FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose delay or discontinuation (see also sections 4.4 and 4.8) Table 1: Dose modification advice for Tecentriq
Croatian: Odgoda primjene doze ili prekid liječenja (vidjeti i dijelove 4.4 i 4.8)
English: Colitis led to discontinuation of atezolizumab in 8 (0.3%) patients.
Croatian: Kolitis je doveo do prekida liječenja atezolizumabom u 8 (0,3%) bolesnika.
English: Figure 13: Kaplan-Meier curve for progression-free survival (IMpower133)
Croatian: Slika 13: Kaplan-Meierova krivulja preživljenja bez progresije bolesti (IMpower133)
English: IMpower130 (GO29537): Randomised phase III trial in chemotherapy-naïve patients with metastatic non-squamous NSCLC, in combination with nab-paclitaxel and carboplatin
Croatian: IMpower130 (GO29537): Randomizirano ispitivanje faze III provedeno u bolesnika s metastatskim neplanocelularnim NSCLC-om koji prethodno nisu primali kemoterapiju, u kombinaciji s nab-paklitakselom i karboplatinom
English: Roche s. r. O. Tel: +420 - 2 20382111
Croatian: Slovenská republika Roche Slovensko, s.r.o. Tel: +421 - 2 52638201
English: The demographic and baseline disease characteristics of the study population were well balanced between the treatment arms.
Croatian: Demografske i početne značajke bolesti u ispitivanoj populaciji bile su dobro ujednačene između liječenih skupina.
English: The Kaplan-Meier curve for OS in the all comer population is presented in Figure 1.
Croatian: 3. Kaplan-Meierova krivulja za OS u populaciji svih uključenih bolesnika prikazana je na Slici 1.
English: Tecentriq in combination with nab-paclitaxel and carboplatin
Croatian: Tecentriq u kombinaciji s nab-paklitakselom i karboplatinom
English: Figure 6: Kaplan-Meier curves for overall survival (IMpower130)
Croatian: Slika 6: Kaplan-Meierove krivulje ukupnog preživljenja (IMpower130)
English: NSCLC patients (hazard ratio [HR] of 0.73, 95% CI: 0.60, 0.89; median OS of 15.6 vs. 11.2 months for atezolizumab and docetaxel, respectively) and squamous NSCLC patients (HR of 0.73, 95% CI: 0.54, 0.98; median OS of 8.9 vs. 7.7 months for atezolizumab and docetaxel, respectively).
Croatian: 15,6 mjeseci uz atezolizumab naspram 11,2 mjeseca uz docetaksel) i u onih s planocelularnim NSCLC-om (HR: 0,73; 95% CI: 0,54 - 0,98; medijan OS-a: 8,9 mjeseci uz atezolizumab naspram 7,7 mjeseci uz docetaksel).
English: Tumour specimens were evaluated for PD-L1 expression on tumour cells (TC) and tumour-infiltrating immune cells (IC) and the results were used to define the PD-L1 expression subgroups for the analyses described below.
Croatian: Uzorci tumora ocjenjivali su se kako bi se utvrdila ekspresija PD-L1 na tumorskim stanicama (TC) i imunosnim stanicama koje infiltriraju tumor (IC), a dobiveni su se rezultati koristili za definiranje podskupina bolesnika prema ekspresiji PD-L1 za analize opisane u nastavku.
English: Tecentriq in combination with carboplatin and etoposide
Croatian: Tecentriq u kombinaciji s karboplatinom i etopozidom
English: Treatment with atezolizumab must be permanently discontinued for any grade of meningitis or encephalitis.
Croatian: U slučaju meningitisa ili encefalitisa bilo kojeg stupnja liječenje atezolizumabom mora se trajno prekinuti.
English: Investigator-assessed PFS (RECIST v1.1) - Primary analysis
Croatian: PFS prema ocjeni ispitivača (RECIST v1.1 ) - Primarna analiza Broj događaja (%)
English: Hepatitis occurred in 2.0% (62/3,178) of patients who received atezolizumab monotherapy.
Croatian: Hepatitis se javio u 2,0% (62/3178) bolesnika koji su primali atezolizumab u monoterapiji.
English: a Atezolizumab is administered until loss of clinical benefit as assessed by the investigator b
Croatian: Najbolja potporna skrb ili pemetreksed a Atezolizumab se primjenjuje do gubitka kliničke koristi prema ocjeni ispitivača b
English: Common hypothyroidismg
Croatian: Često hipotireoza g
English: musculoskeletal painx arthralgia, musculoskeletal painx, back pain
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Vrlo često artralgija, bol u leđima, mišićno koštana bolx artralgija, mišićno-koštana bolx, bol u leđima
English: Table 2: Summary of adverse reactions occurring in patients treated with atezolizumab Atezolizumab monotherapy
Croatian: Tablica 2: Sažetak nuspojava koje su se javile u bolesnika liječenih atezolizumabom Atezolizumab u monoterapiji
English: shortness of breath, and chest pain
Croatian: Poremećaji jetre i žuči
English: Figure 12: Kaplan-Meier curve for overall survival (IMpower133)
Croatian: Slika 12: Kaplan-Meierova krivulja ukupnog preživljenja (IMpower133)
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.
Croatian: Poznato je da humani imunoglobulini G1 (IgG1) prolaze kroz placentalnu barijeru.
English: The median duration was 2.1 months (range 0 day to 22.0+ months; + denotes a censored value).
Croatian: Medijan trajanja iznosio je 2,1 mjesec (raspon od 0 dana do 22,0+ mjeseci; ‘+' označava cenzuriranu vrijednost).
English: Colitis occurred in 1.1% (34/3,178) of patients who received atezolizumab monotherapy.
Croatian: Kolitis se javio u 1,1% (34/3178) bolesnika koji su primali atezolizumab u monoterapiji.
English: NAME OF THE MEDICINAL PRODUCT Tecentriq 1,200 mg concentrate for solution for infusion.
Croatian: NAZIV LIJEKA Tecentriq 1200 mg koncentrat za otopinu za infuziju
English: A phase III, open-label, multicenter, international, randomised study, IMpower150, was conducted to evaluate the efficacy and safety of atezolizumab in combination with paclitaxel and carboplatin, with or without bevacizumab, in chemotherapy-naïve patients with metastatic non-squamous NSCLC.
Croatian: Ispitivanje IMpower150 bilo je otvoreno, multicentrično, međunarodno, randomizirano ispitivanje faze III provedeno radi ocjene djelotvornosti i sigurnosti atezolizumaba u kombinaciji s paklitakselom i karboplatinom, uz bevacizumab ili bez njega, u bolesnika s metastatskim neplanocelularnim NSCLC-om koji prethodno nisu primali kemoterapiju.
English: A total of 403 patients were enrolled and randomised (1:1) to receive one of the treatment regimens described in Table 11.
Croatian: U ispitivanje su uključena ukupno 403 bolesnika, koja su randomizirana (1:1) za primanje jednoga od terapijskih protokola opisanih u Tablici 11. Randomizacija je bila stratificirana prema spolu, funkcionalnom ECOG statusu i prisutnosti moždanih metastaza.
English: Tel: + 372 - 6 177 380
Croatian: Roche Eesti OÜ Tel: + 372 - 6 177 380
English: Treatment with atezolizumab may be resumed when serum amylase and lipase levels improve to ≤ Grade 1 within 12 weeks, or symptoms of pancreatitis have resolved, and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day.
Croatian: Liječenje atezolizumabom može se nastaviti kada se serumske vrijednosti amilaze i lipaze poboljšaju do ≤ 1. stupnja unutar 12 tjedana, ili kada se povuku simptomi pankreatitisa, a doza kortikosteroida smanji na ≤ 10 mg prednizona ili ekvivalenta na dan.
English: 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 and patient is stable on replacement therapy
Croatian: Liječenje se može nastaviti kada se simptomi poboljšaju do 0. ili 1. stupnja unutar 12 tjedana, doza kortikosteroida smanji na ≤ 10 mg prednizona ili ekvivalenta na dan, a bolesnikovo stanje stabilizira nadomjesnom terapijom
English: GERMANY
Croatian: Portugal
English: AST increased, ALT increased, hepatitisv
Croatian: Često povišene vrijednosti AST-a, povišene vrijednosti ALT-a, hepatitisv povišene vrijednosti AST-a, povišene vrijednosti ALT-a
English: The median duration was 1.4 months (range 0 day to 21.2+ months; + denotes a censored value).
Croatian: Medijan trajanja iznosio je 1,4 mjeseca (raspon od 0 dana do 21,2+ mjeseca; ‘+' označava cenzuriranu vrijednost).
English: Stratified hazard ratio‡ (95% CI) p-value
Croatian: Stratificiran omjer hazarda‡ (95% CI) p-vrijednost
English: Hyperthyroidism occurred in 0.9% (30/3,178) of patients who received atezolizumab monotherapy.
Croatian: Hipertireoza se javila u 0,9% (30/3178) bolesnika koji su primali atezolizumab u monoterapiji.
English: • After dilution, one mL of solution contains approximately 3.2 mg of atezolizumab for 840 mg dose and 6.0 mg of atezolizumab for 1680 mg dose.
Croatian: Nakon razrjeđivanja, 1 ml otopine sadrži približno 3,2 mg atezolizumaba za dozu od 840 mg, odnosno približno 6,0 mg atezolizumaba za dozu od 1680 mg.
English: Roche Slovensko, s.r.o.
Croatian: Česká republika Roche s. r. O.
English: Stratified hazard ratio‡^ (95% CI) p-value Based on the stratified log-rank test For informational purposes; in the ITT population, comparisons between Arm A and Arm B were not included in the pre-specified analysis hierarchy ‡ Stratified by sex, presence of liver metastases and PD-L1 expression on TC and IC
Croatian: 2 Samo za informaciju; usporedbe između skupine A i skupine B u ITT populaciji nisu bile obuhvaćene unaprijed specificiranom hijerarhijskom analizom
English: Arm B (Atezolizumab + Bevacizumab + Paclitaxel + Carboplatin)
Croatian: Skupina B (atezolizumab + bevacizumab + paklitaksel
English: 2,759 patients across multiple tumour types.
Croatian: Sigurnost atezolizumaba primijenjenog u kombinaciji s drugim lijekovima ocjenjivala se u 2759 bolesnika s različitim vrstama tumora.
English: Investigator-assessed PFS (RECIST v1.1)
Croatian: PFS prema ocjeni ispitivača (RECIST v1.1)
English: Each 14 mL vial contains 840 mg of atezolizumab.
Croatian: Jedna bočica sa 14 ml sadrži 840 mg atezolizumaba.
English: Hypothyroidism occurred in 5.2% (164/3,178) of patients who received atezolizumab monotherapy.
Croatian: Hipotireoza se javila u 5,2% (164/3178) bolesnika koji su primali atezolizumab u monoterapiji.
English: 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
Croatian: Liječenje se može nastaviti kada se serumske vrijednosti amilaze i lipaze poboljšaju do 0. ili 1. stupnja unutar 12 tjedana, ili kada se povuku simptomi pankreatitisa, a doza kortikosteroida smanji na ≤ 10 mg prednizona ili ekvivalenta na dan
English: NAME OF THE MEDICINAL PRODUCT Tecentriq 840 mg concentrate for solution for infusion.
Croatian: NAZIV LIJEKA Tecentriq 840 mg koncentrat za otopinu za infuziju
English: No. of responders (%) 95% CI No. of complete response (%) No. of partial response (%)
Croatian: Broj bolesnika s odgovorom (%) 95% CI Broj bolesnika s potpunim odgovorom (%) Broj bolesnika s djelomičnim odgovorom (%) Broj bolesnika sa stabilnom bolešću Trajanje odgovora prema ocjeni ispitivača n=109
English: General disorders and administration site conditions Very Common pyrexia, fatigue, asthenia pyrexia, fatigue, asthenia
Croatian: Opći poremećaji i reakcije na mjestu primjene Vrlo često pireksija, umor, astenija pireksija, umor, astenija
English: Includes reports of oropharyngeal pain, oropharyngeal discomfort, throat irritation.
Croatian: Uključuje prijavljene slučajeve boli u usnoj šupljini i ždrijelu, nelagode u usnoj šupljini i ždrijelu, nadraženosti grla.
English: Respiratory, thoracic, and mediastinal disorders Very common cough, dyspnoea dyspnoea, cough
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Vrlo često kašalj, dispneja dispneja, kašalj
English: Patients should be monitored for signs and symptoms of myositis.
Croatian: Bolesnike treba nadzirati zbog moguće pojave znakova i simptoma miozitisa.
English: Pneumonitis requiring the use of corticosteroids occurred in 1.6% (51/3,178) of patients receiving atezolizumab monotherapy.
Croatian: Pneumonitis koji je zahtijevao primjenu kortikosteroida zabilježen je u 1,6% (51/3178) bolesnika koji su primali atezolizumab u monoterapiji.
English: Treatment with atezolizumab should be withheld for Grade 2 pneumonitis, and 1 to 2 mg/kg/day prednisone or equivalent should be started.
Croatian: U slučaju pneumonitisa 2. stupnja treba odgoditi primjenu atezolizumaba i uvesti 1 - 2 mg/kg/dan prednizona ili ekvivalenta.
English: Upon improvement to Grade ≤ 1, corticosteroid should be tapered over ≥ 1 month.
Croatian: Nakon poboljšanja do ≤ 1. stupnja, primjenu kortikosteroida treba prekinuti postupnim smanjivanjem doze tijekom razdoblja od ≥ 1 mjeseca.
English: For Grade 3 diarrhoea or colitis, treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started.
Croatian: U slučaju proljeva ili kolitisa 3. stupnja treba započeti liječenje intravenskim kortikosteroidima (1 - 2 mg/kg/dan metilprednizolona ili ekvivalenta).
English: Hypophysitis Hypophysitis occurred in < 0.1% (2/3,178) of patients who received atezolizumab monotherapy.
Croatian: Hipofizitis se javio u < 0,1% (2/3178) bolesnika koji su primali atezolizumab u monoterapiji.
English: If the event improves to ≤ Grade 1, corticosteroids should be tapered over ≥ 1 month.
Croatian: Ako se događaj poboljša do ≤ 1. stupnja, primjenu kortikosteroida treba prekinuti postupnim smanjivanjem doze tijekom razdoblja od ≥ 1 mjeseca.
English: 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.
Croatian: U ovo ispitivanje nisu bili uključeni bolesnici koji su imali autoimunu bolest u anamnezi, koji su imali aktivne ili o kortikosteroidima ovisne moždane metastaze, koji su primili živo atenuirano cjepivo unutar 28 dana prije uključivanja u ispitivanje te oni koji su primili sistemske imunostimulatore unutar 4 tjedna ili sistemske imunosupresive unutar 2 tjedna prije uključivanja u ispitivanje.
English: Pancreatitis requiring the use of corticosteroids occurred in 0.1% (4/3,178) of patients receiving atezolizumab monotherapy.
Croatian: Pankreatitis koji je zahtijevao primjenu kortikosteroida zabilježen je u 0,1% (4/3178) bolesnika koji su primali atezolizumab u monoterapiji.
English: Both patients required corticosteroids and discontinued atezolizumab.
Croatian: Kod oba je bolesnika bila potrebna primjena kortikosteroida i oba su prekinula liječenje atezolizumabom.
English: If symptoms improve to ≤ Grade 1, corticosteroids should be tapered over ≥ 1 month.
Croatian: Ako se simptomi poboljšaju do ≤ 1. stupnja, primjenu kortikosteroida treba prekinuti postupnim smanjivanjem doze tijekom razdoblja od ≥ 1 mjeseca.
English: Docetaxel was administered 75 mg/m by intravenous infusion on day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Croatian: Docetaksel se primjenjivao u dozi od 75 mg/m2 intravenskom infuzijom 1. dana svakog 3-tjednog ciklusa do progresije bolesti ili pojave neprihvatljive toksičnosti.
English: For the description of Tecentriq trials, refer to the Tecentriq 1,200 mg concentrate for solution for infusion Summary of Product Characteristics (SmPC) section 5.1.
Croatian: Za opis ispitivanja lijeka Tecentriq vidjeti dio 5.1 sažetka opisa svojstava lijeka za Tecentriq 1200 mg koncentrat za otopinu za infuziju.
English: How much Tecentriq is given
Croatian: Koliko lijeka Tecentriq ćete primiti
English: Diabetes mellitus occurred in 0.3% (11/3,178) of patients who received atezolizumab monotherapy.
Croatian: Šećerna bolest javila se u 0,3% (11/3178) bolesnika koji su primali atezolizumab u monoterapiji.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 20 mL vial of concentrate contains 1,200 mg atezolizumab After dilution, 1 mL of solution contains approximately 4.4 mg of atezolizumab
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica s 20 ml koncentrata sadrži 1200 mg atezolizumaba.
English: Immune-related myositis
Croatian: Imunološki uzrokovan miozitis
English: Myocarditis has been observed in clinical trials with atezolizumab (see section 4.8).
Croatian: U kliničkim ispitivanjima atezolizumaba primijećen je miokarditis (vidjeti dio 4.8).
English: Tumour specimens were evaluated prospectively for PD-L1 expression on tumour cells (TC) and tumour-infiltrating immune cells (IC).
Croatian: Uzorci tumora prospektivno su se ocjenjivali kako bi se utvrdila ekspresija PD-L1 na tumorskim stanicama i imunosnim stanicama koje infiltriraju tumor.
English: No. of partial response (%) 95% CI
Croatian: Broj bolesnika s djelomičnim odgovorom (%) 95% CI
English: PD-L1 expression of ≥ 5% in IC
Croatian: PD-L1 ≥ 5% (vidjeti dio 5.1).
English: Use of atezolizumab in combination with bevacizumab, paclitaxel and carboplatin
Croatian: Primjena atezolizumaba u kombinaciji s bevacizumabom, paklitakselom i karboplatinom
English: Hepatitis requiring the use of corticosteroids occurred in 0.6% (18/3,178) of patients receiving atezolizumab monotherapy.
Croatian: Hepatitis koji je zahtijevao primjenu kortikosteroida zabilježen je u 0,6% (18/3178) bolesnika koji su primali atezolizumab u monoterapiji.
English: EU/1/17/1220/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1220/001
English: Investigator-assessed DOR (RECIST 1.1)** ^
Croatian: ORR prema ocjeni ispitivača (RECIST v1.1)** ^
English: 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.
Croatian: U ispitivanje nisu bili uključeni bolesnici koji su imali autoimunu bolest u anamnezi, koji su primili živo atenuirano cjepivo unutar 28 dana prije randomizacije, koji su primili imunostimulatore unutar 4 tjedna ili sistemske imunosupresive unutar 2 tjedna prije randomizacije, kao ni oni koji su imali aktivne ili neliječene metastaze u središnjem živčanom sustavu (SŽS).
English: 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
Croatian: Liječenje se može nastaviti kada se simptomi poboljšaju do 0. ili 1. stupnja unutar 12 tjedana, a doza kortikosteroida smanji na ≤ 10 mg prednizona ili ekvivalenta na dan
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE Prije uporabe pročitajte uputu o lijeku Za intravensku primjenu nakon razrjeđivanja
English: No. of complete response (%) 95% CI
Croatian: Broj bolesnika s potpunim odgovorom (%) 95% CI
English: Cases of pneumonitis, including fatal cases, have been observed in clinical trials with atezolizumab (see section 4.8).
Croatian: U kliničkim ispitivanjima atezolizumaba primijećeni su slučajevi pneumonitisa, uključujući slučajeve sa smrtnim ishodom (vidjeti dio 4.8).
English: Investigator-assessed ORR (RECIST v1.1)
Croatian: ORR prema ocjeni ispitivača (RECIST v1.1)
English: The rate of infusion should be reduced or treatment should be interrupted in patients with Grade 1 or 2 infusion-related reactions.
Croatian: U bolesnika s reakcijama na infuziju 1. ili 2. stupnja potrebno je smanjiti brzinu infuzije ili privremeno prekinuti primjenu.
English: Adrenal insufficiency requiring the use of corticosteroids occurred in 0.3% (9/3,178) of patients receiving atezolizumab monotherapy.
Croatian: Insuficijencija nadbubrežne žlijezde koja je zahtijevala primjenu kortikosteroida zabilježena je u 0,3% (9/3178) bolesnika koji su primali atezolizumab u monoterapiji.
English: ORR (IRF-assessed; RECIST v1.1)
Croatian: ORR (prema ocjeni neovisnog ocjenjivačkog povjerenstva; RECIST v1.1)
English: 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.
Croatian: U slučaju miozitisa 2. ili 3. stupnja treba odgoditi primjenu atezolizumaba i započeti liječenje kortikosteroidima (1 do 2 mg/kg prednizona ili ekvivalenta na dan).
English: aStratified HR for ITT and TC or IC ≥ 1%.
Croatian: a Stratificirani HR za ITT i bolesnike s ekspresijom PD-L1 na tumorskim stanicama (TC) ili imunosnim stanicama koje infiltriraju tumor (IC) ≥ 1%.
English: Reporting of side effects
Croatian: Sekundarne mjere ishoda
English: Meningoencephalitis occurred in 0.4% (13/3,178) of patients who received atezolizumab monotherapy.
Croatian: Meningoencefalitis se javio u 0,4% (13/3178) bolesnika koji su primali atezolizumab u monoterapiji.
English: Includes reports of thrombocytopenia and platelet count decreased.
Croatian: Uključuje prijavljene slučajeve trombocitopenije i smanjenog broja trombocita.
English: • 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,
Croatian: Relevantne informacije (npr. ozbiljnost, težina, učestalost, vrijeme do nastupa, reverzibilnost, ako je primjenjivo) o sljedećim sigurnosnim problemima povezanima s primjenom lijeka Tecentriq:
English: Appropriate management of patients with abnormal thyroid function tests at baseline should be considered.
Croatian: Treba razmotriti odgovarajuće liječenje bolesnika koji na početku liječenja imaju odstupanja u nalazima testova funkcije štitnjače.
English: Myositis occurred in 0.4% (12/3178) of patients who received atezolizumab monotherapy.
Croatian: Miozitis se javio u 0,4% (12/3178) bolesnika koji su primali atezolizumab u monoterapiji.
English: EU/1/17/1220/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1220/002
English: 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.
Croatian: U slučaju nefritisa 2. stupnja treba odgoditi primjenu atezolizumaba i započeti liječenje sistemskim kortikosteroidima u dozi od 1 do 2 mg/kg prednizona ili ekvivalenta na dan.
English: Myasthenia gravis occurred in < 0.1% (1/3,178) of patients who received atezolizumab monotherapy.
Croatian: Miastenija gravis javila se u < 0,1% (1/3178) bolesnika koji su primali atezolizumab u monoterapiji.
English: PFS (IRF-assessed; RECIST v1.1)
Croatian: PFS (prema ocjeni neovisnog ocjenjivačkog povjerenstva; RECIST v1.1)
English: 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.
Croatian: U slučaju miokarditisa 2. stupnja treba odgoditi primjenu atezolizumaba i započeti liječenje sistemskim kortikosteroidima u dozi od 1 do 2 mg/kg prednizona ili ekvivalenta na dan.
English: compared to 57.5%), Grade 5 events (6.1% compared to 2.5%), adverse events of special interest to atezolizumab (52.4% compared to 48.0%), as well as adverse events leading to withdrawal of any study treatment (33.8% compared to 13.3%).
Croatian: U ispitivanju prve linije liječenja NSCLC-a (IMpower150), u skupini koja je primala četverostruki protokol koji je uključivao atezolizumab, bevacizumab, paklitaksel i karboplatin opažena je ukupno veća učestalost štetnih događaja nego u skupini koja je primala atezolizumab, paklitaksel i karboplatin, uključujući događaje 3. i 4. stupnja (63,6% u odnosu na 57,5%), događaje 5. stupnja (6,1% u odnosu na 2,5%), štetne događaje od posebnog značaja za atezolizumab (52,4% u odnosu na 48,0%) kao i štetne događaje koje su dovele do prekida primjene bilo kojeg od lijekova u ispitivanju (33,8% u odnosu na 13,3%).