natgillin/translations-raw huggingface dataset:
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