FrancophonIA/ELRC3.0 huggingface dataset:
English: Data about efficacy and safety of pembrolizumab in combination with platinum chemotherapy are limited in this patient population.
Croatian: Podaci o djelotvornosti i sigurnosti primjene pembrolizumaba u kombinaciji s kemoterapijom temeljenom na platini u toj populaciji bolesnika su ograničeni.
English: For patients who completed 24 months of therapy or had a complete response, treatment with pembrolizumab could be reinitiated for disease progression and administered for up to 1 additional year.
Croatian: U bolesnika koji su završili 24 mjeseca terapije ili ostvarili potpuni odgovor, liječenje pembrolizumabom moglo se ponovno uvesti u slučaju progresije bolesti te se moglo primjenjivati tijekom dodatnih godinu dana.
English: The primary efficacy outcome measures were investigator-assessed recurrence-free survival (RFS) in the whole population and in the population with PD-L1 positive tumours, where RFS was defined as the time between the date of randomisation and the date of first recurrence (local, regional, or distant metastasis) or death, whichever occurs first.
Croatian: Primarne mjere ishoda za djelotvornost bile su preživljenje bez recidiva bolesti (engl. recurrence-free survival, RFS) prema ocjeni ispitivača u cjelokupnoj populaciji i u populaciji s PD-L1-pozitivnim tumorima, pri čemu se RFS definirao kao vrijeme od datuma randomizacije do datuma prvog recidiva (lokalne, regionalne ili udaljene metastaze) ili smrti, što god nastupi prije.
English: When administering KEYTRUDA as part of a combination with intravenous chemotherapy, KEYTRUDA should be administered first.
Croatian: Kada se KEYTRUDA primjenjuje kao dio kombinirane terapije koja uključuje intravensku kemoterapiju, KEYTRUDA se treba primijeniti prva.
English: Infections and infestations Common pneumonia pneumonia pneumonia
Croatian: Infekcije i infestacije Često pneumonija pneumonija pneumonija
English: It is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
Croatian: Preporučuje se nastaviti liječenje u klinički stabilnih bolesnika koji pokazuju početne znakove progresije bolesti, dok se progresija bolesti ne potvrdi.
English: Both pembrolizumab arms were superior to chemotherapy for PFS, and there was no difference between pembrolizumab doses.
Croatian: Obje skupine koje su primale pembrolizumab su bile superiorne u odnosu na kemoterapiju za PFS i nije bilo razlika između doza pembrolizumaba.
English: - Your doctor will give you KEYTRUDA through an infusion into your vein (IV) for about
Croatian: - Liječnik će Vam davati lijek KEYTRUDA infuzijom u venu (intravenski, i.v.) tijekom približno
English: Pembrolizumab was administered prior to chemotherapy on Day 1.
Croatian: Pembrolizumab se primjenjivao prije kemoterapije 1. dana.
English: Discard the vial if visible particles are observed.
Croatian: Bacite bočicu ako u njoj primijetite vidljive čestice.
English: Prior therapy included platinum-doublet regimen (100%); patients received one (69%) or two or more (29%) treatment lines.
Croatian: Prethodna terapija uključivala je dvojnu terapiju koja je sadržavala platinu (100%); bolesnici su primili jednu (69%) odnosno dvije ili više (29%) terapijskih linija.
English: Response: Best objective response as confirmed complete response or partial response
Croatian: Odgovor: Najbolji objektivan odgovor kao potvrđen potpun odgovor ili djelomičan odgovor
English: Pembrolizumab should not be used during pregnancy unless the clinical condition of the woman requires treatment with pembrolizumab.
Croatian: Pembrolizumab se ne smije koristiti u trudnoći, osim u slučajevima kada kliničko stanje žene zahtijeva liječenje pembrolizumabom.
English: • a kind of skin cancer called melanoma
Croatian: • jedne vrste raka kože koji se zove melanom
English: TPS 1 to 49%
Croatian: TPS 1 - 49%
English: However, systemic corticosteroids or other immunosuppressants can be used after starting pembrolizumab to treat immune-related adverse reactions (see section 4.4).
Croatian: Međutim, sistemski kortikosteroidi ili drugi imunosupresivi mogu se koristiti nakon uvođenja pembrolizumaba za liječenje imunološki uzrokovanih nuspojava (vidjeti dio 4.4).
English: Pembrolizumab may be restarted within 12 weeks after last dose of KEYTRUDA if the adverse reaction remains at Grade ≤ 1 and corticosteroid dose has been reduced to ≤ 10 mg prednisone or equivalent per day.
Croatian: Pembrolizumab se može ponovno uvesti unutar 12 tjedana nakon posljednje doze lijeka KEYTRUDA ako nuspojava ostane ≤1. stupnja težine i ako je doza kortikosteroida snižena na ≤10 mg prednizona ili ekvivalenta na dan.
English: KEYTRUDA is a humanised monoclonal antibody which binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with ligands PD-L1 and PD-L2.
Croatian: KEYTRUDA je humanizirano monoklonsko protutijelo koje se veže na receptor programirane stanične smrti-1 (PD-1) i blokira njegovu interakciju s ligandima PD-L1 i PD-L2.
English: The most serious adverse reactions were immune-related adverse reactions and severe infusion-related reactions (see section 4.4).
Croatian: Najozbiljnije nuspojave bile su imunološki uzrokovane nuspojave i teške reakcije na infuziju (vidjeti dio 4.4).
English: Combination with chemotherapy
Croatian: Kombinacija s kemoterapijom
English: The most common tumour types by histology were Hodgkin lymphoma (11.7%), glioblastoma multiforme (9.1%), neuroblastoma (6.5%), osteosarcoma (6.5%) and melanoma (5.2%).
Croatian: Najčešći histološki tipovi tumora bili su Hodgkinov limfom (11,7%), multiformni glioblastom (9,1%), neuroblastom (6,5%), osteosarkom (6,5%) i melanom (5,2%).
English: People get KEYTRUDA after they have had surgery to remove melanoma to help prevent their cancer from coming back (adjuvant therapy).
Croatian: Bolesnicima se KEYTRUDA daje nakon kirurškog zahvata provedenog radi uklanjanja melanoma, kako bi se spriječila ponovna pojava raka (adjuvantna terapija).
English: Pneumonitis occurred more frequently in patients with a history of prior thoracic radiation (8.1%) than in patients who did not receive prior thoracic radiation (3.4%).
Croatian: Pneumonitis se češće javljao u bolesnika koji su prethodno liječeni radioterapijom prsišta (8,1%) nego u bolesnika koji prethodno nisu primali radioterapiju prsišta (3,4%).
English: In the absence of these data, pembrolizumab should be used with caution in this population after careful consideration of the potential risk-benefit on an individual basis.
Croatian: U nedostatku tih podataka, pembrolizumab u navedenoj populaciji treba primjenjivati uz oprez, nakon pažljivog razmatranja mogućeg omjera koristi i rizika za pojedinog bolesnika.
English: Hypothyroidism is more frequently reported in patients with HNSCC with prior radiation therapy.
Croatian: Hipotireoza je češće prijavljivana u bolesnika s HNSCC-om prethodno liječenih radioterapijom.
English: No findings of toxicological significance were observed and the no observed adverse effect level (NOAEL) in both studies was ≥ 200 mg/kg, which produced exposure multiples of 19 and 94 times the exposure in humans at doses of 10 and 2 mg/kg, respectively.
Croatian: Nisu primijećeni nikakvi toksikološki značajni nalazi, a razina izloženosti pri kojoj nisu opaženi štetni učinci (engl. no observed adverse effect level, NOAEL) u oba je ispitivanja iznosila ≥200 mg/kg, a njome je postignuta izloženost 19 odnosno 94 puta viša od izloženosti koja se postiže u ljudi nakon primjene doza od 10 odnosno 2 mg/kg.
English: Non-squamous patients could receive pemetrexed maintenance).
Croatian: Bolesnici s neskvamoznim NSCLC-om mogli su primati terapiju održavanja pemetreksedom).
English: Table 22: ORR and OS by PD-L1 Expression
Croatian: Tablica 22: ORR i OS prema ekspresiji PD-L1
English: BRAF mutations were reported in 302 (36%) patients.
Croatian: Mutacije u genu BRAF prijavljene su u 302 (36%) bolesnika.
English: Note: toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4).
Croatian: National Cancer Institute Common Terminology Criteria for Adverse Events) (NCI-CTCAE v.4).
English: Factors associated with early deaths were fast progressive disease on prior platinum therapy and liver metastases.
Croatian: Faktori povezani s ranim nastupom smrti bili su brza progresija bolesti tijekom prethodne terapije platinom te jetrene metastaze.
English: * Cetuximab, platinum, and 5-FU
Croatian: * Cetuksimab, platina i 5-FU
English: Methotrexate, docetaxel, or cetuximab
Croatian: Metotreksat, docetaksel ili cetuksimab
English: Both studies included patients regardless of PD-L1 expression.
Croatian: U oba su ispitivanja bolesnici uključivani neovisno o ekspresiji PD-L1.
English: Following administration of pembrolizumab 200 mg every 3 weeks in patients with cHL, the observed median Cmin at steady-state was up to 40% higher than that in other tumour types treated with the same dosage; however, the range of trough concentrations is similar.
Croatian: Nakon primjene pembrolizumaba u dozi od 200 mg svaka 3 tjedna u bolesnika s kHL-om, opaženi medijan Cmin u stanju dinamičke ravnoteže bio je do 40% veći nego kod drugih vrsta tumora liječenih istom dozom; međutim, raspon najnižih koncentracija je sličan.
English: Hazard ratio* (98% CI) p-Value (stratified log-rank) RFS at 6 months RFS rate RFS at 12 months RFS rate RFS at 18 months RFS rate
Croatian: Omjer hazarda* (98% CI) p-vrijednost (stratificirani log-rang test) RFS nakon 6 mjeseci Stopa RFS-a RFS nakon 12 mjeseci Stopa RFS-a RFS nakon 18 mjeseci Stopa RFS-a
English: What KEYTRUDA looks like and contents of the pack KEYTRUDA is a white to off-white lyophilised powder.
Croatian: Kako KEYTRUDA izgleda i sadržaj pakiranja KEYTRUDA je bijeli do bjelkasti liofilizirani prašak.
English: Sixty-seven percent (67%) of patients had M1 disease and the majority had Stage IV disease (Stage IV 32%, Stage IVa 14%, Stage IVb 4%, and Stage IVc 44%).
Croatian: Šezdeset i sedam posto (67%) bolesnika imalo je bolest stadija M1, a većina ispitanika imala je bolest IV. stadija (stadij IV 32%, stadij IVa 14%, stadij IVb 4% te stadij IVc 44%).
English: The Kaplan-Meier curve for OS for the TPS ≥ 50% population is shown in Figure 15.
Croatian: Kaplan-Meierova krivulja za OS za populaciju s TPS-om ≥50% prikazana je na Slici 15.
English: Overall response rate ORR
Croatian: Stopa ukupnog odgovora ORR
English: Patients with active infections were excluded from clinical trials and were required to have their infection treated prior to receiving pembrolizumab.
Croatian: Bolesnici s aktivnim infekcijama nisu bili uključeni u klinička ispitivanja te su morali izliječiti infekciju prije primanja pembrolizumaba.
English: KEYNOTE-087 and KEYNOTE-013: Open-label studies in patients with relapsed or refractory classical Hodgkin lymphoma (cHL)
Croatian: KEYNOTE-087 i KEYNOTE-013: Otvorena ispitivanja u bolesnika s relapsirajućim ili refraktornim klasičnim Hodgkinovim limfomom (kHL)
English: Patients must have received first line platinum-containing regimen for locally advanced/metastatic disease or as neoadjuvant/adjuvant treatment, with recurrence/progression ≤ 12 months following completion of therapy.
Croatian: Bolesnici su prethodno morali primiti prvu liniju liječenja protokolom koji je sadržavao platinu za lokalno uznapredovalu/metastatsku bolest ili kao neoadjuvantno/adjuvantno liječenje, te su morali doživjeti rekurenciju/progresiju ≤ 12 mjeseci nakon završetka terapije.
English: Most immune-related adverse reactions occurring during treatment with pembrolizumab were reversible and managed with interruptions of pembrolizumab, administration of corticosteroids and/or supportive care.
Croatian: Većina imunološki uzrokovanih nuspojava koje se javljaju za vrijeme liječenja pembrolizumabom je bila reverzibilna te se zbrinjavala privremenim prekidom liječenja pembrolizumabom, primjenom kortikosteroida i/ili potpornom skrbi.
English: What KEYTRUDA is and what it is used for What you need to know before you are given KEYTRUDA How you are given KEYTRUDA Possible side effects
Croatian: Što je KEYTRUDA i za što se koristi Što morate znati prije nego počnete primati lijek KEYTRUDA
English: Adrenal insufficiency Symptomatic hypophysitis Type 1 diabetes associated with Grade ≥ 3 hyperglycaemia (glucose > 250 mg/dL or > 13.9 mmol/L) or associated with ketoacidosis Hyperthyroidism Grade ≥ 3
Croatian: Insuficijencija nadbubrežnih žlijezda Simptomatski hipofizitis Šećerna bolest tipa 1 povezana sa hiperglikemijom ≥3. stupnja (glukoza >250 mg/dl ili >13,9 mmol/l) ili povezana s ketoacidozom Hipertireoza ≥3. stupnja
English: Feeling tired or weak is a very common side effect of KEYTRUDA.
Croatian: Osjećaj umora ili slabosti vrlo je česta nuspojava lijeka KEYTRUDA.
English: Secondary efficacy outcome measures were duration of response, PFS and OS.
Croatian: Sekundarne mjere ishoda za djelotvornost bile su trajanje odgovora, PFS i OS.
English: The following factors had no clinically important effect on the clearance of pembrolizumab: age (range 15-94 years), gender, race, mild or moderate renal impairment, mild hepatic impairment and tumour burden.
Croatian: Sljedeći faktori nisu imali klinički važnog učinka na klirens pembrolizumaba: dob (raspon: 15-94 godine), spol, rasa, blago ili umjereno oštećenje funkcije bubrega, blago oštećenje funkcije jetre i tumorsko opterećenje.
English: If refrigerated, the vials and/or intravenous bags must be allowed to come to room temperature prior to use.
Croatian: Ako se bočice i/ili infuzijske vrećice čuvaju u hladnjaku, prije primjene mora se pričekati da se ugriju na sobnu temperaturu.
English: For the adjuvant treatment of melanoma, KEYTRUDA should be administered until disease recurrence, unacceptable toxicity, or for a duration of up to one year.
Croatian: Za adjuvantno liječenje melanoma lijek KEYTRUDA treba primjenjivati do recidiva bolesti, pojave neprihvatljive toksičnosti ili tijekom najviše godinu dana.
English: Since pembrolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected.
Croatian: Budući da se pembrolizumab izlučuje iz cirkulacije katabolizmom, ne očekuju se metaboličke interakcije s drugim lijekovima.
English: Sixteen percent (16%) had disease progression following platinum-containing neoadjuvant or adjuvant chemotherapy, and 84% had received 1-2 prior systemic regimens for metastatic disease.
Croatian: Šesnaest posto (16%) bolesnika imalo je progresiju bolesti nakon neoadjuvantne ili adjuvantne kemoterapije koja sadrži platinu, a 84% bolesnika ranije je primilo 1-2 sistemska režima liječenja za metastatsku bolest.
English: Patients with ECOG performance status score ≥ 2 were excluded from the clinical trials of melanoma, NSCLC, cHL, and HNSCC (see sections 4.4 and 5.1).
Croatian: Bolesnici s funkcionalnim ECOG statusom ≥2 nisu bili uključeni u klinička ispitivanja primjene kod melanoma, NSCLC-a, kHL-a i HNSCC-a (vidjeti dijelove 4.4 i 5.1).
English: Hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids.
Croatian: Hipotireoza se može zbrinuti nadomjesnom terapijom bez prekida liječenja i bez kortikosteroida.
English: • a kind of cancer called classical Hodgkin lymphoma
Croatian: • jedne vrste raka koji se zove klasični Hodgkinov limfom
English: Randomization was stratified by tumour PD-L1 expression (TPS ≥ 50% or < 50%), HPV status (positive or negative), and ECOG PS (0 vs. 1).
Croatian: Randomizacija je bila stratificirana prema tumorskoj ekspresiji PD-L1 (TPS ≥ 50% ili < 50%), HPV statusu (pozitivan ili negativan) i funkcionalnom ECOG statusu (0 ili 1).
English: Patients with an ECOG performance status of 2 had to have a hemoglobin ≥ 10 g/dL, could not have liver metastases, and must have received the last dose of their last prior chemotherapy regimen ≥ 3 months prior to enrollment.
Croatian: Bolesnici s funkcionalnim ECOG statusom 2 morali su imati vrijednost hemoglobina ≥10 g/dl, nisu smjeli imati jetrene metastaze i morali su primiti posljednju dozu prethodnog kemoterapijskog protokola ≥3 mjeseca prije uključivanja u ispitivanje.
English: Hypothyroidism may be managed with replacement therapy without treatment interruption.
Croatian: Hipotireoza se može zbrinuti nadomjesnom terapijom bez prekida liječenja.
English: Grade 2 with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 to 5 times ULN or total bilirubin > 1.5 to 3 times ULN
Croatian: 2. stupanj s vrijednostima aspartat aminotransferaze (AST) ili alanin aminotransferaze (ALT) >3 do 5 puta iznad GGN-a ili ako je ukupni bilirubin >1,5 do 3 puta iznad GGN-a
English: Patients with active infections occurring during treatment with pembrolizumab were managed with appropriate medical therapy.
Croatian: Bolesnici s aktivnim infekcijama koje su nastupile tijekom liječenja pembrolizumabom primili su odgovarajuću terapiju.
English: The median OS was 8.4 months for pembrolizumab compared to 7.1 months for standard treatment.
Croatian: Medijan OS-a za pembrolizumab iznosio je 8,4 mjeseca u usporedbi sa 7,1 mjesecom za stadardno liječenje.
English: Pembrolizumab is most commonly associated with immune-related adverse reactions.
Croatian: Pembrolizumab se najčešće povezuje s imunološki uzrokovanim nuspojavama.
English: Of the 154 patients, 134 were enrolled with solid tumours, 18 with Hodgkin lymphoma, and 2 with other lymphomas.
Croatian: Od 154 bolesnika, njih 134 je pri uključivanju u ispitivanje imalo solidan tumor, 18 bolesnika imalo je Hodgkinov limfom, a 2 su imala druge limfome.
English: Grades 2 or 3
Croatian: 2. ili 3. stupanj
English: Common colitis n, dry mouth colitis n, dry mouth colitis n, dry mouth
Croatian: Često kolitis n, suha usta kolitis n, suha usta kolitis n, suha usta
English: KEYTRUDA must not be administered as an intravenous push or bolus injection.
Croatian: KEYTRUDA se ne smije primijeniti intravenski brzom ili bolusnom injekcijom.
English: Animal reproduction studies have not been conducted with pembrolizumab; however, in murine models of pregnancy blockade of PD-L1 signaling has been shown to disrupt tolerance to the foetus and to result in an increased foetal loss (see section 5.3).
Croatian: Nisu provedena ispitivanja reprodukcije na životinjama s pembrolizumabom; međutim, u modelima skotnosti miševa i štakora pokazalo se da blokada PD-L1 signalizacije poremeti toleranciju na plod i rezultira povećanom stopom gubitka ploda (vidjeti dio 5.3).
English: cardiac arrhythmia (including atrial fibrillation)
Croatian: † (uključujući fibrilaciju atrija)
English: KEYTRUDA as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Croatian: KEYTRUDA kao monoterapija je indicirana za liječenje uznapredovalog (neresektabilnog ili metastatskog) melanoma u odraslih.
English: Grade 4 or recurrent Grade 3
Croatian: 4. stupanj ili rekurentan 3. stupanj
English: Pembrolizumab CL is approximately 23% lower (geometric mean, 195 mL/day [CV%: 40%]) after achieving maximal change at steady-state compared with the first dose (252 mL/day [CV%: 37%]); this decrease in CL with time is not considered clinically meaningful.
Croatian: Klirens pembrolizumaba je približno 23% niži (geometrijska srednja vrijednost, 195 ml/dan [koeficijent varijacije: 40%]) nakon postizanja maksimalne promjene u stanju dinamičke ravnoteže u usporedbi s prvom dozom (252 ml/dan [koeficijent varijacije: 37%]); ovo se smanjenje klirensa s vremenom ne smatra klinički značajnim.
English: What KEYTRUDA looks like and contents of the pack KEYTRUDA is a clear to slightly opalescent, colourless to slightly yellow solution, pH 5.2 - 5.8.
Croatian: Kako KEYTRUDA izgleda i sadržaj pakiranja KEYTRUDA je bistra do blago opalescentna, bezbojna do blijedo žuta otopina, (pH 5,2 - 5,8).
English: The safety of re-initiating pembrolizumab therapy in patients previously experiencing immune-related myocarditis is not known.
Croatian: Nije poznata sigurnost ponovnog uvođenja liječenja pembrolizumabom u bolesnika koji su prethodno imali imunološki uzrokovan miokarditis.
English: Forty-five percent had no prior therapies for advanced melanoma.
Croatian: 45% bolesnika prethodno nije primalo terapiju za uznapredovali melanom.
English: Standard Treatment
Croatian: Standardno liječenje
English: Disease subtypes were 97% nodular sclerosis and 3% mixed cellularity.
Croatian: Podtipovi bolesti bili su: 97% nodularna skleroza i 3% bolest mješovitih stanica.
English: The Kaplan-Meier curves for OS and PFS based on an additional four months of follow up are shown in Figures 16 and 17.
Croatian: Kaplan-Meierove krivulje za OS i PFS temeljene na dodatnom praćenju u trajanju od četiri mjeseca prikazane su na Slikama 16 i 17.
English: When you get KEYTRUDA, you can have some serious side effects.
Croatian: Tijekom liječenja lijekom KEYTRUDA možete imati neke ozbiljne nuspojave.
English: A total of 67 patients in the placebo plus chemotherapy arm crossed over to receive monotherapy pembrolizumab at the time of disease progression and 18 additional patients received a checkpoint inhibitor as subsequent therapy.
Croatian: Ukupno je 67 bolesnika iz skupine koja je primala placebo plus kemoterapiju prešlo na monoterapiju pembrolizumabom u trenutku progresije bolesti, a 18 dodatnih bolesnika je kao daljnju terapiju primalo inhibitor kontrolnih točaka imunosnog sustava.
English: In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
Croatian: U slučaju predoziranja, bolesnike je potrebno pažljivo nadzirati zbog moguće pojave znakova ili simptoma nuspojava te treba uvesti odgovarajuće simptomatsko liječenje.
English: • Genomic analyses using whole exome sequencing and/or RNAseq (e.g.
Croatian: • Genomske analize pomoću sekvencioniranja cijelog eksoma i/ili
English: There are limited data on the safety and efficacy of KEYTRUDA in patients with ocular melanoma (see section 5.1).
Croatian: Podaci o sigurnosti i djelotvornosti lijeka KEYTRUDA u bolesnika s očnim melanomom su ograničeni (vidjeti dio 5.1).
English: There was no statistically significant difference between pembrolizumab and chemotherapy with respect to PFS.
Croatian: Nije bilo statistički značajne razlike između pembrolizumaba i kemoterapije s obzirom na PFS.
English: What you need to know before you are given KEYTRUDA
Croatian: Što morate znati prije nego počnete primati lijek KEYTRUDA
English: Based on the modelling and simulation of dose/exposure relationships for efficacy and safety for pembrolizumab, there are no clinically significant differences in efficacy or safety among the doses of 200 mg every 3 weeks, 2 mg/kg every 3 weeks, and 400 mg every 6 weeks as monotherapy (see section 4.2).
Croatian: Na temelju modeliranja i simulacije odnosa doze i izloženosti za djelotvornost i sigurnost pembrolizumaba, nema klinički značajnih razlika u djelotvornosti ili sigurnosti između doze od 200 mg svaka 3 tjedna, doze od 2 mg/kg svaka 3 tjedna i doze od 400 mg svakih 6 tjedana kod primjene u monoterapiji (vidjeti dio 4.2).
English: Axitinib could be interrupted or reduced to 3 mg twice daily and subsequently to 2 mg twice daily to manage toxicity.
Croatian: Primjena aksitiniba mogla se privremeno prekinuti ili se njegova doza mogla smanjiti na 3 mg dvaput na dan, a nakon toga i na 2 mg dvaput na dan radi zbrinjavanja toksičnosti.
English: Pembrolizumab concentrations with weight-based dosing at 2 mg/kg every 3 weeks in paediatric patients (2 to 17 years) are comparable to those of adults at the same dose.
Croatian: Koncentracije pembrolizumaba kod doziranja prema tjelesnoj težini (2 mg/kg svaka 3 tjedna) u pedijatrijskih bolesnika (2 do 17 godina) usporedive su s onima koje se postižu u odraslih kod primjene iste doze.
English: Of the patients randomised to the chemotherapy arm, 55% crossed over and subsequently received treatment with pembrolizumab.
Croatian: Među bolesnicima randomiziranima za primanje kemoterapije, njih 55% prešlo je u drugu skupinu i nakon toga primalo liječenje pembrolizumabom.