FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on population PK analysis that included 1878 patients in the dose range of ≥ 10 mg/kg every 2 weeks, the geometric mean steady state volume of distribution (Vss) was 5.64 L. Durvalumab clearance (CL) decreased over time resulting in a geometric mean steady state clearance (CLss) of 8.16 mL/h at Day 365; the decrease in CLss was not considered clinically relevant.
Croatian: Prema populacijskoj farmakokinetičkoj analizi koja je obuhvatila 1878 bolesnika liječenih dozama ≥ 10 mg/kg svaka 2 tjedna, geometrijska srednja vrijednost volumena distribucije u stanju dinamičke ravnoteže (Vss) iznosila je 5,64 l.
English: • skin rash or itchiness
Croatian: • kožni osip ili svrbež
English: Forty-five of the 79 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day), and 2 patients also received infliximab.
Croatian: Četrdeset i pet (45) od 79 bolesnika primalo je visoke doze kortikosteroida (najmanje 40 mg prednizona ili ekvivalent na dan), a 2 bolesnika primala su i infliksimab.
English: Grade 2 with ALT or AST > 3-5 x ULN and/or total bilirubin > 1.5-3 x ULN
Croatian: 2. stupanj, uz ALT ili AST > 3 - 5 x GGN i/ili ukupni bilirubin > 1,5 - 3 x GGN Odgoditi primjenu doze
English: Kaplan-Meier curve of PFS for PD-L1 TC ≥ 1%
Croatian: Slika 4. Kaplan-Meierove krivulje PFS-a za PD-L1 TC ≥ 1%
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.
Croatian: U bazi objedinjenih podataka o sigurnosti monoterapije lijekom IMFINZI, imunološki uzrokovana hipertireoza javila se kod 34 (1,8%) bolesnika, bez slučajeva 3. ili 4. stupnja.
English: For symptomatic hypophysitis or hypopituitarism, patients should be managed as recommended in section 4.2.
Croatian: U slučaju simptomatskog hipofizitisa ili hipopituitarizma bolesnike treba liječiti u skladu s preporukama navedenima u dijelu 4.2.
English: Resolution occurred in 23 patients.
Croatian: Nuspojave su se povukle kod 23 bolesnika.
English: Two (0.1%) patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Croatian: Dva (0,1%) bolesnika primala su visoke doze kortikosteroida (najmanje 40 mg prednizona ili ekvivalent na dan).
English: One ml of concentrate contains 50 mg of durvalumab.
Croatian: Jedan ml koncentrata sadrži 50 mg durvalumaba.
English: What IMFINZI looks like and contents of the pack IMFINZI concentrate for solution for infusion is a sterile, preservative-free, clear to opalescent, colourless to slightly yellow solution, free from visible particles.
Croatian: IMFINZI koncentrat za otopinu za infuziju je sterilna, bistra do opalescentna, bezbojna do blijedožuta otopina koja ne sadrži konzervanse ni vidljive čestice.
English: • Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
Croatian: • Lijekove za parenteralnu primjenu treba prije primjene vizualno pregledati kako bi se utvrdilo sadrže li čestice i jesu li promijenili boju.
English: The median time to onset was 74 days (range: 1-365 days).
Croatian: Medijan vremena do nastupa iznosio je 74 dana (raspon: 1 - 365 dana).
English: Patients should be monitored for signs and symptoms and managed as recommended for other immune-mediated adverse reactions, in section 4.2.
Croatian: Bolesnike treba nadzirati zbog moguće pojave znakova i simptoma te ih liječiti prema preporukama za druge imunološki uzrokovane nuspojave navedenima u dijelu 4.2.
English: One patient also received mycophenolate treatment.
Croatian: Jedan je bolesnik primao i mikofenolat.
English: • inflammation of the heart muscle: symptoms may include chest pain, shortness of breath or irregular heartbeat;
Croatian: • upalu srčanog mišića: simptomi mogu uključivati bol u prsnom košu, nedostatak zraka ili nepravilne otkucaje srca
English: PFS was assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1.
Croatian: PFS je ocjenjivalo zaslijepljeno neovisno središnje ocjenjivačko povjerenstvo prema verziji 1.1 Kriterija za ocjenu odgovora kod solidnih tumora (engl.
English: Hepatobiliary disorders Aspartate aminotransferase increased or Alanine aminotransferase increased
Croatian: Poremećaji jetre i žuči povišene vrijednosti aspartat aminotransferaze ili povišene vrijednosti alanin aminotransferaze često hepatitis c,m manje često
English: IMFINZI was discontinued in all 3 patients.
Croatian: Primjena lijeka IMFINZI obustavljena je kod sva 3 bolesnika.
English: The median time to onset was 53 days (range: 1-341 days).
Croatian: Medijan vremena do nastupa iznosio je 53 dana (raspon: 1 - 341 dan).
English: For non-immune-mediated adverse reactions, consider withholding IMFINZI for Grade 2 and 3 adverse reactions until ≤ Grade 1 or baseline.
Croatian: Kod nuspojava 2. i 3 stupnja koje nisu imunološki uzrokovane potrebno je razmotriti odgodu primjene lijeka IMFINZI dok se nuspojava ne ublaži do ≤ 1. stupnja ili početne vrijednosti.
English: • inflammation of the kidneys: symptoms may include decrease in the amount of urine you pass;
Croatian: • upalu bubrega: simptomi mogu uključivati smanjenu količinu mokraće
English: Discard any unused portion left in the vial.
Croatian: Bacite sav neupotrijebljen lijek koji je preostao u bočici.
English: One vial of 2.4 ml of concentrate contains 120 mg of durvalumab.
Croatian: Jedna bočica od 2,4 ml koncentrata sadrži 120 mg durvalumaba.
English: Within each system organ class, the adverse drug reactions are presented in decreasing frequency.
Croatian: Unutar svakog organskog sustava nuspojave se navode u padajućem nizu prema učestalosti.
English: Grade 3 with serum creatinine > 3 x baseline or > 3-6 x ULN; Grade 4 with serum creatinine > 6 x ULN
Croatian: 3. stupanj, uz serumski kreatinin > 3 x početna vrijednost ili > 3 - 6 x GGN;
English: Patients should be monitored for clinical signs and symptoms of adrenal insufficiency.
Croatian: Bolesnike treba nadzirati zbog moguće pojave kliničkih znakova i simptoma insuficijencije nadbubrežnih žlijezda.
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.
Croatian: Bolesnike treba nadzirati zbog mogućih odstupanja u nalazima pretraga kojima se ocjenjuje funkcija bubrega prije i periodički tijekom liječenja lijekom IMFINZI te liječiti u skladu s preporukama navedenima u dijelu 4.2.
English: IMFINZI 50 mg/ml sterile concentrate durvalumab
Croatian: IMFINZI 50 mg/ml sterilni koncentrat durvalumab i.v.
English: All 7 patients received systemic corticosteroids; 2 of the 7 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Croatian: Svih 7 bolesnika bilo je liječeno sistemskim kortikosteroidima, a dvoje njih primalo je visoke doze kortikosteroida (najmanje 40 mg prednizona ili ekvivalent na dan).
English: Patients should be monitored for abnormal liver tests prior to and periodically during treatment with IMFINZI, and as indicated based on clinical evaluation.
Croatian: Bolesnike treba nadzirati zbog mogućih odstupanja u nalazima jetrenih pretraga, prije i periodički tijekom liječenja lijekom IMFINZI te kada je to potrebno prema kliničkoj procjeni.
English: For symptomatic type 1 diabetes mellitus, patients should be managed as recommended in section 4.2.
Croatian: U slučaju simptomatske šećerne bolesti tipa 1 bolesnike treba liječiti u skladu s preporukama navedenima u dijelu 4.2.
English: Histidine hydrochloride monohydrate Trehalose dihydrate Polysorbate 80
Croatian: 6.1 Popis pomoćnih tvari histidin histidinklorid hidrat trehaloza dihidrat polisorbat 80 voda za injekcije
English: MedImmune Pharma B.V. Lagelandseweg 78
Croatian: MedImmune Pharma B.V.
English: IMFINZI was discontinued due to type 1 diabetes mellitus.
Croatian: Primjena lijeka IMFINZI obustavljena je zbog šećerne bolesti tipa
English: • inflammation of the lungs: symptoms may include new or worsening cough, shortness of breath or chest pain;
Croatian: • upalu pluća: simptomi mogu uključivati razvoj ili pogoršanje kašlja, nedostatak zraka ili bol u prsnom košu
English: Patients should be monitored for abnormal thyroid function tests prior to and periodically during treatment and as indicated based on clinical evaluation.
Croatian: Bolesnike treba nadzirati zbog mogućih odstupanja u nalazima pretraga za ocjenjivanje funkcije štitnjače, prije i periodički tijekom liječenja te kada je to potrebno prema kliničkoj procjeni.
English: Kaplan-Meier curve of OS
Croatian: Slika 1 Kaplan-Meierove krivulje OS-a
English: Severe infusion related reactions have been reported in patients receiving IMFINZI (see section 4.8).
Croatian: Kod bolesnika koji su primali IMFINZI prijavljene su teške reakcije na infuziju (vidjeti dio 4.8).
English: • Visually inspect the medicinal product for particulate matter and discolouration.
Croatian: • Vizualno pregledajte lijek kako biste utvrdili sadrži li čestice i je li promijenio boju.
English: • underactive thyroid gland that can cause tiredness or weight gain
Croatian: • smanjena aktivnost štitne žlijezde koja može uzrokovati umor ili povećanu težinu
English: Kaplan-Meier curve of PFS
Croatian: Slika 2 Kaplan-Meierove krivulje PFS-a
English: IMFINZI was not discontinued in any patient due to adrenal insufficiency.
Croatian: Primjena lijeka IMFINZI nije obustavljena ni u jednog bolesnika zbog insuficijencije nadbubrežnih žlijezda.
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;
Croatian: • upalu crijeva: simptomi mogu uključivati proljev ili učestalije pražnjenje crijeva nego inače, stolice koje su crne, katranaste ili ljepljive i koje sadrže krv ili sluz te jaku bol u trbuhu ili osjetljivost trbuha na dodir
English: The concentrate is a clear to opalescent, colourless to slightly yellow solution, free from visible particles.
Croatian: Koncentrat je bistra do opalescentna, bezbojna do blijedožuta otopina koja ne sadrži vidljive čestice.
English: Patients should be monitored for signs and symptoms of rash or dermatitis and managed as recommended in section 4.2.
Croatian: Bolesnike treba nadzirati zbog moguće pojave znakova i simptoma osipa ili dermatitisa te liječiti u skladu s preporukama navedenima u dijelu 4.2.
English: IMFINZI 50 mg/mL concentrate for solution for infusion
Croatian: IMFINZI 50 mg/ml koncentrat za otopinu za infuziju
English: IMFINZI was discontinued in 4 patients.
Croatian: Primjena lijeka IMFINZI obustavljena je kod 4 bolesnika.
English: Resolution occurred in 2 patients.
Croatian: Nuspojave su se povukle kod 2 bolesnika.
English: Hypophysitis/hypopituitarism
Croatian: Hipofizitis/hipopituitarizam
English: IMFINZI was discontinued in 2 patients.
Croatian: Primjena lijeka IMFINZI obustavljena je kod 2 bolesnika.
English: Dose withholding or discontinuation may be required based on individual safety and tolerability.
Croatian: Ovisno o sigurnosti i podnošljivosti lijeka kod pojedinog bolesnika, možda će biti potrebno odgoditi ili prekinuti primjenu lijeka.
English: IMFINZI 50 mg/ml concentrate for solution for infusion durvalumab
Croatian: IMFINZI 50 mg/ml koncentrat za otopinu za infuziju durvalumab
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.
Croatian: U bazi objedinjenih podataka o sigurnosti monoterapije lijekom IMFINZI, reakcije na infuziju javile su se kod 35 (1,9%) bolesnika, uključujući događaje 3. stupnja kod 5 (0,3%) bolesnika.
English: Immune-mediated myocarditis
Croatian: Imunološki uzrokovan miokarditis
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.
Croatian: U bazi objedinjenih podataka o sigurnosti monoterapije lijekom IMFINZI, imunološki uzrokovan hepatitis javio se kod 19 (1,0%) bolesnika, uključujući događaje 3. stupnja kod 11 (0,6%) bolesnika i događaj 5. stupnja (sa smrtnim ishodom) kod 1 (< 0,1%) bolesnika.
English: Each mL of concentrate for solution for infusion contains 50 mg of durvalumab.
Croatian: Jedan ml koncentrata za otopinu za infuziju sadrži 50 mg durvalumaba.
English: Grade 3
Croatian: 3. stupanj
English: Preparation and administration of the infusion
Croatian: Priprema i primjena infuzije
English: One vial of 10 mL of concentrate contains 500 mg of durvalumab.
Croatian: Jedna bočica od 10 ml koncentrata sadrži 500 mg durvalumaba.
English: IMFINZI was not discontinued in any patient due to hypothyroidism.
Croatian: Primjena lijeka IMFINZI nije zbog hipotireoze obustavljena ni u jednog bolesnika.
English: includes lung infection, pneumocystis jirovecii pneumonia, pneumonia, pneumonia adenoviral, pneumonia bacterial, pneumonia cytomegaloviral, pneumonia haemophilus, pneumonia klebsiella, pneumonia necrotising, pneumonia pneumococcal and pneumonia streptococcal.
Croatian: periferni edem često Ozljede, trovanja i proceduralne komplikacije reakcija na infuziju često a uključuje laringitis, nazofaringitis, peritonzilarni apsces, faringitis, rinitis, sinusitis, tonzilitis, traheobronhitis i infekciju gornjih dišnih putova. uključuje infekciju pluća, pneumoniju uzrokovanu gljivicom Pneumocystis jirovecii, pneumoniju, adenovirusnu pneumoniju, bakterijsku pneumoniju, citomegalovirusnu pneumoniju, pneumoniju uzrokovanu vrstama roda Haemophilus, pneumoniju uzrokovanu vrstama roda Klebsiella, nekrotizirajuću pneumoniju, pneumokoknu pneumoniju i streptokoknu pneumoniju c prijavljena stopa pneumonitisa sa smrtnim ishodom i pneumonije sa smrtnim ishodom u ispitivanju PACIFIC bila je slična u skupini liječenoj lijekom IMFINZI i onoj koja je primala placebo; u drugim su kliničkim ispitivanjima prijavljeni i hepatitis sa smrtnim ishodom te polimiozitis sa smrtnim ishodom d uključuje gingivitis, infekciju usne šupljine, periodontitis, upalu zubne pulpe (pulpitis), zubni apsces i zubnu infekciju e uključuje autoimunu hipotireozu i hipotireozu f uključuje hipertireozu, autoimuni tireoiditis, tireoiditis, subakutni tireoiditis i Basedowljevu bolest g učestalost se temelji na događajima koji nisu opaženi u ispitivanju PACIFIC, ali jesu u drugim kliničkim ispitivanjima (n = 1889).
English: Hypothyroidism and hyperthyroidism
Croatian: Hipotireoza i hipertireoza
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.
Croatian: U bazi objedinjenih podataka o sigurnosti monoterapije lijekom IMFINZI, imunološki uzrokovan osip ili dermatitis javio se kod 30 (1,6%) bolesnika, uključujući događaje 3. stupnja kod 7 (0,4%) bolesnika.
English: For symptomatic adrenal insufficiency, patients should be managed as recommended in section 4.2.
Croatian: U slučaju simptomatske insuficijencije nadbubrežnih žlijezda bolesnike treba liječiti u skladu s preporukama navedenima u dijelu 4.2.
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.
Croatian: U bazi objedinjenih podataka o sigurnosti monoterapije lijekom IMFINZI, imunološki uzrokovan kolitis ili proljev javio se kod 31 (1,6%) bolesnika, uključujući događaje 3. stupnja kod 6 (0,3%) bolesnika i događaj 4. stupnja kod 1 (< 0,1%) bolesnika.
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.
Croatian: Kod bolesnika koji su primali IMFINZI javili su se imunološki uzrokovan pneumonitis ili intersticijska bolest pluća, koji su definirani kao stanja koja su zahtijevala primjenu sistemskih kortikosteroida i za koje nije utvrđena jasna alternativna etiologija.
English: Other immune-mediated adverse reactions
Croatian: Ostale imunološki uzrokovane nuspojave
English: Immune-mediated hyperthyroidism
Croatian: Imunološki uzrokovana hipertireoza
English: Immune-mediated hypothyroidism
Croatian: Imunološki uzrokovana hipotireoza
English: At baseline, no differences in patient reported symptoms, function and HRQoL were observed between IMFINZI and placebo groups.
Croatian: Na početku ispitivanja nisu opažene nikakve razlike u simptomima, funkciji i kvaliteti života vezanoj uz zdravlje prema ocjeni bolesnika između skupine liječene lijekom IMFINZI i one koja je primala placebo.
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.
Croatian: U bazi objedinjenih podataka o sigurnosti monoterapije lijekom IMFINZI, imunološki uzrokovana hipotireoza javila se kod 137 (7,3%) bolesnika, uključujući događaj 3. stupnja kod 1 (< 0,1%) bolesnika.
English: Median OS (95% CI)
Croatian: Medijan OS-a (95% CI)
English: Immune-mediated colitis or diarrhoea
Croatian: Imunološki uzrokovan kolitis ili proljev
English: Immune-mediated type 1 diabetes mellitus occurred in patients receiving IMFINZI (see section 4.8).
Croatian: Kod bolesnika koji su primali IMFINZI javila se imunološki uzrokovana šećerna bolest tipa 1 (vidjeti dio 4.8).
English: Uncommon General disorders and administration site conditions Pyrexia
Croatian: Opći poremećaji i reakcije na mjestu primjene pireksija vrlo često
English: In the combined safety database with IMFINZI monotherapy, immune-mediated hypopituitarism occurred in 1 (< 0.1%) patient (Grade 3).
Croatian: U bazi objedinjenih podataka o sigurnosti monoterapije lijekom IMFINZI, imunološki uzrokovan hipopituitarizam javio se kod 1 (< 0,1%) bolesnika (3. stupanj).
English: Immune-mediated hypophysitis or hypopituitarism occurred in patients receiving IMFINZI (see section 4.8).
Croatian: Kod bolesnika koji su primali IMFINZI javili su se imunološki uzrokovan hipofizitis ili hipopituitarizam (vidjeti dio 4.8).
English: Eleven of the 30 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Croatian: Jedanaest (11) od tih 30 bolesnika primalo je visoke doze kortikosteroida (najmanje 40 mg prednizona ili ekvivalent na dan).
English: Sixteen of the 31 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Croatian: Šesnaest (16) od 31 bolesnika primalo je visoke doze kortikosteroida (najmanje 40 mg prednizona ili ekvivalent na dan).
English: Discard the vial if the solution is cloudy, discoloured or visible particles are observed.
Croatian: Bacite bočicu ako je otopina mutna, ako je promijenila boju ili ako sadrži vidljive čestice.
English: Forest plot of PFS by PD-L1 expression
Croatian: Slika 6. Grafikon raspona pouzdanosti PFS-a prema ekspresiji PD-L1
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.
Croatian: U bazi objedinjenih podataka o sigurnosti monoterapije lijekom IMFINZI, imunološki uzrokovan nefritis javio se kod 3 (0,2%) bolesnika, uključujući događaj 3. stupnja kod 1 (< 0,1%) bolesnika.
English: Clear to opalescent, colourless to slightly yellow solution, free from visible particles.
Croatian: Bistra do opalescentna, bezbojna do blijedožuta otopina koja ne sadrži vidljive čestice.
English: d includes gingivitis, oral infection, periodontitis, pulpitis dental, tooth abscess and tooth infection.
Croatian: Infekcije i infestacije infekcije gornjih dišnih putova vrlo često pneumonija b,c vrlo često infekcije zuba i mekog tkiva u usnoj šupljini često oralna kandidijaza često
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.
Croatian: U bazi objedinjenih podataka o sigurnosti monoterapije lijekom IMFINZI, imunološki uzrokovana insuficijencija nadbubrežnih žlijezda javila se kod 7 (0,4%) bolesnika, uključujući događaj 3. stupnja kod 1 (< 0,1%) bolesnika.
English: Patients should be monitored for signs and symptoms of colitis or diarrhoea and managed as recommended in section 4.2.
Croatian: Bolesnike treba nadzirati zbog moguće pojave znakova i simptoma kolitisa ili proljeva te liječiti u skladu s preporukama navedenima u dijelu 4.2.
English: Thirteen of the 19 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Croatian: Trinaest (13) od 19 bolesnika primalo je visoke doze kortikosteroida (najmanje 40 mg prednizona ili ekvivalent na dan).
English: In the combined safety database with IMFINZI monotherapy, immune-mediated type 1 diabetes mellitus occurred in 1 (< 0.1%) patient (Grade 3).
Croatian: U bazi objedinjenih podataka o sigurnosti monoterapije lijekom IMFINZI, imunološki uzrokovana šećerna bolest tipa 1 javila se kod 1 (< 0,1%) bolesnika (3. stupanj).
English: One patient also received infliximab treatment.
Croatian: Jedan je bolesnik primao i infliksimab.
English: Immune-mediated adrenal insufficiency occurred in patients receiving IMFINZI (see section 4.8).
Croatian: Kod bolesnika koji su primali IMFINZI javila se imunološki uzrokovana insuficijencija nadbubrežnih žlijezda (vidjeti dio 4.8).
English: Resolution occurred in 1 patient.
Croatian: Nuspojava se povukla kod 1 bolesnika.
English: AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00
Croatian: AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100
English: Adrenal insufficiency
Croatian: Insuficijencija nadbubrežnih žlijezda
English: Initiate 1 to 2 mg/kg/day prednisone or equivalent followed by a taper
Croatian: Uvesti prednizon u dozi od 1 - 2 mg/kg na dan ili ekvivalent, koja se zatim postupno smanjuje
English: Rare Respiratory, thoracic and mediastinal disorders Cough/Productive Cough
Croatian: Srčani poremećaji miokarditis rijetko Poremećaji dišnog sustava, prsišta i sredoprsja kašalj/produktivni kašalj vrlo često pneumonitis vrlo često disfonija često intersticijska bolest pluća manje često
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).
Croatian: Kod bolesnika koji su primali IMFINZI javili su se imunološki uzrokovan osip ili dermatitis, koji su definirani kao stanja koja su zahtijevala primjenu sistemskih kortikosteroida i za koja nije utvrđena jasna alternativna etiologija (vidjeti dio 4.8).
English: Immune-mediated colitis or diarrhoea, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMFINZI (see section 4.8).
Croatian: Kod bolesnika koji su primali IMFINZI javili su se imunološki uzrokovan kolitis ili proljev, koji su definirani kao stanja koja su zahtijevala primjenu sistemskih kortikosteroida i za koje nije utvrđena jasna alternativna etiologija (vidjeti dio 4.8).
English: Immune-mediated nephritis, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMFINZI (see section 4.8).
Croatian: Kod bolesnika koji su primali IMFINZI javio se imunološki uzrokovan nefritis, koji je definiran kao stanje koje je zahtijevalo primjenu sistemskih kortikosteroida i za koje nije utvrđena jasna alternativna etiologija (vidjeti dio 4.8).
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).
Croatian: Kod bolesnika koji su primali IMFINZI javio se imunološki uzrokovan hepatitis, koji je definiran kao stanje koje je zahtijevalo primjenu sistemskih kortikosteroida i za koje nije utvrđena jasna alternativna etiologija (vidjeti dio 4.8).
English: Initiate 2 to 4 mg/kg/day prednisone or equivalent followed by a taper
Croatian: Uvesti prednizon u dozi od 2 - 4 mg/kg na dan ili ekvivalent, koja se zatim postupno smanjuje