FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinically important differences in the clearance of avelumab were found between patients with mild (glomerular filtration rate (GFR) 60 to 89 mL/min, Cockcroft-Gault Creatinine Clearance (CrCL); n=623), moderate (GFR 30 to 59 mL/min, n=320) and patients with normal (GFR ≥ 90 mL/min, n=671) renal function.
Croatian: Oštećenje funkcije bubrega Nisu pronađene klinički važne razlike u klirensu avelumaba između bolesnika s blagim oštećenjem funkcije bubrega (brzina glomerularne filtracije (GFR) od 60 do 89 ml/min, klirens kreatinina prema Cockcroft-Gaultovoj formuli (CrCL); n=623), umjerenim oštećenjem funkcije bubrega (GFR od 30 do 59 ml/min, n=320) i bolesnika s normalnom (GFR ≥ 90 ml/min, n=671) funkcijom bubrega.
English: Type 1 diabetes mellitus Avelumab can cause Type 1 diabetes mellitus, including diabetic ketoacidosis (see section 4.8).
Croatian: Šećerna bolest tipa 1 Avelumab može uzrokovati šećernu bolest tipa 1, uključujući dijabetičku ketoacidozu (vidjeti dio 4.8).
English: If you stop receiving Bavencio
Croatian: Ako prestanete primati Bavencio
English: Type 1 diabetes mellitus did not resolve in any of the patients at the time of data cut-off.
Croatian: Šećerna bolest tipa 1 nije se povukla ni u jednog bolesnika u vrijeme prestanka prikupljanja podataka.
English: For renal cell cancer, Bavencio is to be used in combination with axitinib.
Croatian: Kod karcinoma bubrežnih stanica, Bavencio se primjenuje u kombinaciji s aksitinibom.
English: The primary efficacy endpoints were progression-free survival (PFS), as assessed by BICR using RECIST v1.1 and overall survival (OS) in the first-line treatment of patients with advanced RCC who have PD-L1-positive tumours (PD-L1 expression level ≥ 1%).
Croatian: Mjere primarnog ishoda bile su preživljenje bez progresije bolesti (engl. progression-free survival, PFS), prema procjeni BICR-a na temelju kriterija RECIST, v1.1, i ukupno preživljenje (engl. overall survival, OS) kod prve linije liječenja bolesnika s uznapredovalim karcinomom bubrežnih stanica koji imaju PD-L1-pozitivne tumore (razina ekspresije PD-L1 ≥ 1%).
English: Part A was a single-arm, multi-centre study conducted in patients with histologically confirmed metastatic MCC, whose disease had progressed on or after chemotherapy administered for distant metastatic disease, with a life expectancy of more than 3 months.
Croatian: Dio A bilo je multicentrično ispitivanje provedeno na jednoj skupini bolesnika s histološki potvrđenim metastatskim karcinomom Merkelovih stanica, čija je bolest progredirala tijekom ili nakon kemoterapije primijenjene zbog udaljenih metastaza, s očekivanim trajanjem života duljim od
English: The prespecified interim analysis for Part B included 39 patients who received at least one dose of avelumab and 29 patients with a minimum 13 weeks of follow-up at the time of the data cut-off (cut-off date 24 March 2017).
Croatian: Unaprijed određena interim analiza za dio B uključila je 39 bolesnika koji su primili najmanje jednu dozu avelumaba i 29 bolesnika koji su praćeni najmanje 13 tjedana do trenutka prestanka prikupljanja podataka za analizu (datum prestanka prikupljanja podataka: 24. ožujka 2017.).
English: Confirmed myocarditis
Croatian: Potvrđeni miokarditis
English: Renal cell carcinoma (study B9991003)
Croatian: Karcinom bubrežnih stanica (ispitivanje B9991003)
English: Response rate, CR+PR** n (%) (95% CI)
Croatian: Stopa odgovora, CR+PR** n (%) (95 % CI)
English: AST or ALT greater than 5 times ULN or total bilirubin greater than 3 times ULN
Croatian: AST ili ALT više od 5 puta iznad GGN-a ili ukupni bilirubin više od 3 puta iznad GGN-a
English: Avelumab is most frequently associated with immune-related adverse reactions.
Croatian: Avelumab je najčešće povezan s imunološki posredovanim nuspojavama.
English: Patients should be monitored for signs and symptoms of infusion-related reactions including pyrexia, chills, flushing, hypotension, dyspnoea, wheezing, back pain, abdominal pain, and urticaria.
Croatian: Bolesnike je potrebno pratiti zbog mogućih znakova i simptoma reakcija povezanih s infuzijom uključujući pireksiju, zimicu, navalu crvenila, hipotenziju, dispneju, piskanje pri disanju, bol u leđima, bol u abdomenu i urtikariju.
English: In patients treated with avelumab in combination with axitinib, Grades 3 and Grade 4 increased ALT and increased AST were reported in 9% and 7% of patients, respectively.
Croatian: U bolesnika liječenih avelumabom u kombinaciji s aksitinibom, povišene vrijednosti ALT-a i AST-a 3. i 4. stupnja zabilježene su u 9 % odnosno 7 % bolesnika.
English: • Numbness, tingling, weakness, burning sensation in arms or legs
Croatian: • utrnulost, trnci, slabost, osjećaj pečenja u rukama i nogama
English: Autoimmune colitis, autoimmune pancreatitis, enterocolitis, ileus, pancreatitis necrotizing
Croatian: Manje često autoimuni kolitis, autoimuni pankreatitis, enterokolitis, ileus, nekrotizirajući pankreatitis
English: If corticosteroids are used to treat an adverse reaction, a taper of at least 1 month duration should be initiated upon improvement.
Croatian: Ako se za liječenje nuspojave primjenjuju kortikosteroidi, nakon poboljšanja treba započeti s postupnim snižavanjem doze tijekom najmanje 1 mjeseca.
English: No interaction studies have been conducted with avelumab.
Croatian: Nisu provedena ispitivanja interakcija s avelumabom.
English: Tubulo-interstitial nephritis*
Croatian: Manje često tubulointersticijski nefritis*
English: The Kaplan-Meier curve of PFS of the 88 patients (Part A) with metastatic MCC is presented in Figure 1.
Croatian: Kaplan-Meierova krivulja preživljenja bez progresije bolesti u 88 bolesnika (dio A) s metastatskim karcinomom Merkelovih stanica prikazana je na slici 1.
English: Treatment modifications
Croatian: Prilagodbe liječenja
English: The recommended dose of Bavencio as monotherapy is 800 mg administered intravenously over 60 minutes every 2 weeks.
Croatian: Preporučena doza lijeka Bavencio u monoterapiji je 800 mg primijenjeno intravenski tijekom 60 minuta svaka 2 tjedna.
English: Detailed guidelines for the management of immune-related adverse reactions are described in section 4.4.
Croatian: Detaljne smjernice za zbrinjavanje imunološki posredovanih nuspojava opisane su u dijelu 4.4.
English: • withhold the next dose of Bavencio,
Croatian: • odgoditi primjenu sljedeće doze lijeka Bavencio
English: Hepatitis, hepatotoxicity, immune-mediated hepatitis, liver disorder
Croatian: Manje često hepatitis, hepatotoksičnost, imunološki posredovan hepatitis, poremećaj jetre
English: There are insufficient data in patients with severe renal impairment for dosing recommendations.
Croatian: Nema dovoljno podataka o bolesnicima s teškim oštećenjem funkcije bubrega da bi se mogle dati preporuke za doziranje.
English: PD-L1 is found on the surface of certain tumour cells, and helps protect them from the immune system (the body's natural defences).
Croatian: PD-L1 se nalazi na površini stanica nekih tumora i pomaže im da se zaštite od imunološkog sustava
English: Corticosteroids should be considered for Grade ≥ 2 events (see section 4.2).
Croatian: U slučaju događaja ≥ 2. stupnja treba razmotriti primjenu kortikosteroida (vidjeti dio 4.2).
English: Grade 3 or Grade 4 pneumonitis or recurrent Grade 2 pneumonitis
Croatian: Pneumonitis 3. ili 4. stupnja ili rekurentni pneumonitis 2. stupnja
English: Table 4 summarises efficacy endpoints in patients receiving avelumab at the recommended dose for study EMR100070-003, Part A, with a minimum follow-up of 36 months.
Croatian: Tablica 4 sažeto prikazuje ishode djelotvornosti u bolesnika koji su primali avelumab u preporučenoj dozi u ispitivanju EMR100070-003, dio A, za minimalno trajanje praćenja od 36 mjeseca.
English: For patients with Grade 2 infusion-related reactions, the infusion should be temporary discontinued until Grade 1 or resolved, then the infusion will restart with a 50% slower infusion rate (see section 4.2).
Croatian: U bolesnika s reakcijama 2. stupnja povezanih s infuzijom, infuziju je potrebno privremeno prekinuti do poboljšanja reakcije na 1. stupanj ili njezina povlačenja, a zatim ponovno započeti s infuzijom uz 50 % manju brzinu infuzije (vidjeti dio 4.2).
English: These reactions are presented by system organ class and frequency.
Croatian: Te su reakcije prikazane prema klasifikaciji organskih sustava i učestalosti.
English: From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the diluted solution should be infused immediately.
Croatian: S mikrobiološkog gledišta, razrijeđenu otopinu treba odmah primijeniti infuzijom, osim ako metoda razrjeđivanja isključuje rizik od kontaminacije mikrobima.
English: Of these patients, none experienced immune-related pneumonitis Grade ≥ 3.
Croatian: Među njima nijedan nije imao imunološki posredovan pneumonitis ≥ 3. stupnja.
English: These results indicate a potential risk that administration of avelumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth.
Croatian: Ti rezultati ukazuju na mogući rizik od štetnog djelovanja na fetus ako se avelumab primjenjuje tijekom trudnoće, uključujući povećanje stope pobačaja ili mrtvorođenosti.
English: If ALT or AST ≥ 5 times ULN or > 3 times ULN with concurrent total bilirubin ≥ 2 times ULN or total bilirubin ≥ 3 times ULN, both Bavencio and axitinib should be permanently discontinued and corticosteroid therapy should be considered.
Croatian: Ako su ALT ili AST ≥ 5 puta iznad GGN-a ili > 3 puta iznad GGN-a s ukupnim bilirubinom koji je istovremeno ≥ 2 puta iznad GGN-a ili ako je ukupni bilirubin ≥ 3 puta iznad GGN-a, primjenu oba lijeka, i Bavencio i aksitiniba, potrebno je trajno prekinuti i razmotriti primjenu kortikosteroidne terapije.
English: Figure 1: Kaplan-Meier estimates of progression-free survival (PFS) per RECIST v1.1, IERC (Part A, minimum follow-up of 36 months)
Croatian: Slika 1: Kaplan-Meierova procjena preživljenja bez progresije bolesti (PFS) prema RECIST verziji 1.1, IERC (dio A, minimalno trajanje praćenja od 36 mjeseca)
English: Patients should be monitored for hyperglycaemia or other signs and symptoms of diabetes.
Croatian: Bolesnike je potrebno pratiti zbog moguće hiperglikemije ili drugih znakova i simptoma šećerne bolesti.
English: Blood creatinine increased, amylase increased, lipase increased, gamma-glutamyltransferase increased, blood alkaline phosphatase increased, blood creatine phosphokinase increased, blood thyroid stimulating hormone decreased, transaminases increased
Croatian: Često povišen kreatinin u krvi, povišena amilaza, povišena lipaza, povišena gamaglutamil transferaza, povišena alkalna fosfataza u krvi, povišena kreatin fosfokinaza u krvi, snižen tireotropni hormon u krvi, povišene transaminaze
English: Patients should be monitored for clinical signs and symptoms of endocrinopathies.
Croatian: Bolesnike je potrebno pratiti zbog mogućih kliničkih znakova i simptoma endokrinopatija.
English: Of the 480 patients with at least one valid ADA result at any time point treated with avelumab 10 mg/kg as an intravenous infusion every 2 weeks in combination with axitinib 5 mg twice daily, 453 were evaluable for treatment-emergent ADA and 66 (14.6%) tested positive.
Croatian: Od 480 bolesnika liječenih avelumabom u dozi od 10 mg/kg koji se primjenjivao kao intravenska infuzija svaka 2 tjedna u kombinaciji s aksitinibom u dozi od 5 mg dvaput na dan s najmanje jednim valjanim rezultatom ADA, bez obzira na to kada je izmjeren, prisutnost protutijela na lijek (ADA) nastalih tijekom liječenja mogla se procijeniti u njih 453, a test je bio pozitivan u njih 66 (14,6%).
English: How you will receive Bavencio
Croatian: Kako ćete primati Bavencio
English: Hepatic impairment was defined by National Cancer Institute (NCI) criteria of hepatic dysfunction.
Croatian: Oštećenje funkcije jetre bilo je definirano prema kriterijima jetrene disfunkcije Nacionalnog instituta za rak (engl.
English: Perivascular mononuclear cell cuffing was observed in the brain and spinal cord of monkeys treated with avelumab at ≥ 20 mg/kg for 3 months.
Croatian: Bilo je opaženo perivaskularno nakupljanje mononukleara u obliku manžete u mozgu i leđnoj moždini majmuna liječenih avelumabom u dozi od ≥ 20 mg/kg tijekom 3 mjeseca.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: Patient distribution by Memorial Sloan-Kettering Cancer Center (MSKCC) risk groups was 22% favourable, 65% intermediate, and 11% poor.
Croatian: Kettering Cancer Center, MSKCC) bila je sljedeća: 22% povoljno, 65% srednje i 11% loše.
English: • Patient Information Brochure
Croatian: • Brošuru s informacijama za bolesnika
English: Excipients: Mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injections.
Croatian: Pomoćne tvari: manitol, ledena acetatna kiselina, polisorbat 20, natrijev hidroksid, voda za injekcije.
English: Tumour samples were evaluated for PD-L1 tumour cell expression, and for Merkel cell polyomavirus (MCV) using an investigational immunohistochemistry (IHC) assay.
Croatian: U uzorcima tumora bila je procijenjena ekspresija PD-L1 na tumorskim stanicama i prisutnost poliomavirusa Merkelovih stanica (MCV) pomoću istraživačkog imunohistokemijskog testa.
English: SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Croatian: POSEBNE OBVEZE ZA PROVEDBE MJERA NAKON DAVANJA ODOBRENJA KOD UVJETNOG ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Patients were included irrespective of prognostic risk groups or tumour PD-L1 expression and had to have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 that was not been previously irradiated.
Croatian: Bolesnici su bili uključeni u ispitivanje neovisno o skupini po prognostičkom riziku ili tumorskoj ekspresiji PD-L1 i morali su imati najmanje jednu mjerljivu leziju prema Kriterijima za ocjenu odgovora kod solidnih tumora (engl.
English: Hepatotoxicity occurred in patients treated with avelumab in combination with axitinib with higher than expected frequencies of Grade 3 and Grade 4 ALT and AST elevation compared to avelumab alone (see section 4.8).
Croatian: U bolesnika liječenih avelumabom u kombinaciji s aksitinibom došlo je do razvoja hepatotoksičnosti s učestalošću povišenja vrijednosti ALT-a i AST-a 3. i 4. stupnja većom od očekivane u usporedbi s primjenom avelumaba u monoterapiji (vidjeti dio 4.8).
English: Adrenal insufficiency*, hyperthyroidism*, thyroiditis*, autoimmune thyroiditis*, adrenocortical insufficiency acute*, autoimmune hypothyroidism*, hypopituitarism*
Croatian: Manje često adrenalna insuficijencija*, hipertireoza*, tiroiditis*, autoimuni tiroiditis*, akutna adrenokortikalna insuficijencija*, autoimuna hipotireoza*, hipopituitarizam*
English: Bavencio is a clear, colourless to slightly yellow solution.
Croatian: Bavencio je bistra, bezbojna do blago žuta otopina.
English: All 31 patients with immune-related hepatitis were treated for hepatitis including 30 (96.8%) patients treated with corticosteroids and 1 patient with a non-steroidal immunosuppressant.
Croatian: Svi bolesnici s imunološki posredovanim hepatitisom, njih 31, bili su liječeni zbog hepatitisa, pri čemu je 30 bolesnika (96,8 %) bilo liječeno kortikosteroidima, a 1 nesteroidnim imunosupresivom.
English: The median time to onset of Type 1 diabetes mellitus was 1.9 months (range: 1.1 months to 7.3 months).
Croatian: Medijan vremena do nastupa šećerne bolesti tipa 1 iznosio je 1,9 mjeseci (raspon: od 1,1 mjesec do 7,3 mjeseca).
English: Median, months (95% CI)
Croatian: Medijan, mjeseci (95 % CI)
English: Patients should be more frequently monitored for changes in liver function and symptoms as compared to when avelumab is used as monotherapy.
Croatian: Bolesnike je na promjene funkcije jetre i simptome potrebno pratiti češće nego pri primjeni avelumaba u monoterapiji.
English: Pack size of 1 vial.
Croatian: Veličina pakiranja od 1 bočice.
English: Figure 2: Kaplan-Meier estimates of progression-free survival (PFS) per RECIST v1.1, IERC (Part B, N=116)
Croatian: Slika 2: Kaplan-Meierova procjena preživljenja bez progresije bolesti (PFS) prema RECIST verziji 1.1, IERC (dio B, N=116)
English: Dosing delay or discontinuation may be required based on individual safety and tolerability; see Table 1.
Croatian: Ovisno o sigurnosti primjene i podnošljivosti u pojedinog bolesnika, može biti potrebno odgoditi primjenu doze ili prekinuti primjenu lijeka; vidjeti tablicu 1.
English: In patients treated with avelumab in combination with axitinib, 24.7% (121/489) of patients developed immune-related thyroid disorders, including 111 (22.7%) patients with hypothyroidism, 17 (3.5%) with hyperthyroidism, and 7 (1.4%) with thyroiditis.
Croatian: U bolesnika liječenih avelumabom u kombinaciji s aksitinibom, 24,7 % (121/489) bolesnika razvilo je imunološki posredovane poremećaje štitne žlijezde, što je uključivalo njih 111 (22,7 %) s hipotireozom, 17 (3,5 %) s hipertireozom i 7 (1,4 %) s tireoiditisom.
English: • The vial should be visually inspected for particulate matter and discoloration.
Croatian: • Bočicu je potrebno vizualno pregledati s obzirom na prisutnost čestica i promjenu boje.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: Immune-related hepatitis resolved in 27 (87.1%) of the 31 patients at the time of data cut-off.
Croatian: Imunološki posredovan hepatitis povukao se u 27 (87,1 %) od 31 bolesnika u vrijeme prestanka prikupljanja podataka.
English: Blockade of PD-L1 signalling has been shown in murine models of pregnancy to disrupt tolerance to the foetus and to result in an increase in foetal loss.
Croatian: Na mišjim modelima trudnoće pokazalo se da blokada PD-L1 signalizacije ometa toleranciju na fetus i dovodi do povećanog gubitka fetusa.
English: In order to confirm the efficacy for chemotherapy-naïve treated patients, the MAH should submit the final results of study EMR 100070-003 - Part B.
Croatian: Da bi se potvrdila djelotvornost u bolesnika koji prethodno nisu bili liječeni kemoterapijom, nositelj odobrenja za stavljanje lijeka u promet treba podnijeti konačne rezultate ispitivanja EMR100070-003 - dio B.
English: • Increases in blood pressure
Croatian: • povišenja krvnog tlaka
English: Thyroid disorders resolved in 15 (12.4%) of the 121 patients at the time of data cut-off.
Croatian: Poremećaji štitne žlijezde povukli su se u 15 (12,4 %) od 121 bolesnika u vrijeme prestanka prikupljanja podataka.
English: Patients with prior systemic therapy directed at advanced or metastatic RCC; prior systemic immunotherapy treatment with IL-2, IFN-α, anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or active brain metastasis; active autoimmune disease that might deteriorate when receiving an immunostimulatory agents; a history of other malignancies within the last 5 years; organ transplant were ineligible.
Croatian: Bolesnici koji su prethodno primali sistemsku terapiju usmjerenu na uznapredovali ili metastatski karcinom bubrežnih stanica, bili liječeni sistemskom imunoterapijom s IL-2, IFN-α, protutijelima na PD-1, PD-L1 ili CTLA-4 ili imali aktivne metastaze na mozgu, aktivnu autoimunu bolest koja se mogla pogoršati zbog primanja imunostimulacijskih lijekova, druge zloćudne bolesti u anamnezi u prethodnih 5 godina ili su bili podvrgnuti transplantaciji organa, nisu bili pogodni za ispitivanje.
English: It is very important for you to keep all your appointments to receive Bavencio.
Croatian: Jako je važno da se pridržavate dogovorenog rasporeda primanja lijeka Bavencio.
English: Bavencio contains less than 1 mmol sodium (23 mg) in each dose and therefore is essentially sodium-free.
Croatian: Bavencio sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. sadrži zanemarive količine natrija.
English: Immune-related myocarditis
Croatian: Imunološki posredovan miokarditis
English: Premedication
Croatian: Premedikacija
English: Avelumab has not been studied in patients with moderate hepatic impairment (bilirubin between 1.5 and 3 times ULN) or severe hepatic impairment (bilirubin > 3 times ULN).
Croatian: Avelumab nije ispitan u bolesnika s umjerenim oštećenjem funkcije jetre (bilirubin između 1,5 i 3 puta iznad GGN-a) ili teškim oštećenjem funkcije jetre (bilirubin > 3 puta iznad GGN-a).
English: Minimum, maximum (months) ≥ 3 months by K-M, (95% CI) ≥ 6 months by K-M, (95% CI) ≥ 12 months by K-M, (95% CI)
Croatian: Minimum, maksimum (mjeseci) ≥ 3 mjeseca prema K-M, (95 % CI) ≥ 6 mjeseci prema K-M, (95 % CI) ≥ 12 mjeseci prema K-M, (95 % CI)
English: • or stop your treatment with Bavencio altogether.
Croatian: • potpuno prekinuti liječenje lijekom Bavencio.
English: Withhold until adverse reactions recover to Grade 0-1; restart infusion with a 50% slower rate
Croatian: 0.-1. stupanj; ponovno početi s infuzijom uz 50 % manju brzinu
English: • Joint pain, back pain, belly pain, muscle pain
Croatian: • bol u zglobovima, bol u leđima, bol u trbuhu, bol u mišićima
English: • Red, itchy, scaly patches on the skin
Croatian: • crvene, ljuskave mrlje na koži koje svrbe
English: Handling instructions
Croatian: Upute za rukovanje
English: Fertility studies have not been conducted with avelumab.
Croatian: Nisu provedena ispitivanja plodnosti s avelumabom.
English: Immune-related hepatitis resolved in 9 (56%) of the 16 patients at the time of data cut-off.
Croatian: Imunološki posredovan hepatitis povukao se u 9 (56 %) od tih 16 bolesnika u vrijeme prestanka prikupljanja podataka.
English: These results indicate a potential risk, based on its mechanism of action, that administration of avelumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth.
Croatian: Ovi rezultati, na temelju mehanizma djelovanja avelumaba, ukazuju na mogući rizik od štetnog djelovanja na fetus ako se avelumab primjenjuje tijekom trudnoće, uključujući povećanje stope pobačaja ili mrtvorođenosti.
English: Of these patients, there was 1 (0.1%) patient with a fatal outcome, 1 (0.1%) patient with Grade 4, and 5 (0.3%) patients with Grade 3 immune-related pneumonitis.
Croatian: Među njima je bio 1 (0,1 %) bolesnik sa smrtnim ishodom, 1 (0,1 %) bolesnik s imunološki posredovanim pneumonitisom 4. stupnja i 5 (0,3 %) bolesnika s imunološki posredovanim pneumonitisom 3. stupnja.
English: The safety of avelumab in combination with axitinib has been evaluated in 489 patients with advanced RCC receiving 10 mg/kg avelumab every 2 weeks and axitinib 5 mg orally twice daily in two clinical studies.
Croatian: Sigurnost primjene avelumaba u kombinaciji s aksitinibom procijenjena je u 489 bolesnika s uznapredovalim karcinomom bubrežnih stanica, koji su u dva klinička ispitivanja primali 10 mg/kg avelumaba svaka 2 tjedna i 5 mg aksitiniba peroralno dvaput na dan.
English: • Bowel occlusion
Croatian: • upala oka
English: • infusion-related reactions;
Croatian: • reakcije povezane s infuzijom
English: Avelumab should be resumed when the immune-related adverse reaction returns to Grade 1 or less following corticosteroid taper.
Croatian: S primjenom avelumaba može se nastaviti kad se imunološki posredovana nuspojava nakon snižavanja doze kortikosteroida vrati na 1. stupanj ili niže.
English: It is unknown whether avelumab is excreted in human milk.
Croatian: Nije poznato izlučuje li se avelumab u majčino mlijeko.
English: The median duration was not estimable (range: 8 days to more than 23.9 months).
Croatian: Medijan trajanja nije se mogao procijeniti (raspon: od 8 dana do više od 23,9 mjeseci).
English: Table 7: Efficacy results from study B9991003 in patients irrespective of PD-L1 expression Efficacy endpoints (Based on BICR assessment)
Croatian: Tablica 7: Rezultati ispitivanja djelotvornosti u ispitivanju B9991003 u bolesnika neovisno o ekspresiji PD-L1