natgillin/translations-raw huggingface dataset:
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo za intravensko uporabo po razredčenju
During the induction phase, the recommended dose of Tecentriq is 1,200 mg administered by intravenous infusion followed by carboplatin, and then etoposide administered by intravenous infusion on day 1.
Med uvodno fazo je 1. dan cikla priporočeni odmerek zdravila Tecentriq 1200 mg v intravenski infuziji, čemur sledita najprej karboplatin in nato etopozid v intravenski infuziji.
Pneumonitis occurred in 2.7% (87/3,178) of patients who received atezolizumab monotherapy.
Pnevmonitis se je pojavil pri 2,7 % (87/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Figure 2: Kaplan-Meier curve for overall survival in the primary analysis population (all comers) (OAK)
Slika 2: Kaplan-Meierjeva krivulja celokupnega preživetja v populaciji za primarno analizo (neselekcionirani bolniki) (OAK)
Includes reports of urinary tract infection, cystitis, pyelonephritis, escherichia urinary tract infection, urinary tract infection bacterial, kidney infection, pyelonephritis acute, urinary tract infection fungal, urinary tract infection pseudomonal.
Vključuje poročila o okužbi sečil, cistitisu, pielonefritisu, okužbi sečil z bakterijo Escherichia, bakterijski okužbi sečil, okužbi ledvic, akutnem pielonefritisu, glivični okužbi sečil, okužbi sečil z bakterijo Pseudomonas.
IMpower133 (GO30081): Randomised phase I/III trial in patients with chemotherapy-naïve extensivestage SCLC, in combination with carboplatin and etoposide
IMpower133 (GO30081): randomizirano preskušanje faze I/III v kombinaciji s karboplatinom in etopozidom pri bolnikih z razsejanim DRP, predhodno še nezdravljenih s kemoterapijo
Arm B (Atezolizumab + Bevacizumab + Paclitaxel + Carboplatin)
Skupina B (atezolizumab + bevacizumab + paklitaksel + karboplatin)
Adrenal insufficiency led to discontinuation of atezolizumab in 1 (<0.1%) patient.
Zaradi insuficience nadledvičnih žlez je zdravljenje z atezolizumabom prenehal 1 (< 0,1 %) bolnik.
(hypoxia)
(trombocitopenija)
Nervous system disorders Very Common peripheral neuropathyl , dizziness, headache
Bolezni živčevja zelo pogosti periferna nevropatijal, omotica, glavobol pogosti sinkopa občasni
The confirmed ORR per investigator-assessed mRECIST was 29.0% (95% CI: 20.4, 38.9) in patients with PD-L1 expression ≥ 5%, 23.7% (95% CI: 18.1, 30.1) in patients with PD-L1 expression ≥ 1%, and 19.7% (95% CI: 15.4, 24.6) in all comers.
Potrjeni deleži celokupnega odgovora po oceni raziskovalca glede na merila mRECIST so bili 29,0 % (95-% IZ: 20,4; 38,9) pri bolnikih z izražanjem PD-L1 ≥ 5 %, 23,7 % (95-% IZ: 18,1; 30,1) pri bolnikih z izražanjem PD-L1 ≥ 1 % in 19,7 % (95-% IZ: 15,4; 24,6) pri vseh neselekcioniranih bolnikih.
Treatment with atezolizumab should be withheld for ≥ Grade 3 serum amylase or lipase levels increased (> 2 x ULN), or Grade 2 or 3 pancreatitis, and treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started.
V primeru zvišanja serumske amilaze ali lipaze ≥ 3. stopnje (> 2-kratna ZNM) ali pankreatitisa 2. ali 3. stopnje je treba zdravljenje z atezolizumabom odložiti in uvesti zdravljenje z intravenskimi kortikosteroidi (1 do 2 mg/kg/dan metilprednizolona ali ekvivalenta).
Rare nephritisaa
Okvara ledvic
For the recommended dose of 840 mg: fourteen mL of Tecentriq concentrate should be withdrawn from the vial and diluted into a 250 mL polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP) infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection.
Za priporočeni 840-mg odmerek: 14 ml koncentrata zdravila Tecentriq je treba vzeti iz viale in ga razredčiti v 250-ml infuzijski vrečki iz polivinilklorida (PVC), poliolefina (PO), polietilena (PE) ali polipropilena (PP), ki vsebuje 0,9 % (9 mg/ml) raztopino natrijevega klorida za injiciranje.
Gastrointestinal disorders Very common nausea, vomiting, diarrhoear nausea, diarrhoear, constipation, vomiting
Bolezni prebavil zelo pogosti navzea, bruhanje, diarejar navzea, diarejar, zaprtost, bruhanje pogosti bolečine v trebuhu, kolitiss,
Patients with NSCLC that had clear tumour infiltration into the thoracic great vessels or clear cavitation of pulmonary lesions, as seen on imaging, were excluded from the pivotal clinical study
Bolniki z NDRP ter jasnim vraščanjem v velike žile prsnega koša ali jasno kavitacijo pljučnih lezij, prikazano s slikanjem, so bili izključeni iz ključne klinične študije IMpower150, potem ko je bilo zabeleženih več primerov pljučne krvavitve s smrtnim izidom, ki je znan dejavnik tveganja zdravljenja z bevacizumabom.
Paclitaxel was administered 175 mg/m2 by intravenous infusion over 3 hours on day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Paklitaksel so dajali v odmerku 175 mg/m z intravensko infuzijo v 3 urah na 1. dan vsakega 3tedenskega cikla do napredovanja bolezni ali nesprejemljive toksičnosti.
OAK (GO28915): Randomised phase III trial in locally advanced or metastatic NSCLC patients previously treated with chemotherapy
OAK (GO28915): Randomizirano klinično preskušanje faze III pri bolnikih z lokalno napredovalim ali razsejanim NDRP, ki so bili predhodno zdravljeni s kemoterapijo
For symptomatic adrenal insufficiency, atezolizumab should be withheld and treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started.
V primeru simptomatske insuficience nadledvičnih žlez je treba uporabo atezolizumaba odložiti in uvesti zdravljenje z intravenskimi kortikosteroidi (metilprednizolonom v odmerku 1 do 2 mg/kg/dan ali ekvivalentom).
The median duration was 24 days (range 3 days to 12.0+ months; + denotes a censored value).
Mediano trajanje je bilo 24 dni (razpon: od 3 dni do 12,0+ meseca; + označuje krnjeno vrednost).
Patients should be monitored for clinical signs and symptoms of endocrinopathies.
Bolnike je treba spremljati glede znakov in simptomov endokrinopatij.
ORR (IRF-assessed; RECIST v1.1)
ORR (po oceni IRF; RECIST v1.1)
No dedicated studies of atezolizumab have been conducted in patients with renal impairment.
Namenskih študij z atezolizumabom pri bolnikih z okvaro ledvic niso izvedli.
• infection of the lung
• okužba sečil
Tumour specimens were evaluated prospectively for PD-L1 expression on tumour-infiltrating immune cells (IC) and the results were used to define the PD-L1 expression subgroups for the analyses described below.
Tumorske vzorce so ovrednotili prospektivno na izražanje PD-L1 imunskih celic, ki infiltrirajo tumor, in rezultate uporabili za določitev podskupin izražanja PD-L1 za spodaj opisano analizo.
The median time to onset was 5.2 months (range: 5.1 to 5.3 months).
Mediani čas do pojava je bil 5,2 meseca (razpon: od 5,1 do
Figure 6: Kaplan-Meier curves for overall survival (IMpower130)
Slika 6: Kaplan-Meierjeva krivulja celokupnega preživetja (IMpower130)
Pancreatitis, including increases in serum amylase and lipase levels, has been observed in clinical trials with atezolizumab (see section 4.8).
V kliničnih preskušanjih z atezolizumabom so opazili pankreatitis, vključno z zvišanjem amilaze in lipaze v serumu (glejte poglavje 4.8).
Atezolizumab (n = 425)
Opazovani dogodek učinkovitosti atezolizumab (n = 425)
Initiation of systemic corticosteroids (at a dose of 1 to 2 mg/kg/day of prednisone or equivalent) should be considered.
V poštev pride uvedba sistemskih kortikosteroidov v odmerku 1 do 2 mg/kg/dan prednizona (ali ekvivalenta).
Arm C (Bevacizumab + Paclitaxel + Carboplatin)
Skupina C (bevacizumab + paklitaksel + karboplatin)
No reproductive or teratogenicity studies in animals have been conducted with atezolizumab.
Študij o sposobnosti razmnoževanja in o teratogenosti pri živalih z atezolizumabom niso izvedli.
Nephritis occurred in < 0.1% (3/3,178) of patients who received atezolizumab.
Nefritis se je pojavil pri < 0,1 % (3/3178) bolnikov, ki so prejemali atezolizumab.
No. of complete response (%) 95% CI
Št. popolnih odgovorov (%) 95-% IZ
Cohort 1 included previously untreated patients with locally advanced or metastatic UC who were ineligible or unfit for cisplatin-based chemotherapy or had disease progression at least 12 months after treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen.
V 1. kohorto so bili vključeni še nezdravljeni bolniki z lokalno napredovalim ali razsejanim urotelijskim karcinomom, ki niso bili primerni ali sposobni za kemoterapijo na osnovi platine ali jim je bolezen napredovala najmanj
12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day and the patient is stable on replacement therapy (if required).
≤ 10 mg prednizona (ali ekvivalenta) na dan, bolnik pa je stabilen na nadomestnem zdravljenju.
• The diluted solution should not be kept more 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.
8 ur pri sobni temperaturi (≤ 25 °C), razen če je redčenje potekalo v kontroliranih in validiranih aseptičnih pogojih.
Other endpoints Investigator-assessed ORR (RECIST v1.1)^
Drugi dogodki učinkovitosti ORR po oceni raziskovalca (RECIST v1.1)^
Treatment with atezolizumab should be permanently discontinued for Grade 4 hypophysitis.
V primeru hipofizitisa 4. stopnje je treba zdravljenje z atezolizumabom trajno ukiniti.
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.
Zdravljenje z atezolizumabom se lahko znova začne, ko se serumska amilaza in lipaza v 12 tednih znižata na ≤ 1. stopnjo, ali simptomi pankreatitisa minejo, odmerek kortikosteroidov pa je zmanjšan na ≤ 10 mg prednizona na dan (ali ekvivalenta).
Once symptoms improve, treatment with 1 to 2 mg/kg/day of prednisone or equivalent should follow.
Ko se simptomi izboljšajo, je treba zdravljenje nadaljevati s prednizonom v odmerku 1 do 2 mg/kg/dan ali ekvivalentom.
Treatment with atezolizumab must be permanently discontinued for any grade of meningitis or encephalitis.
V primeru meningitisa ali encefalitisa je treba zdravljenje z atezolizumabom trajno ukiniti ne glede na njuno stopnjo.
Submission of study results: 31 December
31. december
Figure 8: Kaplan-Meier curves for progression free survival (IMpower130)
Slika 8: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni (IMpower130)
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.
Vzorce tumorjev so ocenjevali glede izražanja PD-L1 na tumorskih celicah (TC) in imunskih celicah, ki infiltrirajo tumor (IC); te rezultate so uporabili za določitev podskupin izražanja PD-L1 v analizi, ki je opisana v nadaljevanju.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Tecentriq 1,200 mg concentrate for solution for infusion atezolizumab
IME ZDRAVILA IN POT(I) UPORABE Tecentriq 1200 mg koncentrat za raztopino za infundiranje atezolizumab intravenska uporaba
Randomisation was stratified by PD-L1 expression status on IC, by the number of prior chemotherapy regimens and by histology.
Randomizacija je bila stratificirana glede na stanje izražanja PD-L1 na imunskih celicah, ki infiltrirajo tumor, glede na število predhodnih shem kemoterapije in glede na histologijo.
For Grade 3 diarrhoea or colitis, treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started.
V primeru diareje ali kolitisa 3. stopnje je treba uvesti zdravljenje z intravenskimi kortikosteroidi (1 do 2 mg/kg/dan metilprednizolona ali ekvivalenta).
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%).
V študiji pri zdravljenju NDRP v prvi liniji (IMpower150) so opazili splošno večjo pogostnost neželenih učinkov v skupini s kombinacijo štirih zdravil (atezolizumab, bevacizumab, paklitaksel in karboplatin) v primerjavi s skupino z atezolizumabom, paklitakselom in karboplatinom, vključno z neželenimi učinki 3. in 4. stopnje (63,6 % v primerjavi s 57,5 %), neželenimi učinki 5. stopnje (6,1 % v primerjavi z 2,5 %), neželenimi učinki posebnega pomena za atezolizumab (52,4 % v primerjavi z 48,0 %) in tudi neželenimi učinki, ki so vodili do ukinitve katerega koli študijskega zdravljenja (33,8 % v primerjavi s 13,3 %).
Hyperthyroidism occurred in 0.9% (30/3,178) of patients who received atezolizumab monotherapy.
Hipertiroidizem se je pojavil pri 0,9 % (30/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
No dedicated studies of atezolizumab have been conducted in patients with hepatic impairment.
Namenskih študij z atezolizumabom pri bolnikih z okvaro jeter niso izvedli.
PFS (IRF-assessed; RECIST v1.1)
PFS (po oceni IRF; RECIST v1.1)
The median duration was 1.4 months (range 0 day to 21.2+ months; + denotes a censored value).
Mediano trajanje je bilo 1,4 meseca (razpon: od 0 dni do 21,2+ meseca; + označuje krnjeno vrednost).
DOR (IRF-assessed; RECIST v1.1)
DOR (po oceni IRF; RECIST v1.1)
Treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started.
Uvesti je treba zdravljenje z intravenskimi kortikosteroidi (metilprednizolonom v odmerku 1 do 2 mg/kg/dan ali ekvivalentom).
Kaplan-Meier curves for OS in the ITT population are presented in Figure 10.
Kaplan-Meierjevi krivulji celokupnega preživetja v populaciji ITT sta prikazani na sliki 10.
The paclitaxel starting dose for patients of Asian race/ethnicity was 175 mg/m due to higher overall level of haematologic toxicities in patients from Asian countries compared with those from non-Asian countries c
b Zaradi na splošno večjega deleža hematoloških toksičnih učinkov pri bolnikih iz azijskih držav kot pri bolnikih iz neazijskih držav je bil začetni odmerek paklitaksela za bolnike azijske rase/etnične pripadnosti 175 mg/m c Paklitaksel in karboplatin so uporabljali do dokončanja 4 ali 6 ciklov, napredovanja bolezni ali nesprejemljivih toksičnih učinkov, kar od tega se je zgodilo prej.
The median age was 64 years (range 18 to
Mediana starost je bila 64 let (razpon: od 18 do 86 let).
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
p-vrednost1,2 1 na osnovi stratificiranega testa log-rang za informativne namene; v populaciji ITT primerjavi med skupino A in skupino B nista bili vključeni v predhodno določeno hierarhijo analiz stratificirani glede na spol, prisotnost zasevkov v jetrih in tumorsko izražanje PD-L1 na TC in IC * Posodobljena analiza PFS in vmesna analiza OS na klinični presečni datum 22. januar 2018 ^ Skupina A je primerjalna skupina za vsa razmerja ogroženosti
Atezolizumaba (1,200 mg)
atezolizumaba (1200 mg) + paklitaksel
Figure 12: Kaplan-Meier curve for overall survival (IMpower133)
Slika 12: Kaplan-Meierjeva krivulja celokupnega preživetja (IMpower133)
^ The Arm C is the comparison group for all hazard ratios * Updated PFS analysis and interim OS analysis at clinical cut-off 22 January 2018 PFS = progression-free survival; RECIST = Response Evaluation Criteria in Solid Tumours v1.1.
3 najboljši celokupni odgovor za popolni odgovor in delni odgovor stratificirani glede na spol, prisotnost zasevkov v jetrih in tumorsko izražanje PD-L1 na TC in IC ^ skupina C je primerjalna skupina za vsa razmerja ogroženosti * posodobljena analiza PFS in vmesna analiza OS na klinični presečni datum 22. januar 2018 PFS = preživetje brez napredovanja bolezni (progression-free survival); RECIST = merila RECIST (Response
• inflammation of the liver
• okužba pljuč
Hypothyroidism occurred in 5.2% (164/3,178) of patients who received atezolizumab monotherapy.
Hipotiroidizem se je pojavil pri 5,2 % (164/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Rare myasthenic syndrome o
meningoencefalitis n redki miastenijski sindromo
Treatment with atezolizumab must be permanently discontinued for any grade of myasthenic syndrome / myasthenia gravis or Guillain-Barré syndrome.
Pri bolnikih, zdravljenih z atezolizumabom, so opažali miastenijski sindrom/miastenijo gravis ali Guillain-Barréjev sindrom, ki je lahko življenje ogrožujoč.
Atezolizumab was administered until loss of clinical benefit as assessed by investigator b
a Atezolizumab so uporabljali do izgube klinične koristi po oceni raziskovalca.
Atezolizumab was administered as a fixed dose of 1,200 mg by intravenous infusion every 3 weeks.
Atezolizumab so aplicirali v fiksnem odmerku 1200 mg z intravensko infuzijo na 3 tedne.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Tecentriq 840 mg concentrate for solution for infusion atezolizumab
IME ZDRAVILA IN POT(I) UPORABE Tecentriq 840 mg koncentrat za raztopino za infundiranje atezolizumab intravenska uporaba
Overall, 41% of enrolled patients had PD-L1 expression ≥1%, 27% had liver metastases and 7% asymptomatic brain metastases at baseline.
27 % je imelo zasevke v jetrih in 7 % nesimptomatske zasevke v možganih izhodiščno.
Patients were excluded if they had history of autoimmune disease, administration of a live, attenuated vaccine within 28 days prior to randomisation, administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medicinal product within 2 weeks prior to randomisation, active or untreated CNS metastases, clear tumour infiltration into the thoracic great vessels or clear cavitation of pulmonary lesions, as seen on imaging.
V študijo niso bili vključeni bolniki, ki so imeli v anamnezi avtoimunsko bolezen; ki so prejeli živo, oslabljeno cepivo v 28 dneh pred randomizacijo; ki so uporabljali sistemska imunostimulacijska sredstva v 4 tednih pred randomizacijo ali sistemska imunosupresivna zdravila v 2 tednih pred randomizacijo; ki so imeli aktivne ali nezdravljene zasevke v osrednjem živčevju; ali ki so imeli jasno vraščanje v velike žile prsnega koša ali jasno kavitacijo pljučnih lezij, prikazano s slikanjem.
A phase III, open-label, randomised study, GO29537 (IMpower130), was conducted to evaluate the efficacy and safety of atezolizumab in combination with nab-paclitaxel and carboplatin, in chemotherapy-naïve patients with metastatic non-squamous NSCLC.
Randomizirano študijo faze III z odprtim načrtom zdravljenja GO29537 (IMpower130) so izvedli z namenom ugotavljanja učinkovitosti in varnosti atezolizumaba v kombinaciji z nab-paklitakselom in karboplatinom pri bolnikih z razsejanim neploščatoceličnim NDRP, ki predhodno še niso prejemali kemoterapije.
Investigator-assessed PFS (RECIST v1.1)*
PFS po oceni raziskovalca (RECIST v1.1)*
Skin and subcutaneous tissue disorders Very Common rashw, pruritus rashw, pruritus
Bolezni kože in podkožja zelo pogosti izpuščaj w, srbenje izpuščaj w, srbenje
Hepatitis occurred in 2.0% (62/3,178) of patients who received atezolizumab monotherapy.
Hepatitis se je pojavil pri 2,0 % (62/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
A phase III, double-blind, two-arm, multi-center, international, randomised, placebo-controlled study, IMpassion130, was conducted to evaluate the efficacy and safety of atezolizumab in combination with nab-paclitaxel, in patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease.
Dvojno slepo randomizirano, s placebom nadzorovano multicentrično mednarodno študijo faze III z dvema skupinama IMpassion130 so izvedli zaradi ovrednotenja učinkovitosti in varnosti atezolizumaba v kombinaciji z nab-paklitakselom pri bolnikih z inoperabilnim lokalno napredovalim ali razsejanim TNRD, ki predhodno še niso prejemali kemoterapije zaradi razsejane bolezni.
Docetaxel was administered 75 mg/m by intravenous infusion on day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Docetaksel so dajali v odmerku 75 mg/m z intravensko infuzijo 1. dan vsakega 3-tedenskega cikla do napredovanja bolezni ali nesprejemljive toksičnosti.
Based on the stratified log-rank test For informational purposes; in the ITT population, comparisons between Arm B and Arm C as well as between Arm A and Arm C were not formally tested yet as per the pre-specified analysis hierarchy Overall best response for complete response and partial response ‡ Stratified by sex, presence of liver metastases and PD-L1 tumour expression on TC and IC
2 za informativne namene; v populaciji ITT primerjave med skupino B in skupino C kot tudi med skupino A in skupino C še niso formalno preskusili v skladu s predhodno določeno hierarhijo analiz
Stratified by sex and PD-L1 expression on TC and IC ^ Confirmed ORR and DoR are exploratory endpoints
*** le za opisne namene ^ potrjena ORR in DOR sta eksploratorna opazovana dogodka
Upon improvement to Grade ≤ 1, corticosteroid should be tapered over ≥ 1 month.
Po izboljšanju na ≤ 1. stopnjo je treba odmerek kortikosteroidov postopoma zmanjševati v obdobju ≥ 1 meseca.
NAME OF THE MEDICINAL PRODUCT Tecentriq 1,200 mg concentrate for solution for infusion.
IME ZDRAVILA Tecentriq 1200 mg koncentrat za raztopino za infundiranje
What Tecentriq is
Kaj je zdravilo Tecentriq
PFS improvements were also shown in patients with EGFR mutations or ALK rearrangements (HR of 0.55, 95% CI: 0.35, 0.87; median PFS
Prav tako je bilo ugotovljeno izboljšanje PFS pri bolnikih z dokazanimi mutacijami EGFR ali preureditvami ALK (RO 0,55; 95-% IZ: 0,35; 0,87; mediano PFS 10,0 v primerjavi s 6,1 meseca) in zasevki v jetrih (RO 0,41; 95-% IZ: 0,26; 0,62; mediano PFS 8,2 v primerjavi s 5,4 meseca).
Tecentriq in combination with nab-paclitaxel and carboplatin
Zdravilo Tecentriq v kombinaciji z nab-paklitakselom in karboplatinom
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.
Multicentrična, mednarodna, randomizirana študija faze III z odprtim načrtom zdravljenja IMpower150 je bila izvedena z namenom ugotavljanja učinkovitosti in varnosti atezolizumaba v kombinaciji s paklitakselom in karboplatinom (z bevacizumabom ali brez njega) pri bolnikih z razsejanim neploščatoceličnim NDRP, ki še niso prejemali kemoterapije.
Pancreatitis led to the discontinuation of atezolizumab in 3 (< 0.1%) patients.
Zaradi pankreatitisa so zdravljenje z atezolizumabom prenehali 3 (< 0,1 %) bolniki.
If you notice any of the side effects above or if they get worse, tell your doctor straight away.
Če opazite katerega od zgoraj naštetih neželenih učinkov ali se kakšen neželen učinek poslabša,
In the population pharmacokinetic analysis, no clinically important differences in the clearance of atezolizumab were found in patients with mild (estimated glomerular filtration rate [eGFR] 60 to
Populacijska farmakokinetična analiza ni pokazala klinično pomembnih razlik med očistkom atezolizumaba pri bolnikih z blago (ocenjena hitrost glomerulne filtracije [eGFR] od 60 do 89 ml/min/1,73 m2; n = 208)
QLQ-LC13 was observed with atezolizumab compared to docetaxel (HR of 0.71, 95% CI: 0.49, 1.05;
Atezolizumab je v primerjavi z docetakselom podaljšal čas do poslabšanja bolečin v prsih po navedbi bolnika, merjenih z EORTC QLQ-LC13 (RO 0,71, 95-% IZ: 0,49, 1,05; mediana ni bila dosežena v nobeni skupini).
The median duration was 2.1 months (range 0 day to 22.0+ months; + denotes a censored value).
Mediano trajanje je bilo 2,1 meseca (razpon: od 0 dni do 22,0+ mesecev; + označuje krnjeno vrednost).
NAME OF THE MEDICINAL PRODUCT Tecentriq 840 mg concentrate for solution for infusion.
IME ZDRAVILA Tecentriq 840 mg koncentrat za raztopino za infundiranje