FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with disease control at 12 months were given the option to be re-treated upon disease progression.
Croatian: Bolesnicima kojima je bolest bila pod kontrolom nakon 12 mjeseci ponuđena je mogućnost ponovnog liječenja nakon progresije bolesti.
English: Randomisation was stratified by gender, age (< 65 years vs. ≥ 65 years) and smoking status (smoker vs. non-smoker).
Croatian: Randomizacija je bila stratificirana prema spolu, dobi (< 65 godina naspram ≥ 65 godina) i pušačkom statusu (pušači naspram nepušači).
English: • a condition in which the muscles become weak and there is a rapid fatigue of the muscles (myasthenia gravis).
Croatian: • stanje u kojem mišići postaju slabi i dolazi do brzog umora mišića (mijastenija gravis).
English: The presence of ADAs did not have a clinically relevant effect on safety.
Croatian: Prisutnost protutijela na lijek nije klinički značajno utjecala na sigurnost.
English: EU/1/18/1322/002 120 mg vial EU/1/18/1322/001 500 mg vial
Croatian: EU/1/18/1322/002 bočica od 120 mg EU/1/18/1322/001 bočica od 500 mg
English: • Ask your doctor if you can breast-feed during or after treatment with IMFINZI.
Croatian: • Pitajte liječnika smijete li dojiti tijekom ili nakon liječenja lijekom IMFINZI.
English: Your doctor may delay the next dose of IMFINZI or stop your treatment with IMFINZI, if you have:
Croatian: Liječnik će možda odgoditi primjenu sljedeće doze lijeka IMFINZI ili obustaviti liječenje lijekom IMFINZI ako imate:
English: • a condition leading to high blood sugar levels (type 1 diabetes mellitus)
Croatian: • stanje koje dovodi do visoke razine šećera u krvi (šećerna bolest tipa 1)
English: IMFINZI will be given to you in a hospital or clinic and the healthcare professional will be responsible for its storage.
Croatian: Lijek IMFINZI će Vam dati u bolnici ili klinici i zdravstveni radnik odgovoran je za njegovo čuvanje.
English: The solution has a pH of approximately 6.0 and an osmolality of approximately 400 mOsm/kg.
Croatian: Otopina ima pH od približno 6,0 i osmolalnost od približno 400 mOsm/kg.
English: The demographics and baseline disease characteristics were well balanced between study arms.
Croatian: Demografske i početne značajke bolesti bile su dobro ujednačene među ispitivanim skupinama.
English: No dose adjustment is required for elderly patients (≥ 65 years of age) (see section 5.1).
Croatian: Nije potrebno prilagođavati dozu kod starijih bolesnika (≥ 65 godina) (vidjeti dio 5.1).
English: What you need to know before you are given IMFINZI
Croatian: Što morate znati prije nego primite IMFINZI
English: A decision must be made whether to discontinue breast feeding or to discontinue or abstain from durvalumab therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Mora se donijeti odluka o tome hoće li se prekinuti dojenje ili prekinuti/privremeno odgoditi primjena durvalumaba, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: • Your doctor will give you IMFINZI through an infusion (drip) into your vein for about
Croatian: • Liječnik će Vam dati IMFINZI infuzijom (drip) u venu tijekom razdoblja od približno
English: Probability of OS
Croatian: Vjerojatnost OS-a
English: The recommended dose is 10 mg of durvalumab per kilogram of your body weight.
Croatian: Preporučena doza je 10 mg durvalumaba po kilogramu tjelesne težine.
English: 6545 CG Nijmegen The Netherlands
Croatian: 6545 CG Nijmegen Nizozemska
English: What IMFINZI contains The active substance is durvalumab.
Croatian: Što IMFINZI sadrži Djelatna tvar je durvalumab.
English: In the absence of data, durvalumab should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis.
Croatian: Zbog nedostatka podataka, durvalumab u tim populacijama treba primjenjivati uz oprez nakon pažljivog razmatranja omjera mogućih koristi i rizika kod svakog pojedinog bolesnika.
English: • Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Croatian: • Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku.
English: If refrigerated, intravenous bags must be allowed to come to room temperature prior to use.
Croatian: Ako se vrećica za intravensku primjenu čuva u hladnjaku, mora se pričekati da se prije primjene ugrije na sobnu temperaturu.
English: Carcinogenicity and mutagenicity The carcinogenic and genotoxic potential of durvalumab has not been evaluated.
Croatian: Nije se ocjenjivao kancerogeni ni genotoksični potencijal durvalumaba.
English: This 1 patient received insulin.
Croatian: Taj je jedan bolesnik primao inzulin.
English: Based on population PK analysis, slightly lower exposure are expected in ADA-positive patients however, the reduction of PK exposure is less than 30% compared to a typical patient and is not considered clinically relevant.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, očekuje se nešto niža izloženost u bolesnika koji su pozitivni na protutijela na lijek; međutim, smanjenje farmakokinetičke izloženosti manje je od 30% u usporedbi s tipičnim bolesnikom i ne smatra se klinički značajnim.
English: For myasthenia gravis, if there are signs of muscular weakness or respiratory insufficiency, IMFINZI should be permanently discontinued.
Croatian: Kod mijastenije gravis, ako postoje znakovi mišićne slabosti ili respiratorne insuficijencije, liječenje lijekom IMFINZI treba trajno prekinuti.
English: IMFINZI is used to treat a type of lung cancer called non-small cell lung cancer (NSCLC) in adults.
Croatian: IMFINZI se koristi za liječenje jedne vrste raka pluća koji se zove rak pluća nemalih stanica (engl. non-small cell lung cancer, NSCLC) kod odraslih osoba.
English: IMFINZI contains the active substance durvalumab which is a monoclonal antibody, a type of protein designed to recognise a specific target substance in the body.
Croatian: IMFINZI sadrži djelatnu tvar durvalumab, koja je monoklonsko protutijelo, tj. jedna vrsta proteina oblikovana tako da prepozna specifičnu ciljnu tvar u tijelu.
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
Croatian: Mjesec 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
English: • Call your doctor straight away to reschedule your appointment.
Croatian: • Odmah nazovite liječnika i dogovorite novi termin.
English: Any Grade (%)
Croatian: Bilo koji stupanj (%)
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
Croatian: Mjesec 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
English: The terminal half-life (t1/2), based on baseline CL, was approximately 18 days.
Croatian: Terminalni poluvijek (t1/2) prema početnom klirensu iznosio je približno 18 dana.
English: Durvalumab does not induce antibody dependent cell-mediated cytotoxicity (ADCC).
Croatian: Durvalumab ne inducira staničnu citotoksičnost ovisnu o protutijelima (engl. antibody-dependent cell-mediated cytotoxicity, ADCC).
English: Across all studies, IMFINZI was administered at a dose of 10 mg/kg every 2 weeks.
Croatian: U svim se ispitivanjima IMFINZI primjenjivao u dozi od 10 mg/kg svaka 2 tjedna.
English: Secondary efficacy endpoints included PFS at 12 months (PFS 12) and 18 months (PFS 18) from randomisation and Time from Randomisation to Second Progression (PFS2).
Croatian: Sekundarne mjere ishoda za djelotvornost uključivale su PFS 12 mjeseci (PFS 12) i 18 mjeseci (PFS 18) nakon randomizacije te vrijeme od randomizacije do druge progresije bolesti (PFS2).
English: Data from NSCLC patients 75 years of age or older are limited.
Croatian: Podaci o bolesnicima s NSCLC-om koji imaju 75 ili više godina su ograničeni.
English: Data from patients with severe renal impairment are too limited to draw conclusions on this population (see section 5.2).
Croatian: Podaci o primjeni kod bolesnika s teškim oštećenjem bubrežne funkcije previše su ograničeni da bi se na temelju njih mogli donijeti zaključci za tu populaciju (vidjeti dio 5.2).
English: Human IgG1 is known to cross the placental barrier and placental transfer of durvalumab was confirmed in animal studies.
Croatian: Poznato je da humani IgG1 prolazi kroz posteljičnu barijeru, a prijenos durvalumaba kroz posteljicu potvrđen je u ispitivanjima na životinjama.
English: Durvalumab is produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology.
Croatian: Durvalumab se proizvodi u stanicama sisavaca (jajnika kineskog hrčka) tehnologijom rekombinantne DNK.
English: Patients excluded from clinical trials
Croatian: Bolesnici koji nisu bili uključeni u klinička ispitivanja
English: Expression of programmed cell death ligand-1 (PD-L1) protein is an adaptive immune response that helps tumours evade detection and elimination by the immune system.
Croatian: Ekspresija proteina liganda-1 programirane stanične smrti (engl. programmed cell death ligand-1, PD-L1) adaptivan je imunosni odgovor koji pomaže tumorima izbjeći da ih imunosni sustav otkrije i uništi.
English: IMFINZI is for intravenous use.
Croatian: IMFINZI je namijenjen za intravensku primjenu.
English: • The medicinal product, once diluted, should be used immediately.
Croatian: • Lijek nakon razrjeđivanja treba odmah primijeniti.
English: Number of events (%) Median PFS (months)
Croatian: Broj događaja (%) Medijan PFS-a (mjeseci)
English: Additional subgroup analyses were conducted to evaluate the efficacy by tumour PD-L1 expression (≥ 25%, 1-24%, ≥ 1%, < 1%) and for patients whose PD-L1 status cannot be established (PD-L1 unknown).
Croatian: Provedene su dodatne analize podskupina radi ocjene djelotvornosti prema tumorskoj ekspresiji PD-L1 (≥ 25%, 1 - 24%, ≥ 1%, < 1%) te kod bolesnika kod kojih se nije mogao odrediti PD-L1 status (PD-L1 nepoznat).
English: Do not freeze or shake the solution.
Croatian: Nemojte zamrzavati ni tresti otopinu.
English: OS Number of deaths (%) Median (months) (95% CI)
Croatian: OS Broj smrtnih slučajeva (%) Medijan (mjeseci) (95% CI)
English: The LC13 and C30 were assessed at baseline, every 4 weeks for the first 8 weeks, followed by every 8 weeks until completion of the treatment period or discontinuation of IMFINZI due to toxicity or disease progression.
Croatian: Upitnici LC13 i C30 ispunjavali su se na početku ispitivanja, svaka 4 tjedna tijekom prvih 8 tjedana, a zatim svakih 8 tjedana do kraja razdoblja liječenja ili prekida primjene lijeka IMFINZI zbog toksičnosti ili progresije bolesti.
English: Disease characteristics were as follows: Stage IIIA (53%), Stage IIIB (45%), histological sub-groups of squamous (46%), non-squamous (54%).
Croatian: Značajke bolesti bile su sljedeće: stadij IIIA (53%), stadij IIIB (45%), histološki planocelularna bolest (46%), histološki neplanocelularna bolest (54%).
English: Neutralising antibodies (nAbs) against durvalumab were detected in 0.5% (8/1570) of patients.
Croatian: Neutralizirajuća protutijela na durvalumab pronađena su kod 0,5% (8/1570) bolesnika.
English: There is no information on overdose with durvalumab.
Croatian: Nema podataka o predoziranju durvalumabom.
English: Permanently discontinue IMFINZI if adverse reaction does not resolve to ≤ Grade 1 within 30 days or if there are signs of respiratory insufficiency.
Croatian: Trajno prekinuti liječenje lijekom IMFINZI ako se nuspojava ne ublaži do ≤ 1. stupnja unutar 30 dana ili ako su prisutni znakovi respiratorne insuficijencije.
English: PD-L1 blocks T-cell function and activation through interaction with PD-1 and CD80 (B7.1).
Croatian: PD-L1 blokira funkciju i aktivaciju T-stanica interakcijom s PD-1 i CD80 (B7.1).
English: Durvalumab is a fully human, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that selectively blocks the interaction of PD-L1 with PD-1 and CD80 (B7.1).
Croatian: Durvalumab je potpuno humano, imunoglobulinsko G1 kapa (IgG1κ) monoklonsko protutijelo koje selektivno blokira interakciju PD-L1 s PD-1 i CD80 (B7.1).
English: Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza oznake 'EXP'.
English: There are insufficient number of patients to determine ADA impact on efficacy.
Croatian: Broj bolesnika nedovoljan je za određivanje kako protutijela na lijek utječu na djelotvornost.
English: Age (19-96 years), body weight (34-149 kg), gender, positive anti-drug antibody (ADA) status, albumin levels, LDH levels, creatinine levels, soluble PD-L1, tumour type, race or ECOG status had no clinically significant effect on the PK of durvalumab.
Croatian: Dob (19 - 96 godina), tjelesna težina (34 - 149 kg), spol, pozitivan status protutijela na lijek, razine albumina, razine LDH-a, razine kreatinina, topljivi PD-L1, vrsta tumora, rasa i ECOG status nisu klinički značajno utjecali na farmakokinetiku durvalumaba.
English: Animal studies with durvalumab are not indicative of reproductive toxicity (see section 5.3).
Croatian: Ispitivanja durvalumaba na životinjama ne ukazuju na reproduktivnu toksičnost (vidjeti dio 5.3).
English: Number of patients at risk
Croatian: Broj bolesnika pod rizikom
English: • infections of the upper respiratory tract
Croatian: • infekcija gornjih dišnih puteva
English: Given the mechanism of action of IMFINZI, other potential immune-mediated adverse reactions may occur.
Croatian: S obzirom na mehanizam djelovanja lijeka IMFINZI, mogu se javiti i druge imunološki uzrokovane nuspojave.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with durvalumab in all subsets of the paediatric population in the treatment of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms) (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja durvalumaba u svim podskupinama pedijatrijske populacije za liječenje zloćudnih novotvorina (osim tumora u središnjem živčanom sustavu te novotvorina u hematopoetskom i limfoidnom tkivu) (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: There are no data on the use of durvalumab in pregnant women.
Croatian: Nema podataka o primjeni durvalumaba kod trudnica.
English: Data from patients with moderate and severe hepatic impairment are limited.
Croatian: Podaci o primjeni kod bolesnika s umjerenim i teškim oštećenjem jetrene funkcije su ograničeni.
English: The most frequent Grade 3-4 adverse reaction was pneumonia (6.5% vs 5.6% in placebo).
Croatian: Najčešća nuspojava 3. - 4. stupnja bila je pneumonija (6,5% naspram 5,6% uz placebo).
English: (22.9, NR)
Croatian: (22,9; ND)
English: PD-L1 can be induced by inflammatory signals (e.g., IFN-gamma) and can be expressed on both tumour cells and tumour-associated immune cells in tumour microenvironment.
Croatian: PD-L1 mogu inducirati upalni signali (npr. IFN-gama), a može se eksprimirati i na tumorskim stanicama i na imunosnim stanicama povezanima s tumorom koje se nalaze u tumorskom mikrookruženju.
English: For suspected immune-mediated adverse reactions, adequate evaluation should be performed to confirm etiology or exclude alternate etiologies.
Croatian: U slučaju sumnje na imunološki uzrokovane nuspojave, potrebno je provesti odgovarajuću procjenu kako bi se potvrdila etiologija ili isključile druge moguće etiologije.
English: Withhold dose until clinically stable
Croatian: Odgoditi primjenu doze dok bolesnik ne bude klinički stabilan
English: • It is not known if IMFINZI passes into human breast milk.
Croatian: • Nije poznato izlučuje li se IMFINZI u majčino mlijeko.
English: Women of childbearing potential should use effective contraception during treatment with durvalumab and for at least 3 months after the last dose of durvalumab.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja durvalumabom i još najmanje 3 mjeseca nakon posljednje doze durvalumaba.
English: Of the 713 patients randomised, 63% of patients provided a tissue sample of sufficient quality and quantity to determine PD-L1 expression and 37% were unknown.
Croatian: Od 713 randomiziranih bolesnika, za njih 63% postojao je uzorak tkiva čija je kvaliteta i količina bila dostatna za određivanje ekspresije PD-L1, dok je kod 37% bolesnika PD-L1 status bio nepoznat.
English: It is available in packs containing either 1 glass vial of 2.4 mL of concentrate or 1 glass vial of 10 mL of concentrate.
Croatian: Dostupan je u pakiranjima koja sadrže ili 1 staklenu bočicu od 2,4 ml koncentrata ili 1 staklenu bočicu od 10 ml koncentrata.
English: • has spread within your lung and cannot be removed by surgery, and
Croatian: • kada se NSCLC proširio unutar pluća i ne može se ukloniti kirurškim zahvatom i
English: The PK of durvalumab was studied in 1902 patients with solid tumours with doses ranging from 0.1 to 20 mg/kg administered intravenously once every two, three or four weeks.
Croatian: Farmakokinetika durvalumaba ispitivala se kod 1902 bolesnika sa solidnim tumorima koja su primala intravenske doze u rasponu od 0,1 do 20 mg/kg jedanput svaka dva, tri ili četiri tjedna.
English: Durvalumab may cause foetal harm when administered to a pregnant woman and is not recommended during pregnancy and in women of childbearing potential not using effective contraception during treatment and for at least 3 months after the last dose.
Croatian: Durvalumab može naškoditi plodu kad se primjenjuje kod trudnica i primjena se ne preporučuje kod trudnica i žena reproduktivne dobi koje ne koriste učinkovitu kontracepciju tijekom liječenja i još najmanje 3 mjeseca nakon posljednje doze.
English: • reaction to the infusion of the medicine that can cause fever or flushing
Croatian: • reakcija na infuziju lijeka, koja može uzrokovati vrućicu ili navale crvenila
English: • If you are a woman who could become pregnant you must use effective birth control while you are being treated with IMFINZI and for at least 3 months after your last dose.
Croatian: • Ako ste žena koja bi mogla zatrudnjeti, morate koristiti učinkovitu kontracepciju tijekom liječenja lijekom IMFINZI i još najmanje 3 mjeseca nakon posljednje doze.
English: The two primary endpoints of the study were progression-free survival (PFS) and overall survival (OS) of IMFINZI vs. placebo.
Croatian: Dvije primarne mjere ishoda u ispitivanju bile su preživljenje bez progresije bolesti (engl. progression-free survival, PFS) i ukupno preživljenje (engl. overall survival, OS) uz IMFINZI u odnosu na placebo.
English: The primary elimination pathways of durvalumab are protein catabolism via reticuloendothelial system or target mediated disposition.
Croatian: Primarni putovi eliminacije durvalumaba su proteinski katabolizam putem retikuloendotelnog sustava ili dispozicija vezivanjem za ciljno mjesto.
English: However, systemic corticosteroids or other immunosuppressants can be used after starting durvalumab to treat immune-related adverse reactions (see section 4.4).
Croatian: Međutim, sistemski kortikosteroidi ili drugi imunosupresivi mogu se koristiti nakon uvođenja durvalumaba za liječenje imunološki uzrokovanih nuspojava (vidjeti dio 4.4).
English: What IMFINZI is and what it is used for What you need to know before you are given IMFINZI How you are given IMFINZI Possible side effects
Croatian: Što je IMFINZI i za što se koristi Što morate znati prije nego primite IMFINZI
English: May consider pre-medications for prophylaxis of subsequent infusion reactions
Croatian: Može se razmotriti premedikacija za profilaksu reakcija na sljedeće infuzije
English: As reported in the literature, the PD-1/PD-L1 pathway plays a central role in preserving pregnancy by maintaining maternal immune tolerance to the foetus, and in mouse allogeneic pregnancy models disruption of PD-L1 signalling was shown to result in an increase in foetal loss.
Croatian: Kao što je opisano u literaturi, put PD-1/PD-L1 igra glavnu ulogu u očuvanju trudnoće održavanjem tolerancije majčina imunosnog sustava na plod, pa je u mišjim alogenim modelima skotnosti ometanje signalizacije putem PD-L1 dovelo do povećane stope gubitka ploda.
English: Available toxicological data in cynomolgus monkeys have shown low levels of durvalumab in breast milk on Day 28 after birth (see section 5.3).
Croatian: Dostupni toksikološki podaci prikupljeni kod makaki majmuna pokazali su niske razine durvalumaba u mlijeku 28. dana nakon okota (vidjeti dio 5.3).
English: The efficacy of IMFINZI was evaluated in the PACIFIC Study, a randomised, double-blind, placebo-controlled, multicentre study in 713 patients with locally advanced, unresectable NSCLC.
Croatian: Djelotvornost lijeka IMFINZI ocjenjivala se u ispitivanju PACIFIC, koje je bilo randomizirano, dvostruko slijepo, placebom kontrolirano, multicentrično ispitivanje provedeno kod 713 bolesnika s lokalno uznapredovalim neresektabilnim NSCLC-om.
English: Patient-reported symptoms, function and health-related quality of life (HRQoL) were collected using the EORTC QLQ-C30 and its lung cancer module (EORTC QLQ-LC13).
Croatian: Podaci o simptomima, funkciji i kvaliteti života vezanoj uz zdravlje prema ocjeni bolesnika prikupljali su se upitnikom QLQ-C30 i modulom tog upitnika za rak pluća (EORTC QLQ-LC13).
English: Number of patients at risk Month
Croatian: Broj bolesnika pod rizikom Mjesec
English: • serious lung infections (pneumonia)
Croatian: • ozbiljna infekcija pluća (pneumonija)
English: In this patient population, the most frequent adverse reactions were cough (40.2% vs 30.3% in placebo), upper respiratory tract infections (26.1% vs 11.5% in placebo) and rash (21.7% vs 12.0% in placebo).
Croatian: U toj su populaciji bolesnika najčešće nuspojave bile kašalj (40,2% naspram 30,3% uz placebo), infekcije gornjih dišnih putova (26,1% naspram 11,5% uz placebo) i osip (21,7% naspram 12,0% uz placebo).
English: If you have any further questions about your treatment, ask your doctor.
Croatian: Ako imate dodatnih pitanja o liječenju, obratite se svom liječniku.
English: IMFINZI should be discontinued for Grade 4 adverse reactions (with the exception of Grade 4 laboratory abnormalities, about which the decision to discontinue should be based on accompanying clinical signs/symptoms and clinical judgment).
Croatian: Kod takvih nuspojava 4. stupnja potrebno je trajno prekinuti liječenje lijekom IMFINZI (izuzetak su odstupanja u laboratorijskim vrijednostima 4. stupnja, kod kojih se odluka o prekidu liječenja treba temeljiti na popratnim kliničkim znakovima/simptomima i kliničkoj prosudbi).
English: The safety of IMFINZI (10 mg/kg) has been evaluated in the PACIFIC Study (n = 475) in patients with locally advanced, unresectable NSCLC who had completed treatment with at least 2 cycles of concurrent chemoradiation within 1 to 42 days prior to initiation of the study.
Croatian: Sigurnost lijeka IMFINZI (10 mg/kg) ocjenjivala se u ispitivanju PACIFIC (n = 475) kod bolesnika s lokalno uznapredovalim, neresektabilnim NSCLC-om koji su dovršili liječenje najmanje dvama ciklusima istodobne kemoradioterapije unutar 1 - 42 dana prije početka ispitivanja.
English: 28.7 (22.9, NR)
Croatian: 28,7 (22,9; ND)
English: Of the 1570 patients who were treated with IMFINZI 10 mg/kg every 2 weeks and evaluable for the presence of anti-drug antibodies (ADAs), 2.9% (45/1570) of patients tested positive for treatment-emergent ADAs.
Croatian: Od 1570 bolesnika liječenih lijekom IMFINZI u dozi od 10 mg/kg svaka 2 tjedna kod kojih se mogla provesti ocjena prisutnosti protutijela na lijek, njih 2,9% (45/1570) bilo je pozitivno na protutijela na lijek koja su se razvila tijekom liječenja.