FrancophonIA/ELRC3.0 huggingface dataset:
English: In the combined safety database with IMFINZI monotherapy, immune-mediated hyperthyroidism occurred in 34 (1.8%) patients, there were no Grade 3 or 4 cases.
Slovenian: V kombinirani podatkovni bazi o varnosti pri samostojnem zdravljenju z zdravilom IMFINZI se je imunsko pogojeni hipertiroidizem pojavil pri 34 (1,8 %) bolnikov; 3. ali 4. stopnje ni bilo.
English: Month 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 IMFINZI 212 208 193 187 178 171 165 156 134 105 62 34 12 1 0 0 Placebo 91 81 75 67 64 58 52 46 41 29 17 7 5 2 0 0
Slovenian: Mesec 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 Zdravilo
English: The median time to onset was 41 days (range: 14-195 days).
Slovenian: Mediani čas do pojava je bil 41 dni (razpon od 14 do 195 dni).
English: In the PACIFIC Study, (n = 475 in the IMFINZI arm, and n = 234 in the placebo arm) immune-mediated pneumonitis occurred in 51 (10.7%) patients in the IMFINZI-treated group and 16 (6.8%) patients in the placebo group, including Grade 3 in 8 (1.7%) patients on IMFINZI vs. 6 (2.6%) patients on placebo and Grade 5 (fatal) in 4 (0.8%) patients on IMFINZI vs. 3 (1.3%) patients on placebo.
Slovenian: V študiji PACIFIC (n = 475 v skupini z zdravilom IMFINZI in n = 234 v skupini s placebom) se je imunsko pogojeni pnevmonitis pojavil pri 51 (10,7 %) prejemnikih zdravila IMFINZI in pri 16 (6,8 %) prejemnikih placeba, vključno s 3. stopnjo pri 8 (1,7 %) prejemnikih zdravila IMFINZI in 6 (2,6 %) prejemnikih placeba ter s 5. stopnjo (smrtni izid) pri 4 (0,8 %) prejemnikih zdravila IMFINZI in 3 (1,3 %) prejemnikih placeba.
English: Patients should be monitored for abnormal renal function tests prior to and periodically during treatment with IMFINZI and managed as recommended in section 4.2.
Slovenian: Bolnike je treba spremljati glede nenormalnih izvidov delovanje ledvic pred zdravljenjem in redno med zdravljenjem z zdravilom IMFINZI ter jih obravnavati, kot je priporočeno v poglavju 4.2.
English: f includes hyperthyroidism, autoimmune thyroiditis, thyroiditis, thyroiditis subacute and Basedow's disease.
Slovenian: Vključuje hipertiroidizem, avtoimunski tiroiditis, tiroiditis, subakutni tiroiditis in Basedowovo bolezen.
English: Events of StevensJohnson Syndrome or toxic epidermal necrolysis have been reported in patients treated with PD-1 inhibitors.
Slovenian: Pri bolnikih, ki so bili zdravljeni z zaviralci PD-1, so poročali o pojavljanju Stevens-Johnsonovega sindroma ali toksične epidermalne nekrolize.
English: • inflammation of the intestines: symptoms may include diarrhoea or more bowel movements than usual, or stools that are black, tarry or sticky with blood or mucus, severe stomach pain or tenderness;
Slovenian: • vnetje črevesa: med simptomi so lahko driska ali pogostejše odvajanje blata kot po navadi, blato, ki je črno, smolasto ali lepljivo, ali blato s krvjo ali sluzjo, močna bolečina v trebuhu ali občutljivost trebuha;
English: The median time to onset was 53 days (range: 1-341 days).
Slovenian: Mediani čas do pojava je bil 53 dni (razpon od 1 do 341 dni).
English: Rare (may affect up to 1 in 1000 people)
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1000 bolnikov)
English: Month 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 IMFINZI 476 464 431 415 385 364 343 319 274 210 115 57 23 2 0 0 Placebo 237 220 198 178 170 155 141 130 117 78 42 21 9 3 1 0
Slovenian: Placebo 237 220 198 178 170 155 141 130 117 78 42 21 9 3 1 0
English: Kaplan-Meier curve of OS
Slovenian: Kaplan-Meierjeva krivulja celokupnega preživetja (OS)
English: Grade 3 with AST or ALT > 5-≤ 8 x ULN or total bilirubin > 3≤ 5x ULN Grade 3 with AST or ALT > 8 x ULN or total bilirubin > 5 x ULN
Slovenian: 3. stopnja z AST ali ALT > 8 x ZNM ali celokupni bilirubin > 5 x ZNM trajno prenehajte uporabljati sočasno ALT ali AST > 3 x ZNM in celokupni bilirubin > 2 x ZNM brez drugih vzrokov
English: Placebo Hazard ratio (95% CI):
Slovenian: placebo razmerje ogroženosti (95 % IZ):
English: IMFINZI is clear to opalescent, colourless to slightly yellow solution.
Slovenian: Zdravilo IMFINZI je bistra do opalescentna, brezbarvna do rumenkasta raztopina.
English: For symptomatic adrenal insufficiency, patients should be managed as recommended in section 4.2.
Slovenian: Bolnike s simptomatsko adrenalno insuficienco je treba obravnavati, kot je priporočeno v poglavju 4.2.
English: For symptomatic hypophysitis or hypopituitarism, patients should be managed as recommended in section 4.2.
Slovenian: Bolnike s simptomatskim hipofizitisom ali hipopituitarizmom je treba obravnavati, kot je priporočeno v poglavju 4.2.
English: Nervous System Disorders Myasthenia gravis
Slovenian: Bolezni živčevja miastenija gravis redki
English: 2.4 mL of concentrate in a Type 1 glass vial with an elastomeric stopper and a gray flip-off aluminium seal containing 120 mg durvalumab.
Slovenian: 2,4 ml koncentrata v stekleni viali iz stekla tipa 1 z elastomernim zamaškom in sivo snemno aluminijsko zaporo; viala vsebuje 120 mg durvalumaba.
English: • inflammation of the heart muscle: symptoms may include chest pain, shortness of breath or irregular heartbeat;
Slovenian: • vnetje srčne mišice: med simptomi so lahko bolečina v prsih, kratka sapa ali neredno bitje srca;
English: IMFINZI was discontinued in all 3 patients.
Slovenian: Zdravilo IMFINZI so prenehali uporabljati pri vseh 3 bolnikih.
English: The median time to onset was 74 days (range: 1-365 days).
Slovenian: Mediani čas do pojava je bil 74 dni (razpon od 1 do 365 dni).
English: HR (95% CI) p-value p < 0.0001
Slovenian: Vrednost p p < 0,0001
English: Figure 6.
Slovenian: Slika 6.
English: • inflammation of the skin: symptoms may include rash, itching, skin blistering or ulcers in the mouth or on other moist surfaces;
Slovenian: • vnetje kože: med simptomi so lahko izpuščaj, srbenje, mehurji na koži ali razjede v ustih ali na vlažnih predelih;
English: IMFINZI should be permanently discontinued for recurrent Grade 3 or 4 (severe or life-threatening) immune-mediated adverse reactions.
Slovenian: Če se imunsko pogojeni neželeni učinki 3. ali 4. stopnje (močno izraženi ali življenjsko nevarni) ponavljajo, je treba zdravilo IMFINZI dokončno ukiniti.
English: One vial of 2.4 mL of concentrate contains 120 mg of durvalumab.
Slovenian: Ena viala z 2,4 ml koncentrata vsebuje 120 mg durvalumaba.
English: Kaplan-Meier curve of OS for PD-L1 TC ≥ 1%
Slovenian: Kaplan-Meierjeva krivulja celokupnega preživetja (OS) za bolnike z ekspresijo PD-L1 TC ≥ 1%
English: Withhold dose until clinically stable
Slovenian: 3. ali 4. stopnja odložite uporabo odmerka, dokler stanje ni klinično stabilno
English: Initiate 1 to 2 mg/kg/day prednisone or equivalent followed by a taper and hormone replacement as clinically indicated
Slovenian: stopnja odložite uporabo odmerka, dokler stanje ni klinično stabilno uvedite 1 do 2 mg/kg/dan prednizona ali ekvivalenta in nato postopoma zmanjšujte; uvedite hormonsko nadomeščanje, kot je klinično indicirano
English: Patients should be monitored for signs and symptoms and managed as recommended in section 4.2.
Slovenian: Bolnike je treba spremljati glede znakov in simptomov in ukrepati, kot je priporočeno v poglavju 4.2.
English: One ml of concentrate contains 50 mg of durvalumab.
Slovenian: 1 ml koncentrata vsebuje 50 mg durvalumaba.
English: The concentrate is a clear to opalescent, colourless to slightly yellow solution, free from visible particles.
Slovenian: Koncentrat je bistra do opalescentna, brezbarvna do rumenkasta raztopina brez vidnih delcev.
English: Kaplan-Meier curve of PFS for PD-L1 TC ≥ 1%
Slovenian: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni (PFS) za bolnike z ekspresijo PD-L1 TC ≥ 1 %
English: • Visually inspect the medicinal product for particulate matter and discolouration.
Slovenian: • Zdravilo morate pregledati glede delcev in sprememb barve.
English: Kaplan-Meier curve of PFS
Slovenian: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni (PFS)
English: MedImmune Pharma B.V. Lagelandseweg 78
Slovenian: MedImmune Pharma B.V.
English: • inflammation of the lungs: symptoms may include new or worsening cough, shortness of breath or chest pain;
Slovenian: • vnetje pljuč: med simptomi so lahko novonastali kašelj ali poslabšanje kašlja, kratka sapa ali bolečine v prsih;
English: Hepatobiliary disorders Aspartate aminotransferase increased or Alanine aminotransferase increased
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišanje vrednosti aspartat aminotransferaze ali zvišanje vrednosti alanin aminotransferaze pogosti hepatitis c,m občasni
English: Patients should be monitored for abnormal thyroid function tests prior to and periodically during treatment and as indicated based on clinical evaluation.
Slovenian: Bolnike je treba spremljati glede nenormalnih izvidov delovanje ščitnice pred zdravljenjem in redno med zdravljenjem ter kot je potrebno glede na klinično oceno.
English: If you get any side effects, talk to your doctor.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
English: For symptomatic type 1 diabetes mellitus, patients should be managed as recommended in section 4.2.
Slovenian: Bolnike s simptomatsko sladkorno bolezen tipa 1 je treba obravnavati, kot je priporočeno v poglavju 4.2.
English: Preparation and administration of the infusion
Slovenian: Priprava in dajanje infuzije
English: Hypophysitis/hypopituitarism
Slovenian: Hipofizitis/hipopituitarizem
English: Immune-mediated pneumonitis
Slovenian: Imunsko pogojeni pnevmonitis
English: • Withdraw the required volume from the vial(s) of IMFINZI and transfer into an intravenous (IV) bag containing sodium chloride 9 mg/mL (0.9%) solution for injection, or glucose 50 mg/mL (5%) solution for injection.
Slovenian: vrečko, ki vsebuje 0,9 % (9 mg/ml) raztopino natrijevega klorida za injiciranje ali 5 % (50 mg/ml) raztopino glukoze za injiciranje.
English: Two (0.1%) patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Slovenian: 2 (0,1 %) bolnika sta prejemala visokoodmerno zdravljenje s kortikosteroidi (vsaj 40 mg prednizona ali ekvivalenta na dan).
English: Do not freeze or shake the solution.
Slovenian: Raztopine ne zamrzujte in ne stresajte.
English: You should not be given IMFINZI
Slovenian: Zdravila IMFINZI ne smete dobiti:
English: One vial of 10 mL of concentrate contains 500 mg of durvalumab.
Slovenian: Ena viala z 10 ml koncentrata vsebuje 500 mg durvalumaba.
English: IMFINZI was discontinued in 4 patients.
Slovenian: Zdravilo IMFINZI so prenehali uporabljati pri 4 bolnikih.
English: Where available, archival tumour tissue specimens taken prior to chemoradiation therapy were retrospectively tested for PD-L1 expression on tumour cells (TC) using the VENTANA PD-L1 (SP263) IHC assay.
Slovenian: S testno metodo VENTANA PD-L1 (SP263) IHC so retrospektivno pregledali ekspresijo PD-L1 na tumorskih celicah iz arhivskih vzorcev tumorskega tkiva, ki so bili odvzeti pred kemoradiacijskim zdravljenjem, pri bolnikih, pri katerih so bili taki vzorci na voljo.
English: Immune-mediated adrenal insufficiency occurred in patients receiving IMFINZI (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo IMFINZI, se je pojavila imunsko pogojena adrenalna insuficienca (glejte poglavje 4.8).
English: Patients should be monitored for signs and symptoms of rash or dermatitis and managed as recommended in section 4.2.
Slovenian: Bolnike je treba spremljati glede znakov in simptomov izpuščaja ali dermatitisa ter jih obravnavati, kot je priporočeno v poglavju 4.2.
English: IMFINZI was discontinued in 2 patients.
Slovenian: Zdravilo IMFINZI so prenehali uporabljati pri 2 bolnikih.
English: IMFINZI was not discontinued in any patient due to hyperthyroidism.
Slovenian: Zaradi hipertiroidizma niso zdravila IMFINZI prenehali uporabljati pri nobenem bolniku.
English: Events/N (%) IMFINZI
Slovenian: Dogodki/N (%) zdravilo IMFINZI placebo HR (95 % IZ)
English: Immune-mediated type 1 diabetes mellitus occurred in patients receiving IMFINZI (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo IMFINZI, se je pojavila imunsko pogojena sladkorna bolezen tipa 1 (glejte poglavje 4.8).
English: In the combined safety database with IMFINZI monotherapy, immune-mediated hepatitis occurred in 19 (1.0%) patients, including Grade 3 in 11 (0.6%) patients and Grade 5 (fatal) in 1 (< 0.1%) patient.
Slovenian: V kombinirani podatkovni bazi o varnosti pri samostojnem zdravljenju z zdravilom IMFINZI se je imunsko pogojeni hepatitis pojavil pri 19 (1,0 %) bolnikih, vključno s 3. stopnjo pri 11 (0,6 %) bolnikih in s 5. stopnjo (smrtni izid) pri 1 (< 0,1 %) bolniku.
English: In the combined safety database with IMFINZI monotherapy, infusion related reactions occurred in 35 (1.9%) patients, including Grade 3 in 5 (0.3%) patients.
Slovenian: V kombinirani podatkovni bazi o varnosti pri samostojnem zdravljenju z zdravilom IMFINZI so se z infundiranjem povezane reakcije pojavile pri 35 (1,9 %) bolnikih, vključno s 3. stopnjo pri 5 (0,3 %) bolnikih.
English: IMFINZI was not discontinued in any patient due to adrenal insufficiency.
Slovenian: Zaradi adrenalne insuficience niso zdravila IMFINZI prenehali uporabljati pri nobenem bolniku.
English: No dose adjustment of IMFINZI is recommended in patients with mild or moderate renal impairment.
Slovenian: Bolnikom z blago ali zmerno okvaro ledvic odmerka zdravila IMFINZI ni treba prilagoditi.
English: PFS at 12 months (%) (95% CI) PFS at 18 months (%) (95% CI) PFS2 Median PFS2
Slovenian: HR (95 % IZ) 2-stranska vrednost p OS po 24 mesecih (%) (95 % IZ) Vrednost p PFS Število dogodkov (%) Mediano PFS (meseci) (95 % IZ) HR (95 % IZ)
English: Each mL of concentrate for solution for infusion contains 50 mg of durvalumab.
Slovenian: 1 ml koncentrata za raztopino za infundiranje vsebuje 50 mg durvalumaba.
English: In the combined safety database with IMFINZI monotherapy, immune-mediated rash or dermatitis occurred in 30 (1.6%) patients, including Grade 3 in 7 (0.4%) patients.
Slovenian: V kombinirani podatkovni bazi o varnosti pri samostojnem zdravljenju z zdravilom IMFINZI se sta se imunsko pogojeni izpuščaj ali dermatitis pojavila pri 30 (1,6 %) bolnikih, vključno s 3. stopnjo pri 7 (0,4 %) bolnikih.
English: If any of the above apply to you (or you are not sure), talk to your doctor before you are given IMFINZI.
Slovenian: Če kaj od naštetega velja za vas (ali če niste prepričani), se posvetujte z zdravnikom, preden dobite zdravilo IMFINZI.
English: Immune-mediated pneumonitis or interstitial lung disease, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMFINZI.
Slovenian: Pri bolnikih, ki so prejemali zdravilo IMFINZI, sta se pojavila imunsko pogojeni pnevmonitis ali intersticijska bolezen pljuč, opredeljeno kot potreba po uporabi sistemskih kortikosteroidov in brez jasne druge etiologije.
English: Permanently discontinue IMFINZI if adverse reaction does not resolve to ≤ Grade 1 within 30 days or if there are signs of respiratory insufficiency.
Slovenian: Če se neželeni učinek v 30 dneh ne izboljša na ≤ 1. stopnjo ali če so prisotni znaki respiratorne insuficience, zdravilo IMFINZI dokončno ukinite.
English: IMFINZI 50 mg/mL concentrate for solution for infusion durvalumab
Slovenian: IMFINZI 50 mg/ml koncentrat za raztopino za infundiranje durvalumab
English: Clear to opalescent, colourless to slightly yellow solution, free from visible particles.
Slovenian: Bistra do opalescentna, brezbarvna do rumenkasta raztopina brez vidnih delcev.
English: Immune-mediated colitis or diarrhoea
Slovenian: Imunsko pogojeni kolitis ali driska
English: In the combined safety database with IMFINZI monotherapy, immune-mediated hypothyroidism occurred in 137 (7.3%) patients, including Grade 3 in 1 (< 0.1%) patient.
Slovenian: V kombinirani podatkovni bazi o varnosti pri samostojnem zdravljenju z zdravilom IMFINZI se je imunsko pogojeni hipotiroidizem pojavil pri 137 (7,3 %) bolnikih, vključno s 3. stopnjo pri 1 (< 0,1 %) bolniku.
English: IMFINZI 50 mg/mL concentrate for solution for infusion
Slovenian: IMFINZI 50 mg/ml koncentrat za raztopino za infundiranje
English: IMFINZI was not discontinued in any patient due to hypothyroidism.
Slovenian: Zaradi hipotiroidizma niso zdravila IMFINZI prenehali uporabljati pri nobenem bolniku.
English: Immune-mediated hypophysitis or hypopituitarism occurred in patients receiving IMFINZI (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo IMFINZI, sta se pojavila imunsko pogojena hipofizitis ali hipopituitarizem (glejte poglavje 4.8).
English: In the combined safety database with IMFINZI monotherapy, immune-mediated colitis or diarrhoea occurred in 31 (1.6%) patients, including Grade 3 in 6 (0.3%) patients and Grade 4 in 1 (<0.1%) patient.
Slovenian: V kombinirani podatkovni bazi o varnosti pri samostojnem zdravljenju z zdravilom IMFINZI sta se imunsko pogojeni kolitis ali driska pojavila pri 31 (1,6 %) bolnikih, vključno s 3. stopnjo pri 6 (0,3 %) bolnikih in s 4. stopnjo pri 1 (< 0,1 %) bolniku.
English: It is used when your NSCLC:
Slovenian: Uporablja se, če se vam je nedrobnocelični rak pljuč:
English: Patients should be monitored for signs and symptoms of colitis or diarrhoea and managed as recommended in section 4.2.
Slovenian: Bolnike je treba spremljati glede znakov in simptomov kolitisa oziroma driske in ukrepati, kot je priporočeno v poglavju 4.2.
English: In the combined safety database with IMFINZI monotherapy, immune-mediated adrenal insufficiency occurred in 7 (0.4%) patients, including Grade 3 in 1 (< 0.1%) patient.
Slovenian: V kombinirani podatkovni bazi o varnosti pri samostojnem zdravljenju z zdravilom IMFINZI se je imunsko pogojena adrenalna insuficienca pojavila pri 7 (0,4 %) bolnikih, vključno s 3. stopnjo pri 1 (< 0,1 %) bolniku.
English: Common Musculoskeletal and connective tissue disorders Myalgia
Slovenian: nočno znojenje pogosti Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija pogosti miozitis občasni polimiozitis redki
English: Grade 2 or 3 Withhold dose
Slovenian: 3. ali 4. stopnja trajno prenehajte uporabljati
English: Severe infusion related reactions have been reported in patients receiving IMFINZI (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo IMFINZI, so bile opisane hude z infundiranjem povezane reakcije (glejte poglavje 4.8).
English: How to store IMFINZI
Slovenian: Shranjevanje zdravila IMFINZI
English: At baseline, no differences in patient reported symptoms, function and HRQoL were observed between IMFINZI and placebo groups.
Slovenian: Izhodiščno med skupino z zdravilom IMFINZI in skupino s placebom ni bilo razlik v simptomih, funkciji ali zdravstveni kakovosti življenja (HRQoL - “health related quality of life”) po navedbi bolnikov.
English: In the combined safety database with IMFINZI monotherapy, immune-mediated hypopituitarism occurred in 1 (< 0.1%) patient (Grade 3).
Slovenian: V kombinirani podatkovni bazi o varnosti pri samostojnem zdravljenju z zdravilom IMFINZI se je imunsko pogojeni hipopituitarizem pojavil pri 1 (< 0,1 %) bolniku (3. stopnja).
English: includes abdominal pain, abdominal pain lower, abdominal pain upper and flank pain.
Slovenian: Vključuje bolečine v trebuhu, bolečine v spodnjem delu trebuha, bolečine v zgornjem delu trebuha in bolečine v ledvenem predelu.
English: Rare Respiratory, thoracic and mediastinal disorders Cough/Productive Cough
Slovenian: Srčne bolezni miokarditis redki Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj/produktiven kašelj zelo pogosti pnevmonitis zelo pogosti disfonija pogosti intersticijska bolezen pljuč občasni
English: Sixteen of the 31 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Slovenian: 16 od 31 bolnikov je prejemalo visokoodmerno zdravljenje s kortikosteroidi (vsaj 40 mg prednizona ali ekvivalenta na dan).
English: Thirteen of the 19 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Slovenian: 13 od 19 bolnikov je prejemalo visokoodmerno zdravljenje s kortikosteroidi (vsaj 40 mg prednizona ali ekvivalenta na dan).
English: AUTHORISATION
Slovenian: Izrazitost
English: In the combined safety database with IMFINZI monotherapy, immune-mediated type 1 diabetes mellitus occurred in 1 (< 0.1%) patient (Grade 3).
Slovenian: V kombinirani podatkovni bazi o varnosti pri samostojnem zdravljenju z zdravilom IMFINZI se je imunsko pogojena sladkorna bolezen tipa 1 pojavila pri 1 (< 0,1 %) bolniku (3. stopnja).
English: Infusion related reactions should be managed as recommended in section 4.2
Slovenian: V primerih z infundiranjem povezanih reakcij je treba ukrepati po priporočilih v poglavju 4.2.
English: In the combined safety database with IMFINZI monotherapy, immune-mediated nephritis occurred in 3 (0.2%) patients, including Grade 3 in 1 (< 0.1%) patient.
Slovenian: V kombinirani podatkovni bazi o varnosti pri samostojnem zdravljenju z zdravilom IMFINZI se je imunsko pogojeni nefritis pojavil pri 3 (0,2 %) bolnikih, vključno s 3. stopnjo pri 1 (< 0,1 %) bolniku.
English: Other immune-mediated adverse reactions
Slovenian: Drugi imunsko pogojeni neželeni učinki
English: • overactive thyroid gland that can cause fast heart rate or weight loss
Slovenian: • prekomerno delovanje žleze ščitnice; posledici sta lahko hitro bitje srca ali hujšanje
English: Eleven of the 30 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Slovenian: 11 od 30 bolnikov je prejemalo visokoodmerno zdravljenje s kortikosteroidi (vsaj 40 mg prednizona ali ekvivalenta na dan).
English: Grade 2 with ALT or AST > 3-5 x ULN and/or total bilirubin > 1.5-3 x ULN
Slovenian: 3. stopnja z AST ali ALT > 5-≤ 8 x ZNM ali celokupni bilirubin > 3-≤ 5 x ZNM
English: Consider initial dose of 1 mg/kg/day to 4 mg/kg/day prednisone or equivalent followed by taper
Slovenian: 3. stopnja odložite uporabo odmerka razmislite o začetnem odmerku od 1 do 4 mg/kg/dan prednizona ali ekvivalenta in nato postopoma zmanjšujte
English: Hazard ratio (95% CI):
Slovenian: razmerje ogroženosti (95 % IZ):
English: In the combined safety database with IMFINZI monotherapy, (n = 1889 multiple tumour types), immune-mediated pneumonitis occurred in 79 (4.2%) patients, including Grade 3 in 12 (0.6%) patients, Grade 4 in 1 (< 0.1%) patient, and Grade 5 in 5 (0.3%) patients.
Slovenian: V kombinirani podatkovni bazi o varnosti pri samostojnem zdravljenju z zdravilom IMFINZI (n = 1889, več tipov tumorjev) je do imunsko pogojenega pnevmonitisa prišlo pri 79 bolnikih (4,2 %)
English: Initiate 1 to 2 mg/kg/day prednisone or equivalent followed by a taper
Slovenian: odložite uporabo odmerka uvedite 1 do 2 mg/kg/dan prednizona ali ekvivalenta in nato postopoma zmanjšujte
English: Immune-mediated hepatitis, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMFINZI (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo IMFINZI, se je pojavil imunsko pogojeni hepatitis, opredeljen kot potreba po sistemskih kortikosteroidih in brez jasne druge etiologije (glejte poglavje 4.8).
English: • skin rash or itchiness
Slovenian: • kožni izpuščaj ali srbenje
English: n includes rash erythematous, rash generalised, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, erythema, eczema and rash.
Slovenian: Vključuje eritematozen izpuščaj, generaliziran izpuščaj, makularen izpuščaj, makulopapularen izpuščaj, papularen izpuščaj, pruritičen izpuščaj, pustulozen izpuščaj, eritem, ekcem in izpuščaj.
English: Immune-mediated rash or dermatitis, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMFINZI (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo IMFINZI, se je pojavil imunsko pogojeni izpuščaj ali dermatitis, opredeljen kot potreba po sistemskih kortikosteroidih in brez jasne druge etiologije (glejte poglavje 4.8).