FrancophonIA/ELRC3.0 huggingface dataset:
English: • Withdraw the required volume up to 4 mL (100 mg) of concentrate and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL.
Croatian: • Izvucite željeni volumen od najviše 4 ml (100 mg) koncentrata i prenesite ga u infuzijsku vrećicu koja sadrži otopinu natrijeva klorida od 9 mg/ml (0,9%) ili otopinu glukoze od 50 mg/ml (5%) kako biste pripremili razrijeđenu otopinu konačne koncentracije od 1 do 10 mg/ml.
English: Reconstituted KEYTRUDA is a clear to slightly opalescent, colourless to slightly yellow solution.
Croatian: Rekonstituirani lijek KEYTRUDA je bistra do blago opalescentna, bezbojna do blijedo žuta otopina.
English: • IHC staining for PD-L2
Croatian: • Imunohistokemijsko bojenje PD-L2
English: For the IMDC risk category, the OS hazard ratio for the favourable risk group was 0.94 (95% CI 0.43, 2.07), for the intermediate risk group the OS hazard ratio was 0.52 (95% CI 0.36, 0.75), and for the poor risk group the OS hazard ratio was 0.50 (95% CI 0.29, 0.87).
Croatian: Prema kategorijama rizika na temelju IMDC kriterija, omjer hazarda za OS za grupu s kategorijom niskog rizika bio je 0,94 (95% CI 0,43; 2,07), za grupu s kategorijom umjerenog rizika omjer hazarda za OS je bio 0,52 (95% CI 0,36; 0,75), a za grupu s kategorijom visokog rizika omjer hazarda za OS bio je 0,50 (95% CI 0,29;
English: Table 20: OS by PD-L1 Expression
Croatian: Tablica 20: OS prema ekspresiji PD-L1
English: Of the 89 patients receiving 2 mg/kg of pembrolizumab who were previously treated with ipilimumab, 53% were male, 33% were ≥ 65 years of age and the median age was 59 years (range 18-88).
Croatian: Od 89 bolesnika prethodno liječenih ipilimumabom koji su primali pembrolizumab u dozi od 2 mg/kg, njih 53% bili su muškarci, 33% imalo je ≥65 godina, a medijan dobi iznosio je 59 godina (raspon: 18-88).
English: Skin and subcutaneous tissue disorders Very common rash q, pruritus rash q, alopecia, pruritus palmar-plantar erythrodysaesthesia syndrome, rash q,
Croatian: Poremećaji kože i potkožnog tkiva Vrlo često osip q, pruritus osip q, alopecija, pruritus sindrom palmarno-plantarne eritrodizestezije, osip q,
English: The effect of renal impairment on the clearance of pembrolizumab was evaluated by population pharmacokinetic analyses in patients with mild or moderate renal impairment compared to patients with normal renal function.
Croatian: Učinak oštećenja funkcije bubrega na klirens pembrolizumaba ocjenjivao se u populacijskim farmakokinetičkim analizama u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega u usporedbi s bolesnicima s normalnom bubrežnom funkcijom.
English: Reasons for cisplatin ineligibility included: baseline creatinine clearance of < 60 mL/min (50%), ECOG performance status of 2 (32%), ECOG performance status of 2 and baseline creatinine clearance of < 60 mL/min (9%), and other (Class III heart failure, Grade 2 or greater peripheral neuropathy, and Grade 2 or greater hearing loss; 9%).
Croatian: Razlozi zbog kojih bolesnici nisu bili pogodni za liječenje cisplatinom uključivali su sljedeće: početni klirens kreatinina <60 ml/min (50%), funkcionalni ECOG status 2 (32%), funkcionalni ECOG status 2 i početni klirens kreatinina <60 ml/min (9%) te ostalo (zatajenje srca stadija III, periferna neuropatija 2. ili višeg stupnja te gubitak sluha 2. ili višeg stupnja; 9%).
English: Based on patients with a best overall response as confirmed complete or partial response
Croatian: Na temelju bolesnika s najboljim ukupnim odgovorom kao potvrđenim potpunim ili djelomičnim odgovorom
English: The Kaplan-Meier curves for OS and PFS are shown in Figures 7 and 8.
Croatian: Kaplan-Meierove krivulje za OS i PFS prikazane su na Slikama 7 i 8.
English: • Withdraw the required volume up to 2 mL (50 mg) of KEYTRUDA and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL.
Croatian: • Izvucite željeni volumen od najviše 2 ml (50 mg) lijeka KEYTRUDA i prenesite ga u infuzijsku vrećicu koja sadrži otopinu natrijeva klorida od 9 mg/ml (0,9%) ili otopinu glukoze od 50 mg/ml (5%) kako biste pripremili razrijeđenu otopinu konačne koncentracije od 1 do 10 mg/ml.
English: BRAF mutations were reported in 13% of the study population.
Croatian: Mutacije u genu BRAF prijavljene su u 13% bolesnika uključenih u ispitivanje.
English: Incidences of Grades 3-5 adverse reactions in patients with NSCLC were 67% for pembrolizumab combination therapy and 66% for chemotherapy alone and in patients with HNSCC were 85% for pembrolizumab combination therapy and 84% for chemotherapy plus cetuximab.
Croatian: Incidencija nuspojava 3. - 5. stupnja težine u bolesnika s NSCLC-om iznosila je 67% uz pembrolizumab u kombiniranoj terapiji te 66% uz samo kemoterapiju, dok je u bolesnika s HNSCC-om iznosila 85% uz pembrolizumab u kombiniranoj terapiji te 84% uz kemoterapiju plus cetuksimab.
English: Complete Response Partial Response
Croatian: Potpun odgovor
English: Patients were randomised (2:1) to receive one of the following regimens:
Croatian: Bolesnici su bili randomizirani (2:1) za primanje jednog od sljedećih protokola:
English: Boehringer Ingelheim (BIB) Pharma GmbH & Co. KG Birkendorfer Straße 65 88397 Biberach an der Riss Germany
Croatian: KG Birkendorfer Straße 65 88397 Biberach an der Riss Njemačka
English: #) of patients with duration ≥ 6 months Number (%
Croatian: #) bolesnika s trajanjem odgovora ≥6 mjeseci Broj (%
English: erythema, dry skin severe skin reactions s, dermatitis acneiform, dermatitis, dry skin, alopecia, eczema, erythema
Croatian: suha koža teške kožne reakcije s, akneiformni dermatitis, dermatitis, suha koža, alopecija, ekcem, eritem
English: • a kind of cancer called bladder cancer (urothelial carcinoma)
Croatian: • jedne vrste raka koji se zove rak mokraćnog mjehura (urotelni karcinom)
English: Secondary efficacy outcome measures were duration of response, PFS, and OS. Table 21 summarises the key efficacy measures for the study population at the final analysis based on a median follow-up time of 11.4 months (range: 0.1, 41.2 months) for all patients.
Croatian: Tablica 21 sažeto prikazuje ključne mjere za djelotvornost za ispitivanu populaciju u trenutku završne analize na temelju medijana praćenja od 11,4 mjeseca (raspon: 0,1 do 41,2 mjeseca) za sve bolesnike.
English: Chemotherapy (n=42)
Croatian: Kemoterapija (n=42)
English: Nephritis resolved in 13 patients, 3 with sequelae.
Croatian: Nefritis se povukao u 13 bolesnika, od kojih u 3 s posljedicama.
English: In subgroup analyses, a reduced survival benefit of pembrolizumab compared to docetaxel was observed for patients who were never-smokers or patients with tumours harbouring EGFR activating mutations who received at least platinum-based chemotherapy and a tyrosine kinase inhibitor; however, due to the small numbers of patients, no definitive conclusions can be drawn from these data.
Croatian: U analizama podskupina primijećen je smanjen povoljan učinak pembrolizumaba na preživljenje u usporedbi s docetakselom u bolesnika koji nikada nisu pušili ili bolesnika koji su imali tumore s aktivirajućim mutacijama gena EGFR i koji su primili najmanje kemoterapiju utemeljenu na platini i inhibitor tirozin kinaze; međutim, zbog malog broja bolesnika iz tih se podataka ne mogu izvući definitivni zaključci.
English: The safety of pembrolizumab as monotherapy has been evaluated in 154 paediatric patients with advanced melanoma, lymphoma, or PD-L1 positive advanced, relapsed, or refractory solid tumours at 2 mg/kg every 3 weeks in the Phase I/II study KEYNOTE-051.
Croatian: Sigurnost pembrolizumaba u monoterapiji ocjenjivala se u 154 pedijatrijska bolesnika s uznapredovalim melanomom, limfomom ili PD-L1 pozitivnim uznapredovalim, relapsirajućim ili refraktornim solidnim tumorima uz primjenu doze od 2 mg/kg svaka 3 tjedna u ispitivanju faze I/II KEYNOTE-051.
English: Patients receiving placebo plus chemotherapy who experienced independently-verified progression of disease were offered pembrolizumab as monotherapy.
Croatian: Bolesnicima koji su primali placebo plus kemoterapiju i doživjeli neovisno potvrđenu progresiju bolesti ponuđeno je liječenje pembrolizumabom u monoterapiji.
English: For severe infusion reactions, infusion should be stopped and pembrolizumab permanently discontinued (see section 4.2).
Croatian: U slučaju teških reakcija na infuziju, potrebno je prekinuti infuziju i trajno prekinuti liječenje pembrolizumabom (vidjeti dio 4.2).
English: The efficacy of pembrolizumab was evaluated in KEYNOTE-054, a multicentre, randomised, doubleblind, placebo-controlled trial in patients with completely resected stage IIIA (> 1 mm lymph node metastasis), IIIB or IIIC melanoma.
Croatian: Djelotvornost pembrolizumaba ocjenjivala se u ispitivanju KEYNOTE-054, multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju provedenom u bolesnika kojima je učinjena potpuna resekcija melanoma stadija IIIA (metastaza u limfnom čvoru > 1 mm), IIIB ili IIIC.
English: Of 23 patients with cHL who proceeded to allogeneic HSCT after treatment with pembrolizumab, 6 patients (26%) developed GVHD, one of which was fatal, and 2 patients (9%) developed severe hepatic VOD after reduced-intensity conditioning, one of which was fatal.
Croatian: Komplikacije alogenog HSCT-a kod klasičnog Hodgkinovog limfoma Među 23 bolesnika s kHL-om koja su podvrgnuta alogenom HSCT-u nakon liječenja pembrolizumabom, u 6 bolesnika (26%) razvio se GVHD, koji je u jednom slučaju završio smrtnim ishodom, a u 2 bolesnika (9%) se nakon kondicioniranja smanjenim intenzitetom razvila teška venookluzivna bolest jetre, koja je u jednom slučaju završila smrtnim ishodom.
English: Number at Risk Pembrolizumab:
Croatian: Broj bolesnika pod rizikom Pembrolizumab:
English: Based on stratified Log rank test
Croatian: Na temelju stratificiranog log-rang testa
English: Patients were stratified by PD-L1 expression (TPS ≥ 50%), HPV status and ECOG performance status and then randomised (1:1) to receive either pembrolizumab 200 mg every 3 weeks (n=247) or one of three standard treatments (n=248): methotrexate 40 mg/m2 once weekly (n=64), docetaxel 75 mg/m2 once every 3 weeks
Croatian: Bolesnici su bili stratificirani prema PD-L1 ekspresiji (TPS ≥50%), HPV statusu i ECOG statusu te onda randomizirani (1:1) kako bi primali ili pembrolizumab u dozi od 200 mg svaka 3 tjedna (n=247) ili jedno od 3 standardna liječenja (n=248): metotreksat u dozi od 40 mg/m2 jednom tjedno (n=64),
English: - The recommended dose of KEYTRUDA is either 200 mg every 3 weeks or 400 mg every
Croatian: - Preporučena doza lijeka KEYTRUDA je ili 200 mg svaka 3 tjedna ili 400 mg svakih 6 tjedana.
English: Table 28 summarises key efficacy measures from the pre-specified interim analysis.
Croatian: Tablica 28 sažeto prikazuje ključne mjere za djelotvornost prema unaprijed određenoj interim analizi.
English: KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1 (see section 5.1).
Croatian: KEYTRUDA kao monoterapija ili u kombinaciji s kemoterapijom koja sadrži platinu i 5-fluorouracil (5-FU) indicirana je za prvu liniju liječenja metastatskog ili neresektabilnog rekurentnog karcinoma skvamoznih stanica glave i vrata (engl. head and neck squamous cell carcinoma, HNSCC) u odraslih bolesnika čiji tumori eksprimiraju PD-L1 s CPS-om ≥ 1 (vidjeti dio 5.1).
English: Grade ≥ 3 with creatinine > 3 times ULN
Croatian: ≥3. stupanj s vrijednostima kreatinina >3 puta iznad GGN-a
English: Chemotherapy n=151
Croatian: Kemoterapija n=151
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 uočila moguća prisutnost čestica i promjena boje.
English: The trial excluded patients with autoimmune disease or a medical condition that required immunosuppression.
Croatian: U ispitivanje nisu bili uključeni bolesnici s autoimunom bolešću ili medicinskim stanjem koje je zahtijevalo imunosupresiju.
English: Hypophysitis resolved in 17 patients, 8 with sequelae.
Croatian: Hipofizitis se povukao u 17 bolesnika, od kojih u 8 s posljedicama.
English: Table 3 summarises key efficacy measures in patients naïve to treatment with ipilimumab at the final analysis performed after a minimum of 21 months of follow-up.
Croatian: U Tablici 3 sažeto su prikazane ključne mjere ishoda za djelotvornost u bolesnika koji prethodno nisu liječeni ipilimumabom u trenutku završne analize provedene nakon najmanje 21 mjeseca praćenja.
English: In patients with non-squamous NSCLC treated with pembrolizumab in combination with pemetrexed and platinum chemotherapy (n=488), the incidence of nephritis was 1.4% (all Grades) with 0.8% Grade 3 and 0.4% Grade 4.
Croatian: U bolesnika s neskvamoznim NSCLC-om liječenih pembrolizumabom u kombinaciji s pemetreksedom i kemoterapijom temeljenom na platini (n=488) incidencija nefritisa iznosila je 1,4% (svi stupnjevi), uz 0,8% događaja 3. stupnja i 0,4% događaja 4. stupnja.
English: How to store KEYTRUDA
Croatian: Kako čuvati lijek KEYTRUDA
English: Patients with active, non-infectious pneumonitis, an allogeneic transplant within the past 5 years (or > 5 years but with GVHD), active autoimmune disease or a medical condition that required immunosuppression were ineligible for either trial.
Croatian: Bolesnici s aktivnim, neinfektivnim pneumonitisom, alogenom transplantacijom unutar proteklih 5 godina (ili > 5 godina ako je došlo do GVHD-a), aktivnom
English: In patients with NSCLC whose tumours have high PD-L1 expression, the risk of adverse reactions with combination therapy relative to pembrolizumab monotherapy should be considered and the benefit/risk ratio of the combined therapy evaluated on an individual basis (see sections 4.1, 4.4, 4.8 and 5.1).
Croatian: U bolesnika s NSCLC-om čiji tumori pokazuju visoku razinu ekspresije PD-L1 potrebno je razmotriti rizik od nuspojava uz kombiniranu terapiju u odnosu na monoterapiju pembrolizumabom te ocijeniti omjer koristi i rizika kombinirane terapije za svakog pojedinog bolesnika (vidjeti dijelove 4.1, 4.4, 4.8 i 5.1).
English: Figure 9: Kaplan-Meier Curve for Overall Survival in KEYNOTE-407
Croatian: Slika 9: Kaplan-Meierova krivulja za ukupno preživljenje u ispitivanju KEYNOTE-407
English: The safety of pembrolizumab in combination with axitinib has been evaluated in a clinical study of 429 patients with advanced RCC receiving 200 mg pembrolizumab every 3 weeks and 5 mg axitinib twice daily.
Croatian: Sigurnost pembrolizumaba u kombinaciji s aksitinibom ocijenjena je u kliničkom ispitivanju provedenom u 429 bolesnika s uznapredovalim RCC-om koji su primali pembrolizumab u dozi od 200 mg svaka 3 tjedna i aksitinib u dozi od 5 mg dvaput na dan.
English: Among the 882 patients in KEYNOTE-048, 754 (85%) had tumours that expressed PD-L1 with a CPS ≥ 1 based on the PD-L1 IHC 22C3 pharmDx
Croatian: Od 882 bolesnika iz ispitivanja KEYNOTE-048, njih 754 (85%) imalo je tumore koji su eksprimirali PD-L1 s CPS-om ≥ 1, određenim uz pomoć seta PD-L1 IHC 22C3 pharmDx
English: Eighty-eight percent had M1 disease and 12% had M0 disease.
Croatian: Osamdeset i osam posto (88%) bolesnika imalo je bolest stadija M1, a 12% bolest stadija M0.
English: Uncommon tenosynovitis tenosynovitis
Croatian: Manje često tenosinovitis tenosinovitis
English: For liver enzyme elevations, in patients with RCC being treated with KEYTRUDA in combination with axitinib:
Croatian: U slučaju povišenih vrijednosti jetrenih enzima u bolesnika s RCC-om liječenih lijekom KEYTRUDA u kombinaciji s aksitinibom:
English: Withhold until adverse reactions recover to Grades 0-1* For patients with Grade 3 or Grade 4 endocrinopathy that improved to Grade 2 or lower and is controlled with hormone replacement, if indicated, continuation of pembrolizumab may be considered after corticosteroid taper, if needed.
Croatian: Odgoditi dok se nuspojave ne poboljšaju na 0. ili 1. stupanj* Za bolesnike s 3. ili 4. stupnjem endokrinopatije koja se poboljšala do 2. ili nižeg stupnja i koja se kontrolira nadomjeskom hormona, prema potrebi, može se razmotriti nastavak liječenja pembrolizumabom nakon postupnog snižavanja doze kortikosteroida, ukoliko je potrebno.
English: The benefit of treatment with pembrolizumab versus the risk of possible organ rejection should be considered in these patients.
Croatian: U tih bolesnika potrebno je procijeniti korist od liječenja pembrolizumabom u odnosu na rizik od mogućeg odbacivanja organa.
English: BRAF mutant without prior BRAF treatment
Croatian: Mutacija u genu BRAF bez prethodne BRAF terapije
English: Incidences of Grades 3-5 adverse reactions were 76% for pembrolizumab combination therapy and 71% for sunitinib alone.
Croatian: Incidencija nuspojava 3.- 5. stupnja iznosila je 76% uz pembrolizumab u kombiniranoj terapiji te 71% uz sunitinib primijenjen samostalno.
English: Common dizziness, neuropathy peripheral, lethargy, dysgeusia lethargy dizziness, lethargy, neuropathy peripheral
Croatian: Često omaglica, periferna neuropatija, letargija, disgeuzija letargija omaglica, letargija, periferna neuropatija
English: A total of 57 NSCLC patients aged ≥ 75 years were enrolled in study KEYNOTE-189 (35 in the pembrolizumab combination and 22 in the control).
Croatian: U ispitivanje KEYNOTE-189 bilo je uključeno ukupno 57 bolesnika s NSCLC-om u dobi od ≥ 75 godina (35 u skupinu koja je primala pembrolizumab u kombiniranoj terapiji i 22 u kontrolnu skupinu).
English: Renal cell carcinoma KEYNOTE-426: Controlled trial of combination therapy in RCC patients naïve to treatment The efficacy of pembrolizumab in combination with axitinib was investigated in KEYNOTE-426, a randomised, multicentre, open-label, active-controlled trial conducted in patients with advanced RCC with clear cell component, regardless of PD-L1 tumour expression status and International Metastatic RCC Database Consortium (IMDC) risk group categories.
Croatian: Karcinom bubrežnih stanica KEYNOTE-426: Kontrolirano ispitivanje kombinirane terapije u prethodno neliječenih bolesnika s RCC-om Djelotvornost pembrolizumaba u kombinaciji s aksitinibom ispitivana je u randomiziranom, multicentričnom, otvorenom, aktivnim lijekom kontroliranom ispitivanju KEYNOTE-426, koje se provodilo u bolesnika s uznapredovalim RCC-om sa svjetlostaničnom komponentom, neovisno o statusu tumorske ekspresije PD-L1 i kategorijama rizičnih skupina prema kriterijima Međunarodnog konzorcija za bazu podataka o metastatskom RCC-u (engl.
English: An analysis was performed in KEYNOTE-052 in patients who had tumours that expressed PD-L1 with a CPS < 10 (n=251; 68%) or ≥ 10 (n=110; 30%) based on the PD-L1 IHC 22C3 pharmDx
Croatian: U ispitivanju KEYNOTE-052 provedena je analiza u bolesnika s tumorima koji su eksprimirali PD-L1 s CPS-om < 10 (n=251; 68%) ili ≥ 10 (n=110; 30%), određenim uz pomoć seta PD-L1 IHC 22C3 pharmDx
English: The median duration was not reached (range 2 days to 32.6+ months).
Croatian: Medijan trajanja nije dosegnut (raspon: 2 dana do 32,6+ mjeseci).
English: 4Q 2023
Croatian: 4. tromjesečje 2023.
English: Standard Treatment* n=65
Croatian: Standardno liječenje* n=65
English: Patients with active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible.
Croatian: U ispitivanju nisu mogli sudjelovati bolesnici s aktivnom autoimunom bolešću ili medicinskim stanjem koje je zahtijevalo imunosupresiju, kao ni oni s melanomom sluznice ili očnim melanomom.
English: Forty-five percent had an ECOG Performance Status of 1, 40% had elevated LDH and 23% had a BRAF mutated tumour.
Croatian: 45% bolesnika imalo je funkcionalni ECOG status od 1, 40% imalo je povišene vrijednosti LDH, a njih 23% imalo je tumor s mutiranim genom BRAF.
English: Pneumonitis led to discontinuation of pembrolizumab in 98 (1.7%) patients.
Croatian: Pneumonitis je doveo do prekida liječenja pembrolizumabom u 98 (1,7%) bolesnika.
English: Thyroid disorders, including hypothyroidism, hyperthyroidism and thyroiditis, have been reported in patients receiving pembrolizumab and can occur at any time during treatment.
Croatian: U bolesnika liječenih pembrolizumabom prijavljeni su poremećaji štitnjače, uključujući hipotireozu, hipertireozu i tireoiditis, koji mogu nastupiti u bilo kojem trenutku tijekom liječenja.
English: The pharmacokinetics of pembrolizumab was studied in 2,993 patients with metastatic or unresectable melanoma, NSCLC, or carcinoma who received doses in the range of 1 to 10 mg/kg every 2 weeks, 2 to 10 mg/kg every 3 weeks, or 200 mg every 3 weeks.
Croatian: Farmakokinetika pembrolizumaba ispitivala se u 2993 bolesnika s metastatskim ili neresektabilnim melanomom, NSCLC-om ili karcinomom, koji su primali doze u rasponu od 1 do 10 mg/kg svaka 2 tjedna, 2 do 10 mg/kg svaka 3 tjedna ili 200 mg svaka 3 tjedna.
English: After reconstitution, 1 mL of concentrate contains 25 mg of pembrolizumab.
Croatian: Nakon rekonstitucije, 1 ml koncentrata sadrži 25 mg pembrolizumaba.
English: The median follow-up time was 10.5 months (range: 0.2 to 20.4 months).
Croatian: Medijan praćenja iznosio je 10,5 mjeseci (raspon: 0,2 - 20,4 mjeseca).
English: 12.7 (11.5, NA)
Croatian: 12,7 (11,5; ND)
English: KEYTRUDA has not been studied in patients with severe renal impairment (see sections 4.4 and 5.2).
Croatian: KEYTRUDA se nije ispitivala u bolesnika s teškim oštećenjem funkcije bubrega (vidjeti dijelove 4.4 i 5.2).
English: • Prior to dilution, the vial of liquid can be out of refrigeration (temperatures at or below 25°C) for up to 24 hours.
Croatian: • Bočica s tekućinom se prije razrjeđivanja može čuvati izvan hladnjaka (na temperaturi od 25°C ili manje) najviše 24 sata.
English: Number at Risk Pembrolizumab 2 mg/kg: Pembrolizumab 10 mg/kg: Docetaxel:
Croatian: Broj bolesnika pod rizikom Pembrolizumab 2 mg/kg: Pembrolizumab 10 mg/kg: Docetaksel:
English: Eighty-four percent had M1c stage and 8% of patients had a history of brain metastases.
Croatian: 84% bolesnika imalo je stadij M1c, dok je 8% bolesnika imalo moždane metastaze u anamnezi.
English: The recommended dose of KEYTRUDA as part of combination therapy is 200 mg every 3 weeks administered as an intravenous infusion over 30 minutes.
Croatian: Preporučena doza lijeka KEYTRUDA u kombiniranoj terapiji je 200 mg svaka 3 tjedna, a primjenjuje se intravenskom infuzijom u trajanju od 30 minuta.
English: The median time to onset of severe skin reactions was 3.3 months (range 3 days to 19.4 months).
Croatian: Medijan vremena do nastupa teških kožnih reakcija iznosio je 3,3 mjeseca (raspon: 3 dana do 19,4 mjeseca).
English: Of the 51 patients receiving 2 mg/kg of pembrolizumab who were naïve to treatment with ipilimumab, 63% were male, 35% were ≥ 65 years of age and the median age was 60 years (range 35-80).
Croatian: Od 51 bolesnika koji prethodno nije bio liječen ipilimumabom i koji je primao pembrolizumab u dozi od 2 mg/kg, njih 63% bili su muškarci, 35% imalo je ≥65 godina, a medijan dobi iznosio je 60 godina (raspon: 35-80).
English: Twenty-one percent had received 2 prior systemic regimens in the metastatic setting.
Croatian: Dvadeset i jedan posto (21%) bolesnika primilo je 2 prethodna sistemska protokola za metastatsku bolest.
English: Table 5 summarises key efficacy measures in patients previously treated or naïve to treatment with ipilimumab, receiving pembrolizumab at a dose of 2 mg/kg based on a minimum follow-up time of 30 months for all patients.
Croatian: U Tablici 5 sažeto su prikazane ključne mjere ishoda za djelotvornost u bolesnika prethodno liječenih ipilimumabom i onih koji prethodno nisu primali ipilimumab, a koji su primali pembrolizumab u dozi od 2 mg/kg, na temelju najmanje 30 mjeseci praćenja za sve bolesnike.
English: Urothelial Carcinoma
Croatian: Urotelni karcinom