FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will continue giving you OPDIVO for as long as you keep benefitting from it or until you no longer tolerate the treatment.
Croatian: Liječnik će Vam nastaviti davati OPDIVO sve dok od njega budete imali koristi ili do trenutka kada više ne budete mogli podnositi liječenje.
English: Table 9: Best overall response, time and duration of response (CA209037)
Croatian: Tablica 9: Najbolji ukupan odgovor, vrijeme i trajanje odgovora (CA209037)
English: Additional efficacy measures included duration of response, PFS and OS.
Croatian: Dodatne mjere djelotvornosti uključivale su trajanje odgovora, PFS i OS.
English: Recommended dose and infusion time
Croatian: Preporučena doza i trajanje infuzije
English: If you stop using OPDIVO
Croatian: Ako prestanete primati OPDIVO
English: Do not use OPDIVO if you are pregnant unless your doctor specifically tells you to.
Croatian: Nemojte primati OPDIVO tijekom trudnoće, osim ako Vam to izričito ne kaže Vaš liječnik.
English: 30th June 2021
Croatian: 30. lipnja 2021.
English: Stevens-Johnson syndrome, vitiligo, erythema multiforme, alopecia, psoriasis
Croatian: Stevens-Johnsonov sindrom, vitiligo, multiformni eritem, alopecija, psorijaza
English: An updated OS analysis was performed when all patients had a minimum follow-up of 24 months (see figure 11).
Croatian: Analiza ažuriranih podataka o OS-u provedena je kada su svi bolesnici bili praćeni najmanje 24 mjeseca (vidjeti Sliku 11).
English: (95% CI)c nivolumab investigator's choice nivolumab investigator's choice nivolumab investigator's choice
Croatian: (95% CI)c nivolumab izbor ispitivača nivolumab izbor ispitivača nivolumab izbor ispitivača
English: OPDIVO alone or in combination with ipilimumab may cause changes in the results of tests carried out by your doctor.
Croatian: OPDIVO u monoterapiji ili u kombinaciji s ipilimumabom može uzrokovati promjene u nalazima pretraga koje provodi Vaš liječnik.
English: Responses are summarised in Table 12.
Croatian: Odgovori su sažeto prikazani u Tablici 12.
English: It is recommended to continue treatment with nivolumab or nivolumab in combination with ipilimumab for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
Croatian: Preporučuje se nastaviti liječenje nivolumabom ili nivolumabom u kombinaciji s ipilimumabom u klinički stabilnih bolesnika s početnim znakovima progresije bolesti dok se progresija bolesti ne potvrdi.
English: Not Availableb
Croatian: Nije dostupnob
English: However, once you are treated with OPDIVO, your doctor may give you corticosteroids to reduce any possible side effects that you may have during your treatment and this will not impact the effect of the medicine.
Croatian: Međutim, nakon što započnete liječenje lijekom OPDIVO, liječnik će Vam možda dati kortikosteroide kako bi ublažio nuspojave koje bi mogle nastupiti tijekom liječenja, ali to neće utjecati na učinak lijeka.
English: Number of Subjects at Risk
Croatian: Broj ispitanika pod rizikom
English: Additional outcome measures included duration and timing of response.
Croatian: Dodatne mjere ishoda uključivale su trajanje odgovora i vrijeme njegova nastupa.
English: Twenty-two percent of patients had received prior adjuvant therapy.
Croatian: Dvadeset i dva posto bolesnika prethodno je primalo adjuvantnu terapiju.
English: More than one vial of OPDIVO concentrate may be needed to give the total dose for the patient.
Croatian: Možda će biti potrebno više od jedne bočice koncentrata lijeka OPDIVO da bi se dobila bolesnikova ukupna doza.
English: Grade 4 creatinine elevation
Croatian: Povišenje razine kreatinina 4. stupnja
English: The estimated 1-year survival rate was
Croatian: Procijenjena stopa 1-godišnjeg preživljenja iznosila je 41%.
English: Open-label phase 1 dose-escalation study (MDX1106-03)
Croatian: Otvoreno ispitivanje povećanja doze faze 1 (MDX1106-03)
English: By attaching to PD-1, nivolumab blocks its action and prevents it from switching off your T cells.
Croatian: Vezivanjem za PD-1, nivolumab blokira njegovo djelovanje i sprječava ga da zaustavi aktivnost T-stanica.
English: 95% CI: 1.4, 17.9 OS by tumour PD-L1 expression Minimum follow-up: 13.2 months Number of events (number of patients)
Croatian: 95% CI: 1.4, 17.9 OS prema tumorskoj ekspresiji PD-L1 Minimalno praćenje: 13,2 mjeseca Broj događaja (broj bolesnika)
English: EU/1/15/1014/001 40 mg vial EU/1/15/1014/002 100 mg vial EU/1/15/1014/003 240 mg vial
Croatian: EU/1/15/1014/001 bočica od 40 mg EU/1/15/1014/002 bočica od 100 mg EU/1/15/1014/003 bočica od 240 mg
English: With a minimum follow-up of 11.4 months, the trial demonstrated a statistically significant improvement in OS for patients randomised to nivolumab as compared with investigator's choice.
Croatian: Uz minimalno praćenje od 11,4 mjeseca, ispitivanje je pokazalo statistički značajno poboljšanje OS-a u bolesnika randomiziranih za primanje nivolumaba u usporedbi s onima randomiziranima za terapiju prema izboru ispitivača.
English: If you become pregnant while using OPDIVO tell your doctor.
Croatian: Ako zatrudnite dok primate OPDIVO, obavijestite o tome svog liječnika.
English: The benefit of treatment with nivolumab versus the possible risk should be considered in these patients (see section 4.8).
Croatian: U tih bolesnika treba razmotriti korist liječenja nivolumabom u odnosu na mogući rizik (vidjeti dio 4.8).
English: Squamous Cell Cancer of the Head and Neck
Croatian: Planocelularni rak glave i vrata
English: 240 mg every 2 weeks over 30 minutes
Croatian: 240 mg svaka 2 tjedna tijekom 30 minuta
English: Computed using Kaplan-Meier method.
Croatian: Izračunato uporabom Kaplan-Meierove metode.
English: The median duration of response is 18.0 months (6.6, NE) for the 22 responders to nivolumab who had failed to achieve response with prior brentuximab vedotin treatment.
Croatian: Medijan trajanja odgovora iznosio je 18,0 mjeseci (6,6; NP) za 22 bolesnika s odgovorom na nivolumab koji nisu ostvarili odgovor na prethodno liječenje brentuksimab vedotinom.
English: Pericardial disorders is a composite term which includes pericarditis, pericardial effusion, cardiac tamponade, and Dressler's syndrome.
Croatian: Perikardijalni poremećaji su kompozitni pojam koji uključuje perikarditis, perikardijalni izljev, srčanu tamponadu i Dresslerov sindrom.
English: Stable disease, n (%) Duration of response in all responders (months)c
Croatian: Stabilna bolest, n (%) Trajanje odgovora u svih bolesnika s odgovorom (mjeseci)c
English: The primary OS analysis was not adjusted to account for subsequent therapies, with 54 (40.6%) patients in the chemotherapy arm subsequently receiving an anti-PD1 treatment.
Croatian: Primarna analiza OS-a nije bila prilagođena za uključivanje kasnijih terapija u 54 (40,6%) bolesnika u skupini liječenoj kemoterapijom koja je kasnije primala anti-PD1 liječenje.
English: Dacarbazine
Croatian: Dakarbazin
English: Do not take any other medicines during your treatment without talking to your doctor first.
Croatian: Nemojte uzimati nijedan drugi lijek tijekom liječenja ako o tome niste prethodno razgovarali sa svojim liječnikom.
English: No overall differences in safety or efficacy were reported between elderly (≥ 65 years) and younger patients (< 65 years).
Croatian: Sveukupno nisu prijavljene razlike u sigurnosti i djelotvornosti između starijih osoba (≥ 65 godina) i mlađih bolesnika (< 65 godina).
English: Combination phase, every 3 weeks for 4 dosing cycles
Croatian: Faza kombinirane terapije, svaka 3 tjedna tijekom 4 ciklusa primjene
English: A population PK analysis suggested no difference in CL of nivolumab based on age, gender, race, solid tumour type, tumour size, and hepatic impairment.
Croatian: Populacijska PK analiza nije ukazala na razlike u klirensu nivolumaba na temelju dobi, spola, rase, vrste solidnog tumora, veličine tumora i oštećenje jetrene funkcije.
English: An additional line of TKI therapy was allowed for patients with known EGFR mutation or ALK translocation.
Croatian: Dopuštena je bila i dodatna linija terapije inhibitorom tirozin kinaze za bolesnike s poznatom mutacijom EGFR-a ili translokacijom ALK-a.
English: Based on a stratified proportional hazards model.
Croatian: Na temelju stratificiranog modela proporcionalnih hazarda.
English: Nivolumab CL in cHL patients was approximately 32% lower relative to NSCLC.
Croatian: Klirens nivolumaba u bolesnika s kHL-om bio je približno 32% manji nego u bolesnika s NSCLC-om.
English: Factors associated with early deaths were poorer prognostic factors and/or more aggressive disease combined with low or no tumour PD-L1 expression (see section 5.1).
Croatian: Faktori povezani s ranim nastupom smrti bili su lošiji prognostički faktori i/ili agresivnija bolest u kombinaciji s niskom razinom ili izostankom tumorske ekspresije PD-L1 (vidjeti dio 5.1).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with nivolumab in all subsets of the paediatric population in the treatment of malignant solid tumours, malignant neoplasms of lymphoid tissue and malignant neoplasms of the central nervous system (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja nivolumaba u svim podskupinama pedijatrijske populacije za liječenje zloćudnih solidnih tumora, zloćudnih novotvorina limfoidnog tkiva i zloćudnih novotvorina u središnjem živčanom sustavu (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The median age was 60 years (range: 23-88).
Croatian: Medijan dobi iznosio je 60 godina (raspon: 23-88).
English: Before initiating treatment with the combination, physicians are advised to carefully evaluate the individual patient and tumour characteristics, taking into consideration the observed benefits and the toxicity of the combination relative to nivolumab monotherapy (see sections 4.8 and 5.1).
Croatian: Prije početka liječenja ovom kombinacijom, liječnicima se savjetuje da pažljivo ocijene značajke pojedinog bolesnika i tumora, uzimajući u obzir opaženu korist i toksičnost kombinirane terapije u odnosu na monoterapiju nivolumabom (vidjeti dijelove 4.8 i 5.1).
English: Each vial contains either 40 mg (in 4 mL), 100 mg (in 10 mL) or 240 mg (in 24 mL) of nivolumab.
Croatian: Jedna bočica sadrži ili 40 mg (u 4 ml),100 mg (u 10 ml) ili 240 ml (u 24 ml) nivolumaba.
English: Months (range)
Croatian: Mjeseci (raspon)
English: Because of the small size of this subgroup, no definitive conclusions can be drawn from these data.
Croatian: Zbog male veličine te podskupine, iz navedenih se podataka ne mogu izvesti definitivni zaključci.
English: It is available in packs containing either 1 vial of 4 mL, 1 vial of 10 mL or 1 vial of 24 mL.
Croatian: Dostupan je u pakiranjima koja sadrže 1 bočicu od 4 ml,1 bočicu od 10 ml ili 1 bočicu od 24 ml.
English: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to the programmed death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2.
Croatian: Nivolumab je ljudsko imunoglobulinsko G4 (IgG4) monoklonsko protutijelo (HuMAb), koje se vezuje za receptor programirane stanične smrti-1 (engl. programmed death-1, PD-1) i blokira njegovu interakciju s ligandima PD-L1 i PD-L2.
English: Additionally, based on these relationships, there were no clinically significant differences between a nivolumab dose of 480 mg every 4 weeks or 3 mg/kg every 2 weeks in adjuvant treatment of melanoma, advanced melanoma and advanced RCC.
Croatian: Nadalje, na temelju tih odnosa nisu utvrđene klinički značajne razlike između doze nivolumaba od 480 mg svaka 4 tjedna i doze od 3 mg/kg svaka 2 tjedna kod adjuvantnog liječenja melanoma te liječenja uznapredovalog melanoma i uznapredovalog karcinoma bubrežnih stanica.
English: (95% CI) Difference in ORR (95% CI)d p-valuee,f
Croatian: (95% CI) Razlika u ORR-u (95% CI)d p-vrijednoste,f
English: Efficacy results based on investigator-assessed response rates at week 12 are presented in Table 10 below.
Croatian: Rezultati za djelotvornost utemeljeni na stopama odgovora u 12. tjednu prema ocjeni ispitivača prikazani su u Tablici 10 u nastavku.
English: Most immune-related adverse reactions improved or resolved with appropriate management, including initiation of corticosteroids and treatment modifications (see section 4.2).
Croatian: Većina imunološki uzrokovanih nuspojava poboljšala se ili povukla uz odgovarajuće liječenje, uključujući uvođenje kortikosteroida i modifikacije liječenja (vidjeti dio 4.2).
English: No overall differences in safety were reported between elderly (≥ 65 years) and younger patients (< 65 years).
Croatian: Sveukupno nisu prijavljene razlike u sigurnosti između starijih osoba (≥ 65 godina) i mlađih bolesnika (< 65 godina).
English: 240 mg every 2 weeks over 30 minutes *As per monotherapy indication in section 4.1.
Croatian: 240 mg svaka 2 tjedna tijekom 30 minuta *Prema indikaciji za primjenu u monoterapiji navedenoj u dijelu 4.1.
English: N responders/ N evaluablea 95% CIb a includes confirmed and unconfirmed responses, scans were mandatory only at week 8/9 and week 52.
Croatian: Uključuje potvrđene i nepotvrđene odgovore; oslikavanje je bilo obvezno samo u 8./9. tjednu i 52. tjednu.
English: Probability of Overall Survival
Croatian: Vjerojatnost ukupnog preživljenja
English: Guillain-Barré syndrome, demyelination, myasthenic syndrome, encephalitisa,c
Croatian: Guillain-Barréov sindrom, demijelinizacija, mijastenički sindrom, encefalitisa,c
English: If you miss a dose of OPDIVO
Croatian: Ako ste propustili dozu lijeka OPDIVO
English: The Kaplan-Meier curves for OS (with a minimum follow-up of 24 months) in intermediate/poor risk patients are shown in Figure 11.
Croatian: Kaplan-Meierove krivulje za OS (uz minimalno praćenje od 24 mjeseca) u bolesnika s umjerenim/visokim rizikom prikazane su na Slici 11.
English: Fourty-nine (47.6%) responders had ongoing responses with a duration ranging from 0.0-27.6+ months.
Croatian: Četrdeset i devet (47,6%) ispitanika s odgovorom imalo je postojan odgovor, čije se trajanje kretalo u rasponu od 0,0-27,6+ mjeseci.
English: Unless an alternate aetiology has been identified, signs or symptoms of endocrinopathies should be considered immune-related.
Croatian: Ako se ne utvrdi neka druga etiologija, znakove ili simptome endokrinopatija treba smatrati imunološki uzrokovanima.
English: OPDIVO can be used for intravenous administration either: without dilution, after transfer to an infusion container using an appropriate sterile syringe; or after diluting according to the following instructions: the final infusion concentration should range between 1 and 10 mg/mL.
Croatian: OPDIVO se može upotrijebiti za intravensku primjenu: bez razrjeđivanja, nakon prijenosa u infuzijski spremnik uz pomoć odgovarajuće sterilne štrcaljke; ili nakon razrjeđivanja, prema sljedećim uputama: Konačna koncentracija infuzije mora biti u rasponu od 1 do 10 mg/ml.
English: See “Description of selected adverse reactions; laboratory abnormalities” below.
Croatian: Vidjeti „Opis odabranih nuspojava; odstupanja u laboratorijskim vrijednostima“ u nastavku.
English: Progression Free Survival Events (%)
Croatian: Preživljenje bez progresije bolesti Događaji (%)
English: • Contact details of the OPDIVO prescriber
Croatian: • Kontaktne podatke liječnika koji je propisao OPDIVO
English: • Grade 4 or recurrent Grade 3 adverse reactions;
Croatian: • nuspojava 4. stupnja ili rekurentnih nuspojava 3. stupnja;
English: Over 15 weeks of follow-up, patients treated with nivolumab exhibited stable PROs, while those assigned to investigator's choice therapy exhibited significant declines in functioning (e.g., physical, role, social) and health status as well as increased symptomatology (e.g., fatigue, dyspnoea, appetite loss, pain, sensory problems, social contact problems).
Croatian: Tijekom 15 tjedana praćenja, ishodi koje prijavljuju bolesnici bili su stabilni u bolesnika liječenih nivolumabom, dok su oni kojima je dodijeljena terapija po izboru ispitivača pokazivali značajan pad funkcioniranja (npr. tjelesne funkcije, obavljanja svakodnevnih aktivnosti, društvene funkcije) i zdravstvenog statusa, kao i izraženije simptome (npr. umor, dispneju, gubitak teka, bol, senzorne tegobe, probleme s društvenim kontaktima).
English: Derived from a stratified proportional hazards model.
Croatian: Dobiveno iz stratificiranog modela proporcionalnih hazarda.
English: The value of biomarkers to predict the efficacy of nivolumab and/or nivolumab + ipilimumab combination therapy should be further explored, specifically:
Croatian: Potrebno je dodatno istražiti vrijednost bioloških biljega u predviđanju djelotvornosti nivolumaba i/ili kombinirane terapije nivolumabom + ipilimumabom, osobito:
English: Uncommon bronchitis bronchitis, aseptic meningitis
Croatian: Manje često bronhitis bronhitis, aseptički meningitis
English: All were considered not related to nivolumab by investigators except arrhythmia (atrial fibrillation, tachycardia and ventricular arrhythmia).
Croatian: Ispitivači su smatrali da nijedna nije bila povezana s nivolumabom, osim aritmije (fibrilacija atrija, tahikardija i ventrikularna aritmija).
English: Treatment with nivolumab may increase the risk of rejection in solid organ transplant recipients.
Croatian: Liječenje nivolumabom može povećati rizik od odbacivanja solidnih organa kod bolesnika kojima je transplantiran.
English: Longer follow-up data from Cohort B (minimum 20.5 months) and efficacy of Cohort C from CA209205 are presented below in Table 22.
Croatian: Podaci iz dugoročnijeg praćenja kohorte B (minimalno 20,5 mjeseci) i podaci za djelotvornost u kohorti C iz ispitivanja CA209205 prikazani su u Tablici 22.
English: The differences between the two nivolumab-containing groups were evaluated descriptively.
Croatian: Razlike između dviju skupina čija je terapija uključivala nivolumab ocjenjivale su se opisno.
English: • patients with prior autoimmune disease, and any condition requiring systemic treatment with either corticosteroids (≥ 10 mg daily prednisone or equivalent) or other immunosuppressive medications,
Croatian: • u bolesnika koji su prethodno imali autoimunu bolest ili bilo koje stanje koje je zahtijevalo sistemsko liječenje kortikosteroidima (≥ 10 mg prednizona ili ekvivalenta na dan) ili drugim imunosupresivima
English: For adjuvant therapy, the maximum treatment duration with OPDIVO is 12 months.
Croatian: Kod adjuvantnog liječenja OPDIVO se smije primjenjivati najviše 12 mjeseci.
English: At a minimum follow-up of 9 months, investigator-assessed confirmed ORR was 24.4% (95% CI: 15.3, 35.4).
Croatian: Nakon praćenja od najmanje 9 mjeseci potvrđeni ORR prema ocjeni ispitivača iznosio je 24,4% (95% CI: 15,3; 35,4).
English: It is to be administered as an intravenous infusion over a period of 30 or 60 minutes depending on the dose (see Tables 1, 2 and 3).
Croatian: Primjenjuje se intravenskom infuzijom tijekom razdoblja od 30 ili 60 minuta, ovisno o dozi (vidjeti Tablice 1, 2 i 3).
English: The co-primary efficacy outcome measures were confirmed ORR in the first 120 patients treated with nivolumab, as measured by independent radiology review committee (IRRC) using RECIST, version 1.1, and comparison of OS of nivolumab to chemotherapy.
Croatian: Koprimarne mjere ishoda za djelotvornost bile su potvrđen ORR u prvih 120 bolesnika liječenih nivolumabom, koji je mjerilo neovisno povjerenstvo za ocjenu radioloških nalaza (engl. independent radiology review committee, IRRC) sukladno verziji 1.1. RECIST kriterija, te usporedba OS-a uz nivolumab u odnosu na kemoterapiju.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mg/4 mL
Croatian: 5. SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 40 mg/4 ml
English: Proportion ≥24 months in duration
Croatian: Udio s trajanjem ≥ 24 mjeseci
English: If you have any questions about ipilimumab, please ask your doctor.
Croatian: Ako imate bilo kakvih pitanja o ipilimumabu, obratite se svom liječniku.
English: Phase 3b/4 safety study (CA209374)
Croatian: Ispitivanje sigurnosti faze 3b/4 (CA209374)
English: Melanoma (advanced or adjuvant treatment)
Croatian: Melanom (liječenje uznapredovale bolesti ili adjuvantno liječenje)
English: Solid organ transplant rejection has been reported in the post-marketing setting in patients treated with PD-1 inhibitors.
Croatian: Nakon stavljanja lijeka u promet prijavljeno je odbacivanje transplantiranog solidnog organa u bolesnika koji su se liječili PD-1 inhibitorima.
English: Tumour assessments were conducted according to the RECIST version 1.1.
Croatian: Procjene tumora provodile su se u skladu s verzijom 1.1 RECIST kriterija.
English: NE (1.4+-25.5+)
Croatian: NP (1,4+-25,5+)
English: Results of a post-hoc, exploratory multivariate analysis indicated that nivolumab-treated patients with poorer prognostic features and/or aggressive disease when combined with lower (e.g., < 50%) or no tumour PD-L1 expression may be at higher risk of death within the first 3 months.
Croatian: Rezultati post-hoc eksploracijske multivarijantne analize ukazali su na to da bolesnici liječeni nivolumabom koji imaju lošije prognostičke značajke i/ili agresivnu bolest u kombinaciji s nižom razinom (npr. < 50%) ili izostankom tumorske ekspresije PD-L1 mogu imati povećan rizik od smrti unutar prva 3 mjeseca.
English: The frequency is based on the program-wide exposure.
Croatian: Učestalost se temelji na izloženosti u cjelokupnom programu ispitivanja.
English: Patients should be monitored for signs and symptoms of hepatitis such as transaminase and total bilirubin elevations.
Croatian: Bolesnike treba nadzirati zbog moguće pojave znakova i simptoma hepatitisa, poput povišenih razina transaminaza i ukupnog bilirubina.
English: Discard the vial if the solution is cloudy, is discoloured, or contains particulate matter other than a few translucentto-white particles.
Croatian: Bacite bočicu ako je otopina mutna, ako je promijenila boju ili ako sadrži bilo kakve čestice osim nekoliko prozirnih do bijelih čestica.
English: 208 35.94 (23.06, NR)
Croatian: 208 35,94 (23,06; NP)
English: However, the role of this biomarker (tumour PD-L1 expression) has not been fully elucidated.
Croatian: Međutim, uloga ovog biološkog biljega (tumorske ekspresije PD-L1) nije posve razjašnjena.
English: Table 10: Response rate at week 12 - all response evaluable patients and by subgroup (CA209172)
Croatian: Tablica 10: Stopa odgovora u 12. tjednu - u svih bolesnika pogodnih za ocjenu i prema podskupinama (CA209172)
English: • Persistent Grade 2 or 3 adverse reactions despite management.
Croatian: • nuspojava 2. ili 3. stupnja koje ne prolaze unatoč zbrinjavanju.
English: P-value is derived from a log-rank test stratified by prior maintenance therapy and line of therapy; the corresponding O'Brien-Fleming efficacy boundary significance level is 0.0408.
Croatian: P-vrijednost dobivena je iz log-rang testa stratificiranog prema prethodnoj terapiji održavanja i liniji terapije; odgovarajuća razina značajnosti za granicu djelotvornosti prema O'Brien-Flemingovoj metodi iznosi 0,0408.
English: The primary endpoint was recurrence-free survival (RFS).
Croatian: Primarna mjera ishoda bila je preživljenje bez recidiva (engl. recurrence-free survival, RFS).
English: Grade 2 myocarditis
Croatian: Miokarditis 2. stupnja
English: PHARMACEUTICAL FORM AND CONTENTS Sterile concentrate
Croatian: 4. FARMACEUTSKI OBLIK I SADRŽAJ Sterilni koncentrat
English: Uncommon tubulointerstitial nephritis tubulointerstitial nephritis
Croatian: Manje često tubulointersticijski nefritis tubulointersticijski nefritis
English: If not used immediately, the solution may be stored under refrigeration conditions (2°C-8°C) and protected from light for up to 24 hours [a maximum of 8 hours of the total 24 hours can be at room temperature (20°C-25°C) and room light].
Croatian: Ako se ne primijeni odmah, otopina se može čuvati u hladnjaku (2°C-8°C), zaštićena od svjetlosti, tijekom najviše 24 sata [lijek se može čuvati na sobnoj temperaturi (20°C-25°C) i sobnoj svjetlosti tijekom najviše 8 sati od ukupna 24 sata].