FrancophonIA/ELRC3.0 huggingface dataset:
English: Across multiple phase III studies, 13.1% to 36.4% of patients developed treatment-emergent anti-drug antibodies (ADAs).
Slovenian: V več študijah faze III so se pri 13,1 % do 36,4 % bolnikov pojavila z zdravljenjem povzročena protitelesa proti zdravilu (anti-drug antibodies - ADA).
English: j Includes reports of adrenal insufficiency and primary adrenal insufficiency.
Slovenian: j Vključuje poročila o insuficienci nadledvičnih žlez in primarni insuficienci nadledvičnih žlez.
English: No fertility studies have been conducted with atezolizumab; however assessment of the cynomolgus monkey male and female reproductive organs was included in the chronic toxicity study.
Slovenian: Z atezolizumabom študij o sposobnosti razmnoževanja niso izvedli, toda študija kronične toksičnosti je vključevala oceno vpliva na reproduktivne organe samcev in samic opic cynomolgus.
English: This means the lung cancer has: - spread to other parts of the body - come back after previous treatment.
Slovenian: To pomeni, da: - se je razširil v druge dele telesa, - se je ponovil po predhodnem zdravljenju.
English: Clinically relevant IRF-assessed ORRs per RECIST v1.1 were shown; however, when compared to a pre-specified historical control response rate of 10%, statistical significance was not reached for the primary endpoint.
Slovenian: Prikazani so bili klinično relevantni deleži objektivnih odgovorov po oceni IRF v skladu z merili RECIST v1.1, toda v primerjavi z vnaprej opredeljenim 10-odstotnim kontrolnim historičnim deležem odgovora primarni opazovani dogodek ni bil statistično značilen.
English: • feeling very tired with no energy (fatigue)
Slovenian: • občutek hude utrujenosti in pomanjkanja energije (izčrpanost)
English: • changes to sense of taste (dysgeusia)
Slovenian: • spremembe zaznavanja okusa (disgevzija)
English: Hepatic impairment was defined by the National Cancer Institute (NCI) criteria of hepatic dysfunction (see section 4.2).
Slovenian: Okvara jeter je bila opredeljena po merilih NCI (National Cancer Institute) za moteno delovanje jeter (glejte poglavje 4.2).
English: Patient alert card
Slovenian: Opozorilna kartica za bolnika
English: It is not known if Tecentriq gets into breast milk.
Slovenian: Dojenje Ni znano, če zdravilo Tecentriq prehaja v materino mleko.
English: Randomisation was stratified by sex, ECOG performance status, and presence of brain metastases.
Slovenian: Randomizacija je bila stratificirana po spolu, stanju zmogljivosti po ECOG in prisotnosti zasevkov v možganih.
English: Human immunoglobulins G1 (IgG1) are known to cross the placental barrier and atezolizumab is an IgG1; therefore, atezolizumab has the potential to be transmitted from the mother to the developing foetus.
Slovenian: Znano je, da humani imunoglobulini G1 (IgG1) prehajajo skozi placentno pregrado, atezolizumab pa je IgG1 in tako obstaja možnost njegovega prenosa od matere v razvijajoči se plod.
English: Of the 87 patients, one experienced a fatal event.
Slovenian: Pri enem od teh 87 bolnikov se je končal s smrtjo.
English: The release of Tecentriq in the environment should be minimised.
Slovenian: Odlaganje zdravila Tecentriq v okolje je treba omejiti na najmanjšo mero.
English: • inflammation of muscles (myositis)
Slovenian: • vnetje mišic (miozitis)
English: The patient will be provided with the patient alert card and instructed to carry the card at all times.
Slovenian: Bolniku je treba dati Opozorilno kartico za bolnika in mu naročiti, naj jo ima vedno pri sebi.
English: Urothelial carcinoma
Slovenian: Urotelijski karcinom
English: • 1,680 milligrams (mg) every four weeks.
Slovenian: • 1680 miligramov (mg) na štiri tedne.
English: • blocked nose (nasal congestion)
Slovenian: • zamašen nos (nazalna kongestija)
English: m Includes reports of Guillain-Barré syndrome and demyelinating polyneuropathy.
Slovenian: m Vključuje poročila o Guillain-Barréjevem sindromu in demielinizacijski polinevropatiji.
English: Grade 4 Diarrhoea or Colitis (life threatening; urgent intervention indicated)
Slovenian: Driska ali kolitis 4. stopnje (življenje ogrožujoče stanje; potrebno je nujno ukrepanje)
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).
Slovenian: Farmakokinetika atezolizumaba se ni klinično pomembno razlikovala med bolniki, starimi < 65 let (n = 274), bolniki, starimi od 65 do 75 let (n = 152), in bolniki, starimi > 75 let (n = 46) (glejte poglavje 4.2).
English: Patients with the following conditions were excluded from clinical trials: a history of autoimmune disease, history of pneumonitis, active brain metastasis, HIV, hepatitis B or hepatitis C infection, significant cardiovascular disease and patients with inadequate hematologic and end-organ function.
Slovenian: V klinična preskušanja niso bili vključeni bolniki z naslednjimi stanji: z anamnezo avtoimunske bolezni, anamnezo pnevmonitisa, simptomatskimi možganskimi zasevki, okužbo z virusom HIV, s hepatitisom B ali hepatitisom C, pomembnimi srčno-žilnimi boleznimi ter bolniki z nezadostnim hematološkim delovanjem in delovanjem končnih organov.
English: Based on an independent Data Monitoring Committee (iDMC) recommendation following an early review of survival data, accrual of patients on the atezolizumab monotherapy treatment arm whose tumours have a low PD-L1 expression (less than 5% of immune cells staining positive for PD-L1 by immunohistochemistry) was stopped after observing decreased overall survival for this subgroup.
Slovenian: V skladu s priporočili neodvisnega Odbora za spremljanje podatkov (independent Data Monitoring Committee - iDMC) po zgodnjem pregledu podatkov o preživetju je bilo vključevanje bolnikov, katerih tumorji imajo nizko raven izražanja PD-L1 (manj kot 5 % PD-L1-pozitivno obarvanih imunskih celic z imunohistokemično metodo), v skupino, ki prejema monoterapijo z atezolizumabom, ustavljeno po ugotovitvi, da je celokupno preživetje pri tej podskupini krajše.
English: Sverige Roche AB
Slovenian: Roche AB
English: In the absence of data, atezolizumab should be used with caution in these populations after careful evaluation of the balance of benefits and risks for the patient.
Slovenian: Pri teh skupinah je treba zaradi pomanjkanja podatkov atezolizumab uporabljati previdno in po skrbni oceni razmerja med koristmi in tveganji zdravila za bolnika.
English: Treatment beyond disease progression may be considered at the discretion of the physician (see section 5.1).
Slovenian: Odločitev o zdravljenju po napredovanju bolezni je v pristojnosti zdravnika (glejte poglavje 5.1).
English: Elderly Based on a population pharmacokinetic analysis, no dose adjustment of Tecentriq is required in patients ≥ 65 years of age (see sections 4.8 and 5.1).
Slovenian: Glede na populacijsko farmakokinetično analizo bolnikom v starosti ≥ 65 let odmerka zdravila Tecentriq ni treba prilagoditi (glejte poglavji 4.8 in 5.1).
English: 12-month OS (%)**
Slovenian: 12-mesečno OS (%)**
English: However, systemic corticosteroids or other immunosuppressants can be used to treat immune-related adverse reactions after starting atezolizumab (see section 4.4).
Slovenian: Vendar pa se sistemske kortikosteroide ali druge imunosupresive lahko uporabi po začetku zdravljenja z atezolizumabom za zdravljenje imunsko pogojenih neželenih učinkov (glejte poglavje 4.4).
English: or blood bilirubin > 1.5 to 3 x ULN)
Slovenian: ali bilirubin v krvi > 1,5- do 3-kratna ZNM)
English: The systemic accumulation in area under the curve, maximum concentration and trough concentration was 1.91, 1.46 and 2.75-fold, respectively.
Slovenian: Sistemsko kopičenje v površini pod krivuljo je bilo 1,91-kratno, maksimalna koncentracija je bila 1,46-kratna, najnižja koncentracija pred naslednjim odmerkom pa 2,75-kratna.
English: At the time of the primary analysis, patients had a median survival follow up time of 13.9 months.
Slovenian: V času primarne analize je bil mediani čas spremljanja preživetja bolnikov 13,9 meseca.
English: Binding of PD-L1 to the PD-1 and B7.1 receptors found on T-cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation and cytokine production.
Slovenian: Vezava PD-L1 na receptorje PD-1 in B7-1 na celicah T in celicah, ki predstavijo antigene, zavre citotoksično dejavnost celic T, proliferacijo celic T in nastajanje citokinov.
English: Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway can lead to immune-related rejection of the developing foetus resulting in foetal death.
Slovenian: Študije na živalih so pokazale, da lahko zavrtje poti PD-L1/PD-1 povzroči imunsko zavrnitev razvijajočega se ploda in povzroči smrt ploda.
English: Includes reports of diarrhoea, defaecation urgency, frequent bowel movements, gastrointestinal hypermotility.
Slovenian: Vključuje poročila o diareji, nujnem iztrebljanju, pogostem odvajanju blata, gastrointestinalni hipermotiliteti.
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.
Slovenian: Kemijska in fizikalna stabilnost med uporabo sta dokazani za največ 24 ur pri temperaturi ≤ 30 °C in do 30 dni pri temperaturi od 2 do 8 °C od časa priprave.
English: Table 4: Summary of updated efficacy (IMvigor210 Cohort 1)
Slovenian: Povzetek posodobljenih rezultatov učinkovitosti študije (IMvigor210, 1. kohorta)
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.
Slovenian: Drugi klinično pomembni neželeni učinki, ki so jih opazili pogosteje v skupini z atezolizumabom, bevacizumabom, paklitakselom in karboplatinom, so bili epistaksa, hemoptiza, cerebrovaskularni dogodek, vključno s smrtnim izidom.
English: • type 1 diabetes
Slovenian: • sladkorna bolezen tipa 1
English: 8.1 months).
Slovenian: 5,3 meseca).
English: OS comparisons between treatment arms in patients with PD-L1 expression ≥1% were not formally tested, as per the pre-specified analysis hierarchy.
Slovenian: 2. primerjave celokupnega preživetja med skupinama pri bolnikih z izražanjem PD-L1 ≥ 1 % še niso formalno preskusili v skladu s predhodno določeno hierarhijo analiz;
English: Permanently discontinue Tecentriq (except endocrinopathies controlled with replacement hormones)
Slovenian: Trajno prenehajte uporabljati zdravilo Tecentriq (razen pri endokrinopatijah,
English: A total of 287 patients were randomised 1:1 to receive either atezolizumab (1,200 mg by intravenous infusion every 3 weeks until loss of clinical benefit) or docetaxel (75 mg/m2 by intravenous infusion on day 1 of each 3-week cycle until disease progression).
Slovenian: Skupno 287 bolnikov je bilo v razmerju 1:1 randomiziranih ali na atezolizumab (1200 mg v intravenski infuziji na 3 tedne do izgube klinične koristi) ali na docetaksel (75 mg/m v intravenski infuziji 1. dan vsakega 3-tedenskega cikla do napredovanja bolezni).
English: • who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1).
Slovenian: • niso primerni za zdravljenje s cisplatinom in katerih tumorji izražajo PD-L1 v ≥ 5 % (glejte poglavje 5.1).
English: and PFS by PD-L1 expression are summarised in Figures 7 and 9, respectively.
Slovenian: Eksploratorni rezultati OS in PFS glede na izražanje PD-L1 so povzeti na slikah 7 in 9.
English: Cohort 1 included 45 patients (38%) with ECOG performance status of 0, 50 patients (42%) with ECOG performance status of 1 and 24 patients (20%) with ECOG performance status of 2, 35 patients (29%) with no Bajorin risk factors (ECOG performance status ≥ 2 and visceral metastasis), 66 patients (56%) with one Bajorin risk factor and 18 patients (15 %) with two Bajorin risk factors, 84 patients (71%) with impaired renal function (glomerular filtration rate [GFR] < 60 mL/min), and 25 patients (21%) with liver metastasis.
Slovenian: V 1. kohorto je bilo vključenih 45 bolnikov (38 %) s stanjem zmogljivosti po ECOG 0, 50 bolnikov (42 %) s stanjem zmogljivosti po ECOG 1, 24 bolnikov (20 %) s stanjem zmogljivosti po ECOG 2, 35 bolnikov (29 %) brez Bajorinovih dejavnikov tveganja (stanje zmogljivosti po ECOG ≥ 2 in visceralne zasevke), 66 bolnikov (56 %) z enim Bajorinovim dejavnikom tveganja in 18 bolnikov (15 %) z dvema Bajorinovima dejavnikoma tveganja, 84 bolnikov (71 %) z okvarjenim delovanjem ledvic (hitrost glomerulne filtracije [GFR] < 60 ml/min) in 25 bolnikov (21 %) z zasevki v jetrih.
English: The effect of moderate or severe hepatic impairment (bilirubin > 1.5 × to 3 × ULN and any AST or bilirubin > 3 × ULN and any AST) on the pharmacokinetics of atezolizumab is unknown.
Slovenian: Vpliv zmerne ali hude okvare jeter (bilirubin > 1,5- do 3-kratna ZNM ne glede na AST ali bilirubin > 3-kratna ZNM ne glede na AST) na farmakokinetiko atezolizumaba ni znan.
English: Exploratory subgroup analyses were performed in patients with PD-L1 expression ≥ 1%, exploring prior (neo)adjuvant treatment, BRCA1/2 mutation and asymptomatic brain metastases at baseline.
Slovenian: Pri bolnikih z izražanjem PD-L1 ≥ 1 % so opravili eksploratorne analize podskupin; v njih so raziskovali predhodno (neo)adjuvantno zdravljenje, mutacije BRCA1/2 in nesimptomatske zasevke v možganih izhodiščno.
English: If you are not sure, talk to your doctor or nurse before you are given Tecentriq.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali medicinsko sestro, preden dobite zdravilo Tecentriq.
English: Atezolizumab in combination therapy
Slovenian: Atezolizumab v kombinirani terapiji
English: A total of 902 patients were enrolled and stratified by presence of liver metastases, prior taxane treatment, and by PD-L1 expression status in tumour-infiltrating immune cells (IC) (PD-L1 stained tumour-infiltrating immune cells [IC] <1% of tumour area vs. ≥ 1% of the tumour area) assessed by the VENTANA PD-L1 (SP142) Assay.
Slovenian: Skupaj sta bila vključena 902 bolnika; bolnike so stratificirali glede na prisotnost zasevkov v jetrih, predhodno zdravljenje s taksani in stanje izražanja PD-L1 v tumorskih infiltratih imunskih celic (IC) (za PD-L1 barvani tumorski infiltrati imunskih celic [IC] < 1 % površine tumorja v primerjavi z ≥ 1 % površine tumorja), ocenjeno s preizkusom VENTANA PD-L1 (SP142).
English: • The other ingredients are L-histidine, glacial acetic acid, sucrose, polysorbate 20 and water for injections.
Slovenian: • Druge sestavine zdravila so L-histidin, koncentrirana ocetna kislina, saharoza, polisorbat 20 in voda za injekcije.
English: In an exploratory analysis with longer follow up (median: 24.1 months), the median OS for both arms was unchanged relative to the primary analysis, with HR = 0.82 (95% CI: 0.67, 1.01).
Slovenian: V eksploratorni analizi z daljšim spremljanjem (mediana: 24,1 meseca) je bilo mediano OS v obeh skupinah glede na primarno analizo nespremenjeno; RO je bilo 0,82 (95-% IZ: 0,67; 1,01).
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).
Slovenian: V 2. kohorti mediano trajanje odgovora ni bilo doseženo v nobeni od podskupin izražanja PD-L1 in tudi ne med neselekcioniranimi bolniki, doseženo pa je bilo pri bolnikih z izražanjem PD-L1 < 1 % (13,3 meseca, 95-% IZ: 4,2; ni ocenljivo).
English: Atezolizumab spares the PD-L2/PD-1 interaction allowing PD-L2/PD-1 mediated inhibitory signals to persist.
Slovenian: Atezolizumab ne vpliva na interakcijo PD-L2/PD-1 in tako ohrani s PD-L2/PD-1 posredovane zaviralne signale.
English: The co-primary efficacy endpoints included investigator-assessed progression free survival (PFS) in the ITT population and in patients with PD-L1 expression ≥ 1% per RECIST v1.1 as well as overall survival (OS) in the ITT population and in patients with PD-L1 expression ≥ 1%.
Slovenian: Soprimarani opazovani dogodki učinkovitosti so obsegali preživetje brez napredovanja bolezni (PFS) po oceni raziskovalca v populaciji ITT in pri bolnikih z izražanjem PD-L1 ≥ 1 % po merilih RECIST v1.1 ter celokupno preživetje (OS) v populaciji ITT in pri bolnikih z izražanjem PD-L1 ≥ 1 %.
English: Patients were treated until loss of clinical benefit as assessed by the investigator.
Slovenian: Bolnike so zdravili do izgube klinične koristi po oceni raziskovalca.
English: It is a clear, colourless to slightly yellowish liquid.
Slovenian: Je bistra, brezbarvna do rahlo rumenkasta tekočina.
English: For symptomatic hypothyroidism, atezolizumab should be withheld and thyroid hormone replacement should be initiated as needed.
Slovenian: V primeru simptomatskega hipotiroidizma je treba uporabo atezolizumaba odložiti in uvesti nadomeščanje ščitničnih hormonov, kot je potrebno.
English: Post-authorisation efficacy study (PAES): In order to further evaluate the efficacy of atezolizumab for the treatment of patients with locally advanced or metastatic urothelial cancer, the MAH should submit the final OS results of study IMvigor210.
Slovenian: Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): Za nadaljnjo oceno učinkovitosti atezolizumaba pri zdravljenju bolnikov z lokalno napredovalim ali razsejanim rakom urotelija mora imetnik dovoljenja za promet z zdravilom predložiti končne rezultate glede celokupnega preživetja iz študije IMvigor210.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1,200 mg/20 mL
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 1200 mg/20 ml
English: The median age was 55 years (range: 20-86).
Slovenian: Mediana starost je bila 55 let (razpon: od 20 do 86 let).
English: Use of atezolizumab in combination with nab-paclitaxel in metastatic triple negative breast cancer
Slovenian: Uporaba atezolizumaba v kombinaciji z nab-paklitakselom pri razsejanem trojno negativnem raku dojk
English: • type 1 diabetes, including acid in the blood produced from diabetes (diabetic ketoacidosis): symptoms may include feeling more hungry or thirsty than usual, need to urinate more often, weight loss, and feeling tired
Slovenian: • sladkorna bolezen tipa 1, vključno z zakisanostjo krvi zaradi sladkorne bolezni (diabetična ketoacidoza): med simptomi so lahko večja lakota ali žeja kot po navadi, pogosto uriniranje, hujšanje in utrujenost;
English: Fifty-nine percent of patients in the nab-paclitaxel and carboplatin arm received any cancer immunotherapy after disease progression, which includes atezolizumab as crossover treatment (41% of all patients), compared to 7.3% of patients in the atezolizumab, nab paclitaxel and carboplatin arm.
Slovenian: Devetinpetdeset odstotkov (59 %) bolnikov v skupini z nab-paklitakselom in karboplatinom je po napredovanju bolezni prejemalo katero koli imunoterapijo za zdravljenje raka (to vključuje navzkrižni prehod na zdravljenje z atezolizumabom (41 % vseh bolnikov)); v primerjavi s skupino z atezolizumabom, nab-paklitakselom in karboplatinom, kjer je bilo takšnih bolnikov 7,3 %.
English: Secondary efficacy endpoints included objective response rate (ORR) and duration of response (DOR) per RECIST v1.1.
Slovenian: Sekundarni opazovani dogodki učinkovitosti so vključevali delež objektivnega odgovora (ORR) in trajanje odgovora (DOR) po merilih RECIST v1.1.
English: Immune-related adverse reactions with atezolizumab may occur after the last dose of atezolizumab.
Slovenian: Imunsko pogojeni neželeni učinki, povezani z atezolizumabom, se lahko pojavijo po zadnjem odmerku atezolizumaba.
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.
Slovenian: Izpostavljenost atezolizumabu se je v razponu odmerkov od 1 mg/kg do 20 mg/kg povečevala sorazmerno z odmerkom, vključno s fiksnim odmerkom 1200 mg, apliciranim na 3 tedne.
English: The data below reflect information for significant adverse reactions for atezolizumab as monotherapy in clinical studies (see section 5.1).
Slovenian: Spodnji podatki prikazujejo informacije o pomembnih neželenih učinkih monoterapije z atezolizumabom v kliničnih študijah (glejte poglavje 5.1).
English: No studies have been conducted to investigate the pharmacokinetics of atezolizumab in children or adolescents.
Slovenian: Študij za proučitev farmakokinetike atezolizumaba pri otrocih in mladostnikih niso izvedli.
English: Myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome and Meningoencephalitis
Slovenian: Miastenijski sindrom/miastenija gravis, Guillain-Barréjev sindrom in meningoencefalitis
English: For each 21-day cycle, Tecentriq, nab-paclitaxel, and carboplatin are administered on day 1.
Slovenian: V vsakem 21-dnevnem ciklu se zdravilo Tecentriq, nab-paklitaksel in karboplatin aplicirajo 1. dan.
English: 472 patients described atezolizumab pharmacokinetics for the dose range: 1 to 20 mg/kg with a linear two-compartment disposition model with first-order elimination.
Slovenian: Populacijska analiza, ki je vključila 472 bolnikov, je popisala farmakokinetiko atezolizumaba v razponu odmerkov od 1 do 20 mg/kg z linearnim modelom dvoprostornega odstranjevanja z izločanjem prvega reda.
English: Patients with event (%) Median (months) (95% CI)
Slovenian: Bolniki z dogodkom (%) Mediana (meseci) (95-% IZ)
English: The majority of patients were white (70%).
Slovenian: Večina bolnikov je bila belcev (70 %).
English: 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).
Slovenian: Pri bolnikih z nesimptomatskimi zasevki v možganih izhodiščno ni bilo dokazov o učinkovitosti, vendar je bilo število zdravljenih bolnikov majhno; mediano PFS je bilo 2,2 meseca v skupini, ki je prejemala atezolizumab in nab-paklitaksel (n = 15), v primerjavi s 5,6 meseca v skupini, ki je prejemala placebo in nab-paklitaksel (n = 11) (RO 1,40; 95-% IZ: 0,57, 3,44).
English: There were 310 patients treated with atezolizumab 1,200 mg by intravenous infusion every 3 weeks until loss of clinical benefit.
Slovenian: 310 bolnikov so zdravili z atezolizumabom v odmerku 1200 mg v intravenski infuziji na 3 tedne do izgube klinične koristi.
English: The majority of patients were white (82%).
Slovenian: Večina bolnikov je bila belcev (82 %).
English: Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway in murine pregnancy models can lead to immune-related rejection of the developing foetus resulting in foetal death (see section 5.3).
Slovenian: Študije na živalih so pokazale, da zavrtje poti PD-L1/PD-1 v modelih brejosti pri miših lahko povzroči imunsko zavrnitev razvijajočega se ploda s posledično smrtjo ploda (glejte poglavje 5.3).
English: e Includes reports of white blood cell count decreased and leukopenia.
Slovenian: Vključuje poročila o zmanjšanju števila belih krvnih celic in levkopeniji.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not shake the vial
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
English: For ES-SCLC and for first-line NSCLC, in patients given Tecentriq in combination with carboplatin and nab-paclitaxel, it is recommended that patients are treated with Tecentriq until disease progression or unmanageable toxicity.
Slovenian: Pri razsejanem DRP in v prvi liniji NDRP pri bolnikih, ki prejemajo zdravilo Tecentriq v kombinaciji s karboplatinom in nab-paklitakselom, je priporočljivo bolnike zdraviti z zdravilom Tecentriq do napredovanja bolezni ali do pojava neobvladljivih toksičnih učinkov.
English: Grade 3 or 4 serum amylase or lipase levels increased (> 2 x ULN) or Grade 2 or 3 pancreatitis
Slovenian: Zvišanje amilaze ali lipaze v serumu 3. ali 4. stopnje (> 2,0-kratna ZNM) ali pankreatitis 2. ali 3. stopnje
English: 12-month PFS (%)
Slovenian: 12-mesečno PFS (%)
English: shortness of breath, and chest pain
Slovenian: težko dihanje in bolečine v prsih;