FrancophonIA/ELRC3.0 huggingface dataset:
English: Each carton contains 1 glass vial with 7 ml of concentrate.
Croatian: Jedna kutija sadrži 1 staklenu bočicu sa 7 ml koncentrata.
English: Secondary endpoints were duration of response (DOR) by ICR and by investigator assessment (IA), ORR by IA, progression free survival (PFS) by ICR and IA, overall survival (OS), complete response rate (CRR) by ICR, and change in scores in patient reported outcomes on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30).
Croatian: Sekundarne mjere ishoda bile su trajanje odgovora (engl. duration of response, DOR) prema neovisnoj središnjoj ocjeni i ocjeni ispitivača, ORR prema ocjeni ispitivača, preživljenje bez progresije bolesti (engl. progression-free survival, PFS) prema neovisnoj središnjoj ocjeni i ocjeni ispitivača, ukupno preživljenje (engl. overall survival, OS), stopa potpunog odgovora (engl. complete response rate, CRR) prema neovisnoj središnjoj ocjeni i promjena rezultata za ishode koje prijavljuju bolesnici prema upitniku o kvaliteti života Europske organizacije za istraživanje i liječenje raka (engl.
English: Malta Sanofi S.p.A
Croatian: Sanofi S.p.A.
English: However, systemic corticosteroids or other immunosuppressants can be used after starting cemiplimab to treat immune-related adverse reactions (see sections 4.2).
Croatian: sistemski kortikosteroidi ili drugi imunosupresivi mogu se koristiti nakon uvođenja cemiplimaba za liječenje imunološki uzrokovanih nuspojava (vidjeti dio 4.2).
English: Patient Alert Card
Croatian: Kartica s upozorenjima za bolesnika
English: The event was Grade 3 hypophysitis.
Croatian: U tom se slučaju radilo o događaju 3. stupnja.
English: For patients with externally visible target lesions (locally advanced CSCC and metastatic CSCC), ORR was determined by a composite endpoint that integrated ICR assessments of radiologic data (RECIST 1.1) and digital medical photography (WHO criteria).
Croatian: Za bolesnike s vidljivim ciljnim lezijama na površini kože (lokalno uznapredovali ili metastatski planocelularni karcinom kože) ORR se utvrđivao na temelju objedinjene mjere ishoda koja je uključivala neovisnu središnju ocjenu radioloških podataka (RECIST 1.1) i digitalnih medicinskih fotografija (kriteriji SZO-a).
English: What you need to know before you are given LIBTAYO
Croatian: Što morate znati prije nego počnete primati LIBTAYO
English: Dispose of any unused medicinal product or waste material in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: Of these 193 patients, 115 had mCSCC and 78 had laCSCC.
Croatian: Od ta 193 bolesnika, njih 115 imalo je metastatski, a njih 78 lokalno uznapredovali planocelularni karcinom kože.
English: Animal reproduction studies have not been conducted with cemiplimab (see section 4.6).
Croatian: Nisu provedena ispitivanja učinaka cemiplimaba na reprodukciju životinja (vidjeti dio 4.6).
English: Immune-related adverse reactions led to permanent discontinuation of cemiplimab in 4.4% of patients.
Croatian: Imunološki uzrokovane nuspojave dovele su do trajnog prekida liječenja cemiplimabom u 4,4% bolesnika.
English: a. Type 1 diabetes mellitus is a composite term that includes diabetes mellitus, diabetic ketoacidosis and type 1 diabetes mellitus.
Croatian: Šećerna bolest tipa 1 skupni je pojam koji obuhvaća šećernu bolest, dijabetičku ketoacidozu i šećernu bolest tipa 1.
English: Resolution of pneumonitis had occurred in 14 (63.6%) of the 22 patients at the time of data cut-off.
Croatian: Do trenutka prekida prikupljanja podataka pneumonitis se povukao u 14 (63,6%) od 22 bolesnika.
English: o Description of the main signs or symptoms of the immune-related adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, immune-related skin adverse reactions, nephritis and other irARs) and infusion related reactions, and the importance of notifying their treating physician immediately if symptoms occur.
Croatian: Opis glavnih znakova ili simptoma imunološki uzrokovanih nuspojava (pneumonitisa, kolitisa, hepatitisa, endokrinopatija, imunološki uzrokovanih kožnih reakcija, nefritisa i drugih imunološki uzrokovanih nuspojava) i reakcija na infuziju te napomenu da je važno o nastupu simptoma odmah obavijestiti nadležnog liječnika.
English: • If you are breast-feeding or plan to breast-feed, ask your doctor for advice before you are given this medicine.
Croatian: • Ako dojite ili planirate dojiti, obratite se svom liječniku za savjet prije nego što primite ovaj lijek.
English: • Skin problems
Croatian: • kožne tegobe
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Croatian: POSEBNE OBVEZE ZA PROVEDBE MJERA NAKON DAVANJA ODOBRENJA KOD UVJETNOG ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Do not shake the solution.
Croatian: Nemojte tresti otopinu.
English: The median age was 72 years (range: 38 to 96): Seventy-eight (40.4%) patients were 75 years or older, 66 patients (34.2%) were 65 to less than 75 years, and 49 patients (25.4%) were less than 65 years.
Croatian: Medijan dobi bolesnika iznosio je 72 godine (raspon: 38 do 96 godina): 78 (40,4%) bolesnika imalo je 75 ili više godina, 66 bolesnika (34,2%) bilo je u dobi od 65 do manje od 75 godina, dok je 49 bolesnika (25,4%) bilo mlađe od 65 godina.
English: Eye disorders: Keratitis Gastrointestinal disorders: Stomatitis a includes meningitis and meningitis aseptic b includes encephalitis and noninfective encephalitis c includes autoimmune myocarditis and myocarditis d includes arthritis and polyarthritis
Croatian: Poremećaji probavnog sustava: stomatitis a uključuje meningitis i aseptički meningitis b uključuje encefalitis i neinfektivni encefalitis c uključuje autoimuni miokarditis i miokarditis d uključuje artritis i poliartritis
English: Immune system disorders Infusion-related reaction
Croatian: Poremećaji imunološkog sustava reakcija na infuziju često
English: LIBTAYO is for single use only.
Croatian: LIBTAYO je namijenjen samo za jednokratnu uporabu.
English: Grade ≥3 with AST or ALT >5×ULN or total bilirubin >3×ULN
Croatian: ≥3. stupanj uz AST ili ALT > 5 x GGN ili ukupan bilirubin > 3 × GGN
English: • cough, inflammation of the lungs
Croatian: • kašalj, upala pluća
English: Name and address of the manufacturer(s) of the biological active substance(s)
Croatian: Naziv i adresa proizvođača biološke djelatne tvari
English: There are limited data for LIBTAYO in patients with severe renal impairment CLcr <30 ml/min (see section 5.2).
Croatian: Podaci o primjeni lijeka LIBTAYO u bolesnika s teškim oštećenjem bubrežne funkcije (CLCr < 30 ml/min) su ograničeni (vidjeti dio 5.2).
English: If you have any of these effects, talk to your doctor immediately.
Croatian: Ako primijetite bilo koju od navedenih nuspojava, odmah se obratite liječniku.
English: The other ingredients are L-Histidine, L-Histidine monohydrochloride monohydrate, L-proline, sucrose, polysorbate 80 and water for injections.
Croatian: Drugi sastojci su L-histidin, L-histidinklorid hidrat, L-prolin, saharoza, polisorbat 80 i voda za injekcije.
English: Preparation and administration
Croatian: Priprema i primjena
English: No effects on fertility assessment parameters or in the male and female reproductive organs were observed in a 3-month repeat dose fertility assessment study with sexually mature cynomolgus monkeys.
Croatian: U 3-mjesečnom ispitivanju utjecaja ponovljenih doza na plodnost spolno zrelih makaki majmuna nisu opaženi učinci na parametre plodnosti ni na reproduktivne organa mužjaka i ženki.
English: Interrupt or slow rate of infusion
Croatian: Privremeno prekinuti primjenu ili smanjiti brzinu infuzije
English: LIBTAYO is used in adults to treat a type of skin cancer called advanced cutaneous squamous cell carcinoma or CSCC.
Croatian: LIBTAYO se koristi u odraslih za liječenje jedne vrste raka kože koji se zove uznapredovali planocelularni karcinom kože.
English: Arthritis is a composite term that includes arthritis and polyarthritis.
Croatian: j Artritis je skupni pojam koji obuhvaća artritis i poliartritis.
English: Resolution of hepatitis had occurred in 8 (72.7%) of the 11 patients at the time of data cut-off.
Croatian: Do trenutka prekida prikupljanja podataka hepatitis se povukao u 8 (72,7%) od 11 bolesnika.
English: 22 advanced CSCC patients with PD-L1 < 1%, ORR per independent central review was 40.9% (9/22).
Croatian: Kod 22 bolesnika s uznapredovalim planocelularnim karcinomom kože i ekspresijom PD-L1 < 1%, ORR je prema neovisnoj središnjoj ocjeni iznosio 40,9% (9/22).
English: • LIBTAYO is for single use only.
Croatian: • LIBTAYO je namijenjen samo za jednokratnu uporabu.
English: For patients with metastatic CSCC without externally visible target lesions, ORR was determined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Croatian: Za bolesnike s metastatskim planocelularnim karcinomom kože i bez vidljivih ciljnih lezija na površini kože ORR se utvrđivao na temelju verzije 1.1 Kriterija za ocjenu odgovora kod solidnih tumora (engl.
English: • Tell your doctor immediately if you become pregnant while you are being treated with
Croatian: • Odmah obavijestite svog liječnika ako zatrudnite tijekom liječenja lijekom LIBTAYO.
English: • Skin problems such as rash or itching, skin blistering and ulcers in mouth or other mucous membrane.
Croatian: • kožne tegobe kao što su osip ili svrbež, mjehuri na koži i vrijedovi u ustima ili na drugim sluznicama
English: Do not store any unused portion of the infusion solution for re-use.
Croatian: Preostala neupotrijebljena otopina za infuziju ne smije se čuvati za ponovnu uporabu.
English: Cemiplimab can cause severe or life-threatening infusion-related reactions (see section 4.8).
Croatian: Cemiplimab može uzrokovati teške ili po život opasne reakcije na infuziju (vidjeti dio 4.8).
English: Severity a
Croatian: Težina a
English: Your doctor will test your blood for certain side effects during your treatment.
Croatian: Tijekom liječenja liječnik će provoditi krvne pretrage zbog moguće pojave određenih nuspojava.
English: Of the 219 patients with mCSCC and laCSCC treated with cemiplimab, 25.1% (55/219) were less than 65 years, 34.2% (75/219) were 65 to less than 75 years, and 40.6% (89/219) were 75 years or older.
Croatian: Od 219 bolesnika s metastatskim ili lokalno uznapredovalim planocelularnim karcinomom kože koji su bili liječeni cemiplimabom, njih 25,1% (55/219) bilo je mlađe od 65 godina, 34,2% (75/219) ih je bilo u dobi od 65 do manje od 75 godina, dok je njih 40,6% (89/219) imalo 75 ili više godina.
English: Each carton contains 1 vial.
Croatian: Jedna kutija sadrži 1 bočicu.
English: Patients should be monitored for changes in thyroid function at the start of treatment and periodically during the treatment as indicated based on clinical evaluation (see section 4.8).
Croatian: Bolesnike treba nadzirati zbog mogućih promjena funkcije štitnjače, koju treba odrediti na početku liječenja i periodički tijekom liječenja kada je to indicirano na temelju kliničke ocjene (vidjeti dio 4.8).
English: (including but not limited to meningitis, paraneoplastic encephalomyelitis, arthritis, Guillain-Barre syndrome, encephalitis, chronic inflammatory demyelinating polyradiculoneuropathy, central nervous system inflammation, autoimmune myocarditis, and immune thrombocytopenic purpura, myalgia, Sjogren's syndrome, vasculitis, myasthenia gravis)b
Croatian: (uključujući između ostalog i sljedeće: meningitis, paraneoplastični encefalomijelitis, artritis, Guillain-Barréov sindrom, encefalitis, kroničnu upalnu demijelinizirajuću poliradikuloneuropatiju, upalu u središnjem živčanom sustavu, autoimuni miokarditis i imunu trombocitopeničnu purpuru, mialgiju, Sjögrenov sindrom, vaskulitis, miasteniju gravis)
English: Among 53 advanced CSCC patients with PD-L1 ≥ 1%, ORR was 54.7% (29/53).
Croatian: Kod 53 bolesnika s uznapredovalim planocelularnim karcinomom kože i ekspresijom PD-L1 ≥ 1%, ORR je iznosio 54,7% (29/53).
English: • inflammation of the heart muscle, which may present as shortness of breath, irregular heartbeat, feeling tired or chest pain
Croatian: • upala srčanog mišića, koja se može očitovati kao nedostatak zraka, nepravilni otkucaji srca, umor ili bol u prsnom košu
English: Excipients: L-histidine, L-histidine monohydrochloride monohydrate, L-proline, polysorbate 80, sucrose, and water for injections.
Croatian: Pomoćne tvari: L-histidin, L-histidinklorid hidrat, L-prolin, polisorbat 80, saharoza i voda za injekcije.
English: No studies have been performed to test the potential of cemiplimab for carcinogenicity or genotoxicity.
Croatian: Nisu provedena ispitivanja kancerogenog i genotoksičnog potencijala cemiplimaba.
English: For storage conditions after first opening or dilution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon prvog otvaranja ili razrjeđivanja lijeka vidjeti u dijelu 6.3. 6.5 Vrsta i sadržaj spremnika
English: Initiate symptomatic management
Croatian: Započeti simptomatsko liječenje
English: Rash is a composite term that includes rash maculo-papular, rash, dermatitis, rash generalised, dermatitis bullous, drug eruption, erythema, pemphigoid, psoriasis, rash erythematous, rash macular, rash pruritic and skin reaction.
Croatian: g Osip je skupni pojam koji obuhvaća makulo-papularni osip, osip, dermatitis, generalizirani osip, bulozni dermatitis, izbijanje kožnih promjena uzrokovano lijekom, eritem, pemfigoid, psorijazu, eritemski osip, makularni osip, pruritički osip i kožnu reakciju.
English: o The contact details of their LIBTAYO prescriber.
Croatian: o Kontaktne podatke liječnika koji je propisao LIBTAYO.
English: In the 193 patients in the efficacy analysis, the objective response rate by ICR (95% CI) was 40.8% (27.0%, 55.8%) in patients less than 65 years, 48.5% (36.0%, 61.1%) in patients 65 to less than 75 years, and 42.3% (31.2%, 54.0%) in patients 75 years or older.
Croatian: Među 193 bolesnika uključena u analizu podataka o djelotvornosti stopa objektivnog odgovora prema neovisnoj središnjoj ocjeni (95% CI) iznosila je 40,8% (27,0%; 55,8%) u bolesnika mlađih od 65 godina, 48,5% (36,0%; 61,1%) u bolesnika u dobi od 65 do manje od 75 godina te 42,3% (31,2%; 54,0%) u bolesnika u dobi od 75 ili više godina.
English: The efficacy and safety of cemiplimab in patients with metastatic (nodal or distant) CSCC (mCSCC) or locally advanced CSCC (laCSCC) who were not candidates for curative surgery or curative radiation were studied in clinical trial R2810-ONC-1540 (Study 1540).
Croatian: Djelotvornost i sigurnost cemiplimaba u bolesnika s metastatskim (metastaze u limfnim čvorovima ili udaljene metastaze) ili lokalno uznapredovalim planocelularnim karcinomom kože koji nisu bili kandidati za kurativno kirurško liječenje ili kurativnu radioterapiju ispitivale su se u kliničkom ispitivanju R2810-ONC-1540 (ispitivanje 1540).
English: Cemiplimab should be resumed when metabolic control is achieved on insulin replacement or anti-hyperglycaemics (see section 4.2).
Croatian: Liječenje cemiplimabom treba nastaviti nakon što se nadomještanjem inzulina ili antihiperglikemicima uspostavi metabolička kontrola (vidjeti dio 4.2).
English: The total clearance appears to decrease by approximately 35% over time, resulting in a steady state clearance (CLss) of 0.21 l/day; the decrease in CL is not considered clinically relevant.
Croatian: Ukupan se klirens tijekom vremena naizgled smanjuje za približno 35% te u stanju dinamičke ravnoteže (CLss) iznosi 0,21 l na dan.
English: Patients that had active infections or that were immunocompromised were not included in the main study.
Croatian: U glavno se ispitivanje nisu uključivali bolesnici koji su imali aktivnu infekciju ili koji su bili imunokopromitirani.
English: Look out for side effects
Croatian: Pripazite na nuspojave
English: LIBTAYO has not been studied in patients with moderate or severe hepatic impairment.
Croatian: LIBTAYO se nije ispitivao u bolesnika s umjerenim ili teškim oštećenjem jetrene funkcije.
English: This leaflet was last revised in June 2019.
Croatian: Ova uputa je zadnji puta revidirana u <{MM/GGGG}>
English: Other fatal and life-threatening immune-related adverse reactions have been observed in patients receiving cemiplimab including paraneoplastic encephalomyelitis and meningitis (see section 4.8 for other immune-related adverse reactions).
Croatian: U bolesnika koji su primali cemiplimab opažene su i druge smrtonosne odnosno po život opasne imunološki uzrokovane nuspojave, uključujući paraneoplastični encefalomijelitis i meningitis (vidjeti dio 4.8 za druge imunološki uzrokovane nuspojave).
English: At dosing regimens of 1 mg/kg to 10 mg/kg every 2 weeks and 350 mg every 3 weeks, kinetics of cemiplimab were observed to be linear and dose proportional, suggesting saturation of the target-mediated pathway over the dosing interval.
Croatian: Kada se primjenjivao prema režimima doziranja od 1 mg/kg do 10 mg/kg svaka 2 tjedna te 350 mg svaka 3 tjedna, cemiplimab je pokazao linearnu kinetiku proporcionalnu dozi, što ukazuje na zasićenje puta posredovanog ciljnim mjestom tijekom intervala doziranja.
English: In order to confirm the efficacy and safety of cemiplimab for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation, the MAH should submit the final study report for Groups 1-3 in the phase 2 pivotal study 1540.
Croatian: Radi potvrde djelotvornosti i sigurnosti cemiplimaba u liječenju bolesnika s metastatskim ili lokalno uznapredovalim planocelularnim karcinomom kože koji nisu kandidati za kurativno kirurško liječenje ili kurativnu radioterapiju, nositelj odobrenja mora dostaviti završno izvješće za skupine br. 1 - 3 iz pivotalnog ispitivanja faze 2 pod nazivom 1540.
English: At the dosing regimens of 1 mg/kg to 10 mg/kg every two weeks, kinetics of cemiplimab were observed to be linear and dose proportional, suggesting saturation of the target-mediated pathway.
Croatian: Kada se primjenjivao prema režimima doziranja od 1 mg/kg do 10 mg/kg svaka 2 tjedna, cemiplimab je pokazao linearnu kinetiku proporcionalnu dozi, što ukazuje na zasićenje puta posredovanog ciljnim mjestom.
English: Partial response (PR) Stable disease (SD) Progressive disease (PD)
Croatian: Djelomičan odgovor Stabilna bolest
English: Progression free survival (PFS)
Croatian: Preživljenje bez progresije bolesti (PFS)a,
English: • inflammation of the pituitary gland situated at the base of the brain; decreased secretion of hormones produced by the adrenal glands; inflammation of the thyroid
Croatian: • upala hipofize (žlijezde smještene na bazi mozga), smanjeno lučenje hormona koje proizvode nadbubrežne žlijezde, upala štitnjače
English: Grade 3 or 4
Croatian: 3. ili 4. stupanj
English: Immune-related pneumonitis
Croatian: Imunološki uzrokovan pneumonitis
English: Eighteen patients (3.0%) received high-dose corticosteroids for a median of 8.5 days (range: 1 day to 5.9 months).
Croatian: Osamnaest je bolesnika (3,0%) primalo visoke doze kortikosteroida tijekom medijana od 8,5 dana (raspon: 1 dan do 5,9 mjeseci).
English: Animal reproduction studies have not been conducted with cemiplimab.
Croatian: Nisu provedena ispitivanja učinaka cemiplimaba na reprodukciju u životinja.
English: No pharmacokinetic drug-drug interaction studies have been conducted with cemiplimab.
Croatian: Nisu provedena farmakokinetička ispitivanja interakcija između cemiplimaba i drugih lijekova.
English: • Lung problems (pneumonitis) such as new or worsening cough, being short of breath and chest pain.
Croatian: • plućne tegobe (pneumonitis) kao što su pojava ili pogoršanje kašlja, nedostatak zraka i bol u prsnom košu
English: LIBTAYO 350 mg sterile concentrate cemiplimab
Croatian: LIBTAYO 350 mg sterilni koncentrat cemiplimab i.v.
English: Patients with DOR ≥ 6 months, % 93.1%
Croatian: Bolesnici u kojih je odgovor trajao ≥ 6 mjeseci, %
English: Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with cemiplimab treatment (see section 4.4).
Croatian: Kod liječenja cemiplimabom prijavljene su teške kožne nuspojave, uključujući Stevens-Johnsonov sindrom (SJS) i toksičnu epidermalnu nekrolizu (TEN) (vidjeti dio 4.4).
English: • you have liver problems
Croatian: • ako imate jetrenih tegoba
English: Specific metabolism studies were not conducted because cemiplimab is a protein.
Croatian: Budući da je cemiplimab protein, nisu provedena specifična ispitivanja metabolizma.
English: mCSCC cemiplimab: 350 mg Q3W (Group 3) (N = 56)
Croatian: Metastatski planocelularni karcinom kože Cemiplimab: 350 mg svaka 3 tjedna (3. skupina) (N = 56)
English: Musculoskeletal and connective tissue disorders: Myalgia, Arthritis d, Sjogren's syndrome
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva: mialgija, artritisd, Sjögrenov sindrom Poremećaji oka: keratitis
English: Resolution of nephritis had occurred in all patients at the time of data cut-off.
Croatian: Do trenutka prekida prikupljanja podataka nefritis se povukao u svih bolesnika.
English: How to store LIBTAYO
Croatian: Kako čuvati LIBTAYO
English: Among the 42 patients with hypothyroidism, the median time to onset was 4.2 months (range: 15 days to 18.9 months).
Croatian: Među 42 bolesnika s hipotireozom medijan vremena do nastupa iznosio je 4,2 mjeseca (raspon: 15 dana do 18,9 mjeseci).
English: No dose adjustment is recommended for patients with mild hepatic impairment.
Croatian: Ne preporučuje se prilagođavati dozu u bolesnika s blagim oštećenjem jetrene funkcije.
English: Preparation
Croatian: Priprema
English: There are insufficient data in patients with moderate or severe hepatic impairment for dosing recommendations (see section 5.2).
Croatian: Nema dovoljno podataka o primjeni u bolesnika s umjerenim ili teškim oštećenjem jetrene funkcije da bi se mogle dati preporuke za doziranje (vidjeti dio 5.2).
English: Among 21 mCSCC patients, ORR was 60% (3/5) in patients with PD-L1 < 1% and 56.3% (9/16) among patients with PD-L1 ≥ 1%.
Croatian: Kod 21 bolesnika s metastatskim planocelularnim karcinomom kože, ORR je iznosio 60% (3/5) u bolesnika s ekspresijom PD-L1 < 1% te 56,3% (9/16) u bolesnika ekspresijom PD-L1 ≥ 1%.
English: Grade 2 or 3
Croatian: 2. ili 3. stupanj
English: Median follow-up was 16.5 months for the mCSCC 3 mg/kg every 2 weeks group, 9.3 months for the laCSCC 3 mg/kg every 2 weeks group and 8.1 months for the mCSCC 350 mg every 3 weeks group.
Croatian: Medijan praćenja bio je 16,5 mjeseci u skupini bolesnika s metastatskim planocelularnim karcinomom kože liječenih dozom od 3 mg/kg svaka 2 tjedna, 9,3 mjeseca u skupini bolesnika s lokalno uznapredovalim planocelularnim karcinomom kože liječenih dozom od 3 mg/kg svaka 2 tjedna te 8,1 mjesec u skupini bolesnika s metastatskim planocelularnim karcinomom kože liječenih dozom od 350 mg svaka 3 tjedna.
English: LIBTAYO is a clear to slightly opalescent, colourless to pale yellow solution that may contain trace amounts of translucent to white particles
Croatian: LIBTAYO je bistra do blago opalescentna, bezbojna do blijedo žuta otopina koja može sadržavati prozirne do bijele čestice u tragovima.
English: In order to confirm the efficacy and safety of cemiplimab for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation, the MAH should provide interim data of a single-arm trial in the same population [study 1540 group 6].
Croatian: Radi potvrde djelotvornosti i sigurnosti cemiplimaba u liječenju bolesnika s metastatskim ili lokalno uznapredovalim planocelularnim karcinomom kože koji nisu kandidati za kurativno kirurško liječenje ili kurativnu radioterapiju, nositelj odobrenja mora dostaviti interim podatke iz ispitivanja s jednom skupinom provedenog u takvoj populaciji [ispitivanje 1540, skupina br. 6].