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 840 mg/14 mL
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 840 mg/14 ml
English: h Includes reports of hyperthyroidism, Basedow's disease, endocrine ophthalmopathy, exophthalmos.
Slovenian: h Vključuje poročila o hipertiroidizmu, Basedowi bolezni, endokrini oftalmopatiji, eksoftalmusu.
English: Dose modifications during treatment
Slovenian: Prilagoditev odmerka med zdravljenjem
English: o Incudes reports of myasthenia gravis.
Slovenian: o Vključuje poročila o miasteniji gravis.
English: It is recommended that patients are treated with Tecentriq until loss of clinical benefit (see section 5.1) or unmanageable toxicity.
Slovenian: Zdravljenje z zdravilom Tecentriq je priporočljivo nadaljevati, dokler je klinično koristno (glejte poglavje 5.1) ali dokler se ne pojavijo neobvladljivi toksični učinki.
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.
Slovenian: Bolnike so randomizirali na prejemanje 840-mg atezolizumaba ali placeba v intravenski infuziji 1. in 15. dan vsakega 28-dnevnega cikla ter nab-paklitaksela (100 mg/m2) v intravenski infuziji 1., 8. in
English: The rate of complete response per IRF-RECIST v1.1 in the all comer population was 6.1% (95% CI: 3.7, 9.4).
Slovenian: Delež popolnega odgovora po oceni IRF glede na merila RECIST v1.1 v populaciji vseh neselekcioniranih bolnikov je bil 6,1 % (95-% IZ: 3,7; 9,4).
English: Use of atezolizumab in urothelial carcinoma for previously untreated patients who are considered cisplatin ineligible
Slovenian: Uporaba atezolizumaba pri urotelijskem karcinomu pri predhodno nezdravljenih bolnikih, ki niso primerni za zdravljenje s cisplatinom
English: 6-month PFS (%) 12-month PFS (%)
Slovenian: 6-mesečno PFS (%) 12-mesečno PFS (%)
English: • severe reactions associated with infusion (events occurring during the infusion or within one day of the infusion): may include fever, chills, shortness of breath and flushing.
Slovenian: • hujšo reakcijo, povezano z infundiranjem zdravil (dogodki, ki se pojavijo med infuzijo ali v enem dnevu po infuziji): zvišana telesna temperatura, mrzlica, težko dihanje in zardevanje.
English: Physicians should consult the nab-paclitaxel summary of product characteristics (SmPC) for specific precautions and contraindications of this medicine.
Slovenian: Glede posebnih previdnostnih ukrepov in kontraindikacij nab-paklitaksela morajo zdravniki prebrati povzetek glavnih značilnosti (SmPC) tega zdravila.
English: In study IMpower150, age ≥ 65 was associated with a diminished effect of atezolizumab in patients receiving atezolizumab in combination with carboplatin and paclitaxel.
Slovenian: V študiji IMpower150 je bila starost ≥ 65 let povezana z zmanjšanim učinkom atezolizumaba pri bolnikih, ki so prejemali atezolizumab v kombinaciji s karboplatinom in paklitakselom.
English: Bladder was the primary tumour site for 71.1% of patients and 25.4% of patients had upper tract urothelial carcinoma.
Slovenian: Pri 71,1 % bolnikov je bilo mesto primarnega tumorja mehur, 25,4 % bolnikov pa je imelo urotelijski karcinom zgornjega trakta.
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.
Slovenian: Zdravilo Tecentriq je v kombinaciji z nab-paklitakselom indicirano za zdravljenje odraslih bolnikov z inoperabilnim lokalno napredovalim ali razsejanim trojno negativnim rakom dojk (TNRD), katerih tumorji izražajo PD-L1 v ≥ 1 % in predhodno še niso prejemali kemoterapije zaradi razsejane bolezni.
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.
Slovenian: Neželeni učinki zdravila so navedeni po organskih sistemih MedDRA in kategorijah pogostnosti v preglednici 2 za atezolizumab v monoterapiji ali kombinaciji.
English: Figure 3 summarises the results of OS in the ITT and PD-L1 subgroups.
Slovenian: Slika 3 povzema rezultate celokupnega preživetja v populaciji ITT in podskupinah PD-L1.
English: u Includes reports of autoimmune pancreatitis, pancreatitis, pancreatitis acute, lipase increased, amylase increased.
Slovenian: Vključuje poročila o avtoimunskem pankreatitisu, pankreatitisu, akutnem pankreatitisu, zvišani lipazi, zvišani amilazi.
English: Each mL contains 60 mg of atezolizumab.
Slovenian: En mililiter vsebuje 60 mg atezolizumaba.
English: Type I glass vial with a butyl rubber stopper and an aluminium seal with a plastic, grey flip-off cap containing 14 mL of concentrate for solution for infusion.
Slovenian: Viala iz stekla tipa I z zamaškom iz butilne gume in aluminijasim tesnilom z odstranljivo plastično sivo zaporko, ki vsebuje 14 ml koncentrata za raztopino za infundiranje.
English: The pharmacokinetic properties of atezolizumab 840 mg administered every 2 weeks and atezolizumab 1,200 mg administered every 3 weeks are comparable.
Slovenian: Farmakokinetične lastnosti 840-mg atezolizumaba, ki se daje na 2 tedna, in 1200-mg atezolizumaba, ki se daje na 3 tedne, so primerljive.
English: No clinical data are available on the possible effects of atezolizumab on fertility.
Slovenian: Kliničnih podatkov o možnih učinkih atezolizumaba na plodnost ni.
English: For TNBC, it is recommended that patients are treated with Tecentriq until disease progression or unmanageable toxicity (see section 5.1).
Slovenian: Pri TNRD je zdravljenje z zdravilom Tecentriq priporočljivo nadaljevati do napredovanja bolezni ali dokler se ne pojavijo neobvladljivi toksični učinki (glejte poglavje 5.1).
English: Treatment may be resumed when the event is resolved
Slovenian: Zdravljenje se lahko znova začne, ko se neželeni učinek razreši.
English: In the population pharmacokinetic analysis, there were no clinically important differences in the clearance of atezolizumab between patients with mild hepatic impairment (bilirubin ≤ ULN and AST > ULN or bilirubin > 1.0 × to 1.5 × ULN and any AST, n= 71) and normal hepatic function (bilirubin and AST ≤
Slovenian: Populacijska farmakokinetična analiza ni pokazala klinično pomembnih razlik med očistkom atezolizumaba pri bolnikih z blago okvaro jeter (bilirubin ≤ ZNM in AST > ZNM ali bilirubin od < 1,0- do 1,5-kratna ZNM in kakršna koli AST, n = 71) in bolnikih z normalnim delovanjem jeter (bilirubin in AST ≤ ZNM, n = 401).
English: 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.
Slovenian: Zdravilo Tecentriq uporabljamo v kombinaciji z zdravilom proti raku (kemoterapijo, imenovano nab-paklitaksel): če je vaš zdravnik pri testiranju raka ugotovil, da imate v telesu visoko raven specifične beljakovine, imenovane ligand za programirano celično smrt 1 (PD-L1), če se je rak razširil na druge dele telesa in se še niste zdravili z zdravili proti raku (kemoterapijo) ali če se je rak dojk po predhodnem zdravljenju ponovil.
English: Asymptomatic patients with abnormal thyroid function tests can receive atezolizumab.
Slovenian: Asimptomatski bolniki z nenormalnimi izvidi testiranja delovanja ščitnice lahko prejmejo atezolizumab.
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%).
Slovenian: Približno 10 % bolnikov je imelo znano mutacijo EGFR, 4 % jih je imelo znano preureditev ALK, 14 % jih je imelo izhodiščno zasevke v jetrih in večina bolnikov je bila trenutnih ali nekdanjih kadilcev (80 %).
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.
Slovenian: Če ni uporabljena takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika in običajno ne presegajo 24 ur pri temperaturi od 2 do 8 °C ali 8 ur pri sobni temperaturi (≤ 25 °C), razen če je redčenje potekalo v kontroliranih in validiranih aseptičnih pogojih.
English: • have been given medicines to suppress your immune system
Slovenian: • ste dobili zdravila za zavrtje imunskega sistema,
English: y Includes reports of myositis, rhabdomyolysis, polymyalgia rheumatica, dermatomyositis, muscle abscess, myoglobin urine present.
Slovenian: Vključuje poročila o miozitisu, rabdomiolizi, revmatični polimialgiji, dermatomiozitisu, mišičnem abscesu, prisotnosti mioglobina v urinu.
English: A population pharmacokinetic analysis suggests that steady-state is obtained after 6 to 9 weeks after multiple doses.
Slovenian: Populacijska farmakokinetična analiza kaže, da je stanje dinamičnega ravnovesja doseženo po 6 do 9 tednih večkratnega odmerjanja.
English: or blood bilirubin > 3 x ULN)
Slovenian: ali bilirubin v krvi > 3-kratna ZNM)
English: Grade 4 or recurrent Grade 3
Slovenian: 4. stopnja ali ponovljena 3. stopnja
English: Tecentriq is given as a drip into a vein (an intravenous infusion).
Slovenian: Zdravilo Tecentriq se daje v veno (v obliki intravenske infuzije).
English: Per second interim analysis for OS and exploratory PFS analysis at clinical cut off January 2
Slovenian: po drugi vmesni analizi OS in eksploratorni analizi PFS na klinični presečni datum 2. januar 2019;
English: Table 9: Summary of efficacy from IMpower130 in the primary analysis (ITT-WT population) Efficacy endpoints
Slovenian: Povzetek učinkovitosti iz študije IMpower130 v primarni analizi (populacija ITTdivji tip)
English: For ≥ Grade 3 hyperglycaemia (fasting glucose > 250 mg/dL or 13.9 mmol/L), atezolizumab should be withheld.
Slovenian: V primeru hiperglikemije ≥ 3. stopnje (glukoza na tešče > 250 mg/dl ali 13,9 mmol/l) je treba uporabo atezolizumaba odložiti.
English: If you miss a dose of Tecentriq
Slovenian: Če ste izpustili odmerek zdravila Tecentriq
English: Induction (Four or Six 21-day cycles)
Slovenian: Uvodno zdravljenje (štiri ali šest 21-dnevnih ciklov)
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).
Slovenian: Inkompatibilnosti med zdravilom Tecentriq in intravenskimi vrečkami iz polivinilklorida (PVC), poliolefina (PO), polietilena (PE) ali polipropilena (PP) niso opazili.
English: Table 12: Summary of efficacy (IMpower133) Key efficacy endpoints
Slovenian: Povzetek učinkovitosti (IMpower133) Ključni opazovani dogodki učinkovitosti
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.
Slovenian: Mediani čas spremljanja preživetja bolnikov je bil 18,6 meseca; celokupno preživetje in preživetje brez napredovanja bolezni sta bila boljša z atezolizumabom, nab-paklitakselom in karboplatinom kakor s primerjavo.
English: The median duration was 16.8 months (range: 0 day to 16.8 months).
Slovenian: Mediano trajanje je bilo 16,8 meseca (razpon: od 0 dni do 16,8 meseca).
English: Tumour assessments were performed every 8 weeks (± 1 week) for the first 12 months after Cycle 1, day 1 and every 12 weeks (± 1 week) thereafter.
Slovenian: Tumorje so ocenjevali na 8 tednov (± 1 teden) prvih 12 mesecev po 1. ciklu 1. dan, pozneje pa na 12 tednov (± 1 teden).
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.
Slovenian: Skupno sta bila vključena 1202 bolnika, ki so jih v razmerju 1:1:1 randomizirali na prejemanje ene od shem zdravljenja, opisanih v preglednici 5.
English: Treatment with insulin should be initiated for type 1 diabetes mellitus.
Slovenian: V primeru sladkorne bolezni tipa 1 je treba uvesti zdravljenje z insulinom.
English: Symptomatic
Slovenian: Simptomatski
English: Approximately three-quarters of patients had non-squamous histology (74%), 10% had known EGFR mutation, 0.2% had known ALK rearrangements, 10% had CNS metastases at baseline, and most patients were current or previous smokers (82%).
Slovenian: Približno tri četrtine bolnikov je imelo neploščatocelično histologijo (74 %), 10 % jih je imelo znano mutacijo EGFR, 0,2 % jih je imelo preureditev ALK, 10 % jih je imelo izhodiščno zasevke v osrednjem živčevju in večina bolnikov je bila trenutnih ali nekdanjih kadilcev (82 %).
English: Most patients were male (81%), and the majority of patients were White (91%).
Slovenian: Večina bolnikov je bila moških (81 %), in večina je bila belcev (91 %).
English: Grade 2:
Slovenian: 2. stopnja:
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.
Slovenian: V 2. kohorto so bili vključeni bolniki, ki so predhodno prejeli vsaj eno shemo kemoterapije na osnovi platine zaradi lokalno napredovalega ali razsejanega urotelijskega karcinoma, ali jim je bolezen napredovala v 12 mesecih po zdravljenju z neoadjuvantno ali adjuvantno kemoterapijo, ki je vsebovala platino.
English: No reproductive and development toxicity studies have been conducted with atezolizumab; however, based on the 26-week repeat dose toxicity study, atezolizumab had an effect on menstrual cycles at an estimated AUC approximately 6 times the AUC in patients receiving the recommended dose and was reversible (see section 5.3).
Slovenian: Toda glede na 26-tedensko študijo toksičnosti ponavljajočih se odmerkov je atezolizumab vplival na menstruacijske cikluse ob ocenjeni AUC, ki je bila približno 6-krat tolikšna, kot je AUC pri bolnikih med uporabo priporočenega odmerka; ta učinek je bil reverzibilen (glejte poglavje 5.3).
English: The majority of the patients were male (59%) and white (90%).
Slovenian: Večina bolnikov je bila moških (59 %) in belcev (90 %).
English: At the time of the interim OS analysis, patients had a median follow-up of 19.7 months.
Slovenian: Ob času vmesne analize celokupnega preživetja (OS) je mediano spremljanje bolnikov trajalo 19,7 meseca.
English: *Atezolizumab is an Fc-engineered, humanised IgG1 anti-programmed death-ligand 1 (PD-L1) monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology.
Slovenian: *Atezolizumab je humanizirano monoklonsko protitelo IgG1 z inženirsko obdelano domeno Fc, ki je pridobljeno iz celic jajčnika kitajskega hrčka s tehnologijo rekombinantne DNA in deluje na ligand za programirano celično smrt 1 (PD-L1).
English: No. of deaths (%)
Slovenian: OS Število smrti (%)
English: 79639 Grenzach-Whylen
Slovenian: 79639 Grenzach-Whylen NEMČIJA
English: LIST OF EXCIPIENTS Excipients: L-histidine, glacial acetic acid, sucrose, polysorbate 20, water for injections
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožne snovi: L-histidin, koncentrirana ocetna kislina, saharoza, polisorbat 20, voda za injekcije
English: • itching of the skin
Slovenian: • srbenje kože
English: Grade 2: (ALT or AST > 3 to 5 x upper limit of normal [ULN]
Slovenian: (ALT ali AST > 3- do 5-kratna zgornja normalna meja [ZNM]
English: Table 5: Intravenous treatment regimens (IMpower150) Treatment regimen
Slovenian: Intravenske sheme zdravljenja (IMpower150) Shema zdravljenja
English: • If you become pregnant while you are being treated with Tecentriq tell your doctor.
Slovenian: • Če med zdravljenjem z zdravilom Tecentriq zanosite, morate o tem obvestiti zdravnika.
English: A total of 403 patients were enrolled and randomised (1:1) to receive one of the treatment regimens described in Table 11.
Slovenian: Skupno so bili vključeni 403 bolniki, ki so jih v razmerju 1:1 randomizirali na prejemanje ene od shem zdravljenja, opisanih v preglednici 11.
English: After dilution (see section 6.6), one mL of solution contains approximately 4.4 mg of atezolizumab.
Slovenian: Po razredčenju (glejte poglavje 6.6) 1 ml raztopine vsebuje približno 4,4 mg atezolizumaba.
English: Carcinogenicity studies have not been performed to establish the carcinogenic potential of atezolizumab.
Slovenian: Študij kancerogenosti za ugotavljanje kancerogenosti atezolizumaba niso izvedli.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 840 mg/14 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 840 mg/14 ml
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.
Slovenian: Pri vseh zdravljenih bolnikih je bilo mediano trajanje zdravljenja 2,8 meseca za skupino, zdravljeno z atezolizumabom, 2,1 meseca za skupini, zdravljeni z vinfluninom ali paklitakselom, in 1,6 meseca za skupino, zdravljeno z docetakselom.
English: Table 5: Summary of efficacy in the primary analysis population (all comers)* (OAK)
Slovenian: Povzetek učinkovitosti v populaciji za primarno analizo (vsi neselekcionirani bolniki)* (OAK)
English: • The active substance is atezolizumab.
Slovenian: • Učinkovina je atezolizumab.
English: Both patients required the use of corticosteroids.
Slovenian: Pri obeh bolnikih je bilo treba uporabiti kortikosteroide.
English: • flu-like illness
Slovenian: • gripi podobna bolezen • mrzlica
English: Two patients required the use of corticosteroids.
Slovenian: Pri dveh bolnikih je bilo treba uporabiti kortikosteroide.
English: Tumour assessments were conducted every 9 weeks for the first 54 weeks, and every 12 weeks thereafter.
Slovenian: Ocene tumorjev so izvedli vsakih 9 tednov v prvih 54 tednih in nato na vsakih 12 tednov.
English: Hypophysitis occurred in 0.4% (2/473) of patients who received atezolizumab in combination with nab-paclitaxel and carboplatin.
Slovenian: Hipofizitis se je pojavil pri 0,4 % (2/473) bolnikov, ki so prejemali atezolizumab v kombinaciji z nab paklitakselom in karboplatinom.
English: Grade 3 or 4 hyperglycaemia (fasting glucose > 250 mg/dL or 13.9 mmol/L)
Slovenian: Sladkorna bolezen tipa 1 Hiperglikemija 3. ali 4. stopnje (glukoza na tešče > 250 mg/dl ali 13,9 mmol/l)
English: Description of the signs and symptoms of immune-related adverse reactions.
Slovenian: - z infundiranjem povezane reakcije Opis znakov in simptomov imunsko pogojenih neželenih učinkov.
English: Patients had to be eligible for taxane monotherapy (i.e. absence of rapid clinical progression, life-threatening visceral metastases, or need for rapid symptom and/or disease control) and were excluded if they had received prior chemotherapy in the neoadjuvant or adjuvant setting within the last 12 months, a history of autoimmune disease; administration of a live, attenuated vaccine within 4 weeks prior to randomisation, administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medications within 2 weeks prior to randomisation; untreated, symptomatic or corticosteroid-dependent brain metastases.
Slovenian: Bolniki so morali biti primerni za monoterapijo s taksani (tj. niso smeli imeti hitrega kliničnega napredovanja, življenje ogrožajočih visceralnih zasevkov ali potrebe po hitrem obvladanju simptomov in/ali bolezni) in niso bili vključeni, če: so predhodno v zadnjih 12 mesecih neoadjuvantno ali adjuvantno prejemali kemoterapijo, so imeli v anamnezi avtoimunsko bolezen, so prejeli živo oslabljeno cepivo v 4 tednih pred randomizacijo, so prejeli sistemske imunostimulanse v 4 tednih ali sistemske imunosupresive v 2 tednih pred randomizacijo, ali če so imeli nezdravljene, simptomatske ali od kortikosteroidov odvisne zasevke v možganih.
English: For symptomatic hyperthyroidism, atezolizumab should be withheld and an anti-thyroid medicinal product should be initiated as needed.
Slovenian: V primeru simptomatskega hipertiroidizma je treba uporabo atezolizumaba odložiti in uvesti zdravila za zdravljenje hipertiroze, kot je potrebno.
English: Triple-negative breast cancer
Slovenian: Trojno negativni rak dojk
English: Patients were randomised (1:1) to receive either atezolizumab or docetaxel.
Slovenian: Bolnike so v razmerju 1:1 randomizirali na prejemanje atezolizumaba ali docetaksela.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,200 mg/20 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1200 mg/20 ml
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.
Slovenian: V študiji IMpower150 je bila starost ≥ 65 povezana s povečanim tveganjem za pojav neželenih učinkov pri bolnikih, ki so prejemali atezolizumab v kombinaciji z bevacizumabom, karboplatinom in paklitakselom.
English: Neutropenia and peripheral neuropathies occurring during treatment with atezolizumab and nabpaclitaxel may be reversible with interruptions of atezolizumab and/or nab-paclitaxel.
Slovenian: Nevtropenija in periferne nevropatije, ki se pojavijo med zdravljenjem z atezolizumabom in nabpaklitakselom, so lahko reverzibilne, če zdravljenje z atezolizumabom in/ali nab-paklitakselom prekinemo.
English: Hrvatska Roche d.o.o.
Slovenian: Roche d.o.o.
English: • low white blood cell count with and without fever, which can increase the risk of infection
Slovenian: • majhno število belih krvnih celic z zvišano telesno temperaturo ali brez nje, ki lahko poveča tveganje za okužbo (nevtropenija, levkopenija)
English: Based on a population pharmacokinetic analysis, no dose adjustment is required for patients with mild hepatic impairment.
Slovenian: Glede na populacijsko farmakokinetično analizo bolnikom z blago okvaro jeter odmerka ni treba prilagoditi.
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.
Slovenian: V študiji IMpower150 ni podatkov o učinkovitosti atezolizumaba v kombinaciji z bevacizumabom, paklitakselom in karboplatinom pri bolnikih z dokazano mutacijo EGFR, ki jim je bolezen napredovala tekom zdravljenja z erlotinibom in bevacizumabom.
English: Investigator-assessed Overall Best Response3* (RECIST 1.1)
Slovenian: 12-mesečno OS (%) Najboljši celokupni odgovor*3 po oceni raziskovalca (RECIST 1.1)
English: Type I glass vial with a butyl rubber stopper and an aluminium seal with a plastic aqua flip-off cap containing 20 mL of concentrate solution for infusion.
Slovenian: Viala iz stekla tipa I z zamaškom iz butilne gume in aluminijasim tesnilom z odstranljivo plastično modro zaporko, ki vsebuje 20 ml koncentrata za raztopino za infundiranje.
English: Appropriate management of patients with abnormal thyroid function tests at baseline should be considered.
Slovenian: Razmisliti je treba o ustrezni izhodiščni obravnavi bolnikov z nenormalnimi testi delovanja ščitnice.
English: No formal pharmacokinetic drug interaction studies have been conducted with atezolizumab.
Slovenian: Formalnih študij farmakokinetičnega medsebojnega delovanja zdravil z atezolizumabom niso izvedli.
English: 79639 Grenzach-Wyhlen
Slovenian: 79639 Grenzach-Wyhlen Nemčija