natgillin/translations-raw huggingface dataset:
Kaplan-Meier curves for OS in the ITT population are presented in Figure 2. 
Kaplan-Meierjevi krivulji celokupnega preživetja v populaciji ITT sta prikazani na sliki 2.
METHOD OF ADMINISTRATION For intravenous use after dilution. 
POSTOPEK UPORABE za intravensko uporabo po razredčenju
Myasthenia gravis occurred in < 0.1% (1/3,178) of patients who received atezolizumab monotherapy. 
Miastenija gravis se je pojavila pri < 0,1 % (1/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Placebo + nab-paclitaxel 
nab-paklitaksel placebo +
Immune system disorders Common infusion-related reactionf Endocrine disorders Very common hypothyroidismg 
Bolezni imunskega sistema pogosti z infundiranjem povezane reakcijef
Median (months) (95% CI) 
Mediani čas do dogodka (meseci) 95-% IZ
The Kaplan-Meier curve for OS in the all comer population is presented in Figure 1. 
Kaplan-Meierjeva krivulja za celokupno preživetje v populaciji vseh neselekcioniranih bolnikov je predstavljena na sliki 1.
In Cohort 1, 119 patients were treated with atezolizumab 1,200 mg by intravenous infusion every 
V 1. kohorto je bilo z atezolizumabom v odmerku 1200 mg v intravenski infuziji na 3 tedne do napredovanja bolezni zdravljenih 119 bolnikov.
Arm A (Atezolizumab + Paclitaxel + Carboplatin) 
Skupina A (atezolizumab + paklitaksel + karboplatin)
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
Ime in naslov izdelovalca biološke učinkovine
Stratified hazard ratio‡ (95% CI) p-value 
Stratificiranoǂ razmerje ogroženosti (95-% IZ) p-vrednost**
Atezolizumab should be permanently discontinued in patients with Grade 3 or 4 infusion-related reactions. 
Pri bolnikih, ki imajo z infundiranjem povezane reakcije 3. ali 4. stopnje, je treba zdravljenje z atezolizumabom trajno ukiniti.
Immune-related myositis 
Imunsko pogojeni miozitis
A phase II, multi-centre, international, two-cohort, single-arm clinical trial, IMvigor210, was conducted in patients with locally advanced or metastatic UC (also known as urothelial bladder cancer). 
Pri bolnikih z lokalno napredovalim ali razsejanim urotelijskim karcinomom (imenovanim tudi urotelijski rak sečnega mehurja) so izvedli multicentrično mednarodno preskušanje faze II z eno skupino in dvema kohortama (IMvigor210).
Meningoencephalitis occurred in 0.4% (13/3,178) of patients who received atezolizumab monotherapy. 
Meningoencefalitis se je pojavil pri 0,4 % (13/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Treatment may be resumed when serum amylase and lipase levels improve to Grade 0 or Grade 1 within 12 weeks, or symptoms of pancreatitis have resolved, and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day 
Zdravljenje se lahko znova začne, ko se raven serumske amilaze in lipaze v 12 tednih zniža na 0. ali 1. stopnjo ali ko simptomi pankreatitisa minejo, odmerek kortikosteroidov pa je zmanjšan na
Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment; systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medicinal products within 2 weeks prior to study entry were excluded from clinical trials. 
Prav tako v klinična preskušanja niso bili vključeni bolniki, ki so bili v obdobju 28 dni pred vključitvijo v študijo cepljeni z živim oslabljenim cepivom, ki so v obdobju 4 tednov pred vključitvijo v študijo dobili sistemska imunostimulacijska sredstva ali v obdobju 2 tednov sistemska imunosupresivna zdravila.
Treatment with atezolizumab should be withheld for Grade 2 myocarditis, and treatment with systemic corticosteroids at a dose of 1 to 2mg/kg/day of prednisone or equivalent should be started. 
V primeru miokarditisa 2. stopnje je treba zdravljenje z atezolizumabom odložiti in uvesti zdravljenje s sistemskimi kortikosteroidi v odmerku 1 do 2 mg/kg/dan prednizona (ali ekvivalenta).
95% CI Stratified hazard ratio‡ (95% CI) 
Stratificirano razmerje ogroženosti‡ (95-% IZ)
Myositis occurred in 0.4% (12/3178) of patients who received atezolizumab monotherapy. 
Miozitis se je pojavil pri 0,4 % (12/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Treatment with atezolizumab must be permanently discontinued for Grade 3 or 4 pneumonitis. 
V primeru pnevmonitisa 3. ali 4. stopnje je treba zdravljenje z atezolizumabom trajno ukiniti.
The Kaplan-Meier curve for OS in the ITT population is presented in Figure 2. 
Kaplan-Meierjeva krivulja celokupnega preživetja v populaciji ITT je prikazana na sliki 2.
Patients should be monitored for signs and symptoms of myositis. 
Bolnike je treba nadzorovati glede znakov in simptomov, ki kažejo na miozitis.
Cases of hepatitis, some leading to fatal outcomes have been observed in clinical trials with atezolizumab (see section 4.8). 
V kliničnih preskušanjih atezolizumaba so opazili primere hepatitisa, nekatere s smrtnim izidom (glejte poglavje 4.8).
Patients were excluded if they had active or untreated CNS metastases; history of autoimmune disease; administration of live, attenuated vaccine within 4 weeks prior to randomisation; administration of systemic immunosuppressive medications within 1 week prior to randomisation. 
V študijo niso bili vključeni bolniki, ki so imeli aktivne ali nezdravljene zasevke v osrednjem živčevju, anamnezo avtoimunske bolezni, so bili v 4 tednih pred randomizacijo cepljeni z živim oslabljenim cepivom, ali so v enem tednu pred randomizacijo prejemali sistemska imunosupresivna zdravila.
Nephritis has been observed in clinical trials with atezolizumab (see section 4.8). 
V kliničnih preskušanjih z atezolizumabom so opazili nefritis (glejte poglavje 4.8).
CI = confidence interval; DOR = duration of response; NE = not estimable; ORR = objective response rate; OS = overall survival; PFS = progression-free survival; RECIST = Response Evaluation Criteria in Solid Tumours v1.1. 
IZ = interval zaupanja; DOR = trajanje odgovora; NO = ni ocenljivo; ORR = delež objektivnega odgovora; OS = celokupno preživetje; PFS = preživetje brez napredovanja bolezni; RECIST = merila RECIST (Response
A phase III, open-label, multi-center, international, randomised study, (IMvigor211), was conducted to evaluate the efficacy and safety of atezolizumab compared with chemotherapy (investigator's choice of vinflunine, docetaxel, or paclitaxel) in patients with locally advanced or metastatic UC who progressed during or following a platinum-containing regimen. 
Pri bolnikih z lokalno napredovalim ali razsejanim urotelijskim karcinomom, ki je napredoval med ali po zdravljenju s kemoterapijo na osnovi platine, so za oceno učinkovitosti in varnosti atezolizumaba v primerjavi s kemoterapijo (raziskovalčeva izbira vinflunina, docetaksela ali paklitaksela) izvedli odprto, multicentrično, mednarodno, randomizirano študijo faze III (IMvigor211).
• blood tests showing low levels of potassium (hypokalaemia) or sodium (hyponatremia) 
• znižana koncentracija kalija (hipokaliemija) ali natrija (hiponatriemija) v krvi, kar pokažejo preiskave krvi
Treatment with atezolizumab should be withheld for Grade 2 pneumonitis, and 1 to 2 mg/kg/day prednisone or equivalent should be started. 
V primeru pnevmonitisa 2. stopnje je treba zdravljenje z atezolizumabom odložiti in uvesti prednizon v odmerku 1 do 2 mg/kg/dan (ali ekvivalenta).
Patients with ECOG performance status ≥ 2 were excluded from the clinical trials in NSCLC, TNBC 
Stanje zmogljivosti po ECOG (Eastern Cooperative Oncology Group) ≥ 2 Bolniki s stanjem zmogljivosti po ECOG ≥ 2 niso bili vključeni v klinična preskušanja pri NDRP, TNRD in pri 2. liniji zdravljenja urotelijskega karcinoma (glejte poglavji 4.4 in 5.1).
b etoposide (100 mg/m2)b,c atezolizumab (1,200 mg) 
2)b,c + karboplatin (AUC 6)c (100 mg/m atezolizumab (1200 mg)a
• 1,680 mg administered intravenously every four weeks. 
• 840 mg intravensko na vsaka dva tedna ali • 1680 mg intravensko na vsake štiri tedne.
Cases of pneumonitis, including fatal cases, have been observed in clinical trials with atezolizumab (see section 4.8). 
V kliničnih preskušanjih atezolizumaba so opažali primere pnevmonitisa, vključno s smrtnimi primeri (glejte poglavje 4.8).
Treatment with atezolizumab should be withheld for Grade 2 nephritis, and treatment with systemic corticosteroids at a dose of 1 to 2mg/kg/day of prednisone or equivalent should be started. 
V primeru nefritisa 2. stopnje je treba zdravljenje z atezolizumabom odložiti in uvesti zdravljenje s sistemskimi kortikosteroidi v odmerku 1 do 2 mg/kg/dan prednizona (ali ekvivalenta).
For all treated patients, the median duration of treatment was 2.1 months for the docetaxel arm and 3.4 months for the atezolizumab arm. 
2,1 meseca v skupini z docetakselom in 3,4 meseca v skupini z atezolizumabom.
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. 
V študijo niso bili vključeni bolniki, ki so imeli anamnezo avtoimunske bolezni, so bili v 28 dneh pred randomizacijo cepljeni z živim oslabljenim cepivom, so v 4 tednih pred randomizacijo prejemali imunostimulacijska sredstva, so v 2 tednih pred randomizacijo prejemali sistemska imunosupresivna zdravila, ali so imeli aktivne ali nezdravljene zasevke v osrednjem živčevju.
No. of partial response (%) 95% CI 
Št. delnih odgovorov (%) 95-% IZ
aStratified HR for ITT and TC or IC ≥ 1%. 
aStratificirano razmerje ogroženosti za populacijo z namenom zdraviti (ITT) in tumorske celice (TC) ali celice imunskega sistema, ki infiltrirajo tumor (IC) ≥ 1%.
Treatment may be resumed when the symptoms improve to Grade 0 or Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day 
Zdravljenje se lahko znova začne, ko se neželeni učinek v 12 tednih izboljša na 0. ali 1. stopnjo in je odmerek kortikosteroidov zmanjšan na ≤ 10 mg prednizona (ali ekvivalenta) na dan.
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. 
V študijo niso bili vključeni bolniki z anamnezo avtoimunske bolezni, z aktivnimi ali od kortikosteroidov odvisnimi zasevki v možganih, prav tako vanjo niso bili vključeni bolniki, ki so v 28 dneh pred vstopom v študijo dobili živo oslabljeno cepivo, sistemska imunostimulacijska sredstva v 4 tednih pred vključitvijo ali sistemska imunosupresivna zdravila v 2 tednih pred vključitvijo.
Meningoencephalitis has been observed in clinical trials with atezolizumab (see section 4.8). 
V kliničnih preskušanjih z atezolizumabom so opažali meningoencefalitis (glejte poglavje 4.8).
No. of complete response (%) No. of partial response (%) No. of stable disease (%) 
Število popolnih odgovorov (%) Število delnih odgovorov (%) Število stabilne bolezni (%) DOR po oceni raziskovalca (RECIST v1.1)
• inflammation of the pancreas (pancreatitis): symptoms may include abdominal pain, nausea and vomiting 
• vnetje trebušne slinavke (pankreatitis): med simptomi so lahko bolečine v trebuhu, slabost (siljenje na bruhanje) in bruhanje;
Physicians should carefully consider the combined risks of the four-drug regimen of atezolizumab bevacizumab, paclitaxel, and carboplatin before initiating treatment (see section 4.8). 
Uporaba atezolizumaba v kombinaciji z bevacizumabom, paklitakselom in karboplatinom pri razsejanem neploščatoceličnem nedrobnoceličnem raku pljuč Zdravniki morajo pred začetkom zdravljenja natančno pretehtati skupna tveganja kombiniranega zdravljenja s štirimi zdravili: z atezolizumabom, bevacizumabom, paklitakselom in karboplatinom (glejte poglavje 4.8).
The confirmed ORRs per IRF-RECIST v1.1 were 21.9% (95% CI: 
ORR po oceni raziskovalca (RECIST v1.1) Št. bolnikov z odgovorom (%) 95-% IZ
Tecentriq in combination with carboplatin and etoposide 
Zdravilo Tecentriq v kombinaciji z bevacizumabom, paklitakselom in karboplatinom
Table 3: Summary of efficacy in all comers (IMvigor211) 
Povzetek učinkovitosti pri vseh neselekcioniranih bolnikih (IMvigor211) Opazovani dogodek učinkovitosti atezolizumab (n = 467)
Infusion-related reactions have been observed with atezolizumab (see section 4.8). 
Pri zdravljenju z atezolizumabom so opažali z infundiranjem povezane reakcije (glejte poglavje 4.8).
Adrenal insufficiency occurred in 0.4% (12/3,178) of patients who received atezolizumab monotherapy. 
Insuficienca nadledvičnih žlez se je pojavila pri 0,4 % (12/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Colitis requiring the use of corticosteroids occurred in 0.6% (19/3,178) of patients receiving atezolizumab monotherapy. 
Kolitis, zaradi katerega je bilo treba uporabiti kortikosteroide, se je pojavil pri 0,6 % (19/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Secondary Endpoints Investigator-assessed PFS (RECIST v1.1)* 
12-mesečno OS (%) PFS po oceni raziskovalca (RECIST v1.1)**
Posology 
Izražanje
expression < 1% in TC and IC. 
95-% IZ ‡ stratificirani glede na spol in izražanje PD-L1 na TC in IC
Treatment with atezolizumab must be permanently discontinued for Grade 3 or 4 nephritis. 
V primeru nefritisa 3. ali 4. stopnje je treba zdravljenje z atezolizumabom trajno ukiniti.
Myasthenia Gravis) - Immune-Related Meningoencephalitis - Immune-Related Myocarditis - Immune-Related Nephritis - Immune-Related Myositis - Infusion-Related Reactions 
- imunsko pogojeni hepatitis - imunsko pogojeni pnevmonitis - imunsko pogojeni kolitis - imunsko pogojeni pankreatitis - imunsko pogojene endokrinopatije (sladkorna bolezen tipa 1, hipotiroidizem,
9.3, 40.0) in patients with PD-L1 expression ≥ 5%, 18.8% (95% CI: 10.9, 29.0) in patients with PD-L1 expression ≥ 1%, and 19.3% (95% CI: 12.7, 27.6) in all comers. 
Potrjeni delež objektivnega odgovora s strani IRF po merilih RECIST v1.1 so bili 21,9 % (95-% IZ: 9,3; 40,0) pri bolnikih z izražanjem PD-L1 ≥ 5 %, 18,8 % (95-% IZ: 10,9; 29,0) pri bolnikih z izražanjem PD-L1 ≥ 1 % in 19,3 % (95-% IZ: 12,7; 27,6) pri neselekcioniranih bolnikih.
Disease-specific precautions 
Previdnostni ukrepi, povezani z boleznijo
Atezolizumab (1,200 mg)a + nab-paclitaxel (100 mg/m2)b,c 
A atezolizumab (1200 mg)a + karboplatin (AUC 5)b + etopozid (100 mg/m2)b,c atezolizumab (1200 mg)a
For each 28-day cycle, Tecentriq is administered on days 1 and 15, and nab-paclitaxel is administered on days 1, 8, and 15. 
V vsakem 28-dnevnem ciklu se zdravilo Tecentriq uporabi 1. in 15. dan, nabpaklitaksel pa 1., 8. in 15. dan. Glejte tudi celotne informacije za predpisovanje zdravila, ki se uporablja v kombinaciji (glejte tudi poglavje 5.1).
Arm B in the ITT population (IMpower150) 
Povzetek posodobljenih podatkov o učinkovitosti za skupino A v primerjavi s skupino B v populaciji ITT (IMpower150)
Cases of myositis, including fatal cases, have been observed in clinical trials with atezolizumab (see section 4.8). 
V kliničnih preskušanjih z atezolizumabom so opazili primere miozitisa, vključno s smrtnimi primeri (glejte poglavje 4.8).
• 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, 
Ustrezne informacije (npr. resnost, izrazitost, pogostnost, čas do pojava, reverzibilnost, kot je ustrezno) o naslednjih varnostnih tveganjih, povezanih z uporabo zdravila
Includes reports of thrombocytopenia and platelet count decreased. 
Vključuje poročila o trombocitopeniji in zmanjšanju števila trombocitov.
Primary efficacy endpoint OS 
Primarni opazovani dogodek učinkovitosti
Guillain-Barré syndrome and demyelinating polyneuropathy occurred in 0.2% (5/3,178) of patients who received atezolizumab monotherapy. 
Imunsko pogojene nevropatije Guillain-Barréjev sindrom in demielinizacijske polinevropatije so se pojavili pri 0,2 % (5/3178)
Treatment with atezolizumab should be withheld for Grade 2 or 3 diarrhoea (increase of ≥ 4 stools/day over baseline) or colitis (symptomatic). 
V primeru diareje 2. ali 3. stopnje (povečanje za ≥ 4 iztrebljanja na dan v primerjavi z izhodiščem) ali (simptomatskega) kolitisa je treba zdravljenje z atezolizumabom odložiti.
Patients should be monitored for signs and symptoms of colitis. 
Bolnike je treba spremljati glede znakov in simptomov kolitisa.
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 
ǂStratificirani glede na ekspresijo PD-L1 na celicah imunskega sistema, ki infiltrirajo tumor, glede na število predhodnih shem kemoterapije in glede na histologijo
No. of stable disease Investigator-assessed DOR 
Število stabilne bolezni
If the event improves to ≤ Grade 1, corticosteroids should be tapered over ≥ 1 month. 
Če se neželeni učinek izboljša na ≤ 1. stopnjo, je treba odmerek kortikosteroidov postopoma zmanjševati v obdobju ≥ 1 meseca.
Treatment with atezolizumab should be withheld for Grade 2 or 3 myositis and corticosteroid therapy (1-2 mg/kg/day prednisone or equivalent) should be initiated. 
V primeru miozitisa 2. ali 3. stopnje je treba zdravljenje z atezolizumabom odložiti in uvesti zdravljenje s kortikosteroidi v odmerku 1 do 2 mg/kg/dan prednizona (ali ekvivalenta).
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, 
nab-paklitakselom in karboplatinom v primerjavi z nab-paklitakselom in karboplatinom (RO 0,93, 95
The physician educational material should contain: 
• Vodnik za zdravstvene delavce mora vsebovati naslednje ključne elemente:
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. 
Za oceno učinkovitosti in varnosti atezolizumaba v primerjavi z docetakselom pri bolnikih z lokalno napredovalim ali razsejanim NDRP, ki jim je bolezen napredovala med shemo zdravljenja na osnovi platine ali po takšnem zdravljenju, so izvedli multicentrično, mednarodno, odprto randomizirano študijo faze III (OAK).
Symptomatic Colitis 
ali simptomatski kolitis
or 
y